copanlisib

What is the most important information I should know about copanlisib?

What is copanlisib?

Copanlisib is used to treat follicular lymphoma that has relapsed after treatment with at least two other medicines.

Copanlisib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Copanlisib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving copanlisib?

Tell your doctor if you have ever had:

• liver disease;
• an infection;
• lung disease or breathing problems;
• high blood pressure; or
• diabetes (copanlisib can raise your blood sugar).

You may need to have a negative pregnancy test before starting this treatment.

Keep using birth control for at least 1 month after your last dose of copanlisib. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using copanlisib.

How is copanlisib given?

Copanlisib is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 1 hour to complete.

Copanlisib is given in a 28-day treatment cycle. You will receive the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with this medicine.

Copanlisib affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Your blood pressure will also need to be checked often.

What happens if I miss a dose?

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving copanlisib?

Grapefruit may interact with copanlisib and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid taking an herbal supplement containing St. John's wort while you are being treated with copanlisib.

What are the possible side effects of copanlisib?

• a new or worsening cough, chest pain, or trouble breathing;
• severe skin redness, itching, or swelling;
• easy bruising, unusual bleeding;
• signs of infection --fever, chills, cold or flu symptoms, mouth sores, skin sores;
• high blood sugar --increased thirst, increased urination, hunger, headache, blurred vision, fruity breath odor; or
• increased blood pressure --severe headache, pounding in your neck or ears, dizziness, or feeling like you might pass out.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• infections, bruising or bleeding;
• feeling weak or tired;
• nausea, diarrhea; or
• trouble breathing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect copanlisib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect copanlisib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about copanlisib.