Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)
Brand names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM Ultra-Filtered Plus, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF, ...show all 17 brand names.
What is RHo (D) immune globulin?
RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don't (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (loss of red blood cells), kidney failure, or shock.
RHo (D) immune globulin is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RHo (D) immune globulin may also be used in the treatment of immune thrombocytopenic purpura (ITP).
RHo (D) immune globulin may also be used for purposes not listed in this medication guide.
What is the most important information I should know about RHo (D) immune globulin?
You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).
Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.
If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.
Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed. Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.
What should I discuss with my healthcare provider before I receive RHo (D) immune globulin?
You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).
To make sure you can safely receive RHo (D) immune globulin, tell your doctor if you have any of these other conditions:
heart disease or a history of coronary artery disease (hardened arteries);
high triglycerides (a type of fat in the blood);
a bleeding disorder (such as hemophilia); or
immune globulin A (IgA) deficiency.
RHo (D) immune globulin is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breast-feeding.
If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.
If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.
RHo (D) immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
How is RHo (D) immune globulin given?
RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.
Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 hours.
For treatment during pregnancy, this medication is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.
For treatment of a mismatched blood transfusion, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).
To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.
This medication can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using RHo (D) immune globulin.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving RHo (D) immune globulin?
Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.
RHo (D) immune globulin side effects
Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
fever, chills, shaking, back pain, dark colored urine;
rapid breathing, feeling short of breath.
urinating less than usual or not at all, swelling, rapid weight gain; or
pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.
Less serious side effects may include:
joint or muscle pain;
headache, dizziness;
feeling weak or tired;
mild itching or skin rash;
nausea, diarrhea, vomiting, stomach pain; or
pain or tenderness where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
RHo (D) immune globulin Dosing Information
Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura:
Treatment must be given by intravenous administration (not all Rho (D) immune globulin products are approved for IV administration)
Initial dose: 50 mcg/kg (250 intl units/kg) body weight IV once. The initial dose, if desired, may be administered in two divided doses given on separate days.
Prior to administering the initial dose, the patient must be confirmed as Rho (D) positive.
Subsequent dosing: 25 to 60 mcg/kg (125 to 300 intl units/kg) body weight IV with the exact dose and frequency to be determined by the clinical response of the patient which is assessed by platelet counts, red cell counts, hemoglobin (Hgb), and reticulocyte levels.
Guidelines for maintenance IV therapy:
If the patient responded to the initial dose with a satisfactory increase in platelets: 25 to 60 mcg/kg (125 to 300 intl units/kg) with the exact dose to be based on the platelet and Hgb levels.
If the patient did not respond to the initial dose, subsequent doses are to be as follows (based on the Hgb level of the patient):
Hgb Hgb 8 to 10 g/dL administer 25 to 40 mcg/kg (125 to 200 intl units/kg).
Hgb >10 g/dL administer 50 to 60 mcg/kg (250 to 300 intl units/kg).
Usual Adult Dose for Rh-Isoimmunization:
Dose and route varies for each product.
Routine antepartum prophylaxis and postpartum prevention:
WinRho: 300 mcg (1500 intl units) IV or IM at 28 weeks' gestation. If administered early in the pregnancy, repeat dose at 12-week intervals until delivery to maintain an adequate level of passively acquired anti-Rh.
RhoGam: 300 mcg IM once at 26 to 28 weeks' gestation. If administered earlier than 26 to 28 weeks' gestation, repeat dose at 12-week intervals until delivery to maintain an adequate level of passively acquired anti-Rh.
Rhophylac: 300 mcg (1500 intl units) IV or IM at 28 to 30 weeks' gestation.
HyperRHO S/D Full Dose: 1500 intl units IM at approximately 28 weeks' gestation. This dose must be repeated preferably within 72 hours following delivery, if the infant is Rh positive.
