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Acalabrutinib

Acalabrutinib is a kinase inhibitor (a targeted cancer medicine) used to treat mantle cell lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma in adults.

Brand name Calquence
Drug class Kinase Inhibitor
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Acalabrutinib at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Acalabrutinib (Calquence) is a targeted medicine for chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma and mantle cell lymphoma that blocks BTK, a protein cancerous B cells (a type of white blood cell) need to grow. On the market since about 2017, it is one of the standard first choices for CLL. Most people handle it well, and the headache many notice in the first weeks usually fades, while diarrhea, tiredness and easy bruising are also common. Watch for serious infection, unusual bleeding and heart rhythm problems, and report fever, black stools, a racing or irregular heartbeat or fainting promptly. Expect regular blood count and liver tests.

Clinical pearls

  • With the capsules, avoid proton pump inhibitors, take Calquence 2 hours before an H2-blocker, and separate antacids by 2 hours.
  • Common drugs like fluconazole, erythromycin, diltiazem and rifampin change acalabrutinib levels, so every new prescription needs an interaction check.
  • Before surgery, ask whether to pause Calquence, since it raises bleeding risk, more so alongside blood thinners.
  • Use sun protection and report new or changing skin spots, because skin cancers have occurred with this medicine.
How you get itPrescription only
Comes asTablet, Capsule
Earliest FDA record2017
Companies listing it with the FDA1
FDA label last updatedFeb 19, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Acalabrutinib, written from its FDA label.

What Acalabrutinib is used for

▾

Acalabrutinib treats certain B-cell blood cancers in adults.

  • Mantle cell lymphoma (MCL) not yet treated, with bendamustine and rituximab, in people who cannot have an autologous stem cell transplant (Calquence capsules and tablets).
  • MCL in people who have had at least one prior therapy (Calquence capsules and tablets).
  • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Calquence capsules and tablets).

How Acalabrutinib works

▾

Acalabrutinib is a BTK inhibitor. It attaches firmly to Bruton tyrosine kinase, a signaling protein inside B cells. Its main active breakdown product, ACP-5862, does the same.

BTK helps B cells multiply, move and stick together. Blocking it slows the growth of cancerous B cells. In lab studies, it reduced cancer cell growth and tumor growth.

Acalabrutinib dosage

▾

Calquence capsules and tablets are taken by mouth about every 12 hours, with or without food. Swallow them whole with water. Do not chew or crush them, and do not open the capsules or dissolve or cut the tablets.

  • If a dose is more than 3 hours late, skip it and take the next one on schedule.
  • Do not double up to make up for a missed dose.
  • Treatment usually continues until the disease progresses or side effects become unacceptable. In some CLL or SLL combinations it stops after a set number of cycles.
  • Your doctor may pause, reduce or stop it if side effects occur.

