Copanlisib Injection

Copanlisib injection is used to treat people with follicular lymphoma (FL; a slow-growing blood cancer) that has returned after being treated 2 or more times with other medications. Copanlisib injection is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

Copanlisib injection comes as a powder to be mixed with liquid and given through a needle or catheter placed into a vein. It is usually injected slowly over a period of 60 minutes on days 1,8, and 15 of a 28-day treatment cycle.

Copanlisib injection may cause high blood pressure for up to 8 hours after the infusion. Your doctor will check your blood pressure before you receive the infusion and for several hours after the infusion is completed. If you experience any of the following symptoms after you receive the medication tell your doctor immediately: dizziness, feeling faint, headache, or pounding heartbeat.

Your doctor may reduce your dose, delay or stop your treatment with copanlisib injection, or treat you with additional medications depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Do not drink grapefruit juice while receiving this medication.

Unless your doctor tells you otherwise, continue your normal diet.

Copanlisib injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting
• mouth sores, ulcers, or pain
• burning, prickling, tingling, or numb feeling on the skin
• pain upon touch
• swelling of nose, throat, or mouth
• lack of strength or energy

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• unusual bleeding or bruising
• new or worsening cough, shortness of breath, or difficulty breathing
• rash; red, itching, peeling or swelling skin
• fever, sore throat, chills, or other signs of infection
• feeling very hungry or thirsty, headache, or frequent urination

Copanlisib injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).