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U.S. Department of Health and Human Services

REGEN-COV: Subcutaneous Injection Instructions for Healthcare Providers

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REGEN-COV: Subcutaneous Injection Instructions for Healthcare Providers.pdf
July 28, 2021



The FDA authorized subcutaneous injection for REGEN-COV™ (casirivimab and imdevimab). HHS.gov REGEN-COV: Subcutaneous Injection Instructions for Healthcare Providers on June 3, 2021 (click here to read in Spanish). Subcutaneous injection is an alternative route of administration when intravenous infusion is not feasible and would lead to delay in treatment. Remember to store casirivimab and imdevimab together in inventory.

 


Preparation for Subcutaneous Injection

Remove the casirivimab and imdevimab vial(s) from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Do not expose to direct heat. Do not shake the vials.

Inspect casirivimab and imdevimab vial(s) visually for particulate matter and discoloration prior to administration. Should either be observed, the vial must be discarded and replaced with a new vial. The solution for each vial should be clear to slightly opalescent, colorless to pale yellow.

  1. 600 mg of casirivimab and 600 mg of imdevimab should be prepared using 4 syringes(Table 3). Obtain four 3 mL or 5 mL polypropylene Luer Lock syringes with luer connection and four 21-gauge 1½ inch transfer needles.

  2. Withdraw 2.5 mL into each syringe (total of 4 syringes) (see Table 3). Prepare all 4 syringes at the same time.

  3. Replace the 21-gauge transfer needle with a 25-gauge or 27-gauge needle for subcutaneous injection.

  4. This product is preservative-free and therefore, the prepared syringes should be administered immediately. If immediate administration is not possible, store the prepared casirivimab and imdevimab syringes in the refrigerator between 2ºC to 8ºC (36ºF to 46ºF) for no more than 4 hours or at room temperature up to 25ºC (77ºF) for no more than 4 total hours. If refrigerated, allow the syringes to equilibrate to room temperature for approximately 20 minutes prior to administration.


Administration of Subcutaneous Injection

For the administration of 600 mg of casirivimab and 600 mg of imdevimab, gather 4 syringes (see table below) and prepare for subcutaneous injections.

  • Administer the subcutaneous injections consecutively, each at a different injection site, into the thigh, back of the upper arm, or abdomen, except for 2 inches (5 cm) around the navel. The waistline should be avoided.

  • When administering the subcutaneous injections, it is recommended that providers use different quadrants of the abdomen or upper thighs or back of the upper arms to space apart each 2.5 mL subcutaneous injection of casirivimab and imdevimab. DO NOT inject into skin that is tender, damaged, bruised, or scarred.

  • Clinically monitor patients after injections an dobserve patients for at least 1 hour.

Prepare 600 mg of Casirivimab and 600 mg of ImdevimabPreparation of FOUR Separate Syringes
Using Casirivimab and Imdevimab Co-formulated VialUsing four separate syringes, withdraw 2.5 mL solution per syringe.
Using Casirivimab and Imdevimab Individual Vials
  • Casirivimab: Using TWO separate syringes, withdraw 2.5 mL solution per syringe.

  • Imdevimab: Using TWO separate syringes, withdraw 2.5 mL solution per syringe.



NOTE:

Intravenous infusion is strongly recommended. Subcutaneous injection is an alternative route of administration when intravenous infusion is not feasible and would lead to delay in treatment. Read more on REGEN-COV subcutaneous injections.

  • This page last reviewed: August 30, 2021