Expiration Date Information

Expiration Date Extension for MICRhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)]

Lot MVP116A1 - NEW Expiration Date: 19 JULY 2021

This is to provide you with important information regarding Rho(D) Immune Globulin (Human), referred to as MICRhoGAM® which is indicated for use in preventing Rh immunization.

The FDA has extended the expiration date on this lot of MICRhoGAM®, from July 19, 2020, to July 19, 2021.  The extension is based upon FDA evaluation of stability data, which determined that this lot of product will maintain stability and potency for an additional year.

If you have prefilled syringes of Lot MVP116A1 in your current inventory, labeled with an expiration date of July 19, 2020, you may continue to maintain the product in your inventory and keep it available for use until July 19, 2021.

Future shipments of Lot MVP116A1 will have a sticker on the carton and pouch indicating that the product has a new expiration date of July 19, 2021.

MICRhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)]

Please visit https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/expiration-date-extension-micrhogam-rhod-immune-globulin-lot-mvp116a1-through-july-19-2021?utm_campaign=What%27sNew2020-07-01&utm_medium=email&utm_source=Eloqua for the FDA announcement of the extension of the expiration date.

Reporting Adverse Events:

Healthcare Providers and patients are encouraged to report adverse events in patients taking MICRhoGAM® to Kedrion Biopharma at 1-855-353-7466. Visit www.medwatch.com or call 1-800-FDA-1088.

If you have any questions about the information contained on this webpage or about the safe, effective use of MICRhoGAM®, please contact the Kedrion Biopharma Inc. Customer Support at 1-855-353-7466, option 1, or email US_Medicalinfo@kedrion.com.

 

Indication

  • RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) and MICRhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (50 μg) are immune globulins indicated for use in preventing Rh immunization for pregnancy and other obstetrical conditions in Rh-negative women unless the father or baby is conclusively Rh-negative, e.g., delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby, any antepartum fetal-maternal hemorrhage (suspected or proven), actual or threatened pregnancy loss at any stage of gestation and ectopic pregnancy.
  • In the case of postpartum use, RhoGAM and MICRhoGAM are intended for maternal administration. Do not inject the newborn infant.

Important Safety Information

  • RhoGAM and MICRhoGAM are contraindicated in Rh-positive individuals and in patients with a known history of anaphylactic or severe systemic reactions to the administration of human immune globulin products.
  • Severe hypersensitivity reactions may occur with the use of RhoGAM or MICRhoGAM. RhoGAM and MICRhoGAM should be administered in a setting where appropriate equipment, medications such as epinephrine, and personnel trained in the management of hypersensitivity, anaphylaxis, and shock are available.
  • Products made from human blood may carry a risk of transmitting infectious agents (e.g., viruses, the variant Creutzfeldt-Jakob disease [vCJD] and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent).
  • After administration of Rho(D) immune globulin, a transitory increase of various passively transferred antibodies in the patient’s blood may yield positive serological testing results.
  • The most frequently reported adverse reactions in patients receiving Rho(D) Immune Globulin (Human) products are injection site reactions, such as swelling, induration, redness and mild pain or warmth. Possible systemic reactions are skin rash, body aches or a slight elevation in temperature. Severe systemic reactions include allergic reactions and hemolytic reactions.

You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch/ or
call 1-800-FDA-1088.

Click here for the RhoGAM and MicRhoGAM Full Prescribing Information
This site is intended for residents of the US only.

 

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