WebSecondary endpoint: NUCALA patients achieved lower daily steroid dose during the last 4 weeks of treatment (OR: 0.20; 95% Cl: 0.09, 0.41). 1. SOC was defined as OCS +/– immunosuppressants. After Week 4, OCS (prednisolone or prednisone) dose could be tapered, per physician judgment or a suggested protocol. Remission was defined as … WebDescription. 32-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled study comparing treatment with NUCALA or mepolizumab 75 mg IV to placebo, each added to SOC in 576 patients aged ≥12 years with severe eosinophilic asthma. Select inclusion criteria1,2. Blood eosinophil counts of ≥150 cells/µL at baseline or ≥ ...
label - Food and Drug Administration
WebJan 7, 2024 · Nucala can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect … WebNov 5, 2024 · Mild side effects that have been reported in people taking Nucala for chronic rhinosinusitis with nasal polyps include: pain in the roof of mouth, tongue, tonsils, or throat. upper abdominal pain ... hill reference frame
FDA approves Nucala (mepolizumab) 40 mg prefilled syringe for …
WebPreparation and Administration of NUCALA Injection Prefilled Autoinjector and Prefilled Syringe NUCALA injection is intended for use under the guidance of a healthcare provider. A patient may self-inject or the patient caregiver may administer NUCALA injection subcutaneously after the healthcare provider determines it is appropriate. WebStorage information. Store in the refrigerator between 36°F and 46°F (2°C and 8°C). Keep in the original carton until time of use to protect from light. Do not freeze. Do not shake. Keep away from heat. If necessary, an unopened carton can be stored outside the refrigerator at up to 86°F (30°C) for up to 7 days. WebSep 17, 2024 · EMA has recommended granting an extension of indication to Nucala (mepolizumab) as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA), a rare disorder that causes vasculitis (a chronic inflammation of small to medium-sized arteries and … smart board wireless tablet