Version October 2024
Dosage guidance:
Dosage form information: Product only available in Canada.
Chemotherapy-induced nausea and vomiting (CINV), prevention: Note: Nabilone is not recommended for prevention of CINV in the most current clinical practice guidelines due to lack of proven efficacy and safety (Ref); poor symptom control was also reported in a retrospective review of pediatric patients (n=110; median age: 14 years [range: 1.1 to 18 years]) receiving prophylaxis for acute CINV where 52.3% of patients achieved complete control; rate is similar to that reported previously with 5HT3 monotherapy (Ref):
Children ≥3 years and Adolescents: Very limited data available, efficacy results variable (Ref): Oral:
<18 kg: 0.5 mg twice daily.
18 to 30 kg: 1 mg twice daily.
>30 kg: 1 mg 3 times daily.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
(For additional information see "Nabilone (United States: Not available): Drug information")
Chemotherapy-associated nausea and vomiting, severe: Note: Nabilone may be offered for refractory or breakthrough nausea and vomiting (which occurs despite optimal prophylaxis) in patients who have already received a trial of olanzapine (Ref).
Oral: Initial: 1 to 2 mg twice daily; begin with the lower dose in the range and adjust dose based on response and/or tolerance; begin the evening prior to chemotherapy, then administer the second dose 1 to 3 hours before chemotherapy; continue for up to 24 hours after the last chemotherapy dose. Maximum: 6 mg/day divided in 3 doses.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with extreme caution in patients with severe impairment.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Gastrointestinal: Xerostomia (22%)
Nervous system: Abnormal sensory symptoms (12%), ataxia (13%), depression (14%), drowsiness (66%), mood elevation (psychological high: 39%), vertigo (59%)
Ophthalmic: Blurred vision (13%)
1% to 10%:
Cardiovascular: Orthostatic hypotension (5%)
Gastrointestinal: Anorexia (8%)
Nervous system: Asthenia (8%), euphoria (4%), hallucination (2%), headache (7%)
<1%:
Cardiovascular: Syncope, tachycardia
Nervous system: Altered time perception, confusion, dissociative reaction, dysphoria, nightmares, psychotic reaction, seizure, tremor
Postmarketing:
Cardiovascular: Chest pain, hypotension
Gastrointestinal: Constipation, nausea, oral paresthesia, vomiting
Hematologic & oncologic: Leukopenia
Hypersensitivity: Facial edema
Nervous system: Anxiety, ataxia, central nervous system depression, central nervous system stimulation, changes in thinking, depersonalization, dizziness, emotional lability, insomnia, psychosis, stupor
Ophthalmic: Visual disturbance
Hypersensitivity to nabilone, marijuana, other cannabinoids, or any component of the formulation; history of psychotic reactions.
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 that require mental alertness (eg, operating machinery, driving). Dizziness, drowsiness, ataxia, depression, hallucinations, and psychosis have been reported; psychiatric adverse reactions may persist for up to 3 days after discontinuing treatment. Use with extreme caution in persons with a history of nonpsychotic emotional disorders.
Disease-related concerns:
• Hepatic impairment: Use with extreme caution in patients with severe liver impairment.
Concurrent drug therapy issues:
• CNS depressants: Effects may be potentiated when used with other psychoactive drugs, sedatives, hypnotics, and/or ethanol.
Special populations:
• Older adult: Use with caution in older adult patients; may cause postural hypotension and elevate heart rate (standing and supine).
Not available in the United States.
Capsules (Cesamet Oral)
1 mg (per each): $47.04
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Cesamet: 0.25 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), quinoline yellow (d&c yellow #10)]
Cesamet: 0.5 mg [contains fd&c red #40 (allura red ac dye), quinoline yellow (d&c yellow #10)]
Cesamet: 1 mg [contains fd&c blue #2 (indigotine,indigo carmine)]
Generic: 0.25 mg, 0.5 mg, 1 mg
CDSA II
Oral: In pediatric trials, initial dose given 8 to 12 hours prior to chemotherapy, followed by scheduled dosing 2 or 3 times daily (based on weight) (Ref). One small study (n=22; ages: 8 months to 17 years) described opening capsules and dividing the powder if necessary to obtain the correct dose (Ref).
Oral: The initial dose should be administered the night before chemotherapy and the second dose should be administered 1 to 3 hours before chemotherapy.
Store at 15°C to 30°C (59°F to 86°F).
Canadian labeling: Treatment of refractory nausea and vomiting associated with cancer chemotherapy in adults.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Agents with Clinically Relevant Anticholinergic Effects: May enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Alcohol (Ethyl): Nabilone may enhance the CNS depressant effect of Alcohol (Ethyl). Risk X: Avoid combination
Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification
Arginine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination
CNS Depressants: Nabilone may enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Cocaine (Topical): May enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy
Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Levodopa-Foslevodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Foslevodopa. Risk C: Monitor therapy
Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: 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. Risk D: Consider therapy modification
Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Silodosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Sympathomimetics: Cannabinoid-Containing Products may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Warfarin: Cannabinoid-Containing Products may increase the serum concentration of Warfarin. Risk C: Monitor therapy
Adverse events have been observed in animal reproduction studies.
Nabilone is a synthetic delta-9-tetrahydrocannabinol (delta-9-THC); THC crosses the placenta (NAP 2017).
Blood pressure, heart rate; signs and symptoms of excessive use, abuse, or misuse.
Nabilone is a synthetic cannabinoid with antiemetic properties. Antiemetic activity may be due to effect on cannabinoid receptors (CB1) within the central nervous system.
Absorption: Rapid and complete.
Metabolism: Extensively metabolized to several active metabolites by oxidation and stereospecific enzyme reduction; CYP450 enzymes may also be involved.
Half-life elimination: Parent compound: ~2 hours; Metabolites: ~35 hours.
Time to peak, serum: Within 2 hours.
Excretion: Feces (~60%); renal (~24%).
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