Dosing & Uses
Dosage Forms & Strengths
capsule
- 100mg
Cutaneous T-cell Lymphoma
Indicated for treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent, or recurrent disease during or following 2 systemic therapies
400 mg PO qDay
May reduce to 300 mg qDay, and then to 300 mg qDay for 5 days/wk if intolerant
Monitor: CBC, electrolytes, serum glucose and creatinine q2week during first 2 months and monthly thereafter
Dosage Modifications
Hepatic impairment
- Mild/moderate (Child-Pugh A or B): Use with caution
- Severe (Child-Pugh C): Contraindicated
Multiple Myeloma (Orphan)
Orphan designation for treatment of multiple myeloma
Sponsor
- Merck Research Laboratories; Merck & Co Inc; PO Box 2000, RY 33-212; Rahway, NJ 07065-0900
Melanoma (Orphan)
Orphan designation for treatment of advanced melanoma (stages IIb, IIc, III, and IV)
Sponsor
- Qameleon Therapeutics; Moslaan 32, 1433 WJ; Kudelstaart, Netherlands
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (24)
- aripiprazole
aripiprazole and vorinostat both increase QTc interval. Avoid or Use Alternate Drug.
- artemether
artemether and vorinostat both increase QTc interval. Avoid or Use Alternate Drug.
- ceritinib
ceritinib and vorinostat both increase QTc interval. Avoid or Use Alternate Drug.
- citalopram
citalopram and vorinostat both increase QTc interval. Avoid or Use Alternate Drug.
- clarithromycin
clarithromycin and vorinostat both increase QTc interval. Avoid or Use Alternate Drug.
- clozapine
clozapine and vorinostat both increase QTc interval. Avoid or Use Alternate Drug.
- deferiprone
deferiprone, vorinostat. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.
- dofetilide
dofetilide increases toxicity of vorinostat by QTc interval. Avoid or Use Alternate Drug.
- fexinidazole
fexinidazole and vorinostat both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate and vorinostat both increase QTc interval. Avoid or Use Alternate Drug.
- ivosidenib
ivosidenib and vorinostat both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.
- lefamulin
lefamulin and vorinostat both increase QTc interval. Avoid or Use Alternate Drug.
- macimorelin
macimorelin and vorinostat both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.
- mefloquine
mefloquine increases toxicity of vorinostat by QTc interval. Avoid or Use Alternate Drug. Mefloquine may enhance the QTc prolonging effect of high risk QTc prolonging agents.
- mobocertinib
mobocertinib and vorinostat both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.
- ondansetron
ondansetron and vorinostat both increase QTc interval. Avoid or Use Alternate Drug. Avoid with congenital long QT syndrome; ECG monitoring recommended with concomitant medications that prolong QT interval, electrolyte abnormalities, CHF, or bradyarrhythmias.
- palifermin
palifermin increases toxicity of vorinostat 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.
- pasireotide
vorinostat and pasireotide both increase QTc interval. Avoid or Use Alternate Drug.
- ribociclib
ribociclib increases toxicity of vorinostat by QTc interval. Avoid or Use Alternate Drug.
- umeclidinium bromide/vilanterol inhaled
vorinostat increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- valproic acid
vorinostat, valproic acid. pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of severe thrombocytopenia and GI bleeding. Monitor platelet count q 2 wks for first 2 months.
- vandetanib
vorinostat, vandetanib. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug. Avoid coadministration with drugs known to prolong QT interval; if a drug known to prolong QT interval must be used, more frequent ECG monitoring is recommended.
- vemurafenib
vemurafenib and vorinostat both increase QTc interval. Avoid or Use Alternate Drug. Concomitant use of vemurafenib with drugs that prolong QT interval is not recommended.
- vilanterol/fluticasone furoate inhaled
vorinostat increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
Monitor Closely (32)
- albuterol
albuterol and vorinostat both increase QTc interval. Use Caution/Monitor.
- alfuzosin
vorinostat and alfuzosin both increase QTc interval. Use Caution/Monitor.
alfuzosin and vorinostat both increase QTc interval. Use Caution/Monitor. - apomorphine
apomorphine and vorinostat both increase QTc interval. Use Caution/Monitor.
- arformoterol
arformoterol and vorinostat both increase QTc interval. Use Caution/Monitor.
- atomoxetine
atomoxetine and vorinostat both increase QTc interval. Use Caution/Monitor.
- bedaquiline
vorinostat and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- cholera vaccine
vorinostat 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.
- citalopram
vorinostat and citalopram both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.
- crizotinib
crizotinib and vorinostat both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.
- dasatinib
dasatinib and vorinostat both increase QTc interval. Use Caution/Monitor.
- degarelix
degarelix and vorinostat both increase QTc interval. Use Caution/Monitor.
- dengue vaccine
vorinostat 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 vorinostat both decrease serum potassium. Use Caution/Monitor.
