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copanlisib (Intravenous route)


Commonly used brand name(s)

In the U.S.

  • Aliqopa

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antineoplastic Agent

Uses For copanlisib

Copanlisib injection is used to treat follicular lymphoma that has come back after treatment with at least two previous medicines did not work as well.

copanlisib is to be given only by or under the direct supervision of your doctor.

Before Using copanlisib

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For copanlisib, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to copanlisib or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Appropriate studies have not been performed on the relationship of age to the effects of copanlisib injection in the pediatric population. Safety and efficacy have not been established.


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of copanlisib injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving copanlisib, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using copanlisib with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Boceprevir
  • Carbamazepine
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Enzalutamide
  • Fosphenytoin
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Lumacaftor
  • Mitotane
  • Nefazodone
  • Nelfinavir
  • Phenytoin
  • Posaconazole
  • Rifampin
  • Ritonavir
  • Saquinavir
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of copanlisib. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetes or
  • Hypertension (high blood pressure) or
  • Infections (eg, pneumonia) or
  • Lung or breathing problems or
  • Neutropenia (blood problem)—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight an infection.

Proper Use of copanlisib

A nurse or other trained health professional will give you copanlisib in a hospital or cancer treatment center. copanlisib is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for 1 hour.

copanlisib comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Do not drink grapefruit juice while you are receiving copanlisib.

Precautions While Using copanlisib

It is very important that your doctor check your progress at regular visits to make sure copanlisib is working properly. Blood tests may be needed to check for unwanted effects.

Using copanlisib while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Both female and male patients should use a highly effective birth control during treatment with copanlisib and for at least 1 month after the last dose. If you think you have become pregnant while using copanlisib, tell your doctor right away.

Call your doctor right away if you start to have a cough that won't go away, weight loss, night sweats, fever, chills, flu-like symptoms (such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips. These may be signs that you have an infection.

copanlisib may increase your blood sugar levels. Check with your doctor right away if you have the following symptoms: confusion, nausea or vomiting, increased hunger, thirst or urination, or unusual tiredness or weakness.

Your blood pressure might get too high while you are using copanlisib. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

copanlisib may cause swelling of the lungs (pneumonitis), which requires immediate medical attention. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

Serious skin reactions can occur with copanlisib. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with copanlisib.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

copanlisib Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • chest pain
  • chills
  • cough
  • cracks in the skin
  • dizziness
  • dry mouth
  • fatigue
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • loss of heat from the body
  • lower back or side pain
  • nausea
  • nervousness
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • red, swollen skin
  • scaly skin
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain
  • sweating
  • swollen glands
  • tightness in the chest
  • troubled breathing
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • cracked lips
  • diarrhea
  • difficulty in swallowing
  • lack or loss of strength
  • swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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