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ALIQOPA- copanlisib injection, powder, lyophilized, for solution


Patient Information

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

Infections Advise patients that ALIQOPA can cause serious infections that may be fatal. Advise patients to immediately report symptoms of infection[see Warnings and Precautions (5.1)].
Hyperglycemia Advise patients that an infusion-related increase in blood glucose may occur, and to notify their healthcare provider of any symptoms such as pronounced hunger, excessive thirst, headaches, or frequently urinating. Blood glucose levels should be well controlled prior to infusion[see Warnings and Precautions (5.2)].
Hypertension Advise patients that an infusion-related increase in blood pressure may occur, and to notify their healthcare provider of any symptoms such as dizziness, passing out, headache, and/or a pounding heart. Blood pressure should be normal or well controlled prior to infusion[see Warnings and Precautions (5.3)].
Non-infectious pneumonitis Advise patients of the possibility of pneumonitis, and to report any new or worsening respiratory symptoms including cough or difficulty breathing[see Warnings and Precautions (5.4)].
Neutropenia Advise patients of the need for periodic monitoring of blood counts and to notify their healthcare provider immediately if they develop a fever or any signs of infection[see Warnings and Precautions (5.5)].
Severe cutaneous reactions Advise patients that a severe cutaneous reaction may occur, and to notify their healthcare provider if they develop skin reactions (rash, redness, swelling, itching or peeling of the skin)[see Warnings and Precautions (5.6)].
Pregnancy Advise females of reproductive potential to use effective contraceptive methods and to avoid becoming pregnant during treatment with ALIQOPA and for at least one month after the last dose. Advise patients to notify their healthcare provider immediately in the event of a pregnancy or if pregnancy is suspected during ALIQOPA treatment. Advise males with female partners of reproductive potential to use effective contraception during treatment with ALIQOPA and for at least one month after the last dose[see Warnings and Precautions (5.7)].
Lactation Advise women not to breastfeed during treatment with ALIQOPA and for at least 1 month after the last dose[see Use in Specific Populations (8.2)].

2017 Bayer HealthCare Pharmaceuticals Inc.



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