GLATOPA- glatiramer acetate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLATIRAMER ACETATE (UNII: 5M691HL4BO) (GLATIRAMER - UNII:U782C039QP)

Available from:

Sandoz Inc

INN (International Name):

GLATIRAMER ACETATE

Composition:

GLATIRAMER ACETATE 20 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Glatiramer acetate injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Available human data on the use of glatiramer acetate injection in pregnant women are not sufficient to support conclusions about drug-associated risk for major birth defects and miscarriage. Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on embryo-fetal or offspring development (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data There are no adequate and well-controlled studies of glatiramer acetate injection in pregnant women. The available postmarketing reports, case series, and small cohort studies do not provide sufficient information to support conclusions about drug-associated risk for major birth defects and miscarriage. Animal Data In rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryo-fetal development were observed at doses up to 37.5 mg/kg/day (18 and 36 times, respectively, the therapeutic human dose of 20 mg/day on a mg/m2 basis). In rats receiving subcutaneous glatiramer acetate at doses of up to 36 mg/kg from day 15 of pregnancy throughout lactation, no significant effects on delivery or on offspring growth and development were observed. Risk Summary There are no data on the presence of glatiramer acetate in human milk. Based on the low systemic exposure because of substantial local hydrolysis of glatiramer acetate following subcutaneous administration, breastfeeding is not expected to result in clinically relevant exposure of the infant to the drug [see Clinical Pharmacology (12.3)] . There are no data on the effects of glatiramer acetate on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glatiramer acetate injection and any potential adverse effects on the breastfed infant from glatiramer acetate injection or from the underlying maternal condition. The safety and effectiveness of glatiramer acetate injection have not been established in patients under 18 years of age. Glatiramer acetate injection has not been studied in elderly patients. The pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined.

Product summary:

Glatopa (glatiramer acetate injection) is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution in a 1 mL single-dose glass syringe with attached 1/2 inch length, 29 gauge needle supplied as: Some glatiramer acetate products can be administered by an optional compatible autoinjector. Compatible autoinjectors are supplied separately if available, but the availability of compatible autoinjectors may change with time [see Warnings and Precautions (5.6) and Patient Counseling Information (17)] . Store Glatopa refrigerated at 2°C to 8°C (36°F to 46°F). If needed, the patient may store Glatopa at room temperature, 15°C to 30°C (59°F to 86°F), for up to one month, but refrigeration is preferred. Avoid exposure to higher temperatures or intense light. Do not freeze Glatopa. If a Glatopa syringe freezes, it should be discarded.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLATOPA- GLATIRAMER ACETATE INJECTION, SOLUTION
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLATOPA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLATOPA.
GLATOPA (GLATIRAMER ACETATE INJECTION), FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
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 (1).
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
Known hypersensitivity to glatiramer acetate or mannitol (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2023
®
Dosage and Administration (2.1, 2.2) 11/2023
Warnings and Precautions (5.6) 11/2023
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)
Injection: 20 mg per mL in a single-dose, pre-filled syringe with a
white plunger. (3)
Injection: 40 mg per mL in a single-dose, pre-filled syringe with a
blue plunger. (3)
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 (5.1)
Chest pain, usually transient (5.2)
Lipoatrophy and skin necrosis may occur. Instruct patients in proper
injection technique and to rotate
injection sites (5.3)
Glatiramer acetate injection can modify immune response (5.4)
Hepatic Injury: if signs or symptoms of hepatic dysfunction o