Dosage & Administration
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Copaxone Prescribing Information
WARNING:ANAPHYLACTIC REACTIONS
Cases of life-threatening and fatal anaphylaxis have been reported with COPAXONE. 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. Prompt identification of anaphylaxis is important to avoid a delay in treatment [see Warnings and Precautions ].
- COPAXONE is contraindicated in patients with a history of hypersensitivity reactions to COPAXONE, including anaphylaxis. If an anaphylactic reaction occurs, treatment with COPAXONE must be immediately discontinued. Unless a clear alternative etiology is identified, COPAXONE must be permanently discontinued [see Contraindications and Warnings and Precautions ].
COPAXONE 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.
Recommended Dose
COPAXONE is for subcutaneous use only [see Dosage and Administration ]. Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended doses are:
- COPAXONE 20 mg per mL: administer once per day
or
- COPAXONE 40 mg per mL: administer three times per week and at least 48 hours apart
COPAXONE 20 mg per mL and COPAXONE 40 mg per mL are not interchangeable.
Instructions for Use
Remove one blister-packaged prefilled syringe from the refrigerated carton. Let the prefilled syringe stand at room temperature for 20 minutes to allow the solution to warm to room temperature. Visually inspect the syringe for particulate matter and discoloration prior to administration. The solution in the syringe should appear clear, colorless to slightly yellow. If particulate matter or discoloration is observed, discard the syringe.
Areas for subcutaneous self-injection include arms, abdomen, hips, and thighs. The prefilled syringe is for single use only. Discard unused portions.
Using an autoinjector that is not compatible for use with TEVA’s COPAXONE may increase the risk for medication errors, such as dose omission or administration of a partial dose [see Warnings and Precautions ].
- Injection: 20 mg per mL in a single-dose, prefilled syringe with a white plunger. For subcutaneous use only.
- Injection: 40 mg per mL in a single-dose, prefilled syringe with a blue plunger. For subcutaneous use only.
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. All pregnancies have a background risk of birth defect, loss, or other outcomes. 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
Data from pharmacovigilance and published observational studies have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes when glatiramer acetate was used during pregnancy. However, the published comparative observational studies have methodological limitations, such as short exposure duration during pregnancy, confounding, selection bias, and exposure misclassification.
Animal Data
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.
Lactation
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 ]. 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 COPAXONE and any potential adverse effects on the breastfed infant from COPAXONE or from the underlying maternal condition.
Pediatric Use
The safety and effectiveness of COPAXONE have not been established in patients under 18 years of age.
Geriatric Use
COPAXONE has not been studied in elderly patients.
Use in Patients with Impaired Renal Function
The pharmacokinetics of glatiramer acetate in patients with impaired renal function have not been determined.
COPAXONE is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Reactions have included anaphylaxis [see Warnings and Precautions ].