View the catalog and prescribing information for all CSL Behring products in the United States at www.cslbehring-us.com/products.htm.

Product Description
AFSTYLA® 250 IU
NDC 69911-0474-02
AFSTYLA® 500 IU
NDC 69911-0475-02
AFSTYLA® 1000 IU
NDC 69911-0476-02
AFSTYLA® 2000 IU
NDC 69911-0477-02
AFSTYLA® 3000 IU
NDC 69911-0478-02
Albuminar ® 5% 250 mL
NDC 00053-7670-31
Albuminar ® 5% 500 mL
NDC 00053-7670-32
Albuminar ® 25% 100ML W/O IV SET
NDC 00053-7680-33
Albuminar ® 25% 50ML W/O IV SET
NDC 00053-7680-32
AlbuRx® 5% 250 mL
NDC 44206-0310-25
AlbuRx® 5% 500 mL
NDC 44206-0310-50
AlbuRx® 25% 50 mL
NDC 44206-0251-05
AlbuRx® 25% 100 mL
NDC 44206-0251-10
Berinert® 500 U
NDC 63833-0825-02
Carimune NF Nanofiltered® 250 IU
NDC 69911-0474-02
Carimune NF Nanofiltered® 500 IU
NDC 69911-0475-02
Carimune NF Nanofiltered® 1000 IU
NDC 69911-0476-02
Carimune NF Nanofiltered® 2000 IU
NDC 69911-0477-02
Carimune NF Nanofiltered® 3000 IU
NDC 69911-0478-02
Corifact® 1000-1600 IU
NDC 63833-0518-02
Cytogam® 2.5 g
NDC 44206-0532-11
Helixate®FS 250 U
NDC 00053-8131-02
Helixate®FS 500 U
NDC 00053-8132-02
Helixate®FS 1000 U
NDC 00053-8133-02
Helixate®FS 2000 U
NDC 00053-8134-02
Helixate®FS 3000 U
NDC 00053-8135-02
Humate-P® 600 RcoF
NDC 63833-0615-02
Humate-P® 1200 RcoF
NDC 63833-0616-02
Humate-P® 2400 RcoF
NDC 63833-0617-02
Hizentra® 250 IU
NDC 69911-0474-02
Hizentra® 500 IU
NDC 69911-0475-02
Hizentra® 1000 IU
NDC 69911-0476-02
Hizentra® 2000 IU
NDC 69911-0477-02
Hizentra® 3000 IU
NDC 69911-0478-02
IDELVION® 250 IU
NDC 69911-0864-02
IDELVION® 500 IU
NDC 69911-0865-02
IDELVION® 1000 IU
NDC 69911-0866-02
IDELVION® 2000 IU
NDC 69911-0867-02
Kcentra® 400-620 IU
NDC 63833-0386-02
Kcentra® 800-1240 IU
NDC 63833-0387-02
Monoclate-P® 250 IU
NDC 00053-7631-02
Monoclate-P® 500 IU
NDC 00053-7632-02
Monoclate-P® 1000 IU
NDC 00053-7633-02
Monoclate-P® 2000 IU
NDC 00053-7634-02
Mononine® 1000 IU
NDC 00053-6233-02
Privigen® 5 g
NDC 44206-0436-05
Privigen® 10 g
NDC 44206-0437-10
Privigen® 20 g
NDC 44206-0438-20
Privigen® 40g
NDC 44206-0439-40
RiaSTAP® Approx 1g (900-1300 mg)
NDC 63833-0891-51
Rhophylac® 1500 IU (300)
NDC 44206-0300-01
Rhophylac® 1500 IU (300) 1
NDC 44206-0300-10
Stimate® 1.5 mg/mL
NDC 00053-6871-00
Zemaira® 1000 mg
NDC 00053-7201-02

Important Safety Information for AFSTYLA

AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, is administered by intravenous injection into the bloodstream, and can be self-administered or administered by a caregiver. Your healthcare provider or hemophilia treatment center will instruct you on how to do an infusion. Carefully follow prescriber instructions regarding dose and infusion schedule, which are based on your weight and the severity of your condition.

