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Rhophylac HUMAN RHO(D) IMMUNE GLOBULIN 1500 [iU]/2mL Solution
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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20 mg / 2 mL
UNII ZIF514RVZR
A protein derived from human blood plasma. In medicines, it acts as a stabilizer and binder, helping maintain drug potency and form, and may improve how the medication disperses or dissolves in the body.
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UNII TE7660XO1C
Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
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UNII 741C1PWQ88
Human immunoglobulin A is an antibody protein naturally found in the human body. In medicines, it's used as an active therapeutic component to help the immune system fight infections and disease, rather than as a typical inactive filler or binder.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $106.47 | $2,129.41 / 20 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J2791 | $4.878 / J2791 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rhophylac 1500 [iU]/2mLthis 44206-0300-10 | CSL | 10 syringes | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 44206-0300-01 | 1 SYRINGE, GLASS in 1 CARTON (44206-300-01) / 2 mL in 1 SYRINGE, GLASS (44206-300-90) | 2009-01-06 | Active |
| 44206-0300-10 You're viewing this | 10 SYRINGE, GLASS in 1 CARTON (44206-300-10) / 2 mL in 1 SYRINGE, GLASS (44206-300-90) | 2009-01-06 | Active |
This pack accounts for about 11% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 44206-0300-10?
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full FDA label FDA SPL
🚨 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.
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Rhophylac is an Rh 0 (D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the suppression of Rh isoimmunization in non-sensitized Rh 0 (D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh 0 (D)-positive patients. Rhophylac is an Rh 0 (D) Immune Globulin Intravenous (Human) indicated for: Suppression of Rhesus (Rh) Isoimmunization ( 1.1 ) in : Pregnancy and obstetric conditions in non-sensitized, Rh 0 (D)-negative women with an Rh-incompatible pregnancy, including: Routine antepartum and postpartum Rh prophylaxis Rh prophylaxis in obstetric complications or invasive procedures Incompatible transfusions in Rh 0 (D)-negative individuals transfused with blood components containing Rh 0 (D)-positive red blood cells (RBCs) Immune Thrombocytopenic Purpura (ITP) ( 1.2 ) Raising platelet counts in Rh 0 (D)-positive, non-splenectomized adults with chronic ITP
1.1Suppression of Rh Isoimmunization Pregnancy and Obstetric Conditions Rhophylac is indicated for suppression of rhesus (Rh) isoimmunization in non-sensitized Rh 0 (D)-negative women with an Rh-incompatible pregnancy, including: Routine antepartum and postpartum Rh prophylaxis Rh prophylaxis in cases of: – Obstetric complications (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage) – Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma) An Rh-incompatible pregnancy is assumed if the fetus/baby is either Rh 0 (D)-positive or Rh 0 (D)-unknown or if the father is either Rh 0 (D)-positive or Rh 0 (D)-unknown.
Incompatible Transfusions Rhophylac is indicated for the suppression of Rh isoimmunization in Rh 0 (D)-negative individuals transfused with Rh 0 (D)-positive red blood cells (RBCs) or blood components containing Rh 0 (D)-positive RBCs. Treatment can be given without a preceding exchange transfusion when the transfused blood represents less than 20% of the total circulating RBCs. If the volume exceeds 20%, an exchange transfusion should be considered prior to administering Rhophylac.
