Nabilone is a synthetic cannabinoid that acts centrally. It is used in the treatment of refractory nausea and vomiting and neuropathic pains.

Nabilone Uses:

• Refractory nausea and vomiting:

  • Used in the treatment of refractory nausea and vomiting associated with cancer chemotherapy in patients who have failed to adequately respond to conventional antiemetic regimens.

• Limitations of use:

  • Due to disturbing psychotomimetic reactions not observed with other antiemetic agents, nabilone should only be used for refractory nausea and vomiting.
  • Nabilone is intended for use under close supervision, particularly during initial use and with dose adjustments.
  • Nabilone is a schedule II controlled substance
  • Such substances have a high potential for abuse
  • Limit prescriptions to the amount necessary for a single chemotherapy cycle (eg, a few days).
  • Nabilone is not intended to be used on an as-needed basis or as an initial antiemetic agent.
  • Monitor patients receiving nabilone for signs of excessive use, abuse & misuse
  • Patients with a personal or familial history of substance misuse (including drug or alcohol abuse) or mental illness may be at a higher risk for substance abuse.

Nabilone dose in Adults

Nabilone dose in the treatment of refractory nausea and vomiting associated with cancer chemotherapy:

• Initial:
• 1 to 2 mg orally twice a day
• Begin with the lower dose in the range and increase if required
• May administer 2 or 3 times per day during the entire chemotherapy course
• Continue for up to 48 hours after the last chemotherapy dose.
• Maximum: 6 mg/day divided in 3 doses.
• A dose of 1 to 2 mg the night before chemotherapy may also be of benefit.

Guideline recommendations:

• American Society of Clinical Oncology:
  • Nausea or vomiting, refractory, or breakthrough:
    • Oral: 1 to 2 mg twice a day on days 1, 2, and 3.

Nabilone dose in the prevention of Chemotherapy-induced nausea and vomiting:

Note: Use in patients receiving moderate to highly emetogenic chemotherapy in whom corticosteroids are contraindicated:

• Infants, Children, and Adolescents:

  • <18 kg:
    • 0.5 mg orally BD
  • 18 to 30 kg:
    • 1 mg orally BD
  • >30 kg:
    • 1 mg orally tds

Pregnancy Risk Factor C

• Animal reproduction studies have shown that adverse events can be observed.

Use of Nabilone while breastfeeding

• Breastfeeding is not recommended because some cannabinoids may be excreted in breastmilk.

Nabilone Dose in Kidney Disease:

The manufacturer's labelling does not mention dosage modifications (has not been studied).

Nabilone Dose in Liver disease:

There are no dosage modifications listed on the manufacturer's label (has not been studied).

Common Side Effects of Nabilone:

• Central Nervous System:

  • Drowsiness
  • Dizziness
  • Vertigo
  • Euphoria
  • Ataxia
  • Depression
  • Lack Of Concentration
  • Sleep Disorder

• Gastrointestinal:

  • Xerostomia

• Ophthalmic:

  • Visual Disturbance

Less Common Side Effects Of Nabilone:

• Cardiovascular:

  • Hypotension

• Central Nervous System:

  • Dysphoria
  • Headache
  • Sedation
  • Depersonalization
  • Disorientation

• Gastrointestinal:

  • Anorexia
  • Nausea
  • Increased Appetite

• Neuromuscular & Skeletal:

  • Weakness

Side effects of Nabilone (frequency not known):

• Cardiovascular:

  • Cardiac Arrhythmia
  • Cerebrovascular Accident
  • Chest Pain
  • Flushing
  • Hypertension
  • Orthostatic Hypotension
  • Palpitations
  • Syncope
  • Tachycardia

• Central Nervous System:

