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Vorinostat (Oral route)

Pronunciation:

vor-IN-oh-stat

Brand Names:

  • Zolinza

Dosage Forms:

  • Capsule

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Histone Deacetylase Inhibitor

Uses of This Medicine:

Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL). CTCL is a type of cancer that affects certain white blood cells and causes lesions to develop on the skin.

Vorinostat interferes with the growth of the cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected by vorinostat, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor. Some unwanted effects may not be serious but may cause concern. Some of the unwanted effects do not occur until months or years after the medicine is used.

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

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of vorinostat in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vorinostat in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies 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.

Breast-feeding—

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.

Other medicines—

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Piperaquine

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.

  • Crizotinib
  • Fluoxetine
  • Ivabradine
  • Ondansetron
  • Pazopanib
  • Quetiapine
  • Valproic Acid
  • Vemurafenib
  • Vinflunine

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
  • Blood clots, history of or
  • Electrolyte imbalance (e.g., low potassium or magnesium in the blood) or
  • Kidney disease or
  • Liver disease, mild to moderate or
  • Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.
  • Diabetes or
  • Hyperglycemia (high blood sugar)—This medicine may cause your blood sugar levels to rise.
  • Liver disease, severe—Should not be used in patients with this condition.
  • Stomach or bowel problems (e.g., severe diarrhea, nausea, or vomiting)—Should be treated first before using this medicine.

Proper Use of This Medicine:

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.

Swallow the capsule whole. Do not open, crush, break, or chew it. Take this medicine with food.

Be careful not to handle crushed or opened capsules. If you have contact with the powder in the capsules, wash your skin with soap and water right away.

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.

This medicine comes with a patient insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

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. 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.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using This Medicine:

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

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 your 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 the 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.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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 the face, arms, hands, lower legs, or feet
blood in the 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 the face, eyelids, lips, tongue, throat, hands, legs, feet, or 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 the face, arms, or legs
numbness or tingling in the hands, feet, or lips
pain, redness, or swelling in the arm or leg
painful or difficult urination
pale skin
pinpoint red spots on the skin
rapid weight gain
runny nose
shortness of breath
sore throat
sores, ulcers, or white spots on the lips or in the 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 the arms, jaw, back, or neck
rapid, shallow breathing
severe nausea or vomiting
sneezing
stomach pain
sweating
tightness in the 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 or thinning of the 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.


Last Updated: 4/4/2014

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