BELEODAQ®
(belinostat) For Injection, For Intravenous Use
DESCRIPTION
Beleodaq is a histone deacetylase inhibitor with a
sulfonamide-hydroxamide structure. The chemical name of belinostat is (2E)-N-hydroxy-3-[3-(phenylsulfamoyl)phenyl]prop-2-enamide.
The structural formula is as follows:
The molecular formula is C15H14N2O4S and the
molecular weight is 318.35 g/mol.
Belinostat is a white to off-white powder. It is slightly
soluble in distilled water (0.14 mg/mL) and polyethylene glycol 400 (about 1.5
mg/mL), and is freely soluble in ethanol (> 200 mg/mL). The pKa values are 7.87 and
8.71 by potentiometry and 7.86 and 8.59 by UV.
Beleodaq (belinostat) for injection is supplied as a sterile
lyophilized yellow powder containing 500 mg belinostat as the active
ingredient. Each vial also contains 1000 mg L-Arginine, USP as an inactive ingredient. The drug product is
supplied in a single-dose 30 mL clear glass vial with a coated stopper and
aluminum crimp seal with “flip-off” cap. Beleodaq is intended for intravenous
administration after reconstitution with 9 mL Sterile Water for injection, and
the reconstituted solution is further diluted with 250 mL of sterile 0.9%
Sodium Chloride injection prior to infusion [See DOSAGE AND ADMINISTRATION].
Indications
& Dosage
INDICATIONS
Beleodaq is indicated for the treatment of patients with
relapsed or refractory peripheral T-cell lymphoma (PTCL).
This indication is approved under accelerated approval based on
tumor response rate and duration of response [See Clinical Studies]. 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.
DOSAGE AND
ADMINISTRATIONDosing Information
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. Cycles can be repeated every 21 days until disease progression or
unacceptable toxicity.
Dosage Modification For Hematologic And Non-Hematologic
Toxicities
Table 1 displays the recommended Beleodaq dosage modifications
for hematologic and non-hematologic toxicities. Base dosage adjustments
for thrombocytopenia and neutropenia on platelet
and absolute neutrophil nadir (lowest value) counts
in the preceding cycle of therapy.
· Absolute neutrophil count (ANC) should be
greater than or equal to 1.0 x 109/L
and the platelet count should be greater than or equal
to 50 x 109/L prior to the start of each
cycle and prior to resuming treatment following toxicity. Resume subsequent
treatment with Beleodaq according to the guidelines described in Table 1 below.
Discontinue Beleodaq in patients who have recurrent ANC nadirs less than 0.5 x 109/L
and/or recurrent platelet count nadirs less than 25 x 109/L
after two dosage reductions.
·
Other toxicities must be NCI-CTCAE Grade 2 or less prior to re-treatment.
Monitor complete blood 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.
Table 1: Dosage
Modifications for Hematologic and Non-Hematologic Toxicities
|
|
Dosage Modification
|
|
Dosage Modifications due to Hematologic
Toxicities
|
|
Platelet count ≥ 25 x 109/L and
nadir ANC ≥ 0.5 x 109/L
|
No Change
|
|
Nadir ANC < 0.5 x 109/L (any
platelet count)
|
Decrease dosage by 25% (750 mg/m2)
|
|
Platelet count < 25 x 109/L
(any nadir ANC)
|
|
Dosage Modifications due to
Non-Hematologic Toxicities
|
|
Any CTCAE Grade 3 or 4 adverse reactiona
|
Decrease dosage by 25% (750 mg/m2)
|
|
Recurrence of CTCAE Grade 3 or 4 adverse
reaction after two dosage reductions
|
Discontinue Beleodaq
|
|
a For nausea, vomiting, and diarrhea, only dose
modify if the duration is greater than 7 days with supportive management
|
Patients With Reduced UGT1A1 Activity
Reduce the starting dose of Beleodaq to 750 mg/m2 in
patients known to be homozygous for the
UGT1A1*28 allele [See CLINICAL PHARMACOLOGY].
Preparation And Administration Precautions
As with other potentially cytotoxic anticancer
agents, exercise care in the handling and preparation of solutions prepared
with Beleodaq.
