Rhophylac Side Effects

Please note - some side effects for Rhophylac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Rhophylac - for the Consumer

Rhophylac

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rhophylac:

Chills; headache; mild fever; mild pain, swelling, or redness at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; blood in the urine; dark urine; decreased urination; fast heartbeat; nausea; severe or persistent fever; shaking chills; shortness of breath; sudden weight gain; swelling; unusual tiredness or weakness; wheezing; vomiting; yellowing of the eyes or skin.

Rhophylac Side Effects - for the Professional

Rhophylac

Suppression of Rh Isoimmunization

Most common adverse reactions are nausea, dizziness, headache, injection-site pain, and malaise (6.1)

ITP

Most common adverse reactions are chills, pyrexia/increased body temperature, headache, and mild extravascular hemolysis (increased bilirubin, decreased hemoglobin) (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring at 1-800-504-5434 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

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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