Pronunciation:

NAB-i-lone

Brand Names:

• Cesamet
• ACT Nabilone
• APO-Nabilone
• pms-Nabilone
• RAN-Nabilone
• TEVA-Nabilone

Classifications:

Chemical—

Cannabinoid

Uses of This Medicine:

Nabilone is used to treat the nausea and vomiting that may occur during treatment with cancer medicines. It is only used when other kinds of medicine for nausea and vomiting do not work.

Nabilone is only available 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—

Studies with this medicine have only been done in adult patients, and there is no specific information comparing use of nabilone in children with use in other age groups. Caution should be used in prescribing nabilone to children under the age of 18 years due to its mind and mood-altering effects.

Older adults—

Fast or pounding heartbeat, feeling faint or lightheaded, and unusual tiredness or weakness may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of nabilone. Also, the effects this medicine may have on the mind may be of special concern in the elderly. Therefore, older people should be watched closely while taking this medicine.

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 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.

• Itraconazole

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:

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)—Dependence on nabilone may develop.

• Emotional problems or
• Heart disease or
• Low blood pressure or
• Manic or depressive states or
• Mental illness (severe) or
• Schizophrenia—Nabilone may make the condition worse.

• Kidney problems or
• Liver problems—Nabilone has not been studied in patients with these conditions.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may lead to other medical problems because of an overdose.

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 oral dosage forms (capsules):
  • For nausea and vomiting caused by cancer medicines:
    • Adults—Usually 1 or 2 milligrams (mg) twice a day. Your doctor will tell you how and when to take this medicine while you are taking your cancer medicine.
    • 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.

Precautions While Using This Medicine:

Nabilone will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you feel drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicines, including other narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

If you think you or someone else may have taken an overdose, get emergency help at once. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may cause severe mental effects. Symptoms of overdose include changes in mood; confusion; difficulty in breathing; hallucinations (seeing, hearing, or feeling things that are not there); nervousness or anxiety (severe); and fast or pounding heartbeat.

This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nabilone may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

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 as soon as possible if any of the following side effects occur:

Changes in mood

confusion

convulsions (seizures)

delusions

dizziness or fainting

fast or pounding heartbeat

hallucinations (seeing, hearing, or feeling things that are not there)

mental depression

nervousness or anxiety

unusual tiredness or weakness (severe)

Symptoms of overdose

Difficulty in breathing

hallucinations (seeing, hearing, or feeling things that are not there)

mental changes (severe)

nervousness or anxiety (severe)

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

Clumsiness or unsteadiness

drowsiness

dryness of mouth

false sense of well-being

headache

Less common or rare

Blurred vision or any changes in vision

dizziness or lightheadedness, especially when getting up from a lying or sitting position—more common with high doses

loss of appetite

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.