Dosing details from the FDA-approved label

From the Acalabrutinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • MCL, CLL or SLL (monotherapy)
    • 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity
    • Swallow whole with water, with or without food; if a dose is missed by more than 3 hours, skip it and take the next dose at the regular time
  • Previously untreated MCL (in combination with bendamustine and rituximab)
    • 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity
    • Start on Day 1 of Cycle 1 (each cycle is 28 days)
    • Bendamustine 90 mg/m2 on Days 1 and 2 and rituximab 375 mg/m2 on Day 1 of Cycle 1, continued for a total of 6 cycles
    • Maximum: Maintenance rituximab: maximum of 12 additional doses
    • Patients achieving a response (PR or CR) after the first 6 cycles may receive maintenance rituximab on Day 1 of every other cycle, starting on Cycle 8 up to Cycle 30
  • Previously untreated CLL or SLL (in combination with obinutuzumab)
    • 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity
    • Start CALQUENCE at Cycle 1 (each cycle is 28 days)
    • Start obinutuzumab at Cycle 2 for a total of 6 cycles
    • Administer CALQUENCE prior to obinutuzumab when given on the same day
  • Previously untreated CLL or SLL (in combination with venetoclax)
    • 100 mg taken orally approximately every 12 hours until disease progression, unacceptable toxicity or completion of 14 cycles of treatment
    • Start CALQUENCE at Cycle 1 (each cycle is 28 days)
    • Start venetoclax at Cycle 3 for total of 12 cycles, at 20 mg daily for first week, increasing weekly over a 5-week ramp up
    • Maximum: venetoclax up to 400 mg daily
  • Use with a moderate CYP3A inhibitor
    • Reduce the CALQUENCE 100 mg every 12 hours dosage to 100 mg once daily
  • Use with a strong CYP3A inducer, if co-administration is unavoidable
    • Increase CALQUENCE dosage to 200 mg approximately every 12 hours
    • Otherwise avoid co-administration
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Recommended dose is 100 mg orally approximately every 12 hours; swallow whole with water and with or without food. ( 2.1 ) • Advise patients not to break, open, or chew capsules. ( 2.1 ) • Manage toxicities using treatment interruption, dose reduction, or discontinuation. ( 2.3 ) • Avoid CALQUENCE in patients with severe hepatic impairment ( 8.6 ) 2.1 Recommended Dosage CALQUENCE Administration Instructions Advise patients to swallow capsule whole with water. Advise patients not to open, break or chew the capsules. CALQUENCE may be taken with or without food. If a dose of CALQUENCE is missed by more than 3 hours, it should be skipped and the next dose should be taken at its regularly scheduled time. Extra capsules of CALQUENCE should not be taken to make up for a missed dose. CALQUENCE as Monotherapy For patients with MCL, CLL, or SLL, the recommended dosage of CALQUENCE is 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity. CALQUENCE in Combination with Bendamustine and Rituximab For patients with previously untreated MCL, the recommended dosage of CALQUENCE is 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity. Start CALQUENCE on Day 1 of Cycle 1 (each cycle is 28 days) and administer until disease progression or unacceptable toxicity. Administer bendamustine 90 mg/m 2 on Days 1 and 2 and rituximab 375 mg/m 2 on Day 1 of Cycle 1 and continue for a total of 6 cycles. Patients achieving a response (PR or CR) after the first 6 cycles may receive maintenance rituximab on Day 1 of every other cycle for a maximum of 12 additional doses, starting on Cycle 8 up to Cycle 30 [see Clinical Studies (14.1) ] . CALQUENCE in Combination with Obinutuzumab For patients with previously untreated CLL or SLL, the recommended dosage of CALQUENCE is 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity. Start CALQUENCE at Cycle 1 (each cycle is 28 days). Start obinutuzumab at Cycle 2 for a total of 6 cycles and refer to the obinutuzumab prescribing information for recommended dosing. Administer CALQUENCE prior to obinutuzumab when given on the same day.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Acalabrutinib side effects

▾

Common side effects seen in studies include:

Common side effects

  • Upper respiratory tract infection (cold-like symptoms)
  • Diarrhea
  • Headache
  • Muscle and joint pain
  • Fatigue
  • Rash
  • Bruising
  • Low blood counts (found on lab tests)
  • Low blood counts, including neutrophils, platelets and hemoglobin

When to get medical help

  • Call your doctor for signs of infection such as fever, chills, cough or trouble breathing. Serious and sometimes fatal infections have occurred.
  • Get medical help for unusual or serious bleeding, including black or bloody stools or bleeding in the brain.
  • Tell your doctor about a racing or irregular heartbeat, palpitations, dizziness, fainting or shortness of breath. These can be signs of a heart rhythm problem.
  • Report new or changing skin spots or growths. Other cancers, including skin cancer, have occurred.
  • Tell your doctor about signs of liver problems. Liver injury, sometimes severe, has occurred.
  • Your doctor will check blood counts regularly because this medicine can lower them.

Call your doctor promptly for signs of infection, unusual bleeding, an irregular heartbeat, yellowing of the skin or eyes, or new skin growths.

Acalabrutinib warnings and precautions

▾
  • Serious infections: Fatal and serious infections have occurred, including hepatitis B reactivation and pneumonia. Your doctor may consider preventive treatment if your risk is higher.
  • Bleeding: Serious bleeding, including fatal cases, has occurred. Blood thinners may add to the risk. Your doctor may pause the medicine for 3 to 7 days before and after surgery.
  • Low blood counts: Blood counts are checked regularly.
  • Second cancers: Skin cancers and other solid tumors have occurred. Use sun protection.
  • Heart rhythm problems: Atrial fibrillation and other serious arrhythmias have occurred.
  • Liver injury: Liver tests are checked before and during treatment.

