Zolinza

Dosage Forms & Strengths

capsule

• 100mg

Cutaneous T-cell Lymphoma

Indicated for treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent, or recurrent disease during or following 2 systemic therapies

400 mg PO qDay

May reduce to 300 mg qDay, and then to 300 mg qDay for 5 days/wk if intolerant

Monitor: CBC, electrolytes, serum glucose and creatinine q2week during first 2 months and monthly thereafter

Dosage Modifications

Hepatic impairment

• Mild/moderate (Child-Pugh A or B): Use with caution
• Severe (Child-Pugh C): Contraindicated

Multiple Myeloma (Orphan)

Orphan designation for treatment of multiple myeloma

Sponsor

• Merck Research Laboratories; Merck & Co Inc; PO Box 2000, RY 33-212; Rahway, NJ 07065-0900

Melanoma (Orphan)

Orphan designation for treatment of advanced melanoma (stages IIb, IIc, III, and IV)

Sponsor

• Qameleon Therapeutics; Moslaan 32, 1433 WJ; Kudelstaart, Netherlands

Safety and efficacy not established

No information provided. Please refer to the WARNINGS AND PRECAUTIONS section.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Zolinza is a prescription medication used to treat a type of cancer called cutaneous T-cell lymphoma (CTCL) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. 

Zolinza belongs to a group of drugs called histone deacetylase (HDAC) inhibitors. These work by killing or stopping the growth of cancer cells.

This medication comes in capsule form. It is usually taken by mouth once daily, with food.

Common side effects include fatigue, diarrhea, and nausea.

Zolinza is part of the drug class:

• OTHER ANTINEOPLASTIC AGENTS

Common side effects with Zolinza include:

• stomach and intestinal problems, including diarrhea, nausea, vomiting, loss of appetite, constipation and weight loss
• tiredness
• dizziness
• headache
• changes in the way things taste and dry mouth
• nuscle aches
• hair loss
• chills
• fever
• upper respiratory infection
• cough
• increase in blood creatinine
• wwelling in the foot, ankle, and leg
• itching

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

In the U.S.

• Zolinza

Available Dosage Forms:

• Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Histone Deacetylase Inhibitor

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.

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.

Zolinza® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.

Dosing Information

The recommended dose is 400 mg orally once daily with food.

Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.

Zolinza capsules should not be opened or crushed [see How Supplied/Storage and Handling (16)].

Dose Modifications

If a patient is intolerant to therapy, the dose may be reduced to 300 mg orally once daily with food. The dose may be further reduced to 300 mg once daily with food for 5 consecutive days each week, as necessary.

Hepatic Impairment

Reduce the starting dose to 300 mg orally once daily with food in patients with mild to moderate hepatic impairment (bilirubin 1 to 3 × ULN or AST > ULN). There is insufficient evidence to recommend a starting dose for patients with severe hepatic impairment (bilirubin > 3 × ULN) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

No specific information is available on the treatment of overdosage of Zolinza.

In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. It is not known if vorinostat is dialyzable.

Zolinza® (zo LINZ ah)
(vorinostat)
capsules

What is Zolinza?

Zolinza is a prescription medicine for a type of cancer called cutaneous T-cell lymphoma (CTCL), which is a blood cell cancer that affects your skin. Zolinza is used when your CTCL gets worse, does not go away, or comes back after you have taken other medicines.

It is not known if Zolinza is safe and effective in children.

Should I take Zolinza?

Pregnancy

• If you are pregnant or trying to get pregnant, tell your doctor right away. You might need to stop taking Zolinza.
• Zolinza has not been studied in pregnant women. It can hurt your baby while you are pregnant.

Breastfeeding

• We do not know if Zolinza can pass into breast milk.
• If you are breastfeeding talk to your doctor about what you should do. You may need to stop breastfeeding.

