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Rhogam Ultra-Filtered Plus (Rho(d) Immune Globulin Human) - Indications and Dosage

 
 



Rho(D) Immune Globulin (Human)

RhoGAM® Ultra-Filtered PLUS
(300 μg) (1500 IU)

MICRhoGAM® Ultra-Filtered PLUS (50 μg) (250 IU)

Rx Only

For Intramuscular Injection Only

Prefilled syringes, preservative-free (thimerosal free), latex-free delivery system

INDICATIONS AND USAGE

Pregnancy and other obstetrical conditions

For administration to Rh-negative women not previously sensitized to the Rho(D) factor, unless the father or baby are conclusively Rh-negative.

  • Delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby
  • Antepartum prophylaxis at 26 to 28 weeks gestation
  • Antepartum fetal-maternal hemorrhage (suspected or proven) as a result of placenta previa, amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma
  • Actual or threatened pregnancy loss at any stage of gestation
  • Ectopic pregnancy

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 blood cells, platelet concentrates, granulocyte concentrates)

DOSAGE AND ADMINISTRATION

For intramuscular use only. Do not inject RhoGAM Ultra-Filtered PLUS (RhoGAM) or MICRhoGAM Ultra-Filtered PLUS (MICRhoGAM) intravenously. In the case of postpartum use, the product is intended for maternal administration. Do not inject the newborn infant. Inject the entire contents of the syringe(s). For single use only. (See WARNINGS AND PRECAUTIONS)

RhoGAM or MICRhoGAM should be administered within 72 hours of delivery or known or suspected exposure to Rh-positive red blood cells. There is little information concerning the effectiveness of Rho(D) Immune Globulin (Human) when given beyond this 72 hour period. In one study, Rho(D) Immune Globulin (Human) provided protection against Rh immunization in about 50% of subjects when given 13 days after exposure to Rh-positive red blood cells.1 Administer every 12 weeks starting from first injection to maintain a level of passively acquired anti-D. If delivery occurs within three weeks after the last antepartum dose, the postpartum dose may be withheld, but a test for fetal-maternal hemorrhage should be performed to determine if exposure to > 15 mL of red blood cells has occurred.2

Parenteral drug products should be inspected visually for particulate matter, discoloration and syringe damage prior to administration. Do not use if particulate matter and / or discoloration are observed. The solution should appear clear or slightly opalescent.

Indications and Recommended Dosage

Indication Dose Notes
Postpartum (if the newborn is Rh-positive) RhoGAM
(300 μg)
(1500 IU)
Additional doses of RhoGAM 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 fetal-maternal hemorrhage.
Administer within 72 hours of delivery.
Antepartum:
  • Prophylaxis at 26 to 28 weeks gestation Administer within 72 hours of suspected or proven exposure to Rh-positive red blood cells resulting from:
  • Amniocentesis, chorionic villus sampling (CVS) and percutaneous umbilical blood sampling (PUBS)
  • Abdominal trauma or obstetrical manipulation
  • Ectopic pregnancy
  • Threatened pregnancy loss after 12 weeks gestation with continuation of pregnancy
  • Pregnancy termination (spontaneous or induced) beyond 12 weeks gestation
If antepartum prophylaxis is indicated, it is essential that the mother receive a postpartum dose if the infant is Rh-positive.
If RhoGAM is administered 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.
  • Actual or threatened termination of pregnancy (spontaneous or induced) up to and including 12 weeks gestation
    Administer within 72 hours
MICRhoGAM
(50 μg)
(250 IU)
RhoGAM may be administered if MICRhoGAM is not available.
Transfusion of Rh-incompatible blood or blood products Administer within 72 hours of suspected or proven exposure to Rh-positive red blood cells.
  • < 2.5 mL Rh-positive red blood cells
MICRhoGAM
(50 μg)
(250 IU)
RhoGAM may be administered if MICRhoGAM is not available.
  • 2.5 - 15.0 mL Rh-positive red blood cells
RhoGAM
(300 μg)
(1500 IU)
  • > 15.0 mL Rh-positive red blood cells
RhoGAM
(300 μg)
(1500 IU)
(multiple syringes)
Additional doses of RhoGAM are indicated when the patient has been exposed to > 15 mL of Rh-positive red blood cells.
Administer 20 μg of RhoGAM per mL of Rh-positive red blood cell exposure.

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.

RhoGAM Administration

Each single dose prefilled syringe of RhoGAM contains 300 μg (1500 IU) of Rho(D) Immune Globulin (Human). This is the dose for the indications associated with pregnancy at or beyond 13 weeks unless there is clinical or laboratory evidence of a fetal-maternal hemorrhage (FMH) in excess of 15 mL of Rh-positive red blood cells.

MICRhoGAM Administration

Each single dose prefilled syringe of MICRhoGAM contains 50 μg (250 IU) of Rho(D) Immune Globulin (Human). This dose will suppress the immune response to up to 2.5 mL of Rh-positive red blood cells. MICRhoGAM is 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.

Multiple Dosage

Multiple doses of RhoGAM are required if a 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.3 In efficacy studies, RhoGAM 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.4 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.5,6 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 blood cell exposure is suspected or documented.6 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.7

Dosage Frequency

To maintain an adequate level of anti-D, RhoGAM should be administered every 12 weeks. The exact timing for the injection is based on 12 week intervals starting from the administration of the first injection. If delivery of the baby does not occur 12 weeks after the administration of the standard antepartum dose (at 26 to 28 weeks), a second dose is recommended to maximize protection antepartum. 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 blood cells has occurred.2

Administration

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.
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. Dispose of the syringe in accordance with local regulations.

DOSAGE FORMS AND STRENGTHS

  • RhoGAM® Ultra-Filtered PLUS - 300 μg (1500 IU) [The anti-D content of RhoGAM / MICRhoGAM is expressed as μg per dose or as International Units (IU) per dose. The conversion factor is 1 μg = 5 IU.8 ] – Prefilled Syringes
  • MICRhoGAM® Ultra-Filtered PLUS - 50 μg (250 IU) – Prefilled Syringes

HOW SUPPLIED / STORAGE AND HANDLING

RhoGAM Ultra-Filtered PLUS package sizes

  • 1 prefilled single-dose syringe of RhoGAM (Product Code 780501)
    NDC 0562-7805-01
    1 package insert, 1 control form, 1 patient identification card
  • 5 prefilled single-dose syringes of RhoGAM (Product Code 780505)
    NDC 0562-7805-05
    5 package inserts, 5 control forms, 5 patient identification cards
  • 25 prefilled single-dose syringes of RhoGAM (Product Code 780525)
    NDC 0562-7805-25
    25 package inserts, 25 control forms, 25 patient identification cards

MICRhoGAM Ultra-Filtered PLUS package sizes

  • 1 prefilled single-dose syringe of MICRhoGAM (Product Code 780601)
    NDC 0562-7806-01
    1 package insert, 1 control form, 1 patient identification card
  • 5 prefilled single-dose syringes of MICRhoGAM (Product Code 780605)
    NDC 0562-7806-05
    5 package inserts, 5 control forms, 5 patient identification cards
  • 25 prefilled single-dose syringes of MICRhoGAM (Product Code 780625)
    NDC 0562-7806-25
    25 package inserts, 25 control forms, 25 patient identification cards

Store at 2 to 8C. Do not store frozen. Do not use after the expiration date printed on the syringe.

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