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