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Taldefgrobep

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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

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    Description

    Taldefgrobep alfa is a fully human recombinant protein engineered to inhibit myostatin and activin receptor signaling pathways. Myostatin is a natural protein that limits skeletal muscle growth. By blocking the formation of the myostatin-activin receptor complex, taldefgrobep alfa prevents downstream activity that leads to muscle atrophy and accumulation of fat mass. This mechanism aims to enhance muscle mass and strength, particularly in individuals with neuromuscular conditions such as spinal muscular atrophy (SMA).

    Directions

    In clinical trials, taldefgrobep alfa has been administered via subcutaneous injection. For instance, in the RESILIENT Phase 3 trial for SMA, participants received weekly weight-based subcutaneous injections of taldefgrobep alfa (35 mg or 50 mg). Specific dosing regimens should be determined by a healthcare provider based on the indication and patient characteristics.

    Ingredients

    Taldefgrobep alfa is a novel, fully human recombinant protein that selectively binds to myostatin and competitively inhibits other ligands that signal through the activin II receptor. The formulation details, including excipients, are proprietary and have not been publicly disclosed.

    Contraindications

    As an investigational drug, comprehensive contraindication profiles are not fully established. However, individuals with known hypersensitivity to components of the formulation should avoid use. Participation in clinical trials may have specific inclusion and exclusion criteria to ensure patient safety.

    Cautions

    While taldefgrobep alfa has been generally well-tolerated in clinical studies, patients should be monitored for potential adverse effects. Caution is advised in individuals with underlying health conditions, and use should be under the supervision of a qualified healthcare professional. Ongoing studies aim to further elucidate the safety profile of this investigational therapy.

    Side Effects

    In clinical trials, taldefgrobep alfa has demonstrated a favorable safety profile. For example, in the RESILIENT trial for SMA, 97% of subjects continued into the optional long-term extension, and there were no taldefgrobep treatment-related serious adverse events. Common side effects have not been extensively reported, but as with any investigational therapy, monitoring for adverse reactions is essential.

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 14565

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