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Vorinostat

(vor-in-uh-stat)

Trade/other name(s): Zolinza, suberoylanilide hydroxamic acid (SAHA)

Why would this drug be used?

Vorinostat is used to treat a type of skin cancer known as cutaneous T-cell lymphoma (CTCL). It is also being studied for use against several other types of cancer.

How does this drug work?

Vorinostat is a type of anti-cancer drug known as a histone deacetylase (HDAC) inhibitor. It is thought to work by blocking enzymes in cells called histone deacetylases. Cancer cells sometimes have too many of these enzymes which stop the cells from making proteins needed to keep them from growing and dividing too fast.

By blocking these HDAC enzymes, vorinostat allows other important proteins to be made, which may cause cancer cells to stop growing or to die.

Before taking this medicine

Tell your doctor…

  • If you are allergic to any medicines, dyes, additives, or foods.
  • If you have nausea, vomiting, or diarrhea. This drug may make these symptoms worse (see "Precautions" below).
  • If you have ever had blood clots. This drug may raise your risk of blood clots in the legs or lungs (see "Precautions" below).
  • If you have high blood sugar or diabetes. This drug may raise your blood sugar levels.
  • If you have an abnormal heart rhythm, heart block, heart failure, prolonged QT interval syndrome, or any other problem with the heart's electrical system. This drug can slow down the heart's electrical impulses and make the problems worse (see "Precautions" below).
  • If you have ever had liver problems (including hepatitis). Reduced liver function may result in more drug than expected staying in the body, which could lead to worse side effects. Your doctor may need to adjust your dose accordingly.
  • If you have any other medical conditions such as kidney disease, high blood pressure, gout, or infections. You may need closer monitoring of these conditions while being treated.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug may cause problems with the fetus if taken at the time of conception or during pregnancy. Although this drug has not been studied in pregnant women, it is known to cause birth defects in animals. Check with your doctor about what kinds of birth control can be used with this medicine. In pregnant women, treatment with this drug should be used only if the potential benefit to the mother outweighs the possible risk to the fetus.
  • If you are breast-feeding. It is not known whether this drug passes into breast milk. If it does, it may affect the baby. If you are nursing, talk to your doctor about whether to stop breast-feeding or stop taking this drug.
  • If you think you might want to have children in the future. This drug's effects on fertility are not yet known. Talk with your doctor about the possible risk with this drug and options that may preserve your ability to have children.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Some drugs that are used for other reasons, such as valproic acid (Depakote, Depakene, Divalproex), may also act as HDAC inhibitors, and may increase a person's risk of bleeding while on vorinostat. Your doctor will likely watch your platelet count carefully if you take valproic acid with vorinostat, especially during the first 2 months.

If you are taking coumadin (Warfarin), you may need your clotting times checked more often. Sometimes vorinostat can make bleeding times longer.

Vorinostat may raise your risk of heart rhythm problems even more if you are taking other drugs that affect the body's mineral (electrolyte) balance or that affect the heart rhythm, such as these:

  • diuretics (water pills)
  • antibiotics such as ciprofloxacin (Cipro), levofloxacin Levaquin), sparfloxacin (Zagam), moxifloxacin (Avelox), erythromycin (E.E.S., E-Mycin, Erythrocin), clarithromycin (Biaxin), or pentamidine (Pentam, NebuPent)
  • anti-fungal drugs (amphotericin B)
  • heart rhythm drugs such as amiodorone (Cordarone, Pacerone), disopyrmide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), quinidine (Quinidex, Cardioquin), sotalol (Betapace), dofetilide (Tikosyn)
  • mental health drugs such as haloperidol (Haldol), thioridazine (Mellaril), pimozide (Orap), mesoridazine (Serentil), chlorpromazine (Thorazine)
  • methadone (Dolophine, Methadose)
  • the anti-nausea drug droperidol (Inapsine)
  • anti-malaria drugs halofantrine (Halfan) and chloroquine (Aralen)
  • bepridil (Vascor), a drug for angina or heart pain

Any drugs or supplements that interfere with blood clotting can raise the risk of bleeding during treatment with vorinostat. These include:

  • vitamin E
  • non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and many others
  • warfarin (Coumadin)
  • ticlopidine (Ticlid)
  • clopidogrel (Plavix)

Note that many cold, flu, fever, and headache remedies contain aspirin or ibuprofen. Ask your pharmacist if you aren't sure what's in the medicines you take.

