Source: FDA, National Drug Code (US) Revision Year: 2025
FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.
This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The recommended dosage of FORZINITY in patients weighing at least 30 kg is 40 mg subcutaneously once daily.
Patients should receive the dose at the same time each day.
If a dose is missed, skip the dose and take the next dose of FORZINITY at the scheduled time. Do not take a double dose of FORZINITY.
Refer to Table 1 for dosage modifications in adults with renal impairment.
Table 1. Recommended Dosage in Adults with Renal Impairment:
| Estimated Glomerular Filtration Rate (eGFR) (mL/minute) | Recommended Dosage |
|---|---|
| Greater than or equal to 30 mL/minute | 40 mg subcutaneously once daily |
| Less than 30 mL/minute and NOT on dialysis | 20 mg subcutaneously once daily |
There is insufficient information to recommend a dosage regimen in adults with eGFR less than 30 mL/minute and on dialysis.
There is insufficient information to recommend a dosage regimen in pediatric patients weighing 30 kg or greater with renal impairment.
FORZINITY is a clear, colorless to yellow aqueous solution that contains the preservative, benzyl alcohol. Visually inspect each vial of FORZINITY for particulate matter and cloudiness prior to administration, whenever solution and container permit. Do not use if the solution is cloudy or particulate matter is present.
Adult patients or caregivers may administer FORZINITY after proper training in preparing FORZINITY vials for administration, if a healthcare provider determines that it is appropriate, and with medical follow-up as necessary.
Use aseptic technique to prepare and administer FORZINITY. Administer FORZINITY by subcutaneous injection in the abdomen (at least 2 inches from the navel) or outer thigh and rotate the injection site daily. Do not inject where the skin is tender, bruised, red, or hard. Avoid injecting into scars or stretch marks. Refer to the Instructions for Use for preparation and administration.
FORZINITY is for single-patient-use only.
Do not mix other products in the same syringe.
Discard vials 8 days after first opening.
There were no reports of overdose during clinical trials with FORZINITY. Symptoms and signs of overdose are likely to be histamine-related (e.g., decreased blood pressure, presyncope) and should be managed according to standard of care. Interrupt treatment with FORZINITY if there is suspicion of overdose.
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Following the first dose, the opened vial can be stored either refrigerated 2°C to 8°C (36°F to 46°F) or at room temperature between 20°C to 25°C (68°F to 77°F). Discard vials 8 days after first opening.
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