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Protect Yourself From a Lapse in Coverage

Coagulation Therapies

For every month in which you use an eligible CSL Behring coagulation therapy, you will earn 1 Assurance point.

If you have been enrolled for at least 3 months, or earned at least 3 points, by the time of your insurance lapse, you will be eligible to redeem your points as follows:

Multiple points (in increments of 3) may be redeemed within 1 month for a 30-day prescription refill. The number of points that may be redeemed for 1 prescription cannot exceed 12.

Please review the program Terms and Conditions for a complete description of CSL Behring Assurance.

Important Safety Information for AFSTYLA

AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, is contraindicated in patients who have had life-threatening hypersensitivity reactions to AFSTYLA or its excipients, or to hamster proteins.

AFSTYLA is for intravenous use only. AFSTYLA can be self-administered or administered by a caregiver with training and approval from a healthcare provider or hemophilia treatment center. Higher and/or more frequent dosing may be needed for patients under 12 years of age.

Hypersensitivity reactions, including anaphylaxis, are possible. Advise patients to immediately report symptoms of a hypersensitivity reaction. If symptoms occur, discontinue AFSTYLA and administer appropriate treatment.

Development of Factor VIII (FVIII) neutralizing antibodies (inhibitors) can occur. If expected FVIII activity levels are not attained or bleeding is not controlled with appropriate dose, perform an assay to measure FVIII inhibitor concentration.

Monitor plasma FVIII activity using a chromogenic assay or one-stage clotting assay. If one-stage clotting assay is used, multiply result by a conversion factor of 2 to determine FVIII activity level.

The most common adverse reactions reported in clinical trials (>0.5%) were dizziness and hypersensitivity.

Indications for AFSTYLA

AFSTYLA is indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for:

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

AFSTYLA is not indicated for the treatment of von Willebrand disease.

Please see full prescribing information for AFSTYLA.


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 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 seek immediate emergency treatment

Neutralizing antibodies (inhibitors) have been reported following administration of Helixate FS predominately in previously untreated patients. 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 of developing 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 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 prophylactic treatment to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without preexisting joint damage.
  • Routine prophylactic treatment to 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 full prescribing information for HELIXATE FS.


Important Safety Information for Humate-P

Antihemophilic Factor/von Willebrand Factor Complex (Human), Humate-P® is approved to treat and prevent bleeding in adult patients with hemophilia A (classical hemophilia). Humate-P also treats spontaneous or trauma-induced bleeding episodes in adults and children with von Willebrand disease (VWD) and prevents excessive bleeding during and after surgery in patients with mild, moderate or severe VWD. Humate-P is not known to prevent spontaneous bleeding episodes.

Do not take Humate-P if you have had extreme sensitivity or an allergic response to antihemophilic or von Willebrand factor preparations. Your doctor will monitor you for events related to abnormal blood clotting.

Humate-P is made from human blood and could contain infectious agents. The risk that these agents may transmit disease cannot be completely eliminated, but has been reduced by screening plasma donors and testing donated plasma for certain viruses, and by inactivating and/or removing viruses during manufacturing.

In studies, more than 5% of patients reported the following adverse reactions to Humate-P: allergic/anaphylactic reactions, including hives, chest tightness, rash, itching, and swelling. The most common adverse reactions after surgery were bleeding at the wound or infusion site, and nosebleeds.

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 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 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.