Nirogacestat Side Effects

Applies to nirogacestat: oral tablet.

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:

• diarrhea that does not go away after taking antidiarrheal medicines and lasting longer than a few days;

• changes in your menstrual periods, hot flashes, night sweats, or vaginal dryness;

• changing or new skin lesions;

• shortness of breath;

• signs of an electrolyte imbalance--increased thirst or urination, constipation, muscle weakness, leg cramps, numbness or tingling, feeling jittery, fluttering in your chest; or

• 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:

• tiredness;

• rash;

• hair loss;

• headache;

• mouth sores;

• nausea, stomach pain;

• cough, shortness of breath; or

• 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%)

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.

Medical Disclaimer