Copanlisib Injection

Copanlisib is no longer commercially available in the U.S. See the FDA website (https://www.accessdata.fda.gov/scripts/cder/daf/) for information on drugs that have been discontinued

Because this drug is no longer available in the U.S. market, this document is no longer updated by AHFS DI. If this drug is used in countries other than the U.S., it is essential that the manufacturers' labeling be consulted for more recently available information

Copanlisib injection is used to treat people with follicular lymphoma (FL; a slow-growing blood cancer) that has returned after being treated 2 or more times with other medications. Copanlisib injection is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

Copanlisib injection comes as a powder to be mixed with liquid and given through a needle or catheter placed into a vein. It is usually injected slowly over a period of 60 minutes on days 1,8, and 15 of a 28-day treatment cycle.

Copanlisib injection may cause high blood pressure for up to 8 hours after the infusion. Your doctor will check your blood pressure before you receive the infusion and for several hours after the infusion is completed. If you experience any of the following symptoms after you receive the medication tell your doctor immediately: dizziness, feeling faint, headache, or pounding heartbeat.

Your doctor may reduce your dose, delay or stop your treatment with copanlisib injection, or treat you with additional medications depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving copanlisib injection,

• tell your doctor and pharmacist if you are allergic to copanlisib, any other medications, or any of the ingredients in copanlisib injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: boceprevir (Victrelis); carbamazepine (Carbatrol, Equetro, Tegretol, others), clarithromycin (Biaxin, in Prevpac), cobicistat (Tybost, in Evotaz, Genvoya, Prezcobix, Stribild), conivaptan (Vaprisol), diltiazem (Cardizem, Cartia XT, Diltzac, others), efavirenz (Sustiva), enzalutamide (Xtandi), idelalisib (Zydelig), indinavir (Crixivan) with ritonavir; itraconazole (Sporonox, Onmel), and ketoconazole, lopinavir with ritonavir (in Kaletra); mitotane (Lysodren), nefazodone, nelfinavir (Viracept), nevirapine (Viramune), paritaprevir, ritonavir, ombitasvir, and/or dasabuvir (Viekira Pak); phenobarbital, phenytoin (Dilantin, Phenytek), posaconazole (Noxafil), rifabutin (Mycobutin), rifampin (Rifadine, in Rifamate, Rifater), ritonavir (Norvir, in Kaletra, Technivie, Viekira Pak), saquinavir (Invirase), and tipranavir (Aptivus) with ritonavir; and voriconazole (Vfend). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with copanlisib injection, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have an infection or if you have or have ever had high blood sugar, diabetes, lung or breathing problems, high blood pressure, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or plan to father a child. You should not become pregnant while you are receiving copanlisib injection. You will need to have a negative pregnancy test before you begin receiving this medication. Use effective birth control during your treatment with copanlisib injection and for 1 month after your final dose. If you are a male and your partner can become pregnant, you should use effective birth control during your treatment and for 1 month after your final dose. If you or your partner become pregnant while receiving copanlisib, call your doctor.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are receiving copanlisib injection, and for 1 month after your final dose.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of receiving copanlisib injection.

Do not drink grapefruit juice while receiving this medication.

Unless your doctor tells you otherwise, continue your normal diet.

Copanlisib injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting
• mouth sores, ulcers, or pain
• burning, prickling, tingling, or numb feeling on the skin
• pain upon touch
• swelling of nose, throat, or mouth
• lack of strength or energy

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• unusual bleeding or bruising
• new or worsening cough, shortness of breath, or difficulty breathing
• rash; or red, itching, peeling or swelling skin
• fever, sore throat, chills, or other signs of infection
• feeling very hungry or thirsty, headache, or frequent urination

Copanlisib injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to copanlisib injection.

Ask your pharmacist any questions you have about copanlisib injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Aliqopa^®