ROFERON-A Injection

Interferon Alfa-2a
4.5 MIU
F. Hoffmann-La Roche Ltd.
Pack size 0.5ml Syringe
Dispensing mode POM
Source SWITZERLAND
AgentCITY MEDICAL STORE
Retail Price 185.50 AED

Indications

ROFERON-A Injection is used for: Renal cell carcinoma, Chronic hepatitis B, Chronic hepatitis C, Hairy cell leukaemia, AIDS related Kaposi's sarcoma, Chronic myeloid leukaemia, Follicular lymphoma, Cutaneous T-cell lymphoma, Melanoma

Adult Dose

Subcutaneous Renal cell carcinoma Adult: As an adjunct to cytotoxic chemotherapy: In an escalating dose of 3 million units 3 times wkly for 1 wk, then 9 million units 3 times wkly for 1 wk, then 18 million units 3 times wkly thereafter for 3-12 mth. Chronic hepatitis B Adult: 2.5-5 million units/m2 3 times/wk for 4-6 mth. Chronic hepatitis C Adult: 3-4.5 million units 3 times wkly for 6 mth when used with ribavirin. As monotherapy: Initial: 3-6 million units 3 times wkly for 6 mth followed by 3 million units 3 times wkly for an additional 6 mth, or 3 million units 3 times wkly for 12 mth. Hairy cell leukaemia Adult: 3 million units daily for 16-24 wk. Maintenance: 3 million units 3 times/wk. May continue treatment for up to 24 wk. AIDS-related Kaposi's sarcoma Adult: In an escalating dose of 3 million units daily for 3 days, 9 million units daily for 3 days, 18 million units daily for 3 days, and 36 million units daily, if tolerated, on days 10-84. thereafter the max tolerated dose (up to 36 million units) may be given 3 times wkly. Chronic myeloid leukaemia Adult: In an escalating dose of 3 million units daily for 3 days, 6 million units daily for 3 days, and 9 million units daily thereafter. For responders after 12 wk: Continue treatment until a complete haematological response is achieved or for a max of 18 mth; for those who achieve a complete haematological response: Continue on 9 million units daily (at least 9 million units 3 times wkly) in order to achieve a cytogenetic response. Follicular lymphoma Adult: As an adjunct to chemotherapy: 6 million units/ m2 daily on days 22-26 of each 28-day chemotherapy cycle. Cutaneous T-cell lymphoma Adult: In an escalating dose of 3 million units daily for 3 days, then 9 million units daily for 3 days, and then 18 million units daily to complete 12 wk of treatment. Thereafter, the max tolerated dose (up to 18 million units) is given 3 times wkly for at least 12 mth in responders. Melanoma Adult: 3 million units 3 times/wk for 18 mth. Start treatment no later than 6 wk after surgery.

Child Dose

Renal Dose

Administration

Contra Indications

Hypersensitivity. Autoimmune hepatitis, hepatic decompensation.

Precautions

History of depression (monitor for signs). Perform regular neuropsychiatric monitoring. Seizure disorders and/or compromised CNS function. Preexisting or any history of cardiac disease. Monitor CBC prior to and during therapy. Myelosuppression or concurrent use of myelosuppressive drugs. Hypothyroidism, hyperthyroidism, DM. Perform ophthalmological exam on patients with preexisting ophthalmologic disorders (e.g. diabetic or hypertensive retinopathy). Monitor patients with impaired renal function. Creatinine clearance <50 ml/min. May impair ability to drive or operate machinery. Pregnancy and lactation.

Pregnancy-Lactation

Interactions

Reduces clearance of theophylline. Enhanced myelosuppression with other myelosuppressive drugs (e.g. zidovudine). Drugs metabolised by CYP450 pathway (monitor for changes in pharmacologic or adverse effects of concomitant drug). Increased risk of toxicity of centrally acting drugs. Increased risk of renal failure with interleukin-2.

Adverse Effects

Side effects of Interferon Alfa-2a : Depressive illness, suicidal behaviour, irritability, insomnia, anxiety. Flu-like symptoms. Headache, dizziness, paraesthesia, confusion, impaired concentration, alteration in taste or smell. GI disturbances. Dryness of oropharynx, epistaxis, rhinitis, arrhythmia, sinusitis. Inj site reaction, alopecia, rash, dry skin or pruritus. Conjunctivitis, menstrual irregularity, visual disturbances. Coughing, dyspnoea. Myalgia, joint or bone pain, arthritis or polyarthritis. Bone marrow depression. Potentially Fatal: Marked increase in triglyceride levels, GI haemorrhage, severe infections, pulmonary infiltrates or pulmonary function impairment.

Mechanism of Action

Interferon alfa-2a has antiviral, antitumour and immunomodulatory activity. It inhibits replication of a wide range of RNA and DNA viruses. It also exerts antiproliferative effects on normal and malignant cells. Interferon alfa-2a suppresses antibody formation through an effect on B-lymphocytes and inhibits onset of delayed hypersensitivity.

Note

ROFERON-A 4.5 MIU Injection manufactured by F. Hoffmann-La Roche Ltd.. Its generic name is Interferon Alfa-2a. ROFERON-A is availble in United Arab Emirates. Farmaco UAE drug index information on ROFERON-A Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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