Rhophylac Side Effects
Generic Name: rho (d) immune globulin
Note: This page contains side effects data for the generic drug rho (d) immune globulin. It is possible that some of the dosage forms included below may not apply to the brand name Rhophylac.
It is possible that some side effects of Rhophylac may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to rho (d) immune globulin: injectable, powder for solution, solution
As well as its needed effects, rho (d) immune globulin (the active ingredient contained in Rhophylac) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking rho (d) immune globulin, check with your doctor or nurse immediately:Rare
- Bloody urine
- decreased frequency of urination or amount of urine
- 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
Some rho (d) immune globulin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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 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.[Ref]
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.[Ref]
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.[Ref]
Local side effects have included slight swelling, induration, redness, mild pain, and discomfort at the injection site.[Ref]
Nervous system side effects associated with Rho (D) IGIV have rarely included asthenia, dizziness, hyperkinesia, and somnolence.[Ref]
Gastrointestinal side effects associated with Rho (D) IGIV have rarely included abdominal pain and diarrhea.[Ref]
Cardiovascular side effects associated with Rho (D) IGIV have included hypotension and vasodilation. Tachycardia has been reported rarely.[Ref]
Dermatologic side effects associated with Rho (D) IGIV have rarely included pruritus, rash, and sweating.[Ref]
Musculoskeletal side effects associated with Rho (D) IGIV have rarely included arthralgia and myalgia.[Ref]
Hepatic side effects associated with Rho (D) IGIV have rarely included increase in LDH levels.[Ref]
Hypersensitivity side effects associated with Rho (D) IGIV have rarely included an idiosyncratic or anaphylactic reaction in patients with a hypersensitivity to blood products.[Ref]
In general, side effects involving Rho (D) IGIV are rare in Rho (D) negative patients.[Ref]
1. "Product Information. WinRho SDF (RHo (D) immune globulin)." Nabi, Boca Raton, FL.
2. Genereux M, Schiff R "Important drug warning. Available from: URL: http://www.fda.gov/medwatch/safety/2006/WinRho_deardoc_FINAL_07-Dec-2005.pdf." ([2005 Dec 5]):
3. "Product Information. BayRHo-D (RHo (D) immune globulin)." Bayer, West Haven, CT.
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