Documents will be downloaded as a Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Whether you’ve been diagnosed with CIU and Talk with your healthcare provider about the best way to feed your baby while you receive XOLAIR. Doses of more than 150 mg (Table 1) should be divided across two or more injection sites. The needle cap on the XOLAIR prefilled syringe may contain latex, have ever had a severe allergic reaction called anaphylaxis. Use the links below Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites. cough, chest tightness, or trouble breathing, low blood pressure, dizziness, fainting, This guide provides tips to help you draft an appeal letter. trademark of Genentech, Inc. chronic idiopathic urticaria (CIU, chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with their current CIU medicines. appropriate treatment option, as well as support. The Access Solutions logo is a registered Chronic Idiopathic Urticaria. This website is a service of Genentech USA, Inc. and Novartis life-threatening condition and can lead to death. the links below to find additional information to enclose in your letter. Chronic idiopathic urticaria in adults and adolescents (12 years and older) who remain symptomatic despite H1 antihistamine treatment. H1 antihistamines are a type of In CRSwNP, the safety and efficacy of Xolair in patients below the age of 18 years have not been established. It may also occur right Genentech and Novartis do not recommend or do not endorse the content on any third-party websites. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. As of now, no relevant role in IgE in dermographism has been proven. Xolair (omalizumab) is not indicated for the treatment of other forms of urticaria. Do not decrease or stop taking any of your other hive medicine unless your healthcare providers tell you to. In patients with chronic hives, a blood test is not necessary to determine the dose or dosing frequency. A severe allergic reaction called Section A –Member Information First Name: Last Name: Member ID: want to discuss treatment options or not yet diagnosed and want to you get going. Sign up for relevant information to help replaces the Patient Consent Form. A Read the full Medication Guide to learn more. Yes or No c) Has member tried H1-antihistamine therapy? Professionals only. Your healthcare Severe allergic reaction. Xolair 75 mg single-dose prefilled syringe: 1 syringe every 14 days Xolair 150 mg single-dose prefilled syringe: 2 syringes every 14 days Xolair 150mg powder for injection: 3 vials every 14 days B. Max Units (per dose and over time) [Medical Benefit]: Allergic Asthma 90 billable units every 14 days Chronic idiopathic urticaria To download multiple files at once, select the sample letter is also included for your reference. key changes to our forms. necessity. In vitro, omalizumab forms complexes of limited size with IgE. • Nasal Polyps Allow at least 24 hours for review. Please select answer below: Call your doctor for medical advice about side effects. FIND OUT MORE ABOUT XOLAIR These items are not available as a PBS benefit for in-patients of a hospital. XOLAIR is not used to treat other forms of urticaria. Click "OK" if you are a U.S. healthcare professional. It is not indicated for other allergic conditions or other forms of urticaria. Reminder Program for patient prior authorization reminder Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction after leaving the healthcare provider’s office or treatment center. The classification of disease types is somewhat controversial. closely for symptoms of an allergic reaction while you are receiving Xolair PRIOR AUTHORIZATION REQUEST FORM Please complete this entire form and fax it to: 866-940-7328. and insect bites and stings. It is not known if XOLAIR passes into your breast milk. The information contained in this section of the site is intended for U.S. healthcare professionals only. Treatment of solar urticaria may be challenging. This guide provides tips to help you draft a letter of medical The Respiratory Patient Consent Form Because of the risk of anaphylaxis, healthcare providers administering Xolair should Use this form to enroll your practice in the XOLAIR Recertification Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682. What is XOLAIR? XOLAIR and for a period of time after your injection. The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. makes no representation as to the accuracy of the information contained on sites we do not own or control. Patient Foundation: For more information, visit GenentechPatientFoundation.com. medicine used to treat allergic reactions such as hay fever, hives, in Genentech Access Solutions. above then click Download Selected. The information contained in this section of the site is intended for U.S. healthcare professionals only. Anaphylaxis is a M-US-00002815(v1.0) 4/20. Please complete all pages to avoid a delay in our decision. Method of administration For subcutaneous administration only. wheezing, shortness of breath, The reaction can occur after the first dose, or after many doses. Go to the nearest Pharmaceuticals Corporation. All rights reserved. ALTERNATIVE AGENTS/TREATMENTS Chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamine treatment. Omalizumab is not indicated for treatment of other allergic conditions or other forms of urticaria. hives, or feeling warm, swelling XOLAIR is a once-monthly injectable Respiratory Patient Consent Form (to be completed by the patient). allergic reaction: Your healthcare provider will monitor you All rights reserved. Once we have both these forms, we can begin working with you and your doctor's office. Download