Aliqopa
Aliqopa (Copanlisib for Injection, for Intravenous Use) side effects drug center
Aliqopa Side Effects Center
What Is Aliqopa?
Aliqopa (copanlisib) for injection is a kinase inhibitor indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
What Are Side Effects for Aliqopa?
Common side effects of Aliqopa include:
- high blood sugar (hyperglycemia),
- diarrhea,
- decreased general strength and energy,
- high blood pressure (hypertension),
- low white blood cell count (leukopenia, neutropenia),
- nausea,
- 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:
- carbamazepine,
- enzalutamide,
- mitotane,
- phenytoin,
- rifampin,
- St. John's wort,
- antiretroviral drugs,
- drugs used to treat HIV/AIDS,
- macrolide antibiotics,
- cobicistat,
- conivaptan,
- azole antifungals,
- diltiazem,
- grapefruit juice,
- idelalisib,
- 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.
Additional Information
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.
Aliqopa Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Call your doctor at once if you have:
- a new or worsening cough, chest pain, or trouble breathing;
- severe skin redness, itching, or swelling;
- easy bruising, unusual bleeding;
- signs of infection--fever, chills, cold or flu symptoms, mouth sores, skin sores;
- high blood sugar--increased thirst, increased urination, hunger, headache, blurred vision, fruity breath odor; or
- increased blood pressure--severe headache, pounding in your neck or ears, dizziness, or feeling like you might pass out.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- infections, bruising or bleeding;
- feeling weak or tired;
- nausea, diarrhea; or
- trouble breathing.
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.
Read the entire detailed patient monograph for Aliqopa (Copanlisib for Injection, for Intravenous Use)
Aliqopa Professional Information
SIDE EFFECTS
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 with ALIQOPA
| ADVERSE REACTIONS | ALIQOPA N = 168 |
||
| Any Grade n (%) | Grade 3 n (%) | Grade 4 n (%) | |
| 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 |
| Gastrointestinal disorders | |||
| 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 |
| Vomiting | 21 (13%) | 0 | 0 |
| Vascular disorders | |||
| Hypertension (includes secondary hypertension) | 59 (35%) | 46 (27%) | 0 |
| Infections | |||
| 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
| Laboratory Parameter | ALIQOPA N = 168* |
||
| Any Grade** n (%) | Grade 3**n (%) | Grade 4** n (%) | |
| Hematology abnormalities | |||
| 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 values available. **NCI-CTCAE v4.03 |
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DRUG INTERACTIONS
Effect Of Other Drugs On Copanlisib
Table 4 lists the potential effects of coadministration of ALIQOPA with strong CYP3A inhibitors and inducers.
Table 4: Drug Interactions with ALIQOPA that affect Copanlisib Concentrations
| Strong CYP3A inducers | |
| Clinical impact |
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| Prevention management |
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| Strong CYP3A inhibitors | |
| Clinical impact |
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| Prevention management |
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Read the entire FDA prescribing information for Aliqopa (Copanlisib for Injection, for Intravenous Use)
© Aliqopa Patient Information is supplied by Cerner Multum, Inc. and Aliqopa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.