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Anzemet (DOLASETRON)
Anzemet (Dolasetron) is a serotonin-3 receptor antagonist developed by Sanofi Aventis US and currently owned by Validus Pharms. It targets the 5-hydroxytryptamine receptor 3A and is a small molecule modality. FDA-approved in 1997 for post-operative nausea and vomiting, Anzemet is a non-generic, off-patent medication with no active Orange Book patents. Key safety considerations include its short half-life of 0.13 hours and 75% bioavailability. Anzemet is a valuable option for preventing post-operative nausea and vomiting.
At a glance
| Generic name | DOLASETRON |
|---|---|
| Sponsor | Validus Pharms |
| Drug class | Serotonin-3 Receptor Antagonist |
| Target | 5-hydroxytryptamine receptor 3A |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 1997 |
Approved indications
- Post-Operative Nausea and Vomiting
- Prevention of Post-Operative Nausea and Vomiting
Common side effects
- Headache
- Bradycardia
- Fatigue
- Diarrhea
- Pain
- Dyspepsia
- Tachycardia
- Chills/Shivering
- Dizziness
- Rash
- Increased sweating
- Constipation
Serious adverse events
- Ventricular fibrillation cardiac arrest
- Wide complex tachycardia/ventricular tachycardia
- Severe hypotension
- Severe bradycardia
- Syncope
- Anaphylactic reaction
- Pancreatitis
- Acute renal failure
- Bronchospasm
- Myocardial ischemia
Drug interactions
- High Risk QT Prolonging Agents
- flecainide
- quinidine
- verapamil
- ziprasidone
Key clinical trials
- Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (PHASE4)
- Efficacy of Dolasetron in Patients With Fibromyalgia (PHASE3)
- Dolasetron for the Prevention of CINV in Children With Acute Lymphoblastic Leukemia
- Evaluating the Efficacy and Safety of HSK21542 Injection in Chemotherapy-induced Nausea and Vomiting (PHASE2)
- Effect of Dexmedetomidine on Parturient Undergoing Elective Cesarean Section. (PHASE4)
- Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis (NA)
- A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC) (PHASE4)
- Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |