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Product Code: 11597
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Enfluvir 75 mg ( Oseltamivir ) 10 capsules

Therapeutic Indications:

Treatment of influenza

Enfluvir 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.

Prevention of influenza

- 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 Enfluvir 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.

- Enfluvir is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak.

Enfluvir 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.

Dosage (Posology) and method of administration

Enfluvir hard capsules and Enfluvir suspension are bioequivalent formulations. 75 mg doses can be administered as either

- one 75 mg capsule or

- one 30 mg capsule plus one 45 mg capsule or

- by administering one 30 mg dose plus one 45 mg dose of suspension.

Commercially manufactured Enfluvir powder for oral suspension (6 mg/ml) is the preferred product for paediatric and adult patients who have difficulties swallowing capsules or where lower doses are needed.

Adults, and adolescents 13 years and over

Treatment: The recommended oral dose is 75 mg oseltamivir twice daily for 5 days for adolescents (13 to 17 years of age) and adults.

Body Weight

Recommended dose for 5 days

> 40 kg

75 mg twice daily

Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.

Post-exposure prevention: The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days for adolescents (13 to 17 years of age) and adults.

Body Weight

Recommended dose for 10 days

> 40 kg

75 mg once daily

Therapy should begin as soon as possible within two days of exposure to an infected individual.

Prevention during an influenza epidemic in the community: The recommended dose for prevention of influenza during a community outbreak is 75 mg oseltamivir once daily for up to 6 weeks.

Paediatric population

Children 1 to 12 years of age

Enfluvir 30 mg, 45 mg and 75 mg capsules and oral suspension are available for infants and children 1 year of age or older

Treatment: The following weight-adjusted dosing regimens are recommended for treatment of infants and children 1 year of age or older:

Body Weight

Recommended dose for 5 days

10 kg to 15 kg

30 mg twice daily

> 15 kg to 23 kg

45 mg twice daily

> 23 kg to 40 kg

60 mg twice daily

> 40 kg

75 mg twice daily

Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.

Post-exposure prevention: The recommended post-exposure prevention dose of Enfluvir is:

Body Weight

Recommended dose for 10 days

10 kg to 15 kg

30 mg once daily

> 15 kg to 23 kg

45 mg once daily

> 23 kg to 40 kg

60 mg once daily

> 40 kg

75 mg once daily

Prevention during an influenza epidemic in the community: Prevention during an influenza epidemic has not been studied in children below 12 years of age.

Infants 0 - 12 months of age

Treatment: 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. The following dosing regimen is recommended for treatment of infants 0 - 12 months of age:

Body weight*

Recommended dose for 5 days

3 kg

9 mg twice daily

4 kg

12 mg twice daily

5 kg

15 mg twice daily

6 kg

18 mg twice daily

7 kg

21 mg twice daily

8 kg

24 mg twice daily

9 kg

27 mg twice daily

10 kg

30 mg twice daily

Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.

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.

Post-exposure prevention: The recommended prophylaxis dose for infants less than 1 year of age during a pandemic influenza outbreak is half of the daily treatment dose:

Age

Recommended dose for 10 days

0 - 12 months

3 mg/kg once daily

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 in the community: Prevention during an influenza epidemic has not been studied in children 0-12 months of age.

Special populations

Hepatic impairment

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.

Renal impairment

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 nephrologist.

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.

Elderly

No dose adjustment is required, unless there is evidence of moderate or severe renal impairment.

Immunocompromised patients

Longer duration of seasonal prophylaxis up to 12 weeks has been evaluated in immunocompromised patients.

Method of administration

Oral use.

Patients who are unable to swallow capsules may receive appropriate doses of Enfluvir suspension.

Contraindications:

Special warnings and precautions for use:

Oseltamivir is effective only against illness caused by influenza viruses. There is no evidence for efficacy of oseltamivir in any illness caused by agents other than influenza viruses.

Enfluvir is not a substitute for influenza vaccination. Use of Enfluvir must not affect the evaluation of individuals for annual influenza vaccination. The protection against influenza lasts only as long as Enfluvir is administered. Enfluvir should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community.

Susceptibility of circulating influenza virus strains to oseltamivir has been shown to be highly variable. Therefore, prescribers should take into account the most recent information available on oseltamivir susceptibility patterns of the currently circulating viruses when deciding whether to use Enfluvir.

Severe concomitant condition

No information is available regarding the safety and efficacy of oseltamivir in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalisation.

Immunocompromised patients

The efficacy of oseltamivir in either treatment or prophylaxis of influenza in immunocompromised patients has not been firmly established.

Cardiac / respiratory disease

Efficacy of oseltamivir in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population.

Paediatric population

No data allowing a dose recommendation for premature children (< 36 weeks post-conceptual age) are currently available.

Severe renal impairment

Dose adjustment is recommended for both treatment and prevention in adolescents (13 to 17 years of age) and adults with severe renal impairment. There is insufficient clinical data available in infants and children (1 year of age or older) with renal impairment to be able to make any dosing recommendation.

