"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
Rhophylac Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Rhophylac (immune globulin intravenous human solution) is a solution made from human blood used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. It may also be used in the treatment of immune thrombocytopenic purpura (ITP). Common side effects include joint or muscle pain, headache, dizziness, feeling weak or tired, mild itching or skin rash, nausea, diarrhea, vomiting, stomach pain, or pain or tenderness where the medicine was injected.
Dosing of Rhophylac is determined based on the condition being treated. Rhophylac may interact with other drugs. Tell your doctor all medications and supplements you use and all vaccines you recently received. Rhophylac is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breastfeeding. Tell your doctor if you are pregnant or breastfeeding before using this medication.
Our Rhophylac (immune globulin intravenous human solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Rhophylac in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- fever, chills, shaking, back pain, dark colored urine;
- rapid breathing, feeling short of breath.
- urinating less than usual or not at all, swelling, rapid weight gain; or
- pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.
Less serious side effects may include:
- joint or muscle pain;
- headache, dizziness;
- feeling weak or tired;
- mild itching or skin rash;
- nausea, diarrhea, vomiting, stomach pain; or
- pain or tenderness where the medicine was injected.
Read the entire detailed patient monograph for Rhophylac (Immune Globulin Intravenous (Human) solution)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Rhophylac FDA Prescribing Information: Side Effects
The most serious adverse reactions in patients receiving Rh0(D) immune globulin have been observed in the treatment of ITP. These reactions include intravascular hemolysis, clinically compromising anemia, acute renal insufficiency, and, very rarely, DIC and death (see Warnings and Precautions ).
The most common adverse reactions observed in the use of Rhophylac® (immune globulin intravenous (human) solution) for suppression of Rh isoimmunization are nausea, dizziness, headache, injection-site pain, and malaise.
The most common adverse reactions observed in the treatment of ITP are chills, pyrexia/increased body temperature, and headache. Mild extravascular hemolysis (manifested by an increase in bilirubin and a decrease in hemoglobin) was also observed.
Clinical 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 Rh0(D)-negative pregnant women received either an intravenous or intramuscular injection of Rhophylac® (immune globulin intravenous (human) solution) 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 Rh0(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).
The most common adverse reactions 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. All adverse reactions were mild to moderate in intensity.
In a clinical study, 98 Rh0(D)-positive adult subjects with chronic ITP received an intravenous dose of Rhophylac® 250 IU (50 mcg) per kg body weight (see Clinical Studies ). Premedication to alleviate infusion-related side effects was not used except in a single subject who received acetaminophen and diphenhydramine.
Adverse reactions were mild to moderate in intensity with the exception of one case of severe headache. 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 extravascular hemolysis, manifested as an increase in bilirubin, a decrease in hemoglobin, or a decrease in haptoglobin, was observed, as expected when an anti-D product is given to an Rh-positive individual. 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® (immune globulin intravenous (human) solution) .
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
| Number of Subjects (%) Witha Drug-Related
|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%)|
|* Defined as TEAEs with a possible, probable, definite, or unknown relationship to the study drug.|
Serious adverse events (SAEs) were reported in 10 (10.2%) subjects. SAEs considered to be drug-related were intravascular hemolytic reaction (hypotension, nausea, chills and headache, and a decrease in haptoglobin and hemoglobin) in two subjects; headache, dizziness, nausea, pallor, shivering, and weakness requiring hospitalization in one subject; and an increase in blood pressure and severe headache in one subject. All four subjects recovered completely.
Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. Evaluation and interpretation of these postmarketing reactions is confounded by underlying diagnosis, concomitant medications, pre-existing conditions, and inherent limitations of passive surveillance.
Suppression of Rh Isoimmunization
The following adverse reactions have been identified during postapproval use of Rhophylac® (immune globulin intravenous (human) solution) for suppression of Rh isoimmunization: hypersensitivity reactions, including rare cases of anaphylactic shock or anaphylactoid reactions, headache, dizziness, vertigo, hypotension, tachycardia, dyspnea, nausea, vomiting, rash, erythema, pruritus, chills, pyrexia, malaise, and, rarely, diarrhea and back pain. Transient injection-site irritation and pain have been observed following intramuscular administration.
Transient hemoglobinuria has been reported in a patient being treated with Rhophylac® (immune globulin intravenous (human) solution) for ITP.
Read the entire FDA prescribing information for Rhophylac (Immune Globulin Intravenous (Human) solution)
Additional Rhophylac Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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