10/12/2024

Rho(D) Immune Globulin (Human)

Products Affected - Description

- HyperRHO S/D Full Dose intramuscular injection, Grifols, 1,500 units (300 mcg), syringe, 1 count, NDC 13533-0631-02
- HyperRHO S/D Full Dose intramuscular injection, Grifols, 1,500 units (300 mcg), syringe, 10 count, NDC 13533-0631-11
- RhoGAM Ultra-Filtered Plus intramuscular injection, Kedrion Biopharma, Inc., 1,500 units (300 mcg), syringe, 1 count, NDC 00562-7805-01
- RhoGAM Ultra-Filtered Plus intramuscular injection, Kedrion Biopharma, Inc., 1,500 units (300 mcg), syringe, 5 count, NDC 00562-7805-05
- RhoGAM Ultra-Filtered Plus intramuscular injection, Kedrion Biopharma, Inc., 1,500 units (300 mcg), syringe, 25 count, NDC 00562-7805-25
- Rhophylac injection, CSL Behring, 1,500 units (300 mcg), 2 mL syringe, 10 count, NDC 44206-0300-10

Reason for the Shortage

- CSL Behring has Rhophylac available to current customer and some extra for new customers depending on demand at any given time. They discontinued the 10-count presentation in August 2024.
- Grifols did not provide a reason for the shortage.
- Kedrion has RhoGAM on shortage due to the shortage of an active ingredient and manufacturing issues and plant maintenance requirements.
- Kamada has WinRho available. All presentations of WinRho SDF have the same concentration. There is a letter describing how to dose WinRho SDF with different vial sizes at https://www.kamada.com/wp-content/uploads/2024/05/WINRHO-DHCP-letter-May-2024.pdf

Available Products

- Rhophylac injection, CSL Behring, 1,500 units (300 mcg), 2 mL syringe, 1 count, NDC 44206-0300-01
- WinRho SDF injection, Kamada, 1,500 units (300 mcg)/1.3 mL, vial, 1 count, NDC 49591-0330-51
- WinRho SDF injection, Kamada, 5,000 units (1,000 mcg)/4.4 mL, vial, 1 count, NDC 49591-0310-51

Estimated Resupply Dates

- Grifols has HyperRHO S/D Full Dose 1,500 units (300 mcg) syringes in 1 count and 10 count on allocation.
- Kedrion has RhoGAM Ultra-Filtered Plus 1,500 units (300 mcg) syringes in 1 count, 5 count, and 25 count on allocation.

Updated

Updated October 12, 2024 by Elyse MacDonald, PharmD, MS, BCPS. Created January 10, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

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