Nabilone (Oral)

Nabilone is man-made cannabis used to treat severe vomiting and nausea when caused by cancer chemotherapy.

Overview

Nabilone is a form of cannabis (marijuana) used to treat severe cases of chemotherapy-induced vomiting and nausea when other forms of medication have been unable to control these symptoms. It was approved in the United States in 1985 by the FDA for this specific purpose, but marketing did not begin until 2006. As a capsule, nabilone is a man-made drug with similar natural substances found in marijuana which works by decreasing the signals in the brain that lead to nausea and vomiting.

Nabilone is intended for use under close supervision, particularly during initial use and with dosage adjustments for treatment of uncontrollable vomiting and nausea. As a controlled substance, nabilone has a high potential for abuse and prescriptions are limited to the necessary amount for a single chemotherapy cycle.

The patient must maintain a record of the amount of medicine used from each new bottle as this medication is a prescribed product and they should be aware if anyone else is using this medication inappropriately or without prescription. Alcohol, antihistamines, sedatives and other narcotics when used in conjunction with nabilone, will increase the effects of these medications in the patient, creating additional unwanted side effects.

A physician should monitor a patient on nabilone for signs of excessive abuse, use or misuse as patients who may have either a personal or family history of substance abuse may have reactions not observed with other antiemetic medications. Consequently, there is a possibility that nabilone (Cesamet) may become habit forming, especially if there is a history of drug abuse or continual marijuana use. Nabilone should never be used if a patient has had an allergic reaction to natural or man-made cannabis and must not share this medication with anyone else.

Although nabilone is primarily used as an antiemetic for chemotherapy patients, it has shown progress in the area of chronic pain management for patients who suffer from fibromyalgia, multiple sclerosis, treatment of anorexia and weight loss in patients with AIDS.

The patient must not increase their dose or use this medication for longer than necessary. In the event a patient decides to discontinue using this medication, withdrawal signs may occur. Their doctor may lower the dose in order to prevent these symptoms from occurring. This usually takes place when a patient has been using nabilone over a long period of time. The patient must tell their healthcare provider or pharmacist immediately if they have stopped taking this medication.

Conditions Treated

  • Chemotherapy-induced nausea and vomiting
  • Anorexia
  • Fibromyalgia

Type Of Medicine

  • Brand Name: Cesamet
  • Generic: Nabilone
  • Pharmacologic Category: Antiemetic

Chemical: Cannabinoid

Side Effects

Some medicines may create some unwanted or bothersome effects while a patient is adjusting to the product. While a number of these side effects may not take place, a patient should contact their healthcare professional as soon as possible if certain changes take place such as the following:

  • Breathing difficulties
  • Convulsions
  • Fast heart rate
  • Hallucinations
  • Nervousness
  • Severe mental changes
  • Unusual weakness

Whereas some side effects may not need medical attention, however, it is important that the patient check with their healthcare professional should any issues continue or if there is a question about the side effects:

More common

  • Clumsiness
  • Drowsiness
  • False sense of well-being
  • Headache pain
  • Poor concentration
  • Mouth dryness

Less common or rare

Dosage

The recommended dose of nabilone is 1mg or 2mg capsule given orally two times a day. A dose of 1mg or 2mg given the night before each sequence of chemotherapy may be helpful, but is not intended for use on an as needed basis or in place of other antiemetic medication.

Initial dose:

  • The dose should be given orally two to three times a day, one to three hours before the first dose of chemotherapy is administered
  • A lower starting dosage should be used to minimize side effects and can be increased as necessary

Maintenance dose:

  • This medication may be given two or three times a day during the entire course of each series of chemotherapy and, if necessary, for 48 hours after the last dose of each cycle

Maximum dose:

  • 2mg three times a day given orally

Adult dose:

  • 1 to 2mg twice daily starting with a lower dosage and increase as needed. May be administered two or three times a day during the entire course of chemotherapy and continue for up to 48 hours after the last chemotherapy dose. The maximum amount is 6mg a day divided into three doses. A dose of 1 to 2mg the evening before chemotherapy may also be beneficial to the patient.

Pediatric dose when nausea and vomiting are present

  • <18kg: 0.5mg every 12 hours
  • 18 to 30kg: 1mg every 12 hours
  • >30kg: 1mg every eight to 12 hours
  • Maximum dose: 0.06mg/kg per day

There are no dosage modifications for renal or hepatic impairment provided in the manufacturer's labeling which have been studied.

This medication should not be taken in larger or smaller amounts or for longer than recommended; therefore, the patient should follow all directions provided by their healthcare practitioner or from the prescription label. In the event of a missed dose, the medication should be taken as soon as possible unless it is time to take your next dose. The patient should never double dose with this medication.