1.2ITP Rhophylac is indicated in Rh 0 (D)-positive, non-splenectomized adult patients with chronic ITP to raise platelet counts.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION As with all blood products, patients should be observed for at least 20 minutes following administration of Rhophylac. Suppression of Rh Isoimmunization ( 2.2 ) Intravenous or intramuscular administration Pregnancy and obstetric conditions Rh-incompatible pregnancy – 1500 IU (300 mcg) at Week 28-30 of gestation and another 1500 IU (300 mcg) within 72 hours of birth of an Rh 0 (D)-positive baby Obstetric complications/invasive procedures – 1500 IU (300 mcg) within 72 hours of the at-risk event Excessive fetomaternal hemorrhage – 1500 IU (300 mcg) within 72 hours plus 100 IU (20 mcg) per mL fetal RBCs >15 mL (excess transplacental bleeding quantified) or another 1500 IU (300 mcg) (excess transplacental bleeding not quantified) Exposure to >15 mL of Rh 0 (D)-positive RBCs (in postpartum prophylaxis and obstetric complications/invasive procedures) – Increase the dose based on guidelines for excessive fetomaternal hemorrhage Incompatible transfusions – 100 IU (20 mcg) per 2 mL transfused blood or per 1 mL erythrocyte concentrate within 72 hours of exposure ITP ( 2.3 ) Intravenous administration only Recommended dosage – 250 IU (50 mcg) per kg body weight Rate of administration – 2 mL per 15 to 60 seconds
2.1Preparation 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.
2.2Suppression of Rh Isoimmunization Rhophylac should be administered by intravenous or intramuscular injection. If large doses (greater than 5 mL) are required and intramuscular injection is chosen, it is advisable to administer Rhophylac in divided doses at different sites. Table 1 provides dosing guidelines based on the condition being treated.
Table 1: Dosing Guidelines for Suppression of Rh Isoimmunization Indication Timing of Administration Dose A 1500 IU (300 mcg) dose of Rhophylac will suppress the immunizing potential of ≥15 mL of Rh 0 (D)-positive RBCs. 2 (Administer by Intravenous or Intramuscular Injection) IU, international units; mcg, micrograms. Rh-incompatible pregnancy Routine antepartum prophylaxis At Week 28-30 of gestation 1500 IU (300 mcg) Postpartum prophylaxis (required only if the newborn is Rh 0 (D)-positive) Within 72 hours of birth 1500 IU (300 mcg) The dose of Rhophylac must be increased if the patient is exposed to >15 mL of Rh 0 (D)-positive RBCs; in this case, follow the dosing guidelines for excessive fetomaternal hemorrhage.
Obstetric complications (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage) Within 72 hours of complication 1500 IU (300 mcg) Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma) Within 72 hours of procedure 1500 IU (300 mcg) Excessive fetomaternal hemorrhage (>15 mL) Within 72 hours of complication 1500 IU (300 mcg) plus: 100 IU (20 mcg) per mL fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantified or An additional 1500 IU (300 mcg) dose if excess transplacental bleeding cannot be quantified Incompatible transfusions Within 72 hours of exposure 100 IU (20 mcg) per 2 mL transfused blood or per 1 mL erythrocyte concentrate
2.3ITP 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 recomme…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 1500 IU (300 mcg) per 2 mL prefilled, ready-to-use, glass syringe 1500 IU (300 mcg) per 2 mL prefilled, ready-to-use glass syringe ( 3 )
⛔ Contraindications ▾
4 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Both Indications ( 5.1 ) IgA deficient patients with known antibodies to IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions ( 5.1.1 ). Rhophylac is made from human blood; therefore it may contain infectious agents; e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent ( 5.1.3 ). Suppression of Rh Isoimmunization ( 5.2 ) For postpartum use following an Rh-incompatible pregnancy, administer Rhophylac to the mother only.
Do not administer to the newborn infant ( 5.2.1 ). ITP ( 5.3 ) Intravascular hemolysis has occurred in a clinical study; monitor patients for signs and symptoms and perform confirmatory laboratory tests ( 5.3.1 ). In ITP patients with pre-existing anemia, weigh the benefits of Rhophylac vs. the potential risk of increasing the severity of the anemia ( 5.3.2 ).
5.1Both Indications 5.1.1 Hypersensitivity Severe hypersensitivity reactions may occur. If symptoms of allergic or early signs of hypersensitivity reactions (including generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis) occur, discontinue Rhophylac administration immediately and institute appropriate treatment. Medications such as epinephrine should be available for immediate treatment of acute hypersensitivity reactions.
