Drugs Details

Drugs Info of PegIntron, PegIntron Redipen, Sylatron
Drugs Details
  • Drugs Type  : FDA
  • Date : 9th Mar 2015 07:43 am
  • Brand Name : PegIntron, PegIntron Redipen, Sylatron
  • Generic Name : peginterferon alfa-2b (Pronunciation: peg in ter FEAR on AL fa 2 b)
Descriptions

SYLATRON, peginterferon alfa-2b, is a covalent conjugate of recombinant alfa-2b interferon with monomethoxy polyethylene glycol (PEG). The average molecular weight of the PEG portion of the molecule is 12,000 daltons. The average molecular weight of the SYLATRON molecule is approximately 31,000 daltons. The specific activity of pegylated interferon alfa-2b is approximately 0.7 x 108 international units/mg protein.

Interferon alfa-2b is a protein with a molecular weight of 19,271 daltons produced by recombinant DNA techniques. It is obtained from the bacterial fermentation of a strain of Escherichia coli bearing a genetically engineered plasmid containing an interferon gene from human leukocytes.

Each vial contains either 296 mcg, 444 mcg or 888 mcg of peginterferon alfa-2b as a sterile, white to off-white lyophilized powder, and dibasic sodium phosphate anhydrous (1.11 mg), monobasic sodium phosphate dihydrate (1.11 mg), polysorbate 80 (0.074 mg), and sucrose (59.2 mg).

What are the possible side effects of peginterferon alfa-2b (PegIntron, PegIntron Redipen, Sylatron)?

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

Stop using peginterferon alfa-2b and call your doctor at once if you have severe or worsening symptoms such as: confusion, depression, tired feeling, anxiety, aggression, tremors, muscle twitching, seizure, unusual thoughts or behavior, or thoughts about suicide or hurting yourself. Once you have had this type of reaction to peginterferon alfa-2b, you must never use it...

Read All Potential Side Effects and See Pictures of Sylatron »

What are the precautions when taking peginterferon alfa-2b (Sylatron)?

Before using peginterferon alfa-2b, tell your doctor or pharmacist if you are allergic to it; or to polyethylene glycol (PEG); or to other interferons; or if you have any other allergies. This product may contain inactive ingredients, 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: liver disease, mental/mood disorders (such as depression), history of drug/alcohol abuse, thyroid disease, diabetes, eye problems, inflammation of the bowels (such as colitis), pancreatitis, high blood triglyceride levels.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can...

Read All Potential Precautions of Sylatron »


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

 

Indications

SYLATRON™ is an alpha interferon indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.

Dosage Administration

Recommended Dosing

  • The recommended starting dose is 6 mcg/kg/week subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously for up to 5 years.
  • Premedicate with acetaminophen 500 to 1000 mg orally 30 minutes prior to the first dose of SYLATRON and as needed for subsequent doses.
  • The recommended starting doses of SYLATRON in patients with moderate or severe renal impairment or end-stage renal disease (ESRD) are listed in Table 1 [see Use in Specific Populations]. No dose adjustment is needed for patients with a creatinine clearance (CLcr) > 50 mL/min/1.73m².

Table 1: Recommended Starting Dose for Moderate and Severe Renal Impairment and End-Stage Renal Disease

Degree of Renal Impairment Creatinine Clearance (mL/min/1.73m ) Initial doses for 8 weeks Follow-up doses for 5 years
Moderate 30 - 50 4.5 mcg/kg/week 2.25 mcg/kg/week
Severe < 30 3 mcg/kg/week 1.5 mcg/kg/week
End-Stage Renal Disease On dialysis 3 mcg/kg/week 1.5 mcg/kg/week

Dose Modification Guidelines

Guidelines for Dose Modification provided below are based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 2.0).

  • Permanently discontinue SYLATRON for:
    • Persistent or worsening severe neuropsychiatric disorders
    • Grade 4 non-hematologic toxicity
    • Inability to tolerate a dose of 1 mcg/kg/wk
    • New or worsening retinopathy
  • Withhold SYLATRON dose for any of the following:
    • Absolute Neutrophil Count (ANC) less than 0.5x109/L
    • Platelet Count (PLT) less than 50x109/L
    • ECOG PS greater than or equal to 2
    • Non-hematologic toxicity greater than or equal to Grade 3
  • Resume dosing at a reduced dose (see Table 1) when all of the following are present:
    • Absolute Neutrophil Count (ANC) greater than or equal to 0.5x109/L
    • Platelet Count (PLT) greater than or equal to 50x109/L
    • ECOG PS 0-1
    • Non-hematologic toxicity has completely resolved or improved to Grade 1

Table 2: SYLATRON Dose Modifications

Starting Dose Dose Modifications for Doses 1 to 8
6 mcg/kg/week First Dose Modification: 3 mcg/kg/week
Second Dose Modification: 2 mcg/kg/week
Third Dose Modification: 1 mcg/kg/week
Permanently discontinue if unable to tolerate 1 mcg/kg/week
Starting Dose Dose Modifications for Doses 9 to 260
3 mcg/kg/week First Dose Modification: 2 mcg/kg/week
Second Dose Modification: 1 mcg/kg/week
Permanently discontinue if unable to tolerate 1 mcg/kg/week

Preparation And Administration

Reconstitute SYLATRON with 0.7 mL of Sterile Water for Injection, USP. The Sterile Water for Injection supplied contains 5 mL. Each vial of Sterile Water for Injection is intended for single use. Discard any unused Sterile Water for Injection, USP.

Table 3: Reconstitution of SYLATRON Single-Use Vials

SYLATRON Single-Use Vial   Diluent (Sterile Water for Injection, USP)   Deliverable Product and Volume Final Concentration
200 mcg* add 0.7 mL = 200 mcg in 0.5 mL 40 mcg/0.1 mL
300 mcg† add 0.7 mL = 300 mcg in 0.5 mL 60 mcg/0.1 mL
600 mcg‡ add 0.7 mL = 600 mcg in 0.5 mL 120 mcg/0.1 mL
*Total vial content of SYLATRON is 296 mcg.
†Total vial content of SYLATRON is 444 mcg.
‡Total vial content of SYLATRON is 888 mcg.
  • Swirl gently to dissolve the lyophilized powder. DO NOT SHAKE.
  • Visually inspect the solution for particulate matter and discoloration prior to administration. Discard if solution is discolored, cloudy, or if particulates are present.
  • Do not withdraw more than 0.5 mL of reconstituted solution from each vial.
  • Administer SYLATRON subcutaneously. Rotate injection sites.
  • If reconstituted solution is not used immediately, store at 2°-8°C (36°-46°F) for no more than 24 hours. Discard reconstituted solution after 24 hours. DO NOT FREEZE.
  • For single-use only. DISCARD ANY UNUSED PORTION.

