Ogsiveo Side Effects
Generic name: nirogacestat
Note: This document contains side effect information about nirogacestat. Some dosage forms listed on this page may not apply to the brand name Ogsiveo.
Applies to nirogacestat: oral tablet.
Warning
Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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diarrhea that does not go away after taking antidiarrheal medicines and lasting longer than a few days;
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changes in your menstrual periods, hot flashes, night sweats, or vaginal dryness;
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changing or new skin lesions;
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signs of an electrolyte imbalance--increased thirst or urination, constipation, muscle weakness, leg cramps, numbness or tingling, feeling jittery, fluttering in your chest; or
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liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Your treatment may be changed, or temporarily or permanently discontinued if you have certain side effects.
Common side effects may include:
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tiredness;
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rash;
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mouth sores;
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nausea, stomach pain;
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cough, shortness of breath; or
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cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to nirogacestat: oral tablet.
General
The most common reactions/laboratory abnormalities occurring in 15% of patients or greater included diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection, dyspnea, decreased phosphate, increased urine glucose, increased urine protein, increased AST, increased ALT, and decreased potassium.[Ref]
Dermatologic
Very common (10% or more): Rash (68%), alopecia (19%)
Frequency not reported: Hidradenitis suppurativa, folliculitis
Endocrine
Very common (10% or more): Ovarian toxicity (75%)
Ovarian toxicity included ovarian failure, premature menopause, amenorrhea, and menopause.
Gastrointestinal
Very common (10% or more): Diarrhea (84%), nausea (54%), stomatitis (39%), abdominal pain (22%)
Hepatic
Very common (10% or more): Increased aspartate aminotransferase (33%), increased alanine aminotransferase (30%)
Metabolic
Very common (10% or more): Decreased phosphate (65%), decreased potassium (22%)
Oncologic
Frequency not reported: Non-melanoma skin cancers
Other
Very common (10% or more): Fatigue (54%)
Frequency not reported: Influenza-like illness
Renal
Very common (10% or more): Increased urine glucose (51%), increased urine protein (40%)
Respiratory
Very common (10% or more): Cough (20%), upper respiratory tract infection (17%), dyspnea (16%)
Frequency not reported: Epistaxis
Nervous system
Very common (10% or more): Headache (30%)
More about Ogsiveo (nirogacestat)
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- Drug class: miscellaneous antineoplastics
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References
1. (2023) "Product Information. Ogsiveo (nirogacestat)." SpringWorks Therapeutics, Inc.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.