COMPOSITION: Glatiramer (as acetate) 20mg. Reconstituted solution contains 20mg/ml.
PRESENTATION: Powder for solution for injection.
STORAGE AND STABILITY: Store at 2-8C.
ACTION: Immunomodulator.
INDICATIONS: Reduction of frequency of relapses in ambulatory patients with relapsing-remitting multiple sclerosis characterised by at least one clinical relapse over the preceding two-year period.
CONTRAINDICATIONS: Allergy to active substance or mannitol.
DOSAGE AND ADMINISTRATION: Patients should be supervised by a health care professional during, and for 30 minutes after, the first time they self-inject.
Adults, 20mg glatiramer acetate reconstituted with 1ml water for injections (see SPC for instructions), administered as a subcutaneous injection once daily. A decision concerning long-term treatment should be made on an individual basis.
Paediatric use (under 18 years of age), not recommended.
Elderly, not specifically studied.
Renal impairment, not specifically studied. Renal function should be monitored during treatment (see SPC).
Pregnancy, safety has not been established. Administration should only be considered if the expected benefit to the mother outweighs any possible risk to the foetus.
Lactation, data unavailable and caution should be exercised when administering to a nursing mother (see SPC).
OVERDOSAGE: A few cases of overdosage (up to 80mg) have been reported (see SPC). In case of overdose, monitor patients and institute appropriate symptomatic and supportive therapy.
PRECAUTIONS: Glatiramer should not be administered by intravenous or intramuscular routes. Caution should be exercised in patients with pre-existing cardiac disorders and these patients should be followed up regularly during treatment.
DRUG INTERACTIONS: Interactions with other drugs have not been formally evaluated. There are no data on interactions with interferon beta. In patients receiving concurrent administration of corticosteroids, an increased incidence of injection site reactions has been seen. Glatiramer has, theoretically, the potential to affect the distribution of protein bound drugs (see SPC) and concomitant use of such products should be monitored.
SIDE EFFECTS: The most common injection site reactions included hypersensitivity, pain, mass, inflammation and oedema. Immediate post-injection reactions included vasodilatation, chest pain, dyspnoea, palpitations or tachycardia. Other adverse reactions were arthralgia, rash, sweating, lymphadenopathy, tremor, peripheral oedema, face oedema and syncope. See SPC for further details.
NET PRICE: Pack of 28 vials of Copaxone 20mg, 28 vials of water for injections, 28 syringes, 28 19-gauge needles and 28 27-gauge needles £510.14.
SUPPLIER: Co-marketed by Aventis Pharma (tel 01732 584000, fax 01732 584086) and Teva Pharmaceuticals (from December 13, tel 01296 719768, fax 01296 719769).
LEGAL CLASS: POM.