Do not use AFSTYLA if you know you are allergic to any of its ingredients, or to hamster proteins. Tell your healthcare provider if you previously had an allergic reaction to any product containing Factor VIII (FVIII), or have been told you have inhibitors to FVIII, as AFSTYLA might not work for you. Inform your healthcare provider of all medical conditions and problems you have, as well as all medications you are taking.

Immediately stop treatment and contact your healthcare provider if you see signs of an allergic reaction, including a rash or hives, itching, tightness of chest or throat, difficulty breathing, lightheadedness, dizziness, nausea, or a decrease in blood pressure.

Your body can make antibodies, called inhibitors, against FVIII, which could stop AFSTYLA from working properly. You might need to be tested for inhibitors from time to time. Contact your healthcare provider if bleeding does not stop after taking AFSTYLA.

In clinical trials, dizziness and allergic reactions were the most common side effects. However, these are not the only side effects possible. Tell your healthcare provider about any side effect that bothers you or does not go away.

Indications for AFSTYLA

AFSTYLA is used to treat and control bleeding episodes in people with hemophilia A. Used regularly (prophylaxis), AFSTYLA can reduce the number of bleeding episodes and the risk of joint damage due to bleeding. Your doctor might also give you AFSTYLA before surgical procedures.

Please see full prescribing information for AFSTYLA, including patient product 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 Albuminar

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 Albuminar

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 AlbuRx

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 AlbuRx

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 Berinert

Berinert®, C1 Esterase Inhibitor (Human), is used in adults and children to treat swelling and/or painful attacks of hereditary angioedema (HAE) affecting the abdomen, face or throat. The safety and efficacy of Berinert in preventing HAE attacks have not been established.

Do not use Berinert if you have experienced life-threatening allergic reactions or severe hypersensitivity to the product. Inform your healthcare provider of all medications you are taking and of any medical conditions, especially any history of blood-clotting problems.

Blood clots have occurred in patients receiving Berinert. Tell your healthcare provider if you have a history of heart or blood vessel disease, stroke, or blood clots, or if you have thick blood, an indwelling catheter/access device in a vein, or have been immobile for some time. Certain medications, such as birth control pills, may also increase your risk of clotting problems.

Report to your physician or an emergency room any signs and symptoms of a blood clot, including pain and/or swelling or discoloration of an arm or leg, with warmth over affected area; unexplained shortness of breath; chest pain or discomfort that worsens on deep breathing; rapid pulse; and numbness or weakness on one side of the body.

In addition, report immediately any signs or symptoms of allergic reactions to Berinert, including hives, chest tightness, wheezing, difficulty breathing, turning blue, faintness, facial swelling and fast heartbeat.

If you have been trained to self-administer Berinert, immediately prepare the prescribed dose at the first symptoms of an attack. Seek immediate medical attention and do not begin to self-adminster if an HAE attack has progressed to a point where you will be unable to prepare or administer a dose of Berinert.

If you self-administer to treat a laryngeal attack, immediately seek medical attention afterward. If you self-administer for an abdominal attack, inform your physician so that other possible causes can be ruled out.

Call your doctor right away if swelling is not controlled after use of Berinert.

In clinical studies, the most serious adverse reaction reported in subjects who received Berinert was an increased severity of the pain associated with HAE. In the placebo-controlled clinical trial, the most common adverse reaction reported more often among subjects who received Berinert than those receiving placebo was dysgeusia (a bad taste in mouth). Tell your healthcare provider about any side effect that bothers you or does not go away.

Because Berinert is made from human blood, the risk that it may transmit infectious agents, including viruses and theoretically, the agents of Creutzfeldt-Jakob Disease (CJD) and its variant form (vCJD), cannot be completely eliminated.

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

Carimune® NF, Nanofiltered Immune Globulin Intravenous (Human) is indicated for the maintenance treatment of patients with primary immunodeficiencies (PI), such as common variable immunodeficiency, X-linked agammaglobulinemia, and severe combined immunodeficiency, as well as for for acute and chronic immune thrombocytopenic purpura (ITP).

