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Important Safety Information | | | Prescribing Information
NovoSeven® RT is used to treat bleeding episodes in people with hemophilia A or B with inhibitors, congenital Factor VII deficiency, Glanzmann’s thrombasthenia with resistance to platelets, and acquired hemophilia.
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Selected Important Safety Information
What is the most important information I should know about NovoSeven® RT?
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
Please click here or scroll below for additional Important Safety Information.
Features of NovoSeven® RT.
If platelets don't work for you, NovoSeven® RT may be right for treating your GT-related bleeds.
Quick to mix with a prefilled syringe
Fast and effective bleed control for bleeding episodes and surgery
Established safety profile that comes from years of experience
The support you need, when you need it.
We offer co-pay support,a free trial prescriptions,b and patient assistance through NovoSecure™ to those who are eligible. Sign up on NovoSecure™ to stay up to date on how we can help.
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aPay as little as $0 per fill for up to 12 months from the date of Savings Card activation, subject to a maximum savings of $12,000 per calendar year. In order to redeem this offer patient must have a valid prescription for the brand being filled. A valid Prescriber ID# is required on the prescription. Patient is not eligible if he/she participates in or seeks reimbursement or submits a claim for reimbursement to any federal or state healthcare program with prescription drug coverage, such as Medicaid, Medicare, Medigap, VA, DOD, TRICARE, or any similar federal or state health care program (each a Government Program), or where prohibited by law. Patient must be enrolled in, and must seek reimbursement from or submit a claim for reimbursement to, a commercial insurance plan. The brand and the prescription being filled must be covered by the patient's commercial insurance plan. Offer excludes full cash-paying patients. This offer may not be redeemed for cash. By using this offer, you are certifying that you meet the eligibility criteria and will comply with the terms and conditions described herein and will not seek reimbursement for any benefit received through this card. Novo Nordisk's Eligibility and Restrictions, and Offer Details may change from time to time. Re-confirmation of information may be requested periodically to ensure accuracy of data and compliance with terms. bPatients who have been prescribed a Novo Nordisk hemophilia and rare bleeding disorder product for an FDA-approved indication, and who have commercial insurance, may be eligible to receive a limited supply of free product. Patient is not eligible if he/she participates in or seeks reimbursement or submits a claim for reimbursement to any federal or state healthcare program with prescription drug coverage, such as Medicaid, Medicare, Medigap, VA, DOD, TRICARE, or any similar federal or state health care program. Product is provided at no cost to the patient or the HCP, is not contingent on any product purchase, and the patient and HCP must not: (1) bill any third party for the free product, or (2) resell the free product.
What is NovoSeven® RT?
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
Important Safety Information (cont’d)
| • | 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
What should I tell my healthcare provider before using NovoSeven® RT?
| • | 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
What are the possible side effects of NovoSeven® RT?
| • | 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 click here for 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.
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NovoSeven® is a registered trademark of Novo Nordisk Health Care AG. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2020 Novo Nordisk All rights reserved. US19NSVN00138 September 2020 |