CALQUENCE- acalabrutinib capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACALABRUTINIB (UNII: I42748ELQW) (ACALABRUTINIB - UNII:I42748ELQW)

Available from:

AstraZeneca Pharmaceuticals LP

INN (International Name):

ACALABRUTINIB

Composition:

ACALABRUTINIB 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CALQUENCE is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). None. Risk Summary Based on findings in animals, CALQUENCE may cause fetal harm and dystocia when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of acalabrutinib to animals during organogenesis resulted in dystocia in rats and reduced fetal growth in rabbits at maternal exposures (AUC) 2 times exposures in patients at the recommended dose of 100 mg approximately every 12 hours (s

Product summary:

How Supplied Pack Size Contents NDC Number 60-count bottle Bottle containing 60 capsules 100 mg, hard gelatin capsules with yellow body and blue cap, marked in black ink with ‘ACA 100 mg’ 0310-0512-60 Storage Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

CALQUENCE- ACALABRUTINIB CAPSULE, GELATIN COATED
ASTRAZENECA PHARMACEUTICALS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALQUENCE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CALQUENCE.
CALQUENCE (ACALABRUTINIB) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
CALQUENCE is a kinase inhibitor indicated for the treatment of adult
patients with:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Capsules: 100 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 30%) were: anemia,
neutropenia, upper respiratory tract
infection, thrombocytopenia, headache, diarrhea, and musculoskeletal
pain. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT
1-800-236-9933 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 3/2022
®
Mantle cell lymphoma (MCL) who have received at least one prior
therapy. (1.1)
This indication is approved under accelerated approval based on
overall response rate. Continued
approval for this indication may be contingent upon verification and
description of clinical benefit in
confirmatory trials. (1.1, 14.1)
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
(SLL). (1.2)
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. (2.2)
Avoid CALQUENCE in patients with severe hepatic impairment (2.2, 8.6)
Serious and Opportunistic Infections: Monitor for signs and symptoms
of infection and treat promptly.
(5.1)
Hemorrhage: Monitor for bleeding and manage appropriately. (5.2)
Cytopenias: Monitor co