Acalabrutinib – Uses, Dosage, Side Effects, Interaction

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 15 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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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.
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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 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)pyrrolidines-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 none, 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.

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.
  • 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 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.
  • Chronic Lymphocytic Leukemia (CLL)
  • Mantle Cell Lymphoma (MCL)
  • Small Lymphocytic Lymphoma

Use in Cancer

Acalabrutinib is approved to treat:

¹This 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

  • Safety and efficacy have not been established in patients younger than 18 years.
  • 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
  • Anticoagulant therapy, bleeding, dental work, intracranial bleeding, surgery.
  • Anemia, 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, 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.
  • Fungal infection, hepatitis B exacerbation, infection, progressive multifocal leukoencephalopathy, viral infection.
  • New primary malignancy, sunlight (UV) exposure.

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 the disease progresses or has unacceptable toxicity.
  • As monotherapy for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
  • As monotherapy or in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Dose Adjustments

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

The Most Common

  • headache
  • nausea
  • vomiting
  • constipation
  • diarrhea
  • abdominal pain
  • rash
  • light bruising or small red or purple spots on skin
  • joint or muscle pain
  • extreme tiredness
  • 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 headache that lasts a long time

More Common

  • arm, leg, and back pain
  • constipation
  • decreased appetite
  • diarrhea
  • dizziness
  • headache
  • mouth sores
  • nausea
  • skin rash or redness
  • stomach pain or cramps
  • tingling, pain, or numbness in the hands, legs, or feet
  • tiredness
  • trouble sleeping
  • unsteadiness, causing falls
  • vomiting
  • watery eyes
  • unusual bleeding (nose, mouth, vagina, or rectum), or any bleeding that will not stop;
  • heart rhythm problems–chest pain, shortness of breath, pounding heartbeats or fluttering in your chest, feeling light-headed;
  • 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).

Rare

  • memory loss
  • new cancers (skin or other)
  • rapid, pounding heartbeat
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • symptoms of irregular heartbeat (e.g., chest pain, dizziness, confusion, rapid, pounding heartbeat, shortness of breath)
  • symptoms of low blood pressure (e.g., fainting, dizziness, lightheadedness, blurred vision, nausea)
  • symptoms of pneumonia (e.g., cough with or without mucus, fever, chills, difficult and painful breathing, shortness of breath when climbing stairs)
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)

Drug Interaction

There may be an interaction between acalabrutinib and any of the following:

  • antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
  • anticancer medications (e.g., cladribine, irinotecan)
  • anticoagulants (e.g. apixaban, dabigatran, edoxaban, rivaroxaban, warfarin)
  • apalutamide
  • aripiprazole
  • “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • baricitinib
  • BCG
  • bosentan
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • carbamazepine
  • clozapine
  • cobicistat
  • conivaptan
  • deferasirox
  • denosumab
  • dronedarone
  • echinacea
  • enzalutamide
  • fingolimod
  • grapefruit juice
  • H2 antagonists (e.g., famotidine, ranitidine)
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • leflunomide
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • mesalamine
  • mifepristone
  • mitotane
  • modafinil
  • natalizumab
  • ocrelizumab
  • phenobarbital
  • phenytoin
  • pimecrolimus
  • primidone
  • protein kinase inhibitors (e.g., crizotinib, dabrafenib, idelalisib, imatinib, palbociclib,)
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • rifabutin
  • rifampin
  • roflumilast
  • St. John’s wort
  • sarilumab
  • sertraline
  • stiripentol
  • tocilizumab
  • tofacitinib
  • vaccines

Pregnancy And Lactation

US FDA pregnancy category Not Assigned

Pregnancy

This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

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.

How should this medicine be used?

Acalabrutinib comes as a capsule to take by mouth. It is usually taken with or without food every 12 hours (twice a day) for as long as your doctor recommends that you receive treatment. Take acalabrutinib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acalabrutinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with a glass of water; do not open, chew, or break them.

