Brukinsa Side Effects

Generic name: zanubrutinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 21, 2023.

Note: This document contains side effect information about zanubrutinib. Some dosage forms listed on this page may not apply to the brand name Brukinsa.

Applies to zanubrutinib: oral capsule.

Serious side effects of Brukinsa

Along with its needed effects, zanubrutinib (the active ingredient contained in Brukinsa) 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 zanubrutinib:

More common

• Black, tarry stools
• bladder pain
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest pain or tightness
• chills
• cough
• coughing up blood
• decreased urine
• difficult, burning, or painful urination
• difficulty in breathing or swallowing
• dizziness
• dry mouth
• ear congestion
• fast, slow, or irregular heartbeat
• fever
• frequent urge to urinate
• headache
• increased menstrual flow or vaginal bleeding
• increased thirst
• large, flat, blue, or purplish patches in the skin
• loss of appetite
• loss of voice
• lower back or side pain
• mood changes
• muscle pain or cramps
• nausea or vomiting
• nervousness
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red spots on the skin
• pounding in the ears
• prolonged bleeding from cuts
• runny or stuffy nose
• seizures
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

Other side effects of Brukinsa

Some side effects of zanubrutinib 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
• rash

For Healthcare Professionals

Applies to zanubrutinib: oral capsule.

General

The most common adverse reactions were decreased neutrophil count, upper respiratory tract infection, decreased platelet count, hemorrhage/hematoma, rash, bruising, and musculoskeletal pain.^[Ref]

Cardiovascular

Serious cardiac arrhythmias have occurred in patients treated with this drug. Atrial fibrillation and atrial flutter were reported in 3.7% of 1550 patients treated with this drug as monotherapy, including grade 3 or higher cases in 1.7% of patients. Grade 3 or higher ventricular arrhythmias were reported in 0.2% of patients.

Very common (10% or more): Hypertension (up to 19%)

Common (1% to 10%): Atrial fibrillation/flutter, supraventricular arrhythmias, palpitation

Uncommon (0.1% to 1%): Ventricular arrhythmias

Frequency not reported: Cardiac arrhythmias, myocardial infarction, aortic dissection, cardiomegaly, congestive cardiac failure

Dermatologic

Very common (10% or more): Rash (up to 37%), bruising (up to 30%), contusion (up to 18%), pruritus (up to 12.9%)

Common (1% to 10%): Petechiae, purpura, ecchymosis

Frequency not reported: General exfoliative dermatitis, allergic dermatitis

Rash included rash, maculopapular rash, erythema, erythematous rash, drug eruption, allergic dermatitis, atopic dermatitis, pruritic rash, dermatitis, photodermatoses, acneiform dermatitis, stasis dermatitis, vasculitic rash, eyelid rash, urticaria, skin toxicity, contact dermatitis, drug reaction with eosinophilia and systemic symptoms, photosensitivity reaction, papular rash, seborrheic dermatitis, toxic skin eruption, and related terms.

Bruising included all related terms containing bruise (including increased tendency to bruise), bruising, contusion (including postprocedural contusion), and ecchymosis.

Gastrointestinal

Diarrhea included diarrhea and hemorrhagic diarrhea.

Abdominal pain included abdominal pain, upper abdominal pain, and abdominal discomfort.

Very common (10% or more): Diarrhea (up to 25%), nausea (up to 18%), constipation (up to 16.8%), abdominal pain (up to 14%), vomiting (up to 12.9%)

Uncommon (0.1% to 1%): Gastrointestinal hemorrhage

Genitourinary

Very common (10% or more): Urinary tract infection (up to 13%)

Common (1% to 10%): Hematuria

Urinary tract infection included urinary tract infection, cystitis, Escherichia urinary tract infection, and pyelonephritis.

Hematologic

Very common (10% or more): Decreased neutrophil count (up to 52%), lymphocytosis (up to 41%), hemorrhage/hematoma (up to 42%), decreased platelet count (up to 44%), decreased lymphocytes (up to 32%), decreased hemoglobin (up to 30%), neutropenia (up to 28%), decreased WBC count/leukopenia (up to 26%), increased leukocytes (up to 21%), thrombocytopenia (up to 16%), anemia (up to 14%)

Common (1% to 10%): Major hemorrhage, febrile neutropenia

Frequency not reported: Cytopenias

Grade 3 or 4 cytopenias (including neutropenia [22%], thrombocytopenia [8%], and anemia [7%] based on laboratory measurements) developed in patients treated with this drug as monotherapy. Grade 4 neutropenia and grade 4 thrombocytopenia occurred in 11% and 2.8% of patients, respectively.

Asymptomatic lymphocytosis (a known effect of Bruton's tyrosine kinase inhibition) has been reported.

Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with this drug as monotherapy. Grade 3 or higher hemorrhage (including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax) was reported in 3.6% of patients treated with this drug as monotherapy in clinical trials, with fatalities occurring in 0.3% of patients. Bleeding of any grade (excluding purpura and petechiae) occurred in 30% of patients. Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy.

