Interferon Beta-1A

Registered South African indications:

• Multiple sclerosis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Current severe depression and/or suicidal ideation

Cautions

• Breastfeeding
• Severe renal impairment
• Severe hepatic impairment
• Elderly
• Previous or current depressive disorders
• History of seizures
• Severe myelosuppression
• Cardiovascular disease
• May impair ability to drive and operate machinery 

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

Relapsing remitting multiple sclerosis
-Characterised by at least 2 recurrent attacks of neurological dysfunction over the preceding 2 years

Prefilled syringe 

• SC: Initial: Week 1-2: 4.4μg, 3 times weekly; Week 3-4: 11μg, 3 times weekly; Maintenance: 22μg, 3 times weekly from week 5
  OR
• IM: 30μg, weekly

Prefilled pen

• SC: Initial: Week 1-2: 8.8μg, 3 times weekly; Week 3-4: 22μg, 3 times weekly; Maintenance: 44μg, 3 times weekly from week 5

Treatment should be initiated and adjusted by a specialist

Inject into upper thigh or lower abdomen; rotate injection sites

Administer preferably on the same three days of the week (at least 48 hours apart, e.g. Monday, Wednesday, Friday) and at the same time of the day (preferably in the evening)

Not established for use in children below 16 years

Pregnancy

• FDA Pregnancy Category C

Breastfeeding

• Caution; not recommended

Renal Impairment

• Severe: Caution; no dose adjustment recommended

Hepatic Impairment

• Severe: Caution; no dose adjustment recommended

Elderly

• Caution; no information available

Central Nervous System Disorders

• Headache
• Muscle spasticity
• Hypoaesthesia
• Neurological symptoms
• Syncope
• Hypertonia
• Dizziness
• Paraesthesia
• Seizures
• Migraine
• Fatigue
• Depression
• Insomnia
• Suicide
• Psychosis
• Anxiety
• Confusion
• Emotional lability

Cardiovascular Disorders

• Cardiomyopathy
• Congestive cardiac failure 
• Palpitations
• Arrhythmia
• Tachycardia
• Flushing
• Vasodilatation
• Chest pain

Respiratory Disorders

• Rhinorrhoea
• Dyspnoea
• Pulmonary arterial hypertension

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea

Hepatobiliary Disorders

• Abnormal hepatic function tests 
• Hepatic failure
• Hepatitis
• Autoimmune hepatitis

Genitourinary Disorders

• Nephrotic syndrome
• Glomerulosclerosis
• Metrorrhagia
• Menorrhagia

Endocrine and Metabolic Disorders

• Decreased weight 
• Increased weight
• Hypothyroidism
• Hyperthyroidism
• Anorexia

Musculoskeletal Disorders

• Muscle cramps
• Neck pain
• Myalgia
• Arthralgia
• Pain in extremity
• Back pain
• Muscle stiffness
• Musculoskeletal stiffness
• Systemic lupus erythematosus
• Muscle weakness
• Arthritis

Skin and Subcutaneous Tissue Disorders

• Rash
• Sweating 
• Contusion
• Alopecia
• Angioneurotic oedema
• Pruritus
• Vesicular rash 
• Urticaria
• Aggravation of psoriasis
• Injection site reactions 

Immune, Blood and Lymphatic System Disorders

• Pancytopenia
• Thrombocytopenia
• Thrombotic microangiopathy 
• Decreased lymphocyte count 
• Decreased white blood cell count 
• Decreased neutrophil count 
• Decreased hematocrit 
• Increased blood potassium 
• Increased blood urea nitrogen
• Decreased platelet count
• Flu-like symptoms
• Fever 
• Chills
• Sweating
• Night sweats
• Anaphylactic reaction
• Anaphylactic shock
• Hypersensitivity reactions

No information available

• Full blood count with differential
• Hepatic function
• Thyroid function test
• Renal function
• Electrolytes
• Mental state 

Interferons are a group of endogenous glycoproteins endowed with immunomodulatory, antiviral and antiproliferative properties. Interferon beta-1A is composed of the native amino acid sequence of natural human interferon beta. It is produced in mammalian cells and is therefore glycosylated like the natural protein. The precise mechanism of action of interferon beta-1A in multiple sclerosis is still under investigation. Interferons exert several different types of biological effects including anti-viral, anti-proliferative, differentiative and immunomodulatory.

Injection (per 0.5ml) 22μg

• Rebif 22 pre-filled pen (Merck) originator

• Rebif 22 pre-filled syringe (Merck) originator

Injection (per 0.5ml) 30μg

• Avonex pre-filled syringe (Pharmaplan) originator
• Avonex (Acino Pharma)

Injection (per 0.5ml) 44μg

• Rebif 44 pre-filled pen (Merck) originator

• Rebif 44 pre-filled syringe (Merck) originator