Acalabrutinib interactions

▾

Several drugs can raise or lower acalabrutinib levels, so tell your pharmacist about everything you take.

  • Strong CYP3A inhibitors (such as itraconazole): raise levels and toxicity risk, so avoid them or pause Calquence for short-term use.
  • Moderate CYP3A inhibitors (erythromycin, fluconazole, diltiazem): may raise levels, so the dose is lowered.
  • Strong CYP3A inducers (such as rifampin): lower levels and may weaken the medicine.
  • Proton pump inhibitors: may lower levels and cannot be fixed by spacing doses, so avoid them with Calquence capsules.
  • H2-blockers and antacids: may lower levels. With Calquence capsules, take Calquence 2 hours before an H2-blocker and separate antacids by at least 2 hours.
  • Antithrombotic (blood-thinning) drugs: may increase bleeding risk.

Interactions listed in the FDA-approved label

From the Acalabrutinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A inhibitors (e.g., itraconazole): Increased acalabrutinib plasma concentrations, which may result in increased toxicity. Avoid co-administration. If the inhibitor will be used short-term (such as anti-infectives for up to seven days), interrupt CALQUENCE; after discontinuation of the strong inhibitor for at least 24 hours, resume the previous dosage.
  • Moderate CYP3A inhibitors: May increase acalabrutinib plasma concentrations, which may result in increased toxicity. Reduce acalabrutinib dose to 100 mg once daily.
  • Strong CYP3A inducers (e.g., rifampin): Decreased acalabrutinib plasma concentrations, which may reduce CALQUENCE activity. Avoid co-administration. If it cannot be avoided, increase the acalabrutinib dose to 200 mg approximately every 12 hours.
  • Antacids: May decrease acalabrutinib plasma concentrations, which may reduce CALQUENCE activity. Separate dosing by at least 2 hours.
  • H2-receptor antagonists: May decrease acalabrutinib plasma concentrations, which may reduce CALQUENCE activity. Take CALQUENCE 2 hours before taking the H2-receptor antagonist.
  • Proton pump inhibitors: May decrease acalabrutinib plasma concentrations, which may reduce CALQUENCE activity. Avoid co-administration. Due to the long-lasting effect of proton pump inhibitors, separation of doses may not eliminate the interaction.
Read the label’s full interactions text

7 DRUG INTERACTIONS • CYP3A Inhibitors: Avoid co-administration with strong CYP3A inhibitors. Dose adjustments may be recommended. ( 2.2 , 7 , 12.3) • CYP3A Inducers: Avoid co-administration with strong CYP3A inducers. Dose adjustments may be recommended. ( 2.2 , 7 , 12.3) • Gastric Acid Reducing Agents: Avoid co-administration with proton pump inhibitors (PPIs). Stagger dosing with H2-receptor antagonists and antacids. ( 2.2 , 7 , 12.3) 7.1 Effect of Other Drugs on CALQUENCE Strong CYP3A Inhibitors Clinical Effect • Co-administration of CALQUENCE with a strong CYP3A inhibitor (itraconazole) increased acalabrutinib plasma concentrations [see Clinical Pharmacology (12.3) ] . • Increased acalabrutinib concentrations may result in increased toxicity. Prevention or Management • Avoid co-administration of strong CYP3A inhibitors with CALQUENCE. • Alternatively, if the inhibitor will be used short-term, interrupt CALQUENCE [see Recommended Dosage for Drug Interactions (2.2) ] . Moderate CYP3A Inhibitors Clinical Effect • Co-administration of CALQUENCE with a moderate CYP3A inhibitor may increase acalabrutinib plasma concentrations [see Clinical Pharmacology (12.3) ]. • Increased acalabrutinib concentrations may result in increased toxicity. Prevention or Management • When CALQUENCE is co-administered with moderate CYP3A inhibitors, reduce acalabrutinib dose to 100 mg once daily. Strong CYP3A Inducers Clinical Effect • Co-administration of CALQUENCE with a strong CYP3A inducer (rifampin) decreased acalabrutinib plasma concentrations [see Clinical Pharmacology (12.3) ] . • Decreased acalabrutinib concentrations may reduce CALQUENCE activity. Prevention or Management • Avoid co-administration of strong CYP3A inducers with CALQUENCE. • If a strong CYP3A inducer cannot be avoided, increase the acalabrutinib dose to 200 mg approximately every 12 hours.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Acalabrutinib

