Usual Adult Dose for Nausea/Vomiting - Chemotherapy Induced

Oral solution:

• Initial dose: 4.2 mg/m2 orally 1 to 3 hours prior to chemotherapy administration, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses a day
• Maintenance dose: May escalate dose by 2.1 mg/m2 increments during a chemotherapy cycle or at subsequent cycles if the initial dose is ineffective and there are no significant side effects
• Maximum dose: 12.6 mg/m2 per dose

Oral solution comments:

• The initial dose should be rounded to the nearest 0.1 mg increment, and may need to be rounded to the nearest 0.1 mL increment (for dosing with an oral syringe).
• Patients should be given the initial dose on an empty stomach at least 30 minutes before eating; subsequent doses may be given without regard to meals.
• Healthcare providers should consider decreasing the dose to 2.1 mg orally once a day 1 to 3 hours prior to chemotherapy to decrease the risk of adverse reactions.

Oral tablets:

• Initial dose: 5 mg/m2 orally 1 to 3 hours prior to chemotherapy administration, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses a day
• Maintenance dose: May escalate dose by 2.5 mg/m2 increments during a chemotherapy cycle or at subsequent cycles if the initial dose is ineffective and there are no significant side effects
• Maximum dose: 15 mg/m2 per dose

Oral tablet comments:

• Most patients respond to 5 mg given 3 or 4 times daily.
• Clinical trial data indicate escalating the dose above 7 mg/m2 increased the frequency of adverse effects with no additional antiemetic benefit.

Use: Treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments

Usual Adult Dose for Anorexia

Oral solution:

• Initial dose: 2.1 mg orally 2 times a day 1 hour before lunch and dinner; reduce dose to 2.1 mg orally once a day 1 hour before dinner or at bedtime for patients unable to tolerate 4.2 mg/day
• Maintenance dose: May increase dose to 2.1 mg/day or 4.2 mg/day orally (2.1 mg 1 hour before lunch and 4.2 mg 1 hour before dinner OR 4.2 mg 1 hour before lunch and 4.2 mg 1 hour before dinner) when adverse effects are absent/minimal or when further therapeutic effect is desired
• Maximum dose: 16.8 mg/day (8.4 mg orally 2 times a day)

Oral tablets:

• Initial dose: 2.5 mg orally 2 times a day 1 hour before lunch and dinner; reduce dose to 2.5 mg orally once a day 1 hour before dinner or at bedtime for patients unable to tolerate 5 mg/day
• Maintenance dose: May increase dose to 7.5 mg/day or 10 mg/day orally (2.5 mg before 1 hour before lunch and 5 mg 1 hour before dinner OR 5 mg 1 hour before lunch and 5 mg 1 hour before dinner) when adverse effects are absent/minimal or when further therapeutic effect is desired
• Maximum dose: 20 mg/day (10 mg orally 2 times a day)

Comments:

• The majority of patients in clinical trials were treated with oral tablet formulations of 5 mg/day, although the dosages ranged from 2.5 to 20 mg/day.
• If CNS symptoms (e.g., feeling high, dizziness, confusion, somnolence) occur, they usually resolve in 1 to 3 days with continued dosage.
• Early morning administration has been associated with an increased frequency of adverse reactions as compared to dosing later in the day.

Use: Appetite stimulant for anorexia associated with weight loss in AIDS patients

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Nausea/Vomiting-Chemotherapy Induced:

• Oral solution: Healthcare providers should consider initial doses of 2.1 mg/m2 orally once a day 1 to 3 hours before chemotherapy in geriatric patients to reduce the risk of CNS reactions.

Severe or Persistent CNS Symptoms (when treating anorexia in AIDS patients):

• Oral solution: 2.1 mg orally once a day 1 hour before dinner OR at bedtime
• Oral tablets: 2.5 mg orally once a day 1 hour before dinner OR at bedtime
• Doses should be given in the evening or at bedtime if symptoms continue to be a problem.

Precautions

Safety and efficacy have not been established in pediatric patients; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

US Controlled Substance:

• Schedule II (oral solution formulations)
• Schedule III (oral capsule formulations)

Dialysis

Data not available

Other Comments

Administration advice:

• Caution is recommended in dose escalation due to the significant increase of disturbing psychiatric symptoms at the maximum dose.
• Coadministration with phenothiazines (e.g., prochlorperazine) may result in improved efficacy, as compared to either drug alone, without additional toxicity.
• Dose individualization is recommended to achieve maximum treatment benefit.
• Therapy should be initiated at the lowest recommended dose and titrated to clinical response.
• Patients should drink a full glass of water after taking a dose of the oral solution.

Storage requirements:

• This drug should be packaged in a well-closed container, with unopened bottles kept refrigerated at 2 to 8 degrees Celsius (36 to 46 Fahrenheit), and protected from freezing.
• Oral solution formulations may be stored at 20 to 25C once opened for up to 28 days.

Reconstitution/preparation techniques: The manufacturer product information should be consulted for further details regarding the oral solution.

General:

• This drug demonstrates reversible, dose-related effects on appetite, mood, cognition, memory, and perception; these phenomena increase in frequency with higher dosages and are subject to great interpatient variability.
• Tachyphylaxis and tolerance develop to some of the pharmacologic effects of this drug and other cannabinoids with chronic use; however, they do not appear to develop to the appetite stimulant effect of this drug.
• The estimated lethal human dose is 30 mg/kg (IV).
• Overdosage: Gut decontamination is recommended for recent serious oral ingestion; the manufacturer product information should be consulted for overdose management.

Monitoring:

• Cardiovascular: Blood pressure and heart rate (after dose adjustments)
• Nervous System: Signs/symptoms of syncope (after dose adjustments); seizures

Patient advice:

• This drug may cause side effects such as dizziness and drowsiness that can affect your ability to perform certain activities; avoid driving and tasks such as operating machinery until you know that you can perform these activities safely during treatment.
• Do not drink alcohol while taking this drug.