Drugs Details

Drugs Info of Xyntha
Drugs Details
  • Drugs Type  : FDA
  • Date : 6th Jan 2015 11:39 pm
  • Brand Name : Xyntha
  • Generic Name : Antihemophilic Factor (Recombinant), Plasma/Albumin-Free] For Intravenous Use, Freeze-Dried Powder
Descriptions

Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, the active ingredient in XYNTHA, is a recombinant coagulation factor VIII produced by recombinant DNA technology for use in therapy of factor VIII deficiency. The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA (antihemophilic factor) is a purified glycoprotein with an approximate molecular mass of 170 kDa consisting of 1438 amino acids, which does not contain the B-domain.13 The amino acid sequence of Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA (antihemophilic factor) is comparable to the 90 + 80 kDa form of human factor VIII.

The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA (antihemophilic factor) is secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The cell line is grown in a chemically defined cell culture medium that contains recombinant insulin, but does not contain any materials derived from human or animal sources. The Antihemophilic Factor (Recombinant), Plasma/Albumin-Free in XYNTHA (antihemophilic factor) is purified by a process that uses a series of chromatography steps, one of which is based on affinity chromatography using a patented synthetic peptide affinity ligand.14 The process also includes a solvent-detergent viral inactivation step and a virus-retaining nanofiltration step.

The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia. The Wyeth manufacturing reference standard for potency has been calibrated against the World Health Organization (WHO) International Standard for factor VIII activity using the one-stage clotting assay. The specific activity of XYNTHA (antihemophilic factor) is 5500 to 9900 IU per milligram of protein.

XYNTHA (antihemophilic factor) is formulated as a sterile, nonpyrogenic, preservative-free, freeze-dried powder preparation for intravenous (IV) injection. Each single-use vial contains nominally 250, 500, 1000 or 2000 IU of XYNTHA (antihemophilic factor) . Upon reconstitution, the product is a clear to slightly opalescent, colorless solution that contains sodium chloride, sucrose, L-histidine, calcium chloride and polysorbate 80.

REFERENCES

13. Sandberg H, Almstedt A, Brandt J, Castro VM, Gray E, Holmquist L et al. Structural and Functional Characterization of B-Domain Deleted Recombinant Factor VIII. Sem Hematol. 2001;38 (Suppl. 4):4-12.

14. Kelley BD, Tannatt, M, Magnusson, R, Hagelberg S. Development and Validation of an Affinity Chromotography Step Using a Peptide Ligand for cGMP Production of Factor VIII. Biotechnol Bioeng. 2004;87(3):400-412.


This monograph has been modified to include the generic and brand name in many instances.

Indications

Control of Bleeding Episodes in Hemophilia A

XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).

XYNTHA (antihemophilic factor) does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand's disease.

Surgical Prophylaxis in Patients with Hemophilia A

XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for surgical prophylaxis in patients with hemophilia A.

Dosage Administration

Treatment with XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free should be initiated under the supervision of a physician experienced in the treatment of hemophilia A.

Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Doses administered should be titrated to the patient's clinical response. In the presence of an inhibitor, higher doses may be required.1

One International Unit (IU) of factor VIII activity corresponds approximately to the quantity of factor VIII in one milliliter of normal human plasma. The calculation of the required dosage of factor VIII is based upon the empirical finding that, on average, 1 IU of factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2 IU/dL.2 The required dosage is determined using the following formula:

Required units = body weight (kg) x desired factor VIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)

The labeled potency of XYNTHA (antihemophilic factor) is based on the European Pharmacopoeia chromogenic substrate assay, in which the Wyeth manufacturing standard has been calibrated using a one- stage clotting assay. This method of potency assignment is intended to harmonize XYNTHA (antihemophilic factor) with clinical monitoring using a one-stage clotting assay. [see CLINICAL PHARMACOLOGY]

Control of Bleeding Episodes

In the case of the following bleeding events, consideration should be given to maintaining the factor VIII activity at or above the plasma levels (in % of normal or in IU/dL) outlined below for the indicated period.

