Medical Editor: John P. Cunha, DO, FACOEP
What Is Aliqopa?
What Are Side Effects for Aliqopa?
Common side effects of Aliqopa include:
- high blood sugar (hyperglycemia),
- decreased general strength and energy,
- high blood pressure (hypertension),
- low white blood cell count (leukopenia, neutropenia),
- lower respiratory tract infections,
- low platelet count (thrombocytopenia),
- swelling and sores inside the mouth,
- vomiting, and rash.
Dosage for Aliqopa
The recommended dosage 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).
What Drugs, Substances, or Supplements Interact with Aliqopa?
Aliqopa may interact with:
- St. John's wort,
- antiretroviral drugs,
- drugs used to treat HIV/AIDS,
- macrolide antibiotics,
- azole antifungals,
- grapefruit juice,
- and nefazodone.
Tell your doctor all medications and supplements you use.
Aliqopa During Pregnancy and Breastfeeding
Aliqopa is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Aliqopa passes into breast milk. Because of the potential for serious adverse reactions in a breastfed child from Aliqopa, breastfeeding is not recommended during treatment with Aliqopa and for at least 1 month after the last dose.
Our Aliqopa (copanlisib) for Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following clinically significant adverse reactions are described elsewhere in the labeling.
- Infections [see WARNINGS AND PRECAUTIONS]
- Hyperglycemia [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Non-infectious pneumonitis [see WARNINGS AND PRECAUTIONS]
- Neutropenia [see WARNINGS AND PRECAUTIONS]
- Severe cutaneous reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in the general patient population.
The safety data reflect exposure to ALIQOPA in 168 adults with follicular lymphoma and other hematologic malignancies treated with ALIQOPA 60 mg or 0.8 mg/kg equivalent in clinical trials. The median duration of treatment was 22 weeks (range 1 to 206 weeks).
Serious adverse reactions were reported in 44 (26%) patients. The most frequent serious adverse reactions that occurred were pneumonia (8%), pneumonitis (5%) and hyperglycemia (5%). The most common adverse reactions (≥20%) were hyperglycemia, diarrhea, decreased general strength and energy, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections, and thrombocytopenia.
Adverse reactions resulted in dose reduction in 36 (21%) and discontinuation in 27 (16%) patients. The most common reasons for dose reduction were hyperglycemia (7%), neutropenia (5%), and hypertension (5%). The most common reasons for drug discontinuation were pneumonitis (2%) and hyperglycemia (2%).
Table 2 provides the adverse reactions occurring in at least 10% of patients receiving ALIQOPA monotherapy, and Table 3 provides the treatment-emergent laboratory abnormalities in ≥20% of patients and ≥4% of Grade ≥3 treated with ALIQOPA.
Table 2: Adverse Reactions Reported in ≥10% of
Patients with Follicular Lymphoma and Other Hematological Malignancies Treated
N = 168
|Metabolism and nutrition disorders|
|Hyperglycemia||90 (54%)||56 (33%)||10 (6%)|
|Blood and lymphatic system disorders|
|Leukopenia||61 (36%)||20 (12%)||26 (15%)|
|Neutropenia (including febrile neutropenia)||53 (32%)||16 (10%)||26 (15%)|
|Thrombocytopenia||37 (22%)||12 (7%)||2 (1%)|
|General disorders and administration site conditions|
|Decreased general strength and energy (includes fatigue and asthenia)||61 (36%)||6 (4%)||0|
|Diarrhea||60 (36%)||8 (5%)||0|
|Nausea||43 (26%)||1 (<1%)||0|
|Stomatitis (includes oropharyngeal erosion and ulcer, oral pain)||24 (14%)||3 (2%)||0|
|Hypertension (includes secondary hypertension)||59 (35%)||46 (27%)||0|
|Lower respiratory tract infections (includes pneumonia, pneumonia bacterial, pneumonia pneumococcal, pneumonia fungal, pneumonia viral, pneumocystis jiroveci pneumonia, bronchopulmonary aspergillosis and lung infection)||35 (21%)||20 (12%)||3 (2%)|
|Skin and subcutaneous tissue disorders|
|Rash (includes exfoliative skin reactions)||26 (15%)||2 (1%)||1 (<1%)|
Additional adverse drug reactions reported at a frequency of <10% in patients with follicular lymphoma and other hematologic malignancies include pneumonitis (9%), mucosal inflammation (8%), and paresthesia and dysesthesia (7%).
Table 3: Treatment-emergent Laboratory Abnormalities
in ≥20% of Patients and ≥4% of Grade ≥3 Treated with ALIQOPA
N = 168*
|Decreased hemoglobin||130 (78%)||7 (4%)||0|
|Lymphocyte count decreased||126 (78%)||43 (27%)||4 (2%)|
|White blood cell decreased||118 (71%)||30 (18%)||3 (2%)|
|Platelet count decreased||109 (65%)||11 (7%)||3 (2%)|
|Neutrophil count decreased||104 (63%)||20 (12%)||25 (15%)|
|Serum chemistry abnormalities|
|Hyperglycemia||160 (95%)||72 (43%)||9 (5%)|
|Hypertriglyceridemia||74 (58%)||6 (5%)||0|
|Hypophosphatemia||72 (44%)||24 (15%)||0|
|Hyperuricemia||42 (25%)||40 (24%)||2 (1%)|
|Serum lipase increased||34 (21%)||11 (7%)||2 (1%)|
|*Denominator for each laboratory
parameter may vary based on number of patients with specific numeric laboratory
Read the entire FDA prescribing information for Aliqopa (Copanlisib for Injection, for Intravenous Use)