WARNING: THROMBOSIS, RENAL DYSFUNCTION or ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin products, including Carimune NF. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis might occur in absence of known risk factors.
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death can occur in predisposed patients with immune globulin intravenous (IGIV) products, including Carimune NF. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age over 65, volume depletion, sepsis, paraproteinemia, and those receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Carimune NF contains sucrose.
  • For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Carimune NF at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

See full prescribing information for full boxed warning.

Carimune NF is contraindicated in patients who have had anaphylactic or severe systemic reactions to the administration of human immune globulin. Individuals with selective IgA deficiency who possess antibody to IgA should only receive Carimune NF with utmost caution due to risk of severe, immediate hypersensitivity reactions, including anaphylaxis.

Increases in creatinine and blood urea nitrogen with progression to oliguria or anuria requiring dialysis have been observed as soon as one to two days following IGIV infusion. Severe renal adverse events have included acute renal failure, acute tubular nephrosis, proximal tubular nephropathy, and osmotic nephrosis.

Patients receiving Carimune NF should be monitored for clinical signs and symptoms of hemolysis, as well pulmonary adverse reactions, including TRALI. An aseptic meningitis syndrome (AMS) has been reported to occur infrequently with IVIG—more frequently in association with high dose (2 g/kg) treatment.

Inflammatory adverse reactions have been observed; they may become apparent within 30 minutes to an hour after beginning infusion. Slow or temporarily stop infusion if patient experiences facial flushing, tightness in chest, chills, fever, nausea, dizziness or other unusual response; stop infusion immediately if anaphylaxis or severe reaction occurs. Headache, usually mild, is the most common adverse reaction; mild hemolysis, arthralgia, myalgia, and transient skin reactions have also been reported.

Carimune NF 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.

Carimune NF should be given to a pregnant woman only if clearly needed.

Please see full prescribing information, including boxed warning on thrombosis and renal dysfunction/failure.

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 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 HELIXATE FS

Helixate® FS is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product.

Hypersensitivity reactions, including anaphylaxis have been reported with Helixate FS. Reported symptoms included facial swelling, flushing, hives, decrease in blood pressure, nausea, rash, restlessness, shortness of breath, tachycardia, tightness of the chest, tingling, urticaria, and vomiting. Discontinue Helixate FS if symptoms occur and administer immediate emergency treatment.

Neutralizing antibodies (inhibitors) have been reported following administration of Helixate FS. Carefully monitor patients for the development of factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.

Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with factor VIII.

Serious adverse reactions seen with Helixate FS are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.

The most common adverse reactions (≥4%) observed in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions, infusion-site reactions, and central venous access device (CVAD)-associated infections.

Indications for HELIXATE FS

HELIXATE FS, Antihemophilic Factor (Recombinant), is a recombinant Factor VIII indicated for:

  • On-demand treatment and control of bleeding episodes in adults and children with hemophilia A.
  • Perioperative management of bleeding in adults and children with hemophilia A.
  • Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.
  • Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

HELIXATE FS is not indicated for the treatment of von Willebrand disease.

Please see the full prescribing information for HELIXATE FS, including patient product 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 Hizentra

Immune Globulin Subcutaneous (Human), Hizentra®, is indicated as replacement therapy for patients with primary humoral immunodeficiency (PI), age 2 and older. This includes but is not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

WARNING: THROMBOSIS

Thrombosis may occur with immune globulin products, including Hizentra. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

For patients at risk of thrombosis, administer Hizentra at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. See full prescribing information for complete boxed warning.

Hizentra is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin preparations or components of Hizentra, such as polysorbate 80. Because it contains the stabilizer L-proline, Hizentra is contraindicated in patients with hyperprolinemia. Hizentra is also contraindicated in patients with immunoglobulin A deficiency who have antibodies against IgA and a history of hypersensitivity.

Hizentra should be administered subcutaneously only. Do not administer intravenously.

IgA-deficient patients with anti-IgA antibodies may be at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions with administration of Hizentra. If hypersensitivity occurs or anaphylactic reactions are suspected, discontinue administration immediately and treat as medically appropriate.