Type of Bleeding Episode Factor VIII
Level Required
(IU/dL or % of normal)
Frequency of Doses /
Duration of Therapy
Minor
Early hemarthrosis, minor muscle or oral bleeds.
20-40
Repeat every 12-24 hours as necessary until resolved. At least 1 day, depending upon the severity of the bleeding episode.
Moderate
Bleeding into muscles. Mild head trauma. Bleeding into the oral cavity.
30-60
Repeat infusion every 12-24 hours for 3-4 days or until adequate local hemostasis is achieved.
Major
Gastrointestinal bleeding. Intracranial, intra-abdominal or intrathoracic bleeding. Fractures.
60-100
Repeat infusion every 8-24 hours until bleeding is resolved.

Surgical Prophylaxis in Patients with Hemophilia A

In the case of the following bleeding events, consideration should be given to maintaining the factor VIII activity at or above the plasma levels (in % of normal or in IU/dL) outlined below for the indicated period. Monitoring of replacement therapy by means of plasma factor VIII activity is recommended, particularly for surgical intervention.

The following chart can be used to guide dosing in surgery:

Type of Bleeding Episode Factor VIII
Level Required
(IU/dL or % of normal)
Frequency of Doses /
Duration of Therapy
Minor
Minor operations, including tooth extraction.
30-60
Repeat infusion every 12-24 hours for 3-4 days or until adequate local hemostasis is achieved. For tooth extraction, a single infusion plus oral antifibrinolytic therapy within 1 hour may be sufficient.
Major
Major operations.
60-100
Repeat infusion every 8-24 hours until threat is resolved, or in the case of surgery, until adequate local hemostasis and wound healing are achieved.

Instructions for Use

XYNTHA (antihemophilic factor) is administered by intravenous (IV) infusion after reconstitution of the freeze-dried powder with the supplied pre-filled diluent (0.9% Sodium Chloride solution) syringe.

Patients should follow the specific reconstitution and administration procedures provided by their physicians. For instructions, patients should follow the recommendations in the FDA-Approved Patient Labeling . The procedures below are provided as general guidelines for the reconstitution and administration of XYNTHA (antihemophilic factor) .

Preparation and Reconstitution

Preparation
  1. Always wash your hands before performing the following procedures.
  2. Aseptic technique (meaning clean and germ-free) should be used during the reconstitution procedure.
  3. All components used in the reconstitution and administration of this product should be used as soon as possible after opening their sterile containers to minimize unnecessary exposure to the atmosphere.

Note: If you use more than one vial of XYNTHA (antihemophilic factor) per infusion, each vial should be reconstituted according to the following instructions. The diluent syringe should be removed, leaving the vial adapter in place, and a separate large luer lock syringe may be used to draw back the reconstituted contents of each vial. Do not detach the diluent syringes or the large luer lock syringe until you are ready to attach the large luer lock syringe to the next vial adapter.

Reconstitution
    1. Allow the vials of freeze-dried XYNTHA (antihemophilic factor) and the pre-filled diluent syringe to reach room temperature.
    2. Remove the plastic flip-top cap from the XYNTHA (antihemophilic factor) vial to expose the central portions of the rubber stopper.

 

Reconstitution - illustration 1
    1. Wipe the top of the vial with the alcohol swab provided, or use another antiseptic solution, and allow to dry. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.
    2. Peel back the cover from the clear plastic vial adapter package. Do not remove the adapter from the package.
    3. Place the vial on a flat surface. While holding the adapter package, place the vial adapter over the vial and press down firmly on the package until the adapter spike penetrates the vial stopper.

 

Reconstitution - illustration 2
    1. Grasp the plunger rod as shown in the diagram. Avoid contact with the shaft of the plunger rod. Attach the threaded end of the plunger rod to the diluent syringe plunger by pushing and turning firmly.

 

Reconstitution - illustration 3
    1. Break off the tamper-resistant plastic tip cap from the diluent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip. The diluent syringe may need to be recapped (if not administering reconstituted XYNTHA (antihemophilic factor) immediately), so place the cap on its top on a clean surface in a spot where it would be least likely to become environmentally contaminated.

 

Reconstitution - illustration 4
    1. Lift the package away from the adapter and discard the package.

