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Logo RHESUGAM IM (Solution for intramuscular injection)
REGISTRATION NUMBER
T/30.2/750

PROPRIETARY NAME
(and dosage form)

RHESUGAM IM (Solution for intramuscular injection)

DESCRIPTIVE NAME OF THE MEDICINE
Human Anti-D (Rho) immunoglobulin

PHARMACOLOGICAL CLASSIFICATION
A 30.2 Biologicals (Antibodies)

SCHEDULING STATUS
S4

COMPOSITION
Rhesugam IM contains gammaglobulin derived from pooled human plasma sourced from healthy Rho-negative donors who have antibodies to the Rho (D) erythrocyte antigen.
Each unit of plasma has been individually tested and found non-reactive for hepatitis B surface antigen, antibodies to hepatitis C virus and antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2, using approved methods.
Rhesugam IM is prepared by cold ethanol fractionation, to further reduce the risk of viral transmission.
Each 2 mL ampoule contains 500 IU (100 µg) of human anti-D (Rho) immunoglobulin.
This preparation contains no antimicrobial preservative and is stabilised with human albumin and glycine.

IDENTIFICATION
A clear, pale-yellow or light brown liquid exhibiting slight opalescence.

PHARMACOLOGICAL ACTION OF THE MEDICINE
Anti-D (Rho) immunoglobulin prevents active immunisation to the Rho (D) erythrocyte antigen in Rho-negative individuals exposed to Rho-positive blood.

INDICATIONS
1. Rhesugam IM is indicated for antenatal prophylaxis when a Rho- negative mother is known to be carrying a Rho-positive child or if the Rho-status of the fetus is unknown.
It is specifically recommended after the following potentially sensitising events:
  • Amniocentesis
  • Antepartum haemorrhage
  •Abdominal trauma
  • External cephalic version
  • Ectopic pregnancy
  • Chorionic villus sampling
  • Stillbirth
  • Fetal Blood Sampling
2. Rhesugam IM should be given to all Rho-negative women after:
  • Therapeutic abortions.
  • Spontaneous abortions, after 12 weeks gestation and especially if there is surgical intervention.
  • Early spontaneous abortions (first trimester). Sensitisation can occur as early as eight weeks gestation.
  • Threatened abortions after 12 weeks gestation.
  • Induced abortions (Termination of pregnancy)
3. Rhesugam IM is essential after every delivery involving a Rho-negative mother and a Rho-positive child, provided that there is no evidence of prior maternal sensitisation to the Rho (D) erythrocyte antigen. If the Rho type of the neonate cannot be determined, this preparation should still be administered to the mother.
  If antepartum anti-D (Rho) immunoglobulin has been given, an additional postpartum dose is also necessary. Rho-negative women with blood group antibodies other than anti-D should still be treated with this preparation.
4. Although the transfusion of Rho-negative individuals with Rho-positive red cell concentrate, whole blood and platelets should be avoided whenever possible, anti-D (Rho) immunoglobulin may also be given in this instance. It is particularly important after transfusion of a Rho-negative woman of child-bearing age with Rho-positive red blood cells, whole blood or platelets.

CONTRA-INDICATIONS
Rhesugam IM should not be given to:
• The baby
• A Rho-positive mother
• A Rho-negative mother who has given birth to a known Rho-negative baby.
• A Rho-negative mother with previous sensitisation to the Rho (D) erythrocyte antigen.
Intramuscular injections are not advocated for patients with bleeding disorders.
The risk-benefit ratio in patients with a history of immunoglobulin A (IgA) deficiency or severe anaphylactic reactions to plasma products should be considered.
Women who have a weak expression of the RhD blood group (Du) do not form anti-D and do not therefore require prophylaxis with Rhesugam IM

WARNINGS:
Anti-D (Rho) immunoglobulin is not effective once the mother has formed anti-D antibodies.
This intramuscular preparation must not be given intravenously.

