Indications and Important safety information1

INDICATION1

MARINOL® (dronabinol) is a cannabinoid indicated in adults for the treatment of:

  • Anorexia associated with weight loss in patients with acquired immune deficiency syndrome (AIDS).
  • Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

MARINOL is contraindicated in patients with a known history of a hypersensitivity reaction to dronabinol or sesame oil. Reported hypersensitivity reactions to dronabinol capsules include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, and throat tightness.

WARNINGS AND PRECAUTIONS

Neuropsychiatric Adverse Reactions

  • Dronabinol has been reported to exacerbate mania, depression, or schizophrenia. Avoid use in patients with a psychiatric history, or if the drug cannot be avoided, monitor patients for new or worsening psychiatric symptoms during treatment. Avoid concomitant use with other drugs with similar psychiatric effects.
  • Reduce the dose or discontinue MARINOL if signs or symptoms of cognitive impairment or altered mental state occur. Use with caution in elderly patients who may be more sensitive to the neurological and psychoactive effects of MARINOL.
  • Inform patients not to drive or operate machinery until it is reasonably certain that MARINOL does not affect them adversely. Avoid concomitant use of sedatives, hypnotics, or other psychoactive drugs because of the potential for additive CNS effects.

Hemodynamic Instability

  • Monitor patients for changes in blood pressure, heart rate, and syncope, as patients (especially the elderly or those with cardiac disorders) may experience or be at increased risk of these hemodynamic changes after initiation or increasing the dosage of MARINOL.
  • Avoid concomitant use of drugs associated with similar cardiac effects.

Seizures

  • Weigh the risks vs benefits of prescribing MARINOL in patients with a history of seizures, including those requiring anti-epileptic medications or with other factors that lower the seizure threshold.
  • Monitor patients with a history of seizure disorders for worsened seizure control, and discontinue MARINOL if seizures occur.

Multiple Substance Abuse

  • Assess risk for abuse or misuse prior to prescribing MARINOL in patients with a history of substance abuse or dependence (including alcohol or marijuana).
  • Monitor patients for the development of these behaviors or conditions.

Paradoxical Nausea, Vomiting, or Abdominal Pain

  • Monitor patients and ask caregivers about the development of worsening nausea, vomiting, or abdominal pain during MARINOL treatment.
  • Consider dose reduction or discontinuation in patients who develop worsening symptoms while on treatment.

ADVERSE REACTIONS

The most common adverse reactions in MARINOL clinical trials (≥3%) were: abdominal pain, abnormal thinking, dizziness, euphoria, nausea, paranoid reaction, somnolence, and vomiting.

Please click here for Full Prescribing Information for MARINOL Capsules.

Reference:
  1. MARINOL [package insert]. North Chicago, IL: AbbVie Inc.