 

Reconstitution - illustration 5
    1. Place the vial on a flat surface. Connect the diluent syringe to the vial adapter by inserting the tip into the adapter opening while firmly pushing and turning the syringe clockwise until secured.

 

Reconstitution - illustration 6
    1. Slowly depress the plunger rod to inject all the diluent into the XYNTHA (antihemophilic factor) vial.

 

Reconstitution - illustration 7
    1. Without removing the syringe, gently swirl the contents of the vial until the powder is dissolved.
      Note: The final solution should be inspected visually for particulate matter before administration. The solution should be clear to slightly opalescent and colorless. If it is not, the solution should be discarded and a new kit should be used.
    2. Invert the vial and slowly draw the solution into the syringe.

 

Reconstitution - illustration 8
  1. Detach the syringe from the vial adapter by gently pulling and turning the syringe counter-clockwise. Discard the vial with the adapter attached.

Note: If the solution is not to be used immediately, the syringe cap should be carefully replaced. Do not touch the syringe tip or the inside of the cap.

The reconstituted solution may be stored at room temperature prior to administration, but should be administered within 3 hours.

XYNTHA (antihemophilic factor) , when reconstituted, contains polysorbate 80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC). This should be considered during the preparation and administration of XYNTHA (antihemophilic factor) , including storage time elapsed in a PVC container following reconstitution. It is important that the recommendations in Dosage and Administration (2) be followed closely.

Administration

XYNTHA (antihemophilic factor) is administered by intravenous (IV) infusion after reconstitution with the supplied pre-filled diluent (0.9% Sodium Chloride solution, 4 mL) syringe. Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.

XYNTHA (antihemophilic factor) should be administered using the tubing provided in this kit and the pre-filled diluent syringe provided, or a single sterile disposable plastic syringe. In addition, the solution should be withdrawn from the vial using the vial adapter.

    1. Attach the syringe to the luer end of the infusion set tubing provided.
    2. Apply a tourniquet and prepare the injections site by wiping the skin well with an alcohol swab provided in the kit.

 

Administration - illustration 1
    1. Perform venipuncture. Insert the needle on the infusion set tubing into the vein, and remove the tourniquet. The reconstituted XYNTHA (antihemophilic factor) product should be injected intravenously over several minutes. The rate of administration should be determined by the patient's comfort level.

 

Administration - illustration 1

Reconstituted XYNTHA (antihemophilic factor) should not be administered in the same tubing or container with other medicinal products.3

Following completion of XYNTHA (antihemophilic factor) treatment, remove the infusion set and discard. Dispose of all unused solution, the empty vial(s), and the used needles and syringes in an appropriate container for throwing away waste that might hurt others if not handled properly.

How Supplied

Dosage Forms And Strengths

XYNTHA (antihemophilic factor) is supplied as a white to off-white powder in the following dosages:

  • 250 IU
  • 500 IU
  • 1000 IU
  • 2000 IU

XYNTHA™ Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is supplied in kits that include single-use (Freeze-Dried) vials that contain nominally 250, 500, 1000, or 2000 IU per vial:

250 IU Kit: NDC 58394-012-01
500 IU Kit: NDC 58394-013-01
1000 IU Kit: NDC 58394-014-01
2000 IU Kit: NDC 58394-015-01

Actual factor VIII activity in IU is stated on the label of each XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free vial.

In addition, each XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free kit contains: one pre-filled diluent syringe containing 4 mL 0.9% Sodium Chloride with plunger rod for assembly, one vial adapter, one sterile infusion set, two alcohol swabs, one bandage, one gauze, and one package insert.

Storage and Handling

Product as packaged for sale: XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free should be stored under refrigeration at a temperature of 2° to 8°C (36° to 46°F). XYNTHA (antihemophilic factor) may also be stored at room temperature not to exceed 25°C (77°F) for up to 3 months, until the expiration date. The patient should write in the space provided on the outer carton the date the product was placed at room temperature. At the end of the 3-month period, the product should not be put back into the refrigerator, but should be used immediately or discarded. The diluent syringe may be stored at 2° to 25°C (36° to 77°F). Freezing should be avoided to prevent damage to the pre-filled diluent syringe. During storage, avoid prolonged exposure of XYNTHA (antihemophilic factor) vial to light. Do not use XYNTHA (antihemophilic factor) after the expiration date on the label.

