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The information provided herein is solely for use by physicians and healthcare professionals in the United States. The products listed may not have been approved in other countries and may not be available everywhere.



Category Brand / Description Product Resources

Alpha-1

Zemaira®

Alpha1-Proteinase Inhibitor (Human)

Product Site
Full Prescribing Information for Zemaira
Important Safety Information
Inhibitors

Berinert®

C1 Esterase Inhibitor, Human
Product Site
Full Prescribing Information for Berinert
Important Safety Information
Coagulation

Corifact®

Factor XIII Concentrate (Human)
Product Site
Full Prescribing Information for Corifact
Important Safety Information

Helixate® FS

Antihemophilic Factor (Recombinant) Formulated with Sucrose
Product Site
Full Prescribing Information for Helixate FS
Important Safety Information

Humate-P®

Antihemophilic Factor/von Willebrand Factor Complex (Human)
Product Site
Full Prescribing Information for Humate-P
Important Safety Information

Monoclate-P®

Antihemophilic Factor (Human) Factor VIII:C Pasteurized Monoclonal Antibody Purified
Product Details
Full Prescribing Information for Monoclate-P
Important Safety Information

Mononine®

Coagulation Factor IX (Human) Monoclonal Antibody Purified
Product Details
Full Prescribing Information for Mononine
Important Safety Information

RiaSTAP®

Fibrinogen Concentrate (Human)
Full Prescribing Information for RiaSTAP
Important Safety Information

Stimate®

(Desmopressin acetate) Nasal Spray, 1.5 mg/mL
Product Site
Full Prescribing Information for Stimate
How to purchase Stimate®
Important Safety Information
Critical Care & Immunology

Critical Care

AlbuRx®

Albumin (Human), 5%/25% Solution
Product Details
Full Prescribing Information for AlbuRx 5
Full Prescribing Information for AlbuRx 25
Important Safety Information

Albuminar®

Albumin (Human) USP, 5%/25% Solution
Product Details
Full Prescribing Information for Albuminar 5
Full Prescribing Information for Albuminar 25
Important Safety Information

Kcentra

Prothrombin Complex Concentrate (Human)
Warning: Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. See full prescribing information for complete boxed warning.
Product Site
Full Prescribing Information for Kcentra
Important Safety Information

Immune Mediated Disorders

Cytogam®

Cytomegalovirus Immune Globulin Intravenous (HUMAN) (CMV-IGIV)
Full Prescribing Information for Cytogam
Important Safety Information

Rh Immunoprophylaxis

Rhophylac®

Rho(D) Immune Globulin Intravenous (Human)
This warning does not apply to Rh0(D)-negative patients treated for the suppression of Rh isoimmunization.
Warning: Intravascular hemolysis leading to death has been reported in Rh0(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh0(D) Immune Globulin Intravenous (Human) products. Intravasular hemolysis can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS). Serious complications, including severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC), have also been reported. Closely monitor patients treated for ITP with Rhophylac in a healthcare setting for at least 8 hours after administration. See full prescribing information for complete boxed warning.
Product Site
Full Prescribing Information for Rhophylac
Important Safety Information


Important Safety Information for Zemaira

Alpha1-Proteinase Inhibitor (Human), Zemaira® is indicated for chronic augmentation and maintenance therapy for adults with alpha1-proteinase inhibitor (A1-PI) deficiency and emphysema. No clinical data are available demonstrating the effect of augmentation therapy with Zemaira or any A1-PI product on the progression of emphysema in A1-PI deficiency.

Zemaira is not indicated for lung disease patients in whom severe A1-PI deficiency has not been established.

Zemaira is contraindicated in patients with a history of severe systemic reactions to the product or to A1-PI protein, including anaphylaxis. Due to the risk of severe hypersensitivity, Zemaira is also contraindicated in immunoglobulin A-deficient patients with antibodies against IgA.

Use caution in administering Zemaira to patients who have experienced anaphylaxis or severe systemic reactions to another A1-PI product. Patients with selective or severe IgA deficiency can develop antibodies to IgA and are at greater risk of such reactions. If anaphylactic or severe anaphylactoid reactions occur during infusion, discontinue immediately.

In clinical studies, the following adverse reactions were reported in at least 5% of subjects receiving Zemaira: headache, sinusitis, upper respiratory infection, bronchitis, asthenia, increased cough, fever, injection-site hemorrhage, rhinitis, sore throat, and vasodilation.

