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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

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.

Rhophylac®, Rho(D), Immune Globulin Intravenous (Human), is indicated for 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 and Rh prophylaxis in cases of obstetric complications or invasive procedures.
  • Incompatible transfusions in Rh (D)-negative individuals transfused with blood components containing Rh (D)-positive red blood cells.

For suppression of Rh isoimmunization, Rhophylac can be administered IM or IV. Consider IV administration if reaching the muscle is of concern.

Rhophylac is indicated to raise platelet counts in Rh (D)-positive, non-splenectomized adult patients with chronic immune thrombocytopenic purpura (ITP). For the treatment of ITP, Rhophylac must be administered IV.

Rhophylac is contraindicated in individuals with known anaphylactic or severe systemic reaction to human immune globulin products, and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to Rhophylac or any of its components. Do not administer Rhophylac to the newborn infant of a mother who received Rhophylac postpartum.

Allergic or hypersensitivity reactions may occur with Rhophylac; early signs of hypersensitivity include generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis.

Rhophylac is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Suppression of Rh Isoimmunization: The most common adverse reactions in the suppression of Rh isoimmunization with Rhophylac (≥0.5% of patients) are nausea, dizziness, headache, injection-site pain, and malaise.

Immune Thrombocytopenic Purpura: The most serious adverse reactions in patients receiving Rh (D) immune globulin have been observed in the treatment of ITP. ITP patients being treated with Rhophylac should be alerted to and monitored for signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and hematuria. Potentially serious complications of intravascular hemolysis include clinically compromising anemia, acute renal insufficiency, and, very rarely, disseminated intravascular coagulation, and death.

The most common adverse reactions observed in the treatment of ITP (>14% of patients) are chills, pyrexia/increased body temperature, headache, and hemolysis. In patients with preexisting anemia, Rhophylac may increase the severity of anemia.

Immunoglobulin administration may transiently interfere with the immune response to live virus vaccines, such as measles, mumps and rubella.

Please see full prescribing information for Rhophylac.

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.


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