What are the primary uses of Nabilone. How should patients take Nabilone for optimal effectiveness. What are the most common side effects of Nabilone. How can patients minimize the risk of addiction when using Nabilone. What precautions should be taken before starting Nabilone treatment.

Understanding Nabilone: A Comprehensive Guide for Patients

Nabilone is a synthetic cannabinoid medication primarily used to manage chemotherapy-induced nausea and vomiting. As a potent drug with both benefits and potential risks, it’s crucial for patients to have a thorough understanding of its proper use, side effects, and precautions.

The Primary Uses and Administration of Nabilone

Nabilone is specifically prescribed to combat the debilitating nausea and vomiting often associated with chemotherapy treatments. Its effectiveness in this area has made it a valuable tool in oncology care.

How should Nabilone be taken?

• Typically administered 2 to 3 times daily
• First dose may be taken the night before chemotherapy
• On chemotherapy days, take 1 to 3 hours before treatment
• Continue throughout the chemotherapy cycle as directed
• May be prescribed for 24 to 48 hours after the treatment cycle ends

Proper timing and consistent use are key to maximizing Nabilone’s benefits. Patients should adhere strictly to their doctor’s instructions and not adjust dosage without consultation.

Navigating Potential Side Effects of Nabilone

While Nabilone can provide significant relief, it’s important to be aware of potential side effects. These can range from mild to severe, and patients should monitor their reactions closely.

What are the most common side effects of Nabilone?

• Dizziness
• Drowsiness
• Dry mouth
• Euphoria or feeling “high”
• Lightheadedness
• Headache
• Sleep disturbances
• Memory problems

These side effects are generally manageable, but if they persist or worsen, it’s crucial to inform your healthcare provider promptly.

Serious Side Effects Requiring Immediate Attention

While less common, some side effects warrant immediate medical intervention:

• Fainting
• Unusual weakness
• Vision changes
• Significant mental/mood changes (depression, anxiety, panic, paranoia, hallucinations, psychosis)
• Fast heartbeat
• Seizures

Patients experiencing any of these symptoms should seek medical help without delay. It’s important to note that Nabilone can cause mental and behavioral changes, necessitating close supervision by a caregiver during treatment.

Mitigating Risks: Addiction and Withdrawal Considerations

As with many medications that affect brain chemistry, Nabilone carries a risk of addiction and withdrawal, particularly in individuals with a history of substance use disorders.

How can patients minimize the risk of addiction when using Nabilone?

1. Adhere strictly to prescribed dosages
2. Do not increase dose or frequency without medical advice
3. Be honest with your doctor about any history of substance abuse
4. Report any urges to use more of the medication than prescribed
5. Follow your doctor’s instructions for tapering off the medication

Sudden discontinuation of Nabilone can lead to withdrawal symptoms such as irritability, insomnia, sweating, and diarrhea. To prevent this, doctors typically implement a gradual dose reduction plan when ending treatment.

Essential Precautions and Considerations Before Starting Nabilone

Before initiating Nabilone treatment, it’s crucial to have a comprehensive discussion with your healthcare provider about your medical history and current health status.

What medical conditions may affect Nabilone use?

• Liver disease
• High blood pressure
• Heart disease
• Mental health conditions (mania, depression, schizophrenia)
• Personal or family history of substance use disorders

Patients should also disclose any allergies, particularly to marijuana or cannabis-related products, as Nabilone is a synthetic cannabinoid.

Lifestyle Considerations and Drug Interactions

Nabilone can significantly impact daily functioning, and patients must adjust their lifestyle accordingly to ensure safety and optimal treatment outcomes.

How does Nabilone affect daily activities?

• May cause dizziness and drowsiness
• Impairs ability to drive or operate machinery
• Interacts with alcohol and marijuana, enhancing sedative effects
• Can exacerbate cognitive impairment

Patients are advised to avoid alcohol and refrain from activities requiring alertness until they understand how Nabilone affects them personally. It’s also crucial to inform healthcare providers about all medications, supplements, and herbal products being used to prevent potential interactions.

Monitoring and Adjusting Nabilone Treatment

The effectiveness and tolerability of Nabilone can vary among individuals. Regular communication with healthcare providers is essential for optimizing treatment.