Zemaira is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Please see full prescribing information for Zemaira.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Important Safety Information for Berinert

Berinert®, C1 Esterase Inhibitor (Human), is a plasma-derived concentrate of C1 Esterase Inhibitor (Human), indicated for the treatment of acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) in adult and adolescent patients. The safety and efficacy of Berinert for prophylactic therapy have not been established.

Berinert is contraindicated in individuals with a history of life-threatening systemic reactions to C1 esterase inhibitor preparations (including anaphylaxis).

Monitor patients for early signs of allergic or hypersensitivity reactions (including hives, generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis). If hypersensitivity is suspected, immediately discontinue administration of Berinert and initiate appropriate treatment. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reactions.

Serious arterial and venous thromboembolic events have been reported at recommended doses of C1 Esterase Inhibitor (Human) products, including Berinert, following administration to patients with HAE. Risk factors may include having an indwelling venous catheter/access device; prior history of thrombosis; underlying atherosclerosis; use of oral contraceptives or certain androgens; morbid obesity; and immobility. Weigh benefits/risks before administering to patients with known risk factors for TE events and closely monitor such patients during and after Berinert administration. TE events also have been reported with C1 Esterase Inhibitor (Human) products when used off-label at higher than labeled doses.

Patients able to recognize signs and symptoms of HAE attack and comprehend necessary training can self-administer Berinert. Patients should not attempt to self-administer unless they have been trained and determined to be capable by healthcare provider. Advise patients to seek medical attention immediately following self-administration for laryngeal attacks, and to seek medical attention if progress of any attack makes them unable to properly prepare or administer dose of Berinert.

Berinert is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The most serious adverse reaction reported in subjects who received Berinert in clinical studies was an increase in the severity of pain associated with HAE. Dysgeusia was the most common adverse reaction reported in over 4% of subjects and more frequently than in the placebo group.

Berinert has not been evaluated in pregnant women or nursing mothers, and should be used only if clearly needed. The safety and efficacy of Berinert have not been established in children (ages 0 through 12) or in the geriatric population. In clinical trials, the half-life of Berinert was shorter and clearance was faster in children than in adults; the clinical implication is not known.

Please see full prescribing information for Berinert, including the patient product information.


Important Safety Information for Corifact

Corifact®, FXIII Concentrate (Human), provides routine preventive treatment and management of surgical bleeding in adults and children with congenital Factor XIII deficiency. Corifact must be given by a healthcare professional through an intravenous injection.

Do not use Corifact if you have experienced severe, immediate sensitivity reactions (including shock) to human plasma-derived products. Before being treated with Corifact, tell your healthcare provider about all medical conditions you may have (including pregnancy and breastfeeding), as well as all prescription and non-prescription medications you are using.

Contact your physician, treatment administrator or local emergency department right away if you notice any of the following symptoms after using Corifact: shortness of breath, hives, rash, tightness or pain in the chest, wheezing, fainting or dizziness, and signs of a blood clot (including pain, swelling, warmth, redness, or a lump in the legs or arms).

Other possible side effects include chills or fever, joint pain, headache,and breakthrough bleeding and pain (caused by formation of antibodies against Corifact). These are not all the possible side effects of Corifact. Tell your healthcare professional about any undesirable side effect that bothers you or does not go away.

Corifact is made from human blood plasma, and the risk of transmitting infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Please see full prescribing information for Corifact.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Important Safety Information for HelixateFS

Helixate® FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Helixate® FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.

The most serious adverse reactions are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to antihemophilic factor. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.

Helixate® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.

Please see the full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Important Safety Information for Humate-P

Antihemophilic Factor/von Willebrand Factor Complex (Human), Humate-P® is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). Humate-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD, and patients with mild and moderate VWD for whom use of desmopressin is known or suspected to be inadequate.Humate-P is not indicated for the prophylaxis of spontaneous bleeding episodes.

Humate-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations.

Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Also monitor VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery.

Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement. Caution should be exercised and antithrombotic measures considered, particularly in patients with risk factors for thrombosis.

Humate-P is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

In patients receiving Humate-P in clinical studies for treatment of VWD, the most commonly reported adverse reactions (reported by >5% of subjects) were allergic-anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, and edema. For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding, and epistaxis.

Please see full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The information provided here is primarily intended for use by physicians and other healthcare professionals in the United States. The CSL Behring product listed may not have been approved in other countries and may not be available everywhere.


Important Safety Information for Monoclate-P

Monoclate-P®, Antihemophilic Factor (Human) Factor VIII: C Pasteurized Monoclonal Antibody Purified, is indicated for treatment of classical hemophilia (Hemophilia A). Affected individuals frequently require therapy following minor accidents. Surgery, when required in such individuals, must be preceded by temporary corrections of the clotting abnormality. Monoclate-P is not effective in controlling the bleeding of patients with von Willebrand's disease.

