Cesamet Has an Established Safety and Tolerability Profile

Placebo-Controlled Studies

Active-Controlled Studies

  • In total, 183 patients treated with Cesamet were included in this analysis
    • 87% of subjects (160 of 183) experienced one or more adverse events (AEs) on study
      • 84% of subjects (153 of 183) experienced one or more drug-related AEs
      • 9% of subjects (16 of 183) experienced one or more AEs of unknown relationship to study drug

Collective Severity of AEs (N=440) Reported During Placebo-Controlled Study2

  • The most common severe AE was vertigo, experienced by 5.7% of subjects (25 patients); however, vertigo was mild or moderate in the majority of patients who reported vertigo (77 patients)

Note: Severity was assessed as mild, moderate, severe, or unspecified by the investigator, based on the investigator’s clinical judgment; relationship of AEs to study drug (either related or unknown) was determined by the investigator. AE severity by dose of study medication has not been analyzed.

AEs by Severity Reported During Placebo-Controlled Study
(n=number of AEs [% of total AEs])*2

Note: Severity was assessed as mild, moderate, severe, or unspecified by the investigator, based on the investigator’s clinical judgment; relationship of AEs to study drug (either related or unknown) was determined by the investigator. AE severity by dose of study medication has not been analyzed.

*Includes AEs reported by ≥4% of patients.

  • In total, 111 patients treated with Cesamet were included in this analysis
    • 79% of subjects (88 of 111) experienced one or more adverse events (AEs) on study
      • 32% of subjects (36 of 111) experienced one or more drug-related AEs
      • 50% of subjects (56 of 111) experienced one or more AEs of unknown relationship to study drug

Collective Severity of AEs (N=232) Reported During Compazine®**-Controlled Study2

  • The most common severe AE was vertigo, experienced by 2.6% of subjects (6 patients); however, vertigo was mild or moderate in the majority of patients who reported and specified the severity of vertigo (17 patients). Eighteen reports of vertigo were of unspecified severity

Note: Severity was assessed as mild, moderate, severe, or unspecified by the investigator, based on the investigator’s clinical judgment; relationship of AEs to study drug (either related or unknown) was determined by the investigator. AE severity by dose of study medication has not been analyzed.

*One investigator in this study reported unspecified severity of AEs for all 43 patients under his/her care.

AEs by Severity Reported During Compazine®**-Controlled Study
(n=number of AEs [% of total AEs])*2

Note: Severity was assessed as mild, moderate, severe, or unspecified by the investigator, based on the investigator’s clinical judgment; relationship of AEs to study drug (either related or unknown) was determined by the investigator. AE severity by dose of study medication has not been analyzed.

*Includes AEs reported by ≥4% of patients.

  • One investigator in this study reported unspecified severity of AEs for all 43 patients under his/her care.

**Trademarks are the property of their respective owners.

*NOTE: for safety analyses, all patients who received ≥1 dose of Cesamet or control were included in the safety populations.

Side Effects of Treatment1,2

  • Because Cesamet acts on the central nervous system (CNS), certain side effects are expected with treatment.
  • In clinical trials, the majority of patients receiving Cesamet had side effects, yet these were mostly mild to moderate and managed without disrupting Cesamet or chemotherapy.
  • The most common side effects were drowsiness, vertigo, dry mouth, euphoria, ataxia, headache, and concentration difficulties.

Rapid Tolerance to Certain CNS Effects1

  • Tolerance to relaxation, drowsiness, and euphoria develops rapidly.
  • Because of individual variation in response and tolerance to the effects of Cesamet, patients should remain under supervision of a responsible adult, especially during initial use of Cesamet and during dose adjustments.
  • Cesamet should not be taken with alcohol, sedatives, hypnotics, or other psychoactive substances because these substances can potentiate the central nervous system effects of nabilone.
  • The effects of Cesamet may persist for a variable and unpredictable period of time following its oral administration. Adverse psychiatric reactions can persist for 48 to 72 hours following cessation of treatment.
  • Patients receiving treatment with Cesamet should be specifically warned not to drive, operate machinery, or engage in any hazardous activity while receiving Cesamet.

Please see Full Prescribing Information and see below for important risk information.

References:

  1. Cesamet Prescribing Information. Somerset, NJ: Meda Pharmaceuticals Inc; 2009.
  2. Data on file (Protocols 20, 28). Meda Pharmaceuticals Inc.