Product after reconstitution: The reconstituted solution may be stored at room temperature prior to administration. The product does not contain a preservative and should be used within 3 hours.

REFERENCES

1. Nilsson IM, Berntorp EE and Freiburghaus C. Treatment of patients with factor VIII and IX inhibitors. Thromb Haemost. 1993;70(1):56-59.

2.   Hoyer LW. Hemophilia A. N Engl J Med. 1994;330:38-47.

3.   Juhlin F. Stability and Compatibility of Reconstituted Recombinant Factor VIII SQ, 250 IU/ml, in a System for Continuous Infusion. Pharmacia Document 9610224, 1996.

Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101. FDA Rev date: n/a


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Helixate® FS Antihemophilic Factor (recombinant) is a sterile, stable, purified, nonpyrogenic, dried concentrate that has been manufactured using recombinant DNA technology. Helixate FS (antihemophilic factor recombinant) is intended for use in the treatment of classical hemophilia (hemophilia A), and is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII (FVIII) gene has been introduced.1 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Helixate FS is a highly purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as FVIII derived from human plasma. Compared to its predecessor product HELIXATE® Antihemophilic Factor (Recombinant), Helixate FS (antihemophilic factor recombinant) incorporates a revised purification and formulation process that eliminates the addition of Albumin (Human).

The purification process includes an effective solvent/detergent virus inactivation step in addition to the use of the classical purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant FVIII and remove contaminating substances.

Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-27 Several of the individual production and raw material preparation steps in the Helixate FS (antihemophilic factor recombinant) manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps included the Fraction II+III separation step for Human Plasma Protein Solution (6.0 log10) and an anion exchange chromatography step (3.6 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.

Helixate FS (antihemophilic factor recombinant) is formulated with sucrose (0.9–1.3%), glycine (21–25 mg/mL), and histidine (18–23 mM) as stabilizers in the final container in place of Albumin (Human) as used in HELIXATE, and is then lyophilized. The final product also contains calcium chloride (2–3 mM), sodium (27–36 mEq/L), chloride (32–40 mEq/L), polysorbate 80 (64-96 µg/mL), and trace amounts of imidazole, tri-n-butyl phosphate, and copper. The product contains no preservatives. The amount of sucrose in each vial is 28 mg.(250, 500, and 1000 IU sizes) and 56mg. Intravenous administration of sucrose contained in Helixate FS (antihemophilic factor recombinant) will not affect blood glucose levels. Each vial of Helixate FS contains the labeled amount of recombinant FVIII in international units (IU). One IU, as defined by the World Health Organization standard for blood coagulation FVIII, human, is approximately equal to the level of FVIII activity found in 1 mL of fresh pooled human plasma. Helixate FS (antihemophilic factor recombinant) must be administered by the intravenous route.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

REFERENCES

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

1. Lawn RM, Vehar GA: The molecular genetics of hemophilia. Sci Am 254(3):48–54, 1986.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

15. Kimberlin RH, Walker CA: Characteristics of a short incubation model of scrapie in the golden hamster. J Gen Virol 34(2):295-304, 1977.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

16. Kimberlin RH, Walker CA: Evidence that the transmission of one source of scrapie agent to hamsters involves separation of agent strains from a mixture. J Gen Virol 39(3):487-96, 1978.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

17. Kimberlin RH, Walker CA: Pathogenesis of scrapie (strain 263K) in hamsters infected intracerebrally, intraperitoneally or intraocularly. J Gen Virol 67(2):255-63, 1986.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

18. Prusiner SB, et al: Further purification and characterization of scrapie prions. Biochemistry 21(26):6942-50, 1982.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

19. Kascsak RJ, et al: Mouse polyclonal and monoclonal antibody to scrapie-associated fibril proteins. J Virol 61(12):3688-93, 1987.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

20. Rubenstein R, et al: Scrapie-infected spleens: analysis of infectivity, scrapie-associated fibrils, and protease- resistant proteins. J Infect Dis 164(1):29-35, 1991.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

