Drugs Details

Drugs Info of Neulasta
Drugs Details
  • Drugs Type  : FDA
  • Date : 9th Mar 2015 05:36 am
  • Brand Name : Neulasta
  • Generic Name : pegfilgrastim (Pronunciation: PEG fil GRAS tim)
Descriptions

Neulasta (pegfilgrastim) is a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypolyethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD.

Neulasta is supplied in 0.6 mL prefilled syringes for subcutaneous injection. Each syringe contains 6 mg pegfilgrastim (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP.

What are the possible side effects of pegfilgrastim (Neulasta)?

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

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

  • sudden or severe pain in your left upper stomach spreading up to your shoulder;
  • severe dizziness, skin rash, or flushing (warmth, redness, or tingly feeling);
  • rapid breathing or feeling short of breath;
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or...

Read All Potential Side Effects and See Pictures of Neulasta »

What are the precautions when taking pegfilgrastim (Neulasta)?

Before using pegfilgrastim, tell your doctor or pharmacist if you are allergic to it or to filgrastim/tbo-filgrastim; or to other medications made in a similar way (biotechnology-produced proteins using E. coli); or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the needle cover on the prefilled syringe), 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, especially of: sickle cell disease, spleen problems.

If you are scheduled only for radiation therapy, pegfilgrastim may still help your body fight off infections. Discuss the risks and benefits with your doctor.

This...

Read All Potential Precautions of Neulasta »
This monograph has been modified to include the generic and brand name in many instances.

Indications

Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies].

Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

 

Dosage Administration

The recommended dosage of Neulasta is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle in adults. Do not administer Neulasta between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Neulasta if discoloration or particulates are observed.

NOTE: The needle cover on the single-use prefilled syringe contains dry natural rubber (latex); persons with latex allergies should not administer this product.

How Supplied

Dosage Forms And Strengths

6 mg per 0.6 mL in single use prefilled syringe.

Storage And Handling

Neulasta is supplied in a prefilled single use syringe containing 6 mg pegfilgrastim, supplied with a 27-gauge, ½- inch needle with an UltraSafe® Needle Guard.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex).

Neulasta is provided in a dispensing pack containing one syringe (NDC 55513-190-01).

Store refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.

Manufactured by: Amgen Inc. One Amgen Center Drive, Thousand Oaks, California 91320-1799. Revised: 06/2011


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

Side Effects

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Splenic Rupture [See WARNINGS AND PRECAUTIONS]
  • Acute Respiratory Distress Syndrome [See WARNINGS AND PRECAUTIONS]
  • Serious Allergic Reactions [See WARNINGS AND PRECAUTIONS]
  • Use in Patients with Sickle Cell Disorders [See WARNINGS AND PRECAUTIONS]
  • Potential for Tumor Growth Stimulatory Effects on Malignant Cells [See WARNINGS AND PRECAUTIONS]

The most common adverse reactions occurring in ≥ 5% of patients and with a between-group difference of ≥ 5% higher in the pegfilgrastim arm in placebo controlled clinical trials are bone pain and pain in extremity.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Neulasta clinical trials safety data are based upon 932 patients receiving Neulasta in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and lymphoma (n = 56) received Neulasta after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles.

The following adverse reaction data in Table 1 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m² every 21 days (Study 3). A total of 928 patients were randomized to receive either 6 mg Neulasta (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and < 1% Asian, Native American or other.

Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients.

Table 1: Adverse Reactions With ≥ 5% Higher Incidence in Neulasta Patients Compared to Placebo in Study 3

System Organ Class
Preferred Term
Placebo
(N= 461)
Neulasta 6 mg SC on Day 2
(N= 467)
Musculoskeletal and connective tissue disorders
  Bone pain 26% 31%
  Pain in extremity 4% 9%
Leukocytosis

In clinical studies, leukocytosis (WBC counts > 100 x 109/L) was observed in less than 1% of 932 patients with non-myeloid malignancies receiving Neulasta. No complications attributable to leukocytosis were reported in clinical studies.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment. None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Neulasta with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Neulasta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) reported frequency of the reaction, or (3) strength of causal relationship to Neulasta.

