Description
- to treat adult patients with a blood cancer named hairy cell leukemia
- to treat certain adult patients with a type of skin cancer named malignant melanoma
- to treat adult patients with some types of Follicular Non-Hodgkin’s Lymphoma together with certain other chemotherapy medications
- to treat certain adult patients with genital warts (condylomata acuminata), by injecting the medication directly into the warts
- to treat certain adult patients with a type of cancer caused by AIDS, named AIDS-related Kaposi’s Sarcoma
- alone to treat adult patients with chronic (lasting a long time) hepatitis C infection with stable liver problems
- with medicine Ribavirin to treat chronic (lasting a long time) hepatitis C infection in individuals aged 3 years and older with stable liver problems
- to treat chronic (lasting a long time) hepatitis B infection in individuals aged 1 year and older with stable liver problems
Hairy cell leukemia: 2 MU/m2 intramuscularly or subcutaneously three times a week for up to 6 months.
Malignant melanoma: 20 MU/ m2 by intravenous infusion, 5 days per week, for 4 weeks followed by 10 MU/ m2 SC 3 times a week for 48 weeks.
Follicular lymphoma: 5 MU SC 3 times a week for up to 18 months along with anthracycline-containing chemotherapy.
Condylomata Acuminata: 1 MU per lesion three times weekly for 3 weeks.
AIDS-Related Kaposi’s Sarcoma: 30 MU/ m2 SC or IM three times a week until the disease is progressive or maximal response has been achieved following 16 weeks of treatment.
Chronic Hepatitis C: 3MU three times a week SC or IM. In patients tolerating therapy with normalization of ALT at 16 weeks treatment therapy should be extended to 18-24 months at 3 MU three times a week for improving the sustained response Rate. Patients that do not normalize their ALTs following 16 weeks of therapy may not be required further treatment.
Chronic Hepatitis B: (adults) 30-35 MU per week SC or IM for 16 weeks, and (Pediatric) 3 MU/m2 SC three times per week times one week followed by the 6 MU/m2 SC three times weekly for a total of 16-24 weeks.
Side Effects:
The most commonly reported side effects of interferon alfa-2b may include:- flu-like symptoms
- headache
- feeling tired
- nausea
- diarrhea
- loss of appetite
- thinning hair
- swelling, pain or burning at the site of injection
Warnings and Precautions:
- Acute hypersensitivity reactions (e.g., urticaria, bronchoconstriction, angioedema, anaphylaxis) have been observed rarely during therapy with Interferon alfa 2b injection. In case such reactions develop, discontinue therapy and institute apt medical therapy. Transient rashes do not necessitate interruption of Interferon treatment.
- Patients developing liver function abnormalities during therapy with Interferon alfa 2b must be monitored precisely and treatment discontinued if signs/symptoms progress. Liver enzymes and hepatic function need to be closely monitored in cirrhotic patients.
- Hypotension may appear during Interferon alfa 2b therapy or up to 2-days post-therapy and may need supportive treatment. Maintain adequate hydration in patients undergoing Interferon alfa therapy since hypotension related to fluid depletion has been observed in some patients. Fluid replacement may be required.
- Interferon-alfa-2b must be used precisely in patients with debilitating medical complications, such as those with a known history of pulmonary disease (chronic obstructive pulmonary disease) or diabetes mellitus prone to ketoacidosis. Caution is required also in patients with coagulation disorders (pulmonary embolism, thrombophlebitis) or severe myelosuppression.
- Periodic visual evaluations during therapy with Interferon-alfa-2b are recommended specifically in patients with disorders that may be related to retinopathy, such as hypertension or diabetes mellitus.
- Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have occurred. Evaluation of lipid levels is, therefore, required.
- Patients co-infected with HIV and receiving Highly Active Antiretroviral Therapy (HAART) may be at greater risk of developing lactic acidosis. Caution is required when adding Interferon-alfa-2b and ribavirin to HAART therapy. Patients treated with Interferon-alfa-2b and ribavirin combination therapy and zidovudine could be at higher risk of developing anemia.
- Cases of hepatitis B reactivation (some with severe consequences) may occur in patients co-infected with hepatitis B/C viruses treated with interferon. Although, the frequency of this occurrence is low. All patients should be screened for hepatitis B prior to starting treatment with interferon for hepatitis C; patients co-infected with hepatitis B/C must then be assessed and managed as per the current clinical guidelines.
- Standard haematological tests, as well as blood chemistries (platelet count, complete blood count and differential, electrolytes, serum protein, liver enzymes, serum bilirubin and serum creatinine), are to be conducted in patients before and periodically during systemic therapy with Interferon alfa-2b.
- In patients treated for malignant melanoma, liver function and WBC count and differential must be assessed weekly during the induction phase of therapy and monthly during the maintenance phase of therapy.
- Women of childbearing age have to use effective contraception during therapy. Decreased serum estradiol and progesterone concentrations have been noted in women treated with human leukocyte interferon. The intalfa must be used with caution in fertile men.
- Use of Ribavirin therapy is restricted in females who are pregnant. It is unknown whether the components of this medicine are excreted in human milk. Due to the potential for side effects in nursing infants, nursing should be discontinued before the initiation of treatment.