Monitor patients for aseptic meningitis syndrome (AMS), which has been reported with SCIg. In patients at risk of acute renal failure, monitor renal function, including blood urea nitrogen, serum creatinine and urine output. Also monitor patients for clinical signs of hemolysis or transfusion-related acute lung injury (TRALI).

Hizentra 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 common adverse reactions (observed in 5% or more of study subjects receiving Hizentra) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, rash, pruritus, vomiting, upper abdominal pain, migraine and pain.

Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella. It can also lead to misinterpretation of serologic testing.

Please see full prescribing information for Hizentra including boxed warning.

Important Safety Information for IDELVION

IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP), is indicated in children and adults with hemophilia B (congenital Factor IX deficiency) for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes

IDELVION is not indicated for induction of immune tolerance in patients with hemophilia B.

IDELVION is contraindicated in patients who have had life-threatening hypersensitivity to the product or its components, including hamster proteins.

IDELVION is for intravenous use only. IDELVION can be self-administered or administered by a caregiver with training and approval from a healthcare provider or hemophilia treatment center. Higher dose per kilogram body weight or more frequent dosing may be needed for pediatric patients.

Hypersensitivity reactions, including anaphylaxis, are possible. Advise patients who self-administer to immediately report symptoms of hypersensitivity, including angioedema, chest tightness, hypotension, generalized urticaria, wheezing, and dyspnea. If symptoms occur, discontinue IDELVION and administer appropriate treatment.

Development of neutralizing antibodies (inhibitors) to IDELVION may occur. If expected Factor IX activity plasma levels are not attained or bleeding is not controlled with appropriate dose, perform an assay to measure Factor IX inhibitor concentration. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.

Thromboembolism (eg, pulmonary embolism, venous thrombosis, and arterial thrombosis) can occur when using Factor IX-containing products. In addition, nephrotic syndrome has been reported following immune tolerance induction in hemophilia B patients with Factor IX inhibitors and allergic reactions to Factor IX.

The most common adverse reaction (incidence ≥1%) reported in clinical trials was headache.

Please see full prescribing information for IDELVION.

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 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 Privigen

Immune Globulin Intravenous (Human), 10% Liquid, Privigen®, is approved for the treatment of primary immunodeficiency (PI), and to raise platelet counts in patients with chronic immune thrombocytopenic purpura (ITP).

WARNINGS:

  • Thrombosis (blood clotting) can occur with immune globulin products, including Privigen. Risk factors may include advanced age, prolonged immobilization, a history of blood clotting or hyperviscosity (thick blood), use of estrogens, installed vascular catheters, and cardiovascular risk factors.
  • In predisposed patients, kidney malfunction and acute kidney failure, potentially fatal, can occur with the administration of human immune globulin intravenous (IGIV) products. Kidney problems occur more commonly in patients receiving IGIV products that contain sucrose. Privigen does not contain sucrose.
  • If you are at high risk of thrombosis or kidney problems, your doctor will prescribe and administer Privigen at the minimum dose and infusion rate practicable, and will monitor you for signs and symptoms of thrombosis and viscosity, as well as kidney function. Always drink sufficient fluids before administration.

See your doctor for a full explanation and the full prescribing information for complete boxed warning.

Treatment with Privigen might not be possible if your doctor determines you have hyperprolinemia (too much proline in the blood) or are IgA-deficient with antibodies to IgA and a history of hypersensitivity. Tell your doctor if you have previously had anaphylaxis (shock) or any other severe reaction to the administration of human immune globulin. Inform your physician if you notice early signs of hypersensitivity reactions to administration of Privigen, including hives, tightness of the chest, wheezing, or shock.

If you notice a decrease in urine output, sudden weight gain, fluid retention, and/or shortness of breath following infusion with Privigen, contact your doctor immediately. Immediately report symptoms that could indicate a blood clot, including pain and/or swelling or discoloration of an arm or leg, shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, and numbness or weakness on one side of the body. Inform your doctor if you experience severe headache; a stiff neck; excessive drowsiness or fatigue; fever; sensitivity to light or painful eye movements; nausea; increased heart rate; yellowing of the skin or eyes, and/or dark-colored urine.

