Rhophylac®

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.

• 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

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

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 located on Dosing tab (for dosing instructions in micrograms) and Table 2  located on Dosing tab (for dosing instructions in International Units) by indication.