IS POLLEN GETTING THE BETTER OF YOU?

Transcription

1 For seasonal nasal allergy sufferers 6 years and older IS POLLEN GETTING THE BETTER OF YOU? 35% of allergy sufferers who have tried an over-thecounter allergy medication feel there is room for improvement. Still suffering with a stuffy, runny, itchy nose or sneezing? APPROVED USES DYMISTA is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in people 6 years of age and older, who need treatment with both azelastine hydrochloride and fluticasone propionate. DYMISTA may help to reduce your nasal symptoms including stuffy nose, runny nose, itching, and sneezing. DYMISTA can cause sleepiness or drowsiness. Do not drive, operate machinery, or do anything that needs you to be alert until you know how DYMISTA affects you. Please see additional Important Safety Information on pages 4 and 5 and accompanying Full Prescribing

2 For seasonal nasal allergy sufferers 6 years and older FIGHT BACK WITH DYMISTA! In patients 12 years and older, 3 key clinical studies of total nasal symptom scores showed FOR STUFFY, RUNNY, ITCHY NOSE AND SNEEZING Greater relief vs products you may have tried VS Dymista offers fast and long-acting relief* of stuffy, runny, itchy nose and sneezing * Patients 12 years and older may get relief in as little as 30 minutes. Relief of seasonal nasal symptoms was experienced by patients over the course of a 2-week study. In 3 studies of patients 12 years and older, Dymista provided greater relief of seasonal stuffy, runny, itchy nose and sneezing compared with the same active ingredient you get in Flonase. Relief was measured by the change in nasal symptoms averaged over a 14-day study period. The comparative products used in these clinical trials are not for sale or otherwise available. DYMISTA may cause serious side effects including: Sleepiness or drowsiness Nasal Problems. Symptoms of nasal problems may include: crusting in the nose, nosebleeds, runny nose, hole in the cartilage between your nose (nasal septal perforation). A whistling sound when you breathe may be a symptom of nasal septal perforation. Slow wound healing. You should not use DYMISTA until your nose has healed if you have a sore in your nose, if you have had surgery on your nose, or if your nose has been injured. Do not drink alcohol or take any other medicines that may cause you to feel sleepy while using DYMISTA. It can increase your chances of having serious side effects. 2 Please see additional Important Safety Information on pages 4 and 5 and accompanying Full Prescribing 3

3 DYMISTA can cause sleepiness or drowsiness. Do not drive, operate machinery, or do anything that needs you to be alert until you know how DYMISTA affects you. Do not drink alcohol or take any other medicines that may cause you to feel sleepy while using DYMISTA. It can increase your chances of having serious side effects. DYMISTA may cause serious side effects including: Sleepiness or drowsiness Nasal Problems. Symptoms of nasal problems may include: crusting in the nose, nosebleeds, runny nose, hole in the cartilage between your nose (nasal septal perforation). A whistling sound when you breathe may be a symptom of nasal septal perforation. Slow wound healing. You should not use DYMISTA until your nose has healed if you have a sore in your nose, if you have had surgery on your nose, or if your nose has been injured. Thrush (Candida), a fungal infection in your nose and throat. Tell your healthcare provider if you have any redness or white colored patches in your nose or mouth. Eye problems, such as glaucoma or cataracts. Some people may have eye problems, including glaucoma and cataracts. You should have regular eye exams when using DYMISTA. Immune system problems that may increase your risk of infections. DYMISTA may cause problems with the way your immune system protects your body against infection and increase your risk of infection. Avoid contact with people who have contagious diseases such as chickenpox or measles while you use DYMISTA. Symptoms of infection may include: fever, aches or pains, chills, feeling tired. Adrenal Insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency may include: tiredness, weakness, nausea, vomiting, low blood pressure. 4 Slowed or delayed growth in children. A child s growth should be checked regularly while using DYMISTA. Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above. The most common side effects of DYMISTA include: changes in taste, nosebleeds, and headache. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of DYMISTA. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. DYMISTA and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take: ritonavir (Norvir) or medicines that contain ritonavir (commonly used to treat HIV infection or AIDS) ketoconazole, fluconazole, or itraconazole (for fungal infections) Before using DYMISTA tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if DYMISTA will harm your unborn baby. APPROVED USES DYMISTA is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in people 6 years of age and older, who need treatment with both azelastine hydrochloride and fluticasone propionate. DYMISTA may help to reduce your nasal symptoms including stuffy nose, runny nose, itching, and sneezing. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA Please see accompanying Full Prescribing 5

