Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 500mg/vial
Peripherial T-Cell Lymphoma
Histone deacetylase (HDAC) inhibitor indicated for relapsed or refractory peripheral T-cell lymphoma
1000 mg/m² IV qDay on days 1-5 of a 21-day cycle
Infuse IV over 30 minutes
Cycles can be repeated every 21 days until disease progression or unacceptable toxicity
Dosage Modifications
ANC should be ≥1.0 x 10^9/L and the platelet count should be ≥50 x 10^9/L prior to the start of each cycle and prior to resuming treatment following toxicity
Discontinue with recurrent ANC nadirs <0.5 x 10^9/L and/or recurrent platelet count nadirs <25 x 10^9/L after 2 dosage reductions
Other toxicities must be ≤grade 2 prior to re-treatment
Monitoring
- Monitor complete blood cell counts at baseline and weekly
- Perform serum chemistry tests, including renal and hepatic functions, prior to the start of the first dose of each cycle
Hematologic toxicities
- Platelet count ≥25 x 10^9/L and nadir ANC ≥0.5 x 10^9/L: No change
- Nadir ANC <0.5 x 10^9/L (any platelet count): Decrease dose by 25% (750 mg/m²)
- Platelet count <25 x 10^9/L (any nadir ANC): Decrease dose by 25% (750 mg/m²)
Non-hematologic toxicities
- Grade 3 or 4 adverse reaction: Decrease dose by 25% (750 mg/m²)
- Grade 3 or 4 nausea/vomiting/diarrhea >7 days: Decrease dose by 25% (750 mg/m²)
- Recurrence of Grade 3 or 4 adverse reaction after 2 dosage reductions: Discontinue
Reduced UGT1A1 activity
- Patients known to be homozygous for the UGT1A1*28 allele: Reduce starting dose to 750 mg/m²
Renal or hepatic impairment
- Metabolized in the liver and hepatic impairment is expected to increase systemic exposure; patients with moderate-to-severe hepatic impairment were excluded from clinical trials
- CrCl >39 mL/min: No dosage adjustment required
- CrCl ≤39 mL/min: Insufficient dose to recommend dosage modification
Dosing Considerations
Indication approved under accelerated approval based on tumor response rate and duration of response
An improvement in survival or disease-related symptoms has not been established
Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (7)
- atazanavir
atazanavir will increase the level or effect of belinostat by decreasing metabolism. Avoid or Use Alternate Drug. Strong UGT inhibitors decrease metabolism of belinostat; reduce belinostat starting dose to 750 mg/m2 when coadministered with UGT inhibitors or in patients known to be homozygous for the UGT1A1*28 allele
- gemfibrozil
gemfibrozil will increase the level or effect of belinostat by decreasing metabolism. Avoid or Use Alternate Drug. Strong UGT inhibitors decrease metabolism of belinostat; reduce belinostat starting dose to 750 mg/m2 when coadministered with UGT inhibitors or in patients known to be homozygous for the UGT1A1*28 allele
- indinavir
indinavir will increase the level or effect of belinostat by decreasing metabolism. Avoid or Use Alternate Drug. Strong UGT inhibitors decrease metabolism of belinostat; reduce belinostat starting dose to 750 mg/m2 when coadministered with UGT inhibitors or in patients known to be homozygous for the UGT1A1*28 allele
- ketoconazole
ketoconazole will increase the level or effect of belinostat by decreasing metabolism. Avoid or Use Alternate Drug. Strong UGT inhibitors decrease metabolism of belinostat; reduce belinostat starting dose to 750 mg/m2 when coadministered with UGT inhibitors or in patients known to be homozygous for the UGT1A1*28 allele
- milk thistle
milk thistle will increase the level or effect of belinostat by decreasing metabolism. Avoid or Use Alternate Drug. Strong UGT inhibitors decrease metabolism of belinostat; reduce belinostat starting dose to 750 mg/m2 when coadministered with UGT inhibitors or in patients known to be homozygous for the UGT1A1*28 allele
- palifermin
palifermin increases toxicity of belinostat by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- valerian
valerian will increase the level or effect of belinostat by decreasing metabolism. Avoid or Use Alternate Drug. Strong UGT inhibitors decrease metabolism of belinostat; reduce belinostat starting dose to 750 mg/m2 when coadministered with UGT inhibitors or in patients known to be homozygous for the UGT1A1*28 allele
Monitor Closely (6)
- apalutamide
apalutamide will decrease the level or effect of belinostat by increasing elimination. Use Caution/Monitor. Apalutamide induces UGT and may decrease systemic exposure of drugs that are UGT substrates.
- cholera vaccine
belinostat decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- dengue vaccine
belinostat decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- dichlorphenamide
dichlorphenamide and belinostat both decrease serum potassium. Use Caution/Monitor.