How Supplied

Dosage Forms And Strengths

  • 200 mcg of deliverable lyophilized powder per single-use vial
  • 300 mcg of deliverable lyophilized powder per single-use vial
  • 600 mcg of deliverable lyophilized powder per single-use vial

Storage And Handling

 

Each SYLATRON Package Contains:  
A box containing one 200 mcg per vial of SYLATRON powder and one 5 mL vial of Sterile Water for Injection, USP, 2 B-D Safety Lok syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-4347-01)
A box containing one 300 mcg per vial of SYLATRON powder and one 5 mL vial of Sterile Water for Injection, USP, 2 B-D Safety Lok syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-4348-01)
A box containing one 600 mcg per vial of SYLATRON powder and one 5 mL vial of Sterile Water for Injection, USP, 2 B-D Safety Lok syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-4349-01)
Storage

SYLATRON should be stored at 25°C (77°F); excursions permitted to 15°-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

Manufactured by: Schering Corporation, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: 11/2014


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:

  • Depression and Other Neuropsychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Retinopathy and Other Serious Ocular Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Hepatic Failure [see WARNINGS AND PRECAUTIONS]
  • Endocrinopathies [see WARNINGS AND PRECAUTIONS]

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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The data described below reflect exposure to SYLATRON in 608 patients with surgically resected, AJCC Stage III melanoma. SYLATRON was studied in an open label, multicenter, randomized, observation controlled trial. The median age of the population was 50 years with 10% of patients 65 years or older, and 42% were female. Fourteen percent of patients completed the 5 year treatment schedule.

Patients randomized to SYLATRON were to receive total doses of 48 mcg/kg (6 mcg/kg subcutaneous once weekly for 8 doses), and 780 mcg/kg (3 mcg/kg subcutaneous once weekly until disease recurrence or for up to 5 years), as tolerated. The median total dose received was 42 mcg/kg (range: 6 to 78 mcg/kg) for the first 8 doses, and 136 mcg/kg (range: 1 to 774 mcg/kg) for doses 9 to 260.

Serious adverse events were reported in 199 (33%) patients who received SYLATRON and 94 (15%) patients in the observation group.

The most common adverse reactions experienced by SYLATRON-treated patients were fatigue (94%), increased ALT (77%), increased AST (77%), pyrexia (75%), headache (70%), anorexia (69%), myalgia (68%), nausea (64%), chills (63%), and injection site reaction (62%). The most common serious adverse reactions were fatigue (7%), increased ALT (3%), increased AST (3%), and pyrexia (3%) in the SYLATRON-treated group vs. < 1% in the observation group for these reactions.

Thirty three percent of patients receiving SYLATRON discontinued treatment due to adverse reactions. The most common adverse reactions present at the time of treatment discontinuation were fatigue (27%), depression (17%), anorexia (15%), increased ALT (14%), increased AST (14%), myalgia (13%), nausea (13%), headache (13%), and pyrexia (11%). Adverse events that occurred in the clinical study at ≥ 5% incidence in the SYLATRON-treated group and with a greater incidence in patients receiving SYLATRON as compared to the observation group are presented in Table 3.

Table 4: Incidence of Adverse Reactions(*) Occurring in ≥ 5% of Melanoma Patients Treated with SYLATRON and with a Greater Incidence as Compared to Observation

Adverse Reaction SYLATRON
N=608
Observation
N=628
All Grades (%) Grade 3 and 4 (%) All Grades (%) Grade 3 and 4 (%)
Any Adverse Reaction 100 51 82 18
General Disorders and Administrative Site Conditions
Fatigue 94 16 41 1
Pyrexia 75 4 9 0
Chills 63 1 6 0
Injection Site Reaction 62 1.8 0 0
Metabolic/Laboratory
ALT or AST Increased 77 11 26 1
Blood Alkaline Phosphatase Increased 23 0 11 < 1
Weight Decreased 11 < 1 1 < 1
GGT Increased 8 4 1 < 1
Proteinuria 7 0 3 0
Anemia 6 < 1 2 < 1
Nervous System Disorders
Headache 70 4 19 1
Dysgeusia 38 0 1 0
Dizziness 35 2 11 < 1
Olfactory Nerve Disorder 23 0 1 0
Paraesthesia 21 < 1 14 < 1
Metabolism and Nutrition Disorders
Anorexia 69 3 13 0
Musculoskeletal and Connective Tissue Disorders
Myalgia 68 4 23 < 1
Arthralgia 51 3 22 1
Gastrointestinal Disorders
Nausea 64 3 11 < 1
Diarrhea 37 1 8 < 1
Vomiting 26 1 4 0
Psychiatric Disorders
Depression 59 7 24 < 1
Skin and Subcutaneous Tissue Disorders
Exfoliative Rash 36 1 4 0
Alopecia 34 0 1 0
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 6 1 2 1
Cough 5 < 1 2 0
* Adverse reactions were graded using NCI CTCAE, V.2.0.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. In a clinical study conducted in patients with melanoma, the incidence of binding antibodies to peg-interferon alfa-2b was approximately 35% (50/144 patients). Among the patients who tested positive for binding antibodies, one patient developed neutralizing antibodies. The impact of antibody formation on pharmacokinetics, safety and efficacy of peg-interferon alfa-2b could not be assessed based on limited available data.

The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing 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 SYLATRON 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 peginterferon alfa-2b as monotherapy and in combination with ribavirin in chronic hepatitis C (CHC) patients. 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.

