Copanlisib

What is Copanlisib?

• Copanlisib ALIQOPA is a kinase inhibitor used to treat adults with follicular lymphoma (FL).

What are the uses of this medicine?

• This medicine is used to treat adults with follicular lymphoma (FL) when the disease has come back after treatment with at least two prior medicines.

How does this medicine work?

• Copanlisib (koe" pan lis' ib) is an intravenously administered small molecule inhibitor of phosphatidylinositol 3-kinase (PI3K) alpha and delta which are essential components in B cell signaling pathways that drive survival of B cells and their migration to lymph nodes and bone marrow.
• Inhibition of this pathway inhibits B cell chemotaxis and adherence and reduces cell viability.
• This pathway is upregulated in many B cell malignancies and is known to be critical for proliferation and survival of leukemia and lymphomatous malignant B lymphocytes.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Avoid concomitant use of ALIQOPA with strong CYP3A inducers (eg: rifampin, carbamazepine, phenytoin, St. John’s wort).
• Concomitant use of ALIQOPA with strong CYP3A inhibitors (eg: itraconazole, ketoconazole, clarithromycin) increases the copanlisib AUC. If concomitant use with strong CYP3A inhibitors cannot be avoided, reduce the ALIQOPA dose to 45 mg.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Recommended Dosage:

• The recommended dose of ALIQOPA is 60 mg administered as a 1-hour intravenous infusion on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (three weeks on and one week off).

Dose Modification for Moderate Hepatic Impairment:

• Reduce ALIQOPA dose to 45 mg in patients with moderate hepatic impairment.

Dose Modification for Use with Strong CYP3A Inhibitors

• Reduce ALIQOPA dose to 45 mg if a strong CYP3A inhibitor must be used.

Administration

• ALIQOPA will be given to you by a healthcare provider as an intravenous (IV) injection into your vein over 1 hour.
• You will receive your ALIQOPA treatment 1 time every week for 3 weeks and then stop for 1 week. This is 1 cycle of treatment. ALIQOPA is usually given on Day 1, Day 8, and Day 15 of a 28-day treatment cycle.
• Your healthcare provider will decide how many treatment cycles you need.
• Your healthcare provider may withhold treatment, decrease your dose, temporarily stop, or permanently stop treatment with ALIQOPA if you have certain side effects.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 60 mg of copanlisib as a lyophilized solid in single-dose vial for reconstitution.

This medicine is available in fallowing brand namesː

• ALIQOPA

What side effects can this medication cause?

The most common side effects of this medicine include:

• low white blood cell count (leukopenia)
• low platelets in your blood (thrombocytopenia)
• diarrhea
• decreased strength and tiredness
• lower respiratory tract infection
• nausea

ALIQOPA can cause serious side effects, including:

• Infections
• High blood sugar (hyperglycemia)
• High blood pressure (hypertension)
• Lung or breathing problems
• Low white blood cell count (neutropenia)
• Severe skin reactions

What special precautions should I follow?

• Avoid taking St. John’s Wort during treatment with ALIQOPA.
• Avoid drinking grapefruit juice during treatment with ALIQOPA.
• Serious, including fatal, infections occurred in 19% of 317 patients treated with ALIQOPA monotherapy. Monitor patients for signs and symptoms of infection. Withhold treatment for Grade 3 and higher infections until resolution.
• Treatment with ALIQOPA may result in infusion-related hyperglycemia. Start each infusion once optimal blood glucose control is achieved. Withhold treatment, reduce dose, or discontinue treatment depending on the severity and persistence of hyperglycemia.
• Treatment with ALIQOPA may result in infusion-related hypertension. Withhold treatment in patients until both the systolic blood pressure (BP) is less than 150 mmHg and the diastolic BP is less than 90 mmHg. Consider reducing dose if anti-hypertensive treatment is required. Discontinue in patients with BP that is uncontrolled or with life-threatening consequences.
• Non-infectious pneumonitis occurred in patients treated with ALIQOPA monotherapy. Treat NIP and reduce dose. Discontinue treatment if Grade 2 NIP recurs or in patients experiencing Grade 3 or higher NIP.
• Grade 3 or 4 neutropenia occurred in patients treated with ALIQOPA monotherapy. Monitor blood counts at least weekly while under treatment. Withhold treatment until ANC ≥0.5 x 103 cells/mm3.
• Serious cutaneous reaction events were reported. Withhold treatment, reduce dose, or discontinue treatment depending on the severity and persistence of severe cutaneous reactions.
• ALIQOPA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• ALIQOPA can cause fetal harm when administered to a pregnant woman.
• There are no available data in pregnant women to inform the drug-associated risk.

Can this medicine be used in children?

• Safety and effectiveness have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: copanlisib
• Inactive ingredients: citric acid anhydrous, mannitol

Who manufactures and distributes this medicine?

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

What should I know about storage and disposal of this medication?

• ALIQOPA vials must be refrigerated at 2°C to 8°C (36°F to 46°F).
• Administer reconstituted and diluted solution immediately.
• If not, refrigerate at 2°C to 8°C (36°F to 46°F) and use within 24 hours.
• After refrigeration, allow the product to adapt to room temperature before use.
• Avoid exposure of the diluted solution to direct sunlight.
• Mix only with sterile 0.9% Sodium Chloride Injection, USP solution.
• Do not mix or inject ALIQOPA with other drugs or other diluents.

• Dailymed label info on Copanlisib
• FDA Copanlisib

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