This medicine contains less than 1 mmol (23 mg)sodiumper 100 mgdose, ie it is essentially sodium-free. \r\rFor US audiences only. Once verified, the information you provide will be displayed on our site. Formulary status may vary and is subject to change. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Discontinue Nucala in the event of a hypersensitivity reaction. This is not a guarantee of partial or full coverage or payment. This site is intended for US healthcare professionals only. The most common side effects of NUCALA include: headache, injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and . Thats why understanding your insurance is important. Before using, check this product visually for particles or discoloration. If you take NUCALA at home, a specialty pharmacy will be used to ship your medicine directly to your home. How long does it take for Nucala to work? Do not stopinjectingyourself with Nucala unless your doctor tells you to. For optimal user experience, please view this site in Chrome, Firefox, Safari, or Edge. The benefits of Nucala in severe eosinophilic asthma that is not well controlled by previous treatment have been shown in three main studies, in which it was compared with a placebo (dummy) injection. If you want to ask a question or request information from EMA, please Send a question to the European Medicines Agency. If your symptoms worsen while you are beinginjectedwith Nucala: If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse. Let it warm up to room temperature for at least 30 minutes. Talk to your doctor before using this medicine. If you miss a dose, use it as soon as you remember. *Studies showed varied improvements in lung function. Co-pay Program (commercial only Patient Assistance Program (PAP) Specialty Pharmacy (SP) Triage Claims and Billing Support If you already have a parasite infection, it should be treated before starting treatment with Nucala. I hope you found the information in this video helpful in caring for and managing your patients with EGPA. patients, even if you dont use Gateway to NUCALA. MPLWCNT230012 May 2023. Nucala can relieve symptoms and preventrelapses. In clinical trials in patients with EGPA (300 mg of NUCALA), no additional adverse reactions were identified to those reported in severe asthma clinical trials. EGPA (eosinophilicgranulomatouspolyangiitis). It can lead to symptoms such as nasal congestion and lost sense of smell and the growth ofpolyps(soft tissue growths) inside the nose. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended [see Warnings and Precautions (5.1)]. This link will take you to a non-GSK website. Discard if it has been out of the refrigerator for more than 7 days. See what NUCALA can offer. NUCALA is an add-on, prescription maintenance treatment for patients 6 and older with severe eosinophilic asthma. Some features of this site may not function properly. are taking oral or inhaled corticosteroid medicines. Very difficult. If you notice other effects not listed above, contact your doctor or pharmacist. Homepage | NUCALA (mepolizumab) for HCPs It is also used to treatchronicrhinosinusitiswith nasal polypsandHES(hypereosinophilic syndrome) in adults. Gateway to NUCALA Coverage Options | NUCALA (mepolizumab) Sign me up. If you think you have injected too much Nucala, talk to yourdoctorfor advice. Talk to your pharmacist for more details. This medication must be used regularly to be effective. Visitwww.fda.gov/medwatch,or call 1-800-FDA-1088. You should not do both without talking with your healthcare provider first. The patient and carer can use the Nucala prefilled pen or syringe themselves once they have been trained, whereas the vial is only for use by a healthcare professional. NUCALA for injection should be reconstituted and administered by a healthcare professional. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. Mepolizumab is also used to treat certain other immune system disorders (chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome). NUCALA is not for the relief of acute bronchospasm or status asthmaticus. If living with breathing difficulty is affecting how patients view their lives as normal, they can create a "nu normal" with Nucala, a drug that is formulated to be taken once a month and lower the number of asthma attacks a patient may experience. Available for Android and iOS devices. Note: Do not shake the reconstituted solution during the procedure as this may lead to product foaming or precipitation. CenterWell Specialty Pharmacy 800-486-2668, Talk to your doctor to see if adding NUCALA for your severe asthma is right for you. This will tell you your insurance company's policies for covering NUCALA and estimate your out-of-pocket cost for NUCALA. are pregnant or plan to become pregnant. Trademarks are owned by or licensed to the GSK group of companies. are taking oral or inhaled corticosteroid medicines. Specialty pharmacies are different than traditional pharmacies because they focus on certain diseases that require more specialized medications, like NUCALA. This website is funded and developed by GSK. MPLWCNT230003 May 2023 Produced in USA. What is Nucala (mepolizumab) used for and how is it given? Treat patients with pre-existing helminth infections before initiating therapy with Nucala. manufacturing authorisationholder responsible for batch release (annex IIA). Your benefits information will be sent to you in the mail. You are about to leave a GSK website. FDA Approves First Drug to Treat Group of Rare Blood Disorders in If you live in a region where suchinfectionsare common or if you travel to such a region: The pre-filled pen is not intended for use inchildren under 12 yearsof age for the treatment of severeeosinophilicasthma. Store in the original package. The third study involved 135 mostly adult patients with eosinophilic asthma severe enough to need regular treatment by mouth with corticosteroids, and the main measure of effectiveness was how much the corticosteroid dose could be reduced using Nucala for 24 weeks compared with placebo. Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. NUCALA (mepolizumab) for Nasal Polyps Nucala is an asthma medicine used to treat patients aged 6 years and above with a particular type of asthma called severe eosinophilic asthma. Inform patients that hypersensitivity reactions have occurred with NUCALA. Learn about taking NUCALA at home Info about NUCALA sent straight to my inbox? For optimal user experience, please view this site in Chrome, Firefox, Safari, or Edge. Sensitive to light. Nucala is supplied as 1 ml clear to opalescent, colorless to pale yellow to pale brown solution in a disposable pre-filledpen. FDA accepts GSK's filing of Nucala (mepolizumab) for use in chronic Visit our Healthcare Professional site, Summary of Product Characteristics and Patient Information Leaflet (GB), Summary of Product Characteristics and Patient Information Leaflet (NI). Nucala is the first biologic treatment to be PBS-subsidised for the treatment of severe chronic rhinosinusitis with nasal polyps 1,2; Chronic rhinosinusitis is a common chronic respiratory disease that affects one in ten Australians. treatment of patients aged 12+ with HES for 6 months without an identifiable non-hematologic secondary cause. Please do not include any personal data, such as your name or contact details. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. The site you are linking to is not controlled or endorsed by GSK, and GSK is not responsible for the content provided on that site. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Severe eosinophilic asthma Nucala received a marketing authorisation valid throughout the EU on 2 December 2015. Difficult. The Autoinjector is an option for adults who are judged to be appropriate for at-home administration and are properly trained. 2021 GSK or licensor. ADVERSE REACTIONS Most common adverse reactions (5%) in patients receiving NUCALA: Systemic reactions, including hypersensitivity, occurred in clinical trials in patients receiving NUCALA. GSK announces FDA approval for Nucala (mepolizumab) for use in adults A very serious allergic reaction to this drug is rare. What does a NuNormal look like? Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as the pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters. I am a patient. This website is funded and developed by GSK. Each of the three 100-mg vials of lyophilized powder requires reconstitution to comprise the 300-mg dose. GSK's national TV push for Nucala gives another meaning to 'new normal' You can connect with Nucala on Facebook or by phone at 1-844-NUCALA4. Herpes zoster infections have occurred in patients receiving Nucala. Competition for Nucala includes and the other brands in the Pharmaceutical & Medical: Rx: Asthma & COPD industry. The second study involved 576 adults and adolescents given Nucala every 4 weeks for 28 weeks. The information you are about to be referred to may not comply with the local regulatory requirements. Allergic reactions and reactions at the injection site. PDF label - Food and Drug Administration Generic name: MEPOLIZUMAB 100mg in 1mL It is used as directed by your doctor, usually once every 4 weeks. MPLWCNT220059 July 2022 Produced in USA. Call 844-4-NUCALA (844-468-2252) Monday through Friday, 8 AM to 8 PM ET; The NUCALA Co-pay Program can help eligible patients covered by commercial insurance pay as little as $0 for NUCALA (maximum of $15,000 for 12 months). You are recommended to use an alternate browser such as Chrome, Opera or FireFox. The recommended dose depends on the use and on the age of the patient. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby,ask your doctorfor advice before using this medicine. This disease is calledeosinophilicasthma the type ofasthmathat Nucala can treat. PDF Respiratory Interleukins (Cinqair , Fasenra , & Nucala - UHCprovider.com or Patient Assistance ProgramGo to https://www.gskforyou.com/gsk-help/ to see if you're eligible. You can check your eligibility by submitting an Enrollment Form to Gateway to NUCALA or by going to www.NUCALACopayProgram.com. For full Program Terms & Conditions, please visit www.GSKCopayPrograms.com. This medication is used by injection under the skin into the upper arm, thigh, or abdomen. EGPA(eosinophilicgranulomatouspolyangiitis). You may not alter, transform, or build upon this work. This medication works by decreasing a certain type of white blood cell (eosinophils). NUCALA, Mepolizumab Page 7 of 85 Eosinophilic Granulomatosis with Polyangiitis: Nucala is not indicated in patients under 18 years of age. By completing this form, you