Details for: ZOLINZA
Company: MERCK CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02327619 | ZOLINZA | VORINOSTAT | 100 MG | CAPSULE | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
ZOLINZA® is used for the treatment of a type of cancer called cutaneous T-cell lymphoma in patients who have progressive, persistent, or recurrent disease after previous systemic therapies. It is also called CTCL.
What is Cutaneous T-cell lymphoma
Cutaneous T-cell lymphoma (CTCL) is a disease in which certain cells of the lymph system develop into cancer cells and affect your skin. The cells are called T-cells. They are the white blood cells which help to fight infection. CTCL usually develops slowly. Patches can first form on the skin and may develop into tumors in the skin. The cancer can continue to spread to large areas of the skin and to other organs of the body.
What it does
ZOLINZA® is a new type of anti-cancer medicine known as an HDAC inhibitor. The full name for HDAC is histone deacetylase. ZOLINZA® has been shown to slow or stop the growth of cancer cells. It has also been shown to cause the death of cancer cells.
When it should not be used
Do not take ZOLINZA® if you:
- are allergic to any of the ingredients in ZOLINZA®
- have severe liver disease
What the medicinal ingredient is
vorinostat
What the non-medicinal ingredients are
magnesium stearate, microcrystalline cellulose and sodium croscarmellose. The capsule shell excipients are gelatin, titanium dioxide and may contain sodium lauryl sulfate.
What dosage form it comes in
Capsules: 100mg vorinostat
Warnings and precautions
Serious Warnings and Precautions
ZOLINZA® should be prescribed and managed by a doctor experienced with the use of cancer drugs and with treatment of cutaneous T-cell lymphoma.
The following are serious side effects:
- blood clots (venous thromboembolism), cases of death have been reported
- reduced red blood cells (anemia) and platelets (thrombocytopenia)
BEFORE you use ZOLINZA® talk to your doctor or pharmacist if you:
- have any medical problems
- have diabetes, especially with associated nerve disorders
- have any allergies
- have had a blood clot in your lung (pulmonary embolus)
- have had a blood clot in a vein (a blood vessel) anywhere in your body (deep vein thrombosis)
- are pregnant or planning to become pregnant. ZOLINZA® may harm your unborn baby
- are breast-feeding or plan to breast-feed. It is not known if ZOLINZA® passes into breast milk. You should stop breast-feeding once you start treatment with ZOLINZA®
- have liver disease
- have QT/QTc prolongation or a family history of QT/QTc prolongation
- have heart disease
- have a personal history of fainting spells
- have a family history of sudden cardiac death at <50 years
- have electrolyte disturbances (e.g., low blood potassium or magnesium levels) or conditions that could lead to electrolyte disturbances (e.g., vomiting, diarrhea, dehydration)
- have an eating disorder or are following a strict diet
- have had recent bowel surgery or plan on having bowel surgery
ZOLINZA® has not been studied in children under 18 years of age.
ZOLINZA® may have an effect on the electrical activity of the heart known as QT/QTc prolongation. This effect can be measured as a change in the electrocardiogram (ECG). In very rare cases, drugs with this effect on the ECG can lead to disturbances in heart rhythm (arrhythmias/dysrhythmias) that could result in dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting or death. These heart rhythm disturbances are more likely in patients with risk factors, such as heart disease, or in the presence of certain interacting drugs. In general, females and people more than 65 years in age are at higher risk. It is important to follow the instructions of your doctor with regard to dosing or any special tests. If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting, or seizures, you should seek immediate medical attention.
Electrocardiograms (ECGs) may be required periodically to monitor the risk of potentially serious side effects during treatment with ZOLINZA®.
Dizziness and fainting have been reported in patients receiving ZOLINZA®, which may affect your ability to drive or operate machinery.
Interactions with this medication
Tell your doctor or pharmacist all the medicines you are taking or planning to take, including medicines you can buy without prescription, vitamins, herbal and alternative products, especially the following medicines:
- other histone deacetylase (HDAC) inhibitors (e.g. valproic acid, divalproex, medicines used to treat seizures and mood disorders). Other HDAC inhibitors should not be taken with ZOLINZA®
- warfarin (Coumadin®) or any other blood thinner. Frequent blood tests may be required while you are taking ZOLINZA®
- drugs to treat heart rhythm disturbances
- painkillers
- antipsychotics
- antidepressants
- drugs used to treat infections (e.g., antibiotics and antifungals)
- drugs to prevent or treat nausea and vomiting
- drugs for asthma
- diuretics
- other cancer drugs.