21. Taylor DM, Fernie K: Exposure to autoclaving or sodium hydroxide extends the dose-response curve of the 263K strain of scrapie agent in hamsters. J Gen Virol 77(4):811-13, 1996.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

22. Stenland CJ, et al: Partitioning of human and sheep forms of the pathogenic prion protein during the purification of therapeutic proteins from human plasma. Transfusion 42(11):1497-500, 2002.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

23. Lee DC, Miller JL, Petteway SR: Pathogen safety of manufacturing processes for biological products: special emphasis on KOGENATE® Bayer. Haemophilia 8(Suppl. 2):6-9, 2002.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

24. Lee DC, Stenland CJ, Hartwell RC, et al: Monitoring plasma processing steps with a sensitive Western blot assay for the detection of the prion protein. J Virol Methods 84(1):77-89, 2000.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

25. Lee DC, Stenland CJ, Miller JL, et al: A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins. Transfusion 41(4):449-55, 2001.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

26. Cai K, Miller JL, Stenland CJ, et al: Solvent-dependent precipitation of prion protein. Biochim Biophys Acta 1597(1):28-35, 2002.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »

27. Trejo SR, Hotta JA, Lebing W, et al: Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process. Vox Sang 84(3):176-87, 2003.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or...

Read All Potential Side Effects and See Pictures of Helixate FS »

What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns...

Read All Potential Precautions of Helixate FS »


This monograph has been modified to include the generic and brand name in many instances.

Interactions

Helixate FS (antihemophilic factor (recombinant)) is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor FVIII. Helixate FS (antihemophilic factor (recombinant)) provides a means of temporarily replacing the missing clotting factor in order to correct or prevent bleeding episodes, or in order to perform emergency or elective surgery in hemophiliacs.

In clinical studies with the predecessor product HELIXATE, some patients who developed inhibitors on study continued to manifest a clinical response when inhibitor titers were less than 10 Bethesda Units (BU) per mL. When an inhibitor is present, the dosage requirement for FVIII is variable. The dosage can be determined only by clinical response, and by monitoring circulating FVIII levels after treatment (see DOSAGE AND ADMINISTRATION). Because Helixate FS (antihemophilic factor (recombinant)) has similar biological activity to HELIXATE it can be used in the same manner.

Helixate FS (antihemophilic factor (recombinant)) does not contain von Willebrand's factor and therefore is not indicated for the treatment of von Willebrand's disease.

Warnings

None.

Precautions

General

Helixate® FS Antihemophilic Factor (Recombinant) is intended for the treatment of bleeding disorders arising from a deficiency in FVIII. This deficiency should be proven prior to administering Helixate FS (antihemophilic factor (recombinant)) .

The development of circulating neutralizing antibodies to FVIII may occur during the treatment of patients with hemophilia A. Inhibitor formation is especially common in young children with severe hemophilia during their first years of treatment, or in patients of any age who have received little previous treatment with FVIII. Nonetheless, inhibitor formation may occur at any time in the treatment of a patient with hemophilia A. Patients treated with any AHF preparation, including Helixate FS (antihemophilic factor (recombinant)) , should be carefully monitored for the development of antibodies to FVIII by appropriate clinical observation and laboratory tests, according to the recommendation of the patient's hemophilia treatment center.

Among patients treated with antihemophilic factor concentrates, cases of hypotension, urticaria, and chest tightness in association with hypersensitivity reactions have been reported in the literature.11-13 Very rare cases of allergic and anaphylactic reactions have been reported with the predecessor product HELIXATE® Antihemophilic Factor (Recombinant), particularly in very young patients or patients who have previously reacted to other FVIII concentrates (see ADVERSE REACTIONS - Post-marketing experience). Serious anaphylactic reactions require immediate emergency treatment with resuscitative measures such as the administration of epinephrine and oxygen.

