Acalabrutinib – Uses, Dosage, Side Effects, Interactions

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 43 min read
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Acalabrutinib is an oral inhibitor of Bruton’s tyrosine kinase that is used in the therapy of B cell malignancies including refractory mantle cell lymphoma and chronic lymphocytic leukemia. Acalabrutinib has been associated with mild-to-moderate serum enzyme elevations during therapy but has not been linked to instances...

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বাংলা রোগী নোট এখনো যোগ করা হয়নি। পোস্ট এডিটরে “RX Bangla Patient Mode” বক্স থেকে সহজ বাংলা সারাংশ যোগ করুন।

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Article Summary

Acalabrutinib is an oral inhibitor of Bruton’s tyrosine kinase that is used in the therapy of B cell malignancies including refractory mantle cell lymphoma and chronic lymphocytic leukemia. Acalabrutinib has been associated with mild-to-moderate serum enzyme elevations during therapy but has not been linked to instances of idiosyncratic acute liver injury, although it has been associated with cases of reactivation of hepatitis B which can be...

Key Takeaways

  • This article explains Mechanism of Action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Contraindications in simple medical language.
  • This article explains Dosage in simple medical language.
Educational health guideWritten for patient understanding and clinical awareness.
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Seek urgent medical care if you notice

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  • Severe symptoms, breathing difficulty, fainting, confusion, or rapidly worsening illness.
  • New weakness, severe pain, high fever, or symptoms after a serious injury.
  • Any symptom that feels urgent, unusual, or unsafe for the patient.
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Definition

Acalabrutinib is an oral inhibitor of Bruton’s tyrosine kinase that is used in the therapy of B cell malignancies including refractory mantle cell lymphoma and chronic lymphocytic leukemia. Acalabrutinib has been associated with mild-to-moderate serum enzyme elevations during therapy but has not been linked to instances of idiosyncratic acute liver injury, although it has been associated with cases of reactivation of hepatitis B which can be severe and even fatal.

Acalabrutinib is an orally available inhibitor of Bruton’s tyrosine kinase (BTK) with potential antineoplastic activity. Upon administration, acalabrutinib inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway. This prevents both B-cell activation and BTK-mediated activation of downstream survival pathways. This leads to an inhibition of the growth of malignant B cells that overexpress BTK. BTK, a member of the src-related BTK/Tec family of cytoplasmic tyrosine kinases, is overexpressed in B-cell malignancies; it plays an important role in B lymphocyte development, activation, signaling, proliferation, and survival.

Acalabrutinib is a member of the class of imidazopyrazines that is imidazo[1,5-a]pyrazine substituted by 4-(pyridine-2-ylcarbamoyl)phenyl, (2S)-1-(but-2-ynoyl)pyrrolidine-2-yl, and amino groups at positions 1, 3 and 8, respectively. It is an irreversible second-generation Bruton’s tyrosine kinase (BTK) inhibitor that is approved by the FDA for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. It has a role as an EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor, an antineoplastic agent, and an apoptosis inducer. It is a secondary carboxamide, a member of benzamides, a member of pyridines, an aromatic amine, a pyrrolidinecarboxamide, an imidazopyridine, a ynone and a tertiary carboxamide.