What should patients monitor during Nabilone treatment?

• Efficacy in managing nausea and vomiting
• Occurrence and severity of side effects
• Changes in mood or mental state
• Impact on daily functioning and quality of life

Patients should keep a diary of their symptoms and side effects to discuss with their doctor during follow-up appointments. This information can be invaluable in making necessary adjustments to the treatment plan.

Understanding the Pharmacology of Nabilone

Nabilone’s effectiveness in managing chemotherapy-induced nausea and vomiting is rooted in its pharmacological properties as a synthetic cannabinoid.

How does Nabilone work in the body?

Nabilone mimics the effects of tetrahydrocannabinol (THC), the primary psychoactive component of marijuana. It interacts with the endocannabinoid system, particularly the CB1 receptors in the brain and nervous system. This interaction affects various physiological processes, including:

• Regulation of nausea and vomiting reflexes
• Modulation of pain perception
• Influence on mood and cognitive functions
• Impact on appetite and metabolism

By modulating these systems, Nabilone can effectively suppress chemotherapy-induced nausea and vomiting, providing relief to patients undergoing cancer treatment.

Comparing Nabilone to Other Antiemetic Medications

While Nabilone is effective, it’s not the only option for managing chemotherapy-induced nausea. Other common antiemetic medications include:

• Serotonin (5-HT3) receptor antagonists (e.g., ondansetron, granisetron)
• Neurokinin-1 (NK1) receptor antagonists (e.g., aprepitant)
• Corticosteroids (e.g., dexamethasone)
• Dopamine antagonists (e.g., metoclopramide)

The choice of antiemetic therapy depends on various factors, including the specific chemotherapy regimen, patient characteristics, and individual response to treatment. In some cases, a combination of different antiemetic medications may be prescribed for optimal symptom control.

Long-Term Considerations and Follow-Up Care

As Nabilone treatment often coincides with chemotherapy cycles, it’s important to consider the long-term aspects of its use and the need for ongoing medical supervision.

What long-term effects should patients be aware of?

• Potential for tolerance development
• Changes in cognitive function
• Impact on mental health
• Possible interactions with other medications

Regular follow-up appointments with healthcare providers are crucial for monitoring these potential long-term effects and adjusting treatment as necessary. Patients should be prepared to discuss any changes in their health status, including improvements in chemotherapy tolerance or new side effects that may have developed over time.

Transitioning Off Nabilone

As chemotherapy treatment concludes, patients may need to discontinue Nabilone. This process should be carefully managed to minimize withdrawal symptoms and ensure a smooth transition. Healthcare providers typically develop a tapering schedule that gradually reduces the dose over time, allowing the body to adjust to decreasing levels of the medication.

Patient Education and Support Resources

Effective management of Nabilone therapy extends beyond medication administration. Patient education and access to support resources play a crucial role in ensuring treatment success and quality of life during chemotherapy.

What educational resources are available for patients using Nabilone?

• Patient Information Leaflets provided by pharmacists
• Educational materials from oncology care teams
• Support groups for cancer patients undergoing chemotherapy
• Online resources from reputable medical organizations

Patients should be encouraged to engage with these resources and to ask questions about their treatment. Understanding the medication, its effects, and how to manage potential side effects can significantly improve the overall treatment experience.

The Role of Caregivers in Nabilone Treatment

Given the potential for mental and behavioral changes associated with Nabilone use, the involvement of a responsible caregiver is often crucial. Caregivers can:

• Help monitor for side effects and changes in behavior
• Assist with medication administration and timing
• Provide support during chemotherapy appointments
• Communicate concerns to healthcare providers

Educating caregivers about Nabilone, its effects, and potential risks is an important aspect of comprehensive patient care.

Integrating Nabilone into a Comprehensive Cancer Care Plan

While Nabilone plays a significant role in managing chemotherapy-induced nausea and vomiting, it’s important to view it as part of a broader cancer care strategy. Integrating Nabilone with other supportive therapies can enhance overall patient well-being during cancer treatment.

How can Nabilone complement other supportive care measures?

