Dronabinol

10MG, 2.5MG, 5MG capsuleVerenigde StatenIn de handelToegelaten op 27 jun 2008

Inhoud in het Engels

Openen in het registerVraag Osler ernaar

Indicaties

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)

Contra-indicaties

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

Waarschuwingen en voorzorgen

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.

Indicaties

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

Contra-indicaties

Waarschuwingen en voorzorgen

Interacties

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.

Bijwerkingen

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)]

Verpakking	Code	Status
DRONABINOL 10MG	ANDA079217-003	Discontinued
DRONABINOL 2.5MG	ANDA079217-001	Discontinued
DRONABINOL 5MG	ANDA079217-002	Discontinued
DRONABINOL 10MG	ANDA207421-003	Prescription
DRONABINOL 2.5MG	ANDA207421-001	Prescription
DRONABINOL 5MG	ANDA207421-002	Prescription
DRONABINOL 10MG	ANDA078292-003	Discontinued
DRONABINOL 2.5MG	ANDA078292-001	Discontinued
DRONABINOL 5MG	ANDA078292-002	Discontinued
DRONABINOL 10MG	ANDA201463-003	Discontinued
DRONABINOL 2.5MG	ANDA201463-001	Discontinued
DRONABINOL 5MG	ANDA201463-002	Discontinued
DRONABINOL 2.5MG	ANDA078501-001	Discontinued
DRONABINOL 5MG	ANDA078501-002	Discontinued
DRONABINOL 10MG	ANDA078501-003	Discontinued

Dronabinol

Indicaties

Contra-indicaties

Waarschuwingen en voorzorgen

Twee geneesmiddelen in één vraag?

Dronabinol

Indicaties

Contra-indicaties

Waarschuwingen en voorzorgen

Twee geneesmiddelen in één vraag?

5.1Neuropsychiatric Adverse Reactions Psychiatric Adverse Reactions

5.2Hemodynamic Instability

5.3Seizures Seizure

5.5Paradoxical Nausea, Vomiting, or Abdominal Pain

Interacties

7.1Additive CNS Effects Additive

7.2Additive Cardiac Effects

7.3Effect of Other Drugs on Dronabinol

7.4Highly Protein-Bound Drugs

Bijwerkingen

6.1Clinical Trials Experience

6.2Postmarketing Experience

In andere landen

Verpakkingen

Documenten

Bronnen en licenties

In het kort