July 28, 2016
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Rhophylac

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Rhophylac




Indications
Dosage
How Supplied

INDICATIONS

Rhophylac is an Rh0(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh0(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh0(D)- positive patients.

Suppression Of Rh Isoimmunization

Pregnancy And Obstetric Conditions

Rhophylac is indicated for suppression of rhesus (Rh) isoimmunization in non-sensitized Rh0(D)-negative women with an Rh-incompatible pregnancy, including:

  • Routine antepartum and postpartum Rh prophylaxis
  • Rh prophylaxis in cases of:
    • Obstetric complications (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage)
    • Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma)

An Rh-incompatible pregnancy is assumed if the fetus/baby is either Rh0(D)-positive or Rh0(D)-unknown or if the father is either Rh0(D)-positive or Rh0(D)-unknown.

Incompatible Transfusions

Rhophylac is indicated for the suppression of Rh isoimmunization in Rh0(D)-negative individuals transfused with Rh0(D)-positive red blood cells (RBCs) or blood components containing Rh0(D)-positive RBCs.

Treatment can be given without a preceding exchange transfusion when the transfused blood represents less than 20% of the total circulating RBCs. If the volume exceeds 20%, an exchange transfusion should be considered prior to administering Rhophylac.

ITP

Rhophylac is indicated in Rh0(D)-positive, non-splenectomized adult patients with chronic ITP to raise platelet counts.

DOSAGE AND ADMINISTRATION

As with all blood products, patients should be observed for at least 20 minutes following administration of Rhophylac.

Preparation And Handling

  • Rhophylac is a clear or slightly opalescent, colorless to pale yellow solution. Inspect Rhophylac visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates.
  • Prior to intravenous use, ensure that the needle-free intravenous administration system is compatible with the tip of the Rhophylac glass syringe.
  • Do not freeze.
  • Bring Rhophylac to room temperature before use.
  • Rhophylac is for single use only. Dispose of any unused product or waste material in accordance with local requirements.

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 [see Postmarketing Experience]. Do not administer Rhophylac subcutaneously into the fatty tissue.

Table 1 provides dosing guidelines based on the condition being treated.

Table 1: Dosing Guidelines for Suppression of Rh Isoimmunization

Indication Timing of Administration Dose* (Administer by Intravenous or Intramuscular Injection)
Rh-incompatible pregnancy
  Routine antepartum prophylaxis At Week 28-30 of gestation 1500 IU (300 mcg)
  Postpartum prophylaxis (required only if the newborn is Rh0(D)-positive) Within 72 hours of birth 1500 IU (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 1500 IU (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 1500 IU (300 mcg)†
  Excessive fetomaternal hemorrhage ( > 15 mL) Within 72 hours of complication 1500 IU (300 mcg) plus:
  • 100 IU (20 mcg) per mL fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantified or
  • An additional 1500 IU (300 mcg) dose if excess transplacental bleeding cannot be quantified
  Incompatible transfusions Within 72 hours of exposure 100 IU (20 mcg) per 2 mL transfused blood or per 1 mL erythrocyte concentrate
IU, international units; mcg, micrograms.
* A 1500 IU (300 mcg) dose of Rhophylac will suppress the immunizing potential of ≤ 15 mL of Rh0(D)-positive RBCs.
† The dose of Rhophylac must be increased if the patient is exposed to > 15 mL of Rh0(D)-positive RBCs; in this case, follow the dosing guidelines for excessive fetomaternal hemorrhage.

ITP

For treatment of ITP, ADMINISTER RHOPHYLAC BY THE INTRAVENOUS ROUTE ONLY [see Preparation and Handling]. Do not administer intramuscularly. A 250 IU (50 mcg) per kg body weight dose of Rhophylac is recommended for patients with ITP. The following formula can be used to calculate the recommended amount of Rhophylac to administer:

Dose (IU) x body weight (kg) = Total IU / 1500 IU per syringe = Number of syringes

Rhophylac should be administered at a rate of 2 mL per 15 to 60 seconds.

HOW SUPPLIED

Dosage Forms And Strengths

1500 IU (300 mcg) per 2 mL prefilled, ready-to-use, glass syringe for IV or IM use.

  • Rhophylac 1500 IU (300 mcg) is supplied in packages of one or ten (10) prefilled, ready-to-use, glass syringe(s), each containing 2 mL liquid for injection. Each syringe is accompanied by a SafetyGlide™ needle for intravenous or intramuscular use.

Each product presentation includes a package insert and the following components:

Presentation Carton NDC Number Components
1500 IU (300 mcg) 44206-300-01
  • Single-use, prefilled 2 mL syringe (NDC 44206300-90)
  • SafetyGlide needle
1500 IU (300 mcg) Multipack 44206-300-10
  • Ten single-use, prefilled 2 mL syringes (NDC 44206-300-90)
  • Ten SafetyGlide needles

Storage And Handling

  • DO NOT FREEZE.
  • Rhophylac contains no preservatives; do not store at room temperature.
  • Store at 2 to 8°C (36 to 46°F) for a shelf life of 36 months from the date of manufacture, as indicated by the expiration date printed on the outer carton and syringe label.
  • Keep Rhophylac in its original carton to protect it from light.
  • The prefilled Rhophylac syringe is not made with natural rubber latex.

Manufactured by: CSL Behring AG, Bern, Switzerland, US License No. 1766. Distributed by: CSL Behring LLC, Kankakee, IL 60901 USA. Revised: May 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/18/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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