The patient should obtain medical attention should an emergency arise or contact the Poison Help Line if overdose warnings occur. Overdose symptoms include extreme forms of some of the side effects such as an allergic reaction that may have been previously discussed with their physician.

If a patient stops using this medication, they might experience withdrawal symptoms, including trouble sleeping, sweating or irritability. The patient's healthcare practitioner may lower the dosage slowly in order to prevent these withdrawal symptoms as these problems may occur when the patient has been using this medicine for a longer period of time.

Major Drug Interactions:

Certain drugs may interact with Nabilone and there are a total of 560 drugs that are known to have major, moderate or minor interactions with this medication.

Major:

  • Acetaminophen
  • Aspirin
  • Buprenorphine
  • Darvocet
  • Darvon
  • Propoxyphene
  • Subutex
  • Trycet
  • Xyrem
  • Zubsolv

Other drug interactions:

  • Alcohol (Ethyl)
  • Alfuzosin
  • Amifostine
  • Anticholinergic agents
  • Benperidol
  • Blood pressure lowering medication
  • Brimonidine (topical)
  • CNS depressants
  • Cocaine
  • Diazoxide
  • DULoxetine
  • Herbs
  • Levodopa
  • Lormetazepam
  • Molsidomine
  • Naftopidil
  • Nicergoline
  • Nicorandil
  • Nitroprusside
  • Obinutuzumab
  • Pentoxifylline
  • Pholcodine
  • Phosphodiesterase 5 inhibitors
  • Prostacyclin analogues
  • Quinagolide
  • Sympathomimetics

Warnings

Patients with cardiovascular disease must proceed with caution when taking nabilone as it may cause tachycardia or hypotension. Nabilone may affect the central nervous system, therefore, it may impair mental or physical abilities, including operating machinery or driving a car.

Hallucinations, psychosis, dizziness, and depression have been reported with use of nabilone and must be used with caution in patients who have schizophrenia or depression. The patient's healthcare practitioner must carefully monitor the usage of nabilone as psychiatric disorders may become evident during this treatment.

Dryness of the mouth is one side effect of nabilone that has temporary relief with the use of sugarless gum or candy or a saliva replacement. Should dry mouth continue for over two weeks, the patient should check with their physician or dentist as the increase of dryness may create dental disease.

Nabilone interacts with alcohol and medications that make a patient drowsy or less mentally alert. The patient should advise their doctor if they are taking any medication, over-the-counter products, or vitamins that may interact with this product.

The safety and effectiveness of using nabilone in patients younger than 18 years old has not been established. Children may have more sensitivity to some side effects of this drug, including dizziness, lightheadedness and mental/ mood changes.

With the elderly, caution must be advised as it may cause excessive tiredness, weakness or feelings of lightheadedness in addition to the possibility of affecting the mind. Adverse effects have been observed in animal reproduction studies, but nothing has been established in human pregnancy. For that reason, it is not recommended for use during pregnancy or while breastfeeding. The patient needs to discuss if there is intent to breastfeed while on this medication as the benefits need to outweigh the risks.

Other medical problems

Other health problems may affect the use of this medication and it is important that the patient discusses with their physician if they have any of the following issues:

  • A history of alcohol abuse
  • Cardiac disease
  • Depression
  • Drug use or dependency
  • Emotional problems
  • Low blood pressure
  • Kidney issues
  • Liver problems
  • Schizophrenia
  • Severe mental illness

Storage

This medication is stored at 25 degrees C (77 degrees F) with deviations permitted to 15 degrees C and 30 degrees C (59 degrees F and 86 degrees F). Store this product at room temperature away from moisture and heat and keep from freezing.

As with all medication, it is advised to keep Nabilone out of the reach of children and pets.

Outdated medication or medicine that is no longer needed should be disposed based on the advice from your physician or pharmacist.

Summary

Nabilone is a synthetic cannabinoid with therapeutic use of neuropathic pain and while it may imitate THC, nevertheless, it has conventional side effects and does not cause elation. Before taking nabilone, the patient should discuss with their physician about any medications consumed, or allergies to cannabis or marijuana related products. Patients that have a history of liver or heart disease, high blood pressure, schizophrenia or a history of substance abuse should not take this product as it may worsen a condition.

This medication may affect mental alertness in addition to other side effects such as dizziness or mood changes. The dosage is based on the patient's condition and how they respond to treatment. The medication must be used regularly throughout the treatment cycle in order to get the most benefit; however, it should not be taken on an as needed basis.

Patients taking nabilone should remain attentive to the potential risk / benefit ratio and discuss with their healthcare practitioner if this is the right course of action to meet their medical needs.