Diabetes

• If you are taking Zolinza and have high blood sugar (hyperglycemia) or diabetes, your doctor may need to change your diet or diabetes medicine to help control your blood sugar.
• Check your blood sugar as often as
your doctor tells you to.
• If your blood sugar is higher than normal, call your doctor.
• If you cannot eat or drink like you usually do because you feel sick, vomit, or have diarrhea, call your doctor.

If you have any of these conditions, tell your doctor before taking Zolinza:

• a blood clot in your lung (called a Pulmonary Embolus or PE)
• a blood clot in a vein or blood vessel (called Deep Vein Thrombosis or DVT)
• high blood sugar (hyperglycemia) or diabetes
• liver disease
• nausea, vomiting or diarrhea
• any allergies

Are you taking other medicines?

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Other medicines can affect the way Zolinza works.

Your doctor may want to do blood tests more often if you take:

• valproic acid, a medicine for seizures
• a blood thinner, like Coumadin® (warfarin)

How do I take Zolinza?

• Take Zolinza exactly as prescribed by your doctor.
• Your doctor will tell you how many capsules to take, and when to take them.
• Take with food.
• Drink 8 glasses of water every day (at least 8 ounces each). This will help to keep you hydrated, especially if you have nausea, vomiting or diarrhea.
• Do not chew or break open the capsule. If you break open or crush a capsule, do not touch the capsule or powder. If the powder gets on your skin or in your eyes, wash your skin or eyes with lots of water right away. Then, call your doctor.
• If you cannot swallow the capsule, tell your doctor. You may need a different medicine.

What if I forget to take Zolinza?

• If you miss a dose, take it as soon as you remember. If you do not remember until it is almost time for your next dose, just skip the missed dose and take the next dose at your regular time. Do not take two doses of Zolinza at the same time.
• If you are not sure what to do, call your doctor.
• If you take more than your prescribed dose, call your doctor, poison center, or emergency room right away.

Zolinza may cause serious side effects

If you have any of the following signs or symptoms, tell your doctor right away.

Signs of a blood clot in your legs- Deep Vein Thrombosis or DVT

Signs of a blood clot in your lungs- Pulmonary Embolus or PE

Signs of losing too much fluid from your body- dehydration

You can become dehydrated if you cannot eat or drink like you usually do. This can happen when you feel sick, vomit, or have diarrhea. Call your doctor if you get any of these signs or symptoms:

Changes in your blood

Your doctor will check your blood during treatment with Zolinza. Here is a list of some side effects that may mean you have a change in your blood:

Common side effects of Zolinza

There may be other side effects to Zolinza that are not listed. For information, ask your doctor or pharmacist. 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 Zolinza?

• Do not let your medicine get really cold or really hot. Keep it at room temperature.
• Keep Zolinza and all medicines out of the reach of children.

More information about Zolinza

• Medicines are sometimes prescribed for purposes other than those listed in the patient information. Do not use Zolinza for a condition for which it was not prescribed. Do not give Zolinza to other people, even if they have the same condition. It may harm them.
• This Patient Information summarizes the most important information about Zolinza. If you would like more information, talk with your doctor or pharmacist. You can ask them for information about Zolinza that was written for healthcare professionals. For more information, call Merck, the company that makes Zolinza, at 1-800-622-4477.

What are the ingredients in Zolinza?

The active ingredient is: vorinostat

The inactive ingredients are: microcrystalline cellulose, sodium croscarmellose, magnesium stearate, titanium dioxide, gelatin, and sodium lauryl sulfate.

Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by: Patheon, Inc., Mississauga, Ontario, Canada L5N 7K9
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 12/2015
For patent information: www.merck.com/product/patent/home.html
Copyright © 2006, 2009, 2011, 2013, 2015 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
usppi-mk0683-c-1512r007

PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label

NDC 0006-0568-40

Zolinza®
(vorinostat) capsules

100 mg

Direct contact of the powder in Zolinza
capsules with the skin or mucous
membranes should be avoided.
(See Package Insert.)

Rx only

120 Capsules

568
100 mg