Need more information on your Novo Nordisk bleeding disorder medication?

NovoSeven^® RT may cause serious side effects, including:

• Serious blood clots that form in veins and arteries with the use of NovoSeven^® RT have been reported
• Your healthcare provider should discuss the risks and explain the signs and symptoms of blood clots to you. Some signs of a blood clot may include pain, swelling, warmth, redness, or a lump in your legs or arms, chest pain, shortness of breath, or sudden severe headache and/or loss of consciousness or function
• Your healthcare provider should monitor you for blood clots during treatment with NovoSeven^® RT
• You should not use NovoSeven^® RT if you have ever had allergic (hypersensitivity) reactions, including severe, whole body reactions (anaphylaxis) to NovoSeven^® RT, any of its ingredients, or mice, hamsters, or cows. Signs of allergic reaction include shortness of breath, rash, itching (pruritus), redness of the skin (erythema), or fainting/dizziness

NovoSeven^® RT (coagulation Factor VIIa, recombinant) is an injectable medicine used for:

• Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with a decreased or absent response to platelet transfusions
• Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults with acquired hemophilia

• Tell your healthcare provider if you have any of the following, as these may increase your risk of blood clots:
  • congenital hemophilia and are also receiving treatment with aPCCs (activated prothrombin complex concentrates)
  • are an older patient particularly with acquired hemophilia and receiving other agents to stop bleeding
  • history of heart or blood vessel diseases
• Tell your healthcare provider and pharmacist about all the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies

• The most common and serious side effects are blood clots
• Tell your healthcare provider about any side effects that bother you or do not go away, and seek medical help right away if you have signs of a blood clot or allergic reaction

Please see Prescribing Information for NovoSeven^® RT.

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.

Alhemo^® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors.

• It is not known if Alhemo^® is safe and effective in people receiving ongoing immune tolerance induction (ITI)
• It is not known if Alhemo^® is safe and effective for hemophilia A and B with and without inhibitors in children younger than 12 years of age

• It is important to follow the daily dosing schedule of Alhemo^® to stay protected against bleeding. This is especially important during the first 4 weeks of treatment to make sure a correct maintenance dose is established. Use Alhemo^® exactly as prescribed by your healthcare provider (HCP). Do not stop using Alhemo^® without talking to your HCP. If you miss doses or stop using Alhemo^®, you may no longer be protected against bleeding
• Your HCP may prescribe bypassing agents during treatment with Alhemo^®. Carefully follow your HCP’s instructions regarding when to use on-demand bypassing agents, and the recommended dose and schedule for breakthrough bleeds

Do not use Alhemo^® if you are allergic to concizumab-mtci or any of the ingredients in Alhemo^®.

• Have a planned surgery. Your HCP may stop treatment with Alhemo^® before your surgery. Talk to your HCP about when to stop using Alhemo^® and when to start it again if you have a planned surgery
• Are pregnant or plan to become pregnant. It is not known if Alhemo^® may harm your unborn baby
  Females who are able to become pregnant    
  • Your HCP may do a pregnancy test before you start treatment with Alhemo^®
  • You should use an effective birth control (contraception) method during treatment with Alhemo^® and for 7 weeks after ending treatment. Talk to your HCP about birth control methods that you can use during this time
• Are breastfeeding or plan to breastfeed. It is not known if Alhemo^® passes into your breast milk. Talk to your HCP about the best way to feed your baby during treatment with Alhemo^®

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your HCP and pharmacist when you get a new medicine.

• Change (rotate) your injection site with each injection. Do not use the same site for each injection
• To determine the right maintenance dose for you, your HCP will do a blood test to check the amount of Alhemo^® in your blood. Your HCP may do additional blood tests during treatment with Alhemo^®
• Do not share your Alhemo^® pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them
• If you miss a dose of Alhemo^® during the first 4 weeks of treatment, contact your HCP right away. Your HCP will tell you how much Alhemo^® to inject

Alhemo^® may cause serious side effects, including:

• Blood clots (thromboembolic events). Alhemo^® may cause blood clots to form in blood vessels, such as in your arms, legs, heart, lung, brain, eyes, kidneys, or stomach. You may be at risk for getting blood clots during treatment with Alhemo^® if you use high or frequent doses of factor products or bypassing agents to treat breakthrough bleeds, or if you have certain conditions. Get medical help right away if you have any signs and symptoms of blood clots, including: swelling, warmth, pain, or redness of the skin; headache; trouble speaking or moving; eye pain or swelling; sudden pain in your stomach or lower back area; feeling short of breath or severe chest pain; confusion; numbness in your face; and problems with your vision
• Allergic reactions. Alhemo^® can cause allergic reactions, including redness of the skin, rash, hives, itching, and stomach-area (abdominal) pain. Stop using Alhemo^® and get emergency medical help right away if you develop any signs or symptoms of a severe allergic reaction, including: itching on large areas of skin; trouble swallowing; wheezing; pale and cold skin; dizziness due to low blood pressure; redness or swelling of lips, tongue, face, or hands; shortness of breath; tightness of the chest; and fast heartbeat

The most common side effects of Alhemo^® include: bruising, redness, bleeding, or itching at the site of injection, and hives.

Please see Prescribing Information and Medication Guide for Alhemo^®.

Alhemo^® is a prescription medication.

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.