  • Abnormal Dreams
  • Akathisia
  • Anxiety
  • Apathy
  • Chills
  • Confusion
  • Difficulty Thinking
  • Dystonia
  • Emotional Disturbance
  • Emotional Lability
  • Equilibrium Disturbance
  • Fatigue
  • Hallucination
  • Hyperactivity
  • Illusion
  • Insomnia
  • Malaise
  • Memory Impairment
  • Nervousness
  • Numbness
  • Pain
  • Psychoneurosis (Phobic)
  • Panic Disorder
  • Paranoia
  • Paresthesia
  • Psychological Disorder (Withdrawal)
  • Psychosis (Including Toxic)
  • Seizure
  • Speech Disturbance
  • Stupor
  • Voice Disorder

• Dermatologic:

  • Anhidrosis
  • Diaphoresis
  • Skin Photosensitivity
  • Pruritus
  • Skin Rash

• Endocrine & Metabolic:

  • Hot Flash
  • Increased Thirst

• Gastrointestinal:

  • Abdominal Pain
  • Aphthous Stomatitis
  • Constipation
  • Diarrhea
  • Dysgeusia
  • Dyspepsia
  • Gastritis
  • Mouth Irritation
  • Vomiting

• Genitourinary:

  • Altered Micturition (Decreased/Increased)
  • Urinary Retention

• Hematologic & Oncologic:

  • Anemia
  • Leukopenia

• Hypersensitivity:

  • Hypersensitivity Reaction

• Infection:

  • Infection

• Neuromuscular & Skeletal:

  • Arthralgia
  • Back Pain
  • Myalgia
  • Neck Pain
  • Tremor

• Ophthalmic:

  • Amblyopia
  • Eye Irritation
  • Mydriasis
  • Photophobia
  • Visual Field Defect
  • Xerophthalmia

• Otic:

  • Tinnitus

• Renal:

  • Polyuria

• Respiratory:

  • Cough
  • Dyspnea
  • Epistaxis
  • Nasal Congestion
  • Pharyngitis
  • Sinus Headache
  • Wheezing

• Miscellaneous:

  • Fever

Contraindications to Nabilone:

• Hypersensitivity to nabilone or other cannabinoids or any component of this formulation

Warnings and precautions

• Cardiovascular effects

  • Orthostatic hypotension and tachycardia may occur.
  • Patients with heart disease should be cautious.

• CNS effects

  • This may cause impairment of mental or physical abilities. Patients should be cautious about driving or operating machinery that requires mental alertness.
  • Reports of dizziness, drowsiness and depression have been made.
  • Patients with schizophrenia, depression, mania or mania should be treated with caution.
  • Cannabinoid usage may indicate psychiatric disorders.
  • It is important to monitor your psychiatric health carefully
  • After discontinuing treatment, psychiatric adverse reactions can persist up to three days.

• Substance abuse

  • Patients with a history or substance abuse should be cautious
  • There is potential for dependence.
  • With prolonged use, tolerance, psychological dependence, and physical dependence can occur.

Monitoring parameters:

• Blood pressure
• Heart rate
• Signs and symptoms of excessive use, abuse, or misuse
• Monitor for neurologic/psychiatric adverse events (eg, dysphoria/euphoria, somnolence, vertigo)

How to administer Nabilone?

• The initial dose (on day 1 of chemotherapy) should be given 1 - 3 hours before chemotherapy.
• Administer orally 2 to 3 times a day.

Mechanism of action of Nabilone:

• Antiemetic activity may be due to the effect on cannabinoid receptors (CB1) within the central nervous system.

Absorption:

• Rapid and complete

Distribution:

• ~12.5 L/kg

Metabolism:

• Extensively metabolized to several active metabolites by oxidation and stereospecific enzyme reduction
• CYP450 enzymes may also be involved

Half-life elimination:

• Parent compound: ~2 hours
• Metabolites: ~35 hours

Time to reach peak serum concentrations:

• Within 2 hours

Excretion:

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• Feces (~60%);
• renal (~24%)

International Brands of Nabilone:

• Cesamet
• ACT Nabilone
• PMS-Nabilone
• RAN-Nabilone
• TEVA-Nabilone

Nabilone Brand Names in Pakistan

No Brands Available in Pakistan.