Mechanism of Action

Mantle Cell Lymphoma (MCL) is a rare yet aggressive type of B-cell non-Hodgkin lymphoma (NHL) with a poor prognosis. Subsequently, relapse is common in MCL patients and ultimately represents disease progression. Lymphoma occurs when immune system lymphocytes grow and multiply uncontrollably. Such cancerous lymphocytes may travel to many parts of the body, including the lymph nodes, spleen, bone marrow, blood, and other organs where they can multiply and form a mass(es) called a tumor. One of the main kinds of lymphocytes that can develop into cancerous lymphomas is the body’s own B-lymphocytes (B-cells). Bruton Tyrosine Kinase (BTK) is a signaling molecule of the B-cell antigen receptor and cytokine receptor pathways. Such BTK signaling causes the activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. Acalabrutinib is a small-molecule inhibitor of BTK. Both acalabrutinib and its active metabolite, ACP-5862, act to form a covalent bond with a cysteine residue (Cys481) in the BTK active site, leading to the inhibition of BTK enzymatic activity. As a result, acalabrutinib inhibits BTK-mediated activation of downstream signaling proteins CD86 and CD69, which ultimately inhibits malignant B-cell proliferation and survival Whereas ibrutinib is typically recognized as the first-in-class BTK inhibitor, acalabrutinib is considered a second generation BTK inhibitor primarily because it demonstrates higher selectivity and inhibition of the targeted activity of BTK while having a much greater IC50 or otherwise virtually no inhibition on the kinase activities of ITK, EGFR, ERBB2, ERBB4, JAK3, BLK, FGR, FYN, HCK, LCK, LYN, SRC, and YES1. In effect, acalabrutinib was rationally designed to be more potent and selective than ibrutinib, all the while demonstrating fewer adverse effects – in theory – because of the drug’s minimized off-target effects.

Acalabrutinib is an oral inhibitor of Bruton’s tyrosine kinase that is used in the therapy of B cell malignancies including refractory mantle cell lymphoma and chronic lymphocytic leukemia. Acalabrutinib has been associated with mild-to-moderate serum enzyme elevations during therapy but has not been linked to instances of idiosyncratic acute liver injury, although it has been associated with cases of reactivation of hepatitis B which can be severe and even fatal.

Indications

  • Acalabrutinib is currently indicated for the treatment of adult patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. It has also been recently approved for chronic lymphocytic leukemia and small lymphocytic lymphoma.
  • Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
  • Chronic Lymphocytic Leukemia (CLL)
  • Mantle Cell Lymphoma (MCL)
  • Small Lymphocytic Lymphoma

Use in Cancer

Acalabrutinib is approved to treat:

  • Chronic lymphocytic leukemia or small lymphocytic lymphoma in adults.
  • Mantle cell lymphoma in adults who have received at least one other type of treatment.¹

This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, a confirmatory trial(s) must show that acalabrutinib provides a clinical benefit in these patients. Acalabrutinib is also being studied in the treatment of other types of cancer.

Contraindications

The following conditions are contraindicated with this drug. Check with your physician if you have any of the following:

  • a bad infection
  • an increased risk of bleeding
  • decreased blood platelets
  • low levels of a type of white blood cell called neutrophils
  • atrial fibrillation
  • pregnancy
  • a patient who is producing milk and breastfeeding

Dosage

 Strengths: 100 mg

 Lymphoma

  • 100 mg orally every 12 hours
  • Start treatment at cycle 1 (each cycle is 28 days) when use concomitantly with obinutuzumab.
  • Start obinutuzumab at Cycle 2 for a total of 6 cycles and refer to the obinutuzumab prescribing information for recommended dosing; administer this drug prior to obinutuzumab when given on the same day.
  • Treatment should be continued until disease progresses or unacceptable toxicity.

RECOMMENDED DOSE ADJUSTMENTS FOR ADVERSE REACTIONS

Grade 3 or greater nonhematologic toxicities, Grade 3 platelet count, which can increase bleeding risk. সহজ বাংলা: প্লাটিলেট কম।" data-rx-term="thrombocytopenia" data-rx-definition="Thrombocytopenia means low platelet count, which can increase bleeding risk. সহজ বাংলা: প্লাটিলেট কম।">thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।" data-rx-term="neutrophil" data-rx-definition="Neutrophil is a white blood cell important for fighting bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।">neutrophil count, which may increase infection risk. সহজ বাংলা: নিউট্রোফিল কম থাকা, সংক্রমণের ঝুঁকি বাড়তে পারে।" data-rx-term="neutropenia" data-rx-definition="Neutropenia means low neutrophil count, which may increase infection risk. সহজ বাংলা: নিউট্রোফিল কম থাকা, সংক্রমণের ঝুঁকি বাড়তে পারে।">neutropenia lasting longer than 7 days:

