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Vorinostat

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Anxiety
  • Black, tarry stools
  • Bleeding gums
  • Bloating or swelling of face, arms, hands, lower legs, or feet
  • Blood in urine or stools
  • Body aches or pain
  • Chest pain
  • Chills
  • Confusion
  • Convulsions
  • Cough
  • Decreased urine
  • Diarrhea
  • Dizziness or lightheadedness
  • Dry mouth
  • Ear congestion
  • Fainting
  • Fast heartbeat
  • Fever
  • Headache
  • Increased thirst
  • Irregular heartbeat
  • Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
  • Loss of appetite
  • Loss of voice
  • Lower back or side pain
  • Mood changes
  • Muscle pain or cramps
  • Nasal congestion
  • Nausea or vomiting
  • No blood pressure
  • No breathing
  • No pulse
  • Numbness or tingling in face, arms or legs
  • Numbness or tingling in hands, feet, or lips
  • Pain, redness, or swelling in arm or leg
  • Painful or difficult urination
  • Pale skin
  • Pinpoint red spots on skin
  • Rapid weight gain
  • Runny nose
  • Shortness of breath
  • Sore throat
  • Sores, ulcers, or white spots on lips or in mouth
  • Sudden shortness of breath or troubled breathing
  • Swollen glands
  • Trouble speaking, thinking or walking
  • Troubled breathing with exertion
  • Unusual bleeding or bruising
  • Unusual drowsiness, dullness, or feeling of sluggishness
  • Unusual tiredness or weakness

Less common

  • Persistent non-healing sore
  • Pink growth
  • Reddish patch or irritated area
  • Shiny bump
  • White, yellow or waxy scar-like area

Rare

  • Chest discomfort
  • General feeling of illness
  • Hoarseness
  • Indigestion
  • Pain or discomfort in arms, jaw, back, or neck
  • Rapid, shallow breathing
  • Severe nausea or vomiting
  • Sneezing
  • Stomach pain
  • Sweating
  • Tightness in chest
  • Vomiting of blood or material that looks like coffee grounds
  • Wheezing
  • Yellow skin and eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Change in taste
  • Cracks in the skin
  • Difficulty having a bowel movement (stool)
  • Hair loss, thinning of hair
  • Itching skin
  • Lack or loss of strength
  • Loss of heat from the body
  • Loss of taste
  • Muscle spasm
  • Red, swollen skin
  • Scaly skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed to check for unwanted effects .

Check with your doctor right away if you start having pain in your chest, groin, or legs, especially the calves; trouble breathing; severe, sudden headache; slurred speech; sudden, unexplained shortness of breath; sudden loss of coordination; sudden, severe weakness or numbness in arm or leg; or vision changes. These may be symptoms of blood clotting problems .

Vorinostat can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur .

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, check with your doctor. Carefully follow your doctor’s instructions about any special diet .

Check with your doctor right away if you have severe diarrhea, nausea, or vomiting. You may also receive medicines to help prevent these symptoms .

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats .

Proper Use

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

This medicine sometimes causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.

Drink at least 2 liters of fluids per day while you are using this medicine. This will help prevent dehydration and keep your kidneys working well .

Swallow the capsule whole. Do not open, crush, break, or chew it .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For cutaneous T-cell lymphoma:
    • For oral dosage form (capsules):
      • Adults—400 milligrams (mg) once a day with food. Your doctor will adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of vorinostat in children up to 18 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of vorinostat in the elderly. However, elderly patients may be more sensitive to the effects of vorinostat than younger adults .

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Dicumarol
  • Phenprocoumon
  • Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia or
  • Bleeding problems (e.g., low blood platelets) or
  • Blood clots, history of or
  • Electrolyte imbalance (e.g., low potassium or magnesium in the blood) or
  • Heart rhythm problems (e.g., QT prolongation)—Vorinostat may worsen any of these conditions .
  • Diabetes—This medicine may cause your blood sugar levels to rise .
  • Kidney disease or
  • Liver disease—Use with caution if you have these conditions .
  • Stomach or bowel problems (e.g., severe diarrhea, nausea, or vomiting)—Should be treated first before using this medicine .

Description

Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL), a type of cancer that affects certain white blood cells and causes lesions to develop on the skin. It works by interfering with the growth of the cancerous cells, which are eventually destroyed .

Before you begin treatment with vorinostat, you and your doctor should talk about the good this medicine will do as well as the risks of using it .

This medicine is available only with your doctor’s prescription .