Beleodaq

Last updated on RxList: 1/16/2020
Beleodaq Side Effects Center

Last reviewed on RxList 1/16/2020

What Is Beleodaq?

Beleodaq (belinostat) for Injection is a histone deacetylase inhibitor used to treat patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

What Are Side Effects of Beleodaq?

Common side effects of Beleodaq include:

Dosage for Beleodaq

The recommended dosage of Beleodaq is 1,000 mg/m² administered over 30 minutes by intravenous infusion once daily on days 1-5 of a 21-day cycle.

What Drugs, Substances, or Supplements Interact with Beleodaq?

Beleodaq may interact with strong inhibitors of UGT1A1.

Beleodaq During Pregnancy and Breastfeeding

Tell your doctor all medications and supplements you use. Beleodaq is not recommended for use during pregnancy. It may harm a fetus. Beleodaq is not recommended for use while breastfeeding.

Additional Information

Our Beleodaq (belinostat) for Injection 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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Beleodaq Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe ongoing nausea, vomiting, or diarrhea;
  • a fever, chills, muscle aches, flu-like symptoms,
  • cough with mucus, chest pain, fast heartbeats, rapid breathing or shortness of breath;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • pain or burning when you urinate;
  • confusion, severe drowsiness, feeling very ill;
  • liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

  • nausea, vomiting, diarrhea;
  • anemia;
  • fever; or
  • tiredness.

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 Beleodaq (Belinostat for Injection for Intravenous Use)

Beleodaq Professional Information

SIDE EFFECTS

The following serious adverse reactions are described in more detail in other sections of the prescribing information.

  • Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
  • Infection [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Toxicity [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 Beleodaq may not reflect the rates observed in practice.

Adverse Reactions In Patients With Peripheral T-Cell Lymphoma

The safety of Beleodaq was evaluated in 129 patients with relapsed or refractory PTCL in the single arm clinical trial in which patients were administered Beleodaq at a dosage of 1,000 mg/m² administered over 30 minutes by IV infusion once daily on Days 1-5 of a 21-day cycle [see Clinical Studies]. The median duration of treatment was 2 cycles (range 1 - 33 cycles).

The most common adverse reactions observed in the trial of patients with relapsed or refractory PTCL treated with Beleodaq were nausea, fatigue, pyrexia, anemia, and vomiting [see Clinical Studies]. Table 2 summarizes the adverse reactions regardless of causality from the trial in patients with relapsed or refractory PTCL.

Table 2: Adverse Reactions Occurring in ≥ 10% of Patients with Relapsed or Refractory PTCL (NCI-CTC Grade 1-4)

Adverse ReactionsPercentage of Patients
(%) (N=129)
All GradesGrade 3 or 4
All Adverse Reactions9761
Nausea421
Fatigue375
Pyrexia352
Anemia3211
Vomiting291
Constipation231
Diarrhea232
Dyspnea226
Rash201
Peripheral Edema200
Cough190
Thrombocytopenia167
Pruritus163
Chills161
Increased Blood Lactate Dehydrogenase162
Decreased Appetite152
Headache150
Infusion Site Pain140
Hypokalemia124
Prolonged QT114
Abdominal pain111
Hypotension103
Phlebitis101
Dizziness100

Note: Adverse reactions are listed by order of incidence in the “All Grades” category first, then by incidence in “the Grade 3 or 4” category; Measured by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0

Serious Adverse Reactions

Sixty-one patients (47.3%) experienced serious adverse reactions while taking Beleodaq or within 30 days after their last dose of Beleodaq. The most common serious adverse reactions (> 2%) were pneumonia, pyrexia, infection, anemia, increased creatinine, thrombocytopenia, and multi-organ failure.

One treatment-related death associated with hepatic failure was reported in the trial. One patient with baseline hyperuricemia and bulky disease experienced Grade 4 tumor lysis syndrome during the first cycle of treatment and died due to multi-organ failure. A treatment-related death from ventricular fibrillation was reported in another monotherapy clinical trial with Beleodaq. ECG analysis did not identify QTc prolongation.

Discontinuations Due To Adverse Reactions

Twenty-five patients (19.4%) discontinued treatment with Beleodaq due to adverse reactions. The adverse reactions reported most frequently as the reason for discontinuation of treatment included anemia, febrile neutropenia, fatigue, and multi-organ failure.

Dosage Modifications Due To Adverse Reactions

In the trial, dosage adjustments due to adverse reactions occurred in 12% of Beleodaq-treated patients.

Read the entire FDA prescribing information for Beleodaq (Belinostat for Injection for Intravenous Use)

© Beleodaq Patient Information is supplied by Cerner Multum, Inc. and Beleodaq Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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