Targeted Therapy / Oncology — Hematologic

Calquence (acalabrutinib)

AstraZeneca · BTK Inhibitor (Bruton's Tyrosine Kinase Inhibitor)

FDA Approved 2019 Oral capsule Specialty Medication
Acalabrutinib maleate monohydrate 100mg capsules, Acalieva brand, pharmacy setting

What is Calquence? Calquence (acalabrutinib) is a second-generation Bruton's tyrosine kinase (BTK) inhibitor by AstraZeneca used in the treatment of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL).

About Calquence

Brand NameCalquence
Generic / INNacalabrutinib
Drug ClassBTK Inhibitor (Bruton's Tyrosine Kinase Inhibitor)
ManufacturerAstraZeneca
AdministrationOral capsule
FDA Approval2019
📦 100 mg capsules; available in 60-count bottles

FDA-Approved Uses for Calquence

Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.

  • Chronic lymphocytic leukemia (CLL) — adult patients
  • Small lymphocytic lymphoma (SLL) — adult patients
  • Mantle cell lymphoma (MCL) — adult patients who have received at least one prior therapy
Biomarker Note: No specific biomarker required for approved CLL/SLL/MCL indications, though del(17p), TP53, and IGHV mutation status inform overall treatment strategy.

How Does Calquence Work?

Acalabrutinib is a selective, covalent BTK inhibitor. It binds irreversibly to the Cys481 residue of BTK, blocking BTK-mediated signaling in the B-cell receptor pathway. This inhibits proliferation and survival of malignant B cells. Calquence has higher selectivity for BTK compared to ibrutinib, which may reduce off-target effects.

Dosage & Administration

100 mg orally twice daily (approximately every 12 hours), with or without food. Taken as capsules whole — do not open, break, or chew. Dose modifications may apply for toxicity or drug interactions (particularly with CYP3A inhibitors/inducers).

⚠️ Important

Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.

Warnings, Precautions & Side Effects

General Warning

Serious and fatal hemorrhagic events reported. Serious infections (bacterial, viral, fungal). Cardiac arrhythmias including atrial fibrillation. Second primary malignancies. Tumor lysis syndrome. Embryo-fetal toxicity. Avoid concomitant use with strong CYP3A inhibitors/inducers where possible.

⛔ Serious Warnings & Precautions
  • Serious hemorrhage
  • Serious infections (opportunistic)
  • Atrial fibrillation / flutter
  • Second primary malignancies
  • Tumor lysis syndrome
  • Embryo-fetal toxicity

Common Side Effects

  • Headache
  • Diarrhea
  • Bruising
  • Fatigue
  • Nausea
  • Arthralgia
  • Upper respiratory tract infection
  • Neutropenia

This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.

Storage & Handling

Store at room temperature 20°C to 25°C (68°F to 77°F). Keep in original container.

BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.

Insurance Coverage, Prior Authorization & Patient Assistance

🛡️ Commercial Insurance

Calquence is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.

✅ Prior Authorization

Prior authorization is required by virtually all insurance plans for Calquence. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.

🏥 Medicare Coverage

Medicare Part D covers this oral specialty medication. Medicaid coverage varies by state.

🆓 Patient Assistance

Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.

Prior Authorization Patient Assistance Insurance & Savings Medication Costs

Frequently Asked Questions — Calquence

Calquence (acalabrutinib) is a second-generation BTK inhibitor by AstraZeneca approved for CLL, SLL, and MCL. It works by blocking the BTK signaling pathway that malignant B cells depend on for growth and survival.

Calquence is taken as 100 mg oral capsules twice daily, approximately every 12 hours. Capsules should be swallowed whole — not opened or chewed. It can be taken with or without food.

Both are BTK inhibitors, but Calquence (acalabrutinib) has higher BTK selectivity. In clinical studies, Calquence has shown a lower rate of atrial fibrillation and certain off-target effects compared to ibrutinib, though both are effective for approved indications.

Calquence is covered by most major commercial insurance plans and Medicare Part D as an oral oncology agent. Prior authorization is virtually always required. BiologicHealthPlus can handle the prior authorization process.

Acalabrutinib maleate monohydrate is the salt form of acalabrutinib used in the capsule formulation of Calquence. Generic versions (such as Acalieva) are also available as acalabrutinib maleate monohydrate 100 mg capsules.

Related Medications

Imbruvica (ibrutinib)  ·  Brukinsa (zanubrutinib)  ·  Venetoclax  ·  Obinutuzumab

Related Conditions

Chronic lymphocytic leukemia (CLL)  ·  Small lymphocytic lymphoma (SLL)  ·  Mantle cell lymphoma (MCL)

Comparisons

Oncology

Authoritative References

Medical Disclaimer: This page is for general educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult your oncologist, hematologist, or licensed healthcare professional before making any treatment decisions. Last reviewed: August 2026 by the BiologicHealthPlus Clinical Team.