Rhophylac 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 Rhophylac.

Some side effects of Rhophylac 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 Rhophylac) 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;

• 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.

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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