July 31, 2016
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Tamiflu

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Tamiflu




Indications
Dosage
How Supplied

INDICATIONS

Treatment Of Influenza

TAMIFLU 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.

Prophylaxis Of Influenza

TAMIFLU is indicated for the prophylaxis of influenza A and B in patients 1 year and older.

Limitations Of Use

  • TAMIFLU 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 TAMIFLU [see Microbiology].
  • TAMIFLU is not recommended for patients with end-stage renal disease not undergoing dialysis [see DOSAGE AND ADMINISTRATION and Use in Specific Populations].

DOSAGE AND ADMINISTRATION

Dosage And Administration Overview

Administer TAMIFLU for the treatment of influenza in patients 2 weeks of age or older [see Recommended Dosage for Treatment of Influenza] or for prophylaxis of influenza in patients 1 year and older [see Recommended Dosage for Prophylaxis of Influenza] using:

  • TAMIFLU capsules or
  • TAMIFLU 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 TAMIFLU powder must be constituted with water by the pharmacist to produce the oral suspension [see Preparation and Storage of Constituted TAMIFLU Oral Suspension].

The capsules and oral suspension may be taken with or without food; however, tolerability may be enhanced if TAMIFLU is taken with food.

Adjust the TAMIFLU dosage in patients with moderate or severe renal impairment [see Dosage in Patients with Renal Impairment].

For patients who cannot swallow capsules, TAMIFLU for oral suspension is the preferred formulation. When TAMIFLU for oral suspension is not available from wholesaler or the manufacturer, TAMIFLU capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup, corn syrup, caramel topping, or light brown sugar (dissolved in water). During emergency situations and when neither the oral suspension or the age-appropriate strengths of TAMIFLU capsules to mix with sweetened liquids are available, then a pharmacist may prepare an emergency supply of oral suspension from TAMIFLU 75 mg capsules [see Emergency Preparation of Oral Suspension from 75 mg TAMIFLU Capsules].

Recommended Dosage For Treatment Of Influenza

Initiate treatment with TAMIFLU within 48 hours of influenza symptom onset.

Adults and Adolescents (13 years of age and older)

The recommended oral dosage of TAMIFLU for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily (one 75 mg capsule or 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 TAMIFLU for treatment of influenza in pediatric patients 2 weeks of age through 12 years of age and provides information about prescribing the capsule or the formulation for oral suspension.

Recommended Dosage For Prophylaxis Of Influenza

Initiate post-exposure prophylaxis with TAMIFLU within 48 hours following close contact with an infected individual. Initiate seasonal prophylaxis with TAMIFLU during a community outbreak.

Adults and Adolescents (13 years of age and older)

The recommended dosage of TAMIFLU for prophylaxis of influenza in adults and adolescents 13 years and older is 75 mg orally once daily (one 75 mg capsule or 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, TAMIFLU may be continued for up to 12 weeks [see Use in Specific Populations]. The duration of protection lasts for as long as TAMIFLU dosing is continued.

Pediatric Patients (1 year to 12 years of age)

Table 1 displays the recommended oral dosage of TAMIFLU for prophylaxis of influenza in pediatric patients 1 year to 12 years of age based on body weight and provides information about prescribing the capsule or 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 and Clinical Studies].

Table 1 : TAMIFLU 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 Number of Capsules to Dispense (Strength)‡
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 Not applicable
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 10 capsules
(30 mg)
15.1 kg to 23 kg 45 mg twice daily 45 mg once daily 7.5 mL 2 bottles 10 capsules
(45 mg)
23.1 kg to 40 kg 60 mg twice daily 60 mg once daily 10 mL 2 bottles 20 capsules
(30 mg)
40.1 kg or more 75 mg twice daily 75 mg once daily 12.5 mL 3 bottles 10 capsules
(75 mg)
* 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 or capsules) 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.
‡ TAMIFLU for oral suspension is the preferred formulation for patients who cannot swallow capsules.
§ For patients less than 1 year of age, provide an appropriate dosing device that can accurately measure and administer small volumes.

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 and CLINICAL PHARMACOLOGY].

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 TAMIFLU is not recommended TAMIFLU is not recommended
* Capsules or 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.

Preparation And Storage Of Constituted TAMIFLU Oral Suspension

Prior to dispensing to the patient, constitute TAMIFLU for oral suspension (supplied as powder):

  1. Tap the closed bottle containing the supplied TAMIFLU white powder several times to loosen the powder.
  2. Measure 55 mL of water in a graduated cylinder.
  3. Add the total amount of water for constitution to the bottle.
  4. Close bottle with child-resistant cap tightly and shake the closed bottle well for 15 seconds.
  5. Label the bottle with instructions to “Shake Well Before Use”.
  6. The constituted oral suspension contains 360 mg of oseltamivir base per 60 mL of volume (6 mg per mL) and is white, tutti-frutti–flavored). Use the constituted oral suspension within 17 days of preparation when stored under refrigeration, 2° to 8°C (36° to 46°F), or within 10 days if stored at controlled room temperature, 25°C (77°F). Write the expiration date of the constituted oral suspension on the bottle label.
  7. 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).

Emergency Preparation Of Oral Suspension From 75 mg TAMIFLU Capsules

The following directions are provided for use only during emergency situations and when FDA-approved, commercially manufactured TAMIFLU for oral suspension is not available from wholesalers or the manufacturer.

The following emergency preparation instructions will provide one patient with enough TAMIFLU for a 5-day course of treatment of influenza or a 10-day course of prophylaxis of influenza:

Step #1: Determine the dosage of TAMIFLU for the patient [see DOSAGE AND ADMINISTRATION] then determine the total volume of oral suspension needed to be prepared (see Table 3).

