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

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

You may get infections more easily, even serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.

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 blood may need to be tested often.

Your blood pressure will also need to be checked often.

Usual Adult Dose for Follicular Lymphoma:

60 mg via 1-hour IV infusion on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (3 weeks on and 1 week off).

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments: Accelerated approval was granted based on overall response rate; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Use: Treatment of relapsed follicular lymphoma (FL) in patients who have received at least 2 prior systemic therapies.

Tell your doctor if you have ever had:

• low white blood cell counts;

• an infection;

• lung disease or breathing problems;

• high blood pressure;

• diabetes (copanlisib can raise your blood sugar); or

• liver disease.

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

Both men and women using copanlisib should use effective birth control to prevent pregnancy. Copanlisib can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 months after your last dose. Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Call your doctor for instructions if you miss an appointment for your copanlisib injection.

In a medical setting an overdose would be treated quickly.

Grapefruit may interact with copanlisib and cause side effects. Avoid consuming grapefruit products.

Avoid taking an herbal supplement containing St. John's wort.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Copanlisib may cause serious side effects. Call your doctor at once if you have:

• a new or worsening cough, chest pain, or trouble breathing;

• severe skin redness, itching, or swelling;

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• increased blood pressure--severe headache, pounding in your neck or ears, dizziness, or feeling like you might pass out; or

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough.

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

Common side effects of copanlisib may include:

• low blood cell counts;

• high blood pressure;

• high blood sugar;

• feeling weak or tired;

• nausea, diarrhea; or

• new or worsening cough, fever, 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.

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

This list is not complete and many other drugs may affect copanlisib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.