Acabrunat® (Acalabrutinib) — Second Generation BTK Inhibitor for CLL and MCL

More Selective BTK Inhibition with Improved Tolerability Profile

Acabrunat® (Acalabrutinib) is a second-generation, highly selective Bruton’s tyrosine kinase (BTK) inhibitor used to treat Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Mantle Cell Lymphoma (MCL). Compared to first-generation BTK inhibitors, Acabrunat offers greater BTK selectivity, potentially reducing off-target side effects while maintaining strong clinical efficacy.

A.K. Pharma is a trusted medicine distributor in Delhi supplying genuine Acabrunat (Acalabrutinib) to hospitals, oncology centres, clinics, and pharmacies across India. Manufactured by AstraZeneca, Acabrunat represents an important advance in BTK inhibitor therapy for haematological malignancies.

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What is Acabrunat (Acalabrutinib)?

Acabrunat contains Acalabrutinib, a next-generation BTK inhibitor that covalently and irreversibly binds to the BTK active site. BTK (Bruton’s Tyrosine Kinase) is a signalling enzyme in the B-cell receptor (BCR) pathway that is essential for B-cell proliferation, trafficking, chemotaxis, and adhesion.

In B-cell malignancies including CLL and MCL, aberrant BTK signalling drives uncontrolled cancer cell proliferation and survival. By irreversibly inhibiting BTK, Acabrunat blocks downstream signalling pathways that cancer cells depend on for growth and survival.

Acalabrutinib was specifically designed to be more selective for BTK than first-generation inhibitors — reducing off-target kinase inhibition and potentially improving tolerability, particularly regarding cardiovascular side effects.

Full prescribing information is available at the FDA label for Acalabrutinib.

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Clinical Studies and Evidence

ELEVATE-TN Trial (Acalabrutinib in Previously Untreated CLL) Published in The Lancet (2020), the ELEVATE-TN trial demonstrated that Acalabrutinib plus Obinutuzumab and Acalabrutinib monotherapy both significantly improved progression-free survival compared to Chlorambucil plus Obinutuzumab in previously untreated CLL patients. Median PFS was not reached for Acalabrutinib combinations vs 22.6 months for the control arm.

ASCEND Trial (Acalabrutinib in Relapsed/Refractory CLL) Published in the Journal of Clinical Oncology (2020), the ASCEND trial showed Acalabrutinib significantly improved PFS compared to investigators choice of Idelalisib plus Rituximab or Bendamustine plus Rituximab in patients with relapsed or refractory CLL.

ELEVATE-RR Trial (Acalabrutinib vs Ibrutinib in CLL) Published in the Journal of Clinical Oncology (2022), the ELEVATE-RR trial demonstrated Acalabrutinib was non-inferior to Ibrutinib in PFS in high-risk relapsed/refractory CLL, with significantly lower rates of atrial fibrillation (9.4% vs 16.0%) and hypertension — confirming its improved cardiovascular tolerability profile.

ACE-LY-004 Trial (Acalabrutinib in MCL) The ACE-LY-004 trial demonstrated an overall response rate of 81% with Acalabrutinib in patients with relapsed or refractory Mantle Cell Lymphoma, leading to its accelerated approval in MCL.

AMPLIFY Trial (Acalabrutinib + Venetoclax for CLL) The Phase III AMPLIFY trial showed that the all-oral fixed-duration combination of Acalabrutinib plus Venclexta (Venetoclax) achieved 77% of patients progression-free at 3 years — establishing the first all-oral, fixed-duration treatment option for CLL and SLL.

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Available Strengths

Acabrunat is available as:

• 100mg Capsules

The recommended dose is 100mg orally twice daily — approximately 12 hours apart. Treatment continues until disease progression or unacceptable toxicity.

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Indications — What Acabrunat is Used For

Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL)

• Treatment of adults with CLL or SLL
• Can be used as first-line therapy or for relapsed/refractory disease
• Used as monotherapy or in combination with Obinutuzumab or Venetoclax

Mantle Cell Lymphoma (MCL)

• Treatment of adults with MCL who have received at least one prior therapy

For detailed indication information refer to NCI Acalabrutinib Drug Information.