Formation of Antibodies to Mouse and Hamster Protein

Assays to detect seroconversion to mouse and hamster protein were conducted on all patients in clinical studies. No patient has developed specific antibodies to these proteins after commencing study, and no animal protein associated serious allergic reactions have been observed with rFVIII-FS infusions. Although no such reactions were observed, patients should be made aware of the possibility of a hypersensitivity reaction to mouse and/or hamster protein, and alerted to the early signs of such a reaction (e.g., hives, localized or generalized urticaria, wheezing, and hypotension). Patients should be advised to discontinue use of the product and contact their physician if such symptoms occur.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

In vitro evaluation of the mutagenic potential of rFVIII failed to demonstrate reverse mutation or chromosomal aberrations at doses substantially greater than the maximum expected clinical dose. In vivo evaluation of rFVIII in animals using doses ranging between 10 and 40 times the expected clinical maximum also indicated that rFVIII does not possess a mutagenic potential. Long-term investigations of carcinogenic potential in animals have not been performed.

Pediatric Use

Helixate® FS Antihemophilic Factor (Recombinant) is appropriate for use in pediatric patients of all ages, including neonates, infants, children, and adolescents. Safety and efficacy studies have been performed in previously untreated and minimally treated pediatric patients (n=62). Helixate FS (antihemophilic factor (recombinant)) is similar to HELIXATE in its biological activity and may be used in pediatric patients in the same manner as HELIXATE.

Geriatric Use

Clinical studies with Helixate FS (antihemophilic factor (recombinant)) did not include sufficient numbers of patients aged 65 and over to be able to determine whether they respond differently from younger patients. However, clinical experience with HELIXATE and other AHF products has not identified differences between the elderly and younger patients. As with any patient receiving Helixate FS (antihemophilic factor (recombinant)) , dose selection for an elderly patient should be individualized.

Pregnancy Category C

Animal reproduction studies have not been conducted with Helixate FS (antihemophilic factor (recombinant)) . It is also not known whether Helixate FS (antihemophilic factor (recombinant)) can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Helixate FS (antihemophilic factor (recombinant)) should be used during pregnancy and lactation only if clearly indicated.

REFERENCES

11. Brettler DB, Forsberg AD, Levine PH, et al: The use of porcine factor VIII concentrate (Hyate:C) in the treatment of patients with inhibitor antibodies to factor VIII. A multicenter US experience. Arch Intern Med 149(6): 1381-5, 1989.

12. Eyster ME, Bowman HS, Haverstick JN: Adverse reactions to factor VIII infusions. Ann Intern Med 87(2):248, 1977.

13. Brettler DB, Levine PH: Factor concentrates for treatment of hemophilia: which one to choose? Blood 73(8):2067-73, 1989.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

Known intolerance or allergic reactions to constituents of the preparation.

Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Helixate FS (antihemophilic factor (recombinant)) .


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Pharmacokinetic studies were conducted in 20 patients with severe hemophilia A in North America. In this comparative pharmacokinetic study, Helixate FS (antihemophilic factor (recombinant)) was shown to be similar to its predecessor product HELIXATE. Mean FVIII recovery measured 10 minutes following infusion was 2.1 ± 0.3 %/IU/kg for Helixate FS (antihemophilic factor (recombinant)) and 2.4 ± 0.7 %/IU/kg for HELIXATE. The two recoveries were not statistically different (confidence interval 0.815–1.01). The mean biological half-life of recombinant FVIII formulated with sucrose (rFVIII-FS) is similar to HELIXATE with a mean of approximately 13 hours, which has previously been shown to be similar to plasma-derived Antihemophilic Factor (AHF). The activated partial thromboplastin time shortened appropriately with both rFVIII and rFVIII-FS. The recovery and half-life data for rFVIII-FS were unchanged after 24 weeks of exclusive treatment indicating continued efficacy and no evidence of FVIII inhibition. The mean FVIII recovery measured 10 minutes following a dose of rFVIII-FS in 37 patients (after 24 weeks of treatment with rFVIII-FS) was 2.1%/IU/kg, which was unchanged from FVIII recovery determined at baseline and at weeks 4 and 12.

Seventy-one patients with severe hemophilia A, ages 12–59, who had been previously treated with other recombinant and with plasma-derived AHF products, were enrolled in 6-month studies of home therapy with rFVIII-FS in Europe and North America. A total of 3995 infusions have been administered under this portion of the study, or 7.4 million units of rFVIII-FS. Treatment of 659 bleeding episodes during the study period required 951 infusions of rFVIII-FS. The majority of bleeding episodes (89.5%) were treated successfully with one or two infusions, using a mean dosage of approximately 28 IU/kg per treatment infusion. Regularly scheduled treatment accounted for 76% of infusions administered on study. Nine patients have received rFVIII-FS on 11 occasions for surgical procedures. The procedures included removal of a brain tumor, two total knee replacements, two joint synovectomies (one with Achilles tendon lengthening), two circumcisions, a hernia repair, and three teeth extractions. Hemostasis was satisfactory in all cases.

