Interferon Alfa-2B

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Hairy cell leukaemia
• Chronic hepatitis B
• Chronic hepatitis C
• Kaposi's sarcoma (AIDS patients)
• Non-Hodgkin's lymphoma
• Philadelphia chromosome positive chronic myeloid leukaemia in the chronic phase
• Malignant melanoma, as adjunct to surgery in patients at high risk of systemic recurrence
• Condylomata acuminata
• Basal cell carcinoma, where standard therapy is considered inappropriate

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Severe renal impairment
• Severe hepatic impairment
• Severe pre-existing cardiac disease
• Epilepsy
• Compromised central nervous system function
• Chronic hepatitis recently treated with immunosuppressive agents
• Autoimmune hepatitis
• History of autoimmune disease
• Immunosuppressed transplant recipients
• Pre-existing thyroid disease
• Coadministration with telbivudine

Cautions

• Pregnancy
• Breastfeeding 
• Mild to moderate renal impairment
• History of severe psychiatric condition
• Substance use disorder
• Pulmonary disease
• Diabetes mellitus
• Coagulation disorders
• Severe myelosuppression
• Hypertension
• History of congestive cardiac failure, myocardial infarction, or arrhythmic disorders
• Psoriasis
• Sarcoidosis
• Kidney or liver transplant
• HIV co-infection

Forms avail. in SA and covered in this monograph: inj

Chronic hepatitis B

• SC/IM: 3-5 million IU, 3 times weekly; Treatment duration: 4-6 months

OR

• SC/IM: 5 million IU, dly; Treatment duration: 4 months

OR

• SC/IM: 10 million IU, 3 times weekly; Treatment duration: 4 months

Chronic hepatitis C

• SC/IM: 3 million IU, 3 times weekly; Minimum treatment duration: 6 months

Condylomata acuminata

• Intralesional: 1 million IU, 3 times weekly; Treatment duration: 3 weeks; Max dose: 15 million IU/week

---

Course may be repeated after 12-16 weeks

---

Hairy cell leukaemia
Kaposi's sarcoma
Non-Hodgkin's lymphoma
Chronic myeloid leukaemia
Malignant melanoma

---

Consult specialist for dosages and regimens

Not established for use in children below 18 years in South Africa

Pregnancy 

• Caution; not recommended - Interferon Alfa-2B alone
• A has been shown to have abortifacient effects in Macaca mulatta (rhesus monkeys) at 15 and 30 million IU/kg (estimated human equivalent of 5 and 10 million IU/kg, based on body surface area adjustment for a 60-kg adult)
• There are no adequate and well-controlled studies in pregnant women
• Interferon Alfa-2B therapy should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus
• Contraindicated - Combined with Ribavirin
• Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin
• Ribovirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant

Breastfeeding

• Caution; not recommended 
• It is not known whether this drug is excreted in human milk. However, studies in mice have shown that mouse interferons are excreted into the milk
• Because of the potential for serious adverse reactions from the drug in nursing infants, a decision should be made whether to discontinue breastfeeding or to discontinue Interferon Alfa-2B therapy, taking into account the importance of the drug to the mother

Fertility

• Interferon may impair fertility. In studies of interferon administration in nonhuman primates, menstrual cycle abnormalities have been observed
• Decreases in serum estradiol and progesterone concentrations have been reported in women treated with human leukocyte interferon. Therefore, fertile women should not receive Interferon Alfa-2B therapy unless they are using effective contraception during the therapy period
• Interferon therapy should be used with caution in fertile men

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Contraindicated

Hepatic Impairment

• Severe: Contraindicated

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Central Nervous System Disorders

• Depression
• Insomnia
• Anxiety
• Emotional lability
• Agitation
• Nervousness
• Confusion
• Sleep disorder
• Decreased libido
• Suicidal ideation
• Suicide attempts
• Aggressive behaviour 
• Psychosis 
• Homicidal ideation
• Mental status change
• Mania
• Bipolar disorders
• Dizziness
• Headache
• Impaired concentration 
• Tremor
• Paresthesia
• Hypoaesthesia
• Migraine
• Somnolence
• Peripheral neuropathy
• Cerebrovascular haemorrhage
• Cerebrovascular ischaemia
• Seizures
• Impaired consciousness
• Encephalopathy
• Mononeuropathies
• Coma
• Fatigue