Rhophylac contains trace amounts of IgA (less than 5 mcg/mL) (s ee Description [11] ). Patients with known antibodies to IgA have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Rhophylac is contraindicated in patients with antibodies against IgA and a history of hypersensitivity reactions ( see Contraindications [4] ).
5.1.2Interference with Laboratory Tests The administration of Rh 0 (D) immune globulin may affect the results of blood typing, the antibody screening test, and the direct antiglobulin (Coombs') test. Antepartum administration of Rh 0 (D) immune globulin to the mother can also affect these tests in the newborn infant. Rhophylac can contain antibodies to other Rh antigens (e.g., anti-C antibodies), which might be detected by sensitive serological tests following administration.
5.1.3Transmissible Infectious Agents Because Rhophylac is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk of infectious agent transmission has been reduced by screening plasma donors for prior exposure to certain viruses, testing for the presence of certain current virus infections, and including virus inactivation/removal steps in the manufacturing process for Rhophylac. Report any infections thought to be possibly transmitted by Rhophylac to CSL Behring Pharmacovigilance at 1-866-915-6958.
5.2Suppression of Rh Isoimmunization 5.2.1 Postpartum Use Following an Rh-incompatible Pregnancy Administer Rhophylac to the mother only. Do not administer to the newborn infant ( see Pediatric Use [8.4] ) .
5.3ITP 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. Closely monitor patients in a healthcare setting for at least 8 hours after administration of Rhophylac. 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 of int…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most serious adverse reactions in patients receiving Rh 0 (D) Immune Globulin Intravenous (Human) have been observed in the treatment of ITP and include intravascular hemolysis, clinically compromising anemia, acute renal insufficiency, and, very rarely, DIC and death ( see Boxed Warning , Warnings and Precautions [5.3.1] ). 1 The most common adverse reactions observed in the use of Rhophylac for suppression of Rh isoimmunization (≥0.5% of subjects) are nausea, dizziness, headache, injection-site pain, and malaise.
The most common adverse reactions observed in the treatment of ITP (>14% of subjects) are chills, pyrexia/increased body temperature, and headache. Mild hemolysis (manifested by an increase in bilirubin, a decrease in hemoglobin, or a decrease in haptoglobin) was also observed. Suppression of Rh Isoimmunization The most common adverse reactions, reported in ≥ 0.5% of subjects, are nausea, dizziness, headache, injection-site pain, and malaise ( 6.1 ).
ITP The most common adverse reactions, reported in > 14% of subjects, are chills, pyrexia/increased body temperature, headache, and mild hemolysis (increased bilirubin, decreased hemoglobin, or decreased haptoglobin) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Studies Experience Because clinical studies are conducted under different protocols and widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. Suppression of Rh Isoimmunization In two clinical studies, 447 Rh 0 (D)-negative pregnant women received either an intravenous or intramuscular injection of Rhophylac 1500 IU (300 mcg) at Week 28 of gestation. A second 1500 IU (300 mcg) dose was administered to 267 (9 in Study 1 and 258 in Study 2) of these women within 72 hours of the birth of an Rh 0 (D)-positive baby.
In addition, 30 women in Study 2 received at least one extra antepartum 1500 IU (300 mcg) dose due to obstetric complications ( see Clinical Studies [14.1] ). The most common adverse reactions in study subjects were nausea (0.7%), dizziness (0.5%), headache (0.5%), injection-site pain (0.5%), and malaise (0.5%). A laboratory finding of a transient positive anti-C antibody test was observed in 0.9% of subjects.
ITP In a clinical study, 98 Rh 0 (D)-positive adult subjects with chronic ITP received an intravenous dose of Rhophylac 250 IU (50 mcg) per kg body weight ( see Clinical Studies [14.2] ). Premedication to alleviate infusion-related side effects was not used except in a single subject who received acetaminophen and diphenhydramine. Eighty-four (85.7%) subjects experienced 392 treatment-emergent adverse events (TEAEs).