Gastro-intestinal disorders: Splenic rupture [see WARNINGS AND PRECAUTIONS]

Blood and lymphatic system disorder: Sickle cell crisis [see WARNINGS AND PRECAUTIONS]

Hypersensitivity reactions: Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, and urticaria, generalized erythema and flushing [see WARNINGS AND PRECAUTIONS]

Respiratory, thoracic, and mediastinal disorder: ARDS [see WARNINGS AND PRECAUTIONS]

General disorders and administration site conditions: Injection site reactions

Skin and subcutaneous tissue disorders: Sweet's syndrome, Cutaneous vasculitis

Read the Neulasta (pegfilgrastim) Side Effects Center for a complete guide to possible side effects

Interactions

No formal drug interaction studies between Neulasta and other drugs have been performed. Increased hematopoietic activity of the bone marrow in response to growth factor therapy may result in transiently positive bone-imaging changes. Consider these findings when interpreting bone-imaging results.

Read the Neulasta Drug Interactions Center for a complete guide to possible interactions

Learn More »

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

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta.

Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta, for ARDS. Discontinue Neulasta in patients with ARDS.

Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta in patients with serious allergic reactions. Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Use in Patients With Sickle Cell Disorders

Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

The granulocyte-colony stimulating factor (G-CSF) receptor through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.

Patient Counseling Information

Advise patients of the following risks:

  • Splenic rupture
  • Acute Respiratory Distress Syndrome
  • Serious allergic reactions
  • Sickle cell crisis

Have patients immediately contact their healthcare provider and report:

  • Left upper quadrant or shoulder pain
  • Shortness of breath
  • Signs or symptoms of sickle cell crisis
  • Signs or symptoms of infection
  • Flushing, dizziness, or rash

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim.

Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area).

Reproductive and Developmental Toxicology

Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural

anomalies were observed in the offspring from either study. Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.

Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. No evidence of fetal loss or structural malformations was observed in any study. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation).

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Pegfilgrastim was embryotoxic and increased pregnancy loss in pregnant rabbits that received cumulative doses approximately 4 times the recommended human dose (based on body surface area). Signs of maternal toxicity occurred at these doses. Neulasta should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

In animal reproduction studies, when pregnant rabbits received pegfilgrastim at cumulative doses approximately 4 times the recommended human dose (based on body surface area), increased embryolethality and spontaneous abortions occurred. Signs of maternal toxicity (reductions in body weight gain/food consumption) and decreased fetal weights occurred at maternal doses approximately equivalent to the recommended human dose (based on body surface area). There were no structural anomalies observed in rabbit offspring at any dose tested. No evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area) [see Nonclinical Toxicology].

Women who become pregnant during Neulasta treatment are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

Nursing Mothers

It is not known whether pegfilgrastim is secreted in human milk. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. Caution should be exercised when administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Neulasta in pediatric patients have not been established. The adverse reaction profile and pharmacokinetics of pegfilgrastim were studied in 37 pediatric patients with sarcoma. The mean (± standard deviation [SD]) systemic exposure (AUC0-inf) of pegfilgrastim after subcutaneous administration at 100 mcg/kg was 22.0 (± 13.1) mcg·hr/mL in the 6 to11 years age group (n = 10), 29.3 (± 23.2) mcg·hr/mL in the 12 to21 years age group (n = 13), and 47.9 (± 22.5) mcg·hr/mL in the youngest age group (0 to5 years, n = 11). The terminal elimination half-lives of the corresponding age groups were 20.2 (± 11.3) hours, 21.2 (± 16.0) hours, and 30.1 (± 38.2) hours, respectively. The most common adverse reaction was bone pain.

Geriatric Use

Of the 932 patients with cancer who received Neulasta in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.

Renal Impairment

In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim. Therefore, pegfilgrastim dose adjustment in patients with renal dysfunction is not necessary [Clinical Pharmacology (12.3)].