▾
  • There are no listed contraindications.
  • Avoid use in severe liver impairment (Child-Pugh class C). No dose change is advised for mild or moderate liver impairment.
  • Pregnancy: may cause fetal harm and difficult labor. Pregnancy testing is recommended first.
  • Use effective contraception during treatment and for 1 week after the last dose.
  • Do not breastfeed during treatment and for 2 weeks after the last dose.
  • Not established for children.
  • Adults 65 and older had more serious side effects in studies, with similar effectiveness.
  • Tell your doctor about heart rhythm problems, high blood pressure, bleeding problems or active infections.

What Acalabrutinib does in the body

▾

At the usual schedule, the medicine kept BTK blocked by at least 95% in blood throughout the 12-hour dosing interval. At 4 times the recommended single dose, it did not meaningfully lengthen the QTc interval, a measure of heart electrical timing.

How your body processes Acalabrutinib

▾

Acalabrutinib is absorbed quickly, reaching peak levels in about 30 minutes. A high-fat meal lowers the peak level but does not change total exposure. It is broken down mainly by CYP3A liver enzymes into an active metabolite that is about half as potent.

Acalabrutinib has a short half-life of about 1.4 hours, and the metabolite about 6.4 hours. Most of the dose leaves in the stool, with some in urine. Severe liver impairment raised acalabrutinib exposure about 5-fold.

How to store Acalabrutinib

▾

Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

144

Supplements & herbs that interact with Acalabrutinib

144 supplements and herbal products have documented interactions with Acalabrutinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 103
  • Minor · 38
Every supplement checked against Acalabrutinib — ranked by severity The full interaction hub: 3 major · 103 moderate · 38 minor · every one linked to its full report. Check Acalabrutinib against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Acalabrutinib: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Acalabrutinib — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

▾
Acalabrutinib treats certain blood cancers in adults: mantle cell lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma. For untreated mantle cell lymphoma, it is used together with bendamustine and rituximab. Your doctor will explain which use applies to you.

How do I take it?

▾
Take it by mouth about every 12 hours, with or without food. Swallow it whole with water. Don't chew or crush it, and don't open the capsules or dissolve or cut the tablets. If a dose is more than 3 hours late, skip it and take the next one on time. Never double up.

What side effects should I expect?

▾
Common ones are colds or other upper respiratory infections, diarrhea, headache, muscle or joint pain, fatigue, rash and bruising. Your blood counts may also drop, which is why you'll have regular blood tests. Call your doctor for fever, unusual bleeding, a racing or irregular heartbeat, or yellowing of the skin or eyes.

Can I take my heartburn medicine with it?

▾
It depends on the type. With Calquence capsules, avoid proton pump inhibitors, take the capsule 2 hours before an H2-blocker, and separate antacids by at least 2 hours. Ask me before starting any acid reducer.

Do other medicines or supplements affect it?

▾
Yes. Some antifungals and antibiotics raise its levels, and drugs like rifampin lower them. Blood thinners may raise bleeding risk. Always check with me before starting or stopping anything.

Is it safe in pregnancy or while breastfeeding?

▾
It may harm an unborn baby, so a pregnancy test is recommended before you start. Use effective contraception during treatment and for 1 week after your last dose. Don't breastfeed while taking it and for 2 weeks after the last dose.

Is Acalabrutinib available over the counter?

▾
No. Acalabrutinib is a prescription medicine: every Acalabrutinib product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Acalabrutinib first available?

