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What brand is glatiramer acetate injection?: Understanding Your Options

4 min read

The first glatiramer acetate product, Copaxone, was approved by the FDA in 1996 for the treatment of multiple sclerosis. When asking what brand is glatiramer acetate injection, it is important to know that several options now exist for this injectable medication, including brand-name and generic versions.

Quick Summary

Glatiramer acetate is an injectable medication for relapsing forms of multiple sclerosis, available under brand names like Copaxone and Glatopa, as well as generic formulations. This article details the different versions, dosages, and key considerations for patients and healthcare providers.

Key Points

  • Original Brand is Copaxone®: The brand-name glatiramer acetate injection is Copaxone®, manufactured by Teva Pharmaceuticals.

  • Branded Generic is Glatopa®: Glatopa® is an FDA-approved generic equivalent of Copaxone®, made by Sandoz.

  • Therapeutically Equivalent : Glatopa is considered therapeutically equivalent to Copaxone, meaning it has the same active ingredient and provides the same clinical effect.

  • Multiple Dosages: Both brand and generic versions are available in 20 mg/mL (daily) and 40 mg/mL (three times weekly) dosage schedules.

  • Rotating Injection Sites is Key: To prevent skin damage like lipoatrophy, it is essential to rotate the injection sites with every dose.

  • Serious Allergic Reaction Warning: The FDA has added a Boxed Warning for the risk of anaphylaxis with glatiramer acetate, which can occur at any point during treatment.

  • Patient Support Programs: Manufacturers like Teva and Sandoz offer dedicated patient support services for their respective brands, Copaxone and Glatopa.

In This Article

The Brand Names of Glatiramer Acetate

Glatiramer acetate is the active ingredient in several injectable medications used to treat relapsing forms of multiple sclerosis (MS). For many years, the brand name Copaxone® was the only option available for patients. However, the landscape has changed with the introduction of FDA-approved generic versions. This has provided patients with more choices, often at a lower cost. The availability of these different products requires patients and healthcare providers to understand the distinctions between them.

The search for what brand is glatiramer acetate injection primarily leads to two main FDA-approved brand names: Copaxone® and Glatopa®.

Understanding Brand vs. Generic Glatiramer Acetate

In the pharmaceutical world, a brand-name drug is the original medication developed and patented by a company. After the patent expires, other manufacturers can produce and sell generic versions, which must demonstrate therapeutic equivalence to the brand-name drug. For glatiramer acetate, this means generic versions like Glatopa are designed to have the same clinical effect and safety profile as Copaxone.

Copaxone®

Copaxone®, manufactured by Teva Pharmaceuticals, is the original brand-name version of glatiramer acetate. It was first approved in 1996 and has been a cornerstone of MS treatment for decades. It is available in two different dosage strengths: 20 mg/mL for daily injections and 40 mg/mL for injections three times per week. A key feature for some patients is the availability of autoinjectors, which can make self-administration easier.

Glatopa®

Glatopa® is the first FDA-approved generic version of glatiramer acetate. It was developed by Momenta and is marketed by Sandoz, a Novartis company. Glatopa is approved as a therapeutically equivalent and substitutable version of Copaxone for both the 20 mg/mL once-daily dose and the 40 mg/mL three-times-a-week dose. The launch of Glatopa introduced a more affordable alternative for many patients needing a disease-modifying therapy for their MS.

Other Generic Versions

Beyond Glatopa, other generic formulations of glatiramer acetate have also entered the market, manufactured by companies such as Mylan. These products similarly provide bioequivalent options to the original brand, offering a broader range of choices for patients. It is always important for a patient to discuss with their healthcare provider which specific product is best for them, as they are not all considered interchangeable in all markets. For example, a prescription might specify dispensing the brand name or an authorized generic only.

Important Differences Between Glatiramer Acetate Brands

While the active ingredient, glatiramer acetate, is the same across brand-name and generic products, there can be differences in the inactive ingredients, injection devices, and specific patient support programs offered by each manufacturer. These can influence a patient's experience with the medication.