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

OverDose

The maximum amount of Neulasta that can be safely administered in single or multiple doses has not been determined. Single subcutaneous doses of 300 mcg/kg have been administered to 8 healthy volunteers and 3 patients with non-small cell lung cancer without serious adverse effects. These patients experienced a mean maximum absolute neutrophil count (ANC) of 55 x 109/L, with a corresponding mean maximum WBC of 67 x 109/L. The absolute maximum ANC observed was 96 x 109/L with a corresponding absolute maximum WBC observed of 120 x 109/L. The duration of leukocytosis ranged from 6 to 13 days. The effectiveness of leukapheresis in the management of symptomatic individuals with Neulasta-induced leukocytosis has not been studied.

ContrainDications

Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.


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

Clinical Pharamacology

Mechanism of Action

Pegfilgrastim is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Pharmacokinetics

The pharmacokinetics of pegfilgrastim were studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim were nonlinear and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils. In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed. The half-life of Neulasta ranged from 15 to 80 hours after subcutaneous injection.

No gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients ( ≥ 65 years of age) compared with younger patients ( < 65 years of age) [see Use In Specific Populations]. The pharmacokinetics of pegfilgrastim were studied in pediatric patients with sarcoma [see Use In Specific Populations]. Renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim. [see Use in Specific Populations]. The pharmacokinetic profile in patients with hepatic insufficiency has not been assessed.

Clinical Studies

Neulasta was evaluated in three randomized, double-blind, controlled studies. Studies 1 and 2 were active-controlled studies that employed doxorubicin 60 mg/m² and docetaxel 75 mg/m² administered every 21 days for up to 4 cycles for the treatment of metastatic breast cancer. Study 1 investigated the utility of a fixed dose of Neulasta. Study 2 employed a weight-adjusted dose. In the absence of growth factor support, similar chemotherapy regimens have been reported to result in a 100% incidence of severe neutropenia (ANC < 0.5 x 109/L) with a mean duration of 5 to 7 days and a 30% to 40% incidence of febrile neutropenia. Based on the correlation between the duration of severe neutropenia and the incidence of febrile neutropenia found in studies with filgrastim, duration of severe neutropenia was chosen as the primary endpoint in both studies, and the efficacy of Neulasta was demonstrated by establishing comparability to filgrastim-treated patients in the mean days of severe neutropenia.

In Study 1, 157 patients were randomized to receive a single subcutaneous injection of Neulasta (6 mg) on day 2 of each chemotherapy cycle or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle. In Study 2, 310 patients were randomized to receive a single subcutaneous injection of Neulasta (100 mcg/kg) on day 2 or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle.

Both studies met the major efficacy outcome measure of demonstrating that the mean days of severe neutropenia of Neulasta-treated patients did not exceed that of filgrastim-treated patients by more than 1 day in cycle 1 of chemotherapy. The mean days of cycle 1 severe neutropenia in Study 1 were 1.8 days in the Neulasta arm compared to 1.6 days in the filgrastim arm [difference in means 0.2 (95% CI -0.2, 0.6)] and in Study 2 were 1.7 days in the Neulasta arm compared to 1.6 days in the Filgrastim arm [difference in means 0.1 (95% CI -0.2, 0.4)]. A secondary endpoint in both studies was days of severe neutropenia in cycles 2 through 4 with results similar to those for cycle 1.

Study 3 was a randomized, double-blind, placebo-controlled study that employed docetaxel 100 mg/m² administered every 21 days for up to 4 cycles for the treatment of metastatic or non-metastatic breast cancer. In this study, 928 patients were randomized to receive a single subcutaneous injection of Neulasta (6 mg) or placebo on day 2 of each chemotherapy cycle. Study 3 met the major trial outcome measure of demonstrating that the incidence of febrile neutropenia (defined as temperature ≥ 38.2°C and ANC ≤ 0.5 x109/L) was lower for Neulasta-treated patients as compared to placebo-treated patients (1% versus 17%, respectively, p < 0.001). The incidence of hospitalizations (1% versus 14%) and IV anti-infective use (2% versus 10%) for the treatment of febrile neutropenia was also lower in the Neulasta-treated patients compared to the placebo-treated patients.


