This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them.
The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.
This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have itching, a rash, hives, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after you receive this medicine. This medicine may cause blood clots, especially in patients with a history of blood clotting problems, heart disease, and atherosclerosis hardening of the arteries or circulation problems.
Patients who stay in bed for a long time because of surgery or illness may also have blood clots. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking. This medicine may cause a rare and serious lung problem a few hours after it is given. Tell your doctor right away if you or your child have any breathing problems with or without a fever after you receive the medicine.
While you are being treated with Rho D immune globulin, do not have any immunizations vaccines without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving Rho D immune globulin. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Some side effects may occur that usually do not need medical attention. ITP is a type of blood disorder where the person has a very low number of platelets. Platelets help to clot the blood. Rho D immune globulin is also used to prevent antibodies from forming after a person with Rh-negative blood receives a transfusion with Rh-positive blood, or during pregnancy when a mother has Rh-negative blood and the baby is Rh-positive.
It belongs to a group of medicines called immunizing agents. Rho D immune globulin works to boost the immune system and prevent excessive bleeding. The Rh factor is one part of the red blood cell. A person has either Rh-positive or Rh-negative blood. If you receive the opposite type of blood, your body will create antibodies that can destroy the red blood cells. 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. 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. 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. 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. 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. 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. 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.
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. 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.
Monitor signs and symptoms of IVH including back pain, chills, fever, and hematuria. 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. Patients with IgA deficiency often develop antibodies against IgA and are more likely to have anaphylactic or immune-mediated adverse reactions to pooled immunoglobulin products such as Rh0 [D] immune globulin.
The benefits of Rh0 [D] immune globulin must be carefully weighed against the potential risk of severe hypersensitivity reactions. The health care professional should have immediate availability of epinephrine injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to Rh0 [D] immune globulin.
Immediately stop the administration of Rh0 [D] immune globulin if allergic or anaphylactic-type symptoms occur. Any condition such as thrombocytopenia, coagulopathy, or other bleeding disorder that contraindicates the use of intramuscular IM injections contraindicates the use of Rh0 [D] immune globulin that is given intramuscularly. Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy e. Rh0 [D] immune globulin is not indicated for use as immunoglobulin replacement therapy for patients with immune globulin deficiency syndromes such as agammaglobulinemia or hypogammaglobulinemia.
The efficacy of the product in patients with ITP who have asplenia or who are Rh0 [D]-negative has not been established. The presence of anti-Rh0 [D] antibodies is detected by an indirect antiglobulin Coombs' test. 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.
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.
Prices and insurance coverage for RhoGAM vary. But most insurance companies will cover at least some of the cost. Talk to your doctor about whether the generic version of RhoGAM — Rho D immune globulin — or a different brand of the drug is more cost effective.
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