Postpartum prevention:
WinRho: 120 mcg (600 intl units) IV or IM, administered to the mother, within 72 hours of birth after an Rh incompatible delivery. Administration within 72 hours is preferred; however, WinRho may be administered up to 28 days postpartum.
RhoGam: 300 mcg IM, administered to the mother, within 72 hours of birth after an Rh incompatible delivery. If delivery occurs within 3 weeks after last antepartum dose, the postpartum dose may be withheld, but a test for FMH should be performed to determine if exposure to greater than 15 mL of red cells has occurred.
Rhophylac: 300 mcg (1500 intl units) IV or IM, administered to the mother, within 72 hours of birth after an Rh incompatible delivery.
HyperRHO S/D Full Dose: 1500 intl units IM within 72 hours of delivery. It may be given beyond the 72-hour period, but a lesser degree of protection is afforded.
Obstetrical conditions:
WinRho:
Threatened abortion at any time during pregnancy: 300 mcg (1500 intl units) IV or IM immediately after event.
Amniocentesis and chorionic villus sampling prior to 34 weeks' gestation: 300 mcg (1500 intl units) IV or IM with dose repeated every 12 weeks until delivery.
Abortion, amniocentesis, or any other manipulation after 34 weeks gestation: 120 mcg (600 intl units) IV or IM within 72 hours of event.
MICRhogam: 50 mcg IM within 72 hours following pregnancy termination occurring up to and including 12 weeks gestation.
RhoGam:
Amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, abdominal trauma, obstetrical manipulation, ectopic pregnancy, abortion or termination of pregnancy after 12 weeks gestation: 300 mcg IM within 72 hours of event.
Threatened abortion at any stage of gestation with continuation of pregnancy: 300 mcg IM within 72 hours of event.
Fetal-maternal hemorrhage less than 15 mL Rh-positive red blood cells: 300 mcg IM within 72 hours of event.
Fetal-maternal hemorrhage of greater than 15 mL Rh-positive red blood cells: a dose greater than 20 mcg/mL Rh-positive red blood cells IM within 72 hours of event may be necessary.
MICRhogam:
Abortion or termination of pregnancy up to and including 12 weeks gestation: 50 mcg IM within 72 hours of event.
Rhophylac:
Miscarriage, abortion, threatened abortion, ectopic pregnancy, hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage: 300 mcg (1500 intl units) IV or IM within 72 hours of event.
Amniocentesis, chorionic biopsy, obstetric manipulative procedures, or any other invasive procedure performed during pregnancy: 300 mcg (1500 intl units) IV or IM within 72 hours of event.
Fetal-maternal hemorrhage less than 15 mL Rho (D) positive red blood cells: 300 mcg IV or IM within 72 hours of event.
Fetal-maternal hemorrhage greater than 15 mL Rho (D) positive red blood cells: 20 mcg/mL cells IV or IM within 72 hours of event. If fetal red blood cells cannot be tested administer 600 mcg IV or IM within 72 hours of event.
HyperRHO S/D Full Dose:
Threatened abortion at any stage gestation with continuation of pregnancy: 1500 intl units IM within 72 hours of event.
Miscarriage, abortion, or termination of ectopic pregnancy at or beyond 13 weeks' gestation: 1500 intl units IM.
Amniocentesis at either 15 to 18 weeks' gestation of during the third trimester, or following abdominal trauma in the second or third trimester: 1500 intl units IM once, then another dose should be given at 26 to 28 weeks. A postpartum dose should be administered within 72 hours after delivery if the baby is Rh positive. If delivery occurs within 3 weeks after the last dose, the postpartum dose may be withheld unless there is a fetal-maternal hemorrhage in excess of 15 mL of red blood cells.
Transfusion accidents or fetal-maternal hemorrhage:
WinRho:
Exposure to Rho (D) positive whole blood: 600 mcg (3000 intl units) IV every 8 hours until a total dose of 9 mcg (45 intl units)/mL blood is administered or 1200 mcg (6000 intl units) IM every 12 hours until a total dose of 12 mcg (60 intl units)/mL blood is administered. The total dose should be administered within 72 hours of exposure.
