Interferon alfa-2b: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Intralesional
Condyloma acuminata

Adult: 1 million IU into each lesion (Max 5 lesions per treatment course) 3 times weekly (every other day) for 3 weeks; repeat after 12-16 weeks as needed. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Indications and routes of administration may vary among countries or individual products. Refer to specific product guidelines.

Parenteral
AIDS-related Kaposi's sarcoma

Adult: 30 million IU/m² 3 times weekly via SC or IM inj. Continue until disease progression or until a maximal response has been achieved after 16 weeks. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Indications and routes of administration may vary among countries or individual products. Refer to specific product guidelines.

Parenteral
Malignant melanoma

Adult: As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence (e.g. patients with primary or recurrent [clinical or pathological] lymph node involvement): Induction: 20 million IU/m² via IV infusion over 20 minutes for 5 consecutive days a week for 4 weeks. Maintenance: 10 million IU//m² via SC inj 3 times weekly (every other day) for 48 weeks. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Indications and routes of administration may vary among countries or individual products. Refer to specific product guidelines.

Parenteral
Hairy cell leukaemia

Adult: 2 million IU/m² via SC or IM inj 3 times weekly (every other day) for up to 6 months. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Indications and routes of administration may vary among countries or individual products. Refer to specific product guidelines.

Parenteral
Chronic hepatitis B

Adult: In cases wherein, there is evidence of hepatitis B viral replication (presence of DNA of hepatitis B virus (HBV-DNA) and hepatitis B antigen (HBAg), elevated ALT and histologically proven active liver inflammation and/or fibrosis: 5-10 million IU via SC inj 3 times weekly (every other day) for 4-6 months. Alternatively, 30-35 million IU weekly (either as 5 million IU daily or as 10 million IU 3 times weekly) via SC or IM inj for 16 weeks. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Indications and routes of administration may vary among countries or individual products. Refer to specific product guidelines.
Child: ≥1 year 3 million IU/m² via SC inj 3 times weekly for the 1st week then increased to 6 million IU/m² 3 times weekly (Max 10 million IU 3 times weekly) administered subcutaneously for a total duration of 16-24 weeks. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Indications and routes of administration may vary among countries or individual products. Refer to specific product guidelines.

Parenteral
Chronic hepatitis C

Adult: In patients with compensated liver disease and who are positive for hepatitis C virus RNA (HCV-RNA): 3 million IU via SC or IM inj 3 times weekly (every other day) for 6-12 months (depending on genotype and patient’s response) when used with ribavirin, or for 6-18 months when used as monotherapy. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Indications and routes of administration may vary among countries or individual products. Refer to specific product guidelines.
Child: ≥3 years In patients with compensated liver disease, not previously treated, and who are positive for HCV-RNA, in combination with ribavirin: 3 million IU/m² via SC inj 3 times weekly (every other day) for 1 year (genotype 1) or for 24 weeks (genotype 2/3). Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Indications and routes of administration may vary among countries or individual products. Refer to specific product guidelines.

Subcutaneous
Carcinoid tumours

Adult: Treatment of carcinoid tumours with lymph node or liver metastases and with carcinoid syndrome: 5 million IU (3-9 million IU) 3 times weekly (every other day). Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Indications and routes of administration may vary among countries or individual products. Refer to specific product guidelines.

Subcutaneous
Follicular lymphoma

Adult: As adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen: 5 million IU 3 times weekly (every other day) for up to 18 months. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Indications and routes of administration may vary among countries or individual products. Refer to specific product guidelines.

Subcutaneous
Chronic myeloid leukaemia

Adult: 4-5 million IU/m² daily. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Indications and routes of administration may vary among countries or individual products. Refer to specific product guidelines.

Subcutaneous
Multiple myeloma

Adult: As maintenance therapy in patients who have achieved objective remission (more than 50% reduction in myeloma protein) following initial induction chemotherapy: 3 million IU/m² 3 times weekly (every other day). Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability. Indications and routes of administration may vary among countries or individual products. Refer to specific product guidelines.

Contraindications

Hypersensitivity. History of severe cardiac disease (e.g. recent MI, uncontrolled CHF, severe arrhythmic disorders), epilepsy and/or compromised CNS function, autoimmune hepatitis or history of autoimmune disease, immunosuppressed transplant recipients, rapidly progressive visceral disease, pre-existing thyroid disease (unless it can be controlled with conventional treatment); current or history of severe psychiatric condition (e.g. severe depression, suicidal ideation or suicide attempt) particularly in children and adolescents. Severe renal or hepatic impairment (including decompensated liver disease or that caused by metastases).

Special Precautions

Patient with current or history of severe psychiatric conditions (adults), previous or current arrhythmic disorders, debilitating medical conditions (e.g. history of pulmonary disease, diabetes mellitus prone to ketoacidosis), coagulation disorders (e.g. thrombophlebitis, pulmonary embolism), pre-existing myelosuppression, thyroid disease or eye disorders; psoriasis or sarcoidosis, predisposition to autoimmune disorders, HCV/HIV co-infection, HCV/HBV co-infection, substance use disorder (alcohol, cannabis). Children. Pregnancy and lactation.

