Dosage & Administration
IU, International Units; mcg, micrograms | ||
| ITP ( 2.1) (IV administration only) | ||
| Dose IU | Dose mcg | Rate of Administration |
| 250 IU kg body weight | 50 mcg/kg body weight | Single injection over 3 to 5 minutes |
| Suppression of Rh Isoimmunization ( 2.1) (IV or IM administration only) | |||
| Indication | Timing | Dose (IV or IM) | Dose (IV or IM) |
| Pregnancy and other obstetric conditions | IU (international units) | mcg (micrograms) | |
| Routine antepartum prophylaxis | 28-weeks gestation | 1,500 IU | 300 mcg |
| Postpartum prophylaxis | Within 72 hours of delivery | 600 IU | 120 mcg |
| Threatened abortion | Immediately | 1,500 IU | 300 mcg |
| Amniocentesis and chorionic villus sampling before 34-weeks gestation | Immediately after procedure | 1,500 IU | 300 mcg |
| Abortion, amniocentesis, or other manipulation after 34-weeks gestation | Within 72 hours | 600 IU | 120 mcg |
| Incompatible transfusions or massive fetal hemorrhage | Within 72 hours of exposure | IV administration of 90 IU per 1 mL transfused RBC or per 2 mL transfused whole blood | IV administration of 18 mcg per 1 mL transfused RBC or per 2 mL transfused whole blood |
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WinRho SDF Prescribing Information
This warning does not apply to Rh o(D)-negative patients treated for the suppression of Rh isoimmunization.
- Intravascular hemolysis (IVH) leading to death has been reported in patients treated with WinRho ®SDF for immune thrombocytopenic purpura (ITP).
- IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS).
- Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation (DIC) have also been reported.
- Closely monitor patients treated with WinRho ®SDF for ITP in a healthcare setting for at least 8 hours after administration. A dipstick urinalysis to monitor for hematuria and hemoglobinuria is to be performed at baseline and then after administration at 2 hours, 4 hours and prior to the end of the monitoring period. Alert patients and monitor the signs and symptoms of IVH including back pain, shaking chills, fever, and discolored urine or hemoglobinuria. Absence of these signs and/or symptoms of IVH within 8 hours do not indicate IVH cannot occur subsequently. If signs and/or symptoms of IVH are present or suspected after WinRho ®SDF administration, post-treatment laboratory tests should be performed including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).
- If ITP patients are to be transfused after receiving WinRho ®SDF, use Rh o(D)-negative red blood cells (PRBCs) so as not to exacerbate ongoing hemolysis.
WinRho ®SDF is a Rh o(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh o(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh o(D)-negative patients.
Treatment of ITP
WinRho ®SDF is indicated for use in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in the treatment of non-splenectomized, Rh o(D)-positive
- children with chronic or acute ITP
- adults with chronic ITP
- children and adults with ITP secondary to HIV infection
The safety and efficacy of WinRho ®SDF have not been evaluated in clinical trials for patients with non-ITP causes of thrombocytopenia or in previously splenectomized patients or in patients who are Rh o(D)-negative.
Suppression of Rh Isoimmunization
Pregnancy and Other Obstetric Conditions
WinRho ®SDF is indicated for the suppression of Rh isoimmunization in non-sensitized, Rh o(D)-negative (D-negative) women with a Rh-incompatible pregnancy, including:
- Routine antepartum and postpartum Rh prophylaxis
- Rh prophylaxis in cases of:
- Obstetric complication (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)
A Rh-incompatible pregnancy is assumed if the fetus/baby is either Rh o(D)-positive or Rh o(D)-unknown or if the father is either Rh o(D)-positive or Rh o(D)-unknown.
Incompatible Transfusions
WinRho ®SDF is indicated for the suppression of Rh isoimmunization in Rh o(D)-negative individuals transfused with Rh o(D)-positive red blood cells (RBCs) or blood components containing Rh o(D)-positive RBCs.
WinRho ®SDF is not indicated for use as immunoglobulin replacement therapy for immune globulin deficiency syndromes.
For intravenous or intramuscular use only.
Dose
Treatment of ITP
ADMINISTER WinRho ®SDF BY THE INTRAVENOUS ROUTE ONLY.