Comparison of Glatiramer Acetate Formulations

Feature Copaxone® (Teva) Glatopa® (Sandoz) Other Generics (e.g., Mylan)
Manufacturer Teva Pharmaceuticals Sandoz (Novartis) Various (e.g., Mylan)
Dosage Strengths 20 mg/mL (daily), 40 mg/mL (3x/week) 20 mg/mL (daily), 40 mg/mL (3x/week) Varies, typically matches brand-name doses
FDA Equivalence Original brand Therapeutically equivalent and substitutable for Copaxone Bioequivalent to brand, may not be fully substitutable in all cases
Injection Device Proprietary autoinjector available Companion autoinjector (Glatopaject®) available Autoinjector availability may vary
Patient Support TEVA Shared Solutions® GlatopaCare® Varies by manufacturer

How Glatiramer Acetate Works for Multiple Sclerosis

The exact mechanism of action for glatiramer acetate is not fully understood, but it is classified as an immunomodulator. In multiple sclerosis, the immune system mistakenly attacks the myelin sheath, the protective covering of nerve fibers. Glatiramer acetate is thought to work by modifying the immune response. It is a combination of four amino acids that resembles myelin basic protein, and it is believed to act as a "decoy" to divert the immune system's attack away from the patient's own myelin. This process reduces the frequency and severity of relapses in patients with MS.

Common Dosages and Administration

Glatiramer acetate is administered via subcutaneous (under the skin) injection. There are two main dosage schedules, depending on the product strength prescribed:

  • 20 mg/mL: A once-daily injection.
  • 40 mg/mL: An injection three times per week, with doses spaced at least 48 hours apart.

Patients should rotate injection sites regularly (arms, abdomen, hips, and thighs) to minimize potential skin damage, such as lipoatrophy (dents in the skin) and necrosis (skin tissue death). Prefilled syringes are designed for single use, and patients are typically trained on proper injection technique.

Potential Side Effects and Safety Warnings

Like all medications, glatiramer acetate can cause side effects. The most common side effects are often related to the injection site, including redness, pain, itching, swelling, or lumps.

More serious side effects are possible and require immediate attention. These can be categorized into two main types of injection-related reactions:

  • Immediate Post-Injection Reaction: A transient and temporary set of symptoms that can occur minutes after injection. This can include flushing, chest pain, palpitations, anxiety, and shortness of breath. These reactions typically subside on their own within 30 minutes, but patients should notify their healthcare provider.
  • Serious Allergic (Anaphylactic) Reaction: A rare but potentially life-threatening reaction that can happen at any point during treatment, sometimes years after starting. Anaphylaxis symptoms can overlap with post-injection reactions but are more severe and require emergency medical care. The FDA has issued a Boxed Warning for this risk.

Other potential side effects include:

  • General body pain
  • Nausea
  • Flu-like symptoms
  • Liver problems (rare, but serious)

Patients should be aware of these risks and discuss them with their healthcare team to ensure they know how to respond if a serious reaction occurs.

Conclusion

Glatiramer acetate, a vital medication for managing relapsing forms of multiple sclerosis, is available under the original brand name Copaxone®, the branded generic Glatopa®, and other generic formulations. While all versions contain the same active ingredient and offer similar therapeutic effects, differences in manufacturers, delivery systems, and support services exist. Understanding these nuances is crucial for both healthcare providers and patients in making informed decisions about treatment. Patients are advised to consult their doctor or pharmacist to determine the most appropriate option based on their medical needs and preferences.

Frequently Asked Questions

Copaxone is the original, brand-name version of glatiramer acetate, manufactured by Teva. Glatopa is a branded generic version, produced by Sandoz, and is considered therapeutically equivalent to Copaxone.

The FDA considers Glatopa to be a substitutable generic for Copaxone. However, any change in medication should always be discussed with your healthcare provider, who can ensure the switch is appropriate for your specific needs.

Glatiramer acetate is typically injected either once daily (at the 20 mg/mL strength) or three times per week (at the 40 mg/mL strength). The three-times-a-week doses must be administered at least 48 hours apart.

Common side effects include reactions at the injection site such as redness, pain, itching, or swelling. Other common side effects may include flushing, chest pain, and a fast heartbeat.

Glatiramer acetate is an immunomodulator, not a traditional immunosuppressant. It modifies the immune system's response to the myelin sheath rather than causing broad immune suppression.

If you experience symptoms of a severe allergic reaction (anaphylaxis), such as difficulty breathing, wheezing, or swelling of the face or throat, you should stop the injection and seek immediate emergency medical care.

Yes, glatiramer acetate is typically stored in the refrigerator. However, the product can be kept at room temperature for a limited time, usually up to one month, if you are traveling.

Yes, the manufacturers of both Copaxone and Glatopa offer patient support programs, such as TEVA Shared Solutions® and GlatopaCare®, which can provide resources and assistance.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.