- escitalopram
escitalopram increases toxicity of vorinostat by QTc interval. Use Caution/Monitor.
- ezogabine
ezogabine, vorinostat. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Slight and transient QT-prolongation observed with ezogabine, particularly when dose titrated to 1200 mg/day. QT interval should be monitored when ezogabine is prescribed with agents known to increase QT interval.
- fluoxetine
vorinostat and fluoxetine both increase QTc interval. Modify Therapy/Monitor Closely.
- haloperidol
haloperidol and vorinostat both increase QTc interval. Use Caution/Monitor.
- indacaterol, inhaled
indacaterol, inhaled, vorinostat. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- metformin
vorinostat decreases effects of metformin by pharmacodynamic antagonism. Use Caution/Monitor.
- mifepristone
mifepristone, vorinostat. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.
- olodaterol inhaled
vorinostat and olodaterol inhaled both increase QTc interval. Use Caution/Monitor. Drugs that prolong the QTc interval and may potentiate the effects of beta2 agonists on the cardiovascular system; increased risk of ventricular arrhythmias
- osilodrostat
osilodrostat and vorinostat both increase QTc interval. Use Caution/Monitor.
- osimertinib
osimertinib and vorinostat both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.
- ozanimod
ozanimod and vorinostat both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.
- quetiapine
quetiapine, vorinostat. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Avoid use with drugs that prolong QT and in patients with risk factors for prolonged QT interval. Postmarketing cases show QT prolongation with overdose in patients with concomitant illness or with drugs known to cause electrolyte imbalance or prolong QT.
- quinine
vorinostat and quinine both increase QTc interval. Use Caution/Monitor.
- rilpivirine
rilpivirine increases toxicity of vorinostat by QTc interval. Use Caution/Monitor. Rilpivirine should be used with caution when co-administered with a drug with a known risk of Torsade de Pointes.
- selpercatinib
selpercatinib increases toxicity of vorinostat by QTc interval. Use Caution/Monitor.
- siponimod
siponimod and vorinostat 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.
- sorafenib
sorafenib and vorinostat both increase QTc interval. Use Caution/Monitor.
- voclosporin
voclosporin, vorinostat. Either increases effects of the other by QTc interval. Use Caution/Monitor.
- warfarin
vorinostat increases effects of warfarin by Mechanism: unspecified interaction mechanism. Use Caution/Monitor. Monitor PT and INR carefully.
Minor (2)
- azithromycin
azithromycin increases toxicity of vorinostat by QTc interval. Minor/Significance Unknown.
- chloroquine
chloroquine increases toxicity of vorinostat by QTc interval. Minor/Significance Unknown.
Adverse Effects
>10%
Diarrhea (52%)
Fatigue (52%)
Nausea (41%)
Dysguesia (28%)
Thrombocytopenia (26%)
Anorexia (24%)
Weight loss (20.9%)
Muscle spasms (19.8%)
Alopecia (18.6%)
Chills (16%)
Dry mouth (16%)
Increase serum Cr (16%)
Dizziness (15%)
Constipation (15%)
Vomiting (15%)
Anemia (14%)
Peripheral edema (12.8%)
Headache (11.6%)
Pruritus (11.6%)
Cough (10.5%)
Upper respiratory infection (10.5%)
Decreased appetite
Pyrexia
1-10%
Prolonged QT interval (3.5-6%)
Pulmonary embolism (4.7%)
Warnings
Contraindications
Severe hepatic Impairment
Cautions
Congenital long QT syndrome, drugs/conditions that prolong QT interval; correct hypokalemia or hypomagnesemia before commencing treatment
Thrombocytopenia and anemia may require dose modification or discontinuation; monitor blood counts every 2 weeks during first 2 months of therapy and monthly thereafter
Severe thrombocytopenia with gastrointestinal bleeding reported with other HDAC inhibitors (e.g., valproic acid); monitor platelet counts more frequently
Monitor for pertinent signs and symptoms of pulmonary embolism and deep vein thrombosis
Potential for hyperglycemia; caution in diabetes; monitor blood glucose every 2 weeks during first 2 months of therapy and monthly thereafter
Dose related anemia and thrombocytopenia may occur; modify dose or discontinue if reduction in platelets or Hgb
Concomitant valproic acid
May cause dizziness or fatigue
Concomitant coumarin-derived anticoagulants
Hepatic/renal impairment
Nausea, vomiting and diarrhea; patients may require antiemetics, antidiarrheals, and fluid and electrolyte replacement to prevent dehydration
Avoid pregnancy
Drink at least 2 L of fluids daily
Measure and correct abnormal electrolytes, creatinine, magnesium and calcium at baseline; monitor every 2 weeks during first 2 months of therapy and at least monthly during treatment
Pregnancy & Lactation
Pregnancy
Based on mechanism of action and findings from animal studies, therapy can cause fetal harm when administered to a pregnant woman
There are insufficient data in pregnant women to inform a drug-associated risk of major birth defects and miscarriage
Advise pregnant women of potential risk to fetus
Animal data
- In animal reproduction studies, administration of drug to pregnant rats and rabbits during period of organogenesis caused adverse developmental outcomes at maternal exposures approximately 0.5 times the human exposure based on AUC0-24 hours
Reproductive potential
- Can cause fetal harm when administered to a pregnant woman
Pregnancy testing
- Perform pregnancy testing in females of reproductive potential within 7 days prior to initiating therapy
Contraception
- Females: Advise patients of reproductive potential to use effective contraception during treatment and for at least 6 months after the last dose
- Males: Advise males with female partners of reproductive potential to use effective contraception and to avoid fathering a child during treatment with ZOLINZA and for at least 3 months after the last dose