Proper care should be taken when calculating the dose of WinRho ®SDF to be administered. A confusion between International Units (IU) and micrograms (mcg) of product (1 mcg = 5 IU), could result in either an overdose that could lead to a severe hemolytic reaction or a dose too low to be effective.
Since Win Rho ®SDF is administered on a weight-based regimen per kilogram (kg), patient weight determination must be taken in kilograms (kg) as inappropriate use of pounds (lbs) will result in significant overdosing of WinRho ®SDF.
Please note that dose for WinRho ®SDF may be calculated using either international units (IU) or micrograms (mcg) per kilograms.
Table 1provides dosing guidelines for ITP patients.
| ||||
| Indication | Initial Dose (dose in either IU or mcg) | Subsequent Doses (dose in either IU or mcg) | ||
| ITP (intravenous use only) | Single intravenous dose or divided doses given on two separate days | Determine frequency by clinical response (platelet counts, RBC, Hgb and reticulocyte count) | ||
| Hemoglobin ≥ 10 g/dl | 250 IU/kg | 50 mcg/kg | 250-300 IU/kg | 50-60 mcg/kg |
| Hemoglobin 8 to <10 g/dl (use alternative treatments for Hgb <8 g/dl) | 125-200 IU/kg | 25-40 mcg/kg | 125-200 IU/kg | 25-40 mcg/kg |
Suppression of Rh Isoimmunization
| ||||
| Indication | Initial Dose (dose in either IU or mcg) | Subsequent Doses (dose in either IU or mcg) | ||
| Suppression of Rh Isoimmunization (intravenous or intramuscular) | Single intravenous or intramuscular dose | |||
| Routine antepartum prophylaxis in Rh- incompatible pregnancy (28 weeks gestation) | 1,500 IU | 300 mcg | ||
| Postpartum (within 72 hours of birth of Rh0(D) positive newborn) | 600 IU | 120 mcg | ||
| Threatened abortion (immediately) | 1,500 IU | 300 mcg | ||
| Amniocentesis and chorionic villus sampling before 34 weeks gestation (immediately following procedure, then every 12 weeks during pregnancy) | 1,500 IU | 300 mcg | 1,500 IU (every 12 weeks) | 300 mcg (every 12 weeks) |
| Abortion, amniocentesis, or any other manipulation after 34 weeks gestation (within 72 hours) | 600 IU | 120 mcg | ||
Incompatible Transfusion
| Indication | Dose (dose in either IU or mcg) | Frequency | |
| Incompatible Transfusion (intravenous or intramuscular) | Begin treatment within 72 hours of exposure | ||
| Intravenous | |||
| If exposed to Rh 0(D)-Positive Whole Blood | 45 IU per ml blood | 9 mcg per ml blood | Every 8 hours |
| If exposed to Rh 0(D)-Positive Red Blood Cells | 90 IU per ml cells | 18 mcg per ml cells | |
| Administer this dose until total dose has been administered | 3000 IU | 600 mcg | Every 8 hours |
| Intramuscular | |||
| If exposed to Rh 0(D)-Positive Whole Blood | 60 IU per ml blood | 12 mcg per ml blood | Every 12 hours |
| If exposed to Rh 0(D)-Positive Red Blood Cells | 120 IU per ml cells | 24 mcg per ml cells | |
| Administer this dose until total dose has been administered | 6000 IU | 1,200 mcg | Every 12 hours |
For incompatible transfusion or massive fetal hemorrhage, treatment must occur within 72 hours and dose may be intravenous or intramuscular, based on the volume of blood or cells replaced.
Preparation
- Bring WinRho ®SDF to room temperature prior to use.
- Inspect WinRho ®SDF for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates.
- WinRho ®SDF is for single use only. Discard any unused portion.
- The solution is ready to use, no reconstitution required.