▾
The earliest FDA record we hold for Acalabrutinib is from 2017: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Acalabrutinib was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Acalabrutinib on HelloPharmacist

Detailed data & references for Acalabrutinib Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Acalabrutinib forms and strengths (how it comes)

Acalabrutinib is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Calquence
How this form is used
What it may be used for
  • Calquence tablets are used for adults with previously untreated MCL (with bendamustine and rituximab) who cannot have a stem cell transplant.
  • Calquence tablets are used for adults with MCL who have had at least one prior therapy.
  • Calquence tablets are used for adults with CLL or SLL.
Important instructions
  • Calquence tablets are swallowed whole with water, with or without food.
  • Do not chew, crush, dissolve or cut Calquence tablets.
  • If a Calquence tablet dose is more than 3 hours late, skip it and take the next dose on schedule.
  • Do not take extra Calquence tablets to make up for a missed dose.
Available strengths 1 strength
5 FDA-listed product records ⓘ

Capsule

By mouth
Brands Calquence
How this form is used
What it may be used for
  • Calquence capsules are used for adults with previously untreated MCL (with bendamustine and rituximab) who cannot have a stem cell transplant.
  • Calquence capsules are used for adults with MCL who have had at least one prior therapy.
  • Calquence capsules are used for adults with CLL or SLL.
Important instructions
  • Calquence capsules are swallowed whole with water, with or without food.
  • Do not open, break or chew Calquence capsules.
  • With Calquence capsules, avoid proton pump inhibitors, take them 2 hours before an H2-blocker and separate antacids by at least 2 hours.
  • If a Calquence capsule dose is more than 3 hours late, skip it and take the next dose on schedule.
Available strengths 1 strength
3 FDA-listed product records ⓘ

Acalabrutinib on the U.S. market: products, makers and brands

How Acalabrutinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 3 Acalabrutinib product records with the FDA, mostly as tablet, capsule; the earliest marketing or approval year on record is 2017. Brand names on the directory include Calquence; the rest are generics.

2
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
3
FDA-listed product records ⓘ
2017
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Acalabrutinib is used (Medicaid data)

A general measure of how commonly Acalabrutinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Acalabrutinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

4,921
Medicaid prescriptions filled (Q1–Q4 2025)
$73.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Acalabrutinib prescribed? Of the 1,601 medications we measure, Acalabrutinib ranks #1,048 by Medicaid prescriptions — more than 35% of them.

Where Acalabrutinib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Acalabrutinib product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

acalabrutinib 100 MG Oral Tablet

4,921 Medicaid prescriptions (Q1–Q4 2025) 100% of Acalabrutinib prescriptions shown $73.2M gross reimbursement (before rebates) ≈ $14,881 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2607734

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Acalabrutinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 3 listed Acalabrutinib NDCs with Medicaid activity.

Compare Acalabrutinib products

A representative set of FDA-listed product records for Acalabrutinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
100 mg Oral AstraZeneca Pharmaceuticals LP NDA View NDC →
💊Tablet
100 mg Oral AstraZeneca Pharmaceuticals LP × 2 listings NDA View NDC →

Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Acalabrutinib NDCs →

Acalabrutinib recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Acalabrutinib recalls since July 2021.

✅No Acalabrutinib recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Acalabrutinib RxCUI 1986808 2 dose forms · 2 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 1986812 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 1986813
  2. Dose form (SCDF) Oral Tablet RxCUI 2607733 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 2607734

Look up RxCUI 1986808 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Acalabrutinib brand names

Acalabrutinib is sold under one brand name in the FDA directory — Calquence. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Calquence

Who makes Acalabrutinib: manufacturers and labelers

One company lists Acalabrutinib products with the FDA. By number of product records, the largest are AstraZeneca Pharmaceuticals LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

AstraZeneca Pharmaceuticals LP 3

Acalabrutinib drug class (RxNorm)

Acalabrutinib belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Bruton's tyrosine kinase (BTK) inhibitors
How it works Tyrosine Kinase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Acalabrutinib page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 19, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Acalabrutinib.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Acalabrutinib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Finished products in the current FDA directory
3
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
AstraZeneca Pharmaceuticals LP
Linked label effective
Feb 19, 2026
Composite sections available
20
Linked SPL Set ID
dd4835ef-e1bc-4997-a399-1ffa2556fbfe
Linked SPL Document ID
aa4e8627-21c7-413a-9d0d-1957ded93283
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. AstraZeneca Pharmaceuticals LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →