Asciminib Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 7, 2025.

Applies to asciminib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests will be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine and for at least 1 week after the last dose to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Some women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have bloating, chills, constipation, dark urine, fast heartbeat, fever, loss of appetite, nausea, pains in the stomach, side, or abdomen, possibly radiating to the back, upset stomach, vomiting, or yellow eyes or skin.

Check with your doctor right away if you have chest discomfort or pain, dizziness, decreased urine output, fast, irregular, or pounding heartbeat, numbness or weakness on one side of the body, pain in the arms, legs, back, neck, or jaw, problems with vision, speech, or walking, rapid weight gain, swelling of the feet or lower legs, sudden or severe headache, trouble breathing, or unusual tiredness or weakness. These could be symptoms of a serious heart or blood vessel problem (eg, blood clots, heart attack, heart failure, stroke).

This medicine may cause hypertension (high blood pressure). Check with your doctor right away if you have blurred vision, dizziness, headache, nervousness, pounding in the ears, or slow or fast heartbeat.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause serious allergic reactions. Check with your doctor right away if you have chest tightness, cough, dizziness, fainting, fast heartbeat, fever, skin rash or redness, swelling of the face, lips, or tongue, or trouble breathing or swallowing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of asciminib

Along with its needed effects, asciminib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking asciminib:

Other side effects of asciminib

Some side effects of asciminib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to asciminib: oral tablet.

General adverse events

The more commonly reported adverse reactions have included upper respiratory tract infections, musculoskeletal pain, fatigue, nausea, rash, and diarrhea.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (13%; includes hypertension and hypertensive crisis)
• Common (1% to 10%): Edema including grade 3 or 4, grade 3 or 4 hypertension
• Frequency not reported: Arrhythmia, palpitations, cardiac failure congestive

Arrhythmia, palpitations, cardiac failure congestive occurred in less than 10% of patients. Cardiovascular toxicity (including ischemic cardiac and CNS conditions, arterial thrombotic and embolic conditions) and cardiac failure occurred in 46 (13%) and in 8 (2.2%) of 356 patients, respectively. Grade 3 cardiovascular toxicity was reported in 12 (3.4%) patients, while grade 3 cardiac failure was observed in 4 (1.1%) patients. Grade 4 cardiovascular toxicity occurred in 2 (0.6%) patients, with fatalities occurring in 3 (0.8%) patients. Permanent discontinuation occurred in 3 (0.8%) patients due to cardiovascular toxicity and in 1 (0.3%) patient due to cardiac failure, respectively. Arrhythmia, including QTc prolongation, occurred in 23 of 356 (7%) patients, with Grade 3 arrhythmia reported in 7 (2%) patients. QTc prolongation occurred in 3 of 356 (0.8%) patients, with Grade 3 QTc prolongation reported in 1 (0.3%) patient.

Hematologic

• Very common (10% or more): Thrombocytopenia (28%), neutropenia (19%), anemia (13%), hemorrhage (15%; includes epistaxis, ear hemorrhage, mouth hemorrhage, post procedural hemorrhage, skin hemorrhage, and vaginal hemorrhage)
• Common (1% to 10%): Grade 3 or 4 hemorrhage

Thrombocytopenia occurred in 98 of 356 (28%) patients, with Grade 3 or 4 reported in 24 (7%) and 42 (12%) of patients, respectively. Of the 98 patients with thrombocytopenia, 7 (2%) patients permanently discontinued therapy and 45 (13%) patients temporarily withheld therapy. Neutropenia occurred in 69 (19%) patients, with Grade 3 and 4 neutropenia reported in 27 (8%) and 29 (8%) patients, respectively. Of the 69 patients with neutropenia, 4 (1.1%) patients permanently discontinued therapy and therapy was temporarily withheld in 34 (10%) patients. Anemia occurred in 45 (13%) patients, with Grade 3 anemia occurring in 19 (5%) patients. Of the 45 patients with anemia, this drug was withheld in 2 (0.6%) patients.

Hypersensitivity

• Very common (10% or more): Hypersensitivity (32%; includes rash, edema, and bronchospasm)
• Common (1% to 10%): Grade 3 or 4 hypersensitivity

Hypersensitivity occurred in 113 of 356 (32%) patients, with Grade 3 or 4 hypersensitivity reported in 6 (1.7%) patients. Reactions included rash, edema, and bronchospasm.

