(NA bi lone)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cesamet: 1 mg [contains fd&c blue #2 (indigotine)]
Brand Names: U.S.
Antiemetic activity may be due to effect on cannabinoid receptors (CB1) within the central nervous system.
Rapid and complete
Extensively metabolized to several active metabolites by oxidation and stereospecific enzyme reduction; CYP450 enzymes may also be involved
Feces (~60%); renal (~24%)
Time to Peak
Serum: Within 2 hours
Parent compound: ~2 hours; Metabolites: ~35 hours
Use: Labeled Indications
Treatment of refractory nausea and vomiting associated with cancer chemotherapy
Hypersensitivity to nabilone, other cannabinoids, or any component of the formulation
Nausea and vomiting associated with cancer chemotherapy: Oral: 1-2 mg twice daily (maximum: 6 mg divided in 3 doses daily); begin with the lower dose in the range and increase if needed. May administer 2 or 3 times per day during the entire chemotherapy course; continue for up to 48 hours after the last chemotherapy dose. A dose of 1-2 mg the night before chemotherapy may also be of benefit.
Refer to adult dosing. Use the lower end of the dosing range (to minimize adverse events).
Nausea and vomiting associated with cancer chemotherapy (off-label use; Dupuis, 2003): Oral: Children >4 years:
<18 kg: 0.5 mg every 12 hours
18-30 kg: 1 mg every 12 hours
>30 kg: 1 mg every 8-12 hours
Dosing: Renal Impairment
No dosage adjustment provided in manufacturer’s labeling (has not been studied).
Dosing: Hepatic Impairment
No dosage adjustment provided in manufacturer’s labeling (has not been studied).
Initial dose should be given 1-3 hours before chemotherapy.
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
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
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
Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. 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
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
Central nervous system: Drowsiness (52% to 66%), dizziness (59%), vertigo (52% to 59%), euphoria (11% to 38%), ataxia (13% to 14%), depression (14%), concentration decreased (12%), sleep disturbance (11%)
Gastrointestinal: Xerostomia (22% to 36%)
Ocular: 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%), appetite increased (2%)
Neuromuscular & skeletal: Weakness (8%)
<1% (Limited to important or life-threatening) and frequency not reported: Abdominal pain, abnormal dreams, akathisia, allergic reaction, amblyopia, anemia, anhydrosis, anxiety, apathy, aphthous ulcer, arrhythmia, back pain, cerebral vascular accident, chest pain, chills, constipation, cough, diaphoresis, diarrhea, dyspepsia, dyspnea, dystonia, emotional disorder, emotional lability, epistaxis, equilibrium dysfunction, eye irritation, fatigue, fever, flushing, gastritis, hallucinations, hot flashes, hyperactivity, hypertension, infection, insomnia, joint pain, leukopenia, lightheadedness, malaise, memory disturbance, mood swings, mouth irritation, muscle pain, nasal congestion, neck pain, nervousness, neurosis (phobic), numbness, orthostatic hypotension, pain, palpitation, panic disorder, paranoia, paresthesia, perception disturbance, pharyngitis, photophobia, photosensitivity, polyuria, pruritus, psychosis (including toxic), pupil dilation, rash, seizure, sinus headache, speech disorder, stupor, syncope, tachycardia, taste perversion, thirst, thought disorder, tinnitus, tremor, urination decreased/increased, urinary retention, visual field defect, voice change, vomiting, wheezing, withdrawal, xerophthalmia
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.
• 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.
• Elderly: Use with caution in the elderly; may cause postural hypotension.
Blood pressure, heart rate; signs and symptoms of excessive use, abuse, or misuse
Pregnancy Risk Factor
Adverse events have been observed in animal reproduction studies.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience loss of strength and energy, fatigue, dry mouth, or insomnia. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, or illogical thinking), confusion, severe dizziness, passing out, behavioral changes, mood changes, tachycardia, hallucinations, memory impairment, change in balance, or vision changes (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about nabilone
- Other brands: Cesamet