Blood and Lymphatic System Disorders

pure red cell aplasia, thrombotic thrombocytopenic purpura

Ear and Labyrinth Disorders

hearing loss, vertigo, hearing impairment

Endocrine Disorders

diabetic ketoacidosis

Eye Disorders

Vogt-Koyanagi-Harada syndrome

Gastrointestinal Disorders

aphthous stomatitis, pancreatitis, colitis

Infusion Reactions

angioedema, urticaria, bronchoconstriction

Immune System Disorders

systemic lupus erythematosus, erythema multiforme, thyroiditis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, rheumatoid arthritis, interstitial nephritis, and systemic lupus erythematosus

Infections

sepsis

Metabolism and Nutrition Disorders

hypertriglyceridemia

Musculoskeletal and Connective Tissue Disorders

rhabdomyolysis, myositis

Nervous System Disorders

seizures, memory loss, peripheral neuropathy, paraesthesia, migraine headache

Respiratory, Thoracic and Mediastinal Disorders

dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, sarcoidosis and pulmonary hypertension

Skin and Subcutaneous Tissue Disorders

Stevens-Johnson syndrome, toxic epidermal necrolysis, psoriasis

Vascular Disorders

hypertension, hypotension, stroke

Read the Sylatron (peginterferon alfa-2b) Side Effects Center for a complete guide to possible side effects

Interactions

Peginterferon alfa-2b inhibits CYP1A2 and CYP2D6 activity. When caffeine (CYP1A2 substrate) or desipramine (CYP2D6 substrate) was coadministered with peginterferon alfa-2b (3 mcg/kg once weekly for two weeks), the exposure to caffeine increased 36% and the exposure to desipramine increased 30% as compared to when caffeine or desipramine was administered alone. Monitor for potential increased toxicities of drugs with a narrow therapeutic range metabolized by CYP1A2 or CYP2D6 when coadministered with SYLATRON. [See CLINICAL PHARMACOLOGY]

Read the Sylatron 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

Depression And Other Serious Neuropsychiatric Adverse Reactions

Peginterferon alfa-2b can cause life-threatening or fatal neuropsychiatric reactions. These include suicide, suicidal and homicidal ideation, depression, and an increased risk of relapse of recovering drug addicts. In the clinical trial, depression occurred in 59% of SYLATRON-treated patients and 24% of patients in the observation group. Depression was severe or life threatening in 7% of SYLATRON-treated patients compared with < 1% of patients in the observation arm.

In post-marketing experience, neuropsychiatric adverse reactions have been reported up to 6 months after discontinuation of peginterferon alfa-2b. Based on post-marketing experience with peginterferon alfa-2b and interferon alfa-2b, treatment may also result in aggressive behavior, psychoses, hallucinations, bipolar disorders, mania, and encephalopathy.

Advise patients and their caregivers to immediately report any symptoms of depression or suicidal ideation to their healthcare provider. Monitor and evaluate patients for signs and symptoms of depression and other psychiatric symptoms every 3 weeks during the first 8 weeks of treatment and every 6 months thereafter. Monitor patients during treatment and for at least 6 months after the last dose of SYLATRON. Permanently discontinue SYLATRON for persistent severe or worsening psychiatric symptoms or behaviors and refer for psychiatric evaluation.

Cardiovascular Adverse Reactions

In the clinical trial, cardiac adverse reactions, including myocardial infarction, bundle-branch block, ventricular tachycardia, and supraventricular arrhythmia occurred in 4% of SYLATRON-treated patients compared with 2% of patients in the observation group. In post-marketing experience, hypotension, cardiomyopathy, and angina pectoris have occurred in patients treated with peginterferon alfa-2b.

Permanently discontinue SYLATRON for new onset of ventricular arrhythmia or cardiovascular decompensation.

Retinopathy And Other Serious Ocular Adverse Reactions

Peginterferon alfa-2b can cause decrease in visual acuity or blindness due to retinopathy. Retinal and ocular changes include macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, papilledema, and serous retinal detachment may be induced or aggravated by treatment with peginterferon alfa-2b or other alpha interferons. In the clinical study, two SYLATRON-treated patients developed partial loss of vision due to retinal thrombosis (n=1) or retinopathy (n=1). The overall incidence of serious retinal disorders, visual disturbances, blurred vision, and reduction in visual acuity was < 1% in both SYLATRON-treated patients and the observation group.

Perform an eye examination that includes assessment of visual acuity and indirect ophthalmoscopy or fundus photography at baseline in patients with preexisting retinopathy and at any time during SYLATRON treatment in patients who experience changes in vision. Permanently discontinue SYLATRON in patients who develop new or worsening retinopathy.

Hepatic Failure

Peginterferon alfa-2b, increases the risk of hepatic decompensation and death in patients with cirrhosis. Monitor hepatic function with serum bilirubin, ALT, AST, alkaline phosphatase, and LDH at 2 and 8 weeks, and 2 and 3 months following initiation of SYLATRON, then every 6 months while receiving SYLATRON. Permanently discontinue SYLATRON for evidence of severe (Grade 3) hepatic injury or hepatic decompensation (Child-Pugh score > 6 [class B and C]) [see CONTRAINDICATIONS].

Endocrinopathies

Peginterferon alfa-2b can cause new onset or worsening of hypothyroidism, hyperthyroidism, and diabetes mellitus. In the clinical study, 1% of patients developed hypothyroidism; the overall incidence of endocrine disorders was 2% in SYLATRON-treated patients compared to < 1% for patients in the observation group.

Obtain TSH levels within 4 weeks prior to initiation of SYLATRON, at 3 and 6 months following initiation, then every 6 months thereafter while receiving SYLATRON. Permanently discontinue SYLATRON in patients who develop hypothyroidism, hyperthyroidism or diabetes mellitus that cannot be effectively managed.

Patient Counseling Information

See FDA-approved patient labeling (Instructions for Use and Medication Guide).

  • Advise patients that SYLATRON may be administered with antipyretics at bedtime to minimize common “flu-like” symptoms (including chills, fever, muscle aches, joint pain, headaches, tiredness).
  • Advise patients to maintain hydration if experiencing “flu-like” symptoms.
  • Advise patients and their caregivers to immediately report any symptoms of depression or suicidal ideation to their healthcare provider during treatment and up to 6 months after the last dose.
  • Use SYLATRON during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use In Specific Populations].
  • Instruct patients to not re-use or share syringes and needles.
  • Instruct patients on proper disposal of vials, syringes and needles.
  • Advise patients that the Sterile Water for Injection vials supplied contain an excess amount of diluent and only 0.7 mL should be withdrawn to reconstitute SYLATRON. Discard the unused portion of sterile water. Do not save or reuse.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis and Mutagenesis

SYLATRON has not been tested for its carcinogenic potential. Neither peginterferon alfa-2b nor its components, interferon or methoxypolyethylene glycol, caused damage to DNA when tested in the standard battery of mutagenesis assays, in the presence and absence of metabolic activation.

