Recombinant interferon alfa-2b

What is Recombinant interferon alfa-2b?

• Recombinant interferon alfa-2b (Intron A) is a form of interferon alfa (a substance normally made by cells in the immune system) and is made in the laboratory.
• It is a type of cytokine and a type of biological response modifier.
• Also called IFN alpha-2B, interferon alfa-2b, and Intron A.

1RH2 Recombinant Human Interferon-Alpha 2b-01

1RH2Recombinant Human Interferon-Alpha 2b

What are the uses of this medicine?

Recombinant interferon alfa-2b (Intron A) is a prescription medicine that is used:

• to treat adults with a blood cancer called hairy cell leukemia
• to treat certain adults with a type of skin cancer called malignant melanoma
• to treat adults with some types of Follicular Non-Hodgkin's Lymphoma along with certain chemotherapy medicines
• to treat certain adults with genital warts (condylomata acuminata), by injecting the medicine directly into the warts
• to treat certain adults with a type of cancer caused by AIDS, called AIDS-related Kaposi's Sarcoma
• alone to treat adults with chronic (lasting a long time) hepatitis C infection with stable liver problems
• with REBETOL to treat chronic (lasting a long time) hepatitis C infection in people 3 years and older with stable liver problems
• to treat chronic (lasting a long time) hepatitis B infection in people 1 year and older with stable liver problems

How does this medicine work?

• The interferons are a family of naturally occurring small proteins and glycoproteins produced and secreted by cells in response to viral infections and to synthetic or biological inducers.
• Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface.
• Once bound to the cell membrane, interferons initiate a complex sequence of intracellular events.
• These include the induction of certain enzymes, suppression of cell proliferation, immunomodulating activities such as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells, and inhibition of virus replication in virus-infected cells.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• had a serious allergic reaction to another alpha interferon product or are allergic to any of the ingredients in INTRON A.
• have certain types of hepatitis (autoimmune hepatitis)
• have certain other liver problems

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following:

• telbivudine (Tyzeka)
• theophylline (Elixophyllin, Theo-24, Theochron)
• zidovudine (Retrovir, in Combivir, in Trizivir)

Is this medicine FDA approved?

• It was developed at Biogen, and ultimately marketed by Schering-Plough under the trade name Intron-A.
• It was also produced in 1986 in recombinant human form, in the Center for Genetic Engineering and Biotechnology of Havana, Cuba, under the name Heberon Alfa R.

How should this medicine be used?

Recommended dosage: Hairy Cell Leukemia:

• The recommended dose for the treatment of hairy cell leukemia is 2 million IU/m2 administered intramuscularly or subcutaneously 3 times a week for up to 6 months.

Malignant Melanoma:

• The recommended daily dose of INTRON A in induction is 20 million IU/m2 as an intravenous infusion, over 20 minutes, 5 consecutive days per week, for 4 weeks.
• The recommended dose of INTRON A for maintenance is 10 million IU/m2 as a subcutaneous injection three times per week for 48 weeks.

Follicular Lymphoma:

• The recommended dose of INTRON A for the treatment of follicular lymphoma is 5 million IU subcutaneously three times per week for up to 18 months in conjunction with anthracycline-containing chemotherapy regimen and following completion of the chemotherapy regimen.

Condylomata Acuminata:

• The recommended dose is 1.0 million IU per lesion in a maximum of 5 lesions in a single course.
• The lesions should be injected three times weekly on alternate days for 3 weeks.
• An additional course may be administered at 12 to 16 weeks.

AIDS-Related Kaposi's Sarcoma:

• The recommended dose of INTRON A for Kaposi's Sarcoma is 30 million IU/m2/dose administered subcutaneously or intramuscularly three times a week until disease progression or maximal response has been achieved after 16 weeks of treatment.

Chronic Hepatitis C:

• The recommended dose of INTRON A for the treatment of chronic hepatitis C is 3 million IU three times a week (TIW) administered subcutaneously or intramuscularly.

Chronic Hepatitis B Adults:

• The recommended dose of INTRON A for the treatment of chronic hepatitis B is 30 to 35 million IU per week, administered subcutaneously or intramuscularly, either as 5 million IU daily (QD) or as 10 million IU three times a week (TIW) for 16 weeks.

Chronic Hepatitis B Pediatrics:

• The recommended dose of INTRON A for the treatment of chronic hepatitis B is 3 million IU/m2 three times a week (TIW) for the first week of therapy followed by dose escalation to 6 million IU/m2 TIW (maximum of 10 million IU TIW) administered subcutaneously for a total duration of 16 to 24 weeks.

