Intravenous TAMIFLU

COMPASSIONATE USE – CU 056
Intravenous TAMIFLU ® (oseltamivir)
4. DRUG ELIGIBILITY CRITERIA FOR THIS CU PROGRAM
This product is actually under evaluation in clinical trials. On January 21 2010, the
CHMP granted positive opinion for a Compassionate use program of Tamiflu intravenous
formulation within the EU.
5. SCOPE AND PATIENTS ELIGIBILITY CRITERIA FOR THIS CU PROGRAM
IV oseltamivir should be considered only to treat critically ill adults and children older
than 1 year of age with acute severe illness due to suspected or confirmed pandemic
(H1N1) infection or infection due to seasonal influenza A or B virus.
Specifically, oseltamivir infusion should only be used for the following patients who are
admitted to a hospital and under the care or consultation of a licensed clinician (skilled in
the diagnosis and management of patients with potentially life-threatening illness and the
ability to recognise and manage medication-related adverse events):
Adult or paediatric patients > 1 year of age with severe influenza illness for
whom therapy with an IV agent is clinically indicated, based upon one or more of
the following reasons:
(1) patient not responding to either oral or inhaled authorised antiviral
medication, or
(2) drug delivery by a route other than IV (e.g. enteral oseltamivir or inhaled
zanamivir) is not expected to be dependable or is not feasible, or
The patient or legally authorized consent giver should provide written consent; for
unconscious patients unable to provide consent for treatment with oseltamivir IV a
surrogate decision maker must sign for the patient.
Pregnant patients may be considered for treatment with oseltamivir IV only if the
potential benefit justifies the potential risk to the fetus.
For infants below 1 year of age, no dose recommendations can be provided, given the
lack of data. Should a physician decide to treat an infant < 1 year of age, based upon a
benefit /risk assessment, the doses which will be investigated in clinical study NP25138
are provided in Section 9 for information.
Oseltamivir IV should not be used in patients on probenecid as probenecid inhibits OAT
function.
Oseltamivir IV should not be administered to patients with clinical evidence of severe
hepatic decompensation or with a history of allergy to the medication.
In case of renal impairment, special dosing instructions must be followed (see further).
Compassionate Use 056 – Intravenous Tamiflu ® (oseltamivir) - Version 20 December
2011
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