Impairment of Fertility

SYLATRON may impair human fertility. Irregular menstrual cycles were observed in female cynomolgus monkeys given subcutaneous injections of 4239 mcg/m²peginterferon alfa-2b alone every other day for 1 month (approximately 72 to 144 times the recommended weekly human dose based upon body surface area). These effects included transiently decreased serum levels of estradiol and progesterone, suggestive of anovulation. Normal menstrual cycles and serum hormone levels resumed in these animals 2 to 3 months following cessation of peginterferon alfa-2b treatment. Every other day dosing with 262 mcg/m²(approximately 3.5 to 7 times the recommended weekly human dose) had no effects on cycle duration or reproductive hormone status. The effects of SYLATRON on male fertility have not been studied.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of SYLATRON in pregnant women. Nonpegylated interferon alfa-2b was an abortifacient in Macaca mulatta (rhesus monkeys) at 15 and 30 million international units (IU)/kg (estimated human equivalent of 5 and 10 million IU/kg, based on body surface area adjustment for a 60-kg adult). The estimated Intron A human equivalent dose of 5 to 10 million IU/kg daily is approximately equal to a human equivalent dose of 79 to 158 mcg/kg/week of SYLATRON. Use SYLATRON during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether the components of SYLATRON are excreted in human milk. Studies in mice have shown that mouse interferons are excreted in breast milk. Because of the potential for adverse reactions from the drug in nursing infants, a decision must be made whether to discontinue nursing or discontinue the SYLATRON treatment, taking into account the importance of the therapy to the mother.

Pediatric Use

Safety and effectiveness in patients below the age of 18 years have not been established.

Geriatric Use

Clinical studies of SYLATRON did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Hepatic Impairment

SYLATRON has not been studied in patients with melanoma who have hepatic impairment. In patients treated for viral hepatitis, peginterferon alfa-2b treatment is contraindicated in those with moderate or severe hepatic impairment (Child-Pugh scores > 6). Discontinue SYLATRON if hepatic decompensation (Child-Pugh scores > 6) occurs during treatment. [See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]

Renal Impairment

Reduce the dose of SYLATRON by 25% in patients with moderate renal impairment (CLcr 30 to 50 mL/min/1.73m²) and 50% in patients with severe renal impairment (CLcr < 30 mL/min/1.73m²) or ESRD requiring dialysis [see DOSAGE AND ADMINISTRATION]. A study in subjects with varying degrees of renal impairment showed that the mean exposure (AUC) to peginterferon alfa-2b increased in subjects with moderate and severe renal impairment or ESRD requiring dialysis, as compared to subjects with normal renal function (CLcr > 80 mL/min/1.73m²) following a single 4.5 mcg/kg dose of peginterferon alfa-2b [see CLINICAL PHARMACOLOGY].


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

OverDose

The experience with overdose of SYLATRON is limited. Patients who were over dosed experienced the following adverse reactions: severe fatigue, headache, myalgia, neutropenia, and thrombocytopenia. The highest single dose administered was 14 mcg/kg.

ContrainDications

SYLATRON is contraindicated in patients with:

  • A history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b
  • autoimmune hepatitis
  • hepatic decompensation (Child-Pugh score > 6 [class B and C])


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

Clinical Pharamacology

Mechanism Of Action

Peginterferon alfa-2b is a pleiotropic cytokine; the mechanism by which it exerts its effects in patients with melanoma is unknown.

Pharmacokinetics

The pharmacokinetics was studied in 32 patients receiving adjuvant therapy for melanoma with SYLATRON according to the recommended dose and schedule (6 mcg/kg/week for 8 doses, followed by 3 mcg/kg/week thereafter). At a dose of 6 mcg/kg/week once weekly, the geometric mean Cmax was 4.4 ng/mL (CV 51%) and the geometric mean AUCtau was 430 ng•hr/mL (CV 35%) at week 8. The mean terminal half-life was approximately 51 hours (CV 18%). The mean accumulation from week 1 to week 8 was 1.7. After administration of 3 mcg/kg/week once weekly, the mean geometric Cmax was 2.5 ng/mL (CV 33%) and the geometric mean AUCtau was 228 ng•hr/mL (CV 24%) at week 4. The mean terminal half-life was approximately 43 hours (CV 19%).

Renal Impairment

Renal clearance accounts for approximately 30% of total peginterferon alfa-2b clearance. The effect of renal impairment on the pharmacokinetics of peginterferon alfa-2b was studied in 24 subjects with normal or impaired renal function after a single 4.5 mcg/kg dose. Compared to subjects with normal renal function (CLcr > 80 mL/min/1.73 m²), the geometric mean AUClast to peginterferon alfa-2b increased by 1.4-fold in subjects with moderate renal impairment (CLcr 30 to 50 mL/min/1.73m²) and 2.1-fold in subjects with severe renal impairment (CLcr < 30 mL/min/1.73m²) or ESRD requiring dialysis [see Use in Specific Populations].

No clinically meaningful amounts of peginterferon alfa-2b were removed during hemodialysis following a single 1 mcg/kg dose in subjects with renal impairment.

Drug Interactions

Peginterferon alfa-2b inhibits CYP1A2 and CYP2D6 activity. In a drug interaction study, healthy subjects received a dose of 200 mg of caffeine (CYP1A2 substrate), 2 mg of midazolam (CYP3A4 substrate), 500 mg of tolbutamide (CYP2C9 substrate), or 50 mg of desipramine (CYP2D6 substrate) before and after two doses of SYLATRON administered subcutaneously at a dose of 3 mcg/kg. The geometric mean AUClast was increased by 36% for caffeine and 30% for desipramine when coadministered with SYLATRON compared to caffeine or desipramine administered alone. No clinically meaningful changes in CYP2C9 activity and CYP3A4 activity were observed. [See DRUG INTERACTIONS]

Clinical Studies

The safety and effectiveness of SYLATRON were evaluated in an open-label, multicenter, randomized (1:1) study conducted in 1256 patients with surgically resected, AJCC Stage III melanoma within 84 days of regional lymph node dissection. Patients were randomized to observation (no therapy) (n=629) or to SYLATRON (n=627) at a dose of 6 mcg/kg by subcutaneous injection once weekly for 8 doses followed by a 3 mcg/kg subcutaneous injection once weekly for a period of up to 5 years total treatment. The dose of SYLATRON was adjusted to maintain an ECOG Performance Status of 0 to 1.

