Human rho(d) immune globulin
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: INTRAVASCULAR HEMOLYSIS IN ITP This warning does not apply to Rh 0 (D)-negative patients treated for the suppression of Rh isoimmunization. Intravascular hemolysis leading to death has been reported in Rh 0 (D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh 0 (D) Immune Globulin Intravenous (Human) products. 1 Intravascular hemolysis can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS). Serious complications, including severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC), have also been reported.
Closely monitor patients treated for ITP with Rhophylac in a healthcare setting for at least 8 hours after administration. Perform a dipstick urinalysis at baseline, 2 hours and 4 hours after administration, and prior to the end of the monitoring period. Alert patients to, and monitor them for, the signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms within 8 hours does not indicate IVH cannot occur subsequently.
If signs and/or symptoms of intravascular hemolysis are present or suspected after Rhophylac administration, perform post-treatment laboratory tests, including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect). WARNING: INTRAVASCULAR HEMOLYSIS IN ITP See full prescribing information for complete boxed warning. This warning does not apply to Rh 0 (D)-negative patients treated for the suppression of Rh isoimmunization. Intravascular hemolysis leading to death has been reported in Rh 0 (D)-positive patients treated for immune thrombocytopenic purpura (ITP) withRh 0 (D) Immune Globulin Intravenous (Human) products .
1 Intravasular hemolysis can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS). Serious complications, including severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC), have also been reported. Closely monitor patients treated for ITP with Rhophylac in a healthcare setting for at least 8 hours after administration.
Human Immunoglobulin G
Dosing in kidney impairment
Do not administer to the newborn infant ( see Pediatric Use [8.4] ) . 5.3 ITP 5.3.1 Intravascular Hemolysis Intravascular hemolysis has occurred in a clinical study with Rhophylac. All cases resolved completely. However, as reported in the literature, some Rh 0 (D)-positive patients treated with Rh 0 (D) Immune Globulin Intravenous (Human) for ITP developed clinically compromising anemia, acute renal insufficiency, and, very rarely, disseminated intravascular coagulation (DIC) and death. 1 Note : This warning does not apply to Rh 0 (D)-negative patients treated for the suppression of Rh isoimmunization.
Preparation and administration
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Preparation and Handling Rhophylac is a clear or slightly opalescent, colorless to pale yellow solution. Inspect Rhophylac visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates. Prior to intravenous use, ensure that the needle-free intravenous administration system is compatible with the tip of the Rhophylac glass syringe.
Do not freeze. Bring Rhophylac to room temperature before use. Rhophylac is for single use only. Dispose of any unused product or waste material in accordance with local requirements.
ITP For treatment of ITP, ADMINISTER RHOPHYLAC BY THE INTRAVENOUS ROUTE ONLY (see Preparation and Handling [2.1] ) . Do not administer intramuscularly . A 250 IU (50 mcg) per kg body weight dose of Rhophylac is recommended for patients with ITP. The following formula can be used to calculate the recommended amount of Rhophylac to administer: Dose (IU) × body weight (kg) = Total IU / 1500 IU per syringe = Number of syringes Rhophylac should be administered at a rate of 2 mL per 15 to 60 seconds.
Drug interactions
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- Human rho(d) immune globulin
Label text (2 paragraphs)
Immunoglobulin administration may transiently interfere with the immune response to live virus vaccines, such as measles, mumps and rubella ( 7.1 ).
7.1 Live Virus Vaccines Passive transfer of antibodies may transiently impair the immune response to live attenuated virus vaccines such as measles, mumps, rubella, and varicella ( see Patient Counseling Information [17.1 ] ).
Contraindications
Rhophylac is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. Rhophylac is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. History of anaphylactic or severe systemic reaction to human immune globulin products ( 4 ) IgA deficient patients with antibodies against IgA and a history of hypersensitivity ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for human rho(d) immune globulin. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Rhophylac. Suppression of Rh Isoimmunization The available evidence suggests that Rhophylac does not harm the fetus or affect future pregnancies or reproduction capacity when given to pregnant Rh 0 (D)-negative women for suppression of Rh isoimmunization. 3 ITP Rhophylac has not been evaluated in pregnant women with ITP.
Lactation
8.3 Nursing Mothers Suppression of Rh Isoimmunization Rhophylac is used in nursing mothers for the suppression of Rh isoimmunization. No undesirable effects on a nursing infant are expected during breastfeeding. ITP Rhophylac has not been evaluated in nursing mothers with ITP.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.