Nirogacestat Side Effects: Common, Severe, Long Term - Drugs.com

Q: Does nirogacestat cause ovarian dysfunction?

Ovarian dysfunction (defined by the MedDRA preferred terms of amenorrhea, premature menopause, menopause, and ovarian failure) occurred in 27 of 36 women of childbearing potential (75%) receiving nirogacestat and in 0 of 37 receiving placebo.

Q: What is nirogacestat clinical progression?

Investigator-determined clinical progression was defined as the onset or worsening of symptoms resulting in a global deterioration of health status, which led to the permanent discontinuation of nirogacestat or placebo and the initiation of other treatment for desmoid tumors.

Q: How long does nirogacestat exposure last?

The median duration of exposure was 20.6 months (range, 0.3 to 33.6) among the patients receiving nirogacestat and 11.4 months (range, 0.2 to 32.5) among those receiving placebo. The median relative dose intensity was 96% for nirogacestat and 100% for placebo.

Q: How does nirogacestat work?

Nirogacestat works by inhibiting gamma-secretase, an enzyme that cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to the growth of desmoid tumors. Ogsiveo was FDA-approved on November 27, 2023.

Q: Is nirogacestat a -secretase inhibitor?

Inhibitors of γ-secretase, initially developed for Alzheimer’s disease and later investigated as a treatment for cancer, have yet to be used in clinical practice. 22,23 DeFi was a phase 3 randomized, controlled trial of nirogacestat, a γ-secretase inhibitor, in patients with desmoid tumors.

Last updated on Aug 6, 2024. Applies to nirogacestat: oral tablets. Side effects include: Most common adverse reactions (incidence ≥15%): diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection, …

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Nirogacestat Side Effects: Common, Severe, Long Term - Drugs.com

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Nirogacestat, A γ-Secretase Inhibitor For Desmoid Tumors

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Mar 8, 2023 · Nirogacestat had a significant progression-free survival benefit over placebo (hazard ratio for disease progression or death, 0.29; 95% confidence interval, 0.15 to 0.55; …

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Ogsiveo (Nirogacestat Hydrobromide Tablets): Side Effects ... - RxList

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Jun 6, 2024 · The most common (≥ 15% with a difference between arms of ≥ 5% compared to placebo) adverse reactions that occurred in patients receiving OGSIVEO were diarrhea, …

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Ogsiveo Side Effects: Common, Severe, Long Term - Drugs.com

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Aug 6, 2024 · For healthcare professionals. Applies to nirogacestat: oral tablet. General adverse events. The most common reactions/laboratory abnormalities occurring in 15% of patients or …

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FAQs about Nirogacestat Side Effects: Common, Severe, Long Term - Drugs.com Coupon?

What are the side effects of nirogacestat?

Patients treated with nirogacestat reported signficant improvements in several secondary PROs, including pain, symptom burden, physical role and functioning, and health-related quality of life (p<0.015). (1) Frequent side effects of nirogacestat were diarrhea (84%), nausea (54%), fatigue (51%), hypophosphatemia (42%), and maculopapular rash (32%). ...

Does nirogacestat cause ovarian dysfunction?

Ovarian dysfunction (defined by the MedDRA preferred terms of amenorrhea, premature menopause, menopause, and ovarian failure) occurred in 27 of 36 women of childbearing potential (75%) receiving nirogacestat and in 0 of 37 receiving placebo. ...

What is nirogacestat clinical progression?

Investigator-determined clinical progression was defined as the onset or worsening of symptoms resulting in a global deterioration of health status, which led to the permanent discontinuation of nirogacestat or placebo and the initiation of other treatment for desmoid tumors. ...

How long does nirogacestat exposure last?

The median duration of exposure was 20.6 months (range, 0.3 to 33.6) among the patients receiving nirogacestat and 11.4 months (range, 0.2 to 32.5) among those receiving placebo. The median relative dose intensity was 96% for nirogacestat and 100% for placebo. ...

How does nirogacestat work?

Nirogacestat works by inhibiting gamma-secretase, an enzyme that cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to the growth of desmoid tumors. Ogsiveo was FDA-approved on November 27, 2023. ...

Is nirogacestat a -secretase inhibitor?

Inhibitors of γ-secretase, initially developed for Alzheimer’s disease and later investigated as a treatment for cancer, have yet to be used in clinical practice. 22,23 DeFi was a phase 3 randomized, controlled trial of nirogacestat, a γ-secretase inhibitor, in patients with desmoid tumors. ...