The median age of the population was 50 years with 11% of patients 65 years or older, and 42% were female. Forty percent of the study population had microscopic, nonpalpable nodal involvement and 59% had clinically palpable nodes prior to lymphadenectomy. A total of 54% of subjects had one pathologically positive lymph node, 34% had 2 to 4 positive nodes, and 12% had 5 or more. Most subjects had no second primary lesion (98%). Ulceration of the primary lesion was present in 30% of subjects (52% had no ulceration of the primary lesion, and the status was missing/unknown for 18% of subjects). The most common sites were the trunk (43%) or the leg (32%). Eighty-four percent had an International Prognostic Index (IPI) score of 0 and 16% had an IPI score of 1. The main outcome measure was relapse-free survival (RFS), defined as the time from randomization to the earliest date of any relapse (local, regional, in-transit, or distant), or death from any cause. Secondary outcome measures included overall survival.

Patients in the SYLATRON arm received 6 mcg/kg/week for a median of 8.0 weeks. Less than 1% of patients took longer than 9 weeks to complete the 6 mcg/kg/week dosing regimen. Approximately one-third (36%) of patients required dose reductions and 29% of patients required a dose delay, with an average delay of 1.2 weeks, during the initial 8 weeks of SYLATRON. Ninety-four patients (16%) did not continue on to the 3 mcg/kg/week dosing regimen.

Patients who continued on SYLATRON after the initial 8 doses, received 3 mcg/kg/week for a median duration of treatment of 14.3 months. Approximately half (52%) of the patients underwent dose reductions and 70% required dose delays (average delay 2.2 weeks).

Based on 696 RFS events, determined by the Independent Review Committee, median RFS was 34.8 months (95% CI: 26.1, 47.4) and 25.5 months (95% CI: 19.6, 30.8) in the SYLATRON and observation arms, respectively. The estimated hazard ratio for RFS was 0.82 (95% CI: 0.71, 0.96; unstratified log-rank p =0.011) in favor of SYLATRON. Figure 1 shows the Kaplan-Meier curves of RFS.

FIGURE 1: Kaplan-Meier Curves for Relapse-Free Survival

View Enlarged Table

There was no statistically significant difference in survival between the SYLATRON and the observation arms. Based on 525 deaths, the estimated hazard ratio of SYLATRON versus observation was 0.98 (95% CI: 0.82, 1.16).
This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Instructions for Use

SYLATRON™
(SY-LA-TRON)
(peginterferon alfa-2b) Powder for Injection

Be sure that you read, understand and follow these instructions before injecting SYLATRON. Your healthcare provider should show you how to prepare, measure, and inject SYLATRON properly before you use it for the first time. Ask your healthcare provider if you have any questions.

Before starting, collect all of the supplies that you will need to use for preparing and injecting SYLATRON. For each injection you will need a SYLATRON vial package that contains:

  • 1 vial of SYLATRON powder
  • 1 vial of sterile water for injection (diluent). The vial contains an excess amount of sterile water (5 mL). You will only need to withdraw 0.7 mL to prepare your single dose.
  • 2 single-use disposable syringes (BD Safety Lok syringes with a safety sleeve)
  • 2 alcohol swabs

You will also need:

  • 1 cotton ball or gauze
  • 1 sharps disposal container to throw away (dispose of) used syringes, needles, and vials. See “How should I dispose of used syringes, needles, and vials?” at the end of this Instructions for Use.

Important:

  • Do not re-use or share syringes and needles.
  • The vial of mixed SYLATRON should be used right away. Do not mix more than 1 vial of SYLATRON at a time. If you do not use the vial of the prepared solution right away, store it in a refrigerator and use within 24 hours. See the end of this Instructions for Use for information about “How should I store SYLATRON?”
  • Make sure you have the right syringe and needle to use with SYLATRON. Your healthcare provider should tell you what syringes and needles to use to inject SYLATRON.

How should I prepare a dose of SYLATRON?

Before you inject SYLATRON, the powder must be mixed with 0.7 mL of the sterile water for injection (diluent) that comes in the SYLATRON vial package.

1. Find a clean, well-lit, flat work surface.

2. Get 1 of your SYLATRON vial packages. Check the date printed on the SYLATRON carton. Make sure that the expiration date has not passed. Do not use your SYLATRON vial packages if the expiration date has passed. The medicine in the SYLATRON vial should look like a white to off-white tablet that is whole, or in pieces, or powdered.
If you have already mixed the SYLATRON solution and stored it in the refrigerator, take it out of the refrigerator before use and allow the solution to come to room temperature.

3. Wash your hands well with soap and water, rinse and towel dry (See Figure A). Keep your work area, your hands, and injection site clean to decrease the risk of infection.

Figure A

Wash your hands well - Illustration

The disposable syringes have needles that are already attached and cannot be removed. Each syringe has a clear plastic safety sleeve that is pulled over the needle for disposal after use. The safety sleeve should remain tight against the flange while using the syringe and moved over the needle only when ready for disposal. (See Figure B)

Figure B

The disposable syringe - Illustration

4. Remove the protective wrapper from one of the syringes provided. Use the syringe for steps 4 through 15. Make sure that the syringe safety sleeve is sitting against the flange. (See Figure B)

5. Remove the protective plastic cap from the tops of both the sterile water for injection (diluent) and the SYLATRON vials (See Figure C). Clean the rubber stopper on the top of both vials with an alcohol swab.

Figure C

Remove the protective plastic cap - Illustration

6. Carefully remove the protective cap straight off of the needle to avoid damaging the needle point.

7. Fill the syringe with air by pulling back on the plunger to 0.7 mL. (See Figure D)

Figure D

Fill the syringe with air - Illustration

8. Hold the diluent vial upright. Do not touch the cleaned top of the vial with your hands.

  • Push the needle through the center of the rubber stopper of the diluent vial. (See Figure E)
  • Slowly inject all the air from the syringe into the air space above the diluent in the vial. (See Figure F)

Figure E

Push the needle through the center of the rubber stopper -  Illustration

Figure F

Slowly inject all the air from the syringe into the air space - Illustration

9. Turn the vial upside down and make sure the tip of the needle is in the liquid.

  • Important: The sterile water for injection vial contains an excess amount of sterile water (5 mL). You will only need to withdraw 0.7 mL to prepare your single dose.

10. Withdraw only 0.7 mL of diluent by pulling the plunger back to the 0.7 mL mark on the side of the syringe. (See Figure G)

Figure G

Withdraw only 0.7 mL of diluent - Illustration

11. With the needle still inserted in the vial, check the syringe for air bubbles.

  • If there are any air bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe.
  • Slowly push the plunger up to remove the air bubbles.
  • If you push diluent back into the vial, slowly pull back on the plunger to draw the correct amount of diluent back into the syringe.