Sixty-nine (70.4%) subjects had 186 drug-related TEAEs (defined as TEAEs with a probable, possible, definite, or unknown relationship to the study drug). Within 24 hours of dosing, 73 (74.5%) subjects experienced 183 TEAEs, and 66 (67%) subjects experienced 156 drug-related TEAEs. Mild hemolysis (manifested as an increase in bilirubin, a decrease in hemoglobin, or a decrease in haptoglobin) was observed.
An increase in blood bilirubin was seen in 21% of subjects. The median decrease in hemoglobin was greatest (0.8 g/dL) at Day 6 and Day 8 following administration of Rhophylac. Table 2 shows the most common TEAEs observed in the clinical study.
Table 2: Most Common Treatment-Emergent Adverse Events (TEAEs) in Subjects with ITP TEAE Number of Subjects (%) With a TEAE n=98 Number of Subjects (%) With a Drug-Related TEAE Defined as TEAEs with a possible, probable, definite, or unknown relationship to the study drug. n=98 Chills 34 (34.7%) 34 (34.7%) Pyrexia/ Increased body temperature 32 (32.6%) 30 (30.6%) Increased blood bilirubin 21 (21.4%) 21 (21.4%) Headache 14 (14.3%) 11 (11.2%) Serious adverse events (SAEs) were reported in 10…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Immunoglobulin administration may transiently interfere with the immune response to live virus vaccines, such as measles, mumps and rubella ( 7.1 ).
7.1Live 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 ] ).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS ITP Pregnancy: No human or animal data. Use only if clearly needed ( 8.1 ).
8.1Pregnancy 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.
8.3Nursing 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.
8.4Pediatric Use Suppression of Rh Isoimmunization in Incompatible Transfusions The safety and effectiveness of Rhophylac have not been established in pediatric subjects being treated for an incompatible transfusion. The physician should weigh the potential risks against the benefits of Rhophylac, particularly in girls whose later pregnancies may be affected if Rh isoimmunization occurs.
8.5Geriatric Use Suppression of Rh Isoimmunization in Incompatible Transfusions Rhophylac has not been evaluated for treating incompatible transfusions in subjects 65 years of age and older. ITP Of the 98 subjects evaluated in the clinical study of Rhophylac for treatment of ITP ( see Clinical Studies [14.2] ), 19% were 65 years of age and older. No overall differences in effectiveness or safety were observed between these subjects and younger subjects.
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Suppression of Rh Isoimmunization in Incompatible Transfusions The safety and effectiveness of Rhophylac have not been established in pediatric subjects being treated for an incompatible transfusion. The physician should weigh the potential risks against the benefits of Rhophylac, particularly in girls whose later pregnancies may be affected if Rh isoimmunization occurs.
🧓 Geriatric Use ▾
8.5Geriatric Use Suppression of Rh Isoimmunization in Incompatible Transfusions Rhophylac has not been evaluated for treating incompatible transfusions in subjects 65 years of age and older. ITP Of the 98 subjects evaluated in the clinical study of Rhophylac for treatment of ITP ( see Clinical Studies [14.2] ), 19% were 65 years of age and older. No overall differences in effectiveness or safety were observed between these subjects and younger subjects.
🆘 Overdosage ▾
10 OVERDOSAGE There are no reports of known overdoses in patients being treated for suppression of Rh isoimmunization or ITP. Patients with incompatible transfusion or ITP who receive an overdose of Rh 0 (D) immune globulin should be monitored because of the potential risk for hemolysis.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Suppression of Rh Isoimmunization The mechanism by which Rh 0 (D) immune globulin suppresses immunization to Rh 0 (D)-positive RBCs is not completely known. In a clinical study of Rh 0 (D)-negative healthy male volunteers, both the intravenous and intramuscular administration of a 1500 IU (300 mcg) dose of Rhophylac 24 hours after injection of 15 mL of Rh 0 (D)-positive RBCs resulted in an effective clearance of Rh 0 (D)-positive RBCs. On average, 99% of injected RBCs were cleared within 12 hours following intravenous administration and within 144 hours following intramuscular administration.
