Applies to asciminib: oral tablet.

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:

More common

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• body aches or pain
• chest pain or tightness
• chills
• cough
• decreased urine output
• dilated neck veins
• dizziness
• ear congestion
• difficulty in breathing
• fainting
• fever
• headache
• hives, itching, skin rash
• hoarseness
• irregular heartbeat
• irritation
• joint pain, stiffness, or swelling
• loss of voice
• lower back or side pain
• nervousness
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• redness of the skin
• slow or fast heartbeat
• sneezing
• sore throat
• stuffy or runny nose
• swelling of the eyelids, face, lips, hands, or feet
• trouble swallowing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight gain

Less common

• Bladder pain
• bloating
• bloody or cloudy urine
• burning urination
• coughing up blood
• frequent urge to urinate
• increased menstrual flow or vaginal bleeding
• indigestion
• nosebleeds
• pains in the chest, groin, or legs, especially calves of the legs
• pains in the stomach, side, or abdomen, possibly radiating to the back
• paralysis
• prolonged bleeding from cuts
• severe headaches of sudden onset
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes
• vomiting
• yellow eyes or skin

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:

More common

• Diarrhea
• difficulty in moving
• muscle or bone pain
• muscle stiffness
• pain in the joints
• stomach pain

Less common

• Constipation

For Healthcare Professionals

Applies to asciminib: oral tablet.

General

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

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.

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

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.

Very common (10% or more): Hypersensitivity (32%; includes rash, edema, and bronchospasm)

Common (1% to 10%): Grade 3 or 4 hypersensitivity

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

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

Very common (10% or more): Headache (19%)

Common (1% to 10%): Grade 3 or 4 headache

Frequency not reported: Dizziness, peripheral neuropathy

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

Urticaria occurred in less than 10% of patients.

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

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

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

Frequency not reported: Urinary tract infection

Endocrine

Hypothyroidism occurred in less than 10% of patients.

Frequency not reported: Hypothyroidism