Nabilone

Contraindications

Hypersensitivity to cannabinoids

History of psychotic reactions

Cautions

Severe liver impairment

Give only to patients in whom conventional antiemetics have failed

Emotionally disturbed patients (non-psychotic)

Concomitant use of alcohol or other psychoactive substances can potentiate psychotropic effects

May cause tachycardia and orthostatic hypotension

May impair ability to drive or perform hazardous tasks

Nabilone is part of the drug class:

• Other antiemetics

Serious side effects have been reported with nabilone. See the “Nabilone Precautions” section.

Common side effects of nabilone include the following:

• drowsiness
• vertigo (a sensation of motion or spinning that is often described as dizziness)
• dry mouth
• euphoria (feeling “high”)
• failure of muscle control in their arms and legs,
• headache
• concentration difficulties

This is not a complete list of nabilone 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

• Risk of additive or synergistic CNS depression during concurrent use with alcohol or other CNS depressants, including benzodiazepines and barbiturates.1 2 Importance of avoiding alcohol and other CNS depressants during nabilone therapy.1 2

• Importance of avoiding driving, operating machinery, or performing hazardous tasks during nabilone therapy.1 2

• Importance of informing patients about possible changes in mood and other adverse behavioral effects of nabilone to avoid panic if such manifestations occur.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1

• Importance of informing patients that they should remain under the supervision of a responsible adult during therapy.1 2

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 2 (See Cautions.)

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Treatment of refractory nausea and vomiting associated with cancer chemotherapy

No dosage adjustment provided in manufacturer’s labeling (has not been studied).

Store at 25°C (77°F); excursion permitted to 15°C and 30°C (59°F and 86°F).

Alcohol (Ethyl): Nabilone may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Anticholinergic Agents: May enhance the tachycardic effect of Cannabinoid-Containing Products. Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

CNS Depressants: Nabilone may enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Cocaine: May enhance the tachycardic effect of Cannabinoid-Containing Products. Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Sympathomimetics: Cannabinoid-Containing Products may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Concerns related to adverse effects:

• Cardiovascular effects: May cause tachycardia and/or orthostatic hypotension; use with caution in patients with cardiovascular disease.

• CNS effects: May impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Dizziness, drowsiness, ataxia, depression, hallucinations, and psychosis have been reported. Use with caution in patients with mania, depression, or schizophrenia; cannabinoid use may reveal symptoms of psychiatric disorders. Careful psychiatric monitoring is recommended; psychiatric adverse reactions may persist for up to 3 days after discontinuing treatment.

Disease-related concerns:

• Substance abuse: Use with caution in patients with a history of substance abuse; potential for dependency exists. Tolerance, psychological and physical dependence may occur with prolonged use.

Concurrent drug therapy issues:

• CNS depressants: Effects may be potentiated when used with other psychoactive drugs, sedatives and/or ethanol.

Special populations:

• Elderly: Use with caution in the elderly; may cause postural hypotension.

Blood pressure, heart rate; signs and symptoms of excessive use, abuse, or misuse

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

General:
-Prescriptions for this drug should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days).
-Cross-tolerance between this drug and delta-9-THC (marijuana) has been demonstrated in animal studies.
-Overdosage: Activated charcoal is often more effective than emesis or lavage in decreasing absorption of drugs from the GI tract; consider charcoal instead of or in addition to gastric emptying and protect the patient's airway during this process. General supportive care and monitoring of vital signs is also recommended. The use of forced diuresis, peritoneal dialysis, hemodialysis, charcoal hemoperfusion, and cholestyramine has not been reported.
-The estimated oral median lethal dose in female mice: between 1,000 to 2,000 mg/kg; in the female rat: greater than 2,000 mg/kg.