• Nutritional support to maintain adequate caloric intake
• Psychological counseling to address emotional aspects of cancer treatment
• Physical therapy to maintain strength and mobility
• Complementary therapies like acupuncture or meditation for symptom management

A multidisciplinary approach that considers all aspects of patient care can lead to better outcomes and improved quality of life during cancer treatment. Patients should discuss with their healthcare team how Nabilone fits into their overall care plan and what additional supportive measures might be beneficial.

Addressing Stigma and Misconceptions

As a synthetic cannabinoid, Nabilone may be subject to misconceptions and stigma similar to those associated with medical marijuana. It’s important for patients, caregivers, and healthcare providers to address these issues openly:

• Educate about the differences between Nabilone and recreational marijuana use
• Discuss the scientific evidence supporting Nabilone’s use in cancer care
• Address concerns about addiction and legal status
• Provide clear information about the medication’s effects and purpose

Open communication can help alleviate concerns and ensure that patients feel comfortable with their treatment plan.

Future Directions in Cannabinoid-Based Therapies

As research in cannabinoid pharmacology continues to advance, new developments may expand the therapeutic potential of medications like Nabilone. Staying informed about emerging research can help patients and healthcare providers make informed decisions about treatment options.

What future developments might impact Nabilone use?

• Development of new synthetic cannabinoids with improved efficacy or reduced side effects
• Expanded indications for cannabinoid-based therapies beyond chemotherapy-induced nausea
• Advances in delivery methods that could enhance bioavailability or reduce side effects
• Greater understanding of the endocannabinoid system and its role in various physiological processes

While these developments are exciting, it’s important for patients to focus on current, evidence-based treatments recommended by their healthcare providers. Any consideration of new therapies should be discussed thoroughly with the medical team to ensure they align with the overall treatment plan and individual patient needs.

Nabilone Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

How to use Nabilone Capsule

See also Side Effects section.

Read the Patient Information Leaflet if available from your pharmacist before you start taking nabilone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 2 to 3 times a day. The first dose may be taken the night before chemotherapy treatment. On the day you start chemotherapy, take nabilone 1 to 3 hours before chemotherapy begins. Continue to take this medication as directed by your doctor throughout your chemotherapy treatment cycle. Your doctor may also direct you to continue taking this medication until 24 to 48 hours after your treatment cycle ends. Follow your doctor’s instructions carefully.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly throughout your treatment cycle to get the most benefit from it. To help you remember, take it at the same times each day. This medication should not be taken on an “as needed” basis.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as irritability, trouble sleeping, sweating, and diarrhea). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used nabilone for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Dizziness, drowsiness, dry mouth, feeling “high,” an exaggerated sense of well-being (euphoria), lightheadedness, headache, trouble sleeping, or memory problems may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: fainting, unusual weakness, vision changes, mental/mood changes (such as depression, anxiety, panic, paranoia, hallucinations, psychosis).

Because nabilone can cause mental, mood, or behavior changes, a responsible caretaker should closely supervise you while you are taking this medication. If you have any such effects, remain calm and tell your doctor right away. Do not take any more nabilone until after you consult with your doctor.

Get medical help right away if you have any very serious side effects, including: fast heartbeat, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking nabilone, tell your doctor or pharmacist if you are allergic to it; or to marijuana (cannabis) or related products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, high blood pressure, heart disease, mental/mood conditions (such as mania, depression, schizophrenia), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially mental/mood changes.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, lightheadedness, and mental/mood changes.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using nabilone. Nabilone may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Does Nabilone Capsule interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast heartbeat, severe dizziness, hallucinations, anxiety, difficulty breathing, loss of consciousness.

Do not share this medication with others. Sharing it is against the law.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Nabilone – LiverTox – NCBI Bookshelf

Last Update: October 2, 2021.

OVERVIEW

Introduction

Nabilone is an orally available cannabinoid agonist that is used to treat chemotherapy induced nausea and vomiting and to stimulate appetite, particularly in patients with wasting disease or cachexia. Nabilone is associated with a minimal rate of serum enzyme elevations during therapy and has not been linked to cases of clinically apparent liver injury with jaundice.

