Adult Dosing

Multiple sclerosis, relapsing-remitting

• 20 mg SC qd or 40 mg SC 3 times/week and administer at least 48 hours apart

Pediatric Dosing

• Safety and effectiveness have not been established in pediatric patients

[Outline]

• Adult Dosing
• Pediatric Dosing

• Management of relapsing-remitting type multiple sclerosis, including patients with a first clinical episode with MRI features consistent with multiple sclerosis.

• Hypersensitivity to glatiramer acetate, mannitol, or any component of the formulation

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• For subcutaneous use only. Do not administer intravenously
• Chest pain may or may not occur with the immediate post-injection reaction; described as a transient pain usually resolving in a few minutes; often unassociated with other symptoms
• Allow syringe to warm to room temperature before administering
• Lipoatrophy and skin necrosis may occur locally at injection site and may not resolve; advise patient to follow proper injection technique and rotate site daily

Caution: Use cautiously in

• Immunosuppressed

Supplemental Patient Information

• Instruct patients to rotate injection sites on a daily basis; caution patients against the reuse of needles or syringes

Pregnancy Category:B

Breastfeeding: Safety unknown. No data available on the use of glatiramer during breastfeeding; glatiramer in breastmilk is probably destroyed in the infant's gastrointestinal tract and not absorbed, except perhaps in neonates. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 4 February 2011). Manufacturer advises caution.

• LOCAL: Injection site reactions
• CV: Vasodilatation, chest pain, palpitations
• DERM: Rash, urticaria, benign neoplasm of skin, hyperhidrosis, skin disorder, sweating
• RESP: Dyspnea, rhinitis, bronchitis, cough, laryngospasm
• CNS: Asthenia, tremor, migraine, syncope, speech disorder
• EENT: Throat constriction
• GI: Gastroenteritis, diarrhea, nausea, vomiting
• GU: Vaginal candidiasis, micturition urgency
• METABOLIC: Increased weight
• MUSC: Back Pain, arthralgia
• PSYCHIATRIC: Anxiety, nervousness
• MISC: Hypersensitivity, pain, edema, pyrexia, chills, face edema, edema peripheral, infection, influenza

• Immunomodulator; exact mechanism of action is unknown; thought to alter immune processes believed to be responsible for pathogenesis of MS (multiple sclerosis)
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Copaxone

US Availability

Copaxone

• INJ (prefilled syringes): 20 mg/mL
• INJ (prefilled syringes): 40 mg/mL

Canadian Trade Name(s)

• Copaxone

Canadian Availability

Copaxone

• INJ: 20 mg/vial
• INJ (prefilled syringes): 20 mg/mL

UK Trade Name(s)

• Copaxone

UK Availability

Copaxone

• INJ (prefilled syringes): 20 mg/mL

Australian Trade Name(s)

• Copaxone

Australian Availability

Copaxone

• INJ (prefilled syringes): 20 mg/mL

[Outline]

Neurologic

Multiple Sclerosis Agent

Immune Response Modifiers