Reconstitution And Infusion InstructionsAseptically reconstitute each vial of Beleodaq
by adding 9 mL of Sterile Water for injection, USP, into the Beleodaq vial
with a suitable syringe to achieve a concentration of 50 mg of belinostat
per mL. Swirl the contents of the vial until there are no visible
particles in the resulting solution. The reconstituted product may be
stored for up to 12 hours at
ambient temperature (15-25°C; 59-77°F).Aseptically withdraw the volume needed
for the required dosage (based on the 50 mg/mL concentration and the
patient’s
BSA [m2])
and transfer to an infusion bag containing 250 mL of 0.9 % Sodium Chloride
injection. The infusion bag with drug solution may be stored at ambient
room temperature (1525°C; 59-77°F) for up to 36 hours including infusion
time.Visually inspect the solution for
particulate matter. Do not use if cloudiness or particulates are observed.Connect the infusion bag containing drug
solution to an infusion set with a 0.22 μm in-line filter for
administration.
Infuse intravenously over 30 minutes. If
infusion site pain or other symptoms potentially attributable to the
infusion occur, the infusion time may be extended to 45 minutes.
HOW SUPPLIEDDosage Forms And Strengths
For injection: 500 mg, lyophilized powder in single-dose vial
for reconstitution
Storage And Handling
Beleodaq (belinostat) for injection is supplied in single
vial cartons; each 30 mL clear vial contains sterile, lyophilized powder
equivalent to 500 mg belinostat.
NDC 68152-108-09: Individual carton of Beleodaq 30 mL
single-dose vial containing 500 mg belinostat.
Store Beleodaq (belinostat) for injection at room temperature
20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C
(59°F and 86°F). Retain in original package until use. [see USP Controlled Room
Temperature].
Beleodaq is a cytotoxic drug. Follow special handling and disposal
procedures [see REFERENCES1].
Side Effects & Drug
Interactions
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 Reactions
|
Percentage of Patients (%)
(N=129)
|
|
|
All Grades
|
Grade 3 or 4
|
|
All Adverse Reactions
|
97
|
61
|
|
Nausea
|
42
|
1
|
|
Fatigue
|
37
|
5
|
|
Pyrexia
|
32
|
11
|
|
Vomiting
|
29
|
1
|
|
Constipation
|
23
|
1
|
|
Diarrhea
|
23
|
2
|
|
Dyspnea
|
22
|
6
|
|
Rash
|
20
|
1
|
|
Peripheral Edema
|
20
|
0
|
|
Cough
|
19
|
0
|
|
Thrombocytopenia
|
16
|
7
|
|
Pruritus
|
16
|
3
|
|
Chills
|
16
|
1
|
|
Increased Blood Lactate Dehydrogenase
|
16
|
2
|
|
Decreased Appetite
|
15
|
2
|
|
Headache
|
15
|
0
|
|
Infusion Site Pain
|
14
|
0
|
|
Hypokalemia
|
12
|
4
|
|
Prolonged QT
|
11
|
4
|
|
Abdominal pain
|
11
|
1
|
|
Hypotension
|
10
|
3
|
|
Phlebitis
|
10
|
1
|
|
Dizziness
|
10
|
0
|
|
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.
DRUG INTERACTIONSUGT1A1 Inhibitors
Belinostat is primarily metabolized by UGT1A1. Avoid
concomitant administration of Beleodaq with strong inhibitors of UGT1A1
[See CLINICAL PHARMACOLOGY].
Warnings
& Precautions
WARNINGS
Included as part of
the "PRECAUTIONS" Section
PRECAUTIONSHematologic Toxicity
Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia),
and/or anemia; monitor blood counts weekly during
treatment, and modify dosage as necessary [See DOSAGE
AND ADMINISTRATION and ADVERSE
REACTIONS].
Infections
Serious and sometimes fatal infections, including pneumonia and sepsis, have occurred with Beleodaq. Do not
administer Beleodaq to patients with an active infection. Patients with a
history of extensive or intensive chemotherapy may be at higher risk of
life threatening infections [See ADVERSE
REACTIONS].
Hepatotoxicity
Beleodaq can cause fatal hepatotoxicity and liver function
test abnormalities [See ADVERSE
REACTIONS]. Monitor liver function tests before treatment and before
the start of each cycle. Interrupt or adjust dosage until recovery, or
permanently discontinue Beleodaq based on the severity of the hepatic toxicity
[See DOSAGE AND ADMINISTRATION].