Adverse Reactions

Significant: Hypotension, prolongation of coagulation markers, liver abnormalities, pyrexia, flu-like symptoms, obtundation and coma (including cases of encephalopathy), hypertriglyceridaemia, exacerbation of pre-existing psoriatic or sarcoidosis, increased rate of kidney graft or liver graft rejection, development of auto-antibodies and autoimmune disorders, dental and periodontal disorders, bone marrow suppression (e.g. neutropenia, thrombocytopenia, anaemia), haemorrhagic and ischaemic cerebrovascular events, hypothyroidism or hyperthyroidism, nausea and vomiting, hepatitis B virus reactivation; weight loss and growth inhibition in children. Rarely, acute serious hypersensitivity reactions (e.g. urticaria, angioedema, bronchoconstriction, anaphylaxis), retinal haemorrhage, cotton wool spots, serous retinal detachment, retinal artery or vein obstruction. Very rarely, seizures (at high doses).
Blood and lymphatic system disorders: Leucopenia, lymphadenopathy, lymphopenia.
Cardiac disorders: Palpitations, tachycardia.
Ear and labyrinth disorders: Tinnitus, vertigo.
Eye disorders: Blurred vision, conjunctivitis, abnormal vision, lacrimal gland disorder, eye pain.
Gastrointestinal disorders: Abdominal pain, diarrhoea, dyspepsia, stomatitis, right upper quadrant pain, glossitis, gingivitis, constipation, loose stools.
General disorders and administration site conditions: Fatigue, rigors, asthenia, chest pain, malaise, inj site reactions (e.g. inflammation, pain).
Hepatobiliary disorders: Hepatomegaly.
Infections and infestations: Viral infection.
Investigations: Decreased weight.
Metabolism and nutrition disorders: Anorexia, dehydration, hypocalcaemia, hyperuricaemia, thirst.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, musculoskeletal pain, arthritis.
Nervous system disorders: Dizziness, headache, impaired concentration, dry mouth, tremors, paraesthesia, hypoaesthesia, migraine, flushing, somnolence, taste perversion.
Psychiatric disorders: Depression, insomnia, agitation, anxiety, emotional lability, nervousness, irritability, confusion, sleep disorder.
Renal and urinary disorders: Micturition frequency.
Reproductive system and breast disorders: Amenorrhoea, breast pain, dysmenorrhoea, menorrhagia, menstrual or vaginal disorder, decreased libido.
Respiratory, thoracic and mediastinal disorders: Bronchitis, pharyngitis, sinusitis, rhinitis dyspnoea, cough, epistaxis, respiratory disorder, nasal congestion, rhinorrhoea.
Skin and subcutaneous tissue disorders: Alopecia, pruritus, rash (including erythematous or maculopapular rash), dry skin, increased sweating, eczema, skin disorder, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Vascular disorders: Hypertension.
Potentially Fatal: Pulmonary infiltrates, pneumonitis, pneumonia; aggravate neuropsychiatric (e.g. depression, suicidal ideation and attempted suicide), autoimmune (e.g. thrombocytopenia, vasculitis, Raynaud's phenomenon, rheumatoid arthritis, lupus erythematosus, rhabdomyolysis), ischaemic, infectious disorders; hepatoxicity.

Patient Counseling Information

Maintain adequate hydration. This drug may cause fatigue, somnolence, or confusion, if affected, do not drive or operate machinery.

Monitoring Parameters

Perform standard haematological tests and blood chemistries (e.g. CBC with differential, platelet count, electrolytes, liver enzymes, lipid levels, serum protein, serum bilirubin and serum creatinine), eye examination prior to and periodically during treatment; liver biopsy to establish the diagnosis of chronic hepatitis. Monitor for weight changes and signs of depression or suicidal ideation.

Drug Interactions

May increase risk of peripheral neuropathy of telbivudine. Increased toxicity with other chemotherapeutic agents (e.g. cytarabine, cyclophosphamide, doxorubicin, teniposide). Concomitant use with hydroxyurea may increase the frequency and severity of cutaneous vasculitis. Increased myelosuppressive effects with other potentially myelosuppressive agents (e.g. zidovudine). Increases serum concentrations of theophylline.

Action

Description:
Mechanism of Action: Interferon alfa-2b binds to specific membrane receptors on the cell surface. Once bound, it initiates a series of intracellular activities including induction of certain enzymes, suppression of cell proliferation, enhancement of the phagocytic activity of macrophages, augmentation of cytotoxicity of lymphocytes for target cells, and inhibition of viral replication.
Pharmacokinetics:
Absorption: Bioavailability: 83% (IM); 90% (SC). Time to peak plasma concentration: Approx 3-12 hours (IM/SC); by the end of a 30-minute infusion (IV).
Distribution: Volume of distribution: 31 L (higher [370-720 L] in patients with leukaemia receiving continuous infusion).
Metabolism: Primarily renal, filtered and absorbed at the renal tubule.
Excretion: Elimination half-life: Approx 2 hours (IV); approx 2-3 hours (IM/SC).

Chemical Structure

Storage

Store between 2-8°C. Do not freeze.

MIMS Class

Antivirals / Cancer Immunotherapy

References

Anon. Interferon Alfa-2b. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 15/10/2021.

Anon. Interferon Alfa. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 15/10/2021.

Buckingham R (ed). Interferon Alfa. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/10/2021.

Intron A 3 million IU/0.5 mL Solution for Injection or Infusion (Merck Sharp & Dohme B.V.). European Medicines Agency [online]. Accessed 15/10/2021.

Intron A Injection, Solution (Merck Sharp & Dohme Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 15/10/2021.

Intron A, Recombinant for Injection (Schering Corporation, a subsidiary of Merck & Co. Inc.). U.S. FDA. https://www.fda.gov. Accessed 15/10/2021.

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