Label: HYPERRHO S/D FULL DOSE (rho(d) immune globulin- human solution

Pregnancy and Other Obstetric Conditions

HyperRHO S/D Full Dose is recommended for the prevention of Rh hemolytic disease of the newborn by its administration to the Rho(D) negative mother within 72 hours after birth of an Rho(D) positive infant,(12) providing the following criteria are met:

1. The mother must be Rho(D) negative and must not already be sensitized to the Rho(D) factor.

2. Her child must be Rho(D) positive, and should have a negative direct antiglobulin test (see PRECAUTIONS).

If HyperRHO S/D Full Dose is administered antepartum, it is essential that the mother receive another dose of HyperRHO S/D Full Dose after delivery of an Rho(D) positive infant.

If the father can be determined to be Rho(D) negative, HyperRHO S/D Full Dose need not be given.

HyperRHO S/D Full Dose should be administered within 72 hours to all nonimmunized Rho(D) negative women who have undergone spontaneous or induced abortion, following ruptured tubal pregnancy, amniocentesis or abdominal trauma unless the blood group of the fetus or the father is known to be Rho(D) negative.(7,8) If the fetal blood group cannot be determined, one must assume that it is Rho(D) positive,(2) and HyperRHO S/D Full Dose should be administered to the mother.

Transfusion

HyperRHO S/D Full Dose may be used to prevent isoimmunization in Rho(D) negative individuals who have been transfused with Rho(D) positive red blood cells or blood components containing red blood cells.(5,13)

General

A large fetomaternal hemorrhage late in pregnancy or following delivery may cause a weak mixed field positive Du test result. If there is any doubt about the mother’s Rh type, she should be given Rho(D) Immune Globulin (Human). A screening test to detect fetal red blood cells may be helpful in such cases.

If more than 15 mL of D-positive fetal red blood cells are present in the mother’s circulation, more than a single dose of HyperRHO S/D Full Dose is required. Failure to recognize this may result in the administration of an inadequate dose.

Although systemic reactions to human immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic reactions.

Drug Interactions

Other antibodies in the Rho(D) Immune Globulin (Human) preparation may interfere with the response to live vaccines such as measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after Rho(D) Immune Globulin (Human) administration.

Drug/Laboratory Interactions

Babies born of women given Rho(D) Immune Globulin (Human) antepartum may have a weakly positive direct antiglobulin test at birth.

Passively acquired anti-Rho(D) may be detected in maternal serum if antibody screening tests are performed subsequent to antepartum or postpartum administration of Rho(D) Immune Globulin (Human).

Pregnancy

Animal reproduction studies have not been conducted with Rho(D) Immune Globulin (Human) — HyperRHO® S/D Full Dose. It is also not known whether HyperRHO S/D Full Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HyperRHO S/D Full Dose should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Pregnancy and Other Obstetric Conditions

1. For postpartum prophylaxis, administer one syringe of HyperRHO S/D Full Dose (1500 IU; 300 mcg), preferably within 72 hours of delivery. Although a lesser degree of protection is afforded if Rh antibody is administered beyond the 72-hour period, HyperRHO S/D Full Dose may still be given.(7,14]) Full-term deliveries can vary in their dosage requirements depending on the magnitude of the fetomaternal hemorrhage. One full dose syringe of HyperRHO S/D Full Dose provides sufficient antibody to prevent Rh sensitization if the volume of red blood cells that has entered the circulation is 15 mL or less.(2-4) In instances where a large (greater than 30 mL of whole blood or 15 mL red blood cells) fetomaternal hemorrhage is suspected, a fetal red cell count by an approved laboratory technique (e.g., modified Kleihauer-Betke acid elution stain technique) should be performed to determine the dosage of immune globulin required.(8,15) The red blood cell volume of the calculated fetomaternal hemorrhage is divided by 15 mL to obtain the number of syringes of HyperRHO S/D Full Dose (1500 IU; 300 mcg) for administration.(3,8,13) If more than 15 mL of red cells is suspected or if the dose calculation results in a fraction, administer the next higher whole number of syringes (e.g., if 1.4, give 2 syringes).

2. For antenatal prophylaxis, one full dose syringe of HyperRHO S/D Full Dose (1500 IU; 300 mcg) is administered at approximately 28 weeks’ gestation. This must be followed by another full dose (1500 IU; 300 mcg) , preferably within 72 hours following delivery, if the infant is Rh positive. 

3. Following threatened abortion at any stage of gestation with continuation of pregnancy, it is recommended that a full dose of HyperRHO S/D Full Dose (1500 IU; 300 mcg) be given. If more than 15 mL of red cells is suspected due to fetomaternal hemorrhage, the same dose modification in No. 1 above applies. 

4. Following miscarriage, abortion, or termination of ectopic pregnancy at or beyond 13 weeks’ gestation, it is recommended that a HyperRHO S/D Full Dose (1500 IU; 300 mcg) be given. If more than 15 mL of red cells is suspected due to fetomaternal hemorrhage, the same dose modification in No. 1 above applies. If pregnancy is terminated prior to 13 weeks’ gestation, where licensed, a single dose of HyperRHO® S/D Mini-Dose (250 IU; 50mcg) may be used instead of HyperRHO S/D Full Dose (1500 IU; 300 mcg). 

