Primary and Secondary Risk Factors for CINV

Primary Risk Factor: Emetogenic Potential of the Chemotherapeutic Regimen

There are various risk factors for CINV, but the intrinsic emetogenic potential of the chemotherapeutic regimen is the predominant risk factor.1 CINV is commonly associated with certain chemotherapeutic agents and regimens given to patients with cancer. In fact, the majority of patients receiving highly emetogenic agents and many patients receiving moderately emetogenic regimens have CINV.2,3

Some of the chemotherapy agents/regimens known to be highly emetogenic are:1

  • AC (doxorubicin or epirubicin with cyclophosphamide)
  • Carmustine >250 mg/m2
  • Cisplatin ≥50 mg/m2
  • Cyclophosphamide >1500 mg/m2
  • Dacarbazine
  • Mechlorethamine
  • Streptozocin

Combining even moderately emetogenic agents may result in highly emetic chemotherapy regimens.3

Other Risk Factors

In addition to the emetogenic potential of the chemotherapeutic regimen, many other factors contribute to a patient's risk for CINV.

  • Chemotherapy-related risk factors1-3
    • High-dose and/or dose-dense chemotherapy
    • Multiday chemotherapy
    • Rate of administration
    • Route of administration
  • Secondary risk factors3,4
    • Female
    • Age <50 years
    • History of CINV
    • History of low alcohol use
    • High anxiety or depression
    • History of nausea/vomiting with pregnancy and motion sickness
    • Low performance status
  • Other nausea and vomiting risk factors3-5
    • Medical procedures: surgery, radiation
    • Medications: digitalis, opioids, antibiotics, antifungals
    • Medical conditions: uremia, hypercalcemia, bowel obstruction, other comorbidities

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

CINV=chemotherapy-induced nausea and vomiting.

Next: Nausea and Vomiting Pathways

References:

  1. Hesketh PJ. Chemotherapy-induced nausea and vomiting. N Engl J Med. 2008;358:2482-2494.
  2. Blanchard EM, Hesketh PJ. Nausea and vomiting. In: DeVita VT Jr, Lawrence TS, Rosenberg SA, eds. Cancer: Principles and Practice of Oncology. 8th ed. Philadelphia: Lippincott, Williams and Wilkins; 2008:2639-2646.
  3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology™. Antiemesis. Ver 4, 2009. Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#supportive. Accessed March 3, 2010.
  4. Lohr I. Chemotherapy-Induced Nausea and Vomiting. Cancer J. 2008;14:85-89.
  5. Berger AM, Clark-Snow RA. Adverse effects of treatment. In: DeVita VJ Jr et al. Cancer: Principles and Practice of Oncology. 6th ed. Philadelphia: Lippincott, Williams and Wilkins; 2001:2869-2880.

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.