Other antiemetics

Dronabinol

Approved 7 Feb 2020OralCapsule

The FDA lists this product in 15 strengths and forms.

Indications

Dronabinol capsules are 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. Dronabinol capsules are a cannabinoid indicated in adults for the treatment of: Anorexia associated with weight loss in patients with AIDS.

(1) Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. (1)

Contraindications

Dronabinol capsules, are contraindicated in patients with a 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 [see Adverse Reactions (6.2)] . History of a hypersensitivity reaction to dronabinol or sesame oil

Warnings and precautions

N e u r o p s y chiatric Adverse Reactions : May cause psychiatric and cognitive effects and impair mental and/or physical abilities. Avoid use in patients with a psychiatric history. Monitor for symptoms and avoid concomitant use of drugs with similar effects. Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that dronabinol capsules does not affect them adversely.

( 5.1 ) H e m o d y n amic Instability : Patients with cardiac disorders may experience hypotension, hypertension, syncope or tachycardia. Avoid concomitant use of drugs with similar effects and monitor for hemodynamic changes after initiating or increasing the dosage of dronabinol capsules. ( 5.2 ) S e izures and Seizure-like Activity : Weigh the potential risk versus benefits before prescribing dronabinol capsules to patients with a history of seizures, including those requiring anti-epileptic medication or with other factors that lower the seizure threshold.

Monitor patients and discontinue if seizures occur. ( 5.3 ) Mu lt iple Substance Abuse : Assess risk for abuse or misuse in patients with a history of substance abuse or dependence, prior to prescribing dronabinol capsules and monitor for the development of associated behaviors or conditions. ( 5.4 ) Paradoxical Nausea, Vomiting, or Abdominal Pain: Consider dose reduction or discontinuation, if worsening of symptoms while on treatment.

At a glance

Brand name: Dronabinol
Drug class: Other antiemetics
Route: Oral
Dosage form: Capsule
Applicant: Ascent Pharms Inc
Status: Prescription
FDA approval: 7 Feb 2020
Application: ANDA207421-002
RxCUI: 10402

Indications

(1) Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. (1)

Contraindications

Warnings and precautions

Interactions

I nh ibitors and inducers of CYP2C9 and CYP3A4 : May alter dronabinol systemic exposure; monitor for potential dronabinol-related adverse reactions or loss of efficacy. (7.3 ) H ighly protein-bound drugs : Potential for displacement of other drugs from plasma proteins; monitor for adverse reactions to concomitant highly protein-bound drugs and narrow therapeutic index drugs (e.g., warfarin, cyclosporine, amphotericin B) when initiating or increasing the dosage of dronabinol capsules.

( 7.4 )

7.1Additive CNS Effects Additive

CNS effects (e.g., dizziness, confusion, sedation, somnolence) may occur when dronabinol capsules are taken concomitantly with drugs that have similar effects on the central nervous system such as CNS depressants [see Warnings and Precautions (5.1)] .

7.2Additive Cardiac Effects

Additive cardiac effects (e.g., hypotension, hypertension, syncope, tachycardia) may occur when dronabinol capsules are taken concomitantly with drugs that have similar effects on the cardiovascular system [see Warnings and Precautions (5.2)] .

7.3Effect of Other Drugs on Dronabinol

Dronabinol is primarily metabolized by CYP2C9 and CYP3A4 enzymes based on published in vitro studies. Inhibitors of these enzymes may increase, while inducers may decrease, the systemic exposure of dronabinol and/or its active metabolite resulting in an increase in dronabinol-related adverse reactions or loss of efficacy of dronabinol capsules. Monitor for potentially increased dronabinol-related adverse reactions when dronabinol capsules are co-administered with inhibitors of CYP2C9 (e.g., amiodarone, fluconazole) and inhibitors of CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice).

7.4Highly Protein-Bound Drugs

Dronabinol is highly bound to plasma proteins, and therefore, might displace and increase the free fraction of other concomitantly administered protein-bound drugs. Although this displacement has not been confirmed in vivo , monitor patients for increased adverse reactions to narrow therapeutic index drugs that are highly protein-bound (e.g., warfarin, cyclosporine, amphotericin B) when initiating treatment or increasing the dosage of dronabinol capsules.

Adverse reactions

Most common adverse reactions (≥3%) are: abdominal pain, dizziness, euphoria, nausea, paranoid reaction, somnolence, thinking abnormal and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Camber Pharmaceuticals, Inc. at 1-866-495-8330 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following serious adverse reactions are described below and elsewhere in the labeling. Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.1)] Hemodynamic Instability [see Warnings and Precautions (5.2)] Seizures [see Warnings and Precautions (5.3)] Paradoxical Nausea, Vomiting, and Abdominal Pain [see Warnings and Precautions (5.5)] Studies of AIDS-related weight loss included 157 patients receiving dronabinol capsules at a dose of 2.5 mg twice daily and 67 receiving placebo.

Studies of nausea and vomiting related to cancer chemotherapy included 317 patients receiving dronabinol capsules and 68 receiving placebo. In the tables below is a summary of the adverse reactions in 474 patients exposed to dronabinol capsules in studies. Studies of different durations were combined by considering the first occurrence of events during the first 28 days. A cannabinoid dose-related “high” (easy laughing, elation and heightened awareness) has been reported by patients receiving dronabinol capsules in both the antiemetic (24%) and the lower dose appetite stimulant clinical trials (8%).

The most frequently reported adverse experiences in patients with AIDS during placebo-controlled clinical trials involved the CNS and were reported by 33% of patients receiving dronabinol capsules. About 25% of patients reported a CNS adverse reaction during the first 2 weeks and about 4% reported such a reaction each week for the next 6 weeks thereafter. adr

6.2Postmarketing Experience

The following adverse reactions have been identified during post-approval use of dronabinol capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General disorders and administration site conditions: Fatigue Hypersensitivity reactions: Lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness [see Contraindications (4)] Injury, poisoning and procedural complications: Fall [see Use in Specific Populations (8.5)] Nervous system disorders: Seizures [see Warnings and Precautions (5.3)] , disorientation, movement disorder, loss of consciousness Psychiatric disorders: Delirium, insomnia, panic attack Vascular disorders: Syncope [see Warnings and Precautions (5.2)]

Dronabinol

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Dronabinol

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Neuropsychiatric Adverse Reactions Psychiatric Adverse Reactions

5.2Hemodynamic Instability

5.3Seizures Seizure

5.5Paradoxical Nausea, Vomiting, or Abdominal Pain

Interactions

7.1Additive CNS Effects Additive

7.2Additive Cardiac Effects

7.3Effect of Other Drugs on Dronabinol

7.4Highly Protein-Bound Drugs

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information