Copanlisib

Copanlisib is a prescription medication used for the treatment of relapsed follicular lymphoma (FL) in patients who have received at least 2 prior systemic therapies.

• Copanlisib is available under the following different brand names: Aliqopa.

Common side effects of Copanlisib include:

• Low white blood cell count (leukopenia)
• Low platelets in the blood (thrombocytopenia)
• Diarrhea
• Decreased strength and tiredness.
• Lower respiratory tract infection
• Nausea

Serious side effects of Copanlisib include:

• Black, tarry stools
• Bleeding gums
• Blood in the urine or stools
• Blurred vision
• Chest pain
• Chills
• Cough
• Cracks in the skin
• Dizziness
• Dry mouth
• Fatigue
• Flushed, dry skin.
• Fruit-like breath odor
• Headache
• Increased hunger
• Increased thirst
• Increased urination
• Loss of heat from the body
• Lower back or side pain
• Nausea
• Nervousness
• Painful or difficult urination
• Pale skin
• Pinpoint red spots on the skin.
• Pounding in the ears
• Red, swollen skin
• Scaly skin
• Slow or fast heartbeat
• Sneezing
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Stomach pain
• Sweating
• Swollen glands
• Tightness in the chest
• Troubled breathing
• Unexplained weight loss
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting

Rare side effects of Copanlisib include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, of lyophilized powder for reconstitution

• 60 mg (single dose)

Follicular Lymphoma

Adult dosage

• 60 mg intravenous on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (21 days on and 7 days off)
• Continue treatment until the disease progresses or has unacceptable toxicity.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Copanlisib has severe interactions with no other drugs.
• Copanlisib has serious interactions with at least 64 other drugs.
• Copanlisib has moderate interactions with the following drugs:
  • belzutifan
  • cenobamate
  • duvelisib
  • elagolix
  • encorafenib
  • fedratinib
  • istradefylline
  • lenacapavir
  • lorlatinib
  • ofatumumab SC
  • ribociclib
  • rucaparib
  • siponimod
  • stiripentol
  • tazemetostat
  • tecovirimat
  • trastuzumab
  • trastuzumab deruxtecan
• Copanlisib has minor interactions with the following drugs:
  • acetazolamide
  • anastrozole
  • cyclophosphamide
  • larotrectinib

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Copanlisib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Copanlisib?”

Cautions

• Serious, including fatal, infections may occur; the most common serious infection was pneumonia; before initiating treatment, consider pneumocystis jiroveci pneumonia (PJP) prophylaxis for populations at risk; withhold therapy in patients with suspected PJP infection of any grade; if confirmed, treat infection until resolution, then resume treatment at previous dose with concomitant PJP prophylaxis; monitor patients for signs/symptoms of infection and withhold treatment for grade 3 and higher infection
• Grade 3 or 4 hyperglycemia (blood glucose above 250 mg/dL) reported; achieve optimal blood glucose control before starting each infusion; withhold, reduce dose, or discontinue treatment depending on the severity and persistence of hyperglycemia.
• Grade 3 hypertension (systolic 160 mm Hg or greater or diastolic 100 mm Hg or greater) may occur; optimal BP control should be achieved before starting each infusion; monitor BP reinfusion and post-infusion; withhold, reduce dose, or discontinue copanlisib depending on severity and persistence of hypertension.
• Noninfectious pneumonitis reported; withhold treatment and conduct a diagnostic examination of a patient who is experiencing pulmonary symptoms (. g, cough, dyspnea, hypoxia, interstitial infiltrates) on radiologic examination; withhold, reduce dose, or discontinue treatment depending on the severity and persistence of noninfectious pneumonitis.
• Grade 3 or 4 neutropenia may occur; withhold, reduce dose, or discontinue copanlisib depending on the severity and persistence of neutropenia.
• Serious cutaneous reaction events (. g, exfoliative dermatitis, exfoliative rash, pruritus, rash [including maculopapular rash]) may occur; withhold, reduce dose, or discontinue treatment depending on the severity and persistence of severe cutaneous reactions.
• Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose.
• Drug interaction overview
  • Concomitant use of copanlisib with strong CYP3A4 inducers may decrease copanlisib AUC and peak plasma concentrations.
  • Coadministration with strong CYP3A5 inhibitors may increase the AUC of copanlisib.

Pregnancy and Lactation

• Based on animal studies and the mechanism of action, copanlisib can cause fetal harm when administered to a pregnant woman
• Advise pregnant women of the potential risk to a fetus.
• Conduct pregnancy testing before initiation of treatment.
• Contraception
  • Advise female patients of reproductive potential to use highly effective contraception during treatment and for at least 1 month after the last dose.
  • Advise male patients with female partners of reproductive potential to use highly effective contraception during and for at least 1 month after the last dose.
• Lactation
  • There are no data on the presence of copanlisib and/or metabolites in human milk, the effects on the breastfed child, or milk production.
  • Because of the potential for serious adverse reactions in a breastfed child from copanlisib, advise a lactating woman not to breastfeed during treatment with copanlisib and for at least 1 month after the last dose.