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Key Benefits of Acabrunat

Greater BTK Selectivity Acalabrutinib is more selective for BTK than first-generation inhibitors, reducing off-target kinase inhibition and potentially improving the tolerability profile — particularly regarding atrial fibrillation and bleeding.

Improved Cardiovascular Tolerability The ELEVATE-RR trial demonstrated significantly lower rates of atrial fibrillation (9.4% vs 16.0%) compared to Ibrutinib in head-to-head comparison, making Acabrunat preferable in patients with cardiac risk factors.

All-Oral Fixed Duration Regimen In combination with Venclexta (Venetoclax), Acabrunat offers the first all-oral, fixed-duration treatment for CLL — eliminating the need for indefinite therapy and allowing patients to complete treatment.

Effective Across CLL Risk Groups Acabrunat demonstrates efficacy regardless of high-risk cytogenetic features including 17p deletion and TP53 mutation, which are associated with poor outcomes with standard chemotherapy.

Twice Daily Oral Capsules Convenient oral administration with capsules taken twice daily — no infusions required.

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How Acabrunat Works

B-cell receptor (BCR) signalling is critical for normal B-cell development but is aberrantly activated in B-cell malignancies:

• Antigen binding to BCR activates BTK
• Activated BTK phosphorylates downstream targets including PLCγ2
• This activates NF-κB and other transcription factors driving B-cell proliferation and survival
• In CLL and MCL cancer cells are dependent on this BCR/BTK signalling for survival

Acabrunat works by:

• Covalently and irreversibly binding to Cysteine 481 in the BTK active site
• Blocking BTK kinase activity
• Preventing phosphorylation of downstream BTK substrates
• Inhibiting B-cell proliferation, migration, and survival signalling
• More selectively targeting BTK compared to first-generation inhibitors — reducing inhibition of other kinases including EGFR, ITK, and TEC

For a detailed mechanism overview refer to the American Society of Hematology educational resources.

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Acabrunat vs Ibrutinib — Key Differences

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Dosage and Administration

• Recommended Dose: 100mg orally twice daily — approximately 12 hours apart
• Administration: Orally with or without food
• Capsules: Swallow whole — do not open, break, or chew
• Missed Dose: Take as soon as possible on the same day — resume normal schedule the following day. Do not take extra capsules to make up a missed dose
• Dose Reduction: 100mg once daily then 100mg every other day for adverse reactions

Full dosing guidelines available at Drugs.com Acalabrutinib Dosage.

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Drug Interactions — Proton Pump Inhibitors

An important drug interaction to note: proton pump inhibitors (PPIs) such as Omeprazole significantly reduce Acalabrutinib absorption. Patients taking PPIs should:

• Switch to an H2-receptor antagonist — take Acabrunat 2 hours after the H2 antagonist
• Or use antacids — take Acabrunat 2 hours before or after the antacid
• Avoid concomitant PPI use where possible

This interaction is clinically significant and should be discussed with all patients before initiating therapy.

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Who Should Use Acabrunat

Acabrunat is prescribed for:

• Adults with newly diagnosed or relapsed/refractory CLL or SLL
• Adults with relapsed or refractory MCL after at least one prior therapy
• Patients with CLL requiring BTK inhibitor therapy who have cardiac risk factors and would benefit from Acalabrutinib’s improved cardiovascular tolerability
• Patients being considered for all-oral fixed-duration therapy in combination with Venetoclax

Acabrunat is prescribed by haematologists and oncologists. A.K. Pharma supplies Acabrunat to hospitals, oncology centres, and pharmacies across Delhi and India.

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Possible Side Effects

Common side effects include headache, neutropenia, diarrhoea, anaemia, thrombocytopenia, fatigue, myalgia, and bruising/petechiae.