Tumor Lysis Syndrome
Tumor lysis syndrome has occurred in
Beleodaq-treated patients in the clinical trial of patients with relapsed
or refractory PTCL [See Clinical
Studies]. Monitor patients with advanced stage disease and/or high
tumor burden and take appropriate precautions [See ADVERSE
REACTIONS].
Gastrointestinal Toxicity
Nausea, vomiting and diarrhea occur with Beleodaq
[See ADVERSE REACTIONS] and may require the use of
antiemetic and antidiarrheal medications.
Embryo-Fetal Toxicity
Beleodaq can cause fetal harm when administered to a
pregnant woman. Beleodaq may cause teratogenicity and/or embryo-fetal lethality
because it is genotoxic and targets actively dividing cells
[see Nonclinical Toxicology]. Women of childbearing potential should be
advised to avoid pregnancy while receiving Beleodaq. If this drug is used
during pregnancy, or if the patient becomes pregnant while taking this drug,
the patient should be apprised of potential hazard to the fetus [see Use
In Specific Populations].
Patient Conseling Information
Physicians should discuss the FDA approved Patient
Information Leaflet with patients prior to treatment with Beleodaq. Instruct
patients to read the Patient Information Leaflet carefully.
Advise the patient or the caregiver to read the
FDA-approved patient labeling (Patient Information).
Advise patients or their caregivers:
· To report symptoms of nausea,
vomiting and diarrhea so that appropriate antiemetic and antidiarrheal
medications can be administered [See WARNINGS AND PRECAUTIONS].
· To report any symptoms of
thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia
[See WARNINGS AND PRECAUTIONS].
· To immediately report symptoms
of infection (e.g., pyrexia) [See WARNINGS AND PRECAUTIONS and ADVERSE
REACTIONS].
· Of the potential risk to the
fetus and for women to avoid pregnancy while receiving Beleodaq
[See WARNINGS AND PRECAUTIONS].
· To understand the importance of
monitoring liver function test abnormalities and to immediately report
potential symptoms of liver injury [See DOSAGE
AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
Nonclinical ToxicologyCarcinogenesis, Mutagenesis,
Impairment Of Fertility
Carcinogenicity studies have not been performed with
belinostat.
Belinostat was genotoxic in a bacterial reverse mutation
test (Amesassay), an in vitro mouse lymphoma cell mutagenesis assay, and an in vivo rat
micronucleus assay.
Beleodaq may impair male fertility. Fertility studies using
belinostat were not conducted. However, belinostat effects on male reproductive
organs observed during the 24-week repeat-dose dog toxicology study included reduced organ
weights of the testes/epididymides that correlated with a delay in testicular
maturation.
Use In Specific
PopulationsPregnancy
Pregnancy Category D [See WARNINGS AND PRECAUTIONS].
Risk
Summary
Beleodaq may cause teratogenicity and/or embryo-fetal
lethality because it is a genotoxic drug and targets actively dividing cells
[see Nonclinical Toxicology]. Women should avoid pregnancy while receiving
Beleodaq. If this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of potential
hazard to the fetus.
Animal
Data
No reproductive and developmental animal toxicology studies
have been conducted with belinostat.
Nursing Mothers
It is not known whether belinostat is excreted in human
milk. Because many drugs are excreted in human milk and because of the
potential for serious adverse reactions in nursing infants from Beleodaq, a
decision should be made whether to discontinue nursing or discontinue drug,
taking into account the importance of the drug to the mother.
Pediatric Use
The safety and effectiveness of Beleodaq in pediatric
patients have not been established.
Geriatric Use
In the single-arm trial, 48% of patients (n = 62) were ≥ 65
years of age and 10% of patients (n=13) were ≥ 75 years of age [See Clinical
Studies]. The median age of the trial population was 63 years.
Patients ≥ 65 years of age had a higher response rate to Beleodaq treatment
than patients < 65 years of age (36% versus 16%) while no meaningful
differences in response rate were observed between patients ≥ 75 years of age
and those < 75 years of age. No clinically meaningful differences in serious
adverse reactions were observed in patients based on age (< 65 years
compared with ≥ 65 years or < 75 years of age compared with ≥ 75 years of
age).
