Aliqopa (copanlisib)

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Aliqopa (copanlisib)

Aliqopa (copanlisib) is a medication used for the treatment of relapsed follicular lymphoma.

How to buy Aliqopa (copanlisib): You can order Aliqopa (copanlisib) from TheSocialMedwork if the drug has not been approved or is not available in your country. TheSocialMedwork processes this import on behalf of its pharmacy licensed partner NA Pharmacy Amsterdam (BIG registration No: 89912008117).

Oncology Lymphoma
Marketing Authorisation Holder Bayer
Mode of Action Tyrosine kinase inhibitor
Administration Intravenous
Regulatory agency approval Food and Drug Administration (FDA), USA
Strength 60 milligram
Package 1 Vials

What is Aliqopa (copanlisib)?

Aliqopa (copanlisib) is a kinase inhibitor for the treatment of adults with relapsed follicular lymphoma1.

Who is Aliqopa (copanlisib) for?

Aliqopa (copanlisib) is indicated for the treatment of adult patients who have received at least two prior treatments known as systemic therapies1. Follicular lymphoma is the most common slow-growing form of Non-Hodgkin Lymphoma (NHL), accounting for approximately 12% of all B-cell NHLs2.

How does Aliqopa (copanlisib) work?

Aliqopa (copanlisib) is a ‘tyrosine kinase inhibitor’. This means that it blocks the activity of enzymes known as tyrosine kinases. These enzymes can be found in cancer cells, where they activate several processes including cell division and the growth of new blood vessels to supply the cancer. By blocking the activity of these enzymes in malignant B cells, Aliqopa (copanlisib) reduces the growth and spread of the cancer1.

Where has Aliqopa (copanlisib) been approved?

Aliqopa (copanlisib) was approved for the treatment of patients with relapsed follicular lymphoma by:

  • Food and Drug Administration (FDA), USA:

    • September 19, 20171 with an accelerated approval

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Aliqopa (copanlisib) taken?

The standard dosage is1:

  • 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).

Modify dosage in case of toxicity.

Complete information about Aliqopa (copanlisib) dosage and administration can be found in the official prescribing information listed in our resources section1.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects or adverse reactions of Aliqopa (copanlisib)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include1:

  • hyperglycemia (high blood sugar)

  • diarrhea

  • decreased general strength and energy

  • hypertension (high blood pressure)

  • leukopenia (decreased number of white blood cells (leukocytes))

  • neutropenia (decreased number of white blood cells (neutrophils))

  • nausea (feeling sick)

  • lower respiratory tract infections

  • thrombocytopenia (decreased number of platelets).

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1:

  • infections, including pneumonia

  • hyperglycemia (high glucose in blood)

  • hypertension (high blood pressure)

  • neutropenia (low levels of white blood cells)

  • severe cutaneous reactions.

Use in specific populations

Aliqopa (copanlisib) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding during treatment and for at least one month after the last dose1.

No dose adjustment is necessary in patients above 65 years of age1.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1.


More Information
Working ingredient copanlisib
Shipping method Cold chain (temperature controlled)
Package 1
Therapeutic Area Oncology
Oncology Lymphoma
Indication Relapsed follicular lymphoma
Administration Intravenous
Mode of Action Tyrosine kinase inhibitor
Regulatory agency approval Food and Drug Administration (FDA), USA
Marketing Authorisation Holder Bayer

Third-line treatment approval

The Food and Drug Administration (FDA), USA, approval of Aliqopa (copanlisib) for relapsed follicular lymphoma in previously untreated patients was  based on a single-arm, multicenter, phase 2 clinical trial (NCT 01660451 - CHRONOS-1)1. This study involved a total of 142 patients, including 104 with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments. All patients had previously received rituximab and an alkylating agent1. Treatment continued until disease progression or unacceptable toxicity1.

Results

Among the  efficacy outcome measures were the overall response rate (ORR) and median duration of response (DOR). CHRONOS-1 was a single-arm study, meaning that Aliqopa (copanlisib) was not tested against another medicine.

The ORR was1:

  • 59% [95 % CI: 49, 68]

    • with 14% complete responses.

The median DOR was1:

  • 12.2 month (range: 0+, 22.6).

  1. Summary of Product Characteristics [FDA]: Aliqopa (copanlisib) [PDF]
    Bayer, Sep. 2017.  

  2. Lymphoma.org: Follicular Lymphoma   
    (last update: November 2017), cited on: 20/12/2017.


Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
Dynamic Weight No
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.