Vimseltinib Side Effects

Applies to vimseltinib: oral capsule.

Important warnings This medicine can cause some serious health issues

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:

• rash; 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 treatments may be reduced, delayed, or permanently discontinued if you have certain side effects.

Common side effects may include:

• abnormal lab tests;

• swelling around your eyes;

• tiredness;

• rash, itching; or

• swelling in your face, hands, or feet.

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 vimseltinib: oral capsule.

General adverse events

The most common adverse reactions included increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (up to 17%)

Dermatologic

• Very common (10% or more): Rash (up to 47%), pruritus (up to 29%)
• Common (1% to 10%): Subcutaneous abscess, cellulitis

Hematologic

• Very common (10% or more): Decreased neutrophils (up to 31%), decreased leukocytes (up to 29%)

Hepatic

• Very common (10% or more): Increased AST (up to 92%), increased ALT (up to 24%)

During clinical trials, grade 3 increases in AST and ALT were reported in 2% and 1% of patients, respectively. Dose interruptions and reductions due to increased AST/ALT occurred in 2% and 1% of patients, respectively; at least 1 patient discontinued therapy due to grade 3 increased AST.

Musculoskeletal

• Common (1% to 10%): Increased creatine phosphokinase

Nervous system

• Very common (10% or more): Neuropathy (up to 12%)

Ocular

• Very common (10% or more): Periorbital edema (up to 60%), increased lacrimation (up to 12%), dry eye (up to 10%)
• Common (1% to 10%): Blurred vision

Other

• Very common (10% or more): Fatigue (up to 59%), increased cholesterol (up to 43%), peripheral edema (up to 33%), face edema (up to 31%), increased alkaline phosphatase (up to 14%), increased magnesium (up to 13%), decreased calcium (up to 13%)

Renal

• Very common (10% or more): Increased creatinine (up to 17%)

Further information

Vimseltinib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer