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:

Mylan Pharmaceuticals Inc.

INN (International Name):

GLATIRAMER ACETATE

Composition:

GLATIRAMER ACETATE 20 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 embryofetal 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. 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. In rats or rabbits receiving glatiramer acetate by subcutaneous injection during the period of organogenesis, no adverse effects on embryofetal 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. Glatiramer Acetate Injection (gla tir′ a mer as′ e tate) 20 mg/mL for subcutaneous use For subcutaneous injection only. Do not inject glatiramer acetate injection in your veins (intravenously). Do not re-use your glatiramer acetate prefilled syringes. Do not share your glatiramer acetate prefilled syringes with another person. You may give another person an infection or get an infection from them. You should receive your first dose of glatiramer acetate injection with a healthcare provider or nurse present. This might be at your healthcare provider’s office or with a visiting home health nurse who will show you how to give your own injections. Glatiramer acetate injection comes in a 20 mg prefilled syringe with needle attached. How often a dose is given depends on the product strength that is prescribed. Your healthcare provider will prescribe the correct dose for you. If you plan to use your glatiramer acetate product with an autoinjector, ask your healthcare provider or pharmacist to make sure that your autoinjector is meant to be used with your glatiramer acetate product. If you use an autoinjector that is not meant to be used with your glatiramer acetate product, you might not get the correct dose of your medicine. Instructions for Using Your Glatiramer Acetate 20 mg Prefilled Syringe: How do I inject glatiramer acetate injection? Step 1 : Gather the supplies you will need to inject glatiramer acetate injection. See Figure A. Step 2 : Remove only 1 blister pack from the glatiramer acetate prefilled syringe carton. See Figure B. Step 3 : Look closely at your glatiramer acetate prefilled syringe. Step 4 : Choose your injection area. See Figure C. See the injection areas you should use on your body. Talk with your healthcare provider about the injection areas that are best for you. Step 5 : Prepare to give your injection. Step 6 : Clean your injection site. Step 7 : Pick up the syringe with 1 hand and hold it like a pencil. Remove the needle cover with your other hand and set it aside. See Figure E. Step 8 : Pinch about a 2 inch fold of skin between your thumb and index finger. See Figure F. Step 9 : Giving your injection. Step 10 : Give your glatiramer acetate injection. To inject the medicine, hold the syringe steady and slowly push down the plunger. See Figure I. Step 11 : Remove the needle. After you have injected all of the medicine, pull the needle straight out. See Figure J. Step 12 : Use a clean, dry cotton ball to gently press on the injection site for a few seconds. Do not rub the injection site or re-use the needle or syringe. See Figure K. Step 13 : Dispose of your needles and syringes. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Gland Pharma Ltd Hyderabad 500 043 India Code No.: AP/DRUGS/10/2012 Revised: 1/2024 GL:GLATIJ:RX2

Product summary:

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: 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 glatiramer acetate injection refrigerated at 2° to 8°C (36° to 46°F). If needed, the patient may store glatiramer acetate injection at room temperature, 15° to 30°C (59° to 86°F), for up to one month, but refrigeration is preferred. Avoid exposure to higher temperatures or intense light. Do not freeze glatiramer acetate injection. If a glatiramer acetate syringe freezes, it should be discarded.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLATIRAMER ACETATE- GLATIRAMER ACETATE INJECTION, SOLUTION
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLATIRAMER ACETATE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GLATIRAMER ACETATE
INJECTION.
GLATIRAMER ACETATE INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.2) 11/2023
Warnings and Precautions (5.6) 11/2023
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 (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 MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 1/2024
For subcutaneous injection only; doses are not interchangeable (2.1)
Glatiramer acetate injection 20 mg/mL per day (2.1)
Before use, allow the solution to warm to room temperature (2.2)
Injection: 20 mg/mL in a single-dose, prefilled syringe with a light
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 can modify immune response (5.4)
Hepatic Injury: if signs or symptoms of hepatic dysfunction occur,
consider discontinuing glatiramer