Rhophylac
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Rhophylac
INDICATIONS
Suppression of Rh Isoimmunization
Pregnancy and Obstetric Conditions
Rhophylac® (immune globulin intravenous (human) solution) 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® (immune globulin intravenous (human) solution) 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 Rh0(D)-positive 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® (immune globulin intravenous (human) solution) .
Immune Thrombocytopenic Purpura (ITP)
Rhophylac® (immune globulin intravenous (human) solution) 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® (immune globulin intravenous (human) solution) .
Preparation and Handling
Bring Rhophylac® (immune globulin intravenous (human) solution) to room temperature before use.
Rhophylac® (immune globulin intravenous (human) solution) is a clear or slightly opalescent, colorless to pale yellow solution. Rhophylac® (immune globulin intravenous (human) solution) should be inspected visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates. Do not use solution that has been frozen.
Rhophylac® (immune globulin intravenous (human) solution) is for single use only. Dispose of any unused product or waste material in accordance with local requirements.
Suppression of Rh Isoimmunization
Rhophylac® (immune globulin intravenous (human) solution) 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® (immune globulin intravenous (human) solution) in divided doses at different sites.
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® (immune globulin intravenous (human) solution) will suppress the immunizing potential of ≥ 15 mL of Rh0(D)-positive RBCs.1 † The dose of Rhophylac® (immune globulin intravenous (human) solution) 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. |
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ITP
For treatment of ITP, Rhophylac® (immune globulin intravenous (human) solution) must be administered by the intravenous route.
A 250 IU (50 mcg) per kg body weight dose of Rhophylac® (immune globulin intravenous (human) solution) is recommended for patients with ITP. The following formula can be used to calculate the amount of Rhophylac® (immune globulin intravenous (human) solution) to administer:
Dose (IU) x body weight (kg) = Total IU / 1500 IU per syringe = # of syringes
Rhophylac® (immune globulin intravenous (human) solution) should be administered at a rate of 2 mL per 15 to 60 seconds.
Dosage Forms And Strengths
1500 IU (300 mcg) per 2 mL prefilled syringe
HOW SUPPLIED
Storage and Handling
Rhophylac® (immune globulin intravenous (human) solution) 1500 IU (300 mcg) is supplied in packages of one or 10 latex-free, ready-to-use, prefilled syringes, each containing 2 mL of preservative-free liquid. Each syringe is accompanied by a SafetyGlide™ needle for intravenous or intramuscular use.
NDC Number Product
Description
44206-300-01 1 prefilled
2 mL syringe
44206-300-10 10 prefilled 2
mL syringes
Store at 2-8°C (36-46°F). If stored at this temperature, Rhophylac® (immune globulin intravenous (human) solution) has 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. Do not freeze. Keep Rhophylac® (immune globulin intravenous (human) solution) in its original carton to protect it from light.
Manufactured by: ZLB Behring AG., Berne, Switzerland US License No. 1710
Distributed by: ZLB Behring LLC., Kankakee, IL 60901 USA
Triton™ is a trademark of The Dow Chemical Company
Planova® is a registered trademark of Asahi Kasei Medical Co., Ltd.
SafetyGlide™ is a trademark of Becton, Dickinson and Company
FDA rev date: 3/26/2007
Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Rhophylac Information
Report Problems to the Food and Drug Administration
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