Dosage & Administration
DO NOT confuse micrograms (mcg) with International Units (IU) when calculating the dose. Miscalculations could result in overdose or underdose
Suppression of Rh Isoimmunization (IV or IM administration only)
| Indication | Timing | Dose * (1 mcg = 5 IU) | |
|---|---|---|---|
| Rh-incompatible Pregnancy: | mcg | IU | |
| Routine antepartum prophylaxis | Week 28-30 of pregnancy | 300 mcg | 1500 IU |
| Postpartum prophylaxis (required only if the newborn is Rh(D)-positive, or of unknown status) | Within 72 hours of birth | 300 mcg † | 1500 IU |
| Obstetric complications/invasive procedures | Within 72 hours of complication / procedure | 300 mcg † | 1500 IU |
| Excessive fetomaternal hemorrhage (>15 mL fetal RBCs) | Within 72 hours of complication | 300 mcg plus: 20 mcg per mL RhD-positive fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantified, or An additional 300 mcg if excess transplacental bleeding cannot be quantified | 1500 IU plus: 100 IU per mL RhD- positive fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantified, or An additional 1500 IU 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 | 100 IU per 2 mL transfused Rh(D)- positive whole blood or per 1 mL Rh(D)- positive RBCs |
Treatment of ITP (IV administration only)
| Dose (mcg) | Rate of administration |
|---|---|
| 50 mcg per kg body weight | 2 mL per 15 to 60 seconds |
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Rhophylac Prescribing Information
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 treated for signs and symptoms of hemolysis in a healthcare setting for at least 8 hours after administration. Perform a dipstick urinalysis at baseline, 2 hours and 4 hours after administration, and prior to the end of the monitoring period. Alert patients to, and monitor them for back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms within 8 hours does not indicate IVH cannot occur subsequently. If signs and/or symptoms of intravascular hemolysis are present or suspected after RHOPHYLAC administration, perform post-treatment laboratory tests, including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).
RHOPHYLAC is a Rh(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh(D)-positive patients.
Suppression of Rh Isoimmunization
Pregnancy and Obstetric Conditions
RHOPHYLAC is indicated for suppression of rhesus (Rh) isoimmunization in non-sensitized Rh(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 Rh(D)-positive or Rh(D)-unknown or if the father is either Rh(D)-positive or Rh(D)-unknown.
Incompatible Transfusions
RHOPHYLAC is indicated for the suppression of Rh isoimmunization in Rh(D)-negative individuals transfused with Rh(D)-positive red blood cells (RBCs) or blood components containing Rh(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 Rh(D)-positive, non-splenectomized adult patients with chronic ITP to raise platelet counts.
Observe patients 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 dose only. Dispose of any unused product or waste material in accordance with local requirements.
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 [see Adverse Reactions (6.2)]. 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.
| MICROGRAMS (mcg) | ||
|---|---|---|
| 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:
|
| 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 |
| INTERNATIONAL UNITS (IU) | ||
|---|---|---|
| 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:
|
| Incompatible transfusions | Within 72 hours of exposure | 100 IU per 2 mL transfused Rh(D)- positive whole blood or per 1 mL RBCs |
Treatment of ITP
For treatment of ITP, ADMINISTER RHOPHYLAC BY THE INTRAVENOUS ROUTE ONLY [see Dosage and Administration (2.1)]. 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 | |
|---|---|---|
| mcg = microgram | ||
| 50 mcg per kg body weight | 2 mL per 15 to 60 seconds | |
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
1500 IU (300 mcg) per 2 mL single-dose, prefilled, ready-to-use, glass syringe for IV or IM use
Pregnancy
Risk Summary
Animal reproduction studies have not been conducted with Rhophylac.
Suppression of Rh Isoimmunization
RHOPHYLAC is used in pregnant women for the suppression of Rh isoimmunization. When administered to pregnant women in a clinical trial to evaluate RHOPHYLAC for suppression of Rh isoimmunization [see Clinical Studies (14.1)] following dosing regimens similar to Table 1 or 2 [see Dosage and Administration (2.2)], RHOPHYLAC was not shown to harm the fetus or newborn.11 In general, anti-D immunoglobulins have been shown to not harm the fetus or affect future pregnancies or reproduction capacity when given to pregnant Rh(D)-negative women for suppression of Rh isoimmunization.4
ITP
RHOPHYLAC has not been evaluated in pregnant women with ITP.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Lactation
Risk Summary
There is no information regarding the presence of RHOPHYLAC in human milk, the effect on the breastfed infant, and the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for RHOPHYLAC and any potential adverse effects on the breastfed child from RHOPHYLAC or from the underlying maternal condition.
Suppression of Rh Isoimmunization
RHOPHYLAC is used in nursing mothers for the suppression of Rh isoimmunization.
ITP
RHOPHYLAC has not been evaluated in nursing mothers with ITP.
Pediatric Use
Suppression of Rh Isoimmunization in Incompatible Transfusions
The safety and effectiveness of RHOPHYLAC have not been established in pediatric subjects being treated for an incompatible transfusion. The physician should weigh the potential risks against the benefits of RHOPHYLAC, particularly in girls whose later pregnancies may be affected if Rh isoimmunization occurs.
Chronic ITP
The safety and effectiveness of RHOPHYLAC have not been established in pediatric subjects with chronic ITP. Dosing in the treatment of children with chronic ITP is expected to be similar to adults.
Geriatric Use
Suppression of Rh Isoimmunization in Incompatible Transfusions
RHOPHYLAC has not been evaluated for treating incompatible transfusions in subjects 65 years of age and older.
ITP
Of the 98 subjects evaluated in the clinical study of RHOPHYLAC for treatment of ITP [see Clinical Studies (14.2)], 19% were 65 years of age and older. No overall differences in effectiveness or safety were observed between these subjects and younger subjects.
RHOPHYLAC is contraindicated in:
- patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin,
- IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to RHOPHYLAC or any of its components,
- the newborn infant of a mother that received RHOPHYLAC postpartum.