WinRho SDF

Other Disease Specific Immunoglobulins

NOTE: Using the International (WHO) Reference, 1 mcg is equivalent to 5 international units. The traditional standard full dose is considered to be approximately 300 mcg (1500 international units).

HyperRHO S/D, MICRhoGAM, and RhoGAM are administered by the intramuscular route only; DO NOT inject intravenously.[52599][52602]
WinRho SDF and Rhophylac are administered intravenously for the treatment of immune thrombocytopenic purpura (ITP) and may be administered intramuscularly or intravenously for suppression of Rh isoimmunization.[41832][52598]
Visually inspect parenteral products for particulate matter and discoloration before administration whenever solution and container permit. The Rhophylac solution should be clear or slightly opalescent and colorless to pale yellow; do not use if the solution is cloudy, has deposits, or has been frozen.[52598]
 
Reconstitution/Dilution of the WinRho SDF lyophilized powder:
No reconstitution or dilution is necessary for BayRho-D (HyperRHO S/D) Mini-dose, BayRho-D (HyperRHO S/D) Full-dose, Rhophylac, MICRhoGAM, RhoGAM, or the liquid formulation of WinRho SDF.
WinRho SDF lyophilized powder for IV use: If the product will be given intravenously, reconstitute the 600 international units or 1500 International Units powder immediately before use with 2.5 mL of sterile diluent. Reconstitute the 5000 International Units powder immediately before use with 8.5 mL of sterile diluent. Add the diluent to the vial by slowly injecting down the side wall of the vial. Gently swirl the vial until the powder is dissolved. Do not shake. Discard any unused diluent.
WinRho SDF lyophilized powder for IM use: If the product will be given intramuscularly, reconstitute the 600 International Units or 1500 International Units powder immediately before use with 1.25 mL of sterile diluent. Reconstitute the 5000 International Units powder immediately before use with 8.5 mL of sterile diluent. Add the diluent to the vial by slowly injecting down the side wall of the vial. Gently swirl the vial until the powder is dissolved. Do not shake. Discard any unused diluent.
Reconstituted WinRho SDF lyophilized powder should be used promptly. If the reconstituted product is not used immediately, it may be stored at room temperature for up to 12 hours; do not freeze. Discard the reconstituted lyophilized product if not used within 12 hours of reconstitution.

Use aseptic technique.
WinRho SDF: Bring the solution to room temperature before use. Remove the entire contents of the vial in order to obtain the labeled dosage. If partial vials are required for dosage calculation, withdraw the entire vial contents to ensure accurate calculation of the dosage requirement. If dilution is desired, ONLY use NS as the diluent. For immune thrombocytopenic purpura (ITP), infuse IV into a suitable vein over 3 to 5 minutes; closely monitor patients in a healthcare setting for at least 8 hours after administration. Also, perform a dipstick urinalysis to monitor for hematuria and hemoglobinuria at baseline and at 2, 4, and 8 hours after administration. For Rh isoimmunization suppression, infuse at a rate of 2 mL per 5 to 15 seconds. Administer separately from other IV drugs and fluids.
Rhophylac: Bring the solution to room temperature before use. Ensure that the needle-free IV administration system is compatible with the tip of the Rhophylac glass syringe. For immune thrombocytopenic purpura (ITP), infuse at a rate of 2 mL per 15 to 60 seconds; closely monitor patients in a healthcare setting for at least 8 hours after administration. Also, perform a dipstick urinalysis to monitor for hematuria and hemoglobinuria at baseline and at 2, 4, and 8 hours after administration.

Rhophylac and WinRho SDF: Bring the solution to room temperature before use.[41832][52598]
If the calculated dose is more than 5 mL, administer the total dose in divided doses at different sites at the same time. Alternatively, each vial or syringe may be administered at intervals, provided the entire calculated dose is administered within 72 hours of the fetomaternal hemorrhage or incompatible blood transfusion. Administer the entire calculated dose as soon as possible.[52598][52602]
Using aseptic technique, inject IM into the deltoid muscle of the upper arm or the anterolateral portion of the upper thigh. Do not use the gluteal muscle as a routine injection site due to the risk of sciatic nerve injury. If the gluteal region is used, the injection should be made only into the upper, outer quadrant.[41832][52599]
RhoGAM, MICRhoGAM, or Rhophylac: Observe patients for at least 20 minutes after administration.[52602][52598]