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

Patient Information

Neulasta®
Pegfilgrastim

This patient package insert provides information and instructions for people who will be receiving Neulasta or their caregivers. This patient package insert does not tell you everything about Neulasta. You should discuss any questions you have about treatment with Neulasta with your doctor.

What is Neulasta?

Neulasta is a man-made form of granulocyte colony-stimulating factor (G-CSF), which is made using the bacteria E coli. G-CSF is a substance produced by the body. It stimulates the growth of neutrophils (nu-tro-fils), a type of white blood cell important in the body's fight against infection.

Who should not take Neulasta?

Do not take Neulasta if you have had:

  • A serious allergic reaction to Neulasta® (pegfilgrastim) or to Neupogen® (filgrastim).

What important information do I need to know about receiving Neulasta?

Occasionally pain and redness may occur at the injection site. If there is a lump, swelling, or bruising at the injection site that does not go away, talk to the doctor.

Neulasta should only be injected on the day the doctor has determined and should not be injected until approximately 24 hours after receiving chemotherapy.

The needle cover on the single-use prefilled syringe contains dry natural rubber (latex), which should not be handled by persons sensitive to this substance.

What should I tell my healthcare provider before taking Neulasta?

If you have a sickle cell disorder, make sure that your doctor knows about it before using Neulasta. If you have a sickle cell crisis after getting Neulasta, tell your doctor right away.

If you have any questions, talk to your doctor.

What are possible serious side effects of Neulasta?

  • Spleen Rupture. Your spleen may become enlarged and can rupture while taking Neulasta. A ruptured spleen can cause death. The spleen is located in the upper left section of your stomach area. Call your doctor right away if you have pain in the left upper stomach area or left shoulder tip area. This pain could mean your spleen is enlarged or ruptured.
  • A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your doctor or seek emergency care right away if you have shortness of breath, trouble breathing, or a fast rate of breathing.
  • Serious Allergic Reactions. Neulasta can cause serious allergic reactions. These reactions can cause shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. If you start to have any of these symptoms, call your doctor or seek emergency care right away. If you have an allergic reaction during the injection of Neulasta, stop the injection. Call your doctor right away.
  • Sickle Cell Crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and take Neulasta. Serious and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, a medicine similar to Neulasta (pegfilgrastim). Call your doctor right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

What are the most common side effects of Neulasta?

The most common side effect you may experience is aching in the bones and muscles. If this happens, it can usually be relieved with a non aspirin pain reliever, such as acetaminophen.

What about pregnancy or breastfeeding?

Neulasta has not been studied in pregnant women, and its effects on unborn babies are not known. If you take Neulasta while you are pregnant, it is possible that small amounts of it may get into your baby's blood. It is not known if Neulasta can get into human breast milk. If you are pregnant, plan to become pregnant, think you may be pregnant, or are breastfeeding, you should tell your doctor before using Neulasta. If you become pregnant during Neulasta treatment, you are encouraged to enroll in Amgen's Pregnancy Surveillance Program. You should call 1- 800-77-AMGEN (1-800-772-6436) to enroll.

HOW TO PREPARE AND GIVE A NEULASTA INJECTION

Neulasta is provided in a prefilled syringe. Neulasta should be stored in its carton to protect from light until use. If you are giving someone else Neulasta injections, it is important that you know how to inject Neulasta. Before getting your Neulasta injection, always check to see that:

  • The name Neulasta appears on the carton and prefilled syringe label.
  • The expiration date on the prefilled syringe has not passed. You should not use a prefilled syringe after the date on the label.
  • The Neulasta liquid should always be clear and colorless. Do not use Neulasta if the contents of the prefilled syringe appear discolored or cloudy, or if the prefilled syringe appears to contain lumps, flakes, or particles.

IMPORTANT: TO HELP AVOID POSSIBLE INFECTION, YOU SHOULD FOLLOW THESE INSTRUCTIONS.

Setting up for an injection

Note: The needle cover on the single-use prefilled syringe contains dry natural rubber (latex), which should not be handled by persons sensitive to this substance.

