Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.
Post-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community.
The appropriate use of Tamiflu for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.
Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2).
Tamiflu is not a substitute for influenza vaccination.
The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations (see section 5.1).
Tamiflu suspension and Tamiflu hard capsules are bioequivalent formulations. 75 mg doses can be administered as either
Adults, adolescents or children (>40 kg) who are able to swallow capsules may receive appropriate doses of Tamiflu capsules.
Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
For adolescents (13 to 17 years of age) and adults: The recommended oral dose is 75 mg oseltamivir twice daily for 5 days.
For infants and children1 year of age or older: The recommended dose of Tamiflu 6 mg/ml oral suspension is indicated in the table below. Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu 6 mg/ml suspension.
The following weight-adjusted dosing regimens are recommended for infants and children 1 year of age or older:
| Body weight | Recommended dose for 5 days | Amount of oral suspension to withdraw |
|---|---|---|
| 10 kg to 15 kg | 30 mg twice daily | 5 ml twice daily |
| >15 kg to 23 kg | 45 mg twice daily | 7.5 ml twice daily |
| >23 kg to 40 kg | 60 mg twice daily | 10 ml twice daily |
| >40 kg | 75 mg twice daily | 12.5 ml twice daily |
Children weighing >40 kg and who are able to swallow capsules may receive treatment with the adult dosage of 75 mg capsules twice daily for 5 days as an alternative to the recommended dose of Tamiflu suspension.
For infants less than 1 year of age: The recommended treatment dose for infants 0-12 months of age is 3 mg/kg twice daily. This is based upon pharmacokinetic and safety data indicating that this dose in infants 0-12 months provides plasma concentrations of the pro-drug and active metabolite that are anticipated to be clinically efficacious with a safety profile comparable to that seen in older children and adults (see section 5.2).
A 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing children 0-12 months of age requiring 1 ml to 3 ml of Tamiflu 6 mg/ml oral suspension. For higher doses the 10 ml syringe should be used. The following dosing regimen is recommended for treatment of infants below 1 year of age.
Dosing table of oseltamivir for children less than 1 year of age: 3 mg/kg twice daily:
| Body Weight* | Recommended dose for 5 days | Amount of oral suspension to withdraw | Dispenser size to use |
|---|---|---|---|
| 3 kg | 9 mg twice daily | 1.5 ml twice daily | 3 ml |
| 3.5 kg | 10.5 mg twice daily | 1.8 ml twice daily | 3 ml |
| 4 kg | 12 mg twice daily | 2.0 ml twice daily | 3 ml |
| 4.5 kg | 13.5 mg twice daily | 2.3 ml twice daily | 3 ml |
| 5 kg | 15 mg twice daily | 2.5 ml twice daily | 3 ml |
| 5.5 kg | 16.5 mg twice daily | 2.8 ml twice daily | 3 ml |
| 6 kg | 18 mg twice daily | 3.0 ml twice daily | 3 ml |
| >6-7 kg | 21 mg twice daily | 3.5 ml twice daily | 10 ml |
| >7-8 kg | 24 mg twice daily | 4.0 ml twice daily | 10 ml |
| >8-9 kg | 27 mg twice daily | 4.5 ml twice daily | 10 ml |
| >9-10 kg | 30 mg twice daily | 5.0 ml twice daily | 10 ml |
* This table is not intended to contain all possible weights for this population.
This dosing recommendation is not intended for premature infants, i.e. those with a post-conceptual age less than 36 weeks. Insufficient data are available for these patients, in whom different dosing may be required due to the immaturity of physiological functions.
For adolescents (13 to 17 years of age) and adults: The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days. Therapy should begin as soon as possible within two days of exposure to an infected individual.
For infants and children 1 year of age or older: Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu 6 mg/ml suspension.
The recommended post-exposure prevention dose of Tamiflu is:
| Body weight | Recommended dose for 10 days | Amount of oral suspension to withdraw |
|---|---|---|
| 10 kg to 15 kg | 30 mg once daily | 5 ml once daily |
| >15 kg to 23 kg | 45 mg once daily | 7.5 ml once daily |
| >23 kg to 40 kg | 60 mg once daily | 10 ml once daily |
| >40 kg | 75 mg once daily | 12.5 ml once daily |
Children weighing >40 kg and who are able to swallow capsules may receive prophylaxis with a 75 mg capsule once daily for 10 days as an alternative to the recommended dose of Tamiflu suspension.
For infants less than 1 year of age: The recommended prophylaxis dose for infants less than 12 months during a pandemic influenza outbreak is half of the daily treatment dose. This is based upon clinical data in children >1 year of age and adults showing that a prophylaxis dose equivalent to half the daily treatment dose is clinically efficacious for the prevention of influenza (see Section 5.2 for exposure simulation).
In case of a pandemic, a 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing children below 1 year of age requiring 1 ml to 3 ml of Tamiflu 6 mg/ml oral suspension. For higher doses the 10 ml syringe should be used.
The following dosing regimen is recommended for infants less than 1 year of age.