Monoclate-P is contraindicated in individuals with a known hypersensitivity to mouse protein. Products of this type are known to have caused allergic reactions, mild chills, nausea, or stinging at the infusion site. In some cases, inhibitors of Factor VIII may occur.

Monoclate-P is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Please see full prescribing information for Monoclate-P.


Important Safety Information for Mononine

Coagulation Factor IX (Human), Mononine ®, is indicated for the prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease.

Mononine is not indicated in the treatment or prophylaxis of Hemophilia A patients with inhibitors to Factor VIII.

Mononine is contraindicated in patients with known hypersensitivity to mouse protein.

The following adverse reactions may be observed after administration: headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, hives, stinging or burning at the infusion site, or other manifestations of allergic reactions, including anaphylaxis.

Mononine is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Since the use of Factor IX Complex concentrates has historically been associated with the development of thromboembolic complications, the use of Factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation (DIC).

Please see full prescribing information for Mononine.


Important Safety Information for RiaSTAP

RiaSTAP®, Fibrinogen Concentrate (Human), is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

The effectiveness of RiaSTAP is based on maximum clot firmness (MCF), which measures the structural integrity of a clot, reflecting the underlying effectiveness of the fibrinogen present to form a fibrin clot. There are no controlled trials demonstrating a direct benefit on treatment of bleeding episodes with RiaSTAP.

RiaSTAP is not indicated for dysfibrinogenemia.

RiaSTAP is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis to RiaSTAP or its components. Monitor patients for early signs of allergic or hypersensitivity reactions and if necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving RiaSTAP; weigh the benefits of administration versus the risks of thrombosis.

RiaSTAP is made from pooled human plasma. Products made from human plasma may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most serious adverse reactions that have been reported in subjects in clinical studies who received RiaSTAP are thromboembolic episodes, including myocardial infarction and pulmonary embolism, and allergic-anaphylactic reactions. The most common adverse reactions observed are allergic reactions, including chills, fever, nausea, and vomiting. Monitor patients for early signs of allergic or hypersensitivity reactions and if necessary, discontinue administration.

Please see full prescribing information for RiaSTAP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Important Safety Information for Stimate

Stimate® (desmopressin acetate) Nasal Spray, 1.5 mg/mL, is indicated for patients with hemophilia A and Factor VIII coagulant activity levels over 5%. Desmopressin acetate is not indicated to treat hemophilia A patients with Factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients with Factor VIII antibodies.

Stimate Nasal Spray is indicated for patients with mild to moderate classic type 1 von Willebrand disease (VWD) and Factor VIII levels greater than 5%. Stimate Nasal Spray is not indicated for the treatment of severe classic VWD (Type I) nor when there is evidence of an abnormal molecular form of Factor VIII antigen.

StimateNasal Spray should not be used in patients with type 2B VWD, since platelet aggregation may be induced. Stimate Nasal Spray is for intranasal use only.

Stimate Nasal Spray is a potent antidiuretic that can lead to water intoxication and/or hyponatremia; hyponatremia can be fatal if not properly diagnosed and treated. Very rare cases of hyponatremia have been reported in worldwide marketing experience.

Fluid intake should be adjusted downward to decrease the potential for water intoxication and/or hyponatremia, especially in patients at increased risk for these conditions, including pediatric and geriatric patients, and those with habitual or psychogenic polydipsia, who may be more likely to drink excessive amounts. All patients receiving Stimate therapy should be observed for signs or symptoms associated with hyponatremia, including: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status, such as hallucinations, decreased consciousness and confusion. Severe symptoms can include one or a combination of the following: seizure, coma and/or respiratory arrest. Particular attention should be paid to the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures that could lead to coma.

Other adverse reactions reported with use of injectable and/or intranasal desmopressin acetate include headache, nausea, somnolence, dizziness, chest pain, palpitations and tachycardia, and severe allergic reactions, including anaphylaxis.

Please see full prescribing information for Stimate Nasal Spray

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Important Safety Information for AlbuRx 5 and AlburRx 25

The use of AlbuRx 5 and 25 is contraindicated in patients with a history of an incompatibility reaction to human albumin. AlbuRx 5 may be contraindicated in patients with cardiac failure or severe anemia due to the risk of acute circulatory overload.

Reported adverse reactions include nausea, chills, fever, urticaria, headache, and hypotension.

AlbuRx is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob (CJD) disease agent, cannot be completely eliminated.

