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Copanlisib

Generic Name: copanlisib (KOE pan LIS ib)
Brand Name: Aliqopa

Medically reviewed on Oct 2, 2017

What is copanlisib?

Copanlisib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

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, people with follicular lymphoma responded to copanlisib. However, further studies are needed.

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

Important Information

Serious and sometimes fatal infections may occur during treatment with copanlisib. Call your doctor right away if you have signs of infection such as: fever, chills, mouth sores, a new or worsening cough, or trouble breathing.

Before taking this medicine

You should not be treated with copanlisib if you are allergic to it.

To make sure copanlisib is safe for you, tell your doctor if you have ever had:

  • 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.

Copanlisib can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using copanlisib, whether you are a man or a woman. Men should use condoms. Copanlisib use by either parent may cause birth defects.

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.

It is not known whether copanlisib passes into breast milk or if it could harm a nursing baby. Do not breast-feed while using this medicine, and for at least 1 month after your last dose.

How is copanlisib given?

Copanlisib is injected into a vein through an IV. 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 can lower blood cells that help your body fight infections. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Your blood pressure will also need to be checked often.

Store this medicine at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while receiving copanlisib?

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

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

Copanlisib side effects

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).

Call your doctor at once if you have:

  • 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;

  • 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.

Copanlisib dosing information

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.

What other drugs will affect copanlisib?

Other drugs may interact with copanlisib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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