Oseltamivir Phosphate For Oral Suspension

OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION — oseltamivir phosphate powder, for suspension
Alvogen Inc.

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1 INDICATIONS AND USAGE

1.1 Treatment of Influenza

Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.

1.2 Prophylaxis of Influenza

Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older.

1.3 Limitations of Use

• Oseltamivir phosphate for oral suspension is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
• Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate for oral suspension [see Microbiology (12.4)].
• Oseltamivir phosphate for oral suspension is not recommended for patients with end-stage renal disease not undergoing dialysis [see Dosage and Administration (2.4) and Use in Specific Populations (8.6)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosage and Administration Overview

Administer oseltamivir phosphate for oral suspension for the treatment of influenza in patients 2 weeks of age or older [see Dosage and Administration (2.2)] or for prophylaxis of influenza in patients 1 year and older [see Dosage and Administration (2.3)] using:

• Oseltamivir phosphate for oral suspension (supplied as a powder). This is the preferred formulation (6 mg per mL) for patients who cannot swallow capsules. Prior to use, the supplied oseltamivir phosphate for oral suspension powder must be constituted with water by the pharmacist to produce the oral suspension [see Dosage and Administration (2.5)].

The oral suspension may be taken with or without food; however, tolerability may be enhanced if oseltamivir phosphate for oral suspension is taken with food.

Adjust the oseltamivir phosphate for oral suspension dosage in patients with moderate or severe renal impairment [see Dosage and Administration (2.4)].

2.2 Recommended Dosage for Treatment of Influenza

Initiate treatment with oseltamivir phosphate for oral suspension within 48 hours of influenza symptom onset.

Adults and Adolescents (13 years of age and older)

The recommended oral dosage of oseltamivir phosphate for oral suspension for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily (12.5 mL of oral suspension twice daily) for 5 days.

Pediatric Patients (2 weeks of age through 12 years of age)

Table 1 displays the recommended oral dosage of oseltamivir phosphate for oral suspension for treatment of influenza in pediatric patients 2 weeks of age through 12 years of age and provides information about prescribing the formulation for oral suspension.

2.3 Recommended Dosage for Prophylaxis of Influenza

Initiate post-exposure prophylaxis with oseltamivir phosphate for oral suspension within 48 hours following close contact with an infected individual. Initiate seasonal prophylaxis with oseltamivir phosphate for oral suspension during a community outbreak.

Adults and Adolescents (13 years of age and older)

The recommended dosage of oseltamivir phosphate for oral suspension for prophylaxis of influenza in adults and adolescents 13 years and older is 75 mg orally once daily (12.5 mL of oral suspension once daily) for at least 10 days following close contact with an infected individual and up to 6 weeks during a community outbreak. In immunocompromised patients, oseltamivir phosphate for oral suspension may be continued for up to 12 weeks [see Use in Specific Populations (8.9)]. The duration of protection lasts for as long as oseltamivir phosphate for oral suspension dosing is continued.

Pediatric Patients (1 year to 12 years of age)

Table 1 displays the recommended oral dosage of oseltamivir phosphate for prophylaxis of influenza in pediatric patients 1 year to 12 years of age based on body weight and provides information about prescribing the formulation for oral suspension. Prophylaxis in pediatric patients is recommended for 10 days following close contact with an infected individual and up to 6 weeks during a community outbreak [see Use in Specific Populations (8.4) and Clinical Studies (14.2)].

Table 1 Oseltamivir Phosphate for Oral Suspension Dosage Recommendations in Pediatric Patients for Treatment and Prophylaxis of Influenza

Weight	Treatment Dosage for 5 days	Prophylaxis Dosage for 10 days*	Volume of Oral Suspension (6 mg/mL) for each Dose†	Number of Bottles of Oral Suspension to Dispense
*The recommended duration for post-exposure prophylaxis is 10 days and the recommended duration for community outbreak (seasonal/pre-exposure) prophylaxis is up to 6 weeks (or up to 12 weeks in immunocompromised patients). The amount supplied (e.g., number of bottles) for seasonal prophylaxis may be greater than for post-exposure prophylaxis.†Use an oral dosing dispensing device that measures the appropriate volume in mL with the oral suspension. ‡For patients less than 1 year of age, provide an appropriate dosing device that can accurately measure and administer small volumes.
Patients from 2 Weeks to less than 1 Year of Age
Any weight	3 mg/kg twice daily	Not applicable	0.5 mL/kg‡	1 bottle
Patients 1 to 12 Years of Age Based on Body Weight
15 kg or less	30 mg twice daily	30 mg once daily	5 mL	1 bottle
15.1 kg to 23 kg	45 mg twice daily	45 mg once daily	7.5 mL	2 bottles
23.1 kg to 40 kg	60 mg twice daily	60 mg once daily	10 mL	2 bottles
40.1 kg or more	75 mg twice daily	75 mg once daily	12.5 mL	3 bottles

2.4 Dosage in Patients with Renal Impairment

Table 2 displays the dosage recommendations for the treatment and prophylaxis of influenza in adults with various stages of renal impairment (estimated creatinine clearance of less than or equal to 90 mL per minute). Dosage modifications are recommended in adults with an estimated creatinine clearance less than or equal to 60 mL per minute [see Use in Specific Population (8.6) and Clinical Pharmacology (12.3)].

Table 2 Recommended Dosage Modifications for Treatment and Prophylaxis of Influenza in Adults with Renal Impairment or End Stage Renal Disease (ESRD) on Dialysis

Renal Impairment(Creatinine Clearance)	Recommended Treatment Regimen*	Recommended Prophylaxis Regimen†
*Oral suspension can be used for 30 mg dosing. †The recommended duration for post-exposure prophylaxis is at least 10 days and the recommended duration for community outbreak (seasonal/pre-exposure) prophylaxis is up to 6 weeks (or up to 12 weeks in immunocompromised patients). ‡Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients.
Mild (>60 to 90 mL/minute)	75 mg twice daily for 5 days	75 mg once daily
Moderate (>30 to 60 mL/minute)	30 mg twice daily for 5 days	30 mg once daily
Severe (>10 to 30 mL/minute)	30 mg once daily for 5 days	30 mg every other day
ESRD Patients on Hemodialysis (≤10 mL/minute)	30 mg immediately and then 30 mg after every hemodialysis cycle (treatment duration not to exceed 5 days)	30 mg immediately and then 30 mg after alternate hemodialysis cycles
ESRD Patients on Continuous Ambulatory Peritoneal Dialysis‡ (≤10 mL/minute)	A single 30 mg dose administered immediately	30 mg immediately and then 30 mg once weekly
ESRD Patients not on Dialysis	Oseltamivir phosphate for oral suspension is not recommended	Oseltamivir phosphate for oral suspension is not recommended