Please see the full prescribing information for AlbuRX® 5.
Please see the full prescribing information for AlbuRx® 25.


Important Safety Information for Albuminar 5 and Albuminar 25

Albuminar is contraindicated in patients with severe anemia or cardiac failure and in patients with a history of allergic reactions to human albumin.

Reports have been received of anaphylaxis, which may be severe, and hypersensitivity reactions, including urticaria, skin rash, pruritus, edema, erythema, hypotension and bronchospasm. Nausea, vomiting, increased salivation, chills and febrile reactions have also been reported.

Albuminar is derived from human plasma. The risk of transmission of infectious agents, including viruses, and theoretically, the Creutzfeldt-Jakob (CJD) disease agent, cannot be completely eliminated.

Please see the full prescribing information for Albuminar 5.
Please see the full prescribing information Albuminar 25.


Important Safety Information for Kcentra

Kcentra®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra is for intravenous use only.

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS

Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.

Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).

Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.

In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The safety and efficacy of Kcentra in pediatric use have not been studied, and Kcentra should be used in women who are pregnant or nursing only if clearly needed.

Please see full prescribing information for Kcentra.


Important Safety Information for Cytogam

Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human), is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients; prophylactic CMV-IGIV should be considered in combination with ganciclovir.

Cytogam is contraindicated in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations and in persons with selective immunoglobulin A deficiency who have known antibodies to IgA.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients predisposed to acute renal failure include patients with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentrations available and the minimum rate of infusion practicable.

Increases in serum creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following IGIV infusion. Progression to oliguria or anuria requiring dialysis has been observed.

Cytogam is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Minor reactions, such as flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, and wheezing, were the most frequent adverse reactions observed during the clinical trials for Cytogam

Please see full prescribing information for Cytogam.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Important Safety Information for Rhophylac

Rhophylac®, Rho(D), Immune Globulin Intravenous (Human), is indicated for suppression of rhesus (Rh) isoimmunization in:

  • Pregnancy and obstetric conditions in non-sensitized, Rho(D)-negative women with an Rh-incompatible pregnancy, including routine antepartum and postpartum Rh prophylaxis and Rh prophylaxis in cases of obstetric complications, invasive procedures during pregnancy, or obstetric manipulative procedures.
  • Incompatible transfusions in Rho(D)-negative individuals transfused with blood components containing Rho(D)-positive red blood cells.

For suppression of Rh isoimmunization, Rhophylac can be administered IM or IV.

Rhophylac is indicated to raise platelet counts in Rho(D)-positive, non-splenectomized adult patients with chronic immune thrombocytopenic purpura (ITP). For the treatment of ITP, Rhophylac must be administered IV.

WARNING: INTRAVASCULAR HEMOLYSIS IN ITP
This warning does not apply to Rh0(D)-negative patients treated for the suppression of Rh isoimmunization.
Intravascular hemolysis leading to death has been reported in Rho(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) Immune Globulin Intravenous (Human) products. Intravascular hemolysis can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS). Serious complications, including severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC), have also been reported. Closely monitor patients treated for ITP with Rhophylac in a healthcare setting for at least 8 hours after administration. See full prescribing information for complete boxed warning.

Rhophylac is contraindicated in individuals with known anaphylactic or severe systemic reaction to human immune globulin products. Rhophylac is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.

Allergic or hypersensitivity reactions may occur with Rhophylac; early signs of hypersensitivity include generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis.

Rhophylac is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Suppression of Rh Isoimmunization: For postpartum use following an Rh-incompatible pregnancy, Rhophylac should not be given to the newborn infant.

The most common adverse reactions in the suppression of Rh isoimmunization with Rhophylac are nausea, dizziness, headache, injection-site pain, and malaise.

Immune Thrombocytopenic Purpura: The most serious adverse reactions in patients receiving Rho(D) immune globulin have been observed in the treatment of ITP. ITP patients being treated with Rhophylac should be monitored for signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and hemoglobinuria. Potentially serious complications of intravascular hemolysis include clinically compromising anemia, acute renal insufficiency, and, very rarely, disseminated intravascular coagulation, and death.

The most common adverse reactions observed in the treatment of ITP are chills, pyrexia/increased body temperature, and headache. Mild extravascular hemolysis has also been observed. In patients with preexisting anemia, weigh the benefits of Rhophylac against the potential risk of increasing the severity of the anemia.

Immunoglobulin administration may transiently interfere with the immune response to live virus vaccines, such as measles, mumps and rubella

Please see full prescribing information for Rhophylac.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.



MTL07-12-0002 10/2012
© 2014 CSL Behring