Interferon Beta-1B

Registered South African indications: 

• Multiple sclerosis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Patients with decompensated liver disease
• Current severe depression and or suicidal ideation

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment
• Hepatic impairment
• Elderly
• Pre-existing monoclonal gammopathy
• Hypertriglyceridaemia
• Previous or current depressive disorders/suicidal ideation
• History of seizures
• Thyroid dysfunction
• Pre-existing cardiac disorders
• Anaemia
• Thrombocytopenia
• Leukopenia
• Neutropenia
• Metastasising malignant disease
• Severe infection and sepsis
• Alcohol abuse

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

Patients with a single clinical event suggestive of multiple sclerosis to delay progression to definite multiple sclerosis and to delay the progression of sustained neurological disability
Ambulatory patients with relapsing-remitting multiple sclerosis characterised by at least 2 attacks of neurologic dysfunction over a two year period followed by complete or incomplete recovery
Secondary progressive multiple sclerosis

• SC: Initial: 0.0625mg (0.25ml), every alternate day; Maintenance: 0.25mg (1.0ml); equivalent to (8.0 million IU), every alternate day
• Schedule for dose titration:

The treatment with Interferon-based therapy should be initiated under the supervision of a physician experienced in the treatment of the disease

Not established for use in children below 18 years

Pregnancy

• Caution; not recommended
• A large amount of data (more than 1000 pregnancy outcomes) from interferon beta registries, national registries, and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure during the first trimester of pregnancy
• However, the duration of exposure during the first trimester is uncertain, because data was collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when pregnancy was detected and/or confirmed. Experience with exposure during the second and third trimester is very limited
• Based on animal data, there is a possible increased risk for spontaneous abortion
• The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data does not suggest an increased risk so far
• If clinically needed, the use of interferon beta-1b may be considered during pregnancy (a case-based approach)
• The relationship between interferon beta-1b and the abortions cannot be determined, at least partially because of the lack of details involving this clinical trial, such as the timing of abortion to drug administration, the dose used, the clinical condition of the women, and the number of pregnant women in the trial

Breastfeeding

• Caution; not recommended
• Limited information available on the transfer of interferon beta-1b into breast milk, together with the chemical/physiological characteristics of interferon beta, suggests that levels of interferon beta-1b excreted in human milk are neglible
• No harmful effects on the breastfed newborn/infant are anticipated
• Interferon beta can be used during breastfeeding
• No reports describing the use of interferon beta-1b during human lactation have been reported

Fertility

• No investigations on fertility have been conducted

Renal Impairment

• Severe: Caution; no dose adjustment recommended
  Discontinue therapy if progressive deteriorations in the patient's eGFR and/or CrCl are observed

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no information available
  Monitor for CNS adverse effects that may be significant in the elderly

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Confusional state
• Suicide attempt
• Emotional lability
• Convulsion

Cardiovascular Disorders

• Tachycardia
• Cardiomyopathy

Respiratory Disorders

• Bronchospasm
• Pulmonary arterial hypertension

Gastrointestinal Disorders

• Pancreatitis

Hepatobiliary Disorders

• Increased blood bilirubin
• Increased gamma-glutamyl-transferase  
• Hepatitis
• Hepatic injury
• Hepatic failure

Genitourinary Disorders

• Nephrotic syndrome
• Glomerulosclerosis
• Menorrhagia

Endocrine and Metabolic Disorders

• Hypothyroidism
• Hyperthyroidism
• Thyroid disorders
• Increased weight
• Decreased weight
• Increased blood triglycerides
• Anorexia

Musculoskeletal Disorders

• Arthralgia
• Drug-induced lupus erythematosus

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Pruritus
• Alopecia
• Skin discolouration
• Injection site necrosis

Immune, Blood and Lymphatic System Disorders

• Anaemia
• Thrombocytopenia
• Thrombotic microangiopathy
• Thrombotic thrombocytopenic purpura
• Haemolytic uraemic syndrome
• Anaphylactic reactions
• Capillary leak syndrome in pre-existing monoclonal gammopathy

• Immunomodulators 
• Agents with an effect on the haematopoetic system
• CYP450 substrates
• Agents with narrow therapeutic index

• Full blood count
• Hepatic function

Specific cases may require

• Thyroid function

Traceability

• In order to improve traceability of biological medicinal products, the name and the batch number of the administered interferon beta-1b product should be clearly recorded

Immunogenicity

• As with all therapeutic proteins, there is potential for immunogenicity
• Interferon beta-1b products contain human albumin and hence carries a potential risk for transmission of viral diseases. The risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded

Interferon beta-1b has been shown to possess both antiviral and immunoregulatory activities. The mechanisms by which interferon beta-1b exerts its actions in multiple sclerosis are not clearly understood. However, it is known that the biologic response-modifying properties of interferon beta-1b are mediated through its interactions with specific cell receptors found on the surface of human cells. The binding of interferon beta-1b to these receptors induces the expression of a number of gene products that are believed to be the mediators of the biological actions of interferon beta-1b.

Injection (per ml) 0.25mg

• Betaferon pre-filled syringe (Bayer) originator