Glatiramer
Generic Name: glatiramer
Brand Names:
Glatiramer Acetate
11 DESCRIPTION Glatiramer acetate, the active ingredient of glatiramer acetate injection, 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. Glatiramer acetate is identified by specific antibodies.
Overview
11 DESCRIPTION Glatiramer acetate, the active ingredient of glatiramer acetate injection, 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. Glatiramer acetate is identified by specific antibodies.
Uses
1 INDICATIONS AND USAGE Glatiramer acetate injection 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. Glatiramer acetate injection 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 ).
Dosage
2 DOSAGE AND ADMINISTRATION • For subcutaneous injection only; doses are not interchangeable ( 2.1 ) • Glatiramer acetate injection 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 Glatiramer acetate injection is for subcutaneous use only [see Dosage and Administration (2.2) ] . Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended dose is: • Glatiramer acetate injection 40 mg per mL: administer three times per week and at least 48 hours apart Glatiramer acetate injection 20 mg per mL and glatiramer acetate injection 40 mg per mL are not interchangeable.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Anaphylactic Reactions [see Warnings and Precautions (5.1) ] • Immediate Post-Injection Reaction [see Warnings and Precautions (5.2) ] • Chest Pain [see Warnings and Precautions (5.3) ] • Lipoatrophy and Skin Necrosis [see Warnings and Precautions (5.4) ] • Potential Effects on Immune Response [see Warnings and Precautions (5.5) ] • Hepatic Injury [see Warnings and Precautions (5.6) ] • In controlled studies of glatiramer acetate injection 20 mg/mL, most common adverse reactions (≥ 10% and ≥ 1.5 times higher than placebo) were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain ( 6.1 ) • In a controlled study of glatiramer acetate injection 40 mg/mL, most common adver...
Warnings
WARNING: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with glatiramer acetate injection. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. • Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction; instruct them to seek immediate medical care should these symptoms occur. 5 WARNINGS AND PRECAUTIONS • Immediate Post-Injection Reaction (flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and/or urticaria), may occur within seconds to minutes after injection and are generally transient and self-limiting ( 5.2 ) • Chest pain, usually transient ( 5.3 ) • Lipoatrophy and skin necrosis may occur. 4 CONTRAINDICATIONS Glatiramer acetate injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] . Known hypersensitivity to glatiramer acetate or mannitol ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data from pharmacovigilance and published observational studies over decades of use with glatiramer acetate during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes ( see Data ). Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryofetal or offspring development (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Glatiramer Acetate Injection is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution in a 1 mL single-dose, prefilled syringe with fixed ½ inch 29 gauge needle supplied as: • 40 mg/mL in a single-dose, prefilled syringe with a light blue plunger, in individual blister packages supplied in 12-count cartons (NDC 0378-6961-12).
Frequently Asked Questions
What is Glatiramer used for?▼
1 INDICATIONS AND USAGE Glatiramer acetate injection 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. Glatiramer acetate injection 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 ).
What are the side effects of Glatiramer?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Anaphylactic Reactions [see Warnings and Precautions (5.1) ] • Immediate Post-Injection Reaction [see Warnings and Precautions (5.2) ] • Chest Pain [see Warnings and Precautions (5.3) ] • Lipoatrophy and Skin Necrosis [see Warnings and Precautions (5.4) ] • Potential Effects on Immune Response [see Warnings and Precautions (5.5) ] • Hepatic Injury [see Warnings and Precautions (5.6) ] • In controlled studies of glatiramer acetate injection 20 mg/mL, most common adverse reactions (≥ 10% and ≥ 1.5 times higher than placebo) were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain ( 6.1 ) • In a controlled study of glatiramer acetate injection 40 mg/mL, most common adver...
Can I take Glatiramer during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from pharmacovigilance and published observational studies over decades of use with glatiramer acetate during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes ( see Data ). Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryofetal or offspring development (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.
What are the important warnings for Glatiramer?▼
WARNING: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with glatiramer acetate injection. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. • Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction; instruct them to seek immediate medical care should these symptoms occur. 5 WARNINGS AND PRECAUTIONS • Immediate Post-Injection Reaction (flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and/or urticaria), may occur within seconds to minutes after injection and are generally transient and self-limiting ( 5.2 ) • Chest pain, usually transient ( 5.3 ) • Lipoatrophy and skin necrosis may occur. 4 CONTRAINDICATIONS Glatiramer acetate injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] . Known hypersensitivity to glatiramer acetate or mannitol ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.