ASH News Daily 2017 - Issue 2 - A-15

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Important Safety Information (cont'd)

Hypertension: Grade 3 hypertension (systolic 160 mmHg or greater or diastolic 100 mmHg or greater)
occurred in 26% of 317 patients treated with ALIQOPA monotherapy. Serious hypertensive events occurred
in 0.9% of 317 patients. Treatment with ALIQOPA may result in infusion-related hypertension. The mean
change of systolic and diastolic BP from baseline to 2 hours post-infusion on Cycle 1 Day 1 was 16.8 mmHg
and 7.8 mmHg, respectively. The mean BP started decreasing approximately 2 hours post-infusion; BP
remained elevated for 6 to 8 hours after the start of the ALIQOPA infusion. Optimal BP control should be
achieved before starting each ALIQOPA infusion. Monitor BP pre- and post-infusion. Withhold, reduce dose,
or discontinue ALIQOPA depending on the severity and persistence of hypertension.
Non-infectious Pneumonitis: Non-infectious pneumonitis occurred in 5% of 317 patients treated with
ALIQOPA monotherapy. Withhold ALIQOPA and conduct a diagnostic examination of a patient who is
experiencing pulmonary symptoms such as cough, dyspnea, hypoxia, or interstitial infiltrates on
radiologic exam. Patients with pneumonitis thought to be caused by ALIQOPA have been managed by
withholding ALIQOPA and administration of systemic corticosteroids. Withhold, reduce dose, or discontinue
ALIQOPA depending on the severity and persistence of non-infectious pneumonitis.
Neutropenia: Grade 3 or 4 neutropenia occurred in 24% of 317 patients treated with ALIQOPA
monotherapy. Serious neutropenic events occurred in 1.3%. Monitor blood counts at least weekly
during treatment with ALIQOPA. Withhold, reduce dose, or discontinue ALIQOPA depending on the
severity and persistence of neutropenia.

Lactation: Advise women not to breastfeed. Advise a lactating woman not to breastfeed during treatment
with ALIQOPA and for at least 1 month after the last dose.
Adverse Drug Reactions: Serious adverse reactions were reported in 44 (26%) patients. The most frequent
serious adverse reactions that occurred were pneumonia (8%), pneumonitis (5%) and hyperglycemia (5%).
Adverse reactions resulted in dose reduction in 36 (21%) and discontinuation in 27 (16%) patients. The most
frequently observed adverse drug reactions (≥20%) in ALIQOPA-treated patients were: hyperglycemia (54%),
leukopenia (36%), diarrhea (36%), decreased general strength and energy (36%), hypertension (35%),
neutropenia (32%), nausea (26%), thrombocytopenia (22%), and lower respiratory tract infections (21%).
Drug Interactions: Avoid concomitant use with strong CYP3A inducers. Reduce the ALIQOPA dose to 45 mg
when concomitantly administered with strong CYP3A inhibitors.

Please see additional Important Safety Information on the previous page and Brief Summary of full
Prescribing Information on the following pages.
© 2017 Bayer. All rights reserved. BAYER, the Bayer Cross, and Aliqopa are registered trademarks of Bayer.

PP-860-US-0496

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Printed in USA

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Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ALIQOPA can cause
fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of
copanlisib to pregnant rats during organogenesis caused embryo-fetal death and fetal abnormalities in
rats at maternal doses as low as 0.75 mg/kg/day (4.5 mg/m2/day body surface area) corresponding to
approximately 12% the recommended dose for patients. Advise pregnant women of the potential risk to
a fetus. Advise females of reproductive potential and males with female partners of reproductive potential
to use effective contraception during treatment and for at least one month after the last dose.

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Severe Cutaneous Reaction: Grade 3 and 4 cutaneous reactions occurred in 2.8% and 0.6% of 317 patients
treated with ALIQOPA monotherapy respectively. Serious cutaneous reaction events were reported in
0.9%. The reported events included dermatitis exfoliative, exfoliative rash, pruritus, and rash (including
maculo-papular rash). Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and
persistence of severe cutaneous reactions.

Table of Contents for the Digital Edition of ASH News Daily 2017 - Issue 2