Background

Nabilone (Nab’ i lone) is a synthetic cannabinoid which is similar to the principal psychoactive constituent of the marijuana plant (Cannabis sativa). Nabilone is a partial agonist of the cannabinoid receptors which are found in the central nervous system (CB1 receptor), but also peripherally (largely CB2 receptors). Activation of CB receptors results in effects on appetite, mood, cognition, memory and perception. Nabilone therapy has been shown to decrease nausea and vomiting in patients undergoing cancer chemotherapy. Nabilone was approved for use in the United States in 1985 and current indications are prevention of cancer chemotherapy associated nausea and vomiting. Nabilone is available as 1 mg capsules under the brand name Cesamet. The typical adult oral dose is 1 to 2 mg twice daily, the initial dose being 1 to 3 hours before the chemotherapeutic agent is given. Nabilone is usually reserved for patients who fail to response to or are intolerant of conventional antiemetics, such as the serotonin [5-HT₃] receptor antagonists. Off-label uses of nabilone include as an appetite stimulant and for chronic pain relief, but its efficacy is not well established for either of these indications. Common side effects include fatigue, sedation, somnolence, dizziness, euphoria, abnormal thinking, paranoid reactions, impairment of driving and operation of heavy equipment, conjunctivitis, diarrhea, nausea, vomiting, abdominal pain, orthostatic hypotension and tachycardia. Rare side effects include hallucinations and seizures. Nabilone is classified as a Schedule II drug, indicating that it has clear potential for physical and psychological dependency and abuse.

Hepatotoxicity

Serum aminotransferase elevations during nabilone therapy are not common, generally mild and similar to the rate in controls who are receiving cancer chemotherapy. There have been no convincing cases of clinically apparent liver injury attributable to nabilone published in the literature and, thus, significant liver injury from nabilone must be exceeding rare, if it occurs at all.

Likelihood score: E (unlikely cause of clinically apparent liver injury).

Mechanism of Injury

Nabilone is metabolized by the liver and undergoes extensive first-pass metabolism to both active and inactive metabolites. Despite its hepatic metabolism by CYP microsomal enzymes, it has not been implicated in causing drug-drug interactions. The lack of reported cases of liver injury and low rate of drug-drug interactions due to nabilone may be due to the low doses and limited duration of typical therapy.

Drug Class: Gastrointestinal Agents, Antiemetic Agents

CHEMICAL FORMULA AND STRUCTURE

ANNOTATED BIBLIOGRAPHY

References updated: 02 October 2021

Abbreviations used: AIDS, acquired immune deficiency syndrome; CB, cannabinoids.

• Zimmerman HJ. Antiemetic and prokinetic compounds. Miscellaneous drugs and diagnostic chemicals. In, Zimmerman, HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999: pp. 721.

  (Expert review of hepatotoxicity published in 1999 does not discuss nabilone).

• Sharkey KA, MacNaughton WK. Antinauseants and antiemetics. Gastrointestinal motility bowel motility and water flux, emesis, and biliary and pancreatic disease. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman’s the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 934-8.

  (Textbook of pharmacology and therapeutics).

• Marijuana. In, PDR for Herbal Medicines. 4th ed. Montvale, New Jersey: Thomson Healthcare Inc. 2007: pp. 562-7.

  (Compilation of short monographs on herbal medications and dietary supplements).

• Fabre LF, McLendon D. The efficacy and safety of nabilone(a synthetic cannabinoid) in the treatment of anxiety. J Clin Pharmacol. 1981;21:377S–382S. [PubMed: 6117575]

  (Among 25 patients with anxiety disorders participating in dose finding studies of nabilone for up to 28 days, the most common side effects were dry mouth and eyes, drowsiness, headaches and insomnia; “nabilone did not alter any value in the clinical chemistry battery”).

• Beal JE, Olson R, Laubenstein L, Morales JO, Bellman P, Yangco B, Lefkowitz L, et al. Dronabinol as a treatment for anorexia associated with weight loss in patients with AIDS. J Pain Symptom Manage. 1995;10:89–97. [PubMed: 7730690]

  (Among 139 patients with AIDS-related anorexia and weight loss treated with dronabinol or placebo for up to 4 weeks, side effects included euphoria, dizziness, drowsiness and difficulty thinking and “no treatment-related toxicity was found on. laboratory tests”).

