Classes
DEA Class; Rx
Common Brand Names; Copaxone, Glatopa
- Immunomodulators;
- Multiple Sclerosis Treatments
Description
Synthetic random peptide given subcutaneously; formerly known as copolymer-1
Used in adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease; also used off-label in pediatric patients
Immediate post-injection reactions (flushing, chest pain, dyspnea, and urticaria) have been reported and may be serious, and often present several months after treatment initiation
Indications
Indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Contraindications
Hypersensitivity to glatiramer, mannitol
Adverse Effects
- Injection site pain (73%)
- Injection site erythema (66%)
- Injection site inflammation (49%)
- Weakness (41%)
- Injection site pruritus (40%)
- Injection site mass (27%)
- Vasodilation (27%)
- Pain (28%)
- Arthralgia (24%)
- Anxiety (23%)
- Hypertonia (22%)
- Nausea (22%)
- Flu syndrome (19%)
- Dyspnea (19%)
- Pruritus (18%)
- Rash (18%)
- Palpitations (17%)
- Chest pain (13-16% 20 mg/day; 2-4% 40 mg 3x/wk)
- Injection site induration (13%)
- Diarrhea (12%)
- Lymphadenopathy (12%)
- Injection site welt (11%)
- Injection site pain/inflammation (10%)
- Anorexia (8%)
- Anxiety
- Arthralgia
- Asthenia
- Hypertonia
- Infection
- Pain
Warnings
Risk of immediate post-injection reactions (in general, symptoms appear several months following treatment initiation), including transient chest pain (seek prompt medical attention if prolonged or unusually intense chest pain); other symptoms include flushing, palpitations, anxiety, dyspnea, constriction of the throat, and urticaria
Cases of hepatic injury, some severe, including liver failure and hepatitis with jaundice, reported; hepatic injury has occurred from days to years after initiating treatment; if signs or symptoms of liver dysfunction occur, consider discontinuation of therapy
Lipoatrophy and skin necrosis may occur at injection site at various times after treatment onset (sometimes after several months) and is thought to be permanent; there is no known therapy for lipoatrophy; to minimize these events, patient must follow injection technique and rotate sites daily
May impair body’s ability to fight infection by interfering with immune function
Therapy may potentially undermine the body’s tumor surveillance and defense system against infection
Pregnancy and Lactation
Available human data in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage
There are no data on presence of drug in human milk, effects on breastfed infants, or on milk production
Maximum Dosage
Once daily dose schedule: 20 mg/day subcutaneously using the 20 mg/mL solution.
Three times weekly dose schedule: 40 mg/dose subcutaneously using the 40 mg/mL solution.
Once daily dose schedule: 20 mg/day subcutaneously using the 20 mg/mL solution.
Three times weekly dose schedule: 40 mg/dose subcutaneously using the 40 mg/mL solution.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Glatiramer acetate
solution for injection
- 20mg/mL (once daily dosing)
- 40mg/mL (3 times/week dosing)