Use In Patients With Hepatic
Impairment
Belinostat is metabolized in the liver and hepatic
impairment is expected to increase exposure to belinostat. Patients with
moderate and severe hepatic impairment (total bilirubin >1.5 x upper limit
of normal (ULN)) were excluded from clinical trials.
There is insufficient data to recommend a dose of Beleodaq
in patients with moderate and severe hepatic impairment [See CLINICAL
PHARMACOLOGY].
Use In Patients With Renal
Impairment
Belinostat exposure is not altered in patients with
Creatinine Clearance (CLcr) > 39 mL/min. There is insufficient data to
recommend a dose of Beleodaq in patients with CLcr ≤ 39 mL/min. [See CLINICAL
PHARMACOLOGY].
Overdosage
& Contraindications
OVERDOSE
No specific information is available on the treatment of
overdosage of Beleodaq. There is no antidote for Beleodaq and it is not known
if Beleodaq is dialyzable. If an overdose occurs, general supportive measures
should be instituted as deemed necessary by the treating physician. The
elimination half-life of belinostat is 1.1 hours [See CLINICAL
PHARMACOLOGY].
CONTRAINDICATIONS
None
Clinical
Pharmacology
CLINICAL PHARMACOLOGYMechanism Of Action
Beleodaq is a histone deacetylase (HDAC) inhibitor.
HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some
non-histone proteins. in vitro, belinostat caused the accumulation
of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells.
Belinostat shows preferential cytotoxicity towards tumor cells compared to
normal cells. Belinostat inhibited the enzymatic activity of histone
deacetylases at nanomolar concentrations (<250 nM).
PharmacodynamicsCardiac
Electrophysiology
Multiple clinical trials have been conducted with Beleodaq,
in many of which ECG data were collected and analyzed by a
central laboratory. Analysis of clinical ECG and belinostat plasma
concentration data demonstrated no meaningful effect of Beleodaq on cardiac
repolarization. None of the trials showed any clinically relevant changes
caused by Beleodaq on heart rate, PR duration or QRS duration as measures of
autonomic state, atrio-ventricular conduction or depolarization;
there were no cases of Torsades de Pointes.
Pharmacokinetics
The pharmacokinetic characteristics of belinostat were
analyzed from pooled data from phase 1/2 clinical studies that used doses of
belinostat ranging from 150 to 1200 mg/m2. The total mean plasma
clearance and elimination half-life were 1240 mL/min and 1.1 hours,
respectively. The total clearance approximates average hepatic blood flow (1500
mL/min), suggesting high hepatic extraction (clearance being flow dependent).
Distribution
The mean belinostat volume of distribution approaches total
body water, indicating that belinostat has limited body tissue
distribution. in vitro plasma studies have shown that between
92.9% and 95.8% of belinostat is bound to protein in an equilibrium dialysis assay, and was independent of
belinostat plasma concentrations from 500 to 25,000 ng/mL.
Elimination
Metabolism
Belinostat is primarily metabolized by hepatic UGT1A1.
Strong UGT1A1 inhibitors are expected to increase exposure to belinostat.
Belinostat also undergoes hepatic metabolism by CYP2A6, CYP2C9, and CYP3A4
enzymes to form belinostat amide and belinostat acid. The enzymes responsible
for the formation of methyl belinostat and
3-(anilinosulfonyl)-benzenecarboxylic acid, ( 3-ASBA) are not known.
Excretion
Following a single dose of [14C]-labelled belinostat
(100 μCi, 1500 mg) administered as a 30-minute intravenous infusion in patients
with recurrent or progressive malignancy (N=6), fecal excretion
accounted for a mean (± SD) of 9.7% (± 6.5%) of the administered radioactive
belinostat dose over 168 hours. The mean (± SD) of the administered radioactive
belinostat dose that was excreted in urine over 168 hours was 84.8% (± 9.8%),
of which unchanged belinostat accounted for only 1.7%.
Drug Interaction Studies
In vitro studies showed
belinostat and its metabolites (including belinostat glucuronide, belinostat
amide, methyl belinostat) inhibited metabolic activities of CYP2C8 and CYP2C9.