Infertility
- Based on findings in animals, therapy has the potential to affect female fertility
Lactation
There are no data on presence of drug or its metabolites in human milk, effects on a breastfed child, or on milk production; because many drugs are excreted in human milk and because of potential for serious adverse drug reactions in a nursing child, advise lactating women not to breastfeed during treatment and for at least 1 week 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 inhibitor for enzymes HDAC1, HDAC2, HDAC3, and HDAC6, which in turn alters chromatin structure and transcription factor activation; as a result, cell growth is terminated and apoptosis occurs
Absorption
Peak plasma time: 4 hr
Peak plasma concentration (400 mg dose): 1.2±0.62 umol/L
Fasted state has quicker peak time, but lower AUC and peak concentration
Taken with a high fat meal increases extent of absorption by 33%
Bioavailability: 43%
Distribution
Protein Bound: 71%
Metabolism
Liver
Metabolites: Inactive
Elimination
Half-Life, Terminal: 2 hr
Excretion: Urine 52%
Administration
Oral Administration
Take with food
Drink at least 2 L of fluids daily
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Zolinza oral - | 100 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
vorinostat oral
VORINOSTAT - ORAL
(vor-IN-oh-stat)
COMMON BRAND NAME(S): Zolinza
USES: Vorinostat is used to treat a certain type of cancer (CTCL-cutaneous T-cell lymphoma). It 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 taking vorinostat and each time you get a refill. If you have any questions regarding the information, ask your doctor or pharmacist.Take this medication by mouth with food as directed by your doctor, usually once daily. Swallow the capsules whole. Do not crush, chew, or open the capsules.Do not use capsules that are opened or crushed. If your skin or eyes come in contact with the powder inside the capsule, wash the area well with plenty of water and call your doctor.The dosage is based on your medical condition and response to treatment.To prevent dehydration while taking this medication, drink at least 8 glasses of water (8 ounces/240 milliliters each) throughout the day unless your doctor directs you otherwise.Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Tiredness, loss of appetite, weight loss, dizziness, dry mouth, change in the sense of taste, hair loss, headache, or cough may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Nausea, vomiting, and diarrhea can also occur and may be severe. Tell your doctor right away if these effects occur. In some cases, your doctor may prescribe medication to prevent or relieve them. Eating several small meals, not eating before treatment, or limiting activity may help to lessen the nausea and vomiting.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.Persistent vomiting/diarrhea may result in dehydration. Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. You may be at an increased risk for stomach/intestine bleeding if you are taking certain medications (see also Drug Interaction section). Tell your doctor right away if you develop any of the following unlikely symptoms: unusual tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding, signs of stomach/intestine bleeding (such as black/bloody stools, vomit that contains blood or looks like coffee grounds, dizziness).Tell your doctor right away if you have any serious side effects, including: signs of low levels of magnesium/potassium/calcium in the blood (such as severe muscle spasms/cramps, irregular heartbeat, mental/mood changes, seizures).This medication may rarely cause blood clots (such as pulmonary embolism and deep vein thrombosis). You may be at increased risk for blood clots if you have a history of blood clots. Get medical help right away if any of these side effects occur: chest pain, pain/redness/swelling usually in the leg, trouble breathing.Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.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 taking this medication, 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: liver disease, certain mineral imbalances (such as low levels of potassium or magnesium in the blood), blood clots.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).Vorinostat may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using vorinostat, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using vorinostat safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially QT prolongation.Tell your doctor if you are pregnant or plan to become pregnant. You should have a pregnancy test before starting this medication. You should not become pregnant while using vorinostat. Vorinostat may harm an unborn baby. Females using this medication should ask about reliable forms of birth control while using this medication and for at least 6 months after stopping treatment. Males using this medication should ask about reliable forms of birth control while using this medication and for at least 3 months after stopping treatment. If you or your partner become 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. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for at least 1 week 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: "blood thinners" (such as warfarin), valproic acid.
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: Do not share this medication with others.Laboratory and/or medical tests (such as complete blood count, kidney function, blood glucose levels, blood mineral levels including potassium/magnesium/calcium) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
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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