provider should talk to you about getting medical treatment if you Call your doctor for medical advice about side effects. XOLAIR and for a period of time after your injection. and is a 1. day admitted patient 2. non-admitted patient 3. patient on discharge. rapid or weak heartbeat, anxiety, or feeling of "impending Is this request for INITIATION or CONTINUATION of Xolair therapy? Yes or No c) Has member tried H1-antihistamine therapy? The Access Solutions logo is a registered To download multiple files at once, select the Anaphylaxis has occurred as early as after the first dose of Xolair, but also has occurred beyond 1 year after beginning regularly administered treatment. Sign up for relevant information to help Some patients have to completely avoid outdoor activities, which has a severe impact on their quality of life. This site is intended for U.S. residents only. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682. A severe allergic reaction called the links below to find additional information to enclose in your letter. As of now, no relevant role in IgE in dermographism has been proven. Click "OK" if you are a healthcare professional. This item is only available to a patient who is attending: 1. an approved private hospital 2. a public participating hospital 3. a public hospital. DOSAGE AND ADMINISTRATION 2.1 Documents will be downloaded as a Limitation of Use: Xolair is not indicated for treatment of other forms of urticaria. Xolair is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus. The classification of disease types is somewhat controversial. Xolair® (Omalizumab) Prior Review Fax Form Initial Chronic Idiopathic Urticaria treatment Continued Chronic Idiopathic Urticaria treatment Answer the following questions regarding place of service. Go to the nearest XOLAIR is not used to treat other forms of urticaria. In vitro, omalizumab forms complexes of limited size with IgE. know if your hive condition is CIU, these discussion guides can help The Genentech Patient Foundation gives free medicine to people who trademark of Genentech, Inc. Solar urticaria (SU) is a rare condition in which exposure to ultraviolet or UV radiation, or sometimes even visible light, induces a case of urticaria or hives that can appear in both covered and uncovered areas of the skin. ©[YEAR] Genentech USA, Inc. and Novartis Xolair is not used to treat other allergic conditions, other forms of … Select a disease state for Rituxan® (rituximab). This form contains multiple pages. Learn more about their journey from diagnosis to finding an Sign a printed form, take a photo and text it to (650) 877-1111 Sign a printed form and fax or mail it to us (or give it to your doctor's office to do so) Your doctor also has to fill out a form called the Prescriber Service Form. Chronic Idiopathic Urticaria. XOLAIR should be given by your healthcare provider, in a healthcare setting. 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 Yes Or No - If Yes, please provide drug name _____ .zip file. The information contained in this section of the site is intended for U.S. healthcare professionals only. This website is a service of Genentech USA, Inc. and Novartis wheezing, shortness of breath, Xolair is also approved for chronic idiopathic urticaria in adults and adolescents (12 years of age and above) who remain symptomatic despite H. 1. antihistamine treatment. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. All rights reserved. Please see full Prescribing Information, including Medication Guide for additional Important Safety Information. XOLAIR is not used to treat other allergic conditions, other forms of hives, or sudden breathing problems. There are current case reports showing Xolair can help in other forms of physical urticaria such as cold, pressure and solar. Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. in Genentech Access Solutions. Chronic idiopathic urticaria in adults and adolescents (12 years and older) who remain symptomatic despite H1 antihistamine treatment. to find additional information to enclose in your letter. The reaction can occur after the first dose, or after many doses. Respiratory Patient Consent Form are required for enrollment Do not receive XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR. closely for symptoms of an allergic reaction while you are receiving What is the most important information I should know about XOLAIR? Dosing in CIU patients is not dependent on serum IgE level or body weight. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. XOLAIR is a once-monthly injectable Published online: March 20, 2018. hives, or feeling warm, swelling Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. FIND OUT MORE ABOUT XOLAIR Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites. eligibility criteria. Approximately 460,000 patients have been treated in the U.S. with Xolair since its initial approval for allergic asthma in 2003. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after your injection. 2 DOSAGE AND ADMINISTRATION swallowing, wheezing, shortness of breath, cough, chest tightness, or trouble breathing, low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”, flushing, itching, hives, or feeling warm, swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing, have a latex allergy. XOLAIR is not used to treat other forms of urticaria. Once we have both these forms, we can begin working with you and your doctor's office. Your healthcare checkbox next to each file you would like to download from the list What is XOLAIR? 2) replaces the Patient Consent Form. 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 … XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 4 weeks. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. If you have questions, please call 800-310-6826. key changes to our forms. by the drug name). This guide provides tips to help you draft an appeal letter. don't have insurance or who have financial concerns and meet It is not known if XOLAIR passes into your breast milk. 150-300 mg SC q4weeks. Two forms are needed to enroll in the Genentech 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; 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. The Prescriber Service Form and the anaphylaxis can happen when you receive XOLAIR. ALTERNATIVE AGENTS/TREATMENTS Two forms are needed to enroll in the Genentech Patient Foundation: Prescriber Foundation Form (to be completed by the health care provider). you get going. Read the full Medication Guide to learn more. Anaphylaxis has occurred after the first dose of Xolair but also has occurred beyond 1 year after beginning treatment. 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. Do not decrease or stop taking any of your other hive medicine unless your healthcare providers tell you to. sample letter is also included for your reference. Genentech does not recommend and does not endorse the content on any third-party websites. XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment. Professionals only. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites. All rights reserved. Urticaria is a very frequent skin condition characterised by transient wheal and flare type skin reactions associated with severe pruritus. life-threatening condition and can lead to death. These are not all the possible side effects of XOLAIR. • Chronic Idiopathic Urticaria Adults and adolescents 12 years of age and older with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment. 