Veklury® (remdesivir)

Compatibility with Alternative Diluents

This document summarizes available information regarding Veklury® (remdesivir [RDV]) and compatibility with alternative diluents.

Some data may be outside of the US FDA-approved Prescribing Information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA approved prescribing information.

The full indication, important safety information, and boxed warnings are available at: www.gilead.com/-/media/files/pdfs/medicines/covid-19/veklury/veklury_pi

Reconstitution with Alternative Diluents

Only use SWFI to reconstitute RDV for Injection, 100 mg (lyophilized powder).1 Please refer to your local label for full dose preparation instructions.

• Reconstitution with D5W and NS resulted in hypertonic drug solutions with higher osmolality compared to reconstitution with SWFI (Table 1).2
• Use SWFI for reconstitution to minimize osmolality of the drug product solution before it is further diluted.2

Table 1. Osmolality of the Reconstituted Solution2

aAverage ± standard deviation of osmolality from 3 measurements using freezing point osmometer.

Reconstitution When SWFI is Unavailable

RDV for Injection, 100 mg is recommended to be reconstituted with SWFI prior to further dilution into NS.1

If the preferred reconstitution diluent SWFI is unavailable for reconstitution, NS may be used to reconstitute RDV.2

• If NS is used to reconstitute RDV, then the subsequent dilution should only be done using 250 mL of NS.2
• The dilution volume is recommended to be 250 mL because dilution of the
  200 mg loading dose into 100 mL of NS results in osmolality greater than 400 mOsm/kg which may affect tolerability (Table 2).2

Table 2. Osmolality of the Final Solution2

aThe final diluted volume is per the recommended preparation instructions for adults.

bThe proportionate amount of infusion fluid was removed from the IV bag prior to addition of dose volume to maintain the overall solution volume of 100 mL or 250 mL.

Dilution with Alternative Diluents

Dilute the reconstituted RDV solution using NS1 or D5W.2 Please refer to your local label for full dose preparation instructions.

• Based on an internal Gilead study, RDV may be diluted with D5W.2
• The type of infusion fluid (NS or D5W) did not have an impact on osmolality for the same dilution ratios (Table 3).2

Table 3. Osmolality of the Final Solution2

aThe final diluted volume is per the recommended preparation instructions for adults.

bThe proportionate amount of infusion fluid was removed from the IV bag prior to addition of dose volume to maintain the overall solution volume of 100 mL or 250 mL.

cOverall average of osmolality from measurements using freezing point osmometer.

There are no data on the compatibility of RDV with Lactated Ringer’s solution for dilution.

Infusion with Other IV Solutions or Medications

The diluted solution should not be administered simultaneously with any other medication in the same IV line. The compatibility of RDV with IV solutions and medications other than NS is not known.1

References

1. Enclosed. Gilead Sciences Inc. Veklury® (remdesivir) for injection, for intravenous use. VEKLURY® (remdesivir) injection, for intravenous use. U.S. Prescribing Information. Foster City, CA.
2. Gilead Sciences Inc. Data on File.

Abbreviations

D5W=dextrose 5% in water
NS=0.9% normal saline

RDV=remdesivir

SWFI=sterile water for injection

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Veklury US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/covid-19/veklury/veklury_pi

Follow Up

For any additional questions, please contact Gilead Medical Information at:

☎1‐866‐MEDI‐GSI (1‐866‐633‐4474) or   www.askgileadmedical.com

Adverse Event Reporting

Please report all adverse events to:

Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
 www.gilead.com/utility/contact/report-an-adverse-event

FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or   www.accessdata.fda.gov/scripts/medwatch

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