• Beal JE, Olson R, Lefkowitz L, Laubenstein L, Bellman P, Yangco B, Morales JO, et al. Long-term efficacy and safety of dronabinol for acquired immunodeficiency syndrome-associated anorexia. J Pain Symptom Manage. 1997;14:7–14. [PubMed: 9223837]

  (Among 94 patients with late stage AIDS treated with dronabinol [2.5-5 mg daily] for up to 12 months, there were “no significant changes in hematology or blood chemistry parameters”).

• Wissel J, Haydn T, Mueller J, Brenneis C, Berger T, Poewe W, Schelosky LD. Low dose treatment with the synthetic cannabinoid Nabilone significantly reduces spasticity-related pain: a double-blind placebo-controlled cross-over trial. J Neurol. 2006;253:1337–41. [PubMed: 16988792]

  (Among 13 patients with upper motor neuron disease and spasticity treated with nabilone [1 mg daily] for up to 9 weeks, pain and spasticity decreased and “no severe side effects were reported”).

• Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang H, Rochon J., Drug Induced Liver Injury Network (DILIN). Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology. 2008;135:1924–34. [PMC free article: PMC3654244] [PubMed: 18955056]

  (Among 300 cases of drug induced liver disease in the US collected between 2004 and 2008, no cases were attributed to cannabinoid agonists or antiemetics).

• Reuben A, Koch DG, Lee WM., Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology. 2010;52:2065–76. [PMC free article: PMC3992250] [PubMed: 20949552]

  (Among 1198 patients with acute liver failure enrolled in a US prospective study between 1998 and 2007, 133 were attributed to drug induced liver injury, but none were attributed to antiemetic agents).

• Borgelt LM, Franson KL, Nussbaum AM, Wang GS. The pharmacologic and clinical effects of medical cannabis. Pharmacotherapy. 2013;33:195–209. [PubMed: 23386598]

  (Review of history and status of cannabis used for medical purposes including severe pain, muscle spasms, anorexia, nausea and vomiting, and glaucoma; adverse events are common, but usually mild and reversible, most frequently dry mouth, dizziness, drowsiness, and changes in cognition and mood).

• Björnsson ES, Bergmann OM, Björnsson HK, Kvaran RB, Olafsson S. Incidence, presentation and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology. 2013;144:1419–25. [PubMed: 23419359]

  (In a population based study of drug induced liver injury from Iceland, 96 cases were identified over a 2 year period, but none were attributed to antiemetics).

• Hernández N, Bessone F, Sánchez A, di Pace M, Brahm J, Zapata R, A, Chirino R, et al. Profile of idiosyncratic drug induced liver injury in Latin America. An analysis of published reports. Ann Hepatol. 2014;13:231–9. [PubMed: 24552865]

  (Systematic review of literature of drug induced liver injury in Latin American countries published from 1996 to 2012 identified 176 cases, the most common implicated agents being nimesulide [n=53: 30%], cyproterone [n=18], nitrofurantoin [n=17], antituberculosis drugs [n=13], and flutamide [n=12: 7%]; no cannabinoid agonist or antiemetic was listed).

• Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al. United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology. 2015;148:1340–52. [PMC free article: PMC4446235] [PubMed: 25754159]

  (Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, none were attributed to nabilone or other antiemetics).

• Polito S, MacDonald T, Romanick M, Jupp J, Wiernikowski J, Vennettilli A, Khanna 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:e27374. [PubMed: 30051617]

  (Among 110 pediatric patients treated with nabilone for prevention of chemotherapy induced nausea and vomiting [usually in combination with a serotonin [5-HT3] receptor antagonist], adverse events arose in 34%, most commonly sedation [20%], dizziness [10%] and euphoria [4%], leading to discontinuation in 9%, but without serious adverse events; no mention of ALT elevations or hepatotoxicity).

• Herrmann N, Ruthirakuhan M, Gallagher D, Verhoeff NPLG, Kiss A, Black SE, Lanctôt KL. Randomized Placebo-Controlled Trial of Nabilone for Agitation in Alzheimer’s Disease. Am J Geriatr Psychiatry. 2019;27:1161–1173. [PubMed: 31182351]

  (Among 38 elderly patients with Alzheimer disease treated with nabilone [titrated] or placebo for 6 weeks in a crossover trial, nabilone therapy was associated with a slight decrease in agitation but increase in sedation; no mention of ALT elevations or hepatoxicity).

