Calquence Patient Counseling Information




Full Prescribing Info
Patient Counseling Information
Advise the patient to read the patient labeling (Patient Information).
Serious and Opportunistic Infections: Inform patients of the possibility of serious infection and to report signs or symptoms suggestive of infection [see Serious and Opportunistic Infections under Precautions].
Hemorrhage: Inform patients to report signs or symptoms of bleeding. Inform patients that CALQUENCE may need to be interrupted for major surgeries [see Hemorrhage under Precautions].
Cytopenias: Inform patients that they will need periodic blood tests to check blood counts during treatment with CALQUENCE [see Cytopenias under Precautions].
Second Primary Malignancies: Inform patients that other malignancies have been reported in patients who have been treated with CALQUENCE, including skin cancer and other solid tumors. Advise patients to use sun protection [see Second Primary Malignancies under Precautions].
Atrial Fibrillation and Flutter: Counsel patients to report any signs of palpitations, dizziness, fainting, chest discomfort, and shortness of breath [see Atrial Fibrillation and Flutter under Precautions].
Pregnancy Complication: CALQUENCE may cause fetal harm and dystocia. Advise women to avoid becoming pregnant during treatment and for at least 1 week after the last dose of CALQUENCE [see Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Lactation: Advise females not to breastfeed during treatment with CALQUENCE and for at least 2 weeks after the final dose [see Lactation under Use in Pregnancy & Lactation].
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 [see Recommended Dosage under Dosage & Administration].
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 [see Recommended Dosage under Dosage & Administration].
Drug Interactions: Advise patients to inform their healthcare providers of all concomitant medications, including over-the-counter medications, vitamins and herbal products [see Interactions].
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