  • First and second occurrence: Temporarily interrupt this drug; when toxicity has resolved to Grade 1 or baseline, this drug may be resumed at 100 mg orally 2 times a day
  • Third occurrence: Temporarily interrupt this drug; when toxicity has resolved to Grade 1 or baseline, this drug may be resumed at 100 mg orally once daily
  • Fourth occurrence: Discontinue this drug

CONCOMITANT USE WITH CYP450 3A INDUCERS OR INHIBITORS:

  • Strong CYP450 3A inhibitor: Avoid concomitant use; if the inhibitor will be used short-term (e.g., anti-infectives for up to 7 days), interrupt this drug
  • Moderate CYP450 3A inhibitor: 100 mg orally once daily
  • Strong CYP450 3A inducer: Avoid concomitant use. If these inducers cannot be avoided, increase the dose to 200 mg approximately every 12 hours

CONCOMITANT USE WITH GASTRIC ACID-REDUCING AGENTS:

  • Proton pump inhibitors: Avoid concomitant use
  • H2 receptor antagonist: Administer this drug 2 hours before or 10 hours after taking an H2-receptor antagonist
  • Antacid: Separate dosing by at least 2 hours

Side Effects

Most Common

  • fever, sore throat, chills, or other signs of infection
  • cough, shortness of breath, chest pain when you breathe or cough, fever
  • fast or irregular heartbeat, palpitations, feeling lightheaded or dizzy, fainting, shortness of breath, chest pain
  • unusual or severe bleeding or bruising
  • blood in your stools or black, tarry stools; pink or brown urine; vomiting blood or coffee-ground vomit; coughing up blood
  • feeling dizzy, weak, or confused; changes in speech; a pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।" data-rx-term="headache" data-rx-definition="Headache means pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।">headache that lasts a long time
  • pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।" data-rx-term="headache" data-rx-definition="Headache means pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।">headache
  • nausea
  • vomiting
  • constipation
  • diarrhea
  • abdominal pain
  • rash
  • light bruising or small red or purple spots on the skin
  • joint or muscle pain
  • extreme tiredness

More Common

  • dizziness, weakness, confusion, headache,
  • speech problems,
  • black or bloody stools,
  • pink or brown urine, or
  • coughing up blood or vomit that looks like coffee grounds.
  • bruising;
  • headache;
  • muscle pain;
  • diarrhea;
  • feeling tired.
  • an active or chronic infection;
  • a heart rhythm disorder
  • bleeding problems; or

Rare

  • unusual bleeding (nose, mouth, vagina, or rectum), or any bleeding that will not stop;
  • signs of bleeding inside your body–dizziness, weakness, confusion, problems with speech, prolonged headache, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds;
  • heart rhythm problems–chest pain, shortness of breath, pounding heartbeats or fluttering in your chest, feeling light-headed;
  • low red blood cells (anemia)–pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
  • signs of infection–fever, chills, tiredness, flu-like symptoms, cough with mucus, chest pain, trouble breathing; or
  • signs of a serious brain infection–any change in your mental state, decreased vision, weakness on one side of your body, or problems with walking (may start gradually and get worse quickly).

Drug Interactions

Drug-Food Interactions

  • Avoid grapefruit products. Grapefruit inhibits CYP3A metabolism, which may increase the serum concentration of acalabrutinib. Dose adjustment may be necessary if co-administered.
  • Exercise caution with St. John’s Wort. The official product labeling recommends avoiding strong CYP3A4 inducers. This herb induces CYP3A metabolism and may reduce serum levels of acalabrutinib.
  • Take it separately from antacids. Take at least 2 hours before or after antacids.
  • Take it with a full glass of water.
  • Take it with or without food.

Pregnancy and Lactation

Pregnancy

TGA pregnancy category C

You should not become pregnant while you are taking acalabrutinib. You should not start taking acalabrutinib until a pregnancy test has shown that you are not pregnant and you should use birth control to prevent pregnancy during your treatment and for at least 1 week after your final dose.