Other metabolites (3-ASBA and belinostat acid) inhibited CYP2C8.
In cancer patients, co-administration of Beleodaq (1,000
mg/m2) and warfarin (5 mg), a known CYP2C9 substrate, did not increase
the AUC or Cmax of either R- or S-warfarin.
Belinostat is likely a glycoprotein (P-gp) substrate but is
unlikely to inhibit P-gp.
Pharmacogenomics
UGT1A1 activity is reduced in individuals with genetic polymorphisms
that lead to reduced enzyme activity such as the UGT1A1*28 polymorphism. Approximately 20% of the black
population, 10% of the white population, and 2% of the Asian population
are homozygous for the UGT1A1*28 allele. Additional reduced function alleles
may be more prevalent in specific populations.
Because belinostat is primarily (80 -90%) metabolized by
UGT1A1, the clearance of belinostat could be decreased in patients with reduced
UGT1A1 activity (e.g., patients with UGT1A1*28 allele). Reduce the starting
dose of Beleodaq to 750 mg/m2 in patients known to be homozygous for the UGT1A1*28 allele to
minimize dose limiting toxicities.
Clinical StudiesRelapsed
Or Refractory Peripheral T-Cell Lymphoma (PTCL)
In an open-label, single-arm, non-randomized international
trial conducted at 62 centers, 129 patients with relapsed or refractory PTCL were treated with
Beleodaq 1,000 mg/m2 administered over 30 minutes via IV infusion once daily on
Days 1-5 of a 21-day cycle. There were 120 patients who had histologically
confirmed PTCL by central review evaluable for efficacy. Patients were treated
with repeat cycles every three weeks until disease progression or unacceptable
toxicity.
Efficacy was evaluated using response rate (complete
response and partial response) as assessed by an independent review committee
(IRC) using the International Workshop Criteria (IWC) (Cheson 2007). Response
assessments were evaluated every 6 weeks for the first 12 months and then every
12 weeks until 2 years from the start of study treatment. Duration of response
was measured from the first day of documented response to disease progression
or death. Response and progression of disease were evaluated by the IRC using
the IWC.
Table 3 summarizes the baseline demographic and disease
characteristics of the study population, who were evaluable for
efficacy.
Table 3: Baseline
Patient Characteristics (PTCL Population)
|
Characteristics
|
Evaluable Patients
(N=120)
|
|
Age (years)
|
|
Median (range)
|
64 (29-81)
|
|
Sex, %
|
|
Male
|
52
|
|
Female
|
48
|
|
Race, %
|
|
White
|
88
|
|
Black
|
6
|
|
Asian
|
3
|
|
Latin
|
3
|
|
Other
|
2
|
|
PTCL Subtype Based on Central Diagnosis, %
|
|
PTCL Unspecified (NOS)
|
64
|
|
Angioimmunoblastic T-cell
lymphoma (AITL)
|
18
|
|
ALK-1 negative anaplastic
large cell lymphoma (ALCL)
|
11
|
|
Other
|
7
|
|
Baseline Platelet Count, %
|
|
≥100,000/µL
|
83
|
|
<100,000/µL
|
17
|
|
ECOG Performance Status, %
|
|
0
|
34
|
|
1
|
43
|
|
2
|
22
|
|
3
|
1
|
|
Median time (months) from Initial PTCL
Diagnosis (Range)
|
12 (2.6 – 266.4)
|
|
Median Number of Prior Systemic Therapies
(Range)
|
2 (1-8)
|
In all evaluable patients (N = 120) treated with Beleodaq,
the overall response rate per central review using IWC was 25.8% (n = 31)
(Table 4) with rates of 23.4% for PTCL, NOS and 45.5% for AITL, the two largest
subtypes enrolled.
Table 4: Response
Analysis per Central Assessment Using IWC in Patients with Relapsed or
Refractory PTCL
|
|
Evaluable Patients
(N=120)
|
|
Response Rate
|
n (%)
|
(95% CI)
|
|
CR+PR
|
31 (25.8)
|
18.3-34.6
|
|
CR
|
13 (10.8)
|
5.9-17.8
|
|
PR
|
18 (15.0)
|
9.1 – 22.7
|
|
CI=confidence interval, CR=complete
response, PR=partial response
|
The median duration of response based on the first date of
response to disease progression or death was 8.4 months (95% CI: 4.5 – 29.4).
