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Rhogam

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Rhogam

INDICATIONS

Pregnancy and Other Obstetrical Conditions in Rh-Negative Women, Unless the Father or Baby are Conclusively Rh Negative

Transfusion

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

DOSAGE AND ADMINISTRATION

For intramuscular use only. Do not inject RhoGAM (rho(d) immune globulin (human)) or MICRhoGAM (rho(d) immune globulin (human)) 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 (rho(d) immune globulin (human)) . This dose will suppress the immune response to 2.5 mL of Rh-positive red blood cells. MICRhoGAM (rho(d) immune globulin (human)) is therefore indicated within 72 hours after termination of pregnancy up to and including 12 weeks' gestation. At or beyond 13 weeks' gestation, RhoGAM (rho(d) immune globulin (human)) should be administered instead of MICRhoGAM (rho(d) immune globulin (human)) .

A single dose (approximately 300 μg)* is contained in each prefilled syringe of RhoGAM (rho(d) immune globulin (human)) . 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 (rho(d) immune globulin (human)) should be administered within 72 hours of known or suspected exposure to Rh-positive red blood cells. The indications and recommended dosage for RhoGAM (rho(d) immune globulin (human)) and MICRhoGAM (rho(d) immune globulin (human)) are summarized in the following table.

Indications and Recommended Dosage

Indication Indicated Dosea
(approximately)
Postpartum (if the newborn is Rh-positive) 300 μgb
Antepartum: Prophylaxis at 26 to 28 weeks' gestationc 300 μg
Antepartum: Amniocentesis, chorionic villus sampling 300 μg
(CVS) and percutaneous umbilical blood sampling (PUBS)
Antepartum: Abdominal trauma or obstetrical manipulation 300 μg
Antepartum: Ectopic pregnancyd 300 μg
Antepartum: Abortion or threatened abortion at any stage of gestation with continuation of pregnancyd 300 μg
Transfusion of Rh-incompatible blood or blood productsd 300 μg
a Additional doses of RhoGAM (rho(d) immune globulin (human)) are indicated when the patient has been exposed to > 15 mL of Rh-positive red blood cells. This may be determined by use of qualitative or quantitative tests for FMH (see below).
b See DESCRIPTION section.
c If antepartum prophylaxis is indicated, it is essential that the mother receive a postpartum dose if the infant is Rh-positive.
d If abortion or termination of pregnancy occurs up to and including 12 weeks' gestation, or less than 2.5 mL of Rh-incompatible red blood cells were administered, a single dose of MICRhoGAM (rho(d) immune globulin (human)) Rho(D) Immune Globulin (Human) (approximately 50 μg)* may be used instead of RhoGAM (rho(d) immune globulin (human)) .

If RhoGAM (rho(d) immune globulin (human)) 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 (rho(d) immune globulin (human)) at 12-week intervals. RhoGAM (rho(d) immune globulin (human)) 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 (rho(d) immune globulin (human)) are required if an FMH exceeds 15 mL. Patients in whom FMH is suspected should be tested for FMH by qualitative or quantitative methods.23 In efficacy studies, RhoGAM (rho(d) immune globulin (human)) was shown to suppress Rh immunization in all subjects when given at a dose of >20 μg per mL of Rh-positive red blood cells.3 Thus, a single dose of RhoGAM (rho(d) immune globulin (human)) 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 (rho(d) immune globulin (human)) per mL of Rh-positive red blood cells should be considered whenever a large FMH or red blood 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.

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.

Administring the injection -  Illustration

Slide safety guard over needle.

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

Keep hands behind needle at all times.

Keep hands behind needle at all times - Illustration

HOW SUPPLIED

RhoGAM (rho(d) immune globulin (human)) is available in packages containing:

  • 1 prefilled single-dose syringe of RhoGAM (rho(d) immune globulin (human)) (Product Code 780701) NDC 0562-7807-01
  • 1 package insert
  • 1 control form
  • 1 patient identification card

and

  • 5 prefilled single-dose syringes of RhoGAM (rho(d) immune globulin (human)) (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 (rho(d) immune globulin (human)) (Product Code 780715) NDC 0562-7807-26
  • 25 package inserts
  • 25 control forms
  • 25 patient identification cards

MICRhoGAM (rho(d) immune globulin (human)) is available in packages containing:

  • 1 prefilled single-dose syringe of MICRhoGAM (rho(d) immune globulin (human)) (Product Code 780801) NDC 0562-7808-01
  • 1 package insert
  • 1 control form
  • 1 patient identification card

and

  • 5 prefilled single-dose syringes of MICRhoGAM (rho(d) immune globulin (human)) (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 (rho(d) immune globulin (human)) (Product Code 780815) NDC 0562-7808-26
  • 25 package inserts
  • 25 control forms
  • 25 patient identification cards

Storage

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

REFERENCES

3. Pollack W, Ascari WQ, Crispen JF, O'Connor RR, Ho TY. Studies on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh-positive blood. Transfusion 1971;11:340-44.

20. Data on file at Ortho-Clinical Diagnostics, Inc.

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.

Ortho-Clinical Diagnostics, Inc, Raritan, New Jersey 08869, Revised October 2005. FDA revision date: n/a

Last reviewed on RxList: 5/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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