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CALQUENCE- acalabrutinib capsule, gelatin coated


  1. Patient Information
  2. Distributed By:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hemorrhage

Inform patients to report signs or symptoms of severe bleeding. Inform patients that CALQUENCE may need to be interrupted for major surgeries[seeWarnings and Precautions (5.1)].

Infections

Inform patients to report signs or symptoms suggestive of infection[seeWarnings and Precautions (5.2)].

Cytopenias

Inform patients that they will need periodic blood tests to check blood counts during treatment with CALQUENCE[seeWarnings and Precautions (5.3)].

Second Primary Malignancies

Inform patients that other malignancies have been reported in patients who have been treated with CALQUENCE, including skin cancer. Advise patients to use sun protection[seeWarnings and Precautions (5.4)].

Atrial Fibrillation and Flutter

Counsel patients to report any signs of palpitations, lightheadedness, dizziness, fainting, shortness of breath, and chest discomfort[seeWarnings and Precautions (5.5)].

Dosing Instructions

Instruct patients to take CALQUENCE orally twice daily, about 12 hours apart. CALQUENCE may be taken with or without food. Advise patients that CALQUENCE capsules should be swallowed whole with a glass of water, without being opened, broken, or chewed[seeDosage and Administration (2.1)].

Missed Dose

Advise patients that if they miss a dose of CALQUENCE, they may still take it up to 3 hours after the time they would normally take it. If more than 3 hours have elapsed, they should be instructed to skip that dose and take their next dose of CALQUENCE at the usual time. Warn patients they should not take extra capsules to make up for the dose that they missed[seeDosage and Administration (2.1)].

Drug Interactions

Advise patients to inform their healthcare providers of all concomitant medications, including over-the-counter medications, vitamins and herbal products[seeDrug Interactions (7)].

Lactation

Advise women not to breastfeed during treatment with CALQUENCE and for at least 2 weeks after the final dose[seeUse in Specific Populations (8.2)].

Distributed By: 

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

CALQUENCE is a registered trademark of the AstraZeneca group of companies.

AstraZeneca 2017



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