• Cannabis and cannabinoids. Med Lett Drugs Ther. 2019;61(1585):179–182. [PubMed: 31770357]

  (Concise review of the beneficial and adverse effects of cannabis and cannabinoids, 3 of which are FDA approved products, two synthetic agents that are used for prevention of chemotherapy induced nausea and vomiting [nabilone and dronabinol] and one a purified natural product used to treat rare forms of severe epilepsy [cannabidiol]; all of the cannabinoids can cause dizziness, somnolence, euphoria, abnormal thinking, difficulty concentrating, hypotension, hypertension, syncope and tachycardia as well as addiction and dependence with long term use; no mention of ALT elevations or hepatoxicity).

• Sholler DJ, Huestis MA, Amendolara B, Vandrey R, Cooper ZD. Therapeutic potential and safety considerations for the clinical use of synthetic cannabinoids. Pharmacol Biochem Behav. 2020;199:173059. [PMC free article: PMC7725960] [PubMed: 33086126]

  (Extensive review of the endocannabinoid system and potential therapies for synthetic cannabinoids [CB] and CB receptor antagonists; while there are CB receptors in the liver [predominantly CB2], there is no evidence that the CBs in clinical practice cause liver injury).

Memorial Sloan Kettering Cancer Center

Adult Medication

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This document, provided by Lexicomp ^® , contains all the information you need to know about this medicine, including indications, directions for use, side effects, and when your healthcare provider should be contacted.

Trade names: USA

Cesamet [DSC]

Brand names: Canada

ACT Nabilone [DSC]; Cesamet; PMS Nabilone; RAN-Nabilone [DSC]; TEVA-Nabilone

What is this drug used for?

• Used to treat nausea and vomiting.

What should I tell my doctor BEFORE taking this drug?

• If you have an allergy to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergies and how they have manifested.
• If you are breastfeeding. Do not breastfeed while taking this drug.

Combining this drug with certain drugs and conditions may be unfavorable.

Tell your doctor and pharmacist about all medicines you take (prescription and over-the-counter, natural products and vitamins) and any health problems you have. You need to make sure that this drug is safe for your conditions and in combination with other drugs you are already taking. Do not start or stop taking any drug or change the dosage without your doctor’s advice.

What do I need to know or do while taking this drug?

• Tell all your health care workers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
• This drug may cause mood changes when started. Make sure you have someone you can trust if you need help while using this drug.
• Some side effects may persist for several days after taking the drug. These effects include decreased concentration, mood changes, and confusion, among others.
• While you are taking this drug, avoid driving or other activities or activities that require increased attention.
• To reduce the risk of dizziness or loss of consciousness, get up slowly from a lying or sitting position. Walking up and down stairs should be done with care.
• Avoid alcohol, marijuana or other forms of cannabis, and prescription or over-the-counter drugs that can slow you down.
• Do not smoke or use other forms of cannabis (marijuana) while taking this drug. Consult your doctor.
• This drug may be habit-forming with long-term use.
• You will be closely monitored to avoid misuse, abuse, or dependence on this drug.
• If you are 65 years of age or older, use this drug with caution. You may experience more side effects.
• Use with caution in children. Consult your doctor.
• Tell your doctor if you are pregnant or plan to become pregnant. The benefits and risks of taking this drug during pregnancy will need to be discussed.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, this drug can cause serious and sometimes deadly side effects in some patients. Call your doctor right away or get medical help if you have any of the following signs or symptoms that could be associated with serious side effects:

• Signs of an allergic reaction such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly in combination with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
• The onset or worsening of psychiatric disorders, mood swings, or behavioral changes.
• Confusion of consciousness.
• Severe dizziness or fainting.
• Cardiopalmus.
• Hallucinations (a person sees or hears something that is not in reality).
• Vision change.

What are some other side effects of this drug?