5. Following amniocentesis at either 15 to 18 weeks’ gestation or during the third trimester, or following abdominal trauma in the second or third trimester, it is recommended that a HyperRHO S/D Full Dose (1500 IU; 300 mcg) be administered. If there is a fetomaternal hemorrhage in excess of 15 mL of red cells, the same dose modification in No. 1 applies. 

If abdominal trauma, amniocentesis, or other adverse event requires the administration of HyperRHO S/D Full Dose (1500 IU; 300 mcg) at 13 to 18 weeks’ gestation, another full dose should be given at 26 to 28 weeks. To maintain protection throughout pregnancy, the level of passively acquired anti-Rho(D) should not be allowed to fall below the level required to prevent an immune response to Rh positive red cells. The half-life of IgG is 23 to 26 days. In any case, a HyperRHO S/D Full Dose should be given 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 fetomaternal hemorrhage in excess of 15 mL of red blood cells.(16)

Transfusion

In the case of a transfusion of Rho(D) positive red cells to an Rho(D) negative recipient, the volume of Rh positive whole blood administered is multiplied by the hematocrit of the donor unit giving the volume of red blood cells transfused. The volume of red blood cells is divided by 15 mL which provides the number of syringes of HyperRHO S/D Full Dose to be administered.

If the dose calculated results in a fraction, the next higher whole number of syringes should be administered (e.g., if 1.4, give 2 syringes). HyperRHO S/D Full Dose should be administered within 72 hours after an incompatible transfusion, but preferably as soon as possible.

Injection Procedure

DO NOT INJECT INTRAVENOUSLY. DO NOT INJECT NEONATE. HyperRHO S/D Full Dose is administered intramuscularly, preferably in the deltoid muscle of the upper arm or lateral thigh muscle. The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve.(17)

A.

Single Syringe Dose 

 

INJECT ENTIRE CONTENTS OF THE SYRINGE INTO THE INDIVIDUAL INTRAMUSCULARLY.

B.

Multiple Syringe Dose

 

1. Calculate the number of syringes of HyperRHO S/D Full Dose to be given (see Dosage section).

2. The total volume of HyperRHO S/D Full Dose can be given in divided doses at different sites at one time or the total dose may be divided and injected at intervals, provided the total dosage is given within 72 hours of the fetomaternal hemorrhage or transfusion. USING STERILE TECHNIQUE, INJECT THE ENTIRE CONTENTS OF THE CALCULATED NUMBER OF SYRINGES INTRAMUSCULARLY INTO THE PATIENT.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HyperRHO S/D Full Dose is supplied with a syringe and an attached UltraSafe® Needle Guard for your protection and convenience. Please follow instructions below for proper use of syringe and UltraSafe® Needle Guard.

Directions for Syringe Usage

1. Remove the prefilled syringe from the package. Lift syringe by barrel, not by plunger.
2. Twist the plunger rod clockwise until the threads are seated.
3. With the rubber needle shield secured on the syringe tip, push the plunger rod forward a few millimeters to break any friction seal between the rubber stopper and the glass syringe barrel.

4. Remove the needle shield and expel air bubbles. [Do not remove the rubber needle shield to prepare the product for administration until immediately prior to the anticipated injection time.]

5. Proceed with hypodermic needle puncture.
6. Aspirate prior to injection to confirm that the needle is not in a vein or artery.
7. Inject the medication.

8. Keeping your hands behind the needle, grasp the guard with free hand and slide forward toward needle until it is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated. (See Diagrams A and B)

9. Place entire prefilled glass syringe with guard activated into an approved sharps container for proper disposal. (See Diagram C)

A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

The Rh Factor and Your Pregnancy

Information About Pregnancy Protection

The Rh Factor and When It Is Important

The Rh factor is one of many blood group antigens found on the surface of red blood cells. If you have this antigen you are considered Rh positive. If you don’t, then you are considered Rh negative. Everyone is either Rh positive or Rh negative. One type is neither better nor worse than the other, only different.

Your Rh factor is important if you are an Rh negative woman and you become pregnant, or if you receive a blood transfusion.

How the Rh Factor Can Affect Your Future

If you have Rh negative blood, there are two situations that can affect you:

1.

If the father of your baby is Rh positive, the baby will probably be Rh positive too. An Rh negative woman carrying an Rh positive baby may have an immune reaction if some of the baby’s Rh positive blood cells enter her bloodstream.

 

This immune reaction, called isoimmunization, means your body’s defense system recognizes Rh positive blood as foreign from your own and produces “antibodies” to destroy the invading Rh positive blood cells.