Cesamet Indication

  • Cesamet (nabilone) capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
  • This restriction in use is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents.
  • Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual, particularly during initial use and during dose adjustments.
  • Cesamet contains nabilone, which is a Schedule II controlled substance and has a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days).
  • Prescribers should monitor patients receiving nabilone for signs of excessive use, abuse, and misuse. Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse or mental illness.
  • Cesamet capsules are not intended to be used on an as-needed basis or as a first antiemetic product prescribed for a patient.

Important Risk Information

  • Cesamet (nabilone) is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid.
  • The effects of Cesamet may persist for a variable and unpredictable period of time following its oral administration. Adverse psychiatric reactions can persist for 48 to 72 hours following cessation of treatment.
  • Cesamet has the potential to affect the CNS, which might manifest itself in dizziness, drowsiness, euphoria (feeling "high"), ataxia, anxiety, disorientation, depression, hallucinations, and psychosis.
  • Since Cesamet can cause tachycardia and orthostatic hypotension, it should be used with caution in the elderly and in patients with hypertension or heart disease.
  • Because of individual variation in response and tolerance to the effects of Cesamet, patients should remain under supervision of a responsible adult, especially during initial use of Cesamet and during dose adjustments.
  • Patients receiving treatment with Cesamet should be specifically warned not to drive, operate machinery, or engage in any hazardous activity while receiving Cesamet.
  • Cesamet should not be taken with alcohol, sedatives, hypnotics, or other psychoactive substances because these substances can potentiate the central nervous system effects of nabilone.
  • Cesamet should also be used with caution in patients with current or previous psychiatric disorders (including manic depressive illness, depression, and schizophrenia), as the symptoms of these disease states may be unmasked by the use of cannabinoids.
  • Cesamet is a Schedule II controlled substance and should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence and marijuana use, since Cesamet contains a similar active compound to marijuana.
  • Cesamet has not been studied in pregnant patients, nursing mothers, or pediatric patients, and, therefore, if used at all in those populations, it should be used with caution.
  • The effects of QT prolongation potential by Cesamet have not been determined.
  • During controlled clinical trials, virtually all patients experienced at least one adverse reaction. The most commonly encountered events were drowsiness, vertigo, dry mouth, euphoria, ataxia, headache, and concentration difficulties.

Important Risk Information

  • Cesamet (nabilone) is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid.
  • The effects of Cesamet may persist for a variable and unpredictable period of time following its oral administration. Adverse psychiatric reactions can persist for 48 to 72 hours following cessation of treatment.
  • Cesamet has the potential to affect the CNS, which might manifest itself in dizziness, drowsiness, euphoria (feeling "high"), ataxia, anxiety, disorientation, depression, hallucinations, and psychosis.
  • Since Cesamet can cause tachycardia and orthostatic hypotension, it should be used with caution in the elderly and in patients with hypertension or heart disease.
  • Because of individual variation in response and tolerance to the effects of Cesamet, patients should remain under supervision of a responsible adult, especially during initial use of Cesamet and during dose adjustments.
  • Patients receiving treatment with Cesamet should be specifically warned not to drive, operate machinery, or engage in any hazardous activity while receiving Cesamet.
  • Cesamet should not be taken with alcohol, sedatives, hypnotics, or other psychoactive substances because these substances can potentiate the central nervous system effects of nabilone.
  • Cesamet should also be used with caution in patients with current or previous psychiatric disorders (including manic depressive illness, depression, and schizophrenia), as the symptoms of these disease states may be unmasked by the use of cannabinoids.
  • Cesamet is a Schedule II controlled substance and should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence and marijuana use, since Cesamet contains a similar active compound to marijuana.
  • Cesamet has not been studied in pregnant patients, nursing mothers, or pediatric patients, and, therefore, if used at all in those populations, it should be used with caution.
  • The effects of QT prolongation potential by Cesamet have not been determined.
  • During controlled clinical trials, virtually all patients experienced at least one adverse reaction. The most commonly encountered events were drowsiness, vertigo, dry mouth, euphoria, ataxia, headache, and concentration difficulties.

Cesamet Indication

  • Cesamet (nabilone) capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
  • This restriction in use is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents.
  • Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual, particularly during initial use and during dose adjustments.
  • Cesamet contains nabilone, which is a Schedule II controlled substance and has a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days).
  • Prescribers should monitor patients receiving nabilone for signs of excessive use, abuse, and misuse. Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse or mental illness.
  • Cesamet capsules are not intended to be used on an as-needed basis or as a first antiemetic product prescribed for a patient.