Amneal Pharmaceuticals Private Limited

Clinical summary

Indications and usage Oseltamivir phosphate capsules are an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2) Limitations of Use : Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3) Standard dosing Treatment of influenza Adults and adolescents (13 years and older): 75 mg twice daily for 5 days. ( 2.2 ) Pediatric patients 1 to 12 years of age: Based on weight twice daily for 5 days. ( 2.2 ) Pediatric patients 2 weeks to less than 1 year of age: 3 mg/kg twice daily for 5 days. ( 2.2 ) Renally impaired adult patients (creatinine clearance > 30 to 60 mL/min): Reduce to 30 mg twice daily for 5 days. ( 2.4) Renally impaired adult patients (creatinine clearance > 10 to 30 mL/min): Reduce to 30 mg once daily for 5 days. (2.4) ESRD patients on hemodialysis: Reduce to 30 mg immediately and then 30 mg after every hemodialysis cycle. Treatment duration not to exceed 5 days. (2.4) ESRD patients on CAPD: Reduce to a single 30 mg dose immediately. (2.4) Prophylaxis of influenza Adults and adolescents (13 years and older): 75 mg once daily for at least 10 days. ( 2.3 ) Community outbreak: 75 mg once daily for up to 6 weeks. ( 2.3 ) Pediatric patients 1 to 12 years of age: Based on weight once daily for 10 days. ( 2.3 ) Community outbreak: Based on weight once daily for up to 6 weeks. ( 2.3 ) Renally impaired adult patients (creatinine clearance > 30 to 60 mL/min): Reduce to 30 mg once daily. (2.4) Renally impaired adult patients (creatinine clearance > 10 to 30 mL/min): Reduce to 30 mg once every other day. (2.4) ESRD patients on hemodialysis: Reduce to 30 mg immediately and then 30 mg after alternate hemodialysis cycles for the recommended duration of prophylaxis. (2.4) ESRD patients on CAPD: Reduce to 30 mg immediately and then 30 mg once weekly for the recommended duration of prophylaxis. (2.4) Contraindications Oseltamivir phosphate capsules are contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme [see Warnings and Precautions (5.1) ] . Key warnings Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue oseltamivir phosphate and initiate appropriate treatment if allergic-like reactions occur or are suspected. (5.1) Neuropsychiatric events: Patients with influenza, including those receiving oseltamivir phosphate, particularly pediatric patients, may be at an increased risk of confusion or abnormal behavior early in their illness. Monitor for signs of abnormal behavior. (5.2) Drug interactions Live attenuated influenza vaccine (LAIV), intranasal: Avoid administration of LAIV within 2 weeks before or 48 hours after oseltamivir phosphate use, unless medically indicated. (7) Pregnancy guidance Risk Summary There are no adequate and well-controlled studies with oseltamivir phosphate in pregnant women to inform a drug‐associated risk of adverse developmental outcomes. Available published epidemiological data suggest that oseltamivir phosphate, taken in any trimester, is not associated with an increased risk of birth defects. However, these studies individually are limited by small sample sizes, use of different comparison groups, and some lacked information on dose, which preclude a definitive assessment of the risk [see Data and Clinical Pharmacology (12.3) ] . In animal reproduction studies with oseltamivir, no adverse developmental effects were observed at clinically relevant exposures (see Data) . The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes including maternal death, still births, birth defects, preterm delivery, low birth weight and small for gestational age. Data Human Data Published prospective and retrospective observational studies of more than 5,000 women exposed to oseltamivir phosphate during pregnancy, including more than 1,000 women exposed in the first trimester, s