Aliqopa

Last updated on RxList: 6/14/2021
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:

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:

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.

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.

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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

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
  • Concomitant use of ALIQOPA with strong CYP3A inducers may decrease copanlisib AUC and Cmax[see CLINICAL PHARMACOLOGY].
Prevention management
  • Avoid concomitant use of ALIQOPA with strong CYP3A inducers
Strong CYP3A inhibitors
Clinical impact
  • Concomitant use of ALIQOPA with strong CYP3A inhibitors increases the copanlisib AUC [see CLINICAL PHARMACOLOGY].
  • An increase in the copanlisib AUC may increase the risk of adverse reactions
Prevention management
  • If concomitant use with strong CYP3A inhibitors cannot be avoided, reduce the ALIQOPA dose to 45 mg [see DOSAGE AND ADMINISTRATION]

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.

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