Privigen is made from human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

Administration of immunoglobulins can impair the effectiveness of live virus vaccines (eg, measles, mumps, and rubella) or lead to misinterpretation of test results. Before receiving any vaccine, tell the immunizing physician if you have had recent therapy with Privigen.

In clinical trials of Privigen, the most common adverse reactions seen in patients with PI, included headache, fatigue, nausea, and chills. In studies of patients being treated for chronic ITP, the most common adverse reactions included headache, anemia, and nausea. These are not the only adverse reactions possible with Privigen. Speak with your physician about any side effect that bothers you or does not go away.

For more information about Privigen, 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.

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.

RiaSTAP is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products.

Monitor patients for early signs of anaphylaxis 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 observed are thrombotic episodes (pulmonary embolism, myocardial infarction, deep vein thrombosis) and anaphylactic reactions. The most common adverse reactions observed in clinical studies (frequency >1%) were fever and headache.

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 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. Consider IV administration if reaching the muscle is of concern.

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); acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC) have also been reported. Monitor patients for signs and symptoms of intravascular hemolysis 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 to Rhophylac or any of its components. Do not administer Rhophylac to the newborn infant of a mother who received Rhophylac postpartum.

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: The most common adverse reactions in the suppression of Rh isoimmunization with Rhophylac (≥0.5% of patients) 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 alerted to and monitored for signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and hematuria. 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 (>14% of patients) are chills, pyrexia/increased body temperature, headache, and hemolysis. In patients with preexisting anemia, Rhophylac may increase the severity of 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.


Important Safety Information for Stimate

Stimate® (desmopressin acetate) Nasal Spray, 1.5 mg/mL is a treatment used to stop some types of bleeding in people with mild hemophilia A or mild to moderate von Willebrand disease (VWD) Type 1. Stimate Nasal Spray should not be used in children under 11 months of age.

All patients using Stimate Nasal Spray are at risk of water intoxication, fluid overload and low sodium levels in the blood. Follow your healthcare provider’s instructions on limiting the amount of fluid you drink when using Stimate Nasal Spray, as too much fluid intake can lead to serious adverse reactions, including seizures, coma, and even death. Fluid restrictions are especially important for children and elderly patients, as they are at higher risk for these reactions.

See the patient information leaflet in the prescribing information for Stimate Nasal Spray for symptoms that could mean your blood sodium level is low—including headache, hallucinations, confusion, restlessness, weight gain and muscle spasms. Immediately report any of these symptoms to your physician or, if necessary, an emergency department. Also contact your doctor immediately if you have uncontrolled bleeding.

Before being prescribed Stimate Nasal Spray, make sure your doctor knows about all your medical conditions and about any medications you are taking. Use Stimate Nasal Spray exactly as your healthcare provider has instructed.

Side effects of Stimate Nasal Spray generally come from having too much water in the body. The most common include facial flushing, nasal congestion, runny nose, nose bleed, sore throat, cough, and upper respiratory infections. Tell your healthcare provider if you experience a side effect that does not go away.

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 Zemaira

Alpha1-Proteinase Inhibitor (Human), Zemaira® is indicated to raise the plasma level of alpha1-proteinase inhibitor (A1-PI) in patients with A1-PI deficiency and related emphysema. The effect of this raised level on the frequency of pulmonary exacerbations and the progression of emphysema have not been established in clinical trials.

Zemaira may not be suitable for everyone; for example, people with known hypersensitivity to components used to make Zemaira, those with a history of anaphylaxis or severe systemic response to A1-PI products, and those with certain IgA deficiencies. If you think any of these may apply to you, ask your doctor.

Early signs of hypersensitivity reactions to Zemaira include hives, rash, tightness of the chest, unusual breathing difficulty, wheezing, and feeling faint. Immediately discontinue use and consult with physician if such symptoms occur.

In clinical studies, the following adverse reactions were reported in at least 5% of subjects receiving Zemaira: headache, sinusitis, upper respiratory infection, bronchitis, fatigue, increased cough, fever, injection-site bleeding, nasal symptoms, sore throat, and swelled blood vessels.

Because Zemaira is made from human blood, 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 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.

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