This list includes some, but not all, of the drugs that may increase the risk of heart rhythm problems and other side effects while receiving ZOLINZA®. You should check with your doctor or pharmacist before taking any other medication with ZOLINZA®.
Proper use of this medication
If ZOLINZA® capsules are broken or crushed, do not touch the capsules or the contents of the capsules. If the contents of a broken capsule get on the skin or in the eyes, wash thoroughly.
Usual Dose
- Take ZOLINZA® exactly as prescribed by your doctor. The
recommended dose of ZOLINZA® is 400 mg once a day.
- Take all 4 capsules (100 mg each) by mouth once a day.
- Swallow each capsule whole. Do not chew or break open the capsule.
- Take ZOLINZA® after a meal.
- Drink at least 8 glasses (8X250mL) of liquid every day to reduce the chances of dehydration.
- Continue to take ZOLINZA® as long as your doctor prescribes it.
A lower dose may be recommended by your doctor based on your individual treatment needs (for example, if you have liver disease).
Overdose
Do not take more than the prescribed dosage of ZOLINZA®. If you take more than the prescribed dosage, call your doctor, local emergency room, or poison control center right away.
Missed Dose
If you miss a dose, take it as soon as you remember. If you do not remember until it is nearly time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of ZOLINZA®.
Side effects and what to do about them
The most common side effects with ZOLINZA® include:
- Stomach problems, including diarrhea, nausea, vomiting, loss of appetite, constipation, abdominal pain and weight loss.
- Low blood cell counts: Your doctor may want to do blood tests to check your blood counts.
- Low red blood cells. Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath.
- Low platelets. Low platelets can cause unusual bleeding or bruising under the skin. You should call your doctor right away if this occurs.
- Tiredness
- Changes in the way things taste and dry mouth
- Hair loss
- Chills
- Dizziness
- Difficulty in breathing
- Headache
- Increased blood creatinine
- Muscle spasms (pain and weakness)
- Proteinuria (the protein in the urine).
Tell your doctor if you develop:
- leg swelling, chest pain, or shortness of breath, which are signs of possible serious side effects.
- excessive vomiting or diarrhea.
These are not all the possible side effects of ZOLINZA®. For more information, ask your doctor or pharmacist. Talk to your doctor if you think you have side effects from taking ZOLINZA®.
If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations, fainting, or seizures, you should seek immediate medical attention.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Blood clots in the lungs (symptoms such as chest pain or shortness of breath) | ✔ | ||
| Anemia (symptoms such as feeling tired, appearing pale, and shortness of breath | ✔ | ||
| Uncommon | |||
| Fainting | ✔ | ||
| Infections of the blood (symptoms such as high fever, chills, headache, confusion, rapid breathing) | ✔ | ||
| Blood clots in the legs, arms (symptoms such as leg swelling, pain or tenderness) | ✔ | ||
| Bleeding in the digestive tract | ✔ | ||
| Stroke (symptoms such as numbness or weakness of the arms or legs, dizziness or confusion, slurred/loss of speech) | ✔ | ||
| Dehydration | ✔ | ||
| Thrombocytopenia (easy bruising and increased bleeding) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ZOLINZA®, contact your doctor or pharmacist.
How to store
Store at room temperature (15 °C – 30 °C). Do not store above 30°C (86°F).
Keep ZOLINZA® and all medicines safely away from children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full Product Monograph, prepared for
health professionals can be found at:
http://www.merck.ca
or by contacting the sponsor, Merck Canada Inc.,
at: 1-800-567-2594
This leaflet was prepared by Merck Canada Inc.
Last revised: October 18, 2013
ZOLINZA® is a Registered Trademark of Merck Sharp & Dohme Corp., a subisidary of Merck & Co., Inc. Used under license.
© 2013, 2012, Merck Canada Inc., a subsidiary of Merck & Co., Inc. All rights reserved.