Applies to acalabrutinib: oral tablet.

Serious side effects of Acalabrutinib

Along with its needed effects, acalabrutinib 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 acalabrutinib:

More common

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• body aches or pain
• chills
• collection of blood under the skin
• coughing up blood
• difficulty in breathing or swallowing
• dizziness
• ear congestion
• fever
• headache
• increased menstrual flow or vaginal bleeding
• itching, pain, redness, or swelling
• large, flat, blue or purplish patches in the skin
• loss of voice
• lower back or side pain
• muscle or bone pain
• nosebleeds
• painful or difficult urination
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• sneezing
• sore throat
• stuffy or runny nose
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Other side effects of Acalabrutinib

Some side effects of acalabrutinib 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

• Constipation
• diarrhea
• difficulty in moving
• joint pain or swelling
• muscle cramps or stiffness
• nausea
• rash
• stomach pain
• vomiting

For Healthcare Professionals

Applies to acalabrutinib: oral capsule, oral tablet.

General

The most common adverse reactions (reported incidence of 20% or greater) were anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising.^[Ref]

Cardiovascular

Very common (10% or more): Bleeding events (50%)

Common (1% to 10%): Hemorrhage/hematoma

Uncommon (0.1% to 1%): Atrial fibrillation, atrial flutter^[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (46%), decreased platelets (44%), decreased neutrophils (36%), neutropenia (23%), anemia (11%)

Common (1% to 10%): Thrombocytopenia^[Ref]

Nervous system

Very common (10% or more): Headache (39%)^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (31%), nausea (19%), abdominal pain (15%), constipation (15%), vomiting (13%)^[Ref]

Dermatologic

Very common (10% or more): Bruising/petechiae/ecchymosis/contusion (21%), rash (18%)^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (21%)^[Ref]

Oncologic

Very common (10% or more): Second primary malignancies (11%)

Common (1% to 10%): Skin cancer^[Ref]

Hepatic

Common (1% to 10%): Increased creatinine^[Ref]

Respiratory

Common (1% to 10%): Epistaxis

Frequency not reported: Pneumonia^[Ref]

Other

Very common (10% or more): Fatigue (28%)

Frequency not reported: Infections^[Ref]