anaphylactoid reactions / Rapid / Incidence not known
anaphylactic shock / Rapid / Incidence not known
acute respiratory distress syndrome (ARDS) / Early / Incidence not known
hemolytic-uremic syndrome / Delayed / Incidence not known
anuria / Delayed / Incidence not known
cardiac arrest / Early / Incidence not known
myocardial infarction / Delayed / Incidence not known
renal failure (unspecified) / Delayed / Incidence not known
heart failure / Delayed / Incidence not known
disseminated intravascular coagulation (DIC) / Delayed / Incidence not known
oliguria / Early / Incidence not known
pulmonary edema / Early / Incidence not known

hyperbilirubinemia / Delayed / 21.4-21.4
hypertension / Early / 2.0-2.0
hypotension / Rapid / 2.0-2.0
peripheral vasodilation / Rapid / Incidence not known
erythema / Early / Incidence not known
chest pain (unspecified) / Early / Incidence not known
wheezing / Rapid / Incidence not known
hematuria / Delayed / Incidence not known
dyspnea / Early / Incidence not known
jaundice / Delayed / Incidence not known
anemia / Delayed / Incidence not known
sinus tachycardia / Rapid / Incidence not known
edema / Delayed / Incidence not known
prolonged bleeding time / Delayed / Incidence not known
hemolysis / Early / Incidence not known
hypoxia / Early / Incidence not known

chills / Rapid / 8.0-34.7
fever / Early / 6.0-30.6
headache / Early / 11.0-11.2
asthenia / Delayed / 4.0-4.0
dizziness / Early / 4.0-4.0
infection / Delayed / 3.0-3.0
back pain / Delayed / 2.0-2.0
abdominal pain / Early / 2.0-2.0
nausea / Early / 2.0-2.0
vomiting / Early / 2.0-2.0
pallor / Early / 2.0-2.0
injection site reaction / Rapid / Incidence not known
arthralgia / Delayed / Incidence not known
hyperkinesis / Delayed / Incidence not known
diarrhea / Early / Incidence not known
diaphoresis / Early / Incidence not known
drowsiness / Early / Incidence not known
myalgia / Early / Incidence not known
rash / Early / Incidence not known
pruritus / Rapid / Incidence not known
urticaria / Rapid / Incidence not known
weakness / Early / Incidence not known
weight gain / Delayed / Incidence not known
hyperhidrosis / Delayed / Incidence not known
ecchymosis / Delayed / Incidence not known
muscle cramps / Delayed / Incidence not known

WinRho SDF and Rhophylac are approved for intravenous use in patients with immune thrombocytopenic purpura (ITP). Increased destruction of Rh0 [D]-positive red cells occurs after Rh0 [D] immune globulin administration, and this will produce decreased serum hemoglobin concentrations and associated clinical symptoms. Because of this, use with caution in patients with preexisting anemia. Patients with ITP who have a hemoglobin < 10 g/dl should receive a reduced dose of WinRho SDF in order to decrease the risk of worsening the severity of the anemia. Alternative treatments should be used in patients with ITP who have a hemoglobin level < 8 g/dl because the risk of the severity of anemia is increased. The safety of Rhophylac in the treatment of ITP has not been established in patients with pre-existing anemia; weigh the benefits of Rhophylac versus the potential risk of increasing the anemia severity. While most of the red cell destruction will occur in the spleen, there have been rare reports of acute hemoglobinuria consistent with intravascular hemolysis that have occurred during Rh0 [D] immune globulin administration to patients with ITP. WinRho SDF is contraindicated for use in patients with pre-existing hemolysis, patients at high risk for hemolysis, and in patients with autoimmune hemolytic anemia. Rh0[D]-positive patients with ITP should be monitored for signs and/or symptoms of intravascular hemolysis (IVH), clinically compromising hemolytic anemia, and renal impairment during treatment. IVH leading to death has been reported in patients treated for ITP with Rh0 [D] immune globulin. 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 impairment, renal failure, and disseminated intravascular coagulation (DIC) have also been reported. WinRho SDF and Rhophylac for ITP requires a specialized care setting; closely monitor patients in a health care setting for at least 8 hours after administration.[41832][52598] Perform a dipstick urinalysis at baseline and at 2 hours, 4 hours, and 8 hours after administration. Monitor signs and symptoms of IVH including back pain, chills, fever, and hematuria. Absence of these signs and/or symptoms of IVH within 8 hours does not indicate that IVH cannot occur subsequently. If signs and/or symptoms of IVH are present or suspected after Rh0 [D] immune globulin administration, post-treatment laboratory tests should be performed including plasma hemoglobin, microscopic and dipstick urinalysis, haptoglobin, LDH, and plasma bilirubin (direct and indirect). Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function in all patients before initiation of Rh0 [D] immune globulin and at appropriate intervals thereafter for at-risk patients. Infusion of intravenous immune globulin at a minimal practical concentration and infusion rate is recommended for patients with renal insufficiency or for patients who are predisposed to acute renal failure. Receipt of intravenous immune globulin has been reported to produce renal dysfunction in these patients. Most reports of renal dysfunction have involved products that contain sucrose as a stabilizer. If renal dysfunction occurs, use clinical judgment to either decrease the infusion rate or stop the infusion.

