Copanlisib for intravenous use was approved by the US FDA in September 2017 to treat adult patients with relapsed follicular lymphoma.
Copanlisib injection is prescribed to treat relapsed follicular lymphoma in adult patients who have been already treated with two prior systemic therapies.
Copanlisib belongs to a class of kinase inhibitors. It blocks the action of a specific protein involved in the multiplication of cancer cells.
Copanlisib should not be used in:
Patients with allergy to copanlisib
Pregnancy and breastfeeding
Children below 18 years of age
With drugs that strongly induce or inhibit the CYP3A enzyme. Some of these are mentioned in the drug interactions below
The recommended adult dose of copanlisib is 60 mg which is administered as an intravenous infusion over 1 hour.
The infusion is administered on an intermittent schedule on days 1, 8, 15 in a treatment cycle of 28 days.
The treatment should be continued until disease progression or any unacceptable toxicity.
A reduced dosage of 45 mg or 30 mg may be required if certain side effects occur during treatment or if it is taken with certain drugs.
Copanlisib comes as a powder for reconstitution which is given as an injection directly into a vein through a needle or a catheter.
4.4 ml of 0.9% sodium chloride should be added to the vial and the vial should be shaken for 30 seconds to dissolve the powder.
The vial can be shaken again gently if any undissolved substances are seen.
The solution should be further diluted in 100 ml of 0.9% sodium chloride and infused over 1 hour.
Before administration of the infusion, it is necessary to inspect the solution for the presence of any particulate matter or discoloration. If present, the solution should be discarded.
Monitor patients for the symptoms and signs of infections such as pneumonia and other infections. The treatment with copanlisib should be stopped temporarily in case of a higher grade of infections.
Treatment with copanlisib can result in infusion-related hyperglycemia (high blood glucose levels). So, blood glucose level should be monitored regularly particularly in patients with diabetes mellitus to avoid the risk of a serious hyperglycemic condition.
The blood pressure should be monitored before and after the administration of the copanlisib infusion since it can increase the blood pressure. Treatment can either be stopped or the dose can be reduced depending on the severity of hypertension.
Monitor blood counts every week during the treatment with copanlisib to diagnose blood abnormalities such as neutropenia that could occur as a side effect of treatment.
The dose of copanlisib should be reduced or the treatment stopped if serious skin reactions occur.
Male and female with reproductive potential are advised to use effective contraceptive measures during the treatment which should be continued for at least 1 month after the last dose of copanlisib.
Common: Pneumonia, raised blood sugar level, hypertension, diarrhea
Gastrointestinal: Mouth ulcer, nausea, vomiting
Respiratory: Lower respiratory tract infections including Pneumocystis jiroveci infection and bronchopulmonary aspergillosis, pneumonitis
Nervous system: Pricking or numbness sensation, abnormal sensations
Skin: Rashes, exfoliative dermatitis, itching, severe skin reactions
Blood: Decreased level of white blood cells, platelets, red blood reduced blood phosphate levels, excess uric acid and triglycerides in blood
Others: General weakness or decreased energy, fatigue or asthenia, mucositis, raised level of serum lipase
Pregnancy test has to be performed before initiating copanlisib treatment and the treatment should be started only if the test results are negative.
Caution is required while using copanlisib injection in the elderly as it may lead to serious side effects.
Do not mix copanlisib injection with other drugs or diluents. It should be administered through a separate intravenous cannula.
Some of the drugs that copanlisib could interact with when taken together are
Lopinavir, indinavir, ritonavir, boceprevir
Itraconazole, ketoconazole, posaconazole, voriconazole
Carbamazepine, mitotane, rifampin, St. Johns wort
Copanlisib injection vials and the diluted solution should be stored in a refrigerator at 2°C to 8 °C.
The diluted solution should be used within 24 hours even if it is stored at 2°C to 8 °C. Allow it to come to room temperature before it is administered.
Any unused reconstituted or diluted solution stored for more than 24 hours should be discarded.
Avoid the exposure to direct sunlight.
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