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Ogsiveo 50mg Tablet
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Indications & Clinical Uses
- Ogsiveo 50mg is a brand of nirogacestat, an oral gamma-secretase inhibitor tablet formulated as nirogacestat hydrobromide but dosed by nirogacestat content.
- It is approved for adult patients with progressing desmoid tumors, a rare, locally aggressive but non-metastasizing soft-tissue growth, who require systemic (whole-body) drug treatment rather than surgery or observation alone.
- Ogsiveo was the first drug specifically approved for desmoid tumors, in November 2023, and works by blocking Notch signalling, a pathway involved in desmoid tumor growth.
- The standard dose is 150mg (three 50mg tablets) taken twice daily, and treatment continues as long as it is tolerated and the tumor is responding or stable.
- Ogsiveo is not approved for use in children, and its effects on fertility mean it is generally reserved for adults who have completed or do not plan future pregnancies, or who have discussed fertility preservation with their healthcare provider.
Side Effects
- Ogsiveo does not carry a boxed warning, but it has several important warnings that patients must be aware of.
- Diarrhea is very common, occurring in more than 8 in 10 patients and sometimes severe, so it should be reported and treated promptly with anti-diarrheal medicine.
- Ovarian toxicity, including impaired fertility and symptoms of early menopause or ovarian failure, affects around 3 in 4 women of reproductive potential taking Ogsiveo.
- Other very common side effects include rash, nausea, fatigue, mouth sores (stomatitis), headache, abdominal pain, cough, hair loss, and breathlessness.
- Liver enzyme elevations occur in about a third of patients, and new skin cancers, including squamous cell and basal cell carcinoma, have been reported.
- Seek prompt medical attention for persistent diarrhea, yellowing of the skin or eyes, unusual fatigue, new skin lesions, or menstrual changes, and have skin checks performed regularly during treatment.
Precautions & Warnings
- Before starting Ogsiveo, liver function tests, electrolytes including phosphate and potassium, and a pregnancy test should be obtained, since the drug can cause liver enzyme elevations, low phosphate and potassium levels, and harm to a developing fetus.
- Ogsiveo should not be started during pregnancy, and effective non-hormonal contraception is recommended during treatment and for a period after stopping, because Ogsiveo can reduce the effectiveness of hormonal contraceptives.
- Ovarian function and fertility may be impaired in women of reproductive potential; fertility preservation should be discussed before starting treatment.
- Skin examinations are recommended periodically because of an increased risk of non-melanoma skin cancers.
- Diarrhea should be managed proactively, and the dose may need to be interrupted or reduced for severe or persistent symptoms.
- Liver function and electrolytes should be monitored periodically during treatment, with dose adjustments made for significant abnormalities.
- There are no listed contraindications on the current label.
Avoid Interactions
- Ogsiveo is broken down by the CYP3A4 liver enzyme, so strong and moderate CYP3A4 inhibitors, such as ketoconazole, clarithromycin, and diltiazem, can raise nirogacestat levels and increase side effects, and should generally be avoided or require dose adjustment.
- Strong and moderate CYP3A4 inducers, including rifampin, carbamazepine, and St. John's wort, can lower nirogacestat levels and reduce its effectiveness, and should also be avoided.
- Proton pump inhibitors and H2-receptor blockers reduce absorption of Ogsiveo and should be avoided; if an antacid is needed, it should be taken several hours apart from the dose.
- Ogsiveo can reduce the effectiveness of hormonal contraceptives, including birth control pills, so a non-hormonal method of contraception is recommended during treatment.
- Patients should tell their healthcare provider about all prescription medicines, over-the-counter drugs, and herbal supplements, particularly anything affecting stomach acid or liver enzymes, before starting Ogsiveo.
References
Frequently Asked Questions
Ogsiveo (nirogacestat) is a tablet for adults with progressing desmoid tumors who need systemic drug treatment. Desmoid tumors are rare, locally aggressive soft-tissue growths that don't spread to other organs. Ogsiveo was the first medicine approved specifically for this condition and works by blocking a growth signal called Notch.
Take 150 mg of Ogsiveo (three 50 mg tablets) by mouth twice daily, with or without food. Swallow tablets whole; do not crush or chew them. Treatment continues as long as it is helping and side effects are manageable, under regular review by your healthcare provider.
Diarrhea is very common and can be severe, affecting over 80% of patients. Ogsiveo can also cause ovarian toxicity and reduced fertility in about 75% of women of reproductive age, liver enzyme changes, rash, and new skin cancers. Ogsiveo has no boxed warning, but these effects need regular monitoring.
Avoid strong CYP3A4 inhibitors like ketoconazole and inducers like rifampin or St. John's wort, which change Ogsiveo levels. Avoid proton pump inhibitors and H2-blockers, which reduce absorption. Ogsiveo can make hormonal birth control less effective, so use a non-hormonal contraceptive method instead.
Your healthcare provider checks liver function and electrolytes, including phosphate and potassium, before and during treatment, since Ogsiveo can affect both. Regular skin checks are recommended because of a higher risk of skin cancers, and diarrhea should be reported early so it can be managed before it becomes severe.
Yes. Ogsiveo can reduce ovarian function and fertility in women and can harm a developing fetus, so it should not be started during pregnancy. Discuss fertility preservation before treatment if you may want children later, and use non-hormonal contraception, since Ogsiveo weakens hormonal birth control.
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