Rhophylac 300

/ Genmedix

Posology: The following dose schedules are recommended based on the clinical studies performed with Rhophylac, however consideration must be given to professional guidelines for the use of anti-D IgG in the individual country of application.
Prevention of Rh(D) immunisation in Rh(D)-negative women
• Antepartum prophylaxis: The recommended dose is a single dose of 300 micrograms (1,500 IU) administered by intravenous or intramuscular injection at 28 to 30 weeks of gestation.
• Postpartum prophylaxis: For intravenous administration, 200 micrograms (1,000 IU) is a sufficient dose. If administered intramuscularly, 200 micrograms (1,000 IU) to 300 micrograms (1,500 IU) is recommended. Rhophylac should be administered as soon as possible within 72 hours of delivery. The postpartum dose must be given even when antepartum prophylaxis has been administered. If a large foetomaternal haemorrhage (greater than 4 ml (0.7% to 0.8% of women)) is suspected, e.g., in the event of foetal anaemia or intrauterine foetal death, its extent should be determined by a suitable method, e.g., Kleihauer-Betke test, and additional doses of anti-D should be administered as indicated (20 micrograms/100 IU for each 1 ml of foetal red blood cells).
• Prophylaxis following complications of pregnancy:
– Interventions and incidents occurring up to 12 weeks gestation: 200 micrograms (1,000 IU) should be administered by intravenous or intramuscular injection as soon as possible and not later than 72 hours after the at-risk event.
– Interventions and incidents occurring after 12 weeks of gestation: at least 200
micrograms (1,000 IU) should be administered by intravenous or intramuscular
injection as soon as possible and not later than 72 hours after the at-risk event.
– Chorionic villus sampling: 200 micrograms (1,000 IU) should be administered
by intravenous or intramuscular injection as soon as possible and not later than
72 hours after the at-risk event.
Incompatible transfusions
The recommended dose is 20 micrograms (100 IU) anti-D immunoglobulin per 2 ml of transfused Rh(D)-positive blood or per 1 ml of erythrocyte concentrate. The intravenous route of administration is recommended. If given by intramuscular administration the large doses should be administered over a period of several days.
A maximum dose of 3,000 micrograms is sufficient in the case of larger incompatible transfusions independent of whether the transfusion volume is greater than 300 ml of Rh(D)-positive blood.
Method of administration: Rhophylac can be administered by intravenous or intramuscular injection. In case of haemorrhagic disorders where intramuscular injections are contraindicated, Rhophylac should be administered intravenously. If large doses (> 5 ml) are required and intramuscular injection is chosen, it is advisable to administer them in divided doses at different sites.

Prophylaxis of Rh(D) immunization in Rh(D)-negative women: Anti-D immune globulin is administered for the prevention of Rh(D) immunization if it has been demonstrated, or if it is suspected that fetal erythrocytes have entered the circulation of the mother. Treatment is not necessary when it is assured that the child or the father are Rh(D)-negative. Criteria for a Rhesus-incompatible pregnancy and the administration of anti-D immune globulin are: a) the mother is Rh(D)-negative; b) the child is Rh(D)-positive, Rh(Dweak)-positive or its Rhesus-type is not known.
Routine antepartum prophylaxis: To prevent Rh(D) immunization due to spontaneous fetomaternal hemorrhage (FMH) during the last trimester of pregnancy.
Postpartum prophylaxis: To prevent Rh(D)immunization of the Rh(D)-negative mother following delivery of an Rh(D)-positive child.
Complications of pregnancy: Interventions during pregnancy, such as invasive prenatal diagnosis (e.g. amniocentisis, chronic villus sampling, fetal blood sampling) or or other intrauterine procedures (e.g. insertion of shunts, embryo reduction), external version of the fetus and therapeutic abortion. Incidents during pregnancy, such as antepartum hemorrhage, spontaneous abortion, ruptured tubal pregnancy, ectopic pregnancy, stillbirths, intrauterine death and persons after incompatible transfusions of Rh(D)-positive blood or erythrocyte concentrate. Prevention of Rh(D)(-) immunization in Rh(D)-negative persons who for any reason have been given blood or blood components containing Rh(D)-positive red cells.

Hypersensitivity to any of the components.
The intramuscular route is contraindicated in persons with severe thrombocytopenia or other disorders of haemostasis.

In the case of postpartum use, anti-D immunoglobulin is intended for maternal administration. It should not be given to the newborn infant. The product is not intended for use in Rh(D)-positive individuals. Patients should be observed for at least 20 minutes after administration. If symptoms of allergic or anaphylactic type reactions occur, immediate discontinuation of the administration is required. Allergic responses to anti-D immunoglobulin may occur. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. The treatment required depends on the nature and severity of the side effect. In case of shock, the current medicdbal standards for treatment of shock should be observed. The concentration of IgA was found to be below the detection limit of 5 mcg/ml. Nevertheless, the product may contain trace amounts of IgA. Although anti-D immunoglobulin has been used successfully to treat selected IgA deficient patients, individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The benefit of treatment should therefore be weighed against the potential risks of hypersensitivity reactions. It is strongly recommended that the name and batch number of the product are recorded every administration, in order to maintain a link between the patient and the batch of the product.

Mild, transient allergic reactions including sensation of heat, headache, chills and nasuea may occasionally occur.
See prescribing information for full details.