Aliqopa

Copanlisib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Copanlisib is used to treat follicular lymphoma that has relapsed after treatment with at least two other medicines.

Copanlisib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, people with follicular lymphoma responded to this medicine. However, further studies are needed.

Copanlisib may also be used for purposes not listed in this medication guide.

Copanlisib is injected into a vein through an IV. 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.

Copanlisib 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 can lower blood cells that help your body fight infections. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Your blood pressure will also need to be checked often.

Store this medicine at room temperature away from moisture and heat.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Other drugs may interact with copanlisib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

In the U.S.

• Aliqopa

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Serious and sometimes fatal infections may occur during treatment with Aliqopa. Call your doctor right away if you have signs of infection such as: fever, chills, mouth sores, a new or worsening cough, or trouble breathing.

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

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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 toxicity

Comments: 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.

Data not available.

Administration Advice:
-Following reconstitution and dilution, administer this drug as a single agent immediately or refrigerate and use within 24 hours.
-After refrigeration, allow this drug product to adapt to room temperature before use.

Storage Requirements:
-Refrigerate drug vials at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).
-Avoid exposure of the diluted solution to direct sunlight.

Reconstitution/Preparation Techniques:
-Mix this drug only with 0.9% sodium chloride (NaCl) solution; do not mix or inject with other drugs or other diluents.
-Consult the manufacturer product information for reconstitution and dilution instructions.

Monitoring:
-Cardiovascular: Blood pressure (pre- and post-infusion)
-Endocrine: Blood glucose (before each infusion)
-Hematologic: Blood counts (at least weekly during treatment)
-Infections/Infestations: Infection signs/symptoms (during treatment)

Patient Advice:
-Avoid taking grapefruit/grapefruit juice and/or St. John's Wort during treatment with this drug.

In animal studies, this drug caused embryo-fetal death (increased resorptions, increased post-implantation loss, and decreased numbers of fetuses/dams) and fetal abnormalities (gross external, soft tissue, and skeletal) at maternally-toxic doses as low as approximately 12% of the recommended dose for humans. Additionally, there were adverse findings in male and female animal reproductive systems including effects on the testes, epididymides, prostate, ovaries, uterus, and vagina. A dose-related reduction in the number of female animals in estrus also has been observed. There are no controlled data in human pregnancy or on human fertility.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Safety has not been established during pregnancy; based on animal studies and its mechanism of action, this drug can cause fetal harm and is expected to cause adverse fertility effects.

US FDA pregnancy category: Not Assigned

Comments:
-Following administration of radiolabeled drug to pregnant animals, approximately 1.5% of the radioactivity (parent compound and metabolites) reached the fetal compartment.
-Advise pregnant women of the potential fetal risk, and conduct pregnancy testing prior to treatment initiation.
-Counsel females of reproductive potential and males with female partners of reproductive potential to use highly effective contraception (failure rate of less than 1% per year) during treatment and for at least 1 month after the last dose.