Hemorrhage included all terms containing hematoma, hemorrhage, and hemorrhagic, and related terms indicative of bleeding including: epistaxis, hematuria, conjunctival hemorrhage, hematoma, rectal hemorrhage, periorbital hemorrhage, mouth hemorrhage, postprocedural hemorrhage, hemoptysis, skin hemorrhage, hemorrhoidal hemorrhage, ear hemorrhage, eye hemorrhage, hemorrhagic diathesis, periorbital hematoma, subdural hemorrhage, wound hemorrhage, gastric hemorrhage, lower gastrointestinal hemorrhage, spontaneous hematoma, traumatic hematoma, traumatic intracranial hemorrhage, tumor hemorrhage, retinal hemorrhage, hematochezia, hemorrhagic diarrhea, hemorrhage, melena, postprocedural hematoma, subdural hematoma, anal hemorrhage, hemorrhagic disorder, pericardial hemorrhage, postmenopausal hemorrhage, stoma site hemorrhage, subarachnoid hemorrhage, urinary tract hemorrhage, pulmonary hematoma, subcutaneous hematoma, gingival bleeding, and upper gastrointestinal hemorrhage.

Major hemorrhage (defined as grade 3 or higher hemorrhage or central nervous system hemorrhage of any grade) was reported in 5% of patients.

Hepatic

Very common (10% or more): Increased ALT (up to 30%), increased bilirubin (up to 26%), increased AST (up to 12.1%)

Uncommon (0.1% to 1%): Hepatitis B reactivation

Frequency not reported: Drug-induced liver injury, hepatitis B

Metabolic

Very common (10% or more): Increased glucose (up to 55%), increased blood uric acid (up to 31%), hypokalemia (up to 14%)

Uncommon (0.1% to 1%): Tumor lysis syndrome

Musculoskeletal

Musculoskeletal pain included musculoskeletal pain, musculoskeletal discomfort, myalgia, back pain, arthralgia, arthritis, pain in extremity, bone pain, spinal pain, musculoskeletal chest pain, and neck pain.

Very common (10% or more): Musculoskeletal pain (up to 45%), pain in extremity (up to 13.9%), arthralgia (up to 13%)

Common (1% to 10%): Muscle spasms, back pain

Nervous system

Dizziness included dizziness and vertigo.

Very common (10% or more): Headache (up to 18%), dizziness (up to 13.9%)

Frequency not reported: Cerebral hemorrhage, subdural hemorrhage, peripheral neuropathy, peripheral sensory neuropathy, cerebral infarction

Oncologic

Second primary malignancies (including nonskin carcinoma) have occurred in 13% of patients treated with this drug as monotherapy. The most frequent second primary malignancy was nonmelanoma skin cancer (7%); other second primary malignancies included malignant solid tumors (5%), melanoma (1.2%), and hematologic malignancies (0.5%).

Second primary malignancy included nonmelanoma skin cancer, malignant solid tumors (including lung, renal, genitourinary, breast, ovarian, rectal, bladder, prostate, pelvis, and ureter), chronic myeloid leukemia, and malignant melanoma.

Very common (10% or more): Second primary malignancy (up to 22%), nonmelanoma skin cancer (up to 13%)

Common (1% to 10%): Basal cell carcinoma, squamous cell carcinoma of skin

Frequency not reported: Plasma cell myeloma

Other

Very common (10% or more): Fatigue (up to 31%), increased magnesium (up to 31%), decreased calcium (up to 27%), decreased phosphate (up to 27%), increased potassium (up to 24%), pyrexia (up to 16%), peripheral edema (up to 13.9%)

Common (1% to 10%): Edema, asthenia, sepsis, localized infection

Frequency not reported: Coronavirus disease 2019 (COVID-19)-related death, sepsis, road traffic accident

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with this drug as monotherapy. Grade 3 or higher infections occurred in 24% of patients (most commonly pneumonia [11%]), with fatal infections occurring in 2.9% of patients. Infections due to hepatitis B virus reactivation have occurred.

Fatigue included asthenia, fatigue, and lethargy.

Renal

Very common (10% or more): Increased creatinine (up to 34%)

Frequency not reported: Renal insufficiency

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 44%), pneumonia (up to 20%), cough (up to 19%), epistaxis (up to 15.8%), dyspnea (up to 14.9%), COVID-19 (up to 14%), nasopharyngitis (up to 10.9%)

Common (1% to 10%): Influenza, lower respiratory tract infection, bronchitis

Frequency not reported: Respiratory tract infection, pleural effusion, lung infection

Upper respiratory tract infection included upper respiratory tract infection, viral upper respiratory tract infection, laryngitis, nasopharyngitis, sinusitis, rhinitis, pharyngitis, rhinovirus infection, upper respiratory tract congestion, tonsillitis, upper respiratory tract inflammation, and related terms.

Pneumonia included pneumonia, fungal pneumonia, cryptococcal pneumonia, streptococcal pneumonia, atypical pneumonia, lung infection, lower respiratory tract infection, bacterial lower respiratory tract infection, viral lower respiratory tract infection, lung infiltration, aspiration pneumonia, viral pneumonia, COVID-19 pneumonia, bronchopulmonary aspergillosis, organizing pneumonia, and related terms (including specific types of infection).

Cough included cough and productive cough.

COVID-19 included COVID-19, COVID-19 pneumonia, post-acute COVID-19 syndrome, and positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test.

Frequently asked questions

• What are the names of the BTK inhibitors?

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.

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