ITP Rhophylac has been shown to increase platelet counts and to reduce bleeding in non-splenectomized Rh 0 (D)-positive subjects with chronic ITP. The mechanism of action is thought to involve the formation of Rh 0 (D) immune globulin RBC complexes, which are preferentially removed by the reticuloendothelial system, particularly the spleen. This results in Fc receptor blockade, thus sparing antibody-coated platelets.
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12.3Pharmacokinetics Suppression of Rh Isoimmunization In a clinical study comparing the pharmacokinetics of intravenous versus intramuscular administration, 15 Rh 0 (D)-negative pregnant women received a single 1500 IU (300 mcg) dose of Rhophylac at Week 28 of gestation. 8 Following intravenous administration, peak serum levels of Rh 0 (D) immune globulin ranged from 62 to 84 ng/mL after 1 day (i.e., the time the first blood sample was taken following the antepartum dose). Mean systemic clearance was 0.20 ± 0.03 mL/min, and half-life was 16 ± 4 days.
Following intramuscular administration, peak serum levels ranged from 7 to 46 ng/mL and were achieved between 2 and 7 days. Mean apparent clearance was 0.29 ± 0.12 mL/min, and half-life was 18 ± 5 days. The absolute bioavailability of Rhophylac was 69%.
Regardless of the route of administration, Rh 0 (D) immune globulin titers were detected in all women up to at least 9 weeks following administration of Rhophylac. ITP Pharmacokinetic studies with Rhophylac were not performed in Rh 0 (D)-positive subjects with ITP. Rh 0 (D) immune globulin binds rapidly to Rh 0 (D)-positive erythrocytes.
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🧬 Mechanism of Action ▾
12.1Mechanism of Action Suppression of Rh Isoimmunization The mechanism by which Rh 0 (D) immune globulin suppresses immunization to Rh 0 (D)-positive RBCs is not completely known. In a clinical study of Rh 0 (D)-negative healthy male volunteers, both the intravenous and intramuscular administration of a 1500 IU (300 mcg) dose of Rhophylac 24 hours after injection of 15 mL of Rh 0 (D)-positive RBCs resulted in an effective clearance of Rh 0 (D)-positive RBCs. On average, 99% of injected RBCs were cleared within 12 hours following intravenous administration and within 144 hours following intramuscular administration.
ITP Rhophylac has been shown to increase platelet counts and to reduce bleeding in non-splenectomized Rh 0 (D)-positive subjects with chronic ITP. The mechanism of action is thought to involve the formation of Rh 0 (D) immune globulin RBC complexes, which are preferentially removed by the reticuloendothelial system, particularly the spleen. This results in Fc receptor blockade, thus sparing antibody-coated platelets.
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📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Rhophylac 1500 IU (300 mcg) is supplied in packages of one or ten (10) prefilled, ready-to-use, glass syringe(s), each containing 2 mL liquid for injection. Each syringe is accompanied by a SafetyGlide™ needle for intravenous or intramuscular use. Rhophylac contains no preservatives.
The prefilled Rhophylac syringe contains no latex. DO NOT FREEZE. Store at 2 to 8°C (36 to 46°F) for a shelf life of 36 months from the date of manufacture, as indicated by the expiration date printed on the outer carton and syringe label.
Keep Rhophylac in its original carton to protect it from light. The following presentations of Rhophylac are available: NDC Number Product Description 44206-300-01 1 prefilled 2 mL syringe 44206-300-10 10 prefilled 2 mL syringes
📋 Description ▾
11 DESCRIPTION Rhophylac is a sterile Rh 0 (D) Immune Globulin Intravenous (Human) (anti-D) solution in a ready-to-use prefilled glass syringe for intravenous or intramuscular injection. One syringe contains at least 1500 IU (300 mcg) of IgG antibodies to Rh 0 (D) in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL of Rh-positive RBCs. 1 The product potency is expressed in IUs by comparison to the World Health Organization (WHO) standard, which is also the US and the European Pharmacopoeia standard.