- See Table 4for the target fill volumes for each of the dosage sizes for WinRho ®SDF.
| Dose (IU) | Dose (mcg) | Target Fill Volume |
| 600 IU | 120 mcg | 0.5 mL |
| 1,500 IU | 300 mcg | 1.3 mL |
| 2,500 IU | 500 mcg | 2.2 mL |
| 5,000 IU | 1,000 mcg | 4.4 mL |
| 15,000 IU | 3,000 mcg | 13.0 mL |
Note:Remove the entire contents of the vial to obtain the labelled dosage of WinRho ®SDF. If partial vials are required for dosage calculation, withdraw the entire contents of the vial to ensure accurate calculation of the dosage requirement. For ease in withdrawing the contents of the vial, draw back the plunger of a sterile syringe (with the needle and needle cover in place) to admit air into the syringe. Depress the plunger of the syringe to inject air into the vial. Invert vial and aspirate contents of vial into syringe.
Administration
Route of administration depends on the indication as follows:
| ITP | Intravenous (IV) only |
| Suppression of Rh | Intravenous (IV) or intramuscular (IM) |
| Incompatible transfusion | Intravenous (IV) or intramuscular (IM) |
ITP
- Administer the entire dose of WinRho ®SDF into a suitable vein over three to five minutes.
- Administer WinRho ®SDF separately from other drugs.
- If dilution of WinRho ®SDF is preferred prior to intravenous administration, use onlynormal saline as diluent. Do not use Dextrose (5%) in water (D5W).
Suppression of Rh Isoimmunization
- For intravenous administration, administer WinRho ®SDF separately from other drugs. WinRho ®SDF should be administered at a rate of 2 mL per 5 to 15 seconds.
- For intramuscular administration, administer into the deltoid muscle of the upper arm or the anterolateral aspects of the upper thigh. Due to the risk of sciatic nerve injury, avoid the gluteal region. If the gluteal region is used, use only the upper, outer quadrant.
WinRho ®SDF, Rh o(D) Immune Globulin Intravenous (Human), is available as a ready to use solution for injection available in single dose vials of 600 IU (120 mcg), 1,500 IU (300 mcg), 2,500 IU (500 mcg), 5,000 IU (1,000 mcg) and 15,000 IU (3,000 mcg).
Pregnancy
Risk Summary
For the treatment of ITP, there is no human data or animal data available to establish the presence or absence of drug-associated risk.
When administered to pregnant women in a clinical trial to evaluate WinRho ®SDF for suppression of Rh isoimmunization [see Clinical Studies( 14.2)] following dosing regimens similar to Table 2[see Dosing and Administration( 2.1)], WinRho ®SDF was not shown to harm the fetus or newborn. 12
Lactation
Risk Summary
There is no information regarding the presence of WinRho ®SDF in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for WinRho ®SDF and any potential adverse effects on the breastfed infant from WinRho ®SDF or from the underlying maternal condition.
Pediatric Use
The safety and effectiveness of WinRho ®SDF has been evaluated for the treatment of chronic or acute ITP in children and in children (<16 years of age) with ITP secondary to HIV infection [see Adverse Reactions( 6.2)]. The dosing recommendation in the treatment of children with ITP is the same as in adults [see Dosage and Administration( 2.1)].
Geriatric Use
Clinical studies of WinRho ®SDF did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Post marketing clinical experience suggests that patients of advanced age (age over 65) with co-morbid conditions including but not limited to cardio-respiratory decompensation, renal failure or insufficiency or prothrombotic conditions are at increased risk of developing serious complications from acute hemolytic reactions such as IVH. Patients receiving doses in excess of 300 IU/kg of WinRho ®SDF may also be at an increased risk of developing increased hemolysis. Fatal outcomes associated with IVH and its complications have occurred most frequently in patients of advanced age (age over 65) with co-morbid conditions.
Given the prevalence of co-morbid conditions and concomitant drug therapy in geriatric patients, consider starting at the low end of the dosing range when using WinRho ®SDF in this population.
WinRho ®SDF is contraindicated in:
- Patients who have had known anaphylactic or severe systemic reaction to the administration of human immune globulin products.
- IgA-deficient patients with antibodies to IgA or a history of hypersensitivity reaction to WinRho ®SDF or any of its components.
- Patients with autoimmune hemolytic anemia, with pre-existing hemolysis or at high risk for hemolysis.
- Infants for the suppression of Rh o(D) isoimmunization.