How is nabilone used to manage chemotherapy-induced nausea. What are the potential side effects of nabilone. Who should exercise caution when taking nabilone. How can patients safely use nabilone during chemotherapy treatment.

Understanding Nabilone: A Synthetic Cannabinoid for Chemotherapy Patients

Nabilone is a synthetic cannabinoid medication primarily prescribed to manage chemotherapy-induced nausea and vomiting. As a derivative of tetrahydrocannabinol (THC), the main psychoactive component in marijuana, nabilone mimics some of the effects of cannabis but with more controlled and predictable outcomes. This medication offers relief to cancer patients undergoing chemotherapy, helping to improve their quality of life during treatment.

What is the primary use of nabilone?

The primary use of nabilone is to control nausea and vomiting associated with cancer chemotherapy. It is particularly beneficial for patients who have not responded well to other antiemetic medications. Nabilone works by interacting with the body’s endocannabinoid system, which plays a role in regulating nausea and vomiting reflexes.

Proper Administration of Nabilone for Optimal Results

To ensure the best possible outcomes, it’s crucial to administer nabilone correctly. The medication is typically taken orally in capsule form, with dosing schedules tailored to each patient’s chemotherapy regimen and individual needs.

How should patients take nabilone?

Patients should take nabilone by mouth as directed by their healthcare provider, usually 2 to 3 times daily. The initial dose is often administered the night before chemotherapy begins. On the day of chemotherapy, patients should take nabilone 1 to 3 hours before the treatment starts. It’s important to continue taking the medication throughout the chemotherapy cycle as prescribed, which may include taking it for 24 to 48 hours after the treatment cycle ends.

Why is consistent dosing important for nabilone?

Consistent dosing is crucial for nabilone because it helps maintain steady levels of the medication in the body, providing continuous relief from nausea and vomiting. Taking the medication at the same times each day can help patients remember their doses and maximize the drug’s effectiveness. It’s not recommended to use nabilone on an “as needed” basis, as this may reduce its efficacy in preventing chemotherapy-induced nausea.

Potential Side Effects of Nabilone: What Patients Should Know

Like all medications, nabilone can cause side effects. While many patients tolerate the drug well, it’s important to be aware of potential adverse reactions and to report any concerning symptoms to a healthcare provider promptly.

What are the common side effects of nabilone?

Common side effects of nabilone include:

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

These effects are usually mild and may diminish as the body adjusts to the medication. However, if they persist or worsen, patients should consult their healthcare provider.

Are there any serious side effects associated with nabilone?

Yes, there are potential serious side effects associated with nabilone that require immediate medical attention:

1. Fainting
2. Unusual weakness
3. Vision changes
4. Severe mental/mood changes (e.g., depression, anxiety, panic, paranoia, hallucinations, psychosis)
5. Fast heartbeat
6. Seizures

Patients experiencing any of these symptoms should seek medical help right away. It’s important to note that while these serious side effects can occur, they are relatively rare, and the benefits of nabilone often outweigh the risks for many patients undergoing chemotherapy.

Precautions and Considerations for Nabilone Use

Before starting nabilone treatment, patients should have a thorough discussion with their healthcare provider about their medical history and any potential risk factors that may affect their use of the medication.

Who should exercise caution when taking nabilone?

Certain individuals should use nabilone with caution or may need to avoid it altogether:

• People with liver disease
• Individuals with high blood pressure or heart disease
• Those with a history of mental health conditions (e.g., mania, depression, schizophrenia)
• Patients with a personal or family history of substance use disorders
• Individuals with allergies to marijuana, cannabis-related products, or any components of nabilone

It’s crucial for patients to provide a complete medical history to their healthcare provider to ensure safe and appropriate use of nabilone.

Interactions and Lifestyle Considerations with Nabilone

Nabilone can interact with other substances and affect a patient’s daily activities. Understanding these interactions and making appropriate lifestyle adjustments is essential for safe use of the medication.

How does nabilone interact with alcohol and other substances?

Nabilone can enhance the effects of alcohol and other central nervous system depressants, potentially increasing drowsiness and dizziness. Patients are advised to avoid alcoholic beverages while taking nabilone. Additionally, the use of marijuana (cannabis) alongside nabilone may intensify certain side effects and should be discussed with a healthcare provider.

Can patients drive or operate machinery while taking nabilone?

Due to its potential to cause dizziness and drowsiness, patients should not drive, use machinery, or engage in activities requiring alertness until they know how nabilone affects them. It’s important to wait until one can safely perform these tasks before attempting them while on this medication.

