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Rhophylac

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Rhophylac

Warnings
Precautions

WARNINGS

No information provided.

PRECAUTIONS

Both Indications

Allergic Reactions

Allergic reactions may occur. If symptoms of allergic or early signs of hypersensitivity reactions (including generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis) occur, immediately discontinue administration. The treatment required depends on the nature and severity of the side effect. If necessary, the current medical standards for shock treatment should be observed (see Patient Counseling Information).

Selective IgA Deficiency

Individuals with selective IgA deficiency can develop antibodies to IgA and anaphylactic reactions (including anaphylaxis and shock) after administration of blood components containing IgA. Although the concentration of IgA was found to be below the detection limit of 5 mcg/mL, Rhophylac® (immune globulin intravenous (human) solution) may contain trace amounts of IgA (see Description).

Those with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Therefore, the physician must weigh the expected benefits of treatment with Rhophylac® (immune globulin intravenous (human) solution) against the potential risks.

Interference With Laboratory Tests

The administration of Rh0(D) immune globulin may affect the results of blood typing, the antibody screening test, and the direct antiglobulin (Coombs') test. Antepartum administration of Rh0(D) immune globulin to the mother can also affect these tests in the newborn infant.

Rhophylac® (immune globulin intravenous (human) solution) can contain antibodies to other Rh antigens (e.g., anti-C antibodies), which might be detected by sensitive serological tests following administration.

Transmissible Infectious Agents

Rhophylac® (immune globulin intravenous (human) solution) is made from human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacturing through solvent/detergent treatment and virus filtration. The solvent/detergent treatment step is effective in inactivating enveloped viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). The virus filtration step is effective in removing both enveloped and non-enveloped viruses (see Description, Patient Counseling Information ).

Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to ZLB Behring at 1-800-504-5434. The physician should discuss the risks and benefits of this product with the patient.

Suppression of Rh Isoimmunization

Postpartum Use Following an Rh-incompatible Pregnancy Rhophylac® (immune globulin intravenous (human) solution) should not be given to the newborn infant (see Pediatric Use for pediatric use in incompatible transfusions and in ITP).

ITP

Intravascular Hemolysis

Intravascular hemolysis has occurred in a clinical study with Rhophylac® (immune globulin intravenous (human) solution) . All cases resolved completely. However, as reported in the literature, some patients treated with Rh0(D) immune globulin (anti-D) developed clinically compromising anemia, acute renal insufficiency, and, very rarely, disseminated intravascular coagulation (DIC) and death.2

Following administration of Rhophylac® (immune globulin intravenous (human) solution) , patients should be monitored for signs and/or symptoms of intravascular hemolysis and its complications including clinically compromising anemia, acute renal insufficiency, and DIC. Patients experiencing intravascular hemolysis may present with back pain, shaking chills, fever, and, most consistently, hemoglobinuria (see Patient Counseling Information ).

ITP patients presenting with signs and/or symptoms of intravascular hemolysis and its complications after Rh0(D) immune globulin administration should have confirmatory laboratory tests. DIC may be difficult to detect in the ITP population; the diagnosis is dependent mainly on laboratory testing.

If patients who develop hemolysis with clinically compromising anemia after receiving Rhophylac® (immune globulin intravenous (human) solution) are to be transfused, Rh0(D)-negative packed RBCs should be used to avoid exacerbating ongoing hemolysis.

Pre-existing Anemia

The safety of Rhophylac® (immune globulin intravenous (human) solution) in the treatment of ITP has not been established in patients with pre-existing anemia. The physician must weigh the benefits of Rhophylac® (immune globulin intravenous (human) solution) against the potential risk of increasing the severity of the anemia.

Use In Specific Populations

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Rhophylac® (immune globulin intravenous (human) solution) .

Suppression of Rh Isoimmunization

The available evidence suggests that Rhophylac® (immune globulin intravenous (human) solution) does not harm the fetus or affect future pregnancies or reproduction capacity when given to pregnant Rh0(D)-negative women for suppression of Rh isoimmunization.

ITP

Rhophylac® (immune globulin intravenous (human) solution) has not been evaluated in pregnant women with ITP.

Nursing Mothers

Suppression of Rh Isoimmunization

Rhophylac® (immune globulin intravenous (human) solution) is used in nursing mothers for the suppression of Rh isoimmunization. No undesirable effects on a nursing infant are expected during breastfeeding.

ITP

Rhophylac® (immune globulin intravenous (human) solution) has not been evaluated in nursing mothers with ITP.

Pediatric Use

Suppression of Rh Isoimmunization in Incompatible Transfusions

The safety and effectiveness of Rhophylac® (immune globulin intravenous (human) solution) have not been established in pediatric subjects being treated for an incompatible transfusion. The physician should weigh the potential risks against the benefits of Rhophylac® (immune globulin intravenous (human) solution) , particularly in girls whose later pregnancies may be affected if Rh isoimmunization occurs.

ITP

Studies have demonstrated the safe and effective use of Rh0(D) Immune Globulin in children with ITP.3-6

Geriatric Use

Suppression of Rh Isoimmunization in Incompatible Transfusions

Rhophylac® (immune globulin intravenous (human) solution) has not been evaluated for treating incompatible transfusions in subjects 65 years of age and older.

ITP

Of the 98 subjects evaluated in the clinical study of Rhophylac® for treatment of ITP (see Clinical Studies), 19% were 65 years of age and older. No overall differences in effectiveness or safety were observed between these subjects and younger subjects.

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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