In clinical studies, Helixate FS (antihemophilic factor (recombinant)) has been used in the treatment of bleeding episodes in previously untreated patients (PUPs) and minimally treated (MTP) pediatric patients. In ongoing studies, 61 PUPs/MTPs have been treated with Helixate FS (antihemophilic factor (recombinant)) . Bleeding episodes were treated effectively with one or two infusions of rFVIII-FS. Ten patients have developed inhibitors. In these trials, approximately half of the patients have achieved 20 or more exposure days, and the incidence of inhibitor formation (15%) is consistent with that observed in other pediatric studies using plasma-derived and recombinant factor VIII products.2-5

REFERENCES

2. Scharrer I, Bray GL, Neutzling O: Incidence of inhibitors in haemophilia A patients — a review of recent studies of recombinant and plasma-derived factor VIII concentrates. Haemophilia 5(3):145-154, 1999.

3. Lusher JM, Arkin S, Abildgaard CF, et al: Recombinant factor VIII for the treatment of previously untreated patients with hemophilia A: safety, efficacy, and development of inhibitors. N Engl J Med 328(7):453-459, 1993.

4. Schwarzinger I, Pabinger I, Korninger C, et al: Incidence of inhibitors in patients with severe and moderate hemophilia A treated with factor VIII concentrates. Am J Hematol 24(3):241–5, 1987.

5. Ehrenforth S, Kreuz W, Scharrer I, et al: Incidence of development of factor VIII and factor IX inhibitors in hemophiliacs. Lancet 339(8793):594–8, 1992.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

ANTIHEMOPHILIC FACTOR (FACTOR VIII), RECOMBINANT - INJECTION

 

(AN-tye-HEE-moe-FIL-ik FAK-tor, ree-KOM-bi-nant)

 

COMMON BRAND NAME(S): Advate, Kogenate, Recombinate

 

USES: This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low factor VIII levels are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIII, also called antihemophilic factor. This product is used to temporarily replace the missing factor VIII, a protein (clotting factor) that is normally in the blood, so that the blood can clot and the bleeding can stop.

This medication should not be used to treat von Willebrand disease.

 

HOW TO USE: This medication is given by injection into a vein as directed by your doctor. The medication may need to be given more slowly over a longer time depending on your dose and how you respond to it.

After first receiving this medication in a hemophilia treatment center or hospital, some patients may be able to give this medication to themselves at home. If your doctor directs you to give this medication at home, read the Patient Information Leaflet available from your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions in the product package. Learn how to store and discard needles and medical supplies safely. If you have any questions, ask your health care professional.

If the medication and the solution used to mix it were refrigerated, bring both to room temperature before combining. After adding the solution to the powder, gently swirl the mixture to completely dissolve the powder. Do not shake. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid. Use immediately according to the product instructions.

The dosage is based on your medical condition, weight, blood test results, and response to treatment. Follow your doctor's instructions closely.

Tell your doctor if your condition does not improve or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Flushing of the face, headache, nausea, and fast heartbeat may sometimes occur and can be lessened by giving this medication more slowly. Burning/redness/irritation at the injection site, fever, and chills may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/tightness.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Helixate FS (antihemophilic factor (recombinant)) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the packaging of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Laboratory blood tests (e.g., factor VIII levels) should be performed frequently to determine your dosage and to check how well this medication is working. Consult your doctor for more details.