  1. Find a clean, flat working surface, such as a table.
  2. Remove the carton containing the prefilled syringe of Neulasta from the refrigerator. Allow Neulasta to reach room temperature (this takes about 30 minutes). Remove the syringe from the carton before injection. Each prefilled syringe should be used only once. DO NOT SHAKE THE PREFILLED SYRINGE. Shaking may damage Neulasta. If the prefilled syringe has been shaken vigorously, the solution may appear foamy and it should not be used.
  3. Assemble the supplies you will need for an injection:
  • Neulasta prefilled syringe with transparent (clear) plastic blue needle guard attached

 

Neulasta prefilled syringe - Illustration
  • An alcohol swab and a cotton ball or gauze

 

An alcohol swab and a cotton ball - Illustration
  • Puncture-proof disposal container

4. Wash your hands with soap and warm water.

 

Wash your hands - Illustration

HOW TO PREPARE FOR INJECTION OF NEULASTA

5. Remove the syringe from the package and the tray. Check to see that the plastic blue needle guard is covering the barrel of the glass syringe. DO NOT push the blue needle guard over the needle cover before injection. This may activate or lock the needle guard. If the blue needle guard is covering the needle that means it has been activated. Do NOT use that syringe. Dispose of that syringe in the puncture-proof disposal container. Use a new syringe. Do not activate the needle guard prior to injection.

6. Hold the syringe barrel through the needle guard windows with the needle pointing up. Holding the syringe with the needle pointing up helps to prevent medicine from leaking out of the needle. Carefully pull the needle cover straight off.

7. Check the syringe for air bubbles. If there are air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. Slowly push the plunger up to force the air bubbles out of the syringe.

8. Gently place the prefilled syringe with the window flat on your clean working surface so that the needle does not touch anything.

Selecting and preparing the injection site

9. Choose an injection site. Four recommended injection sites for Neulasta are:

  • The outer area of the upper arms
  • The abdomen, except for the two-inch area around the navel
  • The front of the middle thighs
  • The upper outer areas of the buttocks

Front

Recommended injection sites - Illustration

Back

Recommended injection sites - Illustration

10. Clean the injection site with an alcohol swab.

 

Clean the injection site - Illustration

Injecting the dose of Neulasta

11. Pick up the prefilled syringe from your clean, flat working surface by grabbing the sides of the needle guard with your thumb and forefinger.

12. Hold the syringe in the hand you will use to inject Neulasta. Use the other hand to pinch a fold of skin at the cleaned injection site. Note: Hold the syringe barrel through the needle guard windows when giving the injection.

 

Pinch a fold of skin - Illustration

13. Holding the syringe like a pencil, use a quick “dart-like” motion to insert the needle either straight up and down (90 degree angle) or at a slight angle (45 degrees) into the skin.

 

Insert the needle - Illustration

14. After the needle is inserted, let go of the skin. Pull the plunger back slightly. If no blood appears, slowly push down on the plunger all the way, until all the Neulasta is injected. If blood comes into the syringe, do not inject Neulasta, because the needle has entered a blood vessel. Withdraw the syringe and discard it in the puncture-proof container. Repeat the steps to prepare a new prefilled syringe and choose and clean a new injection site. Remember to check again for blood before injecting Neulasta.

 

Push down on the plunger - Illustration

15. When the syringe is empty, pull the needle out of the skin and place a cotton ball or gauze over the injection site and press for several seconds.

 

Place a cotton ball - Illustration

16. Use a prefilled syringe with the needle guard only once.

Activating the Needle Guard after the injection has been given

17. After injecting Neulasta from the prefilled syringe, do not recap the needle. Keep your hands behind the needle at all times. While holding the clear plastic finger grip of the syringe with one hand, grasp the blue needle guard with your free hand and slide the blue needle guard over the needle until the needle is completely covered and the needle guard clicks into place. NOTE: If an audible click is not heard, the needle guard may not be completely activated.

 

Activate the Needle Guard -  Illustration

18. Place the prefilled syringe with the activated needle guard into a puncture-proof container for proper disposal as described below.