Esperoct^® [antihemophilic factor (recombinant), glycopegylated-exei] is an injectable medicine used to treat and prevent or reduce the number of bleeding episodes in people with hemophilia A. Your healthcare provider may give you Esperoct^® when you have surgery

• Esperoct^® is not used to treat von Willebrand Disease

• You should not use Esperoct^® if you are allergic to factor VIII or any of the other ingredients of Esperoct^® or if you are allergic to hamster proteins

• Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center
• Call your healthcare provider right away or get emergency treatment right away if you get any signs of an allergic reaction, such as: hives, chest tightness, wheezing, dizziness, difficulty breathing, and/or swelling of the face

• Before taking Esperoct^®, you should tell your healthcare provider if you have or have had any medical conditions, take any medicines (including non-prescription medicines and dietary supplements), are nursing, pregnant or planning to become pregnant, or have been told that you have inhibitors to factor VIII
• Your body can make antibodies called “inhibitors” against Esperoct^®, which may stop Esperoct^® from working properly. Call your healthcare provider right away if your bleeding does not stop after taking Esperoct^®

• Common side effects of Esperoct^® include rash or itching, and swelling, pain, rash or redness at the location of infusion

Please see Prescribing Information for Esperoct^®.

Esperoct^® is a prescription medication.

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.

Novoeight^® (antihemophilic factor, recombinant) is an injectable medicine used to control and prevent bleeding in people with hemophilia A. Your healthcare provider may give you Novoeight^® when you have surgery

• Novoeight^® is not used to treat von Willebrand Disease

• You should not use Novoeight^® if you are allergic to factor VIII or any of the other ingredients of Novoeight^® or if you are allergic to hamster proteins

• Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center
• Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction: rashes or hives, difficulty breathing or swallowing, tightness of the chest, swelling of the lips and tongue, light-headedness, dizziness or loss of consciousness, pale and cold skin, fast heartbeat, or red or swollen face or hands

• Before taking Novoeight^®, you should tell your healthcare provider if you have or have had any medical conditions, take any medicines (including non-prescription medicines and dietary supplements), are nursing, pregnant or planning to become pregnant, or have been told that you have inhibitors to factor VIII
• Your body can make antibodies called “inhibitors” against Novoeight^®, which may stop Novoeight^® from working properly. Call your healthcare provider right away if your bleeding does not stop after taking Novoeight^®

• Common side effects of Novoeight^® include inhibitors in patients who were not previously treated with factor VIII products, swelling or itching at the location of injection, and fever

Please see Prescribing Information for Novoeight^®.

Novoeight^® is a prescription medication.

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.

Rebinyn^®, Coagulation Factor IX (Recombinant), GlycoPEGylated is an injectable medicine used to replace clotting Factor IX that is missing in patients with hemophilia B. Rebinyn^® is used to treat, prevent, or reduce the frequency (number) of bleeding episodes in people with hemophilia B. Your healthcare provider may give you Rebinyn^® when you have surgery. Rebinyn^® is not used for immune tolerance therapy.

• Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center. Carefully follow your healthcare provider’s instructions regarding the dose and schedule for infusing Rebinyn^®.

Do not use Rebinyn^® if you:

• are allergic to Factor IX or any of the other ingredients of Rebinyn^®.
• are allergic to hamster proteins.

Tell your healthcare provider if you:

• have or have had any medical conditions.
• take any medicines, including non-prescription medicines and dietary supplements.
• are nursing, pregnant, or plan to become pregnant.
• have been told you have inhibitors to Factor IX.

• Rebinyn^® is given as an infusion into the vein.
• Call your healthcare provider right away if your bleeding does not stop after taking Rebinyn^®.
• Do not stop using Rebinyn^® without consulting your healthcare provider.

• Common side effects include infusion site reaction (bruising, bleeding, swelling, pain, or redness), itching, and rash.
• Your body can also make antibodies called “inhibitors” against Factor IX, including Rebinyn^®, which may stop Rebinyn^® from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time.
• Call your healthcare provider right away or get emergency treatment right away if you get, for example, any of the following signs of an allergic reaction: hives, chest tightness, wheezing, difficulty breathing, and/or swelling of the face.
• You may be at an increased risk of forming blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider if you have chest pain, difficulty breathing, leg tenderness, or swelling.
• Animals given repeat doses of Rebinyn^® showed Polyethylene Glycol (PEG) in certain cells in the brain. The potential human implications of these animal tests are unknown.

Please see Prescribing Information for Rebinyn^®.

Rebinyn^® is a prescription medication.

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.

• Tretten^® (Coagulation Factor XIII A-Subunit [Recombinant]) is an injectable medicine used to prevent bleeding in adults and children who have congenital Factor XIII (FXIII) A-subunit deficiency.
• Tretten^® is not for use in patients with congenital Factor XIII B-subunit deficiency.

• You should not use Tretten^® if you have ever had allergic (hypersensitivity) reactions, including severe, whole body reaction (anaphylaxis) to Tretten^® or any of the ingredients.

• Tell your healthcare provider about all of your medical conditions, including if you are pregnant, think you may be pregnant or planning to become pregnant, are breast feeding, or have a history of blood clots.
• Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.

• Call your healthcare provider or go to the emergency department right away if you have any of the following symptoms after using Tretten^®:
  • Signs of allergic reaction, including shortness of breath, rash, itching (pruritus), redness of the skin (erythema), or fainting/dizziness.
  • Signs of a blood clot including pain, swelling, warmth, redness, or a lump in your legs or arms, chest pain, or sudden severe headache and/or loss of consciousness or function.
  • Unexpected bleeding.
• Other possible side effects may include pain in your arms or legs, headache, and pain at the injection site.
• These are not all the possible side effects of Tretten^®. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Please see Prescribing Information for Tretten^®.

Tretten^® is a prescription medication.

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.