12. Remove the needle from the vial (See Figure H). Do not let the syringe touch anything.

Figure H

Remove the needle from the vial - Illustration

13. Throw away the diluent that is left over in the vial. Do not save any leftover diluent or use it again. See “How should I dispose of used syringes, needles, and vials?” at the end of this Instructions for Use.

14. Insert the needle through the center of the rubber stopper of the SYLATRON powder vial. Do not touch the cleaned rubber stopper.

  • Place the needle tip, at an angle, against the side of the vial. (See Figure I)
  • Slowly push the plunger down to inject the 0.7 mL diluent. The stream of diluent should run down the side of the vial.
  • To prevent bubbles from forming, do not aim the stream of diluent directly on the medicine in the bottom of the vial.

Figure I

Place the needle tip, at an angle - Illustration

15. Remove the needle from the vial.

  • Firmly grasp the safety sleeve and pull it over the exposed needle until you hear a click (See Figure J). The green stripe on the safety sleeve will completely cover the red stripe on the needle. Dispose of the syringe, needle, and vial in the sharps disposal container. See “How should I dispose of used syringes, needles, and vials?” at the end of this Instructions for Use.

Figure J

Remove the needle from the vial - Illustration

16. Gently swirl the vial in a gentle circular motion, until the SYLATRON is completely dissolved (mixed together). (See Figure K)

  • Do not shake the vial. If any powder remains undissolved in the vial, gently turn the vial upside down until all of the powder is dissolved.
  • The solution may look cloudy or bubbly for a few minutes. If air bubbles form, wait until the solution settles and all bubbles rise to the top.

Figure K

Gently swirl the vial - Illustration

17. After the SYLATRON completely dissolves, the solution should be clear, colorless and without particles. It is normal to see a ring of foam or bubbles on the surface.

  • Do not use the mixed solution if you see particles in it, or it is not clear and colorless. Dispose of the syringe and needle in the sharps disposal container. See the section “How should I dispose of used syringes, needles, and vials?“ at the end of this Instructions for Use. Then, repeat steps 1 through 17 with a new vial of SYLATRON and diluent to prepare a new syringe.

18. After the SYLATRON powder completely dissolves, clean the rubber stopper again with an alcohol swab before you withdraw your dose.

19. Unwrap the second syringe provided. You will use it to give yourself the injection.

  • Carefully remove the protective cap from the needle. Fill the syringe with air by pulling the plunger to the number on the side of the syringe (mL) that matches your prescribed dose. (See Figure L)

Figure L

Carefully remove the protective cap - Illustration
  • Hold the SYLATRON vial upright. Do not touch the cleaned top of the vial with your hands. (See Figure M)

Figure M

Hold the SYLATRON vial upright - Illustration
  • Insert the needle into the vial containing the SYLATRON solution. Inject the air into the center of the vial. (See Figure N)

Figure N

Insert the needle into the vial - Illustration

20. Turn the SYLATRON vial upside down. Be sure the tip of the needle is in the SYLATRON solution.

  • Hold the vial and syringe with one hand. Be sure the tip of the needle is in the SYLATRON solution. With the other hand, slowly pull the plunger back to fill the syringe with the exact amount of SYLATRON into the syringe your healthcare provider told you to use. (See Figure O)

Figure O

Pull the plunger back to fill the syringe with the exact amount - Illustration

21. Check for air bubbles in the syringe. If you see any air bubbles, hold the syringe with the needle pointing up. Gently tap the syringe until the air bubbles rise. Then, slowly push the plunger up to remove any air bubbles. If you push solution into the vial, slowly pull back on the plunger again to draw the correct amount of SYLATRON back into the syringe. When you are ready to inject the medicine, remove the needle from the vial. (See Figure P)

Figure P

Remove the needle from the vial - Illustration

How should I choose a site for injection?

The best sites for giving yourself an injection are those areas with a layer of fat between the skin and muscle, like your thigh, the outer surface of your upper arm, and abdomen (See Figure Q). Do not inject yourself in the area near your navel or waistline. If you are very thin, you should only use the thigh or outer surface of the arm for injection.

Figure Q

Choose a site for injection - Illustration

You should use a different site each time you inject SYLATRON to help avoid soreness at any one site. Do not inject SYLATRON solution into an area where the skin is irritated, red, bruised, infected or has scars, stretch marks, or lumps.

How should I inject a dose of SYLATRON?

22. Clean the skin where the injection is to be given with an alcohol swab. Wait for the area to dry.

  • Make sure the safety sleeve of the syringe is pushed firmly against the syringe flange so that the needle is fully exposed. (See Figure B)

23. With one hand, pinch a fold of skin. With your other hand, pick up the syringe and hold it like a pencil.

  • Insert the needle into the pinched skin at a 45- to 90-degree angle with a quick dart-like motion. (See Figure R)

Figure R

Insert the needle into the pinched skin - Illustration
  • After the needle is inserted, remove the hand that you used to pinch your skin. Use it to hold the syringe barrel.
  • Pull the plunger of the syringe back very slightly.
  • If no blood is present in the syringe, inject the medicine by gently pressing the plunger all the way down the syringe barrel, until the syringe is empty.
  • If blood comes into the syringe, the needle has entered a blood vessel. Do not inject.
    • Withdraw the needle and dispose of the syringe and needle in the sharps disposal container. (See the section “How should I dispose of used syringes, needles, and vials?” at the end of this Instructions for Use.)
    • If there is bleeding, cover the injection site with a bandage.
    • Then, repeat steps 1 through 23 with a new vial of SYLATRON and diluent to prepare a new syringe, and inject the medicine at a new site.

24. When the syringe is empty, pull the needle out of the skin.

  • Place a cotton ball or gauze over the injection site and press for several seconds. Do not massage the injection site.
  • If there is bleeding, cover it with a bandage.

25. After injecting your dose:

  • Firmly grasp the safety sleeve and pull it over the exposed needle until you hear a click, and the green stripe on the safety sleeve covers the red stripe on the needle. (See Figure S)

Figure S

Apply safety mechanism - Illustration

26. Dispose of the used syringes, needles, and vials in the sharps disposal container. (See “How should I dispose of used syringes, needles, and vials?” below.)

How should I dispose of used syringes, needles, and vials?

  • Put your used syringes and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose syringes and needles in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used syringes and needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Always keep the sharps disposal container out of the reach of children.

How should I store SYLATRON?

