Intravenous TAMIFLU

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COMPASSIONATE USE – CU 056 Intravenous TAMIFLU ® (oseltamivir) Other saline infusion solutions (e.g. Ringer’s Lactate Solution) have not been tested for compatibility. Oseltamivir is incompatible with reducing sugars i.e. glucose or fructose. Oseltamivir as a primary amine reacts with reducing sugars forming degradation products in situ. The reconstituted solution must not be co-administered or added to infusion solutions containing reducing sugars. The compatibility of oseltamivir has not been evaluated with any other IV drug. Therefore no IV medications can be co-administered with oseltamivir IV. 10.4. Systemic Monitoring during the Infusion Before the start of infusion: During the infusion and for 1 hour following the infusion: Blood pressure and heart rate for all patients. Adults and adolescents (13 years and older) Heart rate should be monitored with audible alarm limits (alarm limits depending on pre-infusion heart rates) using continuous telemetry. Additionally blood pressure must be measured at 15, 30, 60, 90 and 120 minutes following the start of the infusion and 60 minutes following the end of the infusion (approximately 180 minutes after the start of the infusion). Pulse oximetry may also be used per investigator discretion. Children (1 – 12 years) Heart rate should be monitored with audible alarm limits (alarm limits depending on pre-infusion heart rates and appropriate for age of patient) using continuous telemetry. Additionally in older children, blood pressure must be measured at 15, 30, 60, 90 and 120 minutes following the start of the infusion and 60 minutes following the end of the infusion (approximately 180 minutes after the start of the infusion). In toddlers and younger children, blood pressure may be monitored at the discretion of the physician. Pulse oximetry may be used per investigator discretion. The infusion must be held for all unexplained changes in heart rate, blood pressure or pulse oximetry. Compassionate Use 056 – Intravenous Tamiflu ® (oseltamivir) - Version 20 December 2011 10/15
COMPASSIONATE USE – CU 056 Intravenous TAMIFLU ® (oseltamivir) 10.5. Infusion Site Monitoring The pH of the initially reconstituted solution (with 1.1 mL of Water for Injection) is about 4 (specified as 3.0 - 5.0). After further dilution with normal saline solution to2 mg/mL the measured pH was approximately 4.6. At this dilution the medication is considered isotonic (osmolarity similar to that for 0.9% sodium chloride). Peripheral veins with comparatively slow blood flow may be irritated by extremes of pH. Phlebitis, thrombophlebitis or infiltration of the tissues may result with loss of the vein for therapy and possibly tissue damage . When catheters are positioned in the central veins, blood flow is fast and achieves rapid dilution of injected substances If the patient receives oseltamivir IV through a peripheral venous canula, the site of insertion of the canula must be examined periodically. If there are any reactions (thrombophlebitis, extravasation) at the site of insertion, the site of infusion must be changed. 11. WARNINGS AND PRECAUTIONS Drugs (e.g. probenecid), which inhibit OAT should not be co-administered with oseltamivir. Under no circumstances can oseltamivir be administered if the concentration exceeds 4 mg/mL. Please refer to Section 10.2. for additional information on the preparation of oseltamivir for IV infusion. OP should be administered over 2 hours. An infusion pump which can be programmed to accurately administer at the desired rate of infusion should be used. Residual OP in IV lines must be cleared gradually over several minutes (depending on the dead space of the line and the concentration of OP). PASSIVE DRIP INFUSION IS NOT ALLOWED. Oseltamivir must NEVER be administered by bolus (“IV push”) injection. Please refer Section to 10.3. for details on the administration of oseltamivir IV. Systemic monitoring with some combination of heart rate, blood pressure and oxygen saturation (pulse oximetry), based on the age of the patient is mandatory. If there are any unexplained changes in any of these parameters, the infusion must be withheld. Please refer to Section 0. for additional information. Compassionate Use 056 – Intravenous Tamiflu ® (oseltamivir) - Version 20 December 2011 11/15
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Intravenous TAMIFLU

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