4 With the same anti-inflammatory as Flonase... DYMISTA CAN COST YOU LESS! Over 7 in 10 patients who used the Dymista Savings Card paid $20 or less Take this card with you to the pharmacy This card can be used to reduce the amount of your out-of-pocket expense up to a maximum of $100 after you pay the first $14 per 30-day prescription. No other purchase is necessary. This offer can be used up to a total of 12 times per calendar year through December 31, 2017, with a benefit cap of $1,200 per calendar year. See reverse side of this card for full terms and conditions. Source: TrialCard redemptions data, 01/01/ /31/2016. Pay as little as $14* for Dymista on each 30-day supply, with a maximum benefit of $100. *If you re like most eligible patients with commercial health insurance, you ll pay no more than that with the Dymista Savings Card. Flonase and Dymista may not be comparable in terms of efficacy and safety. * Eligibility restrictions apply. Not valid for patients enrolled in federal or state healthcare programs, such as Medicare, Medicaid, and TriCare, and not valid for uninsured patients (but may be used by commercially insured patients without coverage for Dymista). See complete Terms and Conditions on reverse side. 6 7

5 Full Terms and Conditions This SAVINGS card can be used to reduce the amount of your out-of-pocket expense up to a maximum of $100 after you pay the first $14 per 30 day prescription. No other purchase is necessary. This offer can be used up to a total of 12 times per calendar year through December 31, 2017, with a benefit cap of $1,200 per calendar year. Valid prescription with Prescriber ID# required. Eligibility Requirements: This SAVINGS card can be redeemed only by patients or patient guardians who are 18 years of age or older and who are residents of the United States and its territories. Patients must have commercial insurance. Not valid for uninsured patients (but may be used by commercially insured patients without coverage for Dymista) and patients who are covered by any state or federally funded healthcare program, including but not limited to any state pharmaceutical assistance program, Medicare (Part D or otherwise), Medicaid, Medigap, VA or DOD, or TriCare (regardless of whether Dymista is covered by such government program); not valid if the patient is Medicare eligible and enrolled in an employer-sponsored health plan or prescription benefit program for retirees; and not valid if the patient s insurance plan is paying the entire cost of this prescription. Void outside the US and its territories or where prohibited by law, taxed, or restricted. This program is valid in Massachusetts through June 30, 2019, unless otherwise amended or extended by Massachusetts. This SAVINGS card is not health insurance. The SAVINGS card is not transferable and the amount of the benefit cannot exceed the patient s out-of-pocket expenses. Cannot be combined with any other rebate/ coupon, free trial, or similar offer for the specified prescription. This SAVINGS card is not redeemable for cash. Mylan Specialty reserves the right to amend or end this program at any time without notice. NOTICE: Data related to your use of this SAVINGS card may be collected, analyzed and shared with Mylan Specialty for market research and other purposes related to assessing coupon programs. Data shared with Mylan Specialty will be aggregated and de-identified, meaning it will be combined with data related to other SAVINGS card redemptions and will not identify you. Patient Instructions: Present your SAVINGS card and prescription drug insurance card, along with a valid prescription for Dymista. By using this SAVINGS card, you acknowledge that you currently meet the eligibility criteria and that you understand and will comply with the following additional terms and conditions: You have not submitted and will not submit a claim for reimbursement under any federal, state or other governmental programs for this prescription. Your acceptance of this offer must be consistent with the terms of any drug benefit provided by your health insurer. You agree to report the use of this SAVINGS card to your insurer if required. Pharmacist Instructions: When you accept this SAVINGS card, you are certifying that you have received this SAVINGS card from an eligible patient; you have dispensed the product as indicated; you have not submitted and will not submit a claim for reimbursement under any federal, state or other governmental programs for this prescription; and you will otherwise comply with these terms and all applicable terms and conditions. You further certify that your participation in this program is consistent with all applicable state laws and any obligations, contractual or otherwise, that you have as a pharmacy provider, and that you will report the use of this SAVINGS card to the patient s insurer if required. Submit transaction to McKesson Corporation using BIN # Patient must have primary coverage. Input SAVINGS card information as secondary coverage and transmit using the COB segment of the NCPDP transaction. Applicable discounts will be displayed in the transaction response. Acceptance of this SAVINGS card and your submission of claims for the Dymista program are subject to the Mylan Specialty SAVINGS card Terms and Conditions posted at copay-relief. Acceptance of this SAVINGS card and your submission of claims for the Dymista program are subject to the LoyaltyScript program Terms and Conditions posted at For questions regarding setup, claim transmission, patient eligibility or other issues, call the LoyaltyScript for Dymista program at (8:00 AM-8:00 PM ET, Monday Friday). For more reasons to ask for Dymista, visit DYMISTA.COM Please see Important Safety Information on pages 4 and 5 and accompanying Full Prescribing Information and Patient Information. Flonase is a registered trademark of Glaxo Group Limited. Dymista is a registered trademark of Meda Pharmaceuticals Inc., a Mylan Company. The Mylan logo is a registered trademark of Mylan Inc. LoyaltyScript is a registered trademark of McKesson Corporation Mylan Specialty L.P. All rights reserved. 6/17 DYM