HyperRHO S / D Mini-Dose Side Effects

Generic Name: rho (d) immune globulin

Note: This page contains information about the side effects of rho (d) immune globulin. Some of the dosage forms included on this document may not apply to the brand name HyperRHO S / D Mini-Dose.

Not all side effects for HyperRHO S / D Mini-Dose may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to rho (d) immune globulin: injectable, powder for solution, solution

In addition to its needed effects, some unwanted effects may be caused by rho (d) immune globulin (the active ingredient contained in HyperRHO S / D Mini-Dose). In the event that any of these side effects do occur, they may 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
  • 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

Some of the side effects that can occur with rho (d) immune globulin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

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.

Hematologic

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

Local side effects have included slight swelling, induration, redness, mild pain, and discomfort at the injection site.

Nervous system

Nervous system side effects associated with Rho (D) IGIV have rarely included asthenia, dizziness, hyperkinesia, and somnolence.

Gastrointestinal

Gastrointestinal side effects associated with Rho (D) IGIV have rarely included abdominal pain and diarrhea.

Cardiovascular

Cardiovascular side effects associated with Rho (D) IGIV have included hypotension and vasodilation. Tachycardia has been reported rarely.

Dermatologic

Dermatologic side effects associated with Rho (D) IGIV have rarely included pruritus, rash, and sweating.

Musculoskeletal

Musculoskeletal side effects associated with Rho (D) IGIV have rarely included arthralgia and myalgia.

Hepatic

Hepatic side effects associated with Rho (D) IGIV have rarely included increase in LDH levels.

Hypersensitivity

Hypersensitivity side effects associated with Rho (D) IGIV have rarely included an idiosyncratic or anaphylactic reaction in patients with a hypersensitivity to blood products.

General

In general, side effects involving Rho (D) IGIV are rare in Rho (D) negative patients.

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