Dosing table of oseltamivir for children below one year of age: 3 mg/kg once daily:
| Body Weight* | Recommended dose for 10 days | Amount of oral suspension to withdraw | Dispenser size |
|---|---|---|---|
| 3 kg | 9 mg once daily | 1.5 ml once daily | 3 ml |
| 3.5 kg | 10.5 mg once daily | 1.8 ml once daily | 3 ml |
| 4 kg | 12 mg once daily | 2.0 ml once daily | 3 ml |
| 4.5 kg | 13.5 mg once daily | 2.3 ml once daily | 3 ml |
| 5 kg | 15 mg once daily | 2.5 ml once daily | 3 ml |
| 5.5 kg | 16.5 mg once daily | 2.8 ml once daily | 3 ml |
| 6 kg | 18 mg once daily | 3.0 ml once daily | 3 ml |
| >6-7 kg | 21 mg once daily | 3.5 ml once daily | 10 ml |
| >7-8 kg | 24 mg once daily | 4.0 ml once daily | 10 ml |
| >8-9 kg | 27 mg once daily | 4.5 ml once daily | 10 ml |
| >9-10 kg | 30 mg once daily | 5.0 ml once daily | 10 ml |
* This table is not intended to contain all possible weights for this population.
This dosing recommendation is not intended for premature infants, i.e. those with a post-conceptual age less than 36 weeks. Insufficient data are available for these patients, in whom different dosing may be required due to the immaturity of physiological functions.
Prevention during an influenza epidemic has not been studied in children below 12 years of age. The recommended dose for adults and adolescents for prevention of influenza during a community outbreak is 75 mg oseltamivir once daily for up to 6 weeks.
No dose adjustment is required either for treatment or for prevention in patients with hepatic dysfunction. No studies have been carried out in paediatric patients with hepatic disorder.
Treatment of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years of age) with moderate or severe renal impairment. Recommended doses are detailed in the table below.
| Creatinine clearance | Recommended dose for treatment |
|---|---|
| >60 (ml/min) | 75 mg twice daily |
| >30 to 60 (ml/min) | 30 mg (suspension or capsules) twice daily |
| >10 to 30 (ml/min) | 30 mg (suspension or capsules) once daily |
| ≤10 (ml/min) | Not recommended (no data available) |
| Haemodialysis patients | 30 mg after each haemodialysis session |
| Peritoneal dialysis patients* | 30 mg (suspension or capsules) single dose |
* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used. Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist.
Prevention of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years of age) with moderate or severe renal impairment as detailed in the table below.
| Creatinine clearance | Recommended dose for prevention |
|---|---|
| >60 (ml/min) | 75 mg once daily |
| >30 to 60 (ml/min) | 30 mg (suspension or capsules) once daily |
| >10 to 30 (ml/min) | 30 mg (suspension or capsules) every second day |
| ≤10 (ml/min) | Not recommended (no data available) |
| Haemodialysis patients | 30 mg after every second haemodialysis session |
| Peritoneal dialysis patients* | 30 mg (suspension or capsules) once weekly |
* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used. Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologis t.
There is insufficient clinical data available in infants and children (12 years of age and younger) with renal impairment to be able to make any dosing recommendation.
No dose adjustment is required, unless there is evidence of moderate or severe renal impairment.
Treatment: The recommended oral dose is 75 mg oseltamivir twice daily for 10 days for adults (see sections 4.4, 4.8 and 5.1). Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
Seasonal prophylaxis: Longer duration of seasonal prophylaxis up to 12 weeks has been evaluated in immunocompromised patients (see sections 4.4, 4.8 and 5.1).
For dosing, a 3 ml and 10 ml oral dispenser is provided in the box. It is recommended that Tamiflu powder for oral suspension be constituted by a pharmacist prior to dispensing to the patient (see section 6.6).
Reports of overdoses with Tamiflu have been received from clinical trials and during post-marketing experience. In the majority of cases reporting overdose, no adverse events were reported.
Adverse events reported following overdose were similar in nature and distribution to those observed with therapeutic doses of Tamiflu, described in section 4.8 Undesirable effects.
No specific antidote is known.
Overdose has been reported more frequently for children than adults and adolescents. Caution should be exercised when preparing Tamiflu oral suspension and when administering Tamiflu products to children.
Shelf life: 4 years.
After reconstitution, store below 25°C for 10 days.
Do not store above 30°C.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
100 ml amber glass bottle (with child-resistant polypropylene screw cap, outer part: polyethylene; inner part: polypropylene; liner: polyethylene) with 13 g of powder for oral suspension, a plastic adapter (low density polyethylene), plastic 3 ml oral dispenser (0.1 ml graduation) and 10 ml oral dispenser (0.5 ml graduation) (barrel and plunger: polypropylene, silicon based seal ring) and a plastic measuring cup (polypropylene).
Pack-size of one bottle.
It is recommended that Tamiflu oral suspension should be reconstituted by the pharmacist prior to being dispensed to the patient.
After reconstitution with 55 ml of water, the usable volume of oral suspension allows for the retrieval of a total of 10 doses of 30 mg oseltamivir.
Preparation of oral suspension:
Tamiflu powder for suspension will appear as an opaque and white to light yellow suspension after reconstitution.
Any unused product or waste material should be disposed of in accordance with local requirements.
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