Rhogam Indications, Dosage, Storage, Stability - Rho(D) Immune Globulin (Human)

Rhogam Indications, Dosage, Storage, Stability - Rho(D) Immune Globulin (Human)

INDICATIONS AND USAGE

• Pregnancy/delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby

• Abortion/threatened abortion at any stage of gestation

• Ectopic pregnancy

• Antepartum fetal-maternal hemorrhage (suspected or proven) resulting from antepartum hemorrhage (e.g., placenta previa), amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma

• Transfusion of Rh incompatible blood or blood products

• Prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products (e.g., red cells, platelet concentrates, granulocyte concentrates)

For intramuscular use only. Do not inject RhoGAM^® or MICRhoGAM^® intravenously. In the case of postpartum use, the product is intended for maternal administration. Do not inject the newborn infant.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

A single dose (approximately 50 µg)* is contained in each prefilled syringe of MICRhoGAM. This dose will suppress the immune response to 2.5 mL of Rh-positive red blood cells. MICRhoGAM is therefore indicated within 72 hours after termination of pregnancy up to and including 12 weeks’ gestation. At or beyond 13 weeks’ gestation, RhoGAM should be administered instead of MICRhoGAM.

A single dose (approximately 300 µg)* is contained in each prefilled syringe of RhoGAM. This is the usual dose for the indications associated with pregnancy unless there is clinical or laboratory evidence of a fetal-maternal hemorrhage (FMH) in excess of 15 mL of Rh-positive red blood cells. RhoGAM should be administered within 72 hours of known or suspected exposure to Rh-positive red blood cells. The indications and recommended dosage for RhoGAM and MICRhoGAM are summarized in the following table.

If RhoGAM is administered for one of the above indications early in pregnancy (before 26 to 28 weeks), there is an obligation to maintain a level of passively acquired anti-D by administration of RhoGAM at 12-week intervals. RhoGAM should be administered within 72 hours of delivery or exposure to Rh-positive red blood cells. There is little information concerning the effectiveness of Rh Immune Globulin when given beyond this 72-hour period. In one study, Rh Immune Globulin provided protection against Rh immunization in about 50% of subjects when given 13 days after exposure to Rh-positive cells.²¹ If delivery occurs within three weeks after the last antepartum dose, the postpartum dose may be withheld, but a test for FMH should be performed to determine if exposure to > 15 mL of red cells has occurred.²²

Multiple doses of RhoGAM are required if an FMH exceeds 15 mL, an event that is possible but unlikely prior to the third trimester of pregnancy and is most likely at delivery. Patients known or suspected to be at increased risk of FMH should be tested for FMH by qualitative or quantitative methods.²³ In efficacy studies, RhoGAM was shown to suppress Rh immunization in all subjects when given at a dose of ³20 µg per mL of Rh-positive red blood cells.³ Thus, a single dose of RhoGAM will suppress the immune response after exposure to £15 mL of Rh-positive red blood cells. However, in clinical practice, laboratory methods used to determine the amount of exposure (volume of transfusion or FMH) to Rh-positive red blood cells are imprecise.^24,25 Therefore, administration of more than 20 µg of RhoGAM per mL of Rh-positive red blood cells should be considered whenever a large FMH or red cell exposure is suspected or documented.²⁵

When multiple doses are required, consult your pharmacy for pooling directions. Multiple doses may be administered at the same time or at spaced intervals, as long as the total dose is administered within three days of exposure.

Administer injection per standard protocol. Note: When administering an intramuscular injection, place fingers in contact with syringe barrel through windows in shield to prevent possible premature activation of safety guard.

After injection, use free hand to slide safety guard over needle. An audible "click" indicates proper activation.

RhoGAM^® is available in packages containing:

• 5 prefilled single-dose syringes of RhoGAM

(Product Code 780710) NDC 0562-7807-06

• 5 package inserts

• 5 control forms

• 5 patient identification cards and

• 25 prefilled single-dose syringes of RhoGAM

(Product Code 780715) NDC 0562-7807-26

• 25 package inserts

• 25 control forms

• 25 patient identification cards MICRhoGAM^® is available in packages containing:

• 5 prefilled single-dose syringes of MICRhoGAM

(Product Code 780810) NDC 0562-7808-06

• 5 package inserts

• 5 control forms

• 5 patient identification cards and

• 25 prefilled single-dose syringes of MICRhoGAM

(Product Code 780815) NDC 0562-7808-26

• 25 package inserts

• 25 control forms

• 25 patient identification cards

Store at 2 to 8°C. Do not store frozen.

REFERENCE

21. Samson D, Mollison PL. Effect on primary Rh immunization of delayed administration of anti-Rh. Immunol 1975;28:349-57.

22. Garratty G, ed. Hemolytic disease of the newborn. Arlington, VA: American Association of Blood Banks, 1984:78.

23. Urbaniak SJ. Statement from the Consensus Conference on Anti-D Prophylaxis, The Royal College of Physicians of Edinburgh & The Royal College of Obstetricians and Gynaecologists, UK. Vox Sang 1998;74:127-28.

24. Bayliss KM, Kueck DB, Johnson ST, Fueger JT, McFadden PW, Mikulski D, Gottschall JL. Detecting fetomaternal hemorrhage: a comparison of five methods. Transfusion 1991;31:303-7.

25. Kumpel BM. Quantification of anti-D and fetomaternal hemorrhage by flow cytometry (editorial). Transfusion 2000;40:6-9.

SUMMARY OF REVISIONS

Printing specification change only. No change to directions for use.

U.S. LICENSE 1236, Raritan, New Jersey 08869, ©OCD 2001, Printed in U.S.A., Revised September 2001 U.S. Patent 3,449,314, 631209713