Note: This document contains side effect information about rho (d) immune globulin. Some dosage forms listed on this page may not apply to the brand name WinRho SDF.
Applies to rho (d) immune globulin: solution.
Warning
Intravenous route (Powder for Solution; Solution)
Intravascular hemolysis (IVH) leading to death has been reported in patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) immune globulin. IVH can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS), acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC). Alert patients and closely monitor for the signs and symptoms of IVH in a health care setting for at least 8 hours after administration for ITP. Perform a dipstick urinalysis at baseline, 2 hours, 4 hours after administration, and prior to the end of the monitoring period. If signs and/or symptoms of IVH are present or suspected, post-treatment laboratory tests should be performed.
Serious side effects of WinRho SDF
Along with its needed effects, rho (d) immune globulin (the active ingredient contained in WinRho SDF) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking rho (d) immune globulin:
Rare
- Bloody urine
- decreased frequency of urination or amount of urine
- fever
- increased blood pressure
- increased thirst
- loss of appetite
- lower back pain
- nausea or vomiting
- pale skin
- swelling of the face, fingers, or lower legs
- troubled breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- weight gain
Other side effects of WinRho SDF
Some side effects of rho (d) immune globulin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Soreness at the place of injection
For Healthcare Professionals
Applies to rho (d) immune globulin: injectable powder for injection, injectable solution, intramuscular powder for injection, intramuscular solution.
Other
Very common (10% or more): Chills (34.7%), pyrexia/increased body temperature (32.6%)
Uncommon (0.1% to 1%): Malaise
Very rare (less than 0.01%): Death
Frequency not reported: Shivering, weakness
Postmarketing reports: Chest pain, fatigue, edema[Ref]
Hematologic
Hemolytic reaction includes hypotension, nausea, chills, headache, and a decrease in haptoglobin and hemoglobin.[Ref]
Very rare (less than 0.01%): Disseminated intravascular coagulation
Frequency not reported: Intravascular hemolysis, hemolysis resulting in death, clinically compromising anemia, extravascular hemolysis, hemolytic reaction
Postmarketing reports: Hemoglobinemia, disseminated intravascular coagulation[Ref]
Local
Uncommon (0.1% to 1%): Injection site swelling, injection site pain
Rare (less than 0.1%): Injection site erythema, injection site induration, injection site warmth, injection site pruritus, injection site rash[Ref]
Nervous system
Very common (10% or more): Headache (14.3%)
Uncommon (0.1% to 1%): Dizziness, vertigo[Ref]
Gastrointestinal
Uncommon (0.1% to 1%): Nausea, vomiting
Rare (less than 0.1%): Diarrhea[Ref]
Cardiovascular
Rare (less than 0.1%): Tachycardia, hypotension
Frequency not reported: Increase in blood pressure
Postmarketing reports: Cardiac arrest, cardiac failure, myocardial infarction[Ref]
Dermatologic
Uncommon (0.1% to 1%): Skin reaction, erythema, pruritus, pallor, rash
Postmarketing reports: Hyperhidrosis[Ref]
Musculoskeletal
Rare (less than 0.1%): Arthralgia, back pain
Postmarketing reports: Myalgia, muscle spasm, pain in extremities[Ref]
Hepatic
Very common (10% or more): Increase in blood bilirubin (21.4%)
Postmarketing reports: Jaundice[Ref]
Hypersensitivity
Rare (less than 0.1%): Hypersensitivity, anaphylactic shock, anaphylactic reaction[Ref]
General
The most common adverse events were chills, pyrexia, increased bilirubin, and headache.[Ref]
Respiratory
Rare (less than 0.1%): Dyspnea
Postmarketing reports: Acute respiratory distress syndrome, transfusion related acute lung injury[Ref]
Renal
Frequency not reported: Acute renal insufficiency
Postmarketing reports: Renal failure, renal impairment[Ref]
Immunologic
Uncommon (0.1% to 1%): Transient positive anti-C antibody test
Frequency not reported: Sensitization to repeated injections of human globulin[Ref]
Genitourinary
Postmarketing reports: Hemoglobinuria, anuria, chromaturia, hematuria[Ref]
