Interferon Alfa-2A

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
• Cutaneous T cell lymphoma
• Chronic myelogenous leukaemia
• Low-grade non-Hodgkin's lymphoma
• Kaposi's sarcoma (AIDS related)
• Advanced renal cell carcinoma
• Metastatic malignant melanoma
• AJCC stage II malignant melanoma (Breslow tumour thickness > 1.5mm with no lymph node involvement or cutaneous spread) who are free of disease after surgery
• Chronic active hepatitis B in adults who have viral markers for viral replication, e.g. those who are positive for HBV-DNA polymerase or HBeAg
• Chronic Hepatitis C, diagnosed by HCV antibodies and/or a history of exposure to hepatitis C in patients with compensated liver disease and are 18 years or older

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Severe renal impairment
• Severe hepatic impairment
• Severe pre-existing cardiac disease
• History of cardiac illness
• Severe myeloid dysfunction
• Uncontrolled seizure disorders
• Compromised central nervous system function
• Chronic hepatitis currently or recently treated with immunosuppressive agents
• Children

Cautions

• Pregnancy
• Breastfeeding
• Mild to moderate renal impairment
• Mild to moderate hepatic impairment
• Elderly
• Myeloid dysfunction
• Transplant patients
• Substance use disorders
• Psychiatric disorders
• Diabetes mellitus
• Hypertension
• History of autoimmune disease
• Haemodialysis
• Haemophilia
• Human immunodeficiency virus

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

Chronic hepatitis B
- HBeAg-positive and HBeAg-negative

Interferon alfa-2A

• SC: 2.5-5 million IU/m², 3 times a week; Treatment duration: 4-6 months

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If no improvement observed after 3 to 4 months, discontinuation of therapy should be considered

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Chronic hepatitis C 

Interferon alfa-2A

• SC: 3 million IU, 3 times weekly; Treatment duration: 48 to 52 weeks

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Interferon alfa-2A is given in combination with ribavirin for patients with a relapse of chronic hepatitis C who have previously responded to interferon alpha monotherapy

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Hairy cell leukaemia
Cutaneous T cell lymphoma
Chronic myelogenous leukaemia
Low-grade non-Hodgkin's lymphoma
Kaposi's sarcoma
Advanced renal cell carcinoma
Metastatic malignant melanoma
AJCC stage II malignant melanoma

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Consult specialist for dosages and regimens

Not established for use in children

Pregnancy

• Caution
• There are no adequate data on the use of interferon alpha-2a in pregnant women. Men and women receiving interferon alpha-2a should practise effective contraception. When doses greatly in excess of the recommended clinical dose were administered to pregnant rhesus monkeys in the early to mid-foetal period, an abortifacient effect was observed
• Although animal tests do not indicate that interferon alpha-2a is a teratogen, harm to the foetus from use during pregnancy cannot be excluded. In pregnancy, Interferon alpha-2a should be administered only if the benefit to the woman justifies the potential risk to the foetus

Breastfeeding

• Caution; not recommended
• It is not known whether interferon alpha-2a is excreted in human milk. A decision must be taken whether to suspend breastfeeding or to discontinue the drug, taking into account the importance of interferon alpha-2a to the mother

Renal Impairment

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

Hepatic Impairment

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

Elderly

• Caution; no information available

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Depression
• Anxiety
• Mental status changes
• Confusion
• Abnormal behaviour
• Nervousness
• Memory impairment
• Sleep disorder
• Suicide
• Suicide attempt
• Suicidal ideation
• Mania
• Headache
• Neuropathy
• Dizziness
• Hypoesthesia
• Paraesthesia
• Tremor
• Somnolence
• Coma
• Cerebrovascular accident
• Seizures
• Encephalopathy
• Fatigue

Cardiovascular Disorders

• Arrhythmias
• Palpitations
• Cyanosis
• Cardiorespiratory arrest
• Myocardial infarction
• Congestive cardiac failure
• Pulmonary oedema
• Hypertension
• Hypotension
• Vasculitis
• Chest pain