Lactation

No information is available on the clinical use of acalabrutinib during breastfeeding. Because acalabrutinib is over 97% bound to plasma proteins, and the half-life of the drug and metabolite are less than 7 hours, the amount in milk is likely to be low. However, the protein binding of the active metabolite is not known and the manufacturer recommends that breastfeeding be discontinued during acalabrutinib therapy and for at least 2 weeks after the final dose.

What special precautions should I follow?

Before taking acalabrutinib,

  • tell your doctor and pharmacist if you are allergic to acalabrutinib, any other medications, or any of the ingredients in acalabrutinib capsules. Ask your pharmacist or check the Patient’s Information for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention anticoagulant medications (‘blood thinners) such as warfarin (Coumadin); antiplatelet medications (‘blood thinners) such as aspirin, cilostazol, clopidogrel (Plavix), dipyridamole (Persantine, in Aggrenox), prasugrel (Effient), ticagrelor (Brilinta), and felodipine; diltiazem (Cardizem, Cartia, Diltzac, others); erythromycin (E.E.S., Eryc, Erythrocin, others); fluconazole (Diflucan); itraconazole (Onmel, Sporanox); proton pump inhibitors such as dexlansoprazole (Dexilant), esomeprazole (Nexium, in Vimovo), lansoprazole (Prevacid, in Prevpac), omeprazole (Prilosec, in Yosprala, Zegerid), pantoprazole (Protonix), and rabeprazole (Aciphex); and rifampin (Rifadin, Rimactane, in Rifater, Rifamate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with acalabrutinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • if you are taking cimetidine (Tagamet), famotidine (Pepcid, in Duexis), nizatidine (Axid), or ranitidine (Zantac) take acalabrutinib at least 2 hours before taking these medications.
  • if you are taking antacids (Maalox, Mylanta, Tums, others) take acalabrutinib at least 2 hours before or after taking these medications.
  • tell your doctor if you have an infection or have had surgery recently, or if you have or have ever had liver disease including hepatitis B, problems with your heart rhythm, or bleeding problems.
  • tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking acalabrutinib. You should not start taking acalabrutinib until a pregnancy test has shown that you are not pregnant and you should use birth control to prevent pregnancy during your treatment and for at least 1 week after your final dose. Acalabrutinib may harm your unborn baby. If you become pregnant while taking acalabrutinib, call your doctor immediately.
  • tell your doctor if you are breastfeeding. Your doctor may tell you not to breastfeed during your treatment and for 2 weeks after your final dose.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking acalabrutinib. Your doctor may tell you to stop taking acalabrutinib for some time before and after the surgery or procedure.
  • plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Acalabrutinib may make your skin sensitive to the dangerous effects of sunlight and may increase your risk of developing skin cancer.

References

Doctor visit helper

Prepare before seeing a doctor

A simple rural-patient checklist to help you explain symptoms clearly, ask better questions, and avoid unsafe self-treatment.

Safety note: This is not a prescription or diagnosis. For severe symptoms, pregnancy danger signs, children with serious illness, chest pain, breathing difficulty, stroke-like weakness, or major injury, seek urgent care.

Which doctor may help?

General physician, urologist, nephrologist, or gynecologist depending on symptoms.

What to tell the doctor

  • Write burning, frequency, fever, flank pain, blood in urine, pregnancy, diabetes, and previous UTI history.

Questions to ask

  • Is this UTI, stone, prostate problem, diabetes-related, or another cause?
  • Do I need urine culture before antibiotics?

Tests to discuss

  • Urine routine/microscopy
  • Urine culture for recurrent/severe infection or treatment failure
  • Blood sugar and kidney function when indicated
  • Ultrasound if stone/obstruction/recurrent symptoms

Avoid these mistakes

  • Avoid self-starting antibiotics; wrong antibiotic can cause resistance.
  • Seek urgent care for fever with flank pain, pregnancy, vomiting, confusion, or inability to pass urine.

Medicine safety and first-aid guide

This section is for patient education only. It does not replace a doctor, pharmacist, or emergency care.

Safe first steps

  • Avoid heavy lifting, sudden bending, and prolonged bed rest.
  • Use comfortable posture and gentle movement as tolerated.
  • Discuss physiotherapy, X-ray, or MRI only when clinically needed.