HyperRHO S/D, MICRhoGAM, RhoGAM, Rhophylac, WinRho SDF

Rx

Parenteral IgG product
Administered to females to decrease the risk of erythroblastosis fetalis following Rh0[D]-incompatible delivery, abortion, miscarriage, or trauma
One IV product also used for certain patients with ITP

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: (Major) Do not give immune globulin including varicella zoster immune globulin concurrently with the varicella-zoster virus vaccine, live. Because of the potential inhibition of the immune response to vaccination by passively transferred antibodies, it is advisable not to give varicella-zoster virus vaccine, live to any patient who has received blood (except washed red blood cells), plasma transfusions, or immunoglobulins within the previous 5 months. After varicella vaccination, the CDC recommends that immune globulin products should not be given for 3 weeks, unless the benefit outweighs the risk; the manufacturer recommends waiting 2 months before administering immunoglobulins. In the case that IgG products are administered within 3 weeks of vaccination, the vaccinee should be either revaccinated at 5 months or tested for immunity and revaccinated if seronegative. Consult current CDC guidelines for recommendations. (Major) Rubella virus vaccine or Measles/mumps/rubella vaccines, MMR should not be given for at least 3 months following administration of immunoglobulins because antibodies in these products can neutralize the vaccine.
Measles/Mumps/Rubella Vaccines, MMR: (Major) Rubella virus vaccine or Measles/mumps/rubella vaccines, MMR should not be given for at least 3 months following administration of immunoglobulins because antibodies in these products can neutralize the vaccine.
Rotavirus Vaccine: (Major) Defer vaccination with live virus vaccines such as Rotavirus Vaccine until approximately 3 months after Rh0 [D] immune globulin administration. Inform the immunizing physician of recent therapy with Rh0 [D] immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines such as Rotavirus Vaccine may be impaired by Rh0 [D] immune globulin administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccine.
Varicella-Zoster Virus Vaccine, Live: (Major) Do not give immune globulin including varicella zoster immune globulin concurrently with the varicella-zoster virus vaccine, live. Because of the potential inhibition of the immune response to vaccination by passively transferred antibodies, it is advisable not to give varicella-zoster virus vaccine, live to any patient who has received blood (except washed red blood cells), plasma transfusions, or immunoglobulins within the previous 5 months. After varicella vaccination, the CDC recommends that immune globulin products should not be given for 3 weeks, unless the benefit outweighs the risk; the manufacturer recommends waiting 2 months before administering immunoglobulins. In the case that IgG products are administered within 3 weeks of vaccination, the vaccinee should be either revaccinated at 5 months or tested for immunity and revaccinated if seronegative. Consult current CDC guidelines for recommendations.

HyperRHO S/D/MICRhoGAM/Rho(D) Immune Globulin (Human)/RhoGAM/Rhophylac/WinRho SDF Intramuscular Inj Sol: 250IU, 1500IU, 2500IU, 5000IU, 15000IU
Rho(D) Immune Globulin (Human)/Rhophylac/WinRho SDF Intravenous Inj Sol: 1500IU, 2500IU, 5000IU, 15000IU

The maximum amount depends on the indication.

The maximum amount depends on the indication.

The maximum amount depends on the indication.

The maximum amount depends on the indication.

Not recommended.

Not recommended.

