Rhophylac

Rhophylac

anti-d immunoglobulins

Manufacturer:

CSL Behring

Distributor:

Primal
Concise Prescribing Info
Contents
Anti-D (Rho) Ig
Indications/Uses
Prevention of Rh(D) isoimmunisation in Rh(D) -ve women: Antepartum prophylaxis (planned antepartum prophylaxis, antepartum prophylaxis following complications of pregnancy); postpartum prophylaxis (delivery of a Rh(D) +ve (D, Dweak, Dpartial) baby). Treatment of Rh(D) -ve adults, childn & adolescents (0-18 yr) after incompatible transfusions of Rh(D) +ve blood or other products containing RBC eg, platelet conc.
Dosage/Direction for Use
Prevention of Rh(D) isoimmunisation in Rh(D) -ve women: Planned antepartum prophylaxis 300 mcg (1,500 IU) single dose by IV or IM at 28-30 wk of pregnancy. If beyond 30 wk, administer as soon as possible. Antepartum prophylaxis following complications of pregnancy 300 mcg (1,500 IU) single dose by IV or IM, administered as soon as possible & w/in 72 hr. If >72 hr have elapsed, administer as soon as possible. Dose may be repeated at 6-12 wk intervals throughout the pregnancy, if necessary. Postpartum prophylaxis 300 mcg (1,500 IU) single dose by IV or IM, administered to the mother as soon as possible w/in 72 hr of delivery of Rh +ve (D, Dweak, Dpartial) baby, If >72 hr have elapsed, administer as soon as possible. When administered IV, min dose of 200 mcg may be sufficient provided that large feto-maternal haemorrhage can be excluded. Large feto-maternal haemorrhage (>4 mL) 300 mcg (1,500 IU) single dose w/in 72 hr of complication + 10 mcg (50 IU) per 0.5 mL Rh(D) +ve fetal RBCs, or 10 mcg (50 IU) per 1 mL Rh(D) +ve fetal blood. Incompatible transfusion of RBCs in Rh(D) -ve patient 20 mcg (100 IU) per 2 mL of transfused Rh(D) +ve blood or per 1 mL of Rh(D) +ve RBC conc. Max: 3,000 mcg (15,000 IU). Recommended to be administered IV.
Contraindications
Hypersensitivity anti-D (Rho) Ig or to human Ig. IM route is contraindicated in persons w/ severe thrombocytopenia or other disorders of haemostasis.
Special Precautions
Immediately discontinue in case of symptoms of allergic or anaphylactic type reactions. May contain trace amounts of IgA. Anti-D Ig for postpartum use is intended for maternal administration; do not give to the new-born infant. Not intended for use in Rh(D) +ve individuals & for individuals already immunised to Rh(D) antigen. Risk of haemolytic reaction in patients in receipt of incompatible transfusion receiving very large doses of anti-D Ig. Increased risk of lack of efficacy when administered IM in patients w/ BMI ≥30; consider IV administration in these patients. Possibility of transmitting infective agents. May interfere w/ some serological tests for RBC Ab (eg, Coombs' test) particularly in Rh(D) +ve neonates whose mothers have received antepartum prophylaxis.
Adverse Reactions
Uncommon: Headache; skin reaction, erythema, pruritus; pyrexia, malaise, chills.
Drug Interactions
Efficacy of live virus vaccine may be impaired. Postpone immunisation until 3 mth after the last administration of anti-D Ig.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BB01 - anti-D (rh) immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
Rhophylac soln for inj 300 mcg/2 mL
Packing/Price
1's
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