Disposal of prefilled syringes and needle guards

You should always follow the instructions given by your doctor, nurse, or pharmacist on how to properly dispose of containers with used syringes and needle guards. There may be special state and local laws for disposal of used needles and syringes.

  • Do not throw the container in the household trash. Do not recycle.
  • DO NOT put the needle cover (the cap) back on the needle.
  • Place all used needle covers and syringes in a hard plastic container with a screw-on cap or in a metal container with a plastic lid, such as a coffee can, labeled “used syringes.” If a metal container is used, cut a small hole in the plastic lid and tape the lid to the metal container. If a hard plastic container is used, always screw the cap on tightly after each use.
  • Do not use glass or clear plastic containers.
  • When the container is full, tape around the cap or lid to make sure the cap or lid does not come off.
  • Always keep the container out of the reach of children.

How should Neulasta be stored?

Neulasta should be stored in the refrigerator at 2° to 8°C (36° to 46°F), but not in the freezer. Neulasta should be protected from light, so you should keep it in its carton until you are ready to use it. Avoid shaking Neulasta. If Neulasta is accidentally frozen, allow it to thaw in the refrigerator before injecting. However, if it is frozen a second time, do not use. Neulasta can be left out at room temperature for up to 48 hours. Do not leave Neulasta in direct sunlight. For all questions about storage, contact your doctor, nurse, or pharmacist.

What are the ingredients in Neulasta?

Each syringe contains pegfilgrastim in a sterile, clear, colorless, preservative-free solution containing acetate, sorbitol, polysorbate 20, and sodium.


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.

 

PEGFILGRASTIM - INJECTION

 

(peg-fill-GRASS-tim)

 

COMMON BRAND NAME(S): Neulasta

 

USES: Pegfilgrastim is a long-acting form of the drug, filgrastim. These drugs, called colony-stimulating factors, are used to help stimulate the bone marrow to make white blood cells in patients who are not able to produce enough white blood cells on their own.

White blood cells help the body fight infections. Certain medical conditions (e.g., cancer) and/or medications (e.g., cancer chemotherapy) may reduce the body's ability to make normal white blood cells.

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using pegfilgrastim and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Avoid shaking this medication; doing so may make the drug ineffective.

Remove the medication from the refrigerator 30 minutes before you inject it to allow it to reach room temperature.

Inject this medication under the skin (subcutaneously) usually once during each chemotherapy cycle, or as directed by your doctor. The dosage is usually one 6 milligram injection, but it may be adjusted for children or small adults (weighing less than 100 pounds or 45 kilograms).

Do not give this drug during the period 14 days before to 1 day after your chemotherapy. Giving this drug during this time may increase your risk of certain side effects. Consult your doctor for details.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Choose a new injection site each time you give yourself a dose. This will help prevent soreness. Never inject pegfilgrastim into skin that is tender, red, bruised, and hard, or has scars or stretch marks.

Consumer Overview Side Effect

SIDE EFFECTS: Bone pain may occur. Taking a non-aspirin pain reliever such as acetaminophen may help with this pain. Ask your doctor or pharmacist for more details. Injection site reactions such as redness, swelling, itching, lumps, or bruising may also occur. If any of these effects persist or worsen, notify your doctor 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.

Get medical help right away if any of these rare but very serious side effects occur: breathing problems (e.g., trouble breathing, shortness of breath, fast breathing).

Rarely, possibly fatal damage to the spleen may occur. Get medical help right away if you experience the following side effects: stomach/abdominal pain and/or shoulder pain.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, fast heartbeat, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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 Neulasta (pegfilgrastim) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using pegfilgrastim, tell your doctor or pharmacist if you are allergic to it or to filgrastim/tbo-filgrastim; or to other medications made in a similar way (biotechnology-produced proteins using E. coli); or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the needle cover on the prefilled syringe), 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, especially of: sickle cell disease, spleen problems.

If you are scheduled only for radiation therapy, pegfilgrastim may still help your body fight off infections. Discuss the risks and benefits with your doctor.

This medication should be used only when clearly needed during pregnancy. 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: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Similar products, such as filgrastim and tbo-filgrastim, should not be used at the same time as pegfilgrastim.