 

The passage of blood from the baby to the mother’s bloodstream happens most often at delivery, but can also occur during miscarriage, the termination of pregnancy, amniocentesis (test performed to determine fetal health), or due to an injury or trauma. It is important to note that a small number of women develop antibodies to Rh positive blood cells during pregnancy for no apparent reason.

 

Antibodies to Rh positive blood may not be a problem in first pregnancies; however, the antibodies stay in your bloodstream, ready to attack invading Rh positive blood cells, for many years to come. This can lead to problems in future pregnancies by causing miscarriage or a disease known as hemolytic disease of the newborn.

 

Babies born to Rh positive mothers, regardless of the father’s blood type, will usually be free of the dangers of hemolytic disease.

2.

Someday it may become necessary for you to receive a blood transfusion. If Rh positive antibodies already reside in your bloodstream due to isoimmunization and the blood you receive is Rh positive due to error or lifesaving reasons, your Rh positive antibodies will become mobilized and destroy the donor Rh positive cells. As a result, the transfusion could be unsuccessful and possibly harmful to you.

Hemolytic Disease of the Newborn: A Threat to Your Baby

When an Rh negative woman has Rh positive antibodies in her blood and the baby she is carrying is Rh positive, the antibodies could possibly enter the baby’s bloodstream, attack the baby’s red blood cells and cause hemolytic disease of the newborn. At birth, the infant suffering from hemolytic disease may be jaundiced and anemic or suffer permanent damage of the brain and central nervous system which may result in mental retardation, hearing loss, or cerebral palsy. Extensive medical care can be required, including an exchange transfusion, in which all of the baby’s blood is replaced. This usually stops the destruction of the baby’s red blood cells and gives the infant a chance to survive.

The risk of hemolytic disease of the newborn is slight with the first baby, but increases with each successive pregnancy.

Preventing Hemolytic Disease

HyperRHO® S/D, Rho(D) Immune Globulin (Human) can prevent hemolytic disease of the newborn, provided Rh positive antibodies do not already reside in your bloodstream.

HyperRHO S/D is a specially prepared gamma globulin with a high level of preformed antibodies against Rh positive blood cells. The injection of HyperRHO S/D destroys any Rh positive blood cells that may have entered the mother’s bloodstream and prevents the mother’s immune system from producing Rh positive antibodies; thus protecting the baby from developing hemolytic disease.

HyperRHO S/D Full Dose — When Prescribed

Pregnancy and Other Obstetric Conditions Pertaining to Rh Negative Women

HyperRHO S/D Full Dose (1500 IU; 300 mcg) is administered during pregnancy if you fall into a high-risk category. For example, you are at risk of producing Rh positive antibodies if you have an amniocentesis procedure performed, or if you have a miscarriage or other termination of pregnancy at or beyond 13 weeks' gestation.

Laboratory findings have shown that some Rh negative women develop Rh positive antibodies during the last weeks of pregnancy even without an antibody-stimulating event. As a preventive measure, your physician will probably recommend the first injection of HyperRHO S/D Full Dose at the 28th week of pregnancy.

In both of the above situations, if the blood type of the father or baby can be determined to be Rh negative, an injection of HyperRHO S/D is not required.

Another injection of HyperRHO S/D Full Dose is administered within 72 hours of delivery of an Rh positive baby.

Blood Transfusion

HyperRHO S/D Full Dose (1500 IU; 300 mcg) may be used to prevent isoimmunization in Rh negative individuals who have been transfused with Rh positive red blood cells or blood components containing red blood cells.

HyperRHO S/D Mini-Dose — When Prescribed

A single dose of HyperRHO S/D Mini-Dose (250 IU; 50 mcg) may be prescribed for an Rh negative woman instead of HyperRHO S/D Full Dose in the event of miscarriage or other termination of pregnancy occurring prior to 13 weeks' gestation. HyperRHO S/D Mini-Dose is not required if the blood type of the father or fetus can be determined to be Rh negative.

Will You Need HyperRHO S/D Again?

HyperRHO S/D provides protection only if you have not already produced Rh positive antibodies. Women who have developed antibodies through previous pregnancy, miscarriage, other termination of pregnancy, or blood transfusion cannot be protected by HyperRHO S/D. This is why with each pregnancy it is important to have HyperRHO S/D injections within the prescribed time period.

Reactions to HyperRHO S/D

You may feel a temporary soreness at the site of the injection. You may also have a slight and temporary change in body temperature. In very rare instances, an allergic type of reaction can occur, for which your physician will take appropriate measures.

Delivering a Sound, Healthy Baby

Your physician can answer any questions you may have about receiving a HyperRHO S/D injection to prevent hemolytic disease of the newborn. If you know that you are Rh negative and you are pregnant, you should discuss your situation with your physician. Today, with HyperRHO S/D, hemolytic disease of the newborn can be reduced to its lowest possible rate of incidence.

GRIFOLS

Grifols Therapeutics LLC
Research Triangle Park, NC 27709 USA
U.S. License No. 1871
3052584

(Rev. 6/2018)

Development of Hemolytic Disease

How HyperRHO S/D Immune Globulin Can Prevent Hemolytic Disease