 

MISSED DOSE: It is important to follow the dosing schedule as directed by your doctor. If you miss a dose, contact your doctor to establish a new dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store the medication according to the manufacturer's instructions. Ask your pharmacist if you have any questions. Do not freeze this product or store it in the bathroom. Protect the product from light. After mixing, use the product within the time frame stated in the manufacturer's instructions and throw away any unused portion. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised July 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Advate rAHF-PFM, Helixate FS, Kogenate FS, Kogenate FS with Bioset, Recombinate, Refacto, Xyntha, Xyntha Solofuse

Generic Name: antihemophilic factor (recombinant) (Pronunciation: ant ee hee moe FIL ik FAK tor (ree KOM bin ant))

  • What is recombinant antihemophilic factor (Helixate FS)?
  • What are the possible side effects of recombinant antihemophilic factor?
  • What is the most important information I should know about recombinant antihemophilic factor?
  • What should I discuss with my health care provider before using recombinant antihemophilic factor?
  • How should I use recombinant antihemophilic factor?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using recombinant antihemophilic factor?
  • What other drugs will affect recombinant antihemophilic factor?
  • Where can I get more information?

What is recombinant antihemophilic factor (Helixate FS)?

Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is the cause of hemophilia A.

This medication works by temporarily raising levels of factor VIII in the blood to aid in clotting.

Recombinant antihemophilic factor is used to treat or prevent bleeding episodes in adults and children with hemophilia A. It is also used to control bleeding related to surgery or dentistry in a person with hemophilia, and to prevent joint damage in people age 16 or older with severe hemophilia A and no prior joint damage.

Recombinant antihemophilic factor is not for use in people with von Willebrand disease.

Recombinant antihemophilic factor may also be used for purposes not listed in this medication guide.

What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Less serious side effects may include:

  • sore throat, cough, runny nose;
  • fever or chills;
  • mild nausea, vomiting;
  • unusual or unpleasant taste in your mouth;
  • skin itching or rash;
  • warmth, redness, itching, or tingling under your skin;
  • joint pain or swelling;
  • dizziness;
  • headache; or
  • swelling, stinging, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Helixate FS (antihemophilic factor (recombinant)) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about recombinant antihemophilic factor?

Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past, or if you are allergic to mouse or beef proteins.

Before using recombinant antihemophilic factor, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Human antihemophilic factor will not treat von Willebrand disease.

Your body may develop antibodies to this medication, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

To be sure this medication is helping your condition and is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Side Effects Centers
  • Helixate FS
  • Kogenate FS
  • Recombinate
  • Refacto

Patient Detailed How Take

What should I discuss with my health care provider before using recombinant antihemophilic factor?

Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past, or if you are allergic to mouse or beef proteins.

Before using recombinant antihemophilic factor, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Recombinant antihemophilic factor will not treat von Willebrand disease.

FDA pregnancy category C. It is not known whether recombinant antihemophilic factor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether recombinant antihemophilic factor passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use recombinant antihemophilic factor?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Recombinant antihemophilic factor is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Always wash your hands before preparing and giving your injection.

Recombinant antihemophilic factor must be mixed with a liquid (diluent) before injecting it. If you store your medicine in the refrigerator, take a medicine and diluent vial out of the refrigerator and allow each to reach room temperature before mixing them.

Gently swirl the medicine and diluent to mix them and allow the medicine to completely dissolve.

After mixing the medicine and diluent, the mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Each vial is for one use only. After measuring your dose, throw the vial away, even if there is medicine left in it.

Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Recombinant antihemophilic factor is usually given every 8 to 24 hours for 1 to 4 days, depending on the reason you are using the medication.

To be sure this medication is helping your condition and is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.

Your body may develop antibodies to antihemophilic factor, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Store the medication and the diluent in the refrigerator and do not allow them to freeze.

You may also store the medication and diluent at room temperature until the expiration date on the label. Some brands of this medicine can be stored at room temperature for only a certain number of months, or until the expiration date (whichever comes first). Follow the storage directions on the medicine label.

Do not store this medicine in bright light. Throw away any leftover medicine and diluent if the expiration date has passed.

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Patient Detailed Avoid Taking

What happens if I miss a dose?

Recombinant antihemophilic factor is sometimes used only as needed, so you may not be on a dosing schedule. If you are taking the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using recombinant antihemophilic factor?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect recombinant antihemophilic factor?

There may be other drugs that can interact with recombinant antihemophilic factor. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about recombinant antihemophilic factor.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 6.02. Revision date: 1/5/2012.

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