Vorinostat

Vorinostat is a prescription medication used for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent, or recurrent disease during or following 2 systemic therapies.

• Vorinostat is available under the following different brand names: Zolinza

Common side effects of Vorinostat include:

• nausea
• constipation
• diarrhea
• tiredness
• loss of appetite 
• weight loss
• dizziness
• dry mouth
• change in the sense of taste
• hair loss
• headache
• itching
• chills
• muscle spasms
• cold symptoms (cough, stuffy nose, sneezing, or sore throat)

Serious side effects of Vorinostat include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• dizziness
• drowsiness
• increased thirst
• feeling hot
• inability to urinate
• hot and dry skin
• increased urination
• dry mouth
• fruity breath odor
• pale skin
• easy bruising
• unusual bleeding
• purple or red spots under the skin
• unusual tiredness
• light-headedness
• cold hands and feet
• chest pain
• fast heartbeats
• shortness of breath
• sweating
• coughing up blood
• pain, swelling, warmth, or redness in one or both legs

Rare side effects of Vorinostat include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats, fluttering in the chest; shortness of breath, sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 100 mg

Cutaneous T-cell lymphoma

Adult dosage

• 400 mg orally once daily
• May reduce to 300 mg once a day, and then to 300 mg once a day for 5 days/wk if intolerant

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Vorinostat has severe interactions with the following drugs:
  • dronedarone
  • thioridazine
• Vorinostat has serious interactions with at least 81 other drugs:
• Vorinostat has moderate interactions with at least 83 other drugs.
• Vorinostat has minor interactions with the following drugs:
  • azithromycin
  • chloroquine

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Severe hepatic impairment

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Vorinostat?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Vorinostat?”

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 the first 2 months of therapy and monthly thereafter
• Severe thrombocytopenia with gastrointestinal bleeding reported with other HDAC inhibitors (eg, 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 the first 2 months of therapy and monthly thereafter
• Dose-related anemia and thrombocytopenia may occur; modify the dose or discontinue if there is a 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 the first 2 months of therapy and at least monthly during treatment

Pregnancy and Lactation

• Based on the mechanism of action and findings from animal studies, therapy can cause fetal harm when administered to pregnant women
• There are insufficient data on pregnant women to inform any drug-associated risks for major birth defects and miscarriage
• Advise pregnant women against the potential risks to the fetus
• Reproductive potential
  • Can cause fetal harm when administered to pregnant women
• Pregnancy testing
  • Perform pregnancy testing in women of reproductive potential within 7 days prior to initiating therapy
• Contraception
  • Women: Advise patients of reproductive potential to use effective contraception during treatment and for at least 6 months after the last dose
  • Men: Advise men with women 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 the findings in animals, this therapy has the potential to affect female fertility
• Lactation
  • There are no data on the presence of the drug or its metabolites in human milk, its effects on a breastfed child, or on milk production; because many drugs are excreted in human milk and because of the 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 the last dose