Nirogacestat(OGSIVEO)
Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection
Validity period:
Not specified in the specification.
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OGSIVEO (nirogacestat) is an oral medication classified as a gamma-secretase inhibitor, which plays a role in modulating the Notch signaling pathway. This drug has been approved by the U.S. FDA for the treatment of desmoid tumors in adults who exhibit disease progression and require systemic intervention. The active compound, nirogacestat, works by inhibiting gamma-secretase, a protease involved in the activation of Notch receptors. By blocking this pathway, OGSIVEO helps to reduce tumor proliferation and progression.
Approved in 2023, OGSIVEO is available in tablet form, with dosages of 50 mg, 100 mg, and 150 mg. The recommended dosage for patients is 150 mg taken twice daily until disease progression occurs or unacceptable toxicity is observed. This regimen ensures the drug's efficacy while minimizing the risk of adverse effects. It is crucial to follow the prescribed dose to maintain optimal therapeutic outcomes while managing potential side effects effectively.
Generic name
Nirogacestat(OGSIVEO)
English name
Nirogacestat
Alternative Names
OGSIVEO
Indications
OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment.
Therapeutic Target
OGSIVEO is a gamma-secretase inhibitor.
Active Ingredients
Each tablet contains nirogacestat as the active ingredient.
Description
OGSIVEO (nirogacestat) is a gamma-secretase inhibitor. The chemical name and structure are not specified in the provided highlights but it is an orally administered medication.
Dosage and Administration
Recommended Dosage
150 mg orally twice daily until disease progression or unacceptable toxicity.
Administer with or without food. Tablets must be swallowed whole; do not break, crush, or chew.
Dose Modifications
Grade 3–4 adverse reactions: Withhold dose until resolved to Grade ≤1, then restart at 100 mg twice daily.
Permanent discontinuation: Required for life-threatening reactions or recurrence after dose reduction.
Missed Dose/Vomiting
If a dose is missed or vomited, resume the next dose at the scheduled time.
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