  • Before mixing, store SYLATRON vials at 59°F to 86°F (15°C to 30°C).
  • After mixing, use SYLATRON right away or store it in the refrigerator for up to 24 hours between 36°F to 46°F (2°C to 8°C). Throw away any mixed SYLATRON that is not used within 24 hours.
  • Do not freeze SYLATRON.
  • Keep SYLATRON away from heat.

Keep SYLATRON and all medicines out of the reach of children.


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.

 

PEGINTERFERON ALFA-2B (ANTI-CANCER) - INJECTION

 

(peg-IN-ter-FEER-on AL-fa too bee)

 

COMMON BRAND NAME(S): Sylatron

 

WARNING: Peginterferon alfa-2b may cause you to develop serious mental/mood changes that may get worse during treatment or after your last dose. Tell your doctor right away if you have symptoms such as confusion, depression, suicidal thoughts, unusual irritability, or aggressive behavior. Your doctor may recommend psychiatric therapy and monitoring. Treatment with this medication may be stopped if symptoms are severe.

 

USES: This medication is used to keep malignant melanoma (a type of skin cancer) from coming back after it has been removed by surgery. This medication is the same as a protein that your body naturally makes (interferon). This medication is thought to work by affecting how cells work and grow and by affecting the body's natural defenses (immune system) in many ways. Adding more interferon may help your body fight off cancer.

 

HOW TO USE: Read the Medication Guide and the Instructions for Use Leaflet provided by your pharmacist before you start using peginterferon alfa-2b and each time you get a refill. If you have any questions, ask your doctor, nurse or pharmacist.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Gently swirl the vial to dissolve the medication. Do not shake the vial. 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.

Before injecting each dose, clean the injection site with rubbing alcohol. Use a different place each time you give yourself an injection to help lessen injection site soreness.

Inject this medication under the skin (subcutaneously) on your thigh, stomach, or the outer surface of your upper arm, as directed by your doctor, usually once weekly. Do not inject near the belly button or at the waistline.

The dosage is based on your body weight, medical condition, and response to treatment.

Use this medication regularly to get the most benefit from it. Remember to use it on the same day each week. It may help to mark your calendar with a reminder.

If you have flu-like symptoms, drink plenty of fluids while you are using this medication, unless your doctor directs you otherwise.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Flu-like symptoms (such as fever, chills, muscle/joint aches, fatigue, headache, nausea, stomach pain) may occur. If instructed to do so, taking pain/fever-reducing medications (such as acetaminophen) or injecting this medication at bedtime may help reduce some of these flu-like symptoms. Dry mouth, bad taste in mouth, increased sweating, loss of appetite, weight loss, trouble sleeping, dizziness, diarrhea, vomiting, dry skin, or redness/swelling at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Tooth and gum problems may sometimes occur during treatment. Having a dry mouth can worsen this side effect. Prevent dry mouth by drinking plenty of water or using a saliva substitute. Brush your teeth well at least twice a day and have regular dental exams. If you experience vomiting during treatment, rinse your mouth afterwards to lessen the chance of tooth and gum problems.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

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.

Tell your doctor right away if you have any serious side effects, including: persistent sore throat or fever, easy or unusual bleeding/bruising, unusually severe fatigue, increased thirst/urination, severe stomach pain with nausea/vomiting, bloody diarrhea.

Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusually slow/fast/pounding heartbeat, vision changes (such as blurred vision, partial loss of vision).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, 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 Sylatron (peginterferon alfa-2b) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using peginterferon alfa-2b, tell your doctor or pharmacist if you are allergic to it; or to polyethylene glycol (PEG); or to other interferons; or if you have any other allergies. This product may contain inactive ingredients, 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: liver disease, mental/mood disorders (such as depression), history of drug/alcohol abuse, thyroid disease, diabetes, eye problems, inflammation of the bowels (such as colitis), pancreatitis, high blood triglyceride levels.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially mental mood changes (such as severe depression, thoughts/attempts of suicide).

This medication is not recommended for use during pregnancy because of possible serious harm to the unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. If you become pregnant or think you may be pregnant, inform your doctor right away.

It is unknown if 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.

Some products that may interact with this drug include: hydroxyurea, telbivudine.

 

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 and/or medical tests (such as blood counts, thyroid tests, kidney/liver function, triglyceride levels, eye exams) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Depending on your medical history, other tests (such as EKG) may be needed. Ask your doctor for more details.

Do not change brands of interferon without checking with your doctor or pharmacist. Other interferons may not have the same effects on your disease.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Consult the product instructions and your pharmacist for storage details. 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.

 

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

Patient Detailed Side Effect

Brand Names: PegIntron, PegIntron Redipen, Sylatron

Generic Name: peginterferon alfa-2b (Pronunciation: peg in ter FEAR on AL fa 2 b)

  • What is peginterferon alfa-2b (Sylatron)?
  • What are the possible side effects of peginterferon alfa-2b (Sylatron)?
  • What is the most important information I should know about peginterferon alfa-2b (Sylatron)?
  • What should I discuss with my healthcare provider before using peginterferon alfa-2b (Sylatron)?
  • How should I use peginterferon alfa-2b (Sylatron)?
  • What happens if I miss a dose (Sylatron)?
  • What happens if I overdose (Sylatron)?
  • What should I avoid while using peginterferon alfa-2b (Sylatron)?
  • What other drugs will affect peginterferon alfa-2b (Sylatron)?
  • Where can I get more information?

What is peginterferon alfa-2b (Sylatron)?

Peginterferon alfa-2b is made from human proteins that help the body fight viral infections.

Peginterferon alfa-2b is used to treat chronic hepatitis C in adults. Peginterferon alfa-2b is often used in combination with another medication called ribavirin (Rebetol, Ribasphere) to treat hepatitis C in adults and children who are at least 3 years old.

Peginterferon alfa-2b may be used in combination with boceprevir (Victrelis) or telaprevir (Incivek) to treat hepatitis C in adults. The Sylatron brand of peginterferon alfa-2b is used to treat melanoma (skin cancer) after surgery.

Peginterferon alfa-2b may also be used for purposes not listed in this medication guide.

What are the possible side effects of peginterferon alfa-2b (Sylatron)?

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

Stop using peginterferon alfa-2b and call your doctor at once if you have severe or worsening symptoms such as: confusion, depression, tired feeling, anxiety, aggression, tremors, muscle twitching, seizure, unusual thoughts or behavior, or thoughts about suicide or hurting yourself. Once you have had this type of reaction to peginterferon alfa-2b, you must never use it again.

