What should I tell my HCP before using ADVATE?

Tell your HCP if you:

• Have or have had any medical problems.
• Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies
• Have any allergies, including allergies to mice or hamsters.
• Are breastfeeding. It is not known if ADVATE passes into your milk and if it can harm your baby.
• Are or become pregnant. It is not known if ADVATE may harm your unborn baby.
• Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).

What important information do I need to know about ADVATE?

• You can have an allergic reaction to ADVATE. Call your HCP right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
• Do not attempt to infuse yourself with ADVATE unless you have been taught by your HCP or hemophilia center.

What else should I know about ADVATE and Hemophilia A?

• Your body may form inhibitors to factor VIII. An inhibitor is part of the body's normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Talk with your HCP to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

What are possible side effects of ADVATE?

• Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, unusual taste, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash. Tell your HCP about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.

Please click here for ADVATE full Prescribing Information and discuss with your HCP.

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

What should I tell my HCP before using ADYNOVATE?

Tell your HCP if you:

• Have or have had any medical problems.
• Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
• Have any allergies, including allergies to mice or hamsters.
• Are breastfeeding. It is not known if ADYNOVATE passes into your milk and if it can harm your baby.
• Are or become pregnant. It is not known if ADYNOVATE may harm your unborn baby.
• Have been told that you have inhibitors to factor VIII (because ADYNOVATE may not work for you).

What important information do I need to know about ADYNOVATE?

• You can have an allergic reaction to ADYNOVATE. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
• Do not attempt to infuse yourself with ADYNOVATE unless you have been taught by your HCP or hemophilia center.

What else should I know about ADYNOVATE and Hemophilia A?

• Your body may form inhibitors to factor VIII. An inhibitor is part of the body's normal defense system. If you form inhibitors, it may stop ADYNOVATE from working properly. Talk with your HCP to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

What are possible side effects of ADYNOVATE?

• The common side effects of ADYNOVATE are headache, diarrhea, rash, nausea, dizziness, and hives. These are not all the possible side effects with ADYNOVATE. Tell your HCP about any side effects that bother you or do not go away.

Please click here for ADYNOVATE full Prescribing Information and discuss with your HCP.

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

Who should not use FEIBA?

You should not use FEIBA if:

• You had a previous severe allergic reaction to the product
• You have Disseminated Intravascular Coagulation (DIC), or signs of small blood vessel clots throughout the body
• You have sudden blood vessel clots or blocked blood vessels, (such as, heart attack or stroke)

What other important information should I know about FEIBA?

Events involving blood clots blocking blood vessels (such as blood clot in vein, blood clot in the lung, heart attack, and stroke) can occur with FEIBA, particularly after receiving high doses (above 200 units per kg per day) and/or in patients with risk factors for clotting.

At first sign or symptom of a sudden blood vessel clot or blocked blood vessel (such as chest pain or pressure, shortness of breath, fever, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain), stop FEIBA administration right away and seek immediate emergency medical treatment.

Infusion of FEIBA should not exceed a single dose of 100 units per kg body weight and daily doses of 200 units per kg of body weight. Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute.

The safety and efficacy of FEIBA for breakthrough bleeding in patients receiving emicizumab has not been established. Events of thrombotic microangiopathy (TMA), a condition where blood clots and damage occur in small blood vessels, were reported in an emicizumab (Hemlibra^®) clinical trial where patients received FEIBA with emicizumab as part of a treatment plan for breakthrough bleeding. If you are on emicizumab and are taking or anticipate taking FEIBA for a breakthrough bleeding episode, tell your doctor immediately because there are specific safety considerations and you must be closely monitored by your hemophilia treater or treatment center.

Allergic reactions, including severe, sometimes fatal allergic reactions that can involve the whole body, can occur following the infusion of FEIBA. Stop using FEIBA promptly and call your doctor or get emergency treatment right away if you get a rash, hives or welts, experience itching, tightness of the throat, vomiting, abdominal pain, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.

Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, such as viruses, variant Creutzfeldt-Jakob disease (vCJD) and, theoretically, the Creutzfeldt-Jakob disease (CJD).

What are the possible side effects of FEIBA?

The most common side effects observed during the prophylaxis clinical study were low number of red blood cells, diarrhea, bleeding into a joint, positive test for hepatitis B surface antibodies, nausea, and vomiting.

The serious side effects seen with FEIBA are allergic reactions and clotting events involving blockage of blood vessels, which include stroke, blockage of the main blood vessel to the lung, and deep vein blood clots.

Call your doctor right away about any side effects that bother you during or after you stop taking FEIBA.

What other medications might interact with FEIBA?

Talk with your doctor about the possibility of formation of blood clots when taking drugs that may prevent clot breakdown such as tranexamic acid, and aminocaproic acid. There have not been adequate studies of the use of FEIBA and rFVIIa (NovoSeven^®), or emicizumab together, or one after the other. Use of drugs that may prevent clot breakdown within approximately 6 to 12 hours after the administration of FEIBA is not recommended.

Please click here for FEIBA full Prescribing Information, including BOXED WARNING on blood clots, and discuss with your doctor.

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

What should I tell my healthcare provider before using HEMOFIL M?

Tell your healthcare provider if you:

• Have or have had any medical problems
• Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
• Have any allergies, including allergies to mice.
• Are breastfeeding. It is not known if HEMOFIL M passes into your milk and if it can harm your baby.
• Are or become pregnant. It is not known if HEMOFIL M may harm your unborn baby.
• Have been told that you have inhibitors to factor VIII (because HEMOFIL M may not work for you).