Managing Withdrawal and Addiction Risks Associated with Nabilone

While nabilone is an effective medication for managing chemotherapy-induced nausea, it’s important to be aware of the potential for withdrawal symptoms and the risk of addiction, especially with long-term or high-dose use.

What withdrawal symptoms might occur if nabilone is stopped abruptly?

Abruptly stopping nabilone, especially after long-term use, may lead to withdrawal symptoms such as:

• Irritability
• Trouble sleeping
• Sweating
• Diarrhea

To minimize the risk of withdrawal, healthcare providers may gradually reduce the dosage over time when discontinuing the medication.

Is there a risk of addiction with nabilone use?

While nabilone can be beneficial for many patients, it does carry a potential risk of addiction, particularly for individuals with a history of substance use disorders. To mitigate this risk:

1. Take the medication exactly as prescribed
2. Do not increase the dose without consulting a healthcare provider
3. Avoid using the medication for longer periods than recommended
4. Be honest with your healthcare provider about any history of substance abuse

Healthcare providers carefully weigh the benefits against the risks when prescribing nabilone and monitor patients closely throughout treatment.

Monitoring and Follow-up Care for Patients on Nabilone

Ongoing monitoring and regular follow-up care are essential components of nabilone treatment to ensure its effectiveness and manage any potential side effects or complications.

How should patients monitor their response to nabilone?

Patients should keep track of:

• The effectiveness of nabilone in controlling nausea and vomiting
• Any side effects experienced, including their severity and duration
• Changes in mood or mental state
• Any new symptoms that arise during treatment

Maintaining a symptom diary can be helpful for discussing progress and concerns with healthcare providers during follow-up appointments.

When should patients seek medical attention while taking nabilone?

Patients should contact their healthcare provider immediately if they experience:

1. Severe or persistent side effects
2. Signs of an allergic reaction (e.g., rash, itching/swelling, severe dizziness, trouble breathing)
3. Significant changes in mood or behavior
4. Worsening of their condition despite taking the medication as prescribed

Regular check-ins with the healthcare team allow for timely adjustments to the treatment plan and early intervention if any issues arise.

By understanding the proper use, potential side effects, and necessary precautions associated with nabilone, patients can work closely with their healthcare providers to maximize the benefits of this medication while minimizing risks. As with any medical treatment, open communication and adherence to prescribed guidelines are key to achieving the best possible outcomes in managing chemotherapy-induced nausea and vomiting.

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).

The use of dronabinol in the treatment of children with cancer

Antiemetic drug (antiemetic)

Trademarks:

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 drugs called cannabinoids. It affects the areas of the brain that are responsible for nausea, vomiting, and appetite.

Long-term use of dronabinol may be habit-forming. 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
• Abdominal pain
• 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.

• For 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. Capsules should be stored in a cool place or refrigerator. In no case do not freeze the drug.
• Oral Liquid Form: Use the supplied measuring cup to measure out the required amount. It is recommended to drink a full glass of water. Unopened vials should be stored in the refrigerator. After opening, store the drug at room temperature or in the refrigerator. Keep up to 6 weeks after opening.
• Take your dose as soon as possible if you miss it. Do not do this only if there is little time left until the next appointment. In no case do not double the dose at the next dose!
• Do not share this product with others or use it for other purposes.
• Do not use an expired drug.
• Follow instructions for safe storage and disposal of the drug.

Learn more about dronabinol

instructions for use, dosage, composition, analogues, side effects / Pillintrip

See also:
What are the possible side effects of Nabilone?

To report SUSPENSION COATING REACTIONS, contact Meda Pharmaceuticals Inc. call 1-800-723-1400 or FDA call 1-800-FDA-1088 or www.fda.gov/medwatch.

Commonly Occurred Reactions

During controlled clinical trials with Nabilone, virtually all patients experienced at least one adverse reaction. The most commonly reported events were drowsiness, dizziness, dry mouth, euphoria (feeling “high”), ataxia, headache, and difficulty concentrating.

Comparative frequency of reactions

It is difficult to obtain accurate estimates of the frequency of adverse events associated with the use of any drug. Estimates are influenced by factors such as drug dose, detection technique, staging, and physician judgment, among others. Therefore, the tables below are provided solely to indicate the relative frequency of adverse events reported in representative controlled clinical studies conducted to evaluate the safety and efficacy of nabilone under relatively similar conditions of use. These figures cannot be used to accurately predict the incidence of adverse events during routine medical practice, where patient characteristics and other factors may differ from those prevailing in clinical trials. These incidence rates also cannot be compared with data from other clinical trials involving related drugs because each group of drug trials is conducted under different conditions.