Stop using peginterferon alfa-2b and call your doctor at once if you have:

  • vision problems;
  • fast heart rate, feeling like you might pass out;
  • fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, unusual weakness;
  • high fever with severe stomach pain and bloody diarrhea;
  • pain or burning when you urinate;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • cough with mucus, feeling short of breath, chest pain, uneven heartbeats;
  • sudden numbness or weakness, problems with vision, speech, or balance; or
  • new or worsening liver symptoms (upper stomach pain, dark urine, jaundice).

Other common side effects may include:

  • headache, joint or muscle pain;
  • nausea, dry mouth, loss of appetite, weight loss;
  • dizziness, sleep problems (insomnia), feeling mildly anxious, depressed, or irritable; or
  • pain, redness, swelling, or irritation where the medicine was injected.

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 Sylatron (peginterferon alfa-2b) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about peginterferon alfa-2b (Sylatron)?

You should not use this medication if you are allergic to peginterferon alfa-2b or other alfa interferons, or if you have autoimmune hepatitis, liver failure, severe kidney disease, a hemoglobin blood cell disorder, or if you are pregnant or if you are a man and your sexual partner is pregnant.

Peginterferon alfa-2b is often used together with another medication called ribavirin (Rebetol, Ribasphere), which is known to cause birth defects or death in an unborn baby. Do not use peginterferon alfa-2b and ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant.

Before using peginterferon alfa-2b, tell your doctor about all of your medical conditions.

Stop using peginterferon alfa-2b and call your doctor at once if you have severe or worsening symptoms such as: confusion, depression, tired feeling, anxiety, aggression, tremors, muscle twitching, seizure, unusual thoughts or behavior, or thoughts about suicide or hurting yourself. Once you have had this type of reaction to peginterferon alfa-2b, you must never use it again.

There are many other medicines that can interact with peginterferon alfa-2b. Tell your doctor about all the prescription and over-the-counter medications you use.

Side Effects Centers
  • Peg-Intron
  • Sylatron

Patient Detailed How Take

What should I discuss with my healthcare provider before using peginterferon alfa-2b (Sylatron)?

You should not use this medication if you are allergic to peginterferon alfa-2b or other alfa interferons (Intron A, Rebetron, Alferon N, Infergen, Pegasys), or if you have:

  • autoimmune hepatitis;
  • liver failure;
  • severe kidney disease;
  • a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia;
  • if you are pregnant, or if you are a man and your sexual partner is pregnant.

To make sure this medicine is safe for you, tell your doctor if you have:

  • lung disease;
  • hepatitis B, or liver problems other than hepatitis;
  • a thyroid disorder;
  • uncontrolled diabetes;
  • new or worsening problems with your eyes;
  • cancer;
  • HIV or AIDS;
  • pancreatitis or ulcerative colitis;
  • heart disease, high blood pressure, high cholesterol or triglycerides, or a history of heart attack, or stroke;
  • dental problems or gum disease;
  • an allergy causing severe reaction;
  • history of organ transplant;
  • anemia (low red blood cells) caused by taking ribavirin (Rebetol);
  • any blood cell disorder causing bleeding episodes, infections, or fever-related illness;
  • an autoimmune disorder such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or psoriasis; or
  • a history of drug or alcohol addiction, depression, anxiety, or suicidal thoughts or behaviors.

Peginterferon alfa-2b may be harmful to an unborn baby. Do not use peginterferon alfa-2b without telling your doctor if you are pregnant.

Peginterferon alfa-2b is often used together with another medication called ribavirin. Ribavirin is known to cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before taking these two medications together and every month during your treatment.

  • If you are a woman, do not use peginterferon alfa-2b and ribavirin if you are pregnant.
  • If you are a man, do not use peginterferon alfa-2b and ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.
  • Use at least 2 effective forms of birth control while either sexual partner is using peginterferon alfa-2b with ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.
  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is using peginterferon alfa-2b together with ribavirin.

It is not known whether peginterferon alfa-2b passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medicine.

Peginterferon alfa-2b can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I use peginterferon alfa-2b (Sylatron)?

Peginterferon alfa-2b 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.

Peginterferon alfa-2b is usually given once per week. Your doctor may occasionally change your dose to make sure you get the best results from this medication. If you are being treated with combination therapy, you will also take ribavirin (Rebetol) capsules or liquid by mouth every day. Ribavirin should be taken with food.

Peginterferon alfa-2b is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Do not shake the injection pen or vial (bottle) or you may ruin the medicine. Prepare your dose in a syringe 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 pharmacist for new medication.

You may need regular medical tests to be sure this medication is not causing harmful effects. You may also need regular eye exams. Visit your doctor regularly.

Store the PegIntron Redipen in a refrigerator. Do not allow the medicine to freeze.

Store PegIntron or Sylatron vials (bottles) at room temperature away from moisture and heat. Do not freeze. Do not reuse a vial or injection pen.

Mixed medicine may be stored in the refrigerator but you must use it within 24 hours after mixing. Do not freeze or save any unused mixture.

Side Effects Centers
  • Peg-Intron
  • Sylatron

Patient Detailed Avoid Taking

What happens if I miss a dose (Sylatron)?

Use the medicine as soon as you remember the missed dose, then go back to your regular schedule on the day your next dose is due. If you are more than 2 days late in using your injection, call your doctor for instructions. Do not use extra medicine to make up a missed dose.

What happens if I overdose (Sylatron)?

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

What should I avoid while using peginterferon alfa-2b (Sylatron)?

Treatment with this medication does not prevent spread of the hepatitis virus to other people. Follow your doctor's instructions about how to prevent passing the disease to another person.

What other drugs will affect peginterferon alfa-2b (Sylatron)?

Many drugs can interact with peginterferon alfa-2b. Not all possible interactions are listed here. Tell your doctor about all medicines you use, and any you start or stop using during treatment with peginterferon alfa-2b, especially:

  • a blood thinner such as warfarin, Coumadin;
  • fosphenytoin or phenytoin;
  • methadone;
  • ADHD medication such as Adderall, Ritalin, and others;
  • rifampin;
  • telbivudine;
  • voriconazole;
  • an antidepressant or anti-psychotic medication;
  • cancer medication;
  • cough medicine (prescription or over-the-counter);
  • diabetes medications you take by mouth;
  • heart or blood pressure medication;
  • HIV or AIDS medication;
  • medicines used to prevent organ transplant rejection; or
  • a sulfa drug.

This list is not complete and many other drugs can interact with peginterferon alfa-2b. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about peginterferon alfa-2b.


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.

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