What important information do I need to know about HEMOFIL M?

• Allergic reactions, including anaphylaxis, have been reported with HEMOFIL M. The symptoms of an allergic reaction may include wheezing, difficulty breathing, low blood pressure, lightheadedness, dizziness, fainting, chest tightness or pain, facial swelling, hives, rash, flushing, itching or nausea. If you experience any of these symptoms, stop using HEMOFIL M and call your healthcare provider right away.
• Because HEMOFIL M is made from human blood, it may carry a risk of transmitting infectious agents, such as parvovirus B19, hepatitis A, and Creutzfeldt-Jakob disease agent. Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about two weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, stomach pain, dark urine, and a yellowed complexion. Discontinue use of HEMOFIL M and contact your healthcare provider right away if such symptoms occur. Any infections your doctor thinks may have been transmitted by this product should be reported to Shire Drug Safety (Baxalta-related products) at 1-800-999-1785 (in the U.S.).

What else should I know about HEMOFIL M and Hemophilia A?

• Your body may form inhibitors to factor VIII. An inhibitor is part of the body's normal defense system. If you form inhibitors, it may stop HEMOFIL M from working properly. Talk with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

What are possible side effects of HEMOFIL M?

• The most common side effects reported during clinical studies with HEMOFIL M include: Factor VIII inhibitors, dizziness, headache, unusual taste, fever, and infusion site inflammation. Tell your healthcare provider about any side effects that bother you or do not go away or if your bleeding does not stop after taking HEMOFIL M.

Please click here for HEMOFIL M full Prescribing Information and discuss with your HCP.

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

What should I tell my HCP before using RECOMBINATE?

Tell your HCP if you:

• Have or have had any medical problems.
• Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
• Have any allergies, including allergies to mouse, hamster, or bovine proteins.
• Are breastfeeding. It is not known if RECOMBINATE passes into your milk and if it can harm your baby.
• Are or become pregnant. It is not known if RECOMBINATE may harm your unborn baby.
• Have been told that you have inhibitors to factor VIII (because RECOMBINATE may not work for you).

What important information do I need to know about RECOMBINATE?

• You could have an allergic reaction to RECOMBINATE. Symptoms of an allergic reaction may include rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, or fainting. If you experience any of these symptoms, stop using RECOMBINATE and call your HCP right away.

What else should I know about RECOMBINATE and Hemophilia A?

• Your body may form inhibitors to factor VIII. An inhibitor is part of the body's normal defense system. If you form inhibitors, it may stop RECOMBINATE from working properly. Talk with your HCP to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

What are possible side effects of RECOMBINATE?

• The most common side effects reported during clinical studies with RECOMBINATE include: chills, flushing, rash, and nose bleeds. Tell your HCP about any side effects that bother you or do not go away or if your bleeding does not stop after taking RECOMBINATE.

Please click here for RECOMBINATE full Prescribing Information and discuss with your HCP.

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

What should I tell my healthcare provider before using RIXUBIS?

You should tell your healthcare provider if you

• have or have had any medical problems
• take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies
• have any allergies, including allergies to hamsters.
• are breastfeeding. It is not known if RIXUBIS passes into your milk and if it can harm your baby
• are pregnant or planning to become pregnantIt is not known if RIXUBIS may harm your unborn baby
• have been told that you have inhibitors to factor IX (because RIXUBIS may not work for you)

What are the possible side effects of RIXUBIS?

Allergic reactions may occur with RIXUBIS. Call your healthcare provider or get emergency treatment right away if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting.

Some common side effects of RIXUBIS were unusual taste in the mouth and limb pain.

Tell your healthcare provider about any side effects that bother you or do not go away.

Your body may form inhibitors to factor IX. An inhibitor is part of the body's defense system. If you form inhibitors, it may stop RIXUBIS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for development of inhibitors to factor IX.

Please click here for RIXUBIS full Prescribing Information and discuss with your HCP.

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

How should I use VONVENDI?

Your first dose of VONVENDI for each bleeding episode may be administered with a recombinant factor VIII as instructed by your healthcare provider.

Your healthcare provider will instruct you whether additional doses of VONVENDI with or without recombinant factor VIII are needed.

What should I tell my healthcare provider before I use VONVENDI?

You should tell your healthcare provider if you:

• Have or have had any medical problems.
• Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
• Have any allergies, including allergies to mice or hamsters.
• Are breastfeeding. It is not known if VONVENDI passes into your milk and if it can harm your baby.
• Are pregnant or planning to become pregnant. It is not known if VONVENDI can harm your unborn baby.
• Have been told that you have inhibitors to von Willebrand factor (because VONVENDI may not work for you).
• Have been told that you have inhibitors to blood coagulation factor VIII.

What else should I know about VONVENDI and von Willebrand Disease?

Your body can form inhibitors to von Willebrand factor or factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop VONVENDI or factor VIII from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to von Willebrand factor or factor VIII.

What are the possible side effects of VONVENDI?

You can have an allergic reaction to VONVENDI.

Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.

Side effects that have been reported with VONVENDI include: headache, nausea, vomiting, tingling or burning at infusion site, chest discomfort, dizziness, joint pain, joint injury, increased liver enzyme level in blood, hot flashes, itching, high blood pressure, muscle twitching, unusual taste, blood clots and increased heart rate.

Tell your healthcare provider about any side effects that bother you or do not go away.

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.

Please see VONVENDI full Prescribing Information.