Depocyt (Intrathecal)

Liposomal cytarabine is part of a group of medicines called antineoplastics. It is used to treat cancer in the lymph system that has spread to the brain.

Liposomal cytarabine works by stopping the growth of cancer cells, which are eventually killed. Because this medicine can also affect the growth of normal cells, there may be other effects. Some of these effects can be serious and should be reported to your doctor. Some effects might happen even after you have stopped treatment with liposomal cytarabine.

Before you start treatment with liposomal cytarabine, you and your doctor should discuss the benefits of this medicine as well as its risks.

Liposomal cytarabine must be given only by or under the immediate supervision of your doctor.

It is very important that your doctor checks your progress during regular visits to ensure that this medicine is working correctly and to look for unwanted effects.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This is a choice you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have only been done in adults, and there is no specific information about using liposomal cytarabine in children compared to other age groups.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known if they work the same way in older people as they do in younger adults or if they cause different side effects or problems. There is no specific information about using liposomal cytarabine in the elderly compared to other age groups.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

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

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cedazuridine
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Active meningitis—Use is not recommended

• Blockage to cerebrospinal fluid flow—Increased risk of neurotoxicity

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Back pain
• fever
• headache
• nausea
• neck pain or stiffness
• sleepiness
• vomiting
• weakness

Less common

• Black, tarry stools
• blood in urine or stools
• chills
• cough or hoarseness
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on skin
• sore throat
• swelling of fingers, hands, arms, lower legs, or feet
• unusual bleeding or bruising

Rare

• Fast or irregular breathing
• puffiness or swelling around the face
• shortness of breath
• sudden, severe drop in blood pressure
• unusual tiredness

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:

Less common

• Constipation
• urinary incontinence

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.

In the U.S.

• Depocyt

Pharmacologic Class: Antimetabolite

This medicine often 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 health care professional for ways to lessen these effects.

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.