Exposure to Rho (D) positive red blood cells: 600 mcg (3000 intl units) IV every 8 hours until a total dose of 18 mcg (90 intl units)/mL cells is administered or 1200 mcg (6000 intl units) IM every 12 hours until a total dose of 24 mcg (120 intl units)/mL cells is administered. The total dose should be administered within 72 hours of exposure.
MICRhogam:
Less than 2.5 mL of Rh-incompatible red blood cells administered: 50 mcg IM within 72 hours of event.
RhoGam:
Greater than 2.5 mL of Rh-incompatible red blood cells administered: 300 mcg IM within 72 hours of event.
Rhophylac:
Exposure to Rho (D) positive whole blood: 20 mcg (100 intl units)/2 mL transfused blood IV or IM within 72 hours of event.
Exposure to Rho (D) positive red blood cells: 20 mcg (100 intl units)/ml cells IV or IM within 72 hours of event.
HyperRHO S/D Full Dose:
Exposure to Rho (D) positive red blood cells: the volume of red blood cells divided by 15 mL provides the number of vials/syringes (rounded to the nearest larger whole number) to be administered as soon as possible, but within 72 hours of event.
Usual Pediatric Dose for Idiopathic (Immune) Thrombocytopenic Purpura:
Treatment must be given by intravenous administration (not all Rho (D) immune globulin products are approved for IV administration)
Initial dose: 50 mcg/kg (250 intl units/kg) body weight IV once. The initial dose, if desired, may be administered in two divided doses given on separate days.
Prior to administering the initial dose, the patient must be confirmed as Rho (D) positive.
Subsequent dosing: 25 to 60 mcg/kg (125 to 300 intl units/kg) body weight IV with the exact dose and frequency to be determined by the clinical response of the patient which is assessed by platelet counts, red cell counts, hemoglobin (Hgb), and reticulocyte levels.
Guidelines for maintenance IV therapy:
If the patient responded to the initial dose with a satisfactory increase in platelets: 25 to 60 mcg/kg (125 to 300 intl units/kg) with the exact dose to be based on the platelet and Hgb levels.
If the patient did not respond to the initial dose, subsequent doses are to be as follows (based on the Hgb level of the patient):
Hgb Hgb 8 to 10 g/dL administer 25 to 40 mcg/kg (125 to 200 intl units/kg).
Hgb >10 g/dL administer 50 to 60 mcg/kg (250 to 300 intl units/kg).
What other drugs will affect RHo (D) immune globulin?
There may be other drugs that can interact with RHo (D) immune globulin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More RHo (D) immune globulin resources
- RHo (D) immune globulin Side Effects (in more detail)
- RHo (D) immune globulin Use in Pregnancy & Breastfeeding
- RHo (D) immune globulin Drug Interactions
- RHo (D) immune globulin Support Group
- 2 Reviews for RHo (D) immune globulin - Add your own review/rating
- BayRho-D Advanced Consumer (Micromedex) - Includes Dosage Information
- Bayrho-D full dose
- HyperRHO S/D Full Dose Prescribing Information (FDA)
- MICRhoGAM MedFacts Consumer Leaflet (Wolters Kluwer)
- RhoGAM Ultra-Filtered PLUS Prescribing Information (FDA)
- Rhophylac Prescribing Information (FDA)
- Rhophylac Consumer Overview
- Rhophylac MedFacts Consumer Leaflet (Wolters Kluwer)
- WinRho SDF MedFacts Consumer Leaflet (Wolters Kluwer)
Compare RHo (D) immune globulin with other medications
- Idiopathic Thrombocytopenic Purpura
- Rh-Isoimmunization
Where can I get more information?
- Your doctor or pharmacist can provide more information about RHo (D) immune globulin.
See also: RHo (D) immune globulin side effects (in more detail)
No comments:
Post a Comment