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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Rhophylac:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Rhophylac Side Effects - for the Professional

Rhophylac

The most serious adverse reactions in patients receiving Rh0(D) Immune Globulin Intravenous (Human) have been observed in the treatment of ITP and include intravascular hemolysis, clinically compromising anemia, acute renal insufficiency, and, very rarely, DIC and death.1

The most common adverse reactions observed in the use of Rhophylac for suppression of Rh isoimmunization (≥0.5% of subjects) are nausea, dizziness, headache, injection-site pain, and malaise.

The most common adverse reactions observed in the treatment of ITP (>14% of subjects) are chills, pyrexia/increased body temperature, and headache. Mild hemolysis (manifested by an increase in bilirubin, a decrease in hemoglobin, or a decrease in haptoglobin) was also observed.

Clinical Studies Experience

Because clinical studies are conducted under different protocols and widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.

Suppression of Rh Isoimmunization

In two clinical studies, 447 Rh0(D)-negative pregnant women received either an intravenous or intramuscular injection of Rhophylac 1500 IU (300 mcg) at Week 28 of gestation. A second 1500 IU (300 mcg) dose was administered to 267 (9 in Study 1 and 258 in Study 2) of these women within 72 hours of the birth of an Rh0(D)-positive baby. In addition, 30 women in Study 2 received at least one extra antepartum 1500 IU (300 mcg) dose due to obstetric complications.

The most common adverse reactions in study subjects were nausea (0.7%), dizziness (0.5%), headache (0.5%), injection-site pain (0.5%), and malaise (0.5%). A laboratory finding of a transient positive anti-C antibody test was observed in 0.9% of subjects.

ITP

In a clinical study, 98 Rh0(D)-positive adult subjects with chronic ITP received an intravenous dose of Rhophylac 250 IU (50 mcg) per kg body weight. Premedication to alleviate infusion-related side effects was not used except in a single subject who received acetaminophen and diphenhydramine.

Eighty-four (85.7%) subjects experienced 392 treatment-emergent adverse events (TEAEs). Sixty-nine (70.4%) subjects had 186 drug-related TEAEs (defined as TEAEs with a probable, possible, definite, or unknown relationship to the study drug). Within 24 hours of dosing, 73 (74.5%) subjects experienced 183 TEAEs, and 66 (67%) subjects experienced 156 drug-related TEAEs.

Mild hemolysis (manifested as an increase in bilirubin, a decrease in hemoglobin, or a decrease in haptoglobin) was observed. An increase in blood bilirubin was seen in 21% of subjects. The median decrease in hemoglobin was greatest (0.8 g/dL) at Day 6 and Day 8 following administration of Rhophylac.

Table 2 shows the most common TEAEs observed in the clinical study.

Table 2: Most Common Treatment-Emergent Adverse Events (TEAEs) in Subjects with ITP

TEAE	Number of Subjects (%) With a TEAE n=98	Number of Subjects (%) With a Drug-Related TEAE* n=98
* Defined as TEAEs with a possible, probable, definite, or unknown relationship to the study drug.
Chills	34 (34.7%)	34 (34.7%)
Pyrexia/ Increased body temperature	32 (32.6%)	30 (30.6%)
Increased blood bilirubin	21 (21.4%)	21 (21.4%)
Headache	14 (14.3%)	11 (11.2%)

Serious adverse events (SAEs) were reported in 10 (10.2%) subjects. SAEs considered to be drug-related were intravascular hemolytic reaction (hypotension, nausea, chills and headache, and a decrease in haptoglobin and hemoglobin) in two subjects; headache, dizziness, nausea, pallor, shivering, and weakness requiring hospitalization in one subject; and an increase in blood pressure and severe headache in one subject. All four subjects recovered completely.

Postmarketing Experience

Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. The following adverse reactions have been identified during post-approval use of Rhophylac:

Suppression of Rh Isoimmunization

Hypersensitivity reactions, including rare cases of anaphylactic shock or anaphylactoid reactions, headache, dizziness, vertigo, hypotension, tachycardia, dyspnea, nausea, vomiting, rash, erythema, pruritus, chills, pyrexia, malaise, diarrhea and back pain have been reported. Transient injection-site irritation and pain have been observed following intramuscular administration.

ITP

Transient hemoglobinuria has been reported in a patient being treated with Rhophylac for ITP.

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Side Effects by Body System - for Healthcare Professionals

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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