Immunologic

• Frequency not reported: Influenza

Influenza occurred in less than 10% of patients.

Respiratory

• Very common (10% or more): Upper respiratory tract infection (26%; includes nasopharyngitis, upper respiratory tract infection, rhinitis, pharyngitis, respiratory tract infection, and pharyngotonsillitis), cough (15%)
• Uncommon (0.1% to 1%): Grade 3 or 4 upper respiratory infection
• Frequency not reported: Pneumonia, lower respiratory tract infection, dyspnea, pleural effusion

Pneumonia, lower respiratory tract infection, dyspnea, and pleural effusion occurred in less than 10% of patients.

Nervous system

• Very common (10% or more): Headache (19%)
• Common (1% to 10%): Grade 3 or 4 headache
• Frequency not reported: Dizziness, peripheral neuropathy

Dizziness and peripheral neuropathy occurred in less than 10% of patients.

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 21%; includes diarrhea and colitis), nausea (up to 27%), abdominal pain (up to 17%; includes abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, abdominal tenderness, and epigastric discomfort), vomiting 19%, asymptomatic elevations of amylase and lipase (21%)
• Common (1% to 10%): Grade 3 or 4 diarrhea, grade 3 or 4 vomiting, grade 3 or 4 abdominal pain, Grade 3 or 4 asymptomatic elevations of pancreatic enzymes
• Uncommon (0.1% to 1%): Grade 3 or 4 nausea
• Frequency not reported: Constipation, pancreatitis

Constipation and pancreatitis occurred in less than 10% of patients. Pancreatitis occurred in 9 of 356 (2.5%) patients (Grade 3 pancreatitis in 4 [1.1%]) during the Phase I study. Of the 9 patients with pancreatitis, 2 permanently discontinued therapy, while it was temporarily withheld in 4 (1.1%). Asymptomatic serum lipase and amylase elevations occurred in 76 of 356 (21%) patients, with Grade 3 and Grade 4 pancreatic enzyme elevations occurring in 36 (10%) and 8 (2.2%) patients, respectively. Of the 76 patients with pancreatic enzymes elevated, 7 permanently discontinued therapy.

Hepatic

• Very common (10% or more): Increased transaminases (up to 48%) increased alkaline phosphatase (13%), increased bilirubin (23%)
• Common (1% to 10%): Grade 3 or 4 increased transaminases

Metabolic

• Very common (10% or more): Increased triglycerides (up to 46%), increased potassium (up to 48%), increased cholesterol (15%)
• Common (1% to 10%): Grade 3 or 4 increased triglycerides
• Frequency not reported: Decreased appetite, dyslipidemia

Decreased appetite and dyslipidemia occurred in less than 10% of patients.

Dermatologic

• Very common (10% or more): Rash (up to 27%; includes rash, rash maculopapular, dermatitis acneiform, rash pustular, eczema, dermatitis, skin exfoliation, dermatitis exfoliative generalized, rash morbilliform, drug eruption, erythema multiforme, and rash erythematous), pruritus (13%)
• Uncommon (0.1% to 1%): Grade 3 or 4 rash
• Frequency not reported: Urticaria

Urticaria occurred in less than 10% of patients.

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (up to 42%; includes pain in extremity, back pain, myalgia, non-cardiac chest pain, neck pain, bone pain, spinal pain, arthritis, and musculoskeletal pain), arthralgia (up to 17%), increased creatine kinase (27%)
• Common (1% to 10%): Grade 3 or 4 musculoskeletal pain

Ocular

• Frequency not reported: Dry eye, blurred vision

Dry eye and blurred vision occurred in less than 10% of patients.

Other

• Very common (10% or more): Fatigue (up to 31%; includes fatigue and asthenia)
• Common (1% to 10%): Grade 3 or 4 fatigue
• Frequency not reported: Pyrexia

Pyrexia occurred in less than 10% of patients.

Renal

• Very common (10% or more): Increased creatinine (14%)

Genitourinary

• Frequency not reported: Urinary tract infection

Urinary tract infection occurred in less than 10% of patients.

Endocrine

• Frequency not reported: Hypothyroidism

Hypothyroidism occurred in less than 10% of patients.

See also:

Further information

Asciminib 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