This medication may interfere with certain laboratory tests (e.g., bone tests such as bone imaging). Make sure laboratory personnel and all your doctors know you use this drug.

 

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.

This medication must be taken under close medical supervision so that your blood counts can be monitored. Laboratory and/or medical tests (e.g., blood and platelet counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

It is very important to keep all scheduled medical and laboratory appointments.

 

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Do not freeze. However, if frozen, thaw in the refrigerator before use. Discard syringe if frozen more than once. Keep all medications away from children and pets.

This medication may be kept out of the refrigerator for up to 48 to 72 hours, depending on your brand. After that time, if the medication is left unused, discard it. Consult your product instructions or pharmacist for details.

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.

 

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

Patient Detailed Side Effect

Brand Names: Neulasta

Generic Name: pegfilgrastim (Pronunciation: PEG fil GRAS tim)

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

What is pegfilgrastim (Neulasta)?

Pegfilgrastim is a man-made form of a protein that stimulates the growth of white blood cells in your body. White blood cells help your body fight against infection.

Pegfilgrastim is used to prevent neutropenia, a lack of certain white blood cells caused by receiving chemotherapy.

Pegfilgrastim may also be used for purposes not listed in this medication guide.

What are the possible side effects of pegfilgrastim (Neulasta)?

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

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

  • sudden or severe pain in your left upper stomach spreading up to your shoulder;
  • severe dizziness, skin rash, or flushing (warmth, redness, or tingly feeling);
  • rapid breathing or feeling short of breath;
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness; or
  • bruising, swelling, pain, redness, or a hard lump where the injection was given.

Less serious side effects may include:

  • bone pain;
  • pain in your arms or legs; or
  • bruising, swelling, pain, redness, or a hard lump 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 Neulasta (pegfilgrastim) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about pegfilgrastim (Neulasta)?

You should not use this medication if you are allergic to pegfilgrastim or filgrastim (Neupogen).

Before using pegfilgrastim, tell your doctor if you have sickle cell disorder, chronic myeloid leukemia, myelodysplasia (also called "preleukemia"), or if you are allergic to latex.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Pegfilgrastim is usually given once per chemotherapy cycle. This medication should not be given within 14 days before or 24 hours after you receive chemotherapy.

Side Effects Centers
  • Neulasta

Patient Detailed How Take

What should I discuss with my healthcare provider before using pegfilgrastim (Neulasta)?

You should not use this medication if you are allergic to pegfilgrastim or filgrastim (Neupogen).

To make sure you can safely use pegfilgrastim, tell your doctor if you have any of these other conditions:

  • sickle cell disorder;
  • chronic myeloid leukemia;
  • myelodysplasia (also called "preleukemia"); or
  • if you are allergic to latex.

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

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of pegfilgrastim on the baby.

It is not known whether pegfilgrastim 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 pegfilgrastim (Neulasta)?

Pegfilgrastim is injected under the skin. You may be shown how to use injections 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 and syringes.

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.

Pegfilgrastim is usually given once per chemotherapy cycle. This medication should not be given within 14 days before or 24 hours after you receive chemotherapy.

Do not shake the prefilled syringe or you may ruin the medicine. Prepare your dose only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Each prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

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.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with pegfilgrastim. Visit your doctor regularly.

Store this medication in the refrigerator, do not freeze. Protect from light and do not shake. Take the medicine out and allow it to reach room temperature for 30 minutes before injecting your dose.

Throw away any unused syringes after the expiration date on the label has passed.

Side Effects Centers
  • Neulasta

Patient Detailed Avoid Taking

What happens if I miss a dose (Neulasta)?

Call your doctor for instructions if you miss a dose of pegfilgrastim.

What happens if I overdose (Neulasta)?

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

What should I avoid while using pegfilgrastim (Neulasta)?

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

What other drugs will affect pegfilgrastim (Neulasta)?

There may be other drugs that can interact with pegfilgrastim. 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 doctor or pharmacist can provide more information about pegfilgrastim.


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: 2.05. Revision date: 12/15/2010.

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