Zolinza

The recommended dose of Zolinza (Vorinostat) is 400 mg once daily with food. Your doctor may decrease your dose if you experience severe side effects. You should drink at least 2 litres of fluid a day while taking Zolinza (Vorinostat) to prevent dehydration. Swallow the capsules whole. Do not open or crush the capsules. Contact of the powder in the capsules with the skin or mucous membranes (e.g., mouth, nose) should be avoided. If contact does occur, wash the area thoroughly.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Zolinza (Vorinostat) be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Zolinza (Vorinostat) at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may decrease your appetite; it may cause diarrhea; it may cause unusual tiredness; it may alter your sense of taste; it may cause nausea and vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each white, opaque, hard gelatin capsule with "568" over "100 mg" printed within radial bar in black ink on the capsule body, contains Zolinza (Vorinostat) 100 mg. Nonmedicinal ingredients: magnesium stearate, microcrystalline cellulose, and sodium croscarmellose; capsule shell: gelatin, titanium dioxide, and may contain sodium lauryl sulfate.

Zolinza (Vorinostat) should not be taken by anyone who:

• is allergic to Zolinza (Vorinostat) or to any of the ingredients of the medication
• has severely reduced liver function

There may be an interaction between Zolinza (Vorinostat) and any of the following:

• Amiodarone
• Amitriptyline
• amphoteracin B
• chloroquine
• Chlorpromazine
• clarithromycin
• Dexamethasone
• Disopyramide
• Dolasetron
• Domperidone
• Doxorubicin
• droperidol
• enemas
• Epirubicin
• erythromycin
• Flecainide
• fluconazole
• Fluoxetine
• formoterol
• Furosemide
• Haloperidol
• Hydrochlorothiazide
• ibutilide
• Imipramine
• ketoconazole
• Lapatinib

• laxatives, (e.g., milk of Magnesia, Bisacodyl)
• levofloxacin
• Maprotiline
• Methadone
• moxifloxacin
• Nilotinib
• Ondansetron
• pentamidine
• Pimozide
• Prednisone
• procainamide
• Propafenone
• quinidine
• quinine
• salbutamol
• Sotalol
• Sunitinib
• Tacrolimus
• telithromycin
• Tetrabenazine
• Valproic acid
• Venlafaxine
• Voriconazole
• Warfarin
• Ziprasidone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Zolinza (Vorinostat). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Zolinza (Vorinostat).

Blood Clots: Zolinza (Vorinostat) can increase your risk of getting a blood clot in the legs, arms, or lungs. People who have had a blood clot in the past should discuss with their doctor how Zolinza (Vorinostat) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Zolinza (Vorinostat), and whether any special monitoring is needed. If you experience symptoms of a blood clot in the leg or arm (pain, redness, warmth, swelling), or in the lungs (chest pain, shortness of breath), get immediate medical attention.

Blood effects: Zolinza (Vorinostat) can decrease platelets (help with blood clotting) and reduce red blood cells. Your doctor will monitor for these with blood tests. If you experience unusual bleeding or bruising, shortness of breath, tiredness, or paleness while taking Zolinza (Vorinostat), contact your doctor immediately.

Blood sugar: Zolinza (Vorinostat) can cause high blood sugar levels (hyperglycemia). Your doctor will monitor your blood sugar levels closely while you are receiving Zolinza (Vorinostat). People with Diabetes should report any changes in their blood sugar control to their doctor immediately. Your doctor may suggest dietary and medication changes or may reduce your dose of Zolinza (Vorinostat) to help keep your blood sugar levels controlled.

Dehydration: Zolinza (Vorinostat) can cause dehydration (too much water loss from your body). In order to prevent this, you should drink at least 2 litres of fluids a day while you are taking Zolinza (Vorinostat). If you experience severe nausea, vomiting, and diarrhea while taking Zolinza (Vorinostat), contact your doctor. These side effects can lead to dehydration.

Dizziness and fainting: Zolinza (Vorinostat) can cause dizziness or fainting. Do not drive or operate machinery if you experience these side effects and until you know you can perform these activities safely.

Heart effects: Zolinza (Vorinostat) can have an effect on the electrical activity of the heart called QT prolongation. This can lead to a serious abnormal heart rhythm, which can be fatal. People who are at an increased risk of experiencing abnormal heart rhythms (e.g., women, people 65 years of age and older, people with heart disease, a family history of sudden death, abnormal heart rhythms, congenital long QT syndromes, strokes, Eating Disorders, diabetes, low blood levels of potassium, magnesium, or calcium) should discuss with their doctor how Zolinza (Vorinostat) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Zolinza (Vorinostat), and whether any special monitoring is needed. Your doctor may check your heart rhythm with an ECG (electrocardiogram) to check for the effects of Zolinza (Vorinostat) on your heart.

If you experience symptoms of an abnormal heart rhythm (e.g., dizziness, fainting seizures, pounding or irregular heartbeat) while taking Zolinza (Vorinostat), get immediate medical attention.

Heart rate: Zolinza (Vorinostat) can increase your heart rate. People with heart disease or fast heartbeats should discuss with their doctor how Zolinza (Vorinostat) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Zolinza (Vorinostat), and whether any special monitoring is needed.

Kidney: People with reduced kidney function should discuss with their doctor how Zolinza (Vorinostat) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Zolinza (Vorinostat), and whether any special monitoring is needed.

Liver problems: People with liver problems should discuss with their doctor how Zolinza (Vorinostat) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Zolinza (Vorinostat), and whether any special monitoring is needed. People with severely reduced liver function should not take Zolinza (Vorinostat).

Pregnancy: Women taking Zolinza (Vorinostat) should avoid becoming pregnant. Zolinza (Vorinostat) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Zolinza (Vorinostat), contact your doctor immediately.

Breast-feeding: It is not known if Zolinza (Vorinostat) passes into breast milk. Women taking Zolinza (Vorinostat) should not breast-feed.

Children: The safety and effectiveness of using Zolinza (Vorinostat) have not been established for children.

To fully benefit from the effect of this medication, and to limit any adverse reactions, make sure that the health care facility overseeing your treatment has provided you with all the information needed to properly administer this drug. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. The capsule of this medication should not be opened, crushed or chewed. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication is more effective if taken with food. Always take it with a meal or a snack. It is recommended to drink plenty of water while using this medication.