Finally, it is important to emphasize that these tables do not reflect the relative severity and/or clinical importance of adverse events. For a better understanding of the serious adverse events associated with the use of Nabilone, see the Warnings and PRECAUTIONS sections.

The following tables list, in descending order of frequency, adverse reactions experienced by a significant proportion of Nabilone-treated patients enrolled in representative controlled clinical trials.

Frequency of adverse events in placebo-controlled trials

Frequency of adverse events in active control studies

reduced frequency in body systems for patients treated with Nabilone in controlled clinical trials. All events are listed regardless of causality score.

Blood and hematopoietics Anemia

Cardiovascular Orthostatic hypotension, hypotension, tachycardia, syncope, palpitations, flushing, hypertension, arrhythmia and cerebrovascular insufficiency.

Eye and Ear – Visual impairment, ear tightness, eye irritation, dry eyes, imbalance, tinnitus, visual disturbance, amblyopia, eye edema, eyelid disease, pupillary dilation, photophobia and visual field defect.

Gastrointestinal tract – Dry mouth, nausea, anorexia, vomiting, diarrhea, abdominal pain, constipation, canker sore, mouth irritation, gastritis and dyspepsia.

Genitourinary Increased urination, decreased urination, hot flashes, urinary retention and urinary frequency.

Infection – Bacterial infection

Metabolic and endocrine Thirst

Musculoskeletal system pain.

nervous system.

Psychiatric Euphoria (feeling “high”), sleep disturbance, depression, confusion, disorientation, anxiety, depersonalization syndrome, speech disorder, abnormal dreams, insomnia, mood swings, intoxicated feeling, toxic psychosis, paranoia, apathy, disorder thoughts, withdrawal symptoms, panic disorder, phobic neurosis, emotional distress, and hyperactivity.

Respiratory Shortness of breath, pharyngitis, nasal congestion, sinus headache, thick tongue, dry throat, dry nose, wheezing, nosebleed, cough, voice change and chest pain.

Skin and appendages Anhidrosis, photosensitivity, itching, rash and allergic reactions.

Miscellaneous and ill-defined conditions Headache, fatigue, lightheadedness, incoordination, asthesia, dysphoria, dizziness, change in taste, excessive appetite, chills, excessive sweating, nervousness, malaise, postural dizziness, twitching, irritability, fever, depression walking, loss of consciousness, hypotension and impaired urination.

Post-marketing adverse reactions Nabilone has been on the international market since 1982. Since the sale of Nabilone, the following adverse reactions have been reported, listed in decreasing order of frequency by body system. All events are listed regardless of causality score.

Blood and hematopoietic Leukopenia

Cardiovascular Hypotension and tachycardia

Eye and Ear – Visual impairment

Gastrointestinal tract – Dry mouth, nausea, vomiting and constipation

Nervous system. 02 Psychiatric Drowsiness, confusion, euphoria, depression, dysphoria, depersonalization, anxiety, psychosis, and emotional lability

Variable and ill-defined conditions Dizziness, headache, insomnia, abnormal thinking, chest pain, lack of effect, and swelling of the face

Drug abuse and dependence

Controlled substance

Nabilone, a synthetic cannabinoid pharmacologically related to Cannabis sativa L. (Marijuana; (delta-9-THC), is a highly reusable substance. Nabilone is controlled under Schedule II (CII) Controlled Substances Act Prescriptions for Nabilone must be limited to the amount needed for one cycle of chemotherapy (i.e., several days) Nabilone may cause subjective side effects that may be interpreted as euphoria or marijuana as “high” at therapeutic doses .

It is not known what proportion of people chronically exposed to nabilone or other cannabinoids will develop psychological or physical dependence. However, long-term use of these compounds has been associated with impairments in motivation, judgment, and cognition. However, it is not clear whether this is a manifestation of the underlying personalities of chronic users of this class of drugs, or whether cannabinoids are directly responsible for these effects. Abstinence syndrome has been reported after discontinuation of delta-9-THC at high doses of 200mg per day for 12-16 consecutive days. The acute phase was characterized by mental disorder, insomnia and signs of autonomic hyperactivity (drowning, rhinorrhea, loose stools, hiccups). An extended abstinence phase may have occurred in subjects who reported sleep disturbances within weeks of discontinuing delta-9-THC.

Abuse

Nabilone may cause subjective side effects that may be interpreted as euphoria or marijuana as “high” at therapeutic doses. Nabilone has been shown to be qualitatively and quantitatively similar to delta-9-THC while producing cannabis-like effects, indicating a high potential for abuse.

Preclinical studies in both dogs and monkeys have shown that nabilone is similar to a cannabinoid.