Prevention of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic therapy.
ASCO does not consider cannabinoids (e.g., nabilone, dronabinol) appropriate first-line antiemetics for any group of patients receiving chemotherapy of high emetic risk and states that these drugs should be reserved for patients unable to tolerate or refractory to first-line agents (i.e., a type 3 serotonin [5-HT3] receptor antagonist [e.g., dolasetron, granisetron, ondansetron, palonosetron] with dexamethasone and aprepitant).
Dosage and Administration
Administration
Oral Administration
Administer orally without regard to meals. Has been administered IV; however, a parenteral preparation is not commercially available in the US.
Dosage
Adults
Cancer Chemotherapy-induced Nausea and Vomiting
Oral
Usual dose: 1 or 2 mg twice daily; administer initial dose 1–3 hours before chemotherapy. May be administered 2 or 3 times daily during the entire chemotherapy cycle and for 48 hours after the last dose of chemotherapy in each cycle.
Initiate with the lower dosage (i.e., 1 mg twice daily) to minimize adverse effects, then increase dosage as necessary up to a maximum of 2 mg 3 times daily.
May administer a dose of 1 or 2 mg the night prior to chemotherapy.
Prescribing Limits
Adults
Cancer Chemotherapy-induced Nausea and Vomiting
Oral
Maximum: 2 mg 3 times daily.
Special Populations
Hepatic Impairment
No specific dosage recommendations at this time.
Renal Impairment
No specific dosage recommendations at this time.
Geriatric Patients
Select dosage with caution, usually initiating at the lower end of the recommended dosage range because of possible age-related decreases in hepatic, renal, and/or cardiac function; concomitant diseases and drug therapy; and possible increased sensitivity to adverse effects. (See Geriatric Use under Cautions.)
Effects of nabilone may persist for a variable and unpredictable period of time following oral administration.
CNS Effects
CNS effects, including dizziness, drowsiness or sedation, euphoria (i.e., “high”), ataxia, anxiety, disorientation, depression, hallucinations, and psychosis, reported. Adverse psychiatric reactions can persist for 48–72 hours following discontinuance of nabilone.
Individual response and tolerance may vary; a responsible adult should supervise patients, particularly during initial therapy and during dosage adjustments.
Cardiovascular Effects
May cause tachycardia and orthostatic hypotension. Elevations in supine and standing heart rates also reported.
Individual response and tolerance may vary; a responsible adult should supervise patients, particularly during initial therapy and during dosage adjustments. Carefully evaluate the potential risks and benefits of the drug; use with caution in geriatric patients and in patients with hypertension and/or cardiovascular disease. (See Geriatric Use under Cautions.)
General Precautions
Psychiatric Disorders
Use with caution in patients with current or history of psychiatric disorders (e.g., bipolar disorder, depression, schizophrenia); cannabinoid use may unmask the symptoms of these diseases.
Abuse Potential
Marijuana contains an active compound similar to nabilone. Use nabilone with caution in patients with history of substance abuse, including alcohol abuse or dependence and marijuana use. Increased risk of substance abuse in patients with personal or family history of substance abuse or mental illness. Monitor patients receiving nabilone for signs of excessive use, abuse, and misuse.
High potential for abuse. Limit prescriptions to quantity necessary for a single cycle of chemotherapy (i.e., a few days); not intended for use on an as-needed basis or as the initial prescribed antiemetic therapy.
Specific Populations
Pregnancy
Category C.
Lactation
Not known whether nabilone is distributed into milk. Avoid use in nursing women.
Pediatric Use
Safety and effectiveness not established. Caution is advised because of psychoactive effects.
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults. Use with caution because of increased sensitivity to psychoactive effects and risk of elevated supine and standing heart rates and postural hypotension.
Hepatic Impairment
Not studied in patients with hepatic impairment.
Renal Impairment
Not studied in patients with renal impairment.
Common Adverse Effects
Adverse effects may be similar to those of marijuana (cannabis) and other cannabinoids.
Media Gallery
Drug Info Tools
