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Rhogam Ultra-Filtered Plus

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Rhogam Ultra-Filtered Plus

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Rhogam Ultra-Filtered Plus Side Effects Center

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.

Rhogam Ultra-Filtered Plus 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.

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.

Read the entire detailed patient monograph for Rhogam Ultra-Filtered Plus (Rho(D) Immune Globulin (Human)) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rhogam Ultra-Filtered Plus FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse events (AE) after administration of RhoGAM and MICRhoGAM are rare.

The most frequently reported AEs are anti-D formation and injection site reactions, such as swelling, induration, redness and mild pain or warmth. Possible systemic reactions are skin rash, body aches or a slight elevation in temperature. Severe systemic allergic reactions are extremely rare. Patients should be observed for at least 20 minutes after administration. There have been no reported fatalities due to anaphylaxis or any other cause related to RhoGAM or MICRhoGAM administration.

As with any Rho(D) Immune Globulin (Human), administration to patients who are Rh-positive or have received Rh-positive red blood cells may result in signs and symptoms of a hemolytic reaction, including fever, back pain, nausea and vomiting, hypo- or hypertension, hemoglobinuria/emia, elevated bilirubin and creatinine and decreased haptoglobin.

RhoGAM and MICRhoGAM contain a small quantity of IgA (less than 15 µg per dose).10 Although high doses of intravenous immune globulin containing IgA at levels of 270- 720 µg/mL have been given without incident during treatment of patients with high-titered antibodies to IgA,11 the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions.

Read the entire FDA prescribing information for Rhogam Ultra-Filtered Plus (Rho(D) Immune Globulin (Human)) »

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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