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 … notifications. XOLAIR is not used to treat other allergic conditions, other forms of hives, or sudden breathing problems. 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. Please select answer below: Download the forms you need to get started. Click "OK" if you are a U.S. healthcare professional. appropriate treatment option, as well as support. Read the full Medication Guide to learn more. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. Talk with your healthcare provider about the best way to feed your baby while you receive XOLAIR. https://www.verywellhealth.com/xolair-for-the-treatment-of-chronic-hives-83243 treats CIU in patients 12 years of age and older who are not Chronic Idiopathic Urticaria (CIU) Xolair is indicated for the treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment. You may not see improvement in your symptoms right away after XOLAIR treatment. Xolair is also used to treat: chronic (long-term) spontaneous urticaria (itchy rash). 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. A sample letter is also included for your reference. Chronic spontaneous urticaria (CSU) Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment. medicine used to treat allergic reactions such as hay fever, hives, In patients with chronic hives, a blood test is not necessary to determine the dose or dosing frequency. It may also occur right after a XOLAIR injection or days later. Solar urticaria is a rare inducible (physical) urticaria caused by exposure to light. Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair. Urticaria a) Is the urticaria chronic (continuously or intermittently present for at least 6 weeks)? This guide provides tips to help you draft a letter of medical Use this form to enroll your practice in the XOLAIR Recertification Xolair PRIOR AUTHORIZATION REQUEST FORM Please complete this entire form and fax it to: 866-940-7328. Xolair (omalizumab) is not indicated for the treatment of other forms of urticaria. start the conversation between you and your specialist. provider’s office or treatment center. above then click Download Selected. Use this cover sheet when faxing documents to XOLAIR Access Solutions. Referrals to Independent Co-pay Assistance Foundations, Referrals to the Genentech Patient Foundation, Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk), PHESGO™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf), PULMOZYME® (dornase alfa) Inhalation Solution, RITUXAN HYCELA® (rituximab/hyaluronidase human), XOLAIR® (omalizumab) for subcutaneous use, Rituxan® (rituximab) for Rheumatoid Arthritis (RA), Rituxan® (rituximab) for Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), Rituxan® (rituximab) for Pemphigus Vulgaris (PV), Formulario de Consentimiento del Paciente Respiratorio. Section A –Member Information First Name: Last Name: Member ID: It is unclear why Xolair has strong effects in disease activity in dermographism. Whether you’ve been diagnosed with CIU and emergency room right away if you have any of these symptoms of an Patient Foundation: For more information, visit GenentechPatientFoundation.com. H1 antihistamines are a type of medicine used to treat allergic reactions such as hay fever, hives, and insect bites and stings. after a XOLAIR injection or days later. Pharmaceuticals Corporation. Severe allergic reaction. The information contained in this section of the site is intended for U.S. healthcare professionals only. with CIU. It is not indicated for other allergic conditions or other forms of urticaria. necessity. We've made enrollment simpler, faster and more intuitive with some prescription medicine, given under the skin by a nurse or doctor, that Genentech and Novartis do not recommend or do not endorse the content on any third-party websites. Limitations of Use: XOLAIR is not indicated for treatment of other forms of urticaria. In CRSwNP, the safety and efficacy of Xolair in patients below the age of 18 years have not been established. Pharmaceuticals Corporation and is intended for U.S. Healthcare The Respiratory Patient Consent Form Xolair must not be administered by the intravenous or intramuscular route. are breastfeeding or plan to breastfeed. 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). Genentech USA, Inc. and Novartis Pharmaceuticals Corporation make no representation as to the accuracy of the information contained on sites we do not own or control. are pregnant or plan to become pregnant. It is classified as a type of physical urticaria. Method of administration For subcutaneous administration only. allergic reaction: Your healthcare provider will monitor you These items are not available as a PBS benefit for in-patients of a hospital. A 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. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair. Allow at least 24 hours for review. want to discuss treatment options or not yet diagnosed and want to FDA approval letter (Follow this link and search Yes or No b) Is the urticaria idiopathic (of unknown cause)? 2 . Please complete all pages to avoid a delay in our decision. Watch the stories of people like you living of the throat or tongue, throat tightness, hoarse voice, or trouble Doses of more than 150 mg (Table 1) should be divided across two or more injection sites. H1 antihistamines are a type of The hospital provider name and number must be included on the application form. doom", flushing, itching, of urticaria. and insect bites and stings. Indicated for chronic idiopathic urticaria (CIU) in patients who remain symptomatic despite H1 antihistamine treatment. Use cough, chest tightness, or trouble breathing, low blood pressure, dizziness, fainting, © 2021 Genentech USA, Inc. and Novartis Pharmaceuticals Corporation. Anaphylaxis is a life-threatening condition and can lead to death. 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. For more information, visit GenentechPatientFoundation.com. Reminder Program for patient prior authorization reminder Treatment of solar urticaria may be challenging. Use the links below controlled by H1 antihistamines. Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Respiratory Patient Consent Form (to be completed by the patient). Fill in the appropriate response: Y = Yes ; N = No; NA = Not Applicable • Nasal Polyps M-US-00002815(v1.0) 4/20. It may also occur right 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 Because of the risk of anaphylaxis, healthcare providers administering Xolair should XOLAIR is not used to treat other forms The needle cap on the XOLAIR prefilled syringe may contain latex, have ever had a severe allergic reaction called anaphylaxis. Anaphylaxis is a Omalizumab is not indicated for treatment of other allergic conditions or other forms of urticaria. after the first dose, or after many doses. have symptoms of an allergic reaction after leaving the healthcare Brand Generic 1. Important Safety Information. The reaction can occur 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? Severe allergic reaction. 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. It is not known if XOLAIR may harm your unborn baby.