certify that you are at least 18 years old. This website is funded and developed by GSK. Rate the pronunciation difficulty of nucala. Nucala is an asthma medicine used to treat patients aged 6 years and above with a particular type of asthma called severe eosinophilic asthma. To help prevent withdrawal, your doctor may slowly lower the dose of your corticosteroid medication after you begin using mepolizumab. These cells can damage the bodys organs, especially the heart, lungs, nerves, and skin. For further information on Nucala, please see the Nucala patient information leaflet (PIL). WebMD does not provide medical advice, diagnosis or treatment. All rights reserved. The recommendeddosefor adults and adolescents from the age of 12 is 100 mg.You will receive 1injectionevery four weeks. NUCALA is an add-on, prescription maintenance treatment for patients 6 and older with severe eosinophilic asthma. This medicine is not intended for use inchildren or adolescents under 18 yearsof age for the treatment ofchronicrhinosinusitiswith nasal polyps. 3 /5. If an asthma attack occurs, use your quick-relief inhaler as prescribed. Nucala (Mepolizumab Auto-Injectors and Prefilled Syringes), Eosinophilic Granulomatosis with Polyangiitis. Respiratory Interleukins (Cinqair, Fasenra, & Nucala) - Commercial Medical Benefit Drug Policy. Herpes zoster infections that can cause shingles have happened in people who received NUCALA. Such reactions may be common (they may affectup to 1 in 10 people). Many people using this medication do not have serious side effects. The specialty pharmacies listed below are currently participating in the specialty pharmacy network for NUCALA. Trademarks are owned by or licensed to the GSK group of companies. The specialty pharmacies listed below are currently participating in the specialty pharmacy network for NUCALA. Information provided by Gateway to NUCALA is not a guarantee of coverage. If you are breastfeeding, you must consult your doctorbefore using Nucala. Use your next dose at the regular time. If you are not sure, ask your doctor, pharmacist, or nurse. 2022 GSK or licensor. Have your doctor fill out the Prescriber (blue) Sections and sign the form.The signatures on the form give us permission to ask your insurance company about your coverage. In line with clinical practice, patients should be monitored after administration of biologic agents. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. After 36 and 48 weeks of treatment 32% (22 out of 68) of patients treated with Nucala achieved remission (no signs and symptoms of vasculitis) compared with 3% (2 out of 68) of patients who received placebo. You can also report side effects directly via the Yellow Card Scheme at. Use this medication regularly to get the most benefit from it. The side effects of Nucala are usually mild to moderate but can sometimes be serious. This medicine is authorised for use in the European Union. This site is intended for US healthcare professionals only. NUCALA is the only EGPA treatment to offer your patients once-monthly dosing, no loading dose, and a fixed dose, independent of weight. Severe asthma trials: headache, injection site reaction, back pain, fatigue, CRSwNP trial: oropharyngeal pain, arthralgia, EGPA and HES trials (300 mg of NUCALA): no additional adverse reactions were identified to those reported in severe asthma clinical trials. Eosinophilic granulomatosis with polyangiitis (EGPA). Hepatic Insufficiency Dosage adjustments in patients with hepatic impairment are unlikely to be required (see 10.3 . It is also used to treat chronic rhinosinusitis with nasal polyps and HES . NUCALA | GSK Canada During treatment with either placebo or Nucala for 32 weeks, 15 out of 54 (28%) patients on Nucala had a flare-up, compared with 30 out of 54 (56%) patients on placebo. If you dont have prescription coverage and need help paying for your medicines, call us at 1-844-4-NUCALA (1-844-468-2252). The cost of NUCALA varies depending on your individual insurance plan. In adults the reduction seen in severe asthma attacks and consequent need for hospital treatment was considered important and outweighed the low risk of side effects. Reconstitution is typically complete within 5 minutes after the Sterile Water for Injection has been added, but it may take additional time. GSK does not recommend, endorse or accept liability for sites controlled by third-parties. Do not use to treat acute bronchospasm or status asthmaticus. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. Consider vaccination if medically appropriate. Nucala (mepolizumab) is an interleukin-5 receptor antagonist indicated for add-on maintenance treatment of patients aged 6 years and older with severe asthma and with an eosinophilic phenotype, for add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP) and an inadequate response t. Some features of this site may not function properly. Nucala contains the active substance mepolizumab. If you are regularly using a corticosteroid medication, you should not stop using it unless directed by your doctor. A patient may self-inject or the patient caregiver may administer NUCALA injection 100 mg/mL subcutaneously after the . Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products.

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