Your doctor may temporarily or permanently stop your treatment or decrease your dose of acalabrutinib depending on the side effects that you experience. Be sure to talk to your doctor about how you are feeling during your treatment. Do not stop taking acalabrutinib without talking to your doctor. Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

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 a period of 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: Orthopedic / spine specialist, physical medicine doctor, or qualified clinician
Tests to discuss with doctor
  • Neurological examination for leg power, sensation, reflexes, and straight leg raise
  • X-ray only if injury, deformity, long-lasting pain, or doctor suspects bone problem
  • MRI discussion if severe nerve symptoms, weakness, bladder/bowel problem, or persistent symptoms
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?
  • Is physiotherapy, posture correction, or activity modification needed?

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, Interaction

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

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. 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. 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 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. 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 ¹This 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 Safety and efficacy have not been established in patients younger than 18 years. 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 Anticoagulant therapy, bleeding, dental work, intracranial bleeding, surgery. Anemia, neutropenia, thrombocytopenia. Fungal infection, hepatitis B exacerbation, infection, progressive multifocal leukoencephalopathy, viral infection. New primary malignancy, sunlight (UV) exposure. 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 the disease progresses or has unacceptable toxicity. As monotherapy for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy As monotherapy or in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Dose Adjustments RECOMMENDED DOSE ADJUSTMENTS FOR ADVERSE REACTIONS: Grade 3 or greater nonhematologic toxicities, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 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 The Most Common headache nausea vomiting constipation diarrhea abdominal pain rash light bruising or small red or purple spots on skin joint or muscle pain extreme tiredness 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 headache that lasts a long time More Common arm, leg, and back pain constipation decreased appetite diarrhea dizziness headache mouth sores nausea skin rash or redness stomach pain or cramps tingling, pain, or numbness in the hands, legs, or feet tiredness trouble sleeping unsteadiness, causing falls vomiting watery eyes unusual bleeding (nose, mouth, vagina, or rectum), or any bleeding that will not stop; heart rhythm problems--chest pain, shortness of breath, pounding heartbeats or fluttering in your chest, feeling light-headed; 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). Rare memory loss new cancers (skin or other) rapid, pounding heartbeat signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath) signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding) signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness) symptoms of irregular heartbeat (e.g., chest pain, dizziness, confusion, rapid, pounding heartbeat, shortness of breath) symptoms of low blood pressure (e.g., fainting, dizziness, lightheadedness, blurred vision, nausea) symptoms of pneumonia (e.g., cough with or without mucus, fever, chills, difficult and painful breathing, shortness of breath when climbing stairs) signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds) Drug Interaction There may be an interaction between acalabrutinib and any of the following: antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide) anticancer medications (e.g., cladribine, irinotecan) anticoagulants (e.g. apixaban, dabigatran, edoxaban, rivaroxaban, warfarin) apalutamide aripiprazole "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole) baricitinib BCG bosentan calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil) carbamazepine clozapine cobicistat conivaptan deferasirox denosumab dronedarone echinacea enzalutamide fingolimod grapefruit juice H2 antagonists (e.g., famotidine, ranitidine) HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine) HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir) leflunomide macrolide antibiotics (e.g., clarithromycin, erythromycin) mesalamine mifepristone mitotane modafinil natalizumab ocrelizumab phenobarbital phenytoin pimecrolimus primidone protein kinase inhibitors (e.g., crizotinib, dabrafenib, idelalisib, imatinib, palbociclib,) proton pump inhibitors (e.g., lansoprazole, omeprazole) rifabutin rifampin roflumilast St. John's wort sarilumab sertraline stiripentol tocilizumab tofacitinib vaccines Pregnancy And Lactation US FDA pregnancy category Not Assigned Pregnancy This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately. 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. How should this medicine be used?

Acalabrutinib comes as a capsule to take by mouth. It is usually taken with or without food every 12 hours (twice a day) for as long as your doctor recommends that you receive treatment. Take acalabrutinib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acalabrutinib exactly as directed. Do not take more or less of it or take…

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