Any medicine can have side effects. However, for many people, side effects are either minor or non-existent. Talk to your doctor or get medical help if these or any other side effects bother you or don’t go away:

• Feeling dizzy, drowsy, tired or weak.
• Feeling “high” (laughter and good mood for no particular reason).
• Dry mouth.
• Appetite changes.
• Balance change.
• Sleep disorders.
• Headache.
• Distracted attention.

This list of possible side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Board.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

• Take this drug with or without food.
• Keep taking this drug as instructed by your doctor or other health care professional, even if you feel well.

What if I miss a dose of a drug?

• Take the missed dose as soon as you can.
• If it’s time to take your next dose, don’t take the missed dose and then go back to your regular dosing schedule.
• Do not take 2 doses or an additional dose at the same time.

How do I store and/or discard this drug?

• Store at room temperature in a dry place. Do not store in the bathroom.
• Keep this medicine in a protected place out of sight and reach of children and out of the reach of other people. A box or room that is locked with a key can act as a secure storage place for the drug. Keep all medicines out of the reach of pets.
• Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General information about medicines

• If your health does not improve or even worsens, see your doctor.
• Do not give your medicine to anyone and do not take other people’s medicines.
• Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
• Some medicines may come with other patient information leaflets. Check with your pharmacist. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
• If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

This summary information includes a summary of the diagnosis, treatment, and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a particular patient. It should not be considered medical advice or a substitute for medical advice, diagnosis or treatment provided by a physician based on a medical examination and assessment of the patient’s specific and unique circumstances. Patients should consult with their physician for full information about their health, medical issues, and treatment options, including any risks or benefits regarding the use of medications. This information is not a guarantee that a treatment or drug is safe, effective, or approved for a particular patient. UpToDate, Inc. and its subsidiaries disclaim any warranties or liabilities related to this information or its use. The use of this information is subject to the Terms of Use found at https://www. wolterskluwer.com/en/know/clinical-effectiveness-terms.

Last revision date

2020-04-24

Copyright

© UpToDate, Inc. and its affiliates and/or licensors, 2023. All rights reserved.

Date last updated

Monday, December 12, 2022

The use of dronabinol in the treatment of children with cancer

Antiemetic drug (antiemetic)

Brand names:

Marinol®, Syndros®

Other names:

Delta-9 THC, Delta-9-tetrahydro-cannabinol, Tetrahydrocannabinol, THC

Often used for:

Nausea and vomiting, appetite stimulant

Dronabinol is a drug used to prevent and treat nausea and vomiting caused by chemotherapy. In addition, it can be used to increase appetite in the prevention of weight loss.

Dronabinol belongs to the group of medicines called “cannabinoids”. It affects the areas of the brain that are responsible for nausea, vomiting, and appetite.

Long-term use of dronabinol may cause addiction. In patients taking dronabinol, changes in heart rate, blood pressure, as well as mood swings and changes in behavior can be monitored.

Oral capsules

Oral liquid form

• Dizziness
• Dry mouth
• Drowsiness
• Mood changes
• Pain in the abdomen
• Increased fatigue or general weakness
• Headache
• Problems with thinking, concentration or memory
• Confusion, strange thoughts or hallucinations
• Alarm
• Nausea and vomiting

The listed side effects are not observed in all patients who are prescribed dronabinol. The most common side effects are highlighted in bold, but others are not excluded. Report all possible side effects to your doctor or pharmacist.

Be sure to discuss these and other recommendations with your doctor or pharmacist.

• In the treatment of chemotherapy-induced nausea, dronabinol is taken 4-6 times a day: 1-3 hours before chemotherapy and every 2-4 hours after it.
• Dronabinol is usually taken 1 hour before lunch and dinner to increase appetite.
• If dronabinol is used to stimulate appetite, the doctor may ask the patient to keep a food diary and monitor weight changes. A nutritionist can provide nutritional advice to achieve the desired results.
• Alcoholic beverages should be avoided while taking this drug.
• Pregnant or breastfeeding patients should notify their physician.

Home use of dronabinol:

• Do not exceed the dose and frequency of dronabinol recommended by your doctor.
• This drug may cause dizziness or drowsiness. Do not drive or engage in hazardous activities until a drug reaction has been identified.
• Capsules: Capsules should be swallowed whole. It is not allowed to open, cut, grind or chew the drug.