Copanlisib (koe-pan-LIS-ib)

Treats follicular lymphoma that has come back (relapsed).

Brand Name(s):

Aliqopa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the needle will have to remain in place for 1 hour.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how copanlisib works. Tell your doctor if you are using any of the following:
  • Conivaptan, diltiazem, enzalutamide, idelalisib, mitotane, nefazodone, St John's wort
  • Medicine to treat HIV/AIDS (including boceprevir, cobicistat, danoprevir/ritonavir, elvitegravir/ritonavir, indinavir/ritonavir, lopinavir/ritonavir, nelfinavir, paritaprevir/ritonavir and (ombitasvir or dasabuvir), ritonavir, saquinavir/ritonavir, tipranavir/ritonavir)
  • Medicine to treat infections (including clarithromycin, itraconazole, ketoconazole, posaconazole, rifampin, troleandomycin, voriconazole)
  • Medicine to treat seizures (including carbamazepine, phenytoin)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for 1 month after the last dose. Male patients who have female partners should use an effective birth control during treatment with this medicine and for 1 month after the last dose.
• Do not breastfeed during treatment and for 1 month after the last dose.
• Tell your doctor if you have kidney disease, liver disease, lung or breathing problems, diabetes, high blood pressure, any type of infection (including pneumonia), or a history of cytomegalovirus infection.
• This medicine may cause the following problems:
  • Increased risk for infections, which may be life-threatening
  • High blood sugar
  • High blood pressure
  • Pneumonitis (inflammation of the lungs)
  • Serious skin reactions
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Blistering, peeling, or red skin rash
• Chest pain, trouble breathing
• Fever, chills, sore throat, cough, body aches
• Increased hunger or thirst, change in how much or how often you urinate, unusual weight loss
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Nausea, vomiting
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Tiredness or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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