Oseltamivir Phosphate (Page 2 of 8)

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*†
Mild(>60-90 mL/minute) 75 mg twice daily for 5 days 75 mg once daily
Moderate(>30-60 mL/minute) 30 mg twice daily for 5 days 30 mg once daily
Severe(>10-30 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

* 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.

2.5 Preparation and Storage of Constituted Oseltamivir Phosphate Oral Suspension

Prior to dispensing to the patient, constitute oseltamivir phosphate for oral suspension (supplied as powder):
a) Tap the closed bottle containing the supplied oseltamivir phosphate for oral suspension white to light yellow powder several times to loosen the powder.
b) Measure 55 mL of water in a graduated cylinder.
c) Add the total amount of water for constitution to the bottle.
d) Close bottle with child‐resistant cap tightly and shake the closed bottle well for 15 seconds.
e) Label the bottle with instructions to “Shake Well Before Use”.
f) The constituted oral suspension contains 360 mg of oseltamivir base per 60 mL of volume (6 mg per mL) and is white to light yellow, tutu-Frutti flavored). Use the constituted oral suspension within 17 days of preparation when stored under refrigeration, 2º to 8ºC (36º to 46ºF), or within 10 days if stored at controlled room temperature, 25ºC (77ºF). Write the expiration date of the constituted oral suspension on the bottle label.
g) Ensure patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize the oral dosing dispenser and correctly measure the oral suspension as prescribed (see Tables 1 and 2).

3 DOSAGE FORMS AND STRENGTHS

Oseltamivir phosphate for Oral Suspension: 6 mg per mL (final concentration when constituted)

White to light yellow color powder for constitution to a white to light yellow color oral suspension. After constitution, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL).

4 CONTRAINDICATIONS

Oseltamivir phosphate is 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)].

5 WARNINGS AND PRECAUTIONS

5.1 Serious Skin/Hypersensitivity Reactions

Cases of anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme have been reported in postmarketing experience with oseltamivir phosphate. Stop oseltamivir phosphate and institute appropriate treatment if an allergic-like reaction occurs or is suspected. The use of oseltamivir phosphate is contraindicated in patients with known serious hypersensitivity to oseltamivir phosphate [see Contraindications (4) and Adverse Reactions (6.2)].

5.2 Neuropsychiatric Events


There have been postmarketing reports of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving oseltamivir phosphate [see Adverse Reactions (6.2)].Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on oseltamivir phosphate usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of oseltamivir phosphate to these events has not been established. Influenza can be associated with a variety of neurologic and behavioral symptoms that can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. Closely monitor oseltamivir phosphate -treated patients with influenza for signs of abnormal behavior. If neuropsychiatric symptoms occur, evaluate the risks and benefits of continuing oseltamivir phosphate for each patient.

5.3 Risk of Bacterial Infections

There is no evidence for efficacy of oseltamivir phosphate in any illness caused by pathogens other than influenza viruses. Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Oseltamivir phosphate has not been shown to prevent such complications.
Prescribers should be alert to the potential for secondary bacterial infections and treat them as appropriate.

5.4 Fructose Intolerance in Patients with Hereditary Fructose Intolerance

Fructose can be harmful to patients with hereditary fructose intolerance. One dose of 75 mg oseltamivir phosphate for oral suspension delivers 2 grams of sorbitol. This is above the daily maximum limit of sorbitol for patients with hereditary fructose intolerance, and may cause dyspepsia and diarrhea.

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed below and elsewhere in the labeling:

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