Overview
11 DESCRIPTION Glatiramer acetate, the active ingredient of Glatopa, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 – 9,000 daltons.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism(s) by which glatiramer acetate exerts its effects in patients with MS are not fully understood. However, glatiramer acetate is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS. This hypothesis is supported by findings of studies that have been carried out to explore the pathogenesis of experimental autoimmune encephalomyelitis, a condition induced in animals through immunization against central nervous system derived material containing myelin and often used as an experimental animal model of MS. Studies in animals and in vitro systems suggest that upon its administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery.
Indications
- 1 INDICATIONS AND USAGE Glatopa is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Glatopa is indicated for the treatment of relapsing-forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 ).
Common Doses
- 20 mg
- 40 mg
Dosage
2 DOSAGE AND ADMINISTRATION • For subcutaneous injection only; doses are not interchangeable ( 2.1 ) • Glatopa 20 mg/mL per day ( 2.1 ) • Glatopa 40 mg/mL three times per week ( 2.1 ) • Before use, allow the solution to warm to room temperature ( 2.2 ) 2.1 Recommended Dose Glatopa is for subcutaneous use only. Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended doses are: • Glatopa 20 mg per mL: administer once per day or • Glatopa 40 mg per mL: administer three times per week and at least 48 hours apart.
Contraindications
- 4 CONTRAINDICATIONS Glatopa is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Known hypersensitivity to glatiramer acetate or mannitol ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Immediate Post-Injection Reaction [see Warnings and Precautions ( 5.1 )] • Chest Pain [see Warnings and Precautions ( 5.2 )] • Lipoatrophy and Skin Necrosis [see Warnings and Precautions ( 5.3 )] • Potential Effects on Immune Response [see Warnings and Precautions ( 5.4 )] • Hepatic Injury [see Warnings and Precautions ( 5.5 )] • In controlled studies of glatiramer acetate injection 20 mg/mL, most common adverse reactions (≥10% and ≥1.
Interactions
- 7 DRUG INTERACTIONS Interactions between glatiramer acetate injection and other drugs have not been fully evaluated. Results from existing clinical trials do not suggest any significant interactions of glatiramer acetate injection with therapies commonly used in MS patients, including the concurrent use of corticosteroids for up to 28 days. Glatiramer acetate injection has not been formally evaluated in combination with interferon beta.