Administration:

• HCV, inject the medication either subcutaneously or intramuscularly three times a week.
• HBV, inject the medication either subcutaneously or intramuscularly three times a week usually for 16 weeks.
• hairy cell leukemia, inject the medication either intramuscularly or subcutaneously 3 times a week for up to 6 months.
• malignant melanoma, inject the medication intravenously for 5 consecutive days for 4 weeks, then subcutaneously three times per week for 48 weeks.
• follicular melanoma, inject the medication subcutaneously three times per week for up to 18 months.
• genital warts, inject the medication intralesionally three times weekly on alternate days for 3 weeks, then treatment may be continued for up to 16 weeks.
• Kaposi's sarcoma, inject the medication either subcutaneously or intramuscularly three times a week for 16 weeks.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a powder in a vial to mix with liquid and as a solution to inject intramuscular, subcutaneous, intralesional, or intravenous Injection

This medicine is available in fallowing brand namesː

• INTRON A

What side effects can this medication cause?

The most common side effects of this medicine include:

• Flu-like symptoms
• Tiredness
• Appetite problems
• Skin reactions
• Hair thinning

INTRON A may cause serious side effects including:

• Heart problems
• Stroke or symptoms of a stroke
• Mental health problems, including suicide
• New or worsening autoimmune disease
• Infections

What special precautions should I follow?

• Acute serious hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been observed rarely in INTRON® A-treated patients; if such an acute reaction develops, the drug should be discontinued immediately and appropriate medical therapy instituted.
• Elevated triglyceride levels have been observed in patients treated with interferons, including INTRON A therapy. Elevated triglyceride levels should be managed as clinically appropriate.
• Dental and periodontal disorders have been reported in patients receiving ribavirin and interferon combination therapy. If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
• INTRON A therapy should be used cautiously in patients with a history of cardiovascular disease.
• Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alpha-based therapies, including INTRON A.
• INTRON A should be used with caution in patients with a history of psychiatric disorders. If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period.
• INTRON A therapy suppresses bone marrow function and may result in severe cytopenias including aplastic anemia. It is advised that complete blood counts (CBC) be obtained pretreatment and monitored routinely during therapy.
• Decrease or loss of vision, retinopathy including 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 interferon alfa-2b or other alpha interferons. All patients should receive an eye examination at baseline.
• Infrequently, patients receiving INTRON A therapy developed thyroid abnormalities, either hypothyroid or hyperthyroid. Patients who develop these conditions during treatment and cannot be controlled with medication should not continue INTRON A therapy.
• Hepatotoxicity, including fatality, has been observed in interferon alpha-treated patients, including those treated with INTRON A.
• Rare cases of autoimmune diseases including thrombocytopenia, vasculitis, Raynaud's phenomenon, rheumatoid arthritis, lupus erythematosus, and rhabdomyolysis have been observed in patients treated with alpha interferons, including patients treated with INTRON A. Any patient developing an autoimmune disorder during treatment should be closely monitored and, if appropriate, treatment should be discontinued.
• The powder formulations of this product contain albumin, a derivative of human blood. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
• Peripheral neuropathy has been reported when alpha interferons were given in combination with telbivudine. The safety and efficacy of telbivudine in combination with interferons for the treatment of chronic hepatitis B has not been demonstrated.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Hepatic enzyme abnormalities
• renal failure
• hemorrhage
• myocardial infarction

Treatment of overdosage:

• There is no specific antidote for interferon alfa-2b.
• Hemodialysis and peritoneal dialysis are not considered effective for treatment of overdose.

Can this medicine be used in pregnancy?

• It is not known if INTRON A will harm your unborn baby.
• You should use effective birth control during treatment with INTRON A.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established for indications other than chronic hepatitis B and chronic hepatitis C.

What are the active and inactive ingredients in this medicine?

Active ingredient: interferon alfa-2b Inactive ingredients:

• Powder for injection contains: glycine, sodium phosphate dibasic, sodium phosphate monobasic, human albumin. Sterile water for injection is provided as a diluent.
• Solution Multidose vials for injection contain: sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, edetate disodium, polysorbate 80, and m-cresol as a preservative.

Who manufactures and distributes this medicine?

Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA

What should I know about storage and disposal of this medication?

INTRON A Solution for Injection:

• Store in the refrigerator between 36°F to 46°F (2°C to 8°C).
• INTRON A Solution for Injection in Multidose vials for injection may be used to give more than 1 injection of medicine.
• Do not freeze.
• Throw away any unused INTRON A Solution for Injection remaining in the vial after one month.

INTRON A Powder for Injection:

• Before mixing, store in the refrigerator between 36°F to 46°F (2°C to 8°C).
• After mixing the INTRON A Powder for Injection, use the solution right away or store the solution in the refrigerator for up to 24 hours between 36°F to 46°F (2°C to 8°C).
• Throw away any medicine left in the vial after you withdraw 1 dose.
• Do not freeze.

• Dailymed label info on Recombinant interferon alfa-2b
• FDA Recombinant interferon alfa-2b

Recombinant interferon alfa-2b Resources
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Recombinant interferon alfa-2b Resources
Latest articles Most recent articles Ongoing trials	Wikipedia