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Product Information

Indications

Suppression of Rhesus (Rh) Isoimmunization in
  • Pregnancy and obstetric conditions in non-sensitized, Rh(D)-negative women with an Rh-incompatible pregnancy, including:
    • Routine antepartum and postpartum Rh prophylaxis
    • Rh prophylaxis in obstetric complications or invasive procedures
  • Incompatible transfusions in Rh(D)-negative individuals transfused with blood components containing Rh(D)-positive red blood cells (RBCs) 
Immune Thrombocytopenic Purpura (ITP)
  • Raising platelet counts in Rh(D)-positive, non-splenectomized adults with chronic ITP

WARNING: INTRAVASCULAR HEMOLYSIS IN ITP
This warning does not apply to Rh(D)-negative patients treated for the suppression of Rh isoimmunization.

  • Intravascular hemolysis leading to death has been reported in Rh(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh(D) Immune Globulin Intravenous (Human) products.
  • Intravascular hemolysis can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS), acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC).
  • Monitor patients for signs and symptoms of intravascular hemolysis in a healthcare setting for at least 8 hours after administration.

See full prescribing information for complete boxed warning.

Contraindications

  • History of anaphylactic or severe systemic reaction to human immune globulin products
  • IgA deficient patients with antibodies against IgA and a history of hypersensitivity to RHOPHYLAC or any of its components
  • Do not administer RHOPHYLAC to the newborn infant of the mother that received RHOPHYLAC postpartum
Dosage and Administration:

DO NOT confuse micrograms (mcg) with International Units (IU) when calculating the dose of RHOPHYLAC. Miscalculations could result in a significant overdose or underdose of the product. Note that 1 mcg = 5 IU of RHOPHYLAC.

Suppression of Rh Isoimmunization

RHOPHYLAC should be administered by intravenous or intramuscular injection. If large doses (greater than 5 mL) are required and intramuscular injection is chosen, it is advisable to administer RHOPHYLAC in divided doses at different sites.
Ensure the site of administration will allow the injection to reach the muscle if RHOPHYLAC is administered intramuscularly. Consider intravenous administration if reaching the muscle is of concern. Do not administer RHOPHYLAC subcutaneously into the fatty tissue.
Refer to Table 1 (for dosing instructions in micrograms) and Table 2 (for dosing instructions in International Units) by indication.

Table 1: Dosing Guidelines based on Micrograms (mcg) for Suppression of Rh Isoimmunization

Indication Timing of Administration Dose* (Administer by intravenous (IV) or intramuscular (IM) injection)
Rh-incompatible pregnancy
Routine antepartum prophylaxis Week 28-30 of pregnancy 300 mcg
Postpartum prophylaxis (required only if the newborn is Rh(D)-positive or of unknown status) Within 72 hours of birth 300 mcg
Obstetric complications (e.g. miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage) Within 72 hours of complication 300 mcg
Invasive procedures during pregnancy (e.g. amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g. external version, abdominal trauma) Within 72 hours of procedure 300 mcg
Excessive fetomaternal hemorrhage (>15 mL fetal RBCs) Within 72 hours of complication 300 mcg plus:
  • 20 mcg per mL Rh(D)-positive fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantified or
  • An additional 300 mcg dose if excess transplacental bleeding cannot be quantified
Incompatible transfusions Within 72 hours of exposure 20 mcg per 2 mL transfused Rh(D)-positive whole blood or per 1 mL Rh(D)-positive RBCs
* A 300 mcg dose of RHOPHYLAC will suppress the immunizing potential of ≤ 15 mL of fetal Rh(D)-positive RBCs
† The dose of RHOPHYLAC must be increased if the patient is exposed to > 15mL of fetal Rh(D) positive RBCs; in this case, follow the dosing guidelines for excessive fetomaternal hemorrhage.