Serious side effects include:

• Haemorrhage — minor and major bleeding events including intracranial haemorrhage
• Infections — increased risk of serious bacterial, viral, and fungal infections
• Atrial fibrillation and flutter — monitor for cardiac arrhythmias
• Second primary malignancies including skin cancers
• Tumour lysis syndrome — particularly at treatment initiation

Full side effect information available at FDA Acalabrutinib Safety Information.

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Precautions

• Monitor complete blood count regularly — dose modify for significant haemtological toxicity
• Withhold Acabrunat 3-5 days before and after surgery to reduce bleeding risk
• Avoid anticoagulants and antiplatelet agents where possible
• Monitor for infections throughout treatment
• Monitor for atrial fibrillation and flutter
• Avoid concomitant strong CYP3A inhibitors and inducers
• Effective contraception required during treatment and for at least 1 week after last dose
• Avoid proton pump inhibitors — use H2 antagonists instead

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Storage and Handling

• Store at room temperature between 20°C and 25°C
• Keep in original container — protect from moisture
• Keep out of reach of children
• Do not open, break, or chew capsules

As a responsible medicine distributor in Delhi, A.K. Pharma stores all medicines including Acabrunat under manufacturer-recommended conditions ensuring product integrity for every supply.

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Manufacturer Information

Acabrunat (Acalabrutinib) is manufactured by AstraZeneca. Acalabrutinib received FDA approval in November 2017 for MCL and in November 2019 for CLL/SLL. A.K. Pharma supplies only genuine Acabrunat sourced from authorized AstraZeneca distributors.

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Related Cancer Medicines Available at A.K. Pharma

• Venclexta (Venetoclax) — used in combination with Acabrunat for all-oral fixed-duration CLL treatment
• Blincyto (Blinatumomab) — bispecific antibody for ALL
• Azadine (Azacitidine) — hypomethylating agent for AML and MDS
• Imfinzi (Durvalumab) — PD-L1 inhibitor for solid tumours
• Browse all Cancer Medicines available at A.K. Pharma

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Frequently Asked Questions

Q. What is Acabrunat used for? Acabrunat (Acalabrutinib) is used to treat Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Mantle Cell Lymphoma (MCL). More information available at Cancer.gov.

Q. What is the generic name of Acabrunat? The generic name of Acabrunat is Acalabrutinib. It is a second-generation BTK inhibitor belonging to the targeted kinase inhibitor class of cancer therapies.

Q. How is Acabrunat different from Ibrutinib? Acabrunat is a second-generation BTK inhibitor with greater BTK selectivity than Ibrutinib. The ELEVATE-RR head-to-head trial demonstrated Acabrunat had significantly lower rates of atrial fibrillation (9.4% vs 16.0%) compared to Ibrutinib while maintaining non-inferior efficacy in CLL.

Q. Can Acabrunat be combined with Venetoclax? Yes. The AMPLIFY trial demonstrated that Acabrunat plus Venclexta (Venetoclax) is an effective all-oral, fixed-duration treatment for CLL, achieving 77% of patients progression-free at 3 years.

Q. Is Acabrunat available in India? Acabrunat can be supplied to hospitals, oncology centres, and pharmacies across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi — for availability and pricing.

Q. What is the price of Acabrunat in India? Acabrunat price in India varies by pack size. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.

Q. How to order Acabrunat from A.K. Pharma? You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.

Q. Does A.K. Pharma supply Acabrunat in bulk? Yes. A.K. Pharma supplies Acabrunat in bulk to oncology centres, hospitals, and pharmacies across Delhi and India. Contact us for bulk pricing and availability.

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Why Order Acabrunat from A.K. Pharma?

• Licensed medicine distributor in Delhi with all required drug licenses
• 100% genuine Acabrunat sourced from authorized AstraZeneca distributors
• Reliable supply to oncology centres, hospitals, and pharmacies across India
• Bulk supply available with competitive pricing
• Prompt response to all quote requests
• Serving haematologists and oncologists across Delhi NCR and India

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Contact A.K. Pharma for Acabrunat Supply 📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052 📞 011 4172 6999 📱 WhatsApp: +91 9810034827 🌐 akpharma.in