DOSAGE AND DIRECTIONS FOR USE
For optimal protection, anti-D (Rho) immunoglobulin should be administered intramuscularly as soon as possible, but always within 72 hours of the possible sensitising event.
Immunisation to the Rho (D) erythrocyte antigen is directly related to the volume of Rh-positive cells infused or to the size of a fetomaternal haemorrhage. A 500 IU dose gives protection for fetomaternal haemorrhage of up to 4 mL of red cells. Post delivery or following a potential sensitising event after 20 weeks gestation, a Kleihauer test (which determines the number of fetal cells in the mother's circulation) should be done at the time when the dose of anti-D is being considered. If this shows that the fetomaternal bleed is larger than 4 mL, an additional dose of anti-D must be given. This is calculated using the formula that 125 IU of anti-D is administered per 1 mL of red cells.
Recommended dosages:
The following are recommended dosages of Rhesugam IM. Please note that where appropriate dosages should be determined by doing a Kleihauer test immediately after any sensitising event.
Indication                        Recommended Dosage
Pregnancy associated indications:                       
Antenatal prophylaxis 500 IU (100 µg) is given at 28 and/or 34 weeks gestation. If the infant is Rho- positive, a similar or higher dose should be administered after delivery.
Prophylaxis following potentially sensitising events, including abortions 250 IU (50 µg) is recommended for events up to 20 weeks. For events occurring after 20 weeks, a dose of 500 IU (100 µg) is recommended.
Postnatal prophylaxis 500 IU (100 µg) is recommended.
Non-pregnancy associated indications:                               
Transfusion of Rho incompatible blood The dose is estimated to clear the estimated quantity of red cells given –125 IU (25 µg) for each 1 mL of red cells.
Transfusion of Rh positive platelets in Rh negative women of child bearing age 250 IU (50 µg) for each dose of platelets (i.e. 5-6 units). If more than 10 units are used, administer 500 IU (100 µg).
If anti-D (Rho) immunoglobulin is introduced into fat rather than into muscle, the uptake could be substantially lower. Anti-D (Rho) immunoglobulin should therefore be injected into the deltoid muscle (see bleeding disorders).
Warm the ampoule to body temperature before injecting intramuscularly. Discard any unused portion.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Treating Rho-negative individuals with anti-D (Rho) immunoglobulin poses few risks. It should be noted that inadequate therapy will result in Rho allo-immunisation.
Local reactions, with pain and tenderness may occur at the injection site. Headache, fever, chills, flushing, lightheadedness, backache, nausea and cutaneous reactions have also been reported. In rare cases: vomiting, hypotension, tachycardia and allergic or anaphylactic reactions, including shock have been reported.
Anaphylactic reactions may result if this intramuscular preparation is given intravenously. Measures to treat anaphylaxis, including adrenaline, must be immediately available when administering Rhesugam IM.
Persons with selective IgA deficiency may develop antibodies to the small amount of IgA in this preparation, leading to sensitisation and subsequent reaction to IgA-containing material.
Infectious diseases due to the transmission of infectious agents, cannot be totally excluded. Consideration should be given to appropriate vaccination of patients receiving human blood or plasma-derived medicinal products.
Antibodies contained in Rhesugam IM may interfere with the immune response to certain live attenuated virus vaccines (e.g. measles, mumps, rubella and varicella). These vaccines should be administered at least 14 days prior to or 3 months after administration of Rhesugam IM.
Usage during pregnancy and lactation: This medicinal product has been used in pregnancy. No harmful effects are known with respect to the course of pregnancy and to the newborn and neonate.
Interference with serological testing: After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing. The results of blood typing and antibody testing, including the Coombs or antiglobulin test, may be affected by the administration of anti-D (Rho) immunoglobulin. A good patient history is essential and will ensure that treatment is not withheld.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT
None known.

PRESENTATION
2 mL, single dose, clear, colourless glass ampoule.

STORAGE DIRECTIONS
Transport within 72 hours below 37°C.
Store between 2°C and 8°C.
Do not freeze.
Protect from light.
Keep out of reach of children.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
NATAL BIOPRODUCTS INSTITUTE
Reg. No. 94/02044/08
PRIVATE BAG X9043
PINETOWN
3600

10 EDEN ROAD
PINETOWN
3610
Telephone: (031) 719 6789         Telefax: (031) 708 5614

DATE OF PUBLICATION OF PACKAGE INSERT
9/95

P 0976 2/00

APPROVED PACKAGE INSERT
Date of Approval: 26 November 1999

Updated on this site: May 2000

Please note that the Natal Bioproducts Institute cannot be held responsible for the accuracy of the text. The package insert on the screen may not be the latest version. We therefore recommend that an alternative source of information be consulted, particularly when confirmation of dosages and indications are required. Please refer to the printed package inserts inside the packs, recognised reference books or alternatively, you may contact the NBI Information Centre at (+27)(+31) 719 6789 or 082 870 3705 or 082 895 0056.

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