CINV May Affect Compliance with Chemotherapy⁴

• Nausea and vomiting are two of the most feared side effects of cancer treatment
• CINV has a significant impact on patients, causing many negative effects

Cesamet Offers Effective Control of CINV

• Cesamet is a synthetic cannabinoid for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments²
• The efficacy of Cesamet in reducing nausea and vomiting has been demonstrated in cancer patients receiving a wide variety of chemotherapy regimens, including low-dose cisplatin⁵

Important Safety Information²

Cesamet, a synthetic cannabinoid similar to the active ingredient found in naturally occurring Cannabis sativa L. [Marijuana; delta-9-tetrahydrocannabinol (delta-9-THC)], is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid. Patients receiving treatment with Cesamet should be specifically warned not to drive, operate machinery, or engage in any hazardous activity while receiving Cesamet. During controlled clinical trials of Cesamet, virtually all patients experienced at least one adverse reaction. The most commonly encountered events were drowsiness, vertigo, dry mouth, euphoria (feeling “high”), ataxia, headache, and concentration difficulties. Cesamet should not be taken with alcohol, sedatives, hypnotics, or other psychoactive substances because these substances can potentiate the central nervous system (CNS) effects of nabilone. Since Cesamet can elevate supine and standing heart rates and cause postural hypotension, it should be used with caution in the elderly, and in patients with hypertension or heart disease. 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 should be used with caution in individuals receiving concomitant therapy with sedatives, hypnotics, or other psychoactive drugs because of the potential for additive or synergistic CNS effects. Cesamet 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 should be used with caution in pregnant patients, nursing mothers, or pediatric patients because it has not been studied in these patient populations.

For complete prescribing details, please see full prescribing information.
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References

1. Poli-Bigelli S, Rodrigues-Pereira J, Carides AD, et al. Addition of the neurokinin 1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy-induced nausea and vomiting. Results from a randomized, double-blind, placebo-controlled trial in Latin America. Cancer. 2003;97(12):3090-3098.
2. Cesamet™ [package insert]. Valeant Pharmaceuticals International; 2006.
3. National Comprehensive Cancer Network. Nausea and vomiting. Treatment guidelines for patients with cancer. 2006;3:5-31.
4. Wiser W, Berger A. Practical management of chemotherapy-induced nausea and vomiting. Oncology. 2005;19(5):637-645.
5. Data on File: Protocols 9, 20 and 28. Valeant Pharmaceuticals International.