Plasma is obtained from healthy Rh 0 (D)-negative donors who have been immunized with Rh 0 (D)-positive RBCs. The donors are screened carefully to reduce the risk of receiving donations containing blood-borne pathogens. Each plasma donation used in the manufacture of Rhophylac is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, and HCV antibodies.
In addition, plasma used in the manufacture of Rhophylac is tested by FDA-licensed Nucleic Acid Testing (NAT) for HIV and HCV and found to be negative. An investigational NAT for HBV is also performed on all source plasma used and found to be negative; however, the significance of a negative result has not been established. The source plasma is also tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V).
Rhophylac is produced by an ion-exchange chromatography isolation procedure 4 , using pooled plasma obtained by plasmapheresis of immunized Rh 0 (D)-negative US donors. The manufacturing process includes a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton ™ X-100) that is effective in inactivating enveloped viruses such as HIV, HCV, and HBV. 5,6 Rhophylac is filtered using a Planova ® 15 nanometer (nm) virus filter that has been validated to be effective in removing both enveloped and non-enveloped viruses.
Table 3 presents viral clearance and inactivation data from validation studies, expressed as the mean log 10 reduction factor (LRF). Table 3: Virus Inactivation and Removal in Rhophylac HIV PRV BVDV MVM HIV, a model for HIV-1 and HIV-2; PRV, pseudorabies virus, a model for large, enveloped DNA viruses (e.g., herpes virus); BVDV, bovine viral diarrhea virus, a model for HCV and West Nile virus; MVM, minute virus of mice, a model for B19V and other small, non-enveloped DNA viruses. Virus property Genome RNA DNA RNA DNA Envelope Yes Yes Yes No Size (nm) 80-100 120-200 40-70 18-24 Manufacturing step Mean LRF Solvent/detergent treatment ≥6.0 ≥5.6 ≥5.4 Not tested Chromatographic process steps 4.5 ≥3.9 1.6 ≥2.6 Virus filtration ≥6.3 ≥5.6 ≥5.5
3.4Overall reduction (log 10 units) ≥16.8 ≥15.1 ≥12.5 ≥6.0 Rhophylac contains a maximum of 30 mg/mL of human plasma proteins, 10 mg/mL of which is human albumin added as a stabilizer. Prior to the addition of the stabilizer, Rhophylac has a purity greater than 95% IgG. Rhophylac contains less than 5 mcg/mL of IgA, which is the limit of detection. Additional excipients are approximately 20 mg/mL of glycine and up to
0.25M of sodium chloride. Rhophylac contains no preservative. Human albumin is manufactured from pooled plasma of US donors by cold ethanol fractionation, followed by pasteurization.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION
17.1Both Indications Inform patients to immediately report the following signs and symptoms to their physician: hives, chest tightness, wheezing, hypotension, and anaphylaxis. Inform patients that Rhophylac is made from human blood and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the CJD agent). Explain that the risk Rhophylac may transmit an infectious agent has been reduced by screening all plasma donors, by testing the donated plasma for certain viruses, and by inactivating and/or removing certain viruses during manufacturing.
Advise patients to report any symptoms that concern them and that may be related to viral infections. Inform patients that Rhophylac may interfere with the response to live virus vaccines (e.g., measles, mumps, rubella, and varicella), and instruct them to notify their healthcare professional of this potential interaction when they are receiving vaccinations.
17.2Suppression of Rh Isoimmunization Inform patients receiving the antepartum dose of Rhophylac for suppression of Rh isoimmunization that they will need a second dose within 72 hours of birth if the baby's blood type is Rh-positive.
17.3ITP Instruct patients being treated with Rhophylac for ITP to immediately report symptoms of intravascular hemolysis, including back pain, shaking chills, fever, discolored urine, decreased urine output, sudden weight gain, edema, and/or shortness of breath.