Table 2: Dosing Guidelines based on International Units (IU) for Suppression of Rh Isoimmunization


Indication Timing of Administration Dose* (Administer by intravenous (IV) or intramuscular (IM) injection)
Rh-incompatible pregnancy
Routine antepartum prophylaxis Week 28-30 of pregnancy 1500 IU
Postpartum prophylaxis (required only if the newborn is Rh(D)-positive or of unknown status) Within 72 hours of birth 1500 IU
Obstetric complications (e.g. miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage) Within 72 hours of complication 1500 IU
Invasive procedures during pregnancy (e.g. amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g. external version, abdominal trauma) Within 72 hours of procedure 1500 IU
Excessive fetomaternal hemorrhage (>15 mL fetal RBCs) Within 72 hours of complication 1500 IU plus:
  • 100 IU per mL Rh(D)-positive fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantified or
  • An additional 1500 IU dose if excess transplacental bleeding cannot be quantified
Incompatible transfusions Within 72 hours of exposure 100 IU per 2 mL transfused Rh(D)-positive whole blood or per 1 mL Rh(D)-positive RBCs
* A 1500 IU dose of RHOPHYLAC will suppress the immunizing potential of ≤ 15 mL of fetal Rh(D)-positive RBCs
† The dose of RHOPHYLAC must be increased if the patient is exposed to > 15mL of fetal Rh(D) positive RBCs; in this case, follow the dosing guidelines for excessive fetomaternal hemorhage.

Treatment of ITP

For treatment of ITP, ADMINISTER RHOPHYLAC BY THE INTRAVENOUS ROUTE ONLY. Do not administer intramuscularly.

Calculate the dose of RHOPHYLAC for ITP on the basis of the patient’s weight in kilograms (kg). Inappropriate use of pounds (lbs) will result in an overdose.

Dose mcg Rate of administration
50 mcg per kg body weight 2 mL per 15 to 60 seconds
   mcg = microgram


The following formula can be used to calculate the number of syringes of RHOPHYLAC to administer: Dose (50 mcg) x body weight (kg) = Total mcg / 300 mcg per syringe = Number of syringes

Important Safety Information for Rhophylac

Rhophylac®, Rho(D) Immune Globulin Intravenous (Human), is a blood-derived injection given to women with an Rh-negative who might have an incompatible pregnancy—that is, who may be carrying an unborn child with Rh-positive blood. If a woman in such a pregnancy is not treated, the result could be “isoimmunization,” a condition in which the mother’s Rh-negative blood produces antibodies that could attack the unborn child’s Rh-positive blood cells, potentially creating serious health problems for the unborn child and any future children of the mother.

Rhophylac is given by physicians as routine protection against immunization, typically as administration during pregnancy, often with readministration within 72 hours following childbirth. It is also given in cases of obstetric complications, invasive procedures during pregnancies, incomplete pregnancies, and obstetric manipulative procedures in certain non-pregnant women. Rhophylac is also used in Rh-negative individuals who have received blood components containg Rh(D)-positive red blood cells. For suppression of Rh isoimmunization, Rhophylac can be administered intravenously or intramuscularly, but must not be given to newborn infant.

You should not receive Rhophylac if you have had a previous serious allergic reaction to Rhophylac or other human blood products. It should not be given if your blood has an insufficient quantity of a protein called IgA, has produced antibodies to IgA, or you have known hypersensititivy to IgA. Your physician will do a blood test to assess your situation regarding IgA.

Some women have experienced mild and temporary actions after receiving Rhophylac, such as fever; overall discomfort or uneasiness; headache; skin reactions (like hives or welts); and chills. If you received Rhophylac as a shot (intramuscularly), you could experience pain or tenderness at the injection site. Adverse reactions to Rhophylac typically do not last long. Discuss with your doctor any reaction or symptom you experience after administration of Rhophylac that concerns you.

Rhophylac is made from donated human blood. The risk of transmission of infections agents, including viruses, cannot be completely eliminated.

Immunoglobulin administration can transiently interfere with your response to live vaccines, such as measles, mumps and rubella. (Note that most influenza vaccines are not “live” vaccines.) Tell your doctor if you plan to receive a vaccine after receiving Rhophylac.

Please see full prescribing information for Rhophylac, which includes a boxed warning that does not apply to use of Rhophylac in pregnancy or in cases of incompatible transfusions.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

You can also report side effects to CSL Behring’s Pharmacovigilance Department at 1-866-915-6958.


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For U.S. Healthcare Professionals only

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