Check with your doctor, nurse, or pharmacist about your other medicines, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether some foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Vorinostat is taken by mouth as a capsule. The capsules are taken once a day, with food. They should be swallowed whole and should not be chewed, opened, or crushed. If the powder from inside the capsule touches the skin, wash the area with soap and plenty of water. If the powder gets onto any mucous membranes (such as the eyes, mouth, or inside the nose), you should thoroughly flush the exposed area with water. After washing or flushing, call your doctor or nurse right away.

The usual starting dose is 400 milligrams (mg) per day. Your doctor may reduce this dose if you are having serious side effects.

Take this drug exactly as directed by your doctor or nurse. If you are not sure of the instructions, ask your doctor or nurse to explain them to you.

Keep the medicine in a tightly closed container away from heat and moisture and out of the reach of children and pets.

Precautions

You may have nausea, vomiting, and/or diarrhea while taking this drug. Your doctor may give you prescriptions for medicines that you can take at home to help prevent these side effects. It is important to have these medicines on hand and to take them as prescribed by your doctor. Try to drink at least 2 liters (about 2 quarts) of fluids each day while on this drug to reduce the risk of dehydration. Report vomiting or diarrhea to your doctor or nurse. Call the doctor if vomiting or diarrhea is not controlled by the medicines your doctor prescribes. You may need different drugs or even fluids by vein.

This drug may increase your risk of major blood clots in the veins of the legs or lungs. Tell your doctor right away if you notice chest pain, shortness of breath, coughing up blood, a fast heartbeat, or if you have swelling, pain, redness, or warmth in an arm or leg.

Your doctor will likely test your blood frequently throughout your treatment, looking for possible effects of the drug on blood counts, blood chemistry levels, and blood sugar levels. Based on the test results, you may be given medicines to help treat any effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it altogether. Be sure to keep all your appointments for lab tests and doctor visits.

This drug may lower your platelet count in the weeks after it is given, which can increase your risk of bleeding. Speak with your doctor before taking any drugs or supplements that might affect your body's ability to stop bleeding, such as aspirin or aspirin-containing medicines, warfarin (Coumadin), or vitamin E. Tell your doctor right away if you have unusual bruising or bleeding, such as nosebleeds, bleeding gums when you brush your teeth, or black, tarry stools.

This drug may lower your red blood cell count. If this occurs, it is usually a few weeks after starting treatment. A low red blood cell count (known as anemia) can cause shortness of breath, or make you to feel weak or tired all the time. Your doctor may give you medicines to help prevent or treat this condition, or you may need to get blood transfusions.

Call your doctor right away if you have symptoms of high blood sugar, such as extreme thirst or hunger, passing urine frequently, weakness, or blurred vision.

In rare cases this drug may affect your heart rhythm. Your doctor will likely get tests of your heart rhythm (EKGs) before and during treatment. Tell your doctor right away if you notice slow or irregular heartbeat, chest pain, dizziness, or shortness of breath.

Avoid pregnancy during and for at least a few months after treatment, since exposure to this drug may harm the fetus. Talk with your doctor about this.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • feeling tired
  • nausea/vomiting*
  • diarrhea*
  • loss of appetite
  • changes in how foods taste
  • weight loss
  • muscle aches
  • low blood platelet count with increased risk of bleeding*
  • high blood sugar levels*
  • abnormal blood or urine tests which suggest that the drug is affecting the kidneys (Your doctor will discuss the importance of this finding, if any.)

Less common

  • muscle spasms
  • hair loss (including face and body hair)
  • dry mouth
  • constipation
  • fever, chills
  • feeling dizzy
  • swelling in the hands, feet, legs, or ankles
  • headache
  • itching
  • low red blood cell count (anemia)*
  • cough
  • upper respiratory infection

Rare

  • blood clots in the lungs or legs*
  • changes in electric impulses of the heart, abnormal heart rhythm*
  • slow or fast heart rate*
  • death due to infection or other cause

*See "Precautions" section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2006

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.

Last Medical Review: 02/11/2010
Last Revised: 02/11/2010