Neuropsychiatric events

Neuropsychiatric events have been reported during administration of Enfluvir in patients with influenza, especially in children and adolescents. These events are also experienced by patients with influenza without oseltamivir administration. Patients should be closely monitored for behavioural changes, and the benefits and risks of continuing treatment should be carefully evaluated for each patient.

Effects on ability to drive and use machines

Enfluvir has no influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile

In adults/adolescents, the most commonly reported adverse reactions (ARs) were nausea and vomiting in the treatment studies, and nausea in the prevention studies. The majority of these ARs were reported on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 days. In children, the most commonly reported adverse reaction was vomiting. In the majority of patients, these ARs did not lead to discontinuation of Enfluvir.

The following serious adverse reactions have been rarely reported since oseltamivir has been marketed: Anaphylactic and anaphylactoid reactions, hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice), angioneurotic oedema, Stevens-Johnson syndrome and toxic epidermal necrolysis, gastrointestinal bleeding and neuropsychiatric disorders.

Treatment and prevention of influenza in adults and adolescents:

The safety profile reported in subjects who received the recommended dose of Enfluvir for prophylaxis (75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the treatment studies, despite a longer duration of dosing in the prophylaxis studies.

Adverse reactions in studies investigating Enfluvir for treatment and prevention of influenza in adults and adolescents or through post-marketing surveillance

Infections and infestations

Bronchitis,

Herpes simplex,

Nasopharyngitis,

Upper respiratory tract infections,

Sinusitis

Blood and lymphatic system disorders

Thrombocytopenia

Immune system disorders

Hypersensitivity reaction

Anaphylactic reactions,

Anaphylactoid reactions

Psychiatric disorders

Agitation,

Abnormal behaviour,

Anxiety,

Confusion,

Delusions, Delirium,

Hallucination,

Nightmares,

Self-injury

Nervous system disorders

Headache

Insomnia

Altered level of consciousness,

Convulsion

Eye disorders

Visual disturbance

Cardiac disorders

Cardiac arrhythmia

Respiratory, thoracic and mediastinal disorders

Cough,

Sore throat,

Rhinorrhea

Gastrointestinal disorders

Nausea

Vomiting

Abdominal pain (incl. upper abdominal pain),

Dyspepsia

Gastrointestinal bleedings,

Haemorrhagic colitis

Hepatobiliary disorders

Elevated liver enzymes

Fulminant hepatitis,

Hepatic failure,

Hepatitis

Skin and subcutaneous tissue disorders

Eczema,

Dermatitis,

Rash,

Urticaria

Angioneurotic oedema,

Erythema multiforme,

Stevens-Johnson syndrome,

Toxic epidermal necrolysis

General disorders and administration site conditions

Pain

Dizziness (incl. vertigo),

Fatigue,

Pyrexia,

Pain in limb

Description of selected adverse reactions

Psychiatric disorders and nervous system disorders

Influenza can be associated with a variety of neurologic and behavioural symptoms which can include events such as hallucinations, delirium, and abnormal behaviour, 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.

In patients with influenza who were receiving Enfluvir, there have been postmarketing reports of convulsions and delirium (including symptoms such as altered level of consciousness, confusion, abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares), in a very few cases resulting in self-injury or fatal outcomes. These events were reported primarily among paediatric and adolescent patients and often had an abrupt onset and rapid resolution. The contribution of Enfluvir to those events is unknown. Such neuropsychiatric events have also been reported in patients with influenza who were not taking Enfluvir.

Hepato-biliary disorders

Hepato-biliary system disorders, including hepatitis and elevated liver enzymes in patients with influenza-like illness. These cases include fatal fulminant hepatitis/hepatic failure.

Other special populations

Paediatric population (infants less than one year of age)

Epidemiological databases research and postmarketing reports suggest that the safety profile in infants less than one year of age is similar to the established safety profile of children aged one year and older.

Older people and patients with chronic cardiac and/or respiratory disease

In general, the safety profile in the patients at risk was qualitatively similar to that in otherwise healthy adults/adolescents.

Immunocompromised patients

In a 12-week prophylaxis study in 475 immunocompromised patients, including 18 children 1 to 12 years of age and older, the safety profile in the 238 patients who received oseltamivir was consistent with that previously observed in Enfluvir prophylaxis clinical studies.

Children with pre-existing bronchial asthma

In general, the adverse reaction profile in children with pre-existing bronchial asthma was qualitatively similar to that of otherwise healthy children.

Overdose

Reports of overdoses with Enfluvir have been received from clinical trials and during post-marketing experience. In the majority of cases reporting overdose, no adverse events were reported.

No specific antidote is known.

Paediatric population

Overdose has been reported more frequently for children than adults and adolescents. Caution should be exercised when preparing Enfluvir oral suspension and when administering Enfluvir products to children.

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