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Nabilone (United States: Not available): Drug information

Nabilone (United States: Not available): Drug information
(For additional information see "Nabilone (United States: Not available): Patient drug information" and see "Nabilone (United States: Not available): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • ACT Nabilone [DSC];
  • Cesamet;
  • PMS-Nabilone;
  • RAN-Nabilone [DSC];
  • TEVA-Nabilone
Pharmacologic Category
  • Antiemetic
Dosing: Adult
Chemotherapy-associated nausea and vomiting, severe

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.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with extreme caution in patients with severe impairment.

Dosing: Older Adult

Refer to adult dosing. Use the lower end of the dosing range (to minimize adverse events).

Dosing: Pediatric

(For additional information see "Nabilone (United States: Not available): Pediatric drug information")

Note: Cesamet has been discontinued in the United States for >1 year.

Chemotherapy-induced nausea and vomiting, prevention

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.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Drowsiness (52% to 66%), dizziness (59%), vertigo (52% to 59%), euphoria (11% to 38%), ataxia (13% to 14%), depression (14%), lack of concentration (12%), sleep disorder (11%)

Gastrointestinal: Xerostomia (22% to 36%)

Ophthalmic: Visual disturbance (13%)

1% to 10%:

Cardiovascular: Hypotension (8%)

Central nervous system: Dysphoria (9%), headache (6% to 7%), sedation (3%), depersonalization (2%), disorientation (2%)

Gastrointestinal: Anorexia (8%), nausea (4%), increased appetite (2%)

Neuromuscular & skeletal: Weakness (8%)

Frequency not defined:

Cardiovascular: Cardiac arrhythmia, cerebrovascular accident, chest pain, flushing, hypertension, orthostatic hypotension, palpitations, syncope, tachycardia

Central nervous system: Abnormal dreams, akathisia, anxiety, apathy, chills, confusion, difficulty thinking, dystonia, emotional disturbance, emotional lability, equilibrium disturbance, fatigue, hallucination, hyperactivity, illusion, insomnia, malaise, memory impairment, nervousness, numbness, pain, psychoneurosis (phobic), panic disorder, paranoia, paresthesia, psychological disorder (withdrawal), psychosis (including toxic), seizure, speech disturbance, stupor, voice disorder

Dermatologic: Anhidrosis, diaphoresis, skin photosensitivity, pruritus, skin rash

Endocrine & metabolic: Hot flash, increased thirst

Gastrointestinal: Abdominal pain, aphthous stomatitis, constipation, diarrhea, dysgeusia, dyspepsia, gastritis, mouth irritation, vomiting

Genitourinary: Altered micturition (decreased/increased), urinary retention

Hematologic & oncologic: Anemia, leukopenia

Hypersensitivity: Hypersensitivity reaction

Infection: Infection

Neuromuscular & skeletal: Arthralgia, back pain, myalgia, neck pain, tremor

Ophthalmic: Amblyopia, eye irritation, mydriasis, photophobia, visual field defect, xerophthalmia

Otic: Tinnitus

Renal: Polyuria

Respiratory: Cough, dyspnea, epistaxis, nasal congestion, pharyngitis, sinus headache, wheezing

Miscellaneous: Fever

Contraindications

Hypersensitivity to nabilone, marijuana, other cannabinoids, or any component of the formulation; history of psychotic reactions.

Warnings/Precautions

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).

Product Availability

Not available in the United States.

Pricing: US

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.

Dosage Forms: Canada

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

Controlled Substance

CDSA II

Administration: Adult

Oral: The initial dose should be administered the night before chemotherapy and the second dose should be administered 1 to 3 hours before chemotherapy.

Administration: Pediatric

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).

Use: Labeled Indications

Note: Not approved in the United States.

Chemotherapy-associated nausea and vomiting, severe: Treatment of severe nausea and vomiting associated with cancer chemotherapy in patients ≥18 years of age.

Metabolism/Transport Effects

None known.

Drug Interactions

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

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

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

Pregnancy Considerations

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).

Breastfeeding Considerations

It is not known if nabilone is present in breast milk.

Nabilone is a synthetic delta-9-tetrahydrocannabinol (delta-9-THC); THC is present in breast milk (NAP 2017).

Breastfeeding is not recommended by the manufacturer.

Monitoring Parameters

BP, heart rate; monitor for neurologic/psychiatric adverse events (eg, dysphoria/euphoria, somnolence, vertigo).

Mechanism of Action

Nabilone is a synthetic cannabinoid with antiemetic properties. Antiemetic activity may be due to effect on cannabinoid receptors (CB1) within the central nervous system.

Pharmacokinetics (Adult Data Unless Noted)

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%).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Canemes;
  • (DE) Germany: Canemes;
  • (MX) Mexico: Cesamet
  1. Cesamet (nabilone) [product monograph]. Laval, Quebec, Canada: Bausch Health Canada Inc; May 2019.
  2. Chan HS, Correia JA, and MacLeod SM, “Nabilone Versus Prochlorperazine for Control of Cancer Chemotherapy-Induced Emesis in Children: A Double-Blind, Crossover Trial,” Pediatrics, 1987, 79(6):946-52. [PubMed 3035479]
  3. Dalzell AM, Bartlett H, Lilleyman JS. Nabilone: an alternative antiemetic for cancer chemotherapy. Arch Dis Child. 1986;61(5):502-505. [PubMed 3013104]
  4. Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: ASCO guideline update. J Clin Oncol. 2020;38(24):2782-2797. doi:10.1200/JCO.20.01296 [PubMed 32658626]
  5. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Health Effects of Marijuana: An Evidence Review and Research Agenda. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington (DC): National Academies Press (NAP) (US); 2017. [PubMed 28182367]
  6. Patel P, Robinson PD, Thackray J, et al. Guideline for the prevention of acute chemotherapy-induced nausea and vomiting in pediatric cancer patients: a focused update. Pediatr Blood Cancer. 2017;64(10). [PubMed 28453189]
  7. Polito S, MacDonald T, Romanick M, et al. Safety and efficacy of nabilone for acute chemotherapy-induced vomiting prophylaxis in pediatric patients: A multicenter, retrospective review. Pediatr Blood Cancer. 2018;65(12):e27374. [PubMed 30051617]
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