Table 3 : Emergency Preparation: Volume of Prepared Oral Suspension (6 mg per mL) Based Upon TAMIFLU Dose

TAMIFLU Dose* Total Volume to Prepare per Patient
15 mg or less 37.5 mL
30 mg 75 mL
45 mg 100 mL
60 mg 125 mL
75 mg 150 mL
* If the TAMIFLU dose is between the doses listed, use the greater listed dose to determine the total volume of prepared oral suspension.

Step #2: Preparation must be performed with only one of the following vehicles (other vehicles have not been studied): Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. Determine the number of capsules and the amount of water and vehicle needed to prepare the total volume (see Table 3) of prepared oral suspension (6 mg per mL) for a complete treatment or prophylaxis course (see Table 4).

Table 4 : Emergency Preparation: Number of TAMIFLU 75 mg Capsules and Amount of Water and Vehicle Needed to Prepare the Total Volume of a Prepared Oral Suspension (6 mg per mL)

Total Volume of Prepared Oral Suspension 37.5 mL 75 mL 100 mL 125 mL 150 mL
Number of TAMIFLU 75 mg Capsules (Total Strength)* 3 (225 mg) 6 (450 mg) 8 (600 mg) 10 (750 mg) 12 (900 mg)
Amount of Water 2.5 mL 5 mL 7 mL 8 mL 10 mL
Volume of Vehicle Cherry Syrup (Humco®) OR Ora-Sweet® SF (Paddock Laboratories) OR simple syrup 34.5 mL 69 mL 91 mL 115 mL 137 mL
*Includes overage to ensure all doses can be delivered

Step #3: Follow the instructions below for preparing the 75 mg TAMIFLU capsules to produce the oral suspension (6 mg per mL):

  1. Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle (see Table 4). Constitution in other bottle types is not recommended because there is no stability data with other bottle types.
  2. Carefully separate the capsule body and cap and pour the contents of the required number of TAMIFLU 75 mg capsules into the PET or glass bottle.
  3. Gently swirl the suspension to ensure adequate wetting of the TAMIFLU powder for at least 2 minutes.
  4. Slowly add the specified amount of vehicle to the bottle.
  5. Close the bottle using a child-resistant cap and shake well for 30 seconds to completely dissolve the active drug and to ensure homogeneous distribution of the dissolved drug in the resulting suspension. The active drug, oseltamivir phosphate, readily dissolves in the specified vehicles. The suspension is caused by inert ingredients of TAMIFLU capsules which are insoluble in these vehicles.
  6. Put an ancillary label on the bottle indicating “Shake Well Before Use.”
  7. Instruct the parent or caregiver that any unused suspension remaining in the bottle following completion of therapy must be discarded by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions.
  8. Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, drug name and any other required information to be in compliance with all State and Federal Pharmacy Regulations. Place an appropriate expiration date on the label according to storage conditions below.
  9. Include the recommended dosage on the pharmacy label as per Tables 1 and 2.
  10. Store the prepared oral suspension in glass or PET bottles either:
  • In a refrigerator [2° to 8°C (36° to 46°F)]: Stable for 5 weeks when stored in a refrigerator.
  • At room temperature [25°C (77°F)]: Stable for 5 days when stored at room temperature.

HOW SUPPLIED

Dosage Forms And Strengths

TAMIFLU Capsules:

  • 30-mg (30 mg free base equivalent of the phosphate salt): light yellow, hard gelatin, with “ROCHE” printed in blue ink on the light yellow body and “30 mg” printed in blue ink on the light yellow cap.
  • 45-mg (45 mg free base equivalent of the phosphate salt): grey, hard gelatin, with “ROCHE” printed in blue ink on the grey body and “45 mg” printed in blue ink on the grey cap. 75-mg (75 mg free base equivalent of the phosphate salt): grey/light yellow, hard gelatin, with “ROCHE” is printed in blue ink on the grey body and “75 mg” printed in blue ink on the light yellow cap.

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

  • White powder blend for constitution.

Storage And Handling

TAMIFLU Capsules

30-mg capsules (30 mg free base equivalent of the phosphate salt): light yellow hard gelatin capsules. “ROCHE” is printed in blue ink on the light yellow body and “30 mg” is printed in blue ink on the light yellow cap. Available in blister packages of 10 (NDC 0004-0802-85).

45-mg capsules (45 mg free base equivalent of the phosphate salt): grey hard gelatin capsules. “ROCHE” is printed in blue ink on the grey body and “45 mg” is printed in blue ink on the grey cap. Available in blister packages of 10 (NDC 0004-0801-85).

75-mg capsules (75 mg free base equivalent of the phosphate salt): grey/light yellow hard gelatin capsules. “ROCHE” is printed in blue ink on the grey body and “75 mg” is printed in blue ink on the light yellow cap. Available in blister packages of 10 (NDC 0004-0800-85).

Storage

Store the capsules at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

TAMIFLU For Oral Suspension (Supplied as Powder)

Supplied as a white powder blend in a glass bottle. After constitution, the powder blend produces a white tutti-frutti–flavored oral suspension. After constitution with 55 mL of water, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL) [see DOSAGE AND ADMINISTRATION] (NDC 0004-0822-05).

Storage

Store dry powder at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Store constituted oral suspension under refrigeration for up to 17 days at 2° to 8°C (36° to 46°F). Do not freeze. Alternatively, store constituted oral suspension for up to 10 days at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Distributed by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Revised: June 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/30/2016

Indications
Dosage
How Supplied

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