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