OTC medicine safety

  • For mild back pain, pain-relief medicine may be discussed with a doctor or pharmacist.
  • Avoid repeated painkiller use if you have kidney disease, stomach ulcer, uncontrolled blood pressure, or are taking blood thinners.

Avoid these mistakes

  • Do not start antibiotics without a proper medical decision.
  • Do not use steroid tablets or injections casually for quick relief.
  • Do not delay emergency care because of home remedies.

Get urgent help if

  • Back pain with leg weakness, numbness around private area, loss of urine/stool control, fever, cancer history, or major injury needs urgent care.
Medicine names, dose, and timing must be decided by a qualified clinician or pharmacist after checking age, pregnancy, allergy, other diseases, and current medicines.

For rural patients and family caregivers

Patient health record and symptom diary

Write your symptoms, medicines already taken, test results, and questions before visiting a doctor. This note stays on your device unless you print or copy it.

Doctor to discuss: Medicine doctor / pediatrician for children / qualified clinician
Tests to discuss with doctor
  • Temperature chart and hydration assessment
  • CBC with platelet count if fever persists or dengue/other infection is possible
  • Urine test, malaria/dengue tests, chest evaluation, or blood culture only when clinically indicated
Questions to ask
  • What is the most likely cause of my symptoms?
  • Which warning signs mean I should go to emergency care?
  • Which tests are really needed now?
  • Which medicines are safe for my age, pregnancy status, allergy, kidney/liver/stomach condition, and current medicines?
  • Do I need antibiotics, or is this more likely viral?

Emergency warning signs such as chest pain, severe breathing difficulty, sudden weakness, confusion, severe dehydration, major injury, or loss of bladder/bowel control need urgent medical care. Do not wait for online information.

Safe pathway to proper treatment

Care roadmap for: Acalabrutinib – Uses, Dosage, Side Effects, Interactions

Use this simple roadmap to understand the next safe steps. It is educational and does not replace examination by a doctor.

Go to emergency care if you notice:
  • Severe or rapidly worsening symptoms
  • Breathing difficulty, chest pain, fainting, confusion, severe weakness, major injury, or severe dehydration
Doctor / service to discuss: Qualified healthcare provider; specialist depends on symptoms and examination.
  1. Step 1

    Check danger signs first

    If danger signs are present, seek emergency care and do not wait for online information.

  2. Step 2

    Record the symptom story

    Write when symptoms started, severity, medicines already taken, allergies, pregnancy status, and test results.

  3. Step 3

    Visit a qualified clinician

    A doctor, nurse, or qualified healthcare provider can examine you and decide which tests or treatment are needed.

  4. Step 4

    Do only useful tests

    Do tests after clinical assessment. Avoid unnecessary tests, random antibiotics, or repeated medicines without diagnosis.

  5. Step 5

    Follow up and return early if worse

    If symptoms worsen, new warning signs appear, or treatment is not helping, return for review quickly.

Rural patient practical tips
  • Take a written symptom diary and all previous prescriptions/test reports.
  • Do not hide medicines already taken, even herbal or over-the-counter medicines.
  • Ask which warning signs mean urgent referral to hospital.

This roadmap is for education. A real diagnosis and treatment plan requires history, examination, and clinical judgment.

RX Patient Help

Ask a health question safely

Write your symptom story. A health professional or site editor can review it before any answer is prepared. This box is not for emergency care.

Emergency first: Severe chest pain, breathing trouble, unconsciousness, stroke signs, severe injury, heavy bleeding, or rapidly worsening symptoms need urgent local medical care now.

Frequently Asked Questions

Is this article a replacement for a doctor?

No. It is educational content only. Patients should consult a qualified clinician for diagnosis and treatment.

When should I seek urgent care?

Seek urgent care for severe symptoms, rapidly worsening condition, breathing difficulty, severe pain, neurological changes, or any emergency warning sign.

References

Add references, clinical guidelines, textbooks, journal articles, or trusted medical sources here. You can edit this area from the RX Article Professional Blocks panel.

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