- ponesimod
ponesimod and belinostat both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- siponimod
siponimod and belinostat both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
Minor (0)
Adverse Effects
>10%
All toxicity grades
Nausea (42%)
Fatigue (37%)
Pyrexia (35%)
Anemia (32%)
Vomiting (29%)
Constipation (23%)
Diarrhea (23%)
Dyspnea (22%)
Rash (20%)
Peripheral edema (20%)
Cough (19%)
Thrombocytopenia (16%)
Pruritus (16%)
Chills (16%)
Increased blood lactate dehydrogenase (16%)
Decrease appetite (15%)
Headache (15%)
Infusion site pain (14%)
Hypokalemia (12%)
Prolonged QT (11%)
Abdominal pain (11%)
1-10%
Hypotension (10%)
Phlebitis (10%)
Dizziness (10%)
Warnings
Contraindications
None
Cautions
Thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia may occur; monitor blood cell counts and modify dosage for hematologic toxicities (see Dosage Modifications)
Serious and fatal infections (eg, pneumonia and sepsis) reported; do not administer if patient has an active infection
May cause hepatic toxicity and liver function test abnormalities; monitor liver function tests before treatment and before each treatment cycle; omit or modify dosage for hepatic toxicities (see Dosage Modifications)
Tumor lysis syndrome reported; monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions
Nausea, vomiting, and diarrhea commonly occur and may require the use of antiemetic and antidiarrheal medications
Can cause fetal harm when administered to a pregnant woman; advise women of potential harm to the fetus and to avoid pregnancy
Pregnancy & Lactation
Pregnancy
Based on mechanism of action, drug can cause teratogenicity and/or embryo-fetal lethality because it is genotoxic and targets actively dividing cells
There are no available data on drug use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; no animal reproduction studies conducted; advise pregnant women of potential risk to fetus
Pregnancy testing is recommended for females of reproductive potential prior to initiating therapy
Based on findings from animal studies, drug may impair male fertility; reversibility of effect on fertility is unknown
Contraception
- Females: Drug can cause embryo-fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during treatment with drug and for 6 months after last dose
- Males: Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after last dose
Lactation
There are no data on presence of drug in human milk, effects on breastfed child, or on milk production; because of potential for serious adverse reactions in breastfed child, advise patients that breastfeeding is not recommended during treatment with and for 2 weeks after last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Histone deacetylase (HDAC) inhibitor; HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some nonhistone proteins
In vitro, belinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells; shows preferential cytotoxicity towards tumor cells compared with normal cells
Distribution
Protein bound: 92.9-95.8%
Limited tissue distribution
Metabolism
Primarily by UGT1A1 (80-90%); also CYP2A6, CYP2C9, CYP3A4
Elimination
Half-life: 1.1 hr
Plasma clearance: 124 mL/min
Excretion: 40% urine (as metabolites); <2% urine (unchanged)
Pharmacogenomics
UGT1A1 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity (eg, UGT1A1*28 polymorphism) ~20% of the black population, 10% of the white population, and 2% of the Asian population are homozygous for the UGT1A1*28 allele
Because belinostat is primarily (80-90%) metabolized by UGT1A1, the clearance of belinostat could be decreased in patients with reduced UGT1A1 activity (eg, patients with UGT1A1*28 allele)
Reduce initial dose in patients known to be homozygous for the UGT1A1*28 allele (see Dosage Modifications)
Administration
IV Preparation
Aseptically reconstitute each vial by adding 9 mL of sterile water for injection; resulting concentration is 50 mg/mL
Swirl vial contents until there are no visible particles in the resulting solution
Further dilute by withdrawing volume needed for the required dosage from reconstituted vial and transfer to a 250-mL infusion bag of 0.9 % NaCl
Visually inspect the solution for particulate matter; do not use if cloudiness or particulates are observed
IV Administration
Connect the infusion bag containing drug solution to an infusion set with a 0.22-micron in-line filter for administration
Infuse IV over 30 minutes
May extend infusion time to 45 minutes if infusion site pain or other symptoms attributed to the infusion occur
Cytotoxic agent; follow special handling and disposal procedures for antineoplastic drugs
Storage
Unreconstituted vials: Store at room temperature 20-25°C (68-77°F); excursions are permitted between 15-30°C (59-86°F); retain in original package until use
Reconstituted vial: May store at ambient temperature (15-25°C; 59-77°F) for up to 12 hr
Infusion bag with dose: May be stored at ambient room temperature (15-25°C; 59-77°F) for up to 36 hr, including infusion time
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Beleodaq intravenous - | 500 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
belinostat intravenous
BELINOSTAT - INJECTION
(be-LIN-oh-stat)
COMMON BRAND NAME(S): Beleodaq
USES: Belinostat is used to treat a certain type of cancer (peripheral T-cell lymphoma - PTCL). Belinostat works by slowing or stopping the growth of cancer cells.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using belinostat and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by a health care professional in a clinic or hospital. It is injected into a vein as directed by your doctor, usually once a day on days 1 through 5 of a 21-day treatment cycle. The injection is given slowly, usually over 30 minutes. Tell your doctor or nurse right away if you notice redness, pain, or swelling during your injection. If you have side effects during the injection, your infusion may be given over a longer time, changed, or temporarily stopped.The dosage is based on your medical condition, body size, laboratory test results, and response to treatment.To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days when you are scheduled to receive treatment on your calendar.
SIDE EFFECTS: See also How to Use section.Tell your doctor if you have nausea, vomiting, or diarrhea. Your doctor may prescribe medications to prevent or relieve these symptoms. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. Tiredness, headache, constipation, decreased appetite, or dizziness may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, swelling hands/ankles/feet, symptoms of anemia (such as severe tiredness, pale skin, shortness of breath).This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).Belinostat may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.Belinostat sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using belinostat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent/past infections (such as flu, tuberculosis), kidney disease, liver problems.Belinostat can make you more likely to get infections or may worsen any current infections. Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using belinostat. Belinostat may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after stopping treatment. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Breast-feeding is not recommended while using this drug and for 2 weeks after stopping treatment. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Laboratory and/or medical tests (such as complete blood counts, kidney/liver function tests) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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