Although the mechanism is not well understood, it is believed that the anti-Rh0[D] antibodies contained in Rh0 [D] immune globulin interact directly with the Rh0[D] antigens, thereby preventing the interaction between the antigens and the maternal immune system. Sensitization to Rh0[D]-positive blood is less likely to occur. If Rh immunization has occurred, Rh0 [D] immune globulin is ineffective. Clinical studies indicate that administration of 300 mcg (1,500 International Units) Rh0 [D] immune globulin within 72 hours after delivery of an Rh0[D]-positive infant by an Rh0[D]-negative mother decreases the incidence of active anti-Rh0 [D] production from 12 to 13% to 1% to 2%. When treatment is administered both antenatally at 28 weeks of gestation and postpartum, the Rh isoimmunization rate drops to around 0.1%. The appropriate use of Rh0 [D] immune globulin has reduced the prevalence of Rh isoimmunization in the U.S. and Canada by 96% since the 1940s.
 
The actions of Rh0 [D] immune globulin in immune thrombocytopenic purpura (ITP) are not well understood. Intravenous infusion of Rh0 [D] immune globulin into an Rh0 [D]-positive patient leads to antibody coating of circulating erythrocytes. These coated red cells are cleared primarily by the spleen. The immune-mediated clearance of these sensitized erythrocytes occupies the reticuloendothelial system (RES) and allows for the survival of antibody-coated platelets. The primary mechanism of action of Rh0 [D] immune globulin appears to occur via immunologic blockade of Fc-receptors within the RES.[25345] Other immunomodulatory mechanisms may also play a role in Rh0 [D] immune globulin efficacy in ITP. After administration, Rh0 [D] immune globulin produces a 2 to 3 day delay in increasing the platelet count. The mean duration of response is about 30 days. Children with ITP tend to respond better than adults to Rh0 [D] immune globulin therapy. Repeated Rh0 [D] immune globulin infusions do not cure the disease but are used to maintain platelet counts at levels sufficient enough to provide adequate hemostasis (more than 30,000/microL). Rh0 [D] immune globulin is not effective in splenectomized or Rh0 [D]-negative patients with ITP.

Rho [D] is administered via intravenous or intramuscular injection. The pharmacokinetics of Rh0 [D] immune globulin are not well described, but passively acquired anti-Rh0 [D] antibodies are not detectable 6 months after administration. If a Rh negative mother is exposed to Rh positive cells early in pregnancy, repeat doses of Rh0 [D] immune globulin may be needed (see Dosage). In order to maintain protection throughout pregnancy, the concentration of passively acquired anti-Rh0 [D] must not fall below the concentration necessary to prevent an immune response to Rh positive red cells.

Peak levels following IV administration occur within 2 hours. The calculated AUC is similar for both IV and IM administration. The liquid and lyophilized formulations of WinRho SDF given IV are bioequivalent. Similar pharmacokinetic parameters were obtained for both formulations when given intramuscularly. The mean peak concentrations occurred within 30 minutes of IV administration. The half-life of Rh0 [D] immune globulin is approximately 24 days after IV administration.

Peak levels following IM administration occur within 5—10 days. The calculated AUC is similar for both IV and IM administration. Similar pharmacokinetic parameters were obtained for both the liquid and lyophilized formulations of WinRho SDF when given intramuscularly. The mean peak concentrations is within 2—4 days of IM administration. The half-life of Rh0 [D] immune globulin is approximately 30 days after IM administration.

Although Rh0 [D] immune globulin has not been well studied in pregnant women and animal reproduction studies have not been conducted, some of the products are routinely given during pregnancy. The HyperRHO S/D Mini-Dose product is not indicated for use during pregnancy. Under ideal circumstances, when used to prevent Rh0 [D] isoimmunization from exposure to Rh0[D]-positive blood, Rh0 [D] immune globulin should only be administered to a non-sensitized Rh0 [D]-negative obstetric patient. If there is question about the mother's Rh type or if there is insufficient time to determine fetal Rh typing (as might occur in trauma during pregnancy), then Rh0 [D] immune globulin should be administered as indicated by the clinical situation. Rh0 [D] immune globulin would not be effective in preventing erythroblastosis fetalis in the Rh0 [D]-negative mother who has already formed anti-D IgG antibodies. However, Rh0 [D] negative women who have already been sensitized to the Rh0 [D] erythrocyte factor do not appear to have an increase in adverse reactions if administered the product as a result of unknown Rh status. There is no known obstetric indication for the use of Rh0 [D] immune globulin in women who are Rh0 [D]-positive, as these women are not at risk of isoimmunization from an Rh0 [D]-positive fetus.

Rh0 [D] immune globulin is is a immune globulin (IgG) rich in IgG antibodies. IgG is a normal component of breastmilk. Rh0 [D] immune globulin is frequently used in nursing mothers and no adverse effects have been reported in a breast-feeding infant. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.