Of the responders, the median time to response was 5.6 weeks (range 4.3 - 50.4
weeks). Nine patients (7.5%) were able to proceed to a stem cell transplant after treatment with
Beleodaq.
Medication
Guide
PATIENT INFORMATION
BELEODAQ®
(Be-leo-dak)
(belinostat) For Injection, For Intravenous Use
Read this Patient Information before you receive treatment
with Beleodaq and each time you receive Beleodaq. There may be new information.
This leaflet does not take the place of talking to your doctor about your
medical condition or your treatment.
What is Beleodaq?
Beleodaq is a prescription medicine used to treat people
with a type of cancer called peripheral T-cell Lymphoma (PTCL) that comes back or
does not respond to cancer treatment. It is not known if Beleodaq is safe and
effective in children.
What should I tell my doctor before receiving Beleodaq?
Before receiving Beleodaq, tell your doctor about all of
your medical conditions, including if you:
· have an infection
· have had chemotherapy treatment
· have liver or kidney problems
· have nausea, vomiting, or
diarrhea
· are pregnant or plan to become
pregnant. Beleodaq can harm your unborn baby. You should not become pregnant
while receiving Beleodaq. Tell your doctor right away if you become pregnant
while receiving Beleodaq.
· are breastfeeding or plan to
breastfeed. It is not known if Beleodaq passes into your breast milk. You and
your doctor should decide if you will receive Beleodaq or breastfeed. You
should not do both.
Tell your doctor about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive Beleodaq?
· Beleodaq will be given to you
by intravenous (IV) injection into your vein, usually over 30 minutes.
· Beleodaq is given one time a
day on Days 1 through 5 of a 21-day cycle of treatment.
· you should have regular blood
tests before and during your treatment with Beleodaq.
· Your doctor may change your
dose of Beleodaq, change when you receive your treatment, or stop treatment if
you have certain side effects while receiving Beleodaq.
What are the possible side effects of Beleodaq?
Beleodaq may cause serious side effects, including:
· Low blood cell
counts. Your doctor will do blood tests to check your blood counts during
your treatment with Beleodaq.
o Low platelet counts can cause unusual bleeding or bruising
under your skin.
o Low red blood cell counts may make you feel weak, tired, or you
get tired easily, you look pale, or you feel short of breath.
o Low white blood cell counts can cause you to get infections,
which may be serious.
· Serious infections. People
receiving Beleodaq may develop serious infections that can sometimes lead to
death. You may have a greater risk of life-threatening infections if you have
had chemotherapy in the past. Tell your doctor right away if you have any of
the following signs or symptoms of an infection: fever, flu-like symptoms,
cough, shortness of breath, burning with urination muscle aches, or worsening
skin problems.
· Liver problems. Beleodaq
may cause liver problems which can lead to death. Your doctor will do blood
tests during your treatment with Beleodaq to check for liver problems. Tell
your doctor right away if you have any of the following signs or symptoms of
liver problems: yellowing of the skin or the white part of your eyes (jaundice), dark urine, itching, or pain in the
right upper stomach area.
· Tumor Lysis Syndrome
(TLS). TLS is caused by a fast breakdown of cancer cells. Your doctor will
check you for TLS during treatment with Beleodaq.
· Nausea, vomiting, and
diarrhea are common with Beleodaq and can sometimes be serious. Tell your
doctor if you develop nausea, vomiting or diarrhea. Your doctor may prescribe
medicines to help prevent or treat these side effects.
Common side effects of Beleodaq include fatigue,
fever, and low red blood cell count.
Tell your doctor if you have any side effect that bothers
you or that does not go away. These are not all the possible side effects of
Beleodaq. Call your doctor for medical advice about side effects. You can
report side effects to FDA at 1-800-FDA-1088.
General information about Beleodaq
Medicines are sometimes prescribed for purposes other than
those listed in a Patient Information leaflet. You can ask your pharmacist or
doctor for information about Beleodaq that is written for health professionals.
What are the ingredients in Beleodaq?
Active ingredient: belinostat
Inactive ingredients: L-Arginine
