Aliqopa

Aliqopa was used to treat relapsed follicular lymphoma (FL)(a slow-growing blood cancer) in adults who had received at least two prior systemic treatments.

Aliqopa (copanlisib) was a cancer medicine that worked by blocking an enzyme called phosphatidylinositol-3-kinase that cancer cells needed to survive and multiply. This triggered cancerous B cells to die and disrupted the chemical signals needed for them to spread throughout the body, helping to control FL growth. Aliqopa belonged to the drug class called kinase inhibitors.

Aliqopa is no longer available. Your healthcare provider will prescribe an alternative treatment for follicular lymphoma.

The information below is retained for educational purposes only.

On November 13, 2023, Bayer announced that it would voluntarily withdraw the Aliqopa U.S. New Drug Application after Aliqopa did not meet its target benefits compared to standard immunochemotherapy in the CHRONOS-4 study.

Originally, Aliqopa was granted accelerated approval by the FDA in September 2017 based on CHRONOS-1, an open-label, single-arm Phase II study, with the condition that clinical benefit be confirmed through the CHRONOS-4 study. When clinical benefit could not be confirmed, Bayer announced the voluntary withdrawal of the Aliqopa® (copanlisib) U.S. New Drug Application.

Aliqopa injection is given as an infusion into a vein. 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.

Aliqopa 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 affects your immune system. You may get infections more easily, even serious or fatal infections.

Your blood may need to be tested often.

Your blood pressure will also need to be checked often.

Tell your doctor and pharmacist if you are allergic to copanlisib, any other medications, or any of the ingredients in Aliqopa injection.

You may get infections more easily during treatment with Aliqopa. Serious and sometimes fatal infections may occur. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.

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

• low white blood cell counts;
• an infection;
• lung disease or breathing problems;
• high blood pressure;
• diabetes (Aliqopa can raise your blood sugar); or
• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using Aliqopa should use effective birth control to prevent pregnancy. Copanlisib can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 months after your last dose. Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using Aliqopa, and for at least 1 month after your last dose.

Get emergency medical help if you have signs of an allergic reaction to Aliqopa (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).

Aliqopa may cause serious side effects. Call your doctor at once if you have:

• a new or worsening cough, chest pain, or trouble breathing;
• severe skin redness, itching, or swelling;
• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;
• increased blood pressure - severe headache, pounding in your neck or ears, dizziness, or feeling like you might pass out; or
• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Aliqopa side effects may include:

• low blood cell counts;
• high blood pressure;
• high blood sugar;
• feeling weak or tired;
• nausea, diarrhea; or
• new or worsening cough, fever, 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.

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 toxicityComments: 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.

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

In a medical setting an overdose would be treated quickly.

Grapefruit may interact with copanlisib and cause side effects. Avoid consuming grapefruit products.

Avoid taking an herbal supplement containing St. John's wort.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

This list is not complete and many other drugs may interact with copanlisib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Active ingredient: copanlisibInactive ingredients: citric acid anhydrous, mannitol.

Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981 USA.