WinRho SDF Side Effects
Generic name: rho (d) immune globulin
Note: This document contains side effect information about rho (d) immune globulin. Some of the dosage forms listed on this page may not apply to the brand name WinRho SDF.
Some side effects of WinRho SDF may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to rho (d) immune globulin: injectable powder for injection, injectable solution, intramuscular solution
Get emergency medical help if you have any of these signs of an allergic reaction while taking rho (d) immune globulin (the active ingredient contained in WinRho SDF) 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 of rho (d) immune globulin may include:
joint or muscle pain;
feeling weak or tired;
mild itching or skin rash;
nausea, diarrhea, vomiting, stomach pain; or
pain or tenderness where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to rho (d) immune globulin: injectable powder for injection, injectable solution, intramuscular powder for injection, intramuscular solution
Other side effects associated with RHo (D) IGIV administered for the treatment of ITP have included headache (2%), chills (<2%), and fever (1%). These effects are often reported with intravenous administration of most immunoglobulin agents.
Other side effects associated with Rho (D) IGIV have rarely included slight elevation in temperature, back pain, and pallor.
Hemolysis is an expected event related to the destruction of Rho (D) positive blood cells. It is thought that the majority of red blood cells are destroyed in the spleen; however, signs and symptoms of intravascular hemolysis (IVH) have been reported within 4 hours following intravenous administration of Rho (D) IGIV. Complications of IVH have included death, acute onset or exacerbation of anemia, and renal insufficiency. Acute renal insufficiency has been reported within 2 to 48 hours following the onset of IVH with an average increase in serum creatinine of 3.5 mg/dL reported between 2 to 9 days. As of May 1999, four deaths have been attributed to be a result of intravascular hemolysis (IVH) following Rho (D) IGIV. The etiology of IVH following Rho (D) IGIV has not been determined. Several risk factors, including age, gender, preexisting renal function, preexisting hemoglobin, concomitantly administered packed red blood cells, and dosage, have been examined and found to have no effect on the incidence of IVH following administration of Rho (D) IGIV.
The maximum decrease in hemoglobin was reported to average 1.7 g/dL following an initial intravenous dose of 50 mcg/kg, and 0.81 g/dL following an initial dose ranging from 25 to 40 mcg/kg. An average decrease in hemoglobin of greater than 4 g/dL (range 4.2 to 6.1 g/dL) has been reported in 3.7% of patients receiving Rho (D) IGIV.
A patient may experience signs and symptoms of a hemolytic reaction if Rh-positive red blood cells were administered prior to administration of Rho (D) immune globulin.
Postmarketing safety surveillance has shown rare, but severe and sometimes fatal, intravascular hemolysis and potentially serious complications, including disseminated intravascular coagulation in patients with ITP.
Hematologic side effects associated with Rho (D) IGIV administered for the treatment of ITP have included decreased hemoglobin, intravascular hemolysis (IVH), and acute onset or exacerbation of anemia.
Local side effects have included slight swelling, induration, redness, mild pain, and discomfort at the injection site.
Nervous system side effects associated with Rho (D) IGIV have rarely included asthenia, dizziness, hyperkinesia, and somnolence.
Gastrointestinal side effects associated with Rho (D) IGIV have rarely included abdominal pain and diarrhea.
Cardiovascular side effects associated with Rho (D) IGIV have included hypotension and vasodilation. Tachycardia has been reported rarely.
Dermatologic side effects associated with Rho (D) IGIV have rarely included pruritus, rash, and sweating.
Musculoskeletal side effects associated with Rho (D) IGIV have rarely included arthralgia and myalgia.
Hepatic side effects associated with Rho (D) IGIV have rarely included increase in LDH levels.
Hypersensitivity side effects associated with Rho (D) IGIV have rarely included an idiosyncratic or anaphylactic reaction in patients with a hypersensitivity to blood products.
In general, side effects involving Rho (D) IGIV are rare in Rho (D) negative patients.
More WinRho SDF resources
- WinRho SDF MedFacts Consumer Leaflet (Wolters Kluwer)
- WinRho SDF Advanced Consumer (Micromedex) - Includes Dosage Information
- Bayrho-D full dose
- HyperRHO S/D Full Dose Prescribing Information (FDA)
- MICRhoGAM MedFacts Consumer Leaflet (Wolters Kluwer)
- RhoGAM Ultra-Filtered PLUS Prescribing Information (FDA)
- Rhophylac Prescribing Information (FDA)
- Rhophylac MedFacts Consumer Leaflet (Wolters Kluwer)
- Rhophylac Consumer Overview
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.