Dosing and uses of Copaxone, Glatopa (glatiramer)
Adult dosage forms and strengths
subcutaneous solution for injection
- 20mg/mL (once daily dosing); Copaxone, Glatopa
- 40mg/mL (3 times/week dosing); Copaxone
Multiple Sclerosis
Indicated for the treatment of relapsing forms of multiple sclerosis
20 mg/mL syringe: 20 mg SC qDay, Or
40 mg/mL syringe: 40 mg SC 3 times/week (administer at least 48 hr apart)
Dosing Considerations
Monitor: Hgb, WBC, Platelet, LFTs
ALS (Orphan)
Treatment of amyothrophic lateral sclerosis
Orphan indication sponsor
- Teva Neurosciences, Inc; P. O. Box 1005; Horsham, PA 19044-8005
Primary Progressive Multiple Sclerosis (Orphan)
Orphan indication sponsor
- Teva Neurosciences, Inc; P. O. Box 1005; Horsham, PA 19044-8005
Administration
For SC use only; do not administer IV
The dosing schedule depends on the product strength that is selected; 20 mg/mL and 40 mg/mL are not interchangeable
Let the prefilled syringe stand at room temperature for 20 minutes to allow the solution to warm to room temperature
Visually inspect for particulate matter and discoloration prior to administration; solution should appear clear, colorless to slightly yellow
If particulate matter or discoloration is observed, discard the syringe
Areas for SC self-injection include arms, abdomen, hips, and thigh
The prefilled syringe is for single use only; discard unused portions
Areas for SC self-injection include arms, abdomen, hips, and thigh
Pediatric dosage forms and strengths
Safety and efficacy not established
Copaxone, Glatopa (glatiramer) adverse (side) effects
>10%
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%)
1-10%
Injection site pain/inflammation (10%)
Anorexia (8%)
Frequency not defined
Anxiety
Arthralgia
Asthenia
Hypertonia
Infection
Pain
Postmarketing Reports
Cardiovascular system: Thrombosis; peripheral vascular disease; pericardial effusion; myocardial infarct; deep thrombophlebitis; coronary occlusion; congestive heart failure; cardiomyopathy; cardiomegaly; arrhythmia; angina pectoris
Digestive system: tongue edema; stomach ulcer; hemorrhage; liver function abnormality; liver damage; hepatitis; eructation; cirrhosis of the liver; cholelithiasis
Hemic and lymphatic system: Thrombocytopenia; lymphoma-like reaction; acute leukemia
Metabolic and nutritional disorders: Hypercholesterolemia
Musculoskeletal system: Rheumatoid arthritis; generalized spasm
Nervous system: Myelitis; meningitis; CNS neoplasm; cerebrovascular accident; brain edema; abnormal dreams; aphasia; convulsion; neuralgia
Respiratory system: Pulmonary embolus; pleural effusion; carcinoma of lung
Special Senses: Glaucoma; blindness
Urogenital system: Urogenital neoplasm; urine abnormality; ovarian carcinoma; nephrosis; kidney failure; breast carcinoma; bladder carcinoma; urinary frequency
Warnings
Contraindications
Hypersensitivity to glatiramer, mannitoL
Cautions
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
Lipoatrophy and skin necrosis may occur at injection site (patient must follow injection technique and rotate sties daily
May impair body's ability to fight infection by interfering with immune function
Pregnancy and lactation
Pregnancy category: B
Lactation: not known if excreted in breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Copaxone, Glatopa (glatiramer)
Mechanism of action
Synthetic amino acid copolymer; precise mechanism unknown but possibly through immune modulation; may interfere with antigen presenting function of some immune cells opposing pathogenic T-cell function; may also activate T-lymphocyte suppressor cells specific for myelin antigen
Pharmacokinetics
Metabolism: Drug may be hydrolyzed locally
Distribution: Intact of partially hydrolyzed drug may enter lymphatic circulation and some may enter systemic circulation
