Vorinostat Oral capsule

What is this medicine?

VORINOSTAT (vor IN oh stat) is a chemotherapy drug. It is used to treat cutaneous T-cell lymphoma (CTCL).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• history of blood clots

• history of irregular heartbeat

• liver disease

• take medicines that treat or prevent blood clots

• an unusual or allergic reaction to vorinostat, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Do not chew, crush, or open the capsules. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• chlorpromazine

• cisapride

• grepafloxacin

• halofantrine

• hawthorn

• pimozide

• sparfloxacin

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• alfuzosin

• chloroquine

• cyclobenzaprine

• droperidol

• medicines for depression, anxiety, or psychotic disturbances

• medicines for irregular heart beat

• medicines for nausea/vomiting like dolasetron, ondansetron, palonosetron

• medicines for numbness or sleep during surgery

• medicines that treat or prevent blood clots like enoxaparin, heparin, ticlodipine, warfarin

• other cancer treatments like dasatinib, lapatinib

• methadone

• octreotide

• pentamidine

• prochlorperazine

• propafenone

• some antibiotics like clarithromycin, erythromycin, levofloxacin, mefloquine

• tacrolimus

• valproic acid

• vardenafil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Report any side effects. You will need blood work done while you are taking this medicine.

Talk to your doctor about how many glasses of water to drink each day. It is important to drink plenty of fluids and to avoid dehydration.

If the capsules of this medicine is broken or opened, do not touch the capsules or the powder contents of the capsules. If the powder gets on your skin or in your eyes, wash the area well with plenty of water. Call your doctor.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• change in the amount of urine

• chest pain

• cough

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• fever or chills, sore throat

• increased hunger or thirst

• pain, swelling, warmth in the leg

• problems with balance, talking, walking

• swelling of feet, legs

• unusual bleeding or bruising

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in taste

• constipation

• diarrhea

• dry mouth

• headache

• loss of appetite

• muscle aches

• nausea, vomiting

• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.