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Rhophylac Generic Name & Formulations
Legal Class
Rx
General Description
Rho (D) immune globulin human 1500 IU (300mcg)/2mL; syringe; for IV or IM inj; preservative- and latex-free; contains albumin (human); solvent/detergent treated.
How Supplied
Single-dose prefilled syringes—1, 10
Manufacturer
Rhophylac Indications
Indications
Raising platelet counts in Rho (D) positive non-splenectomized patients with chronic immune thrombocytopenic purpura (ITP).
Rhophylac Dosage and Administration
Adult
See full labeling. 250 IU (50mcg) per kg by IV only at rate of 2mL per 15–60 secs.
Children
Not recommended.
Rhophylac Contraindications
Contraindications
Rho (D) positive patients. IgA deficiency. Newborn infant of a mother that received Rhophylac postpartum.
Rhophylac Boxed Warnings
Boxed Warning
Intravascular hemolysis in immune thrombocytopenic purpura (see full labeling).
Rhophylac Warnings/Precautions
Warnings/Precautions
Monitor patients 20 mins after administration. Have epinephrine available. Discontinue if hypersensitivity reactions occur. Risk of infectious agent transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Pre-existing anemia. Pregnancy (Cat.C).
Rhophylac Pharmacokinetics
See Literature
Rhophylac Interactions
Interactions
Do not give live vaccines within 3 months.
Rhophylac Adverse Reactions
Adverse Reactions
Local or infusion reactions, fever, chills, headache; see full labeling.
Rhophylac Clinical Trials
See Literature
Rhophylac Note
Not Applicable
Rhophylac Patient Counseling
See Literature
Rhophylac Generic Name & Formulations
Legal Class
Rx
General Description
Rho (D) immune globulin human 1500 IU (300mcg)/2mL; syringe; for IV or IM inj; preservative- and latex-free; contains albumin (human); solvent/detergent treated.
How Supplied
Single-dose prefilled syringes—1, 10
Manufacturer
Rhophylac Indications
Indications
Suppression of Rh isoimmunization in non-sensitized Rho (D) negative women during pregnancy and in appropriate obstetrical conditions, unless the fetus or father is known to be Rho (D) negative. Suppression of Rh isoimmunization in Rho (D) negative individuals transfused with Rho (D) positive blood products.
Rhophylac Dosage and Administration
Adult
See full labeling. Pregnancy (28–30 weeks gestation), postpartum prevention (within 72hrs), obstetric complications, invasive procedures during pregnancy: 1500 IU (300mcg). Incompatible transfusions (within 72hrs): 100 IU (20mcg) per 2mL transfused blood or per 1mL erythrocyte concentrate.
Children
Not recommended.
Rhophylac Contraindications
Contraindications
Rho (D) positive patients. IgA deficiency. Newborn infant of a mother that received Rhophylac postpartum.
Rhophylac Boxed Warnings
Not Applicable
Rhophylac Warnings/Precautions
Warnings/Precautions
Monitor patients 20 mins after administration. Have epinephrine available. Discontinue if hypersensitivity reactions occur. Risk of infectious agent transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Pre-existing anemia. Pregnancy (Cat.C).
Rhophylac Pharmacokinetics
See Literature
Rhophylac Interactions
Interactions
Do not give live vaccines within 3 months.
Rhophylac Adverse Reactions
Adverse Reactions
Local or infusion reactions, fever, chills, headache; see full labeling.
Rhophylac Clinical Trials
See Literature
Rhophylac Note
Not Applicable
Rhophylac Patient Counseling
See Literature
