Glatopa meets rigorous standards for FDA approval
Glatopa is the first FDA-approved substitutable generic equivalent of Copaxone®.
GlatopaCare offers free, individualized support services offering dedicated specialists, Nurse Trainers for in-home training, and a $0 Co-Pay Program for eligible* patients.
More than 16,000 patients have been treated with Glatopa 20 mg/mL since 2015.5,6
Glatopa is available at specialty pharmacies nationwide. To prescribe, just fill out our Service Request Form.
Patients can enroll by calling 1.855.GLATOPA (1.855.452.8672) or visiting glatopa.com/enroll
*Glatopa Co-Pay Program Eligibility
The Glatopa Co-Pay Program provides up to $9,000 in annual Co-Pay support for Glatopa prescriptions. This program is not health insurance. This program is for insured patients only; uninsured cash-paying patients are not eligible. Patients are not eligible if prescriptions are paid, in whole or in part, by any state or federally funded programs, including but not limited to Medicare (including Part D, even in the coverage gap) or Medicaid, Medigap, VA, DOD, or TriCare, or private indemnity, or HMO insurance plans that reimburse you for the entire cost of your prescription drugs, or where prohibited by law. Card may not be combined with any other rebate, coupon, or offer. Card has no cash value. Sandoz reserves the right to rescind, revoke, or amend this offer without further notice.
Glatopa® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing-forms of multiple sclerosis.
Glatopa® is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.
Approximately 16% of glatiramer acetate injection 20 mg/mL patients vs 4% of those on placebo, and approximately 2% of glatiramer acetate injection 40 mg/mL patients vs none on placebo experienced a constellation of symptoms that may occur within minutes after injection and included at least 2 of the following: flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and urticaria. These symptoms generally have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.
Transient chest paint was noted in 13% of glatiramer acetate injection 20 mg/mL patients vs 6% of placebo patients and approximately 2% of glatiramer acetate injection 40 mg/mL patients vs 1% on placebo. While some episodes of chest pain occurred in the context of the immediate post-injection reaction described above, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than 1 such episode, and episodes usually began at least 1 month after the initiation of treatment.
At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy may occur at various time after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy.
Because glatiramer acetate can modify immune response, it may interfere with immune functions. For example treatment with glatiramer acetate may interfere with recognition of foreign antigens in a way that would undermine the body’s tumor surveillance and its defenses against infection. There is no evidence that glatiramer acetate does this, but there has not been a systematic evaluation of this risk.
The most common adverse reactions with glatiramer acetate injection 20 mg/mL vs placebo were injection site reactions (ISRs), such as erythema (43% vs 10%); vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain (13% vs 6%). The most common adverse reactions with glatiramer acetate injection 40 mg/mL vs placebo were ISRs, such as erythema (22% vs 2%).
ISRs were one of the most common adverse reactions leading to discontinuation of glatiramer acetate injection. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis and atrophy, occurred at a higher rate with glatiramer acetate than placebo.
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.
Please see full Prescribing Information for Glatopa.