ay 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)].
Patient Package Insert
PATIENT INFORMATION
ALIQOPA™ (AL-ih-KO-pah)
(copanlisib)
for injection
What is ALIQOPA?
ALIQOPA is a prescription medicine used to treat adults with follicular lymphoma (FL) when the disease has come back after treatment with at least two prior medicines.
It is not known if ALIQOPA is safe and effective in children.
Before receiving ALIQOPA, tell your healthcare provider about all of your medical conditions, including if you:
• have an infection • have lung or breathing problems • have high blood pressure (hypertension) • have diabetes or high blood sugar (hyperglycemia) • are pregnant or plan to become pregnant. ALIQOPA can harm your unborn baby. o Your healthcare provider will perform a pregnancy test before starting treatment with ALIQOPA. o Females who are able to become pregnant should use effective birth control (contraception) during treatment with ALIQOPA and for at least 1 month after the last dose of ALIQOPA. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ALIQOPA. o Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with ALIQOPA and for at least 1 month after the last dose of ALIQOPA. • are breastfeeding or plan to breastfeed. It is not known if ALIQOPA passes into your breast milk. Do not breastfeed during treatment with ALIQOPA and for at least 1 month after the la