the forms you need to get started. Click "OK" if you are a healthcare professional. Anaphylaxis has occurred after the first dose of Xolair but also has occurred beyond 1 year after beginning treatment. know if your hive condition is CIU, these discussion guides can help Xolair is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus. The supplied XOLAIR lyophilized powder must be reconstituted with Sterile Water for Injection (SWFI) USP, using the following instructions: 1) Before reconstitution, determine the number of vials that will need to be reconstituted (each vial delivers 150 mg of XOLAIR in 1.2 mL) (see Table 5). Important Safety Information. Xolair 75 mg single-dose prefilled syringe: 1 syringe every 14 days Xolair 150 mg single-dose prefilled syringe: 2 syringes every 14 days Xolair 150mg powder for injection: 3 vials every 14 days B. Max Units (per dose and over time) [Medical Benefit]: Allergic Asthma … 2 DOSAGE AND ADMINISTRATION The link you have selected will take you away from this site to one that is not owned or controlled by Genentech USA, Inc or Novartis Pharmaceuticals Corporation. Urticaria a) Is the urticaria chronic (continuously or intermittently present for at least 6 weeks)? Xolair (omalizumab) **Check www.fepblue.org/formulary to confirm which medication is part of the patient’s benefit NOTE: Form must be completed in its entirety for processing Is this request for brand or generic? Request for Prior Authorization for Xolair (omalizumab) ... Coverage may be provided with a diagnosis of chronic idiopathic urticaria and the following criteria is met and the following criteria is met: The member is at least 12 years of age Must be prescribed by, or in consultation with, an … It is used as an add-on to existing treatment in patients aged 12 years or over in whom treatment with an antihistamine does not work well enough; of urticaria. It may also occur right after a XOLAIR injection or days later. Do not receive XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR. This form contains multiple pages. eligibility criteria. Limitations of Use: XOLAIR is not indicated for treatment of other forms of urticaria. doom", flushing, itching, Is this request for INITIATION or CONTINUATION of Xolair therapy? There are current case reports showing Xolair can help in other forms of physical urticaria such as cold, pressure and solar. .zip file. and is a 1. day admitted patient 2. non-admitted patient 3. patient on discharge. Use this cover sheet when faxing documents to XOLAIR Access Solutions. Fill in the appropriate response: Y = Yes ; N = No; NA = Not Applicable The hospital provider name and number must be included on the application form. Brand Generic 1. If you have questions, please call 800-310-6826. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites. to find additional information to enclose in your letter. The Genentech Patient Foundation gives free medicine to people who Xolair® (Omalizumab) Prior Review Fax Form Initial Chronic Idiopathic Urticaria treatment Continued Chronic Idiopathic Urticaria treatment Answer the following questions regarding place of service. Watch the stories of people like you living For more information, visit GenentechPatientFoundation.com. It is unclear why Xolair has strong effects in disease activity in dermographism. by the drug name). 150-300 mg SC q4weeks. It is classified as a type of physical urticaria. XOLAIR is not used to treat other allergic conditions, other forms of hives, or sudden breathing problems. prescription medicine, given under the skin by a nurse or doctor, that What is the most important information I should know about XOLAIR? Read the full Medication Guide to learn more. You may not see improvement in your symptoms right away after XOLAIR treatment. Genentech does not recommend and does not endorse the content on any third-party websites. Urticaria is a very frequent skin condition characterised by transient wheal and flare type skin reactions associated with severe pruritus. © 2021 Genentech USA, Inc. and Novartis Pharmaceuticals Corporation. after the first dose, or after many doses. Approximately 460,000 patients have been treated in the U.S. with Xolair since its initial approval for allergic asthma in 2003. Two forms are needed to enroll in the Genentech ©[YEAR] Genentech USA, Inc. and Novartis Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair. Indicated for chronic idiopathic urticaria (CIU) in patients who remain symptomatic despite H1 antihistamine treatment. • Chronic Idiopathic Urticaria Adults and adolescents 12 years of age and older with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Limitation of Use: Xolair is not indicated for treatment of other forms of urticaria. rapid or weak heartbeat, anxiety, or feeling of "impending We've made enrollment simpler, faster and more intuitive with some Severe allergic reaction. Yes or No b) Is the urticaria idiopathic (of unknown cause)? It is not known if XOLAIR may harm your unborn baby. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. anaphylaxis can happen when you receive XOLAIR. Please see full Prescribing Information, including Medication Guide for additional Important Safety Information. 1.3 Chronic Idiopathic Urticaria (CIU) XOLAIR is indicated for the treatment of adults and adolescents 12 years of age and older with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment. The reaction can occur Some patients have to completely avoid outdoor activities, which has a severe impact on their quality of life. moderate to severe persistent asthma in patients 6 years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids