Glatopa 20 mg/mL
Glatiramer Acetate · INJECTION, SOLUTION · Bryant Ranch Prepack
Glatopa is a prescription injection used to treat relapsing-remitting multiple sclerosis by helping to reduce the frequency of relapses. You inject it under the skin as prescribed by your doctor.
Key Facts
- Brand Name
- Glatopa
- Generic Name
- Glatiramer Acetate
- NDC Code (Product)
63629-8815- Manufacturer
- Bryant Ranch Prepack
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA090218
- Marketing Start
- 06/18/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 ).
Dosage & Administration
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. Glatopa 20 mg per mL and Glatopa 40 mg per mL are not interchangeable. 2.2 Instructions for Use Remove one blister-packaged pre-filled syringe from the refrigerated carton. Let the pre-filled 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 …
Contraindications
4 CONTRAINDICATIONS Glatopa is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Known hypersensitivity to glatiramer acetate or mannitol ( 4 )
Drug 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.
Adverse Reactions
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 ≥1.5 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 adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions ( 6.1 ) 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another d…
Frequently Asked Questions
What is Glatopa used for?
Glatopa is a prescription injection used to treat relapsing-remitting multiple sclerosis by helping to reduce the frequency of relapses. You inject it under the skin as prescribed by your doctor.
Is Glatopa a controlled substance?
Glatopa is not classified as a controlled substance by the DEA.
What is the generic name for Glatopa?
The generic name for Glatopa is Glatiramer Acetate. There are 8 other brand versions of Glatiramer Acetate.
What is the NDC code for Glatopa 20 mg/mL?
The NDC (National Drug Code) for Glatopa 20 mg/mL is 63629-8815, listed by Bryant Ranch Prepack.