Respiratory Disorders

• Pneumonia
• Dyspnoea
• Cough
• Pulmonary arterial hypertension
• Epistaxis
• Mucosal dryness
• Rhinorrhoea

Gastrointestinal Disorders

• Nausea and vomiting
• Dysgeusia
• Diarrhoea
• Abdominal pain
• Dry mouth
• Pancreatitis
• Intestinal hypermotility
• Constipation
• Dyspepsia
• Flatulence
• Reactivation of peptic ulcer
• Gastrointestinal bleeding (non life threatening)
• Ischaemic colitis
• Ulcerative colitis

Hepatobiliary Disorders

• Hepatic failure
• Hepatitis
• Hepatic dysfunction
• Increased serum transaminases
• Increased serum alkaline phosphatase
• Increased serum bilirubin
• Increased serum lactate dehydrogenase

Genitourinary Disorders

• Transient erectile dysfunction
• Proteinuria
• Increased cell count in urine
• Acute renal failure
• Renal impairment
• Increased serum creatinine
• Increased serum urea

Endocrine and Metabolic Disorders

• Hypothyroidism
• Hyperthyroidism
• Thyroid dysfunction
• Anorexia
• Inconsequential hypocalcaemia
• Dehydration
• Electrolyte imbalance
• Diabetes mellitus
• Hyperglycaemia
• Hypertriglyceridemia
• Hyperlipidaemia
• Decreased appetite
• Decreased weight
• Increased serum uric acid

Musculoskeletal Disorders

• Myalgia
• Arthralgia
• Systemic lupus erythematosus
• Arthritis

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Increased sweating
• Psoriasis
• Pruritus
• Rash
• Dry skin
• Injection site necrosis
• Injection site reaction

Immune, Blood and Lymphatic System Disorders

• Herpes simplex
• Leukopenia
• Thrombocytopenia
• Anaemia
• Agranulocytosis
• Haemolytic anaemia
• Idiopathic thrombocytopenic purpura
• Neutropenia
• Autoimmune disorder
• Acute hypersensivity reactions
• Sarcoidosis
• Graft rejections
• Fever

Sensory Disorders

• Visual disturbance
• Conjunctivitis
• Ischemic retinopathy
• Retinal artery thrombosis
• Optic neuropathy
• Retinal haemorrhage
• Retinal vein thrombosis
• Retinal exudates
• Retinopathy
• Papilloedema
• Vertigo

• Antiretrovirals
• Theophylline
• Centrally acting agents
• Ribavirin

• Full blood count
• Hepatic function
• Renal function
• Serum uric acid
• Thyroid function
• Ophthalmic examination

Specific cases may require

• Pregnancy test
• Mental status
• Hepatitis C RNA levels
• Echocardiogram

• Benzyl alcohol, which is a recognised excipient in interferon Alfa-2A solution for injection (10 mg/ml) has on rare occasions been associated with potentially fatal toxicities and anaphylactoid reactions in children up to 3 years old. Therefore, interferon Alfa-2A solution for injection should not be used in premature babies, neonates, infants or children up to 3 years old

Alpha interferons are proteins that have antiviral, antiproliferative, and immune-regulating activity. Interferon alfa-2A increases cell resistance to viral infection as well as stimulating the immune system to neutralise viruses or destroy virus infected cells. The antineoplastic action of interferon alfa-2A is not well understood.

Injection (per 0.5ml) 3Miu

• Roferon-A pre-filled syringe (Roche) originator

Injection (per 0.5ml) 4.5Miu

• Roferon-A pre-filled syringe (Roche) originator

Injection (per 0.5ml) 6Miu

• Roferon-A pre-filled syringe (Roche) originator

Injection (per 0.5ml) 9Miu

• Roferon-A pre-filled syringe (Roche) originator