Copanlisib injection

What is this medicine?

COPANLISIB (koe pan lis ib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat follicular non-Hodgkin lymphoma.

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• breathing problems

• cough

• headache

• redness, blistering, peeling or loosening of the skin

• signs and symptoms of high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• unusually weak or tired

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• mouth sores

• nausea

• pain, tingling, numbness in the hands or feet

What may interact with this medicine?

This medicine may interact with the following medications:

• antiviral medicines for HIV or AIDS

• boceprevir

• certain medicines for fungal infections like ketoconazole, itraconazole, posaconazole, and voriconazole

• certain medicines for seizures like carbamazepine and phenytoin

• clarithromycin

• conivaptan

• diltiazem

• enzalutamide

• grapefruit juice

• idelalisib

• mitotane

• nefazodone

• rifampin

• St. John's wort

• troleandomycin

What if I miss a dose?

Keep appointments for follow-up doses as directed. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• infection

• high blood pressure

• liver disease

• lung or breathing disease, like asthma

• an unusual or allergic reaction to copanlisib, other medicines, foods, dyes, or preservative

• pregnant, or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You may need blood work done while you are taking this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Do not become pregnant while taking this medicine or for at least 1 month after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for at least 1 month after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for at least 1 month after stopping it.

This medicine may interfere with the ability to have a child. Talk with your doctor or health care professional if you are concerned about your fertility.