Copanlisib

Generic name: copanlisib
Brand name: Aliqopa
Dosage form: intravenous powder for injection (60 mg)
Drug class: PI3K inhibitors

Medically reviewed by  A Ras MD.

What is copanlisib?

Copanlisib is a prescription medicine that is used to treat a type of lymphoma.

Description

ALIQOPA (copanlisib) is a kinase inhibitor for intravenous infusion. The active pharmaceutical ingredient is copanlisib dihydrochloride which exists as a non-stoichiometric hydrate and has the molecular formula of C23H28N8O4 2HCl and a molecular weight of 553.45 g/mol. The molecular formula and molecular weight are based on the anhydrous form. The chemical name is 2-amino-N-{7-methoxy-8-[3-(morpholin-4-yl)propoxy]-2,3-dihydroimidazo[1,2-c]quinazolin-5-yl}pyrimidine-5-carboxamide dihydrochloride. Copanlisib dihydrochloride has the following structural formula:

ALIQOPA is supplied in single-dose vials as a sterile lyophilized solid for reconstitution and further dilution for intravenous infusion. The product is white to slightly yellowish. After reconstitution, the solution is colorless to slightly yellowish. Each vial contains 60 mg copanlisib free base (equivalent to 69.1 mg copanlisib dihydrochloride). After reconstitution, each mL contains 15 mg copanlisib free base (equivalent to 17.3 mg copanlisib dihydrochloride).

Inactive ingredients: Each vial contains 5.8 mg citric acid anhydrous (might increase to 6.1 mg in case pH correction is necessary), 120 mg mannitol (bulking agent). Citric acid anhydrous acts as a buffering agent and may be used together with sodium hydroxide for pH adjustment.

Before taking copanlisib, tell your doctor:

• If you are allergic to copanlisib; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: High blood pressure, high blood sugar, infection, low blood cell counts, or lung or breathing problems.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with copanlisib, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with copanlisib.
• If you are breast-feeding. Do not breast-feed while you take copanlisib or for 1 month after you stop copanlisib.

This is not a list of all drugs or health problems that interact with copanlisib.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take copanlisib with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take copanlisib?

• Tell all of your health care providers that you take copanlisib. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• High blood sugar has happened with copanlisib. This includes diabetes that is new or worse.
• Check your blood sugar as you have been told by your doctor.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• High triglyceride levels have happened with copanlisib. Tell your doctor if you have ever had high triglyceride levels.
• Avoid grapefruit and grapefruit juice.
• If you are 65 or older, use copanlisib with care. You could have more side effects.
• This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child.
• Men with a partner who may get pregnant must use birth control while taking copanlisib and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start copanlisib to show that you are NOT pregnant.
• Women must use birth control while taking copanlisib and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.

How is copanlisib best taken?

Use copanlisib as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of copanlisib that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Signs of low phosphate levels like change in eyesight, feeling confused, mood changes, muscle pain or weakness, shortness of breath or other breathing problems, or trouble swallowing.
• Feeling very tired or weak.
• A burning, numbness, or tingling feeling that is not normal.

What are some other side effects of copanlisib?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea.
• Upset stomach or throwing up.
• Feeling tired or weak.
• Mouth irritation or mouth sores.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out copanlisib?

• If you need to store copanlisib at home, talk with your doctor, nurse, or pharmacist about how to store it.