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Rho(D) Immune Globulin (Human) Solution for injection

RhO [D] IMMUNE GLOBULIN (i MYOON GLOB yoo lin) is used to treat idiopathic thrombocytopenic purpura... more

Generic Name: RHo (D) immune globulin  |  Brand Name: BayRHo-D Mini-Dose

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 03/10/2010] Cangene, Baxter and FDA notified healthcare professionals that cases of intravascular hemolysis (IVH) and its complications, including fatalities, have been reported in patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) Immune Globulin IV -[Human] (WinRho SDF). IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome. Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation have also been reported. Fatal outcomes associated with IVH and its complications have occurred most frequently in patients of advanced age (age over 65) with co-morbid conditions.

The Boxed Warning informs healthcare professionals that:

  • Patients should be closely monitored in a health care setting for at least eight hours after administration.
  • A dipstick urinalysis should be performed at baseline, 2 hours, 4 hours after administration and prior to the end of the monitoring period.
  • Patients should be alerted to and monitor for signs and symptoms of IVH, including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently.
  • If signs and/or symptoms of IVH are present or if IVH is suspected after Rho(D) Immune Globulin IV -[Human] administration, post-treatment laboratory tests should be performed including plasma hemoglobin, urinalysis, haptoglobin, LDH and plasma bilirubin (direct and indirect).
For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

RhO [D] IMMUNE GLOBULIN (i MYOON GLOB yoo lin) is used to treat idiopathic thrombocytopenic purpura (ITP). This medicine is used in RhO negative mothers who are pregnant with a RhO positive child. It is also used after a transfusion of RhO positive blood into a RhO negative person.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • bleeding disorders
  • low levels of immunoglobulin A in the body
  • no spleen
  • an unusual or allergic reaction to human immune globulin, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle or into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

  • live virus vaccines, like measles, mumps, or rubella

What should I watch for while using this medicine?

This medicine is made from human blood. It may be possible to pass an infection in this medicine. Talk to your doctor about the risks and benefits of this medicine.

This medicine may interfere with live virus vaccines. Before you get live virus vaccines tell your health care professional if you have received this medicine within the past 3 months.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • chest pain or tightness
  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • fever
  • pain and tenderness at site where injected

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: August 17, 2009
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