Cardiovascular Disorders

• Flushing
• Palpitation
• Tachycardia
• Cardiomyopathy
• Myocardial infarction
• Cardiac ischaemia
• Congestive cardiac failure
• Pericardial effusion
• Arrhythmia
• Hypertension
• Peripheral ischaemia
• Hypotension
• Chest pain

Respiratory Disorders

• Pharyngitis
• Bronchitis
• Sinusitis
• Rhinitis
• Pneumonia
• Dyspnoea
• Coughing
• Epistaxis
• Respiratory disorder
• Nasal congestion
• Rhinorrhea
• Nonproductive cough
• Pulmonary infiltrates
• Pneumonitis
• Pulmonary fibrosis
• Pulmonary arterial hypertension

Gastrointestinal Disorders

• Dry mouth
• Dysgeusia
• Nausea and vomiting
• Abdominal pain
• Diarrhoea
• Stomatitis
• Dyspepsia
• Ulcerative stomatitis
• Right upper quadrant pain
• Glossitis
• Gingivitis
• Constipation
• Loose stools
• Pancreatitis
• Ischaemic colitis
• Ulcerative colitis
• Gingival bleeding
• Periodontal disorder

Hepatobiliary Disorders

• Hepatomegaly
• Hepatotoxicity

Genitourinary Disorders

• Micturition frequency
• Renal failure
• Renal insufficiency
• Nephrotic syndrome
• Menorrhagia
• Menstrual disorder
• Vaginal disorder

Endocrine and Metabolic Disorders

• Hypothyroidism
• Hyperthyroidism
• Diabetes mellitus
• Anorexia
• Hypocalcaemia
• Dehydration
• Hyperuricemia
• Thirst
• Hyperglycaemia
• Hypertriglyceridaemia
• Increased appetite
• Amenorrhea
• Breast pain
• Dysmenorrhea

Musculoskeletal Disorders

• Myalgia
• Arthralgia
• Musculoskeletal pain
• Arthritis
• Rhabdomyolysis
• Myositis
• Leg cramps
• Back pain

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Pruritus
• Skin dry
• Rash
• Increased sweating
• Psoriasis
• Eczema
• Erythema
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Erythema multiforme
• Injection site reaction
• Fever

Immune, Blood and Lymphatic System Disorders

• Leukopaenia
• Thrombocytopaenia
• Lymphadenopathy
• Lymphopenia
• Aplastic anaemia
• Pure red cell aplasia
• Idiopathic thrombocytopenic purpura
• Thrombotic thrombocytopenic purpura
• Sarcoidosis
• Systemic lupus erythematosus
• Vasculitis
• Rheumatoid arthritis
• Vogt-Koyanagi-Harada syndrome
• Acute hypersensitivity reactions 

Sensory Disorders

• Blurred vision
• Conjunctivitis
• Abnormal vision
• Lacrimal gland disorder
• Eye pain
• Retinal haemorrhages
• Retinopathies 
• Retinal artery or vein obstruction
• Optic neuritis
• Papilloedema
• Loss of visual acuity or visual field
• Cotton-wool spots
• Serous retinal detachment
• Vertigo
• Tinnitus
• Hearing loss
• Hearing disorder

• Central nervous system depressants
• Potentially myelosuppressive agents
• Theophylline
• Aminophylline
• Shosaikoto
• Chemotherapeutic agents
• Telbivudine

• Renal function
• Hepatic function
• Thyroid function
• Serum electrolytes
• Lipid profile
• Full blood count
• Differential count 
• Chest xray
• Prothrombin time
• Weight

Specific cases may require

• Ophthalmic examination
• ECG

Alpha interferons are proteins that have antiviral, antiproliferative, and immune-regulating activity. Interferon alfa-2b has antiproliferative effects as well as significant immunomodulatory activity in vitro. It also inhibits viral replication in vitro and in vivo.  

Injection (per 0.2ml) 3 million IU

• Intron A Redipen (MSD) originator

Injection (per 0.2ml) 5 million IU

• Intron A Redipen (MSD) originator

Injection (per 0.2ml) 10 million IU

• Intron A Redipen (MSD) originator