Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse reactions (greater than 2%) with triclabendazole 20 mg/kg dose are abdominal pain, hyperhidrosis, nausea, decreased appetite, headache, urticaria, diarrhea, vomiting, musculoskeletal chest pain, and pruritus.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical 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 clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of triclabendazole was evaluated in 208 adult and pediatric patients 5 years of age and older who participated in 6 clinical trials for the treatment of fascioliasis and received 10 mg/kg or 20 mg/kg of triclabendazole;
of these, 6 patients failed the 10 mg/kg dose and were retreated with 20 mg/kg.
The 10 mg/kg dosing regimen is not approved [see Dosage and Administration (2)] .
In these trials, 186 patients received a single dose of 10 mg/kg and 28 patients received a dose of 20 mg/kg as two divided doses.
Pooled data for adverse reactions reported in more than 2% of the patients in these clinical trials for the 10 mg/kg and 20 mg/kg dosing regimens are presented in Table
Table 1: Adverse Reactions Occurring in >2% of Patients Who Received a Total of 10 mg/kg or 20 mg/kg Triclabendazole for Fascioliasis Treatment (Pooled Across 6 Studies) 1 Divided doses were given 6-48 hours apart.
2 Abdominal pain upper and abdominal pain.
5 WARNINGS AND PRECAUTIONS QT Prolongation : Prolongs QTc interval.
Monitor electrocardiogram (ECG) in patients with a history of QTc prolongation or with electrolyte imbalance like hypokalemia or who are taking medications which prolong the QTc interval, or on CYP1A2 inhibitors, or have hepatic impairment.
( 5.1 ) 5.1 QT Prolongation EGATEN prolongs the QTc interval [see Clinical Pharmacology (12.2)] .
The magnitude of QTc prolongation can increase with increasing treatment duration of EGATEN.
Administration of EGATEN concurrently with CYP1A2 inhibitors and use in patients with hepatic impairment may result in increased exposures of triclabendazole and/or its metabolites, and, therefore, may increase the risk for QT prolongation.
Like all medications, Egaten can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: