The primary endpoint for Trials 1 and 2 was the rate of asthma exacerbations in patients with baseline blood eosinophil counts of greater than or equal to 300 cells/μL who were taking high-dose ICS and LABA. Your doctor can either administer the injection for you or teach you how to self-inject it. Long-term animal studies have not been performed to evaluate the carcinogenic potential of benralizumab. Let FASENRA warm up at room temperature between 68°F to 77°F (20°C to 25°C) for about 30 minutes before giving the injection. The time to first exacerbation was longer for the patients receiving FASENRA compared with placebo in Trial 1 (Figure 2). Note: REQUIRES PRECERTIFICATION Precertification of benralizumab (Fasenra) is required of all Aetna participating providers and members in applicable plan designs. While 2 dosing regimens were studied in Trials 1, 2, and 3, the recommended dosing regimen is 30 mg FASENRA administered every 4 weeks for the first 3 doses, then every 8 weeks thereafter [see DOSAGE AND ADMINISTRATION]. 5. The trial included an 8-week run-in period during which the OCS was titrated to the minimum effective dose without losing asthma control. Eosinophilic asthma has been identified as a subtype of asthma 10. Discard the used syringe drugs a-z list If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. It is there to prevent you from touching the needle. It is not a rescue medication; instead, it is an add-on treatment, and is used alongside other asthma treatments to control symptoms 1. 30 mg administered subcutaneously every 4 weeks for the first three doses and then once every 8 weeks thereafter. Eosinophilic asthma seems to affect men and women equally. Following subcutaneous administration, the elimination half-life was approximately 15.5 days. Billing Code/Availability Information HCPCS Code: J0517 Injection, benralizumab, 1 mg: 1 billable unit = 1 mg NDC: 30 mg/mL single dose prefilled syringe: 00310-1730-xx VII. A caregiver may inject you in the upper-arm, thigh, or abdomen. Instruct patients to contact their healthcare provider if they experience symptoms of an allergic reaction [see WARNINGS AND PRECAUTIONS]. Median blood basophil counts were 45, 52, 46, and 40 cells/μL in the 2 mg, 20 mg and 100 mg benralizumab and placebo groups, respectively. Patients were required to have a history of 2 or more asthma exacerbations (but no more than 6 exacerbations) requiring systemic corticosteroid treatment in the past 12 months, ACQ-6 score of 1.5 at least twice during screening, and reduced morning lung function at screening [pre-bronchodilator FEV1 below 90%] despite treatment with medium-or high-dose ICS plus LABA. All subjects continued their background asthma therapy throughout the duration of the trials. Important Safety Information & Side Effects: Fasenra contains benralizumab and other ingredients. They may also perform diagnostic tests of your blood, sputum or respiratory tissues 15. At the time of the last dose (Week 40), median blood eosinophil counts were 100, 50, 40, 170 cells/μL in the 2, 20, and 100 mg benralizumab and placebo groups, respectively. into a sharps container. Each single-dose prefilled syringe delivers 1 mL containing 30 mg benralizumab, L-histidine (1.4 mg); L-histidine hydrochloride monohydrate (2.3 mg); polysorbate 20 (0.06 mg); α,α-trehalose dihydrate (95 mg); and Water for Injection, USP. Fasenra [package insert]. Benralizumab has a molecular weight of approximately 150 kDa. The drug is administered via subcutaneous injection, and the recommended dose is 30mg every 4 weeks for the first three doses, followed by 30mg every 8 weeks thereafter. Do not The primary endpoint was the annual exacerbation rate and forced expiratory volume in 1 second (FEV1) and ACQ-6 were key secondary endpoints. Eosinophilic asthma is characterized by abnormally high levels of eosinophils in the blood and respiratory tissues. From population pharmacokinetic analysis, benralizumab exhibited linear pharmacokinetics and no evidence of target receptor-mediated clearance pathway. In Trials 1 and 2, following SC administration of benralizumab at the recommended dose blood eosinophils were reduced to a median absolute blood eosinophil count of 0 cells/μL [see Clinical Studies]. “Fasenra is the only respiratory biologic that provides direct, rapid and near-complete depletion of eosinophils within 24 hours,” said AZ in a statement. Common Health Conditions Among Minorities. Subgroup analyses from Trials 1 and 2 identified patients with a higher prior exacerbation history and baseline blood eosinophil count as potential predictors of improved treatment response. Allergic (or hypersensitivity) reactions to Fasenra may cause the following symptoms: In severe cases, Fasenra can trigger anaphylaxis, for which these symptoms can be life threatening. Table 3. VI. You can help by reporting any side effects you may get. The upper arm can also be used if a healthcare professional or caregiver administers the injection 1; Prior to administration, warm FASENRA by leaving carton at room temperature for about 30 minutes. Each FASENRA PEN contains 1 dose of FASENRA that is for one time use only. After 14 days, throw away the FASENRA PEN. For each injection, choose a different site that is at least 1-inch (3-cm) away from where you last injected. Of those patients, 52% (22 of 42) receiving FASENRA and 19% (8 of 42) on placebo achieved a 100% reduction in OCS dose. At 52 weeks (12 weeks after the last dose), median blood basophil counts were 42, 18, 17, and 46 cells/μL in the 2 mg, 20 mg and 100 mg benralizumab and placebo groups, respectively. No formal clinical studies have been conducted to investigate the effect of renal impairment on benralizumab. 6. This is different to other forms of asthma, which are more commonly triggered by environmental factors, such as dust, pollen or animal hair. Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy [see WARNINGS AND PRECAUTIONS]. There may be state or local laws about how you should throw away used needles and syringes. The single-dose prefilled syringe contains a 1 mL glass syringe with a staked 29 gauge ½ inch stainless steel needle. 4"Discussion - Clinical Review Report: Benralizumab (Fasenra ...." https://www.ncbi.nlm.nih.gov/books/NBK541777/. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. See the end of this leaflet for a complete list of ingredients in FASENRA. FASENRA may cause serious side effects, including: The most common side effects of FASENRA include headache and sore throat. In the Phase 2 dose-ranging trial, blood basophil counts were measured by flow cytometry. Therefore, diagnosis is usually confirmed via blood test. Fasenra ® (benralizumab ... • The recommended dosage of Fasenra for severe asthma is 30 mg administered once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter by SC injection into the upper arm, thigh, or abdomen. Talk to your healthcare provider about the best way to feed your baby if you use FASENRA. Grasp the syringe body, not the plunger, to Administer FASENRA into the thigh or abdomen. The first 3 doses of Fasenra are administered once every 4 weeks, and then once every 8 weeks thereafter. For a long time, asthma was thought to be a single condition, but we now know there are lots of different types of asthma. Results from this trial and exposure-response modelling of exacerbation rate reduction supported the evaluation of benralizumab 30 mg in the subsequent trials [see CLINICAL PHARMACOLOGY]. COPYRIGHT 2018-2020,ASTRAZENECA CANADA INC. 11 Aug. 2020, https://www.mayoclinic.org/diseases-conditions/asthma/symptoms-causes/syc-20369653. In patients with eosinophilic asthma, the inflammation of their airways is caused by abnormally high levels of white blood cells called eosinophils 11. not use FASENRA if the liquid is cloudy, discolored, or if it contains large home Do not remove the cap until you have reached Step 6 of these instructions and are ready to inject FASENRA. There is no specific treatment for an overdose with benralizumab. An effect of benralizumab on the pharmacokinetics of co-administered medications is not expected. The population studied was 12 to 75 years of age, of which 64% were female and 79% were white. Asthma is a cluster of diseases characterized by the narrowing and swelling of the airways 9. 7"Fasenra (Benralizumab): Asthma Uses, Dosage, Side Effects ...." https://www.rxlist.com/fasenra-drug.htm. Fasenra is taken once every four weeks for three doses, and once every eight weeks after that. The recommended dose of FASENRA is 30 mg administered once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter by … 12-15"Eosinophilic Asthma | Apfed." IgG monoclonal antibodies are not primarily cleared via hepatic pathway; change in hepatic function is not expected to influence benralizumab clearance. the syringe body and remove the needle cover by pulling straight off. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Table 2. Doses up to 200 mg were administered subcutaneously in clinical trials to patients with eosinophilic disease without evidence of … Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Therefore, the malignancy risk in humans from an antibody that binds to IL-5Rα such as benralizumab is unknown. FASENRA is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients . Of the total number of patients in clinical trials of benralizumab, 13% (n=320) were 65 and over, while 0.4% (n=9) were 75 and over. If your headache or sore throat doesn’t go away or becomes more severe, consult your doctor to discuss potential treatments. Visit the FDA MedWatch website or call 1-800-FDA-1088. The pharmacokinetics of benralizumab was approximately dose-proportional in patients with asthma following subcutaneous administration over a dose range of 20 to 200 mg. Do not use FASENRA to treat acute bronchospasm or status asthmaticus. FASENRA was studied in a robust clinical trial program for severe eosinophilic asthma. FASENRA is not used to treat other problems caused by eosinophils. 11-12"What to know about eosinophilic asthma - Medical News Today." Refer to the FASENRA PEN ‘Instructions for Use’ for more detailed instructions on the preparation and administration of FASENRA PEN [See Instructions for Use]. Similar findings were seen in Trial 2. Check the expiration date on the If benralizumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to benralizumab are unknown. The syringe may contain a small air Use FASENRA within 14 days of removing from the refrigerator. The FDA approved Fasenra as a prefilled auto-injector, called the Fasenra pen, meant to be taken every eight weeks, AstraZeneca said. FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus. You can ask your doctor or pharmacist for information about FASENRA that is written for health providers. FASENRA (benralizumab) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous injection. Do not use FASENRA past the expiration date. Common side effects of taking Fasenra include: In most cases, these side effects will subside by themselves. Patients were treated with placebo or benralizumab 30 mg SC every 4 weeks for 3 doses. Contact your health insurance provider for more information. The exact causes of eosinophilic asthma are still unknown 14, as patients with the condition do not have the underlying allergies that usually trigger asthma symptoms (such as pollen, pet hair, dust mites and smoke). FASENRA should not be used to treat acute asthma symptoms or acute exacerbations. Inject all of the medication Along with Nucala and Cinqair, severe asthma patients can also be treated with Novartis’ older drug Xolair (omalizumab), although that is indicated for allergic asthma and doesn’t specifically address eosinophilic inflammation. - Medicare.org." FASENRA (n=267), Placebo (n=267) (P0.0001). Fasenra Financial Assistance. You should also contact your doctor if you have a fever lasting more than 3 days or a temperature higher than 103°F (39.4 °C). It’s approved to treat severe eosinophilic asthma in adults as well as children ages 12 years and older. What might happen if I take too much FASENRA? For more information go to www.FasenraPen.com or call 1-800-236-9933. How much is given There is no evidence of IL-5Rα expression on hepatocytes and eosinophil depletion does not produce chronic systemic alterations of proinflammatory cytokines. * Pharyngitis was defined by the following terms: ‘Pharyngitis’, ‘Pharyngitis bacterial’, ‘Viral pharyngitis’, ‘Pharyngitis streptococcal’. After you receive a dose of medication, most infusion centers will monitor you for a period of time to make sure you do not have any reactions to the medication. The first 3 doses are administered once every 4 weeks, and then once every 8 weeks thereafter. There may be new information. Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred following administration of FASENRA. No evidence of an association of anti-drug antibodies with efficacy or safety was observed. 3"FASENRA FAQs | FASENRA® (benralizumab) for Severe ...." https://www.fasenra.com/faq.html. In 2019, FASENRA was approved in the US for self-administration in a single dose prefilled autoinjector, the FASENRA … Before you start treatment with Fasenra, your doctor may perform tests to measure your eosinophil levels. Store FASENRA in the refrigerator between 36°F to 46°F (2°C to 8°C). A patient may self-inject or the patient caregiver may administer FASENRA PEN subcutaneously after the healthcare provider determines it is appropriate. Adverse reactions that occurred at greater than or equal to 3% incidence are shown in Table 1. Across Trials 1, 2, and 3, 1,808 patients received at least 1 dose of FASENRA [see Clinical Studies]. If you have the Medicare Advantage Plan, your insurance may include additional coverage. If your healthcare provider decides that you or a caregiver can give the injection of FASENRA, you or your caregiver should receive training on the right way to prepare and give the injection using the FASENRA PEN. If you think you may have eosinophilic asthma, your doctor will first ask you to describe your symptoms, as well as your personal and family medical history. FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Call your doctor for medical advice about side effects. Healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting mothertobaby.org/Fasenra. The data reflect the percentage of patients whose test results were positive for antibodies to benralizumab in specific assays. Trial 3 evaluated the effect of FASENRA on reducing the use of maintenance oral corticosteroids. 9"Asthma - Symptoms and causes - Mayo Clinic." bubble; this is normal. 1 51% reduction in AER ‡ (0.74) vs placebo + SOC (1.52) in SIROCCO (Trial 1, 48 weeks). Copyright © 2021 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. syringe. Benralizumab crossed the placenta in cynomolgus monkeys. Male and female fertility were unaffected based upon no adverse histopathological findings in the reproductive organs from cynomolgus monkeys treated with benralizumab for 9 months at IV doses up to 25 mg/kg or at SC doses of up to 30 mg/kg once every 2 weeks (approximately 400 and 270 times the MRHD on an AUC basis). Fasenra is given to you by a healthcare professional, such as a doctor or a nurse, as an injection into the fat layer just under the skin (subcutaneous). How do I take it? FASENRA is a prescription medicine used with other asthma medicines for the maintenance treatment of asthma in people 12 years and older whose asthma is not controlled with their current asthma medicines. The trials randomized a total of 2510 patients. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for benralizumab and any potential adverse effects on the breast-fed child from benralizumab or from the underlying maternal condition. 2. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation. The drug is administered via subcutaneous injection, and the recommended dose is 30mg every 4 weeks for the first three doses, followed by 30mg every 8 weeks thereafter. 4. The Phase 2 randomized, double-blind, placebo-controlled, 52-week dose-ranging trial, enrolled 609 asthmatic patients 18 years of age and older. Patients were required to have a history of 2 or more asthma exacerbations requiring oral or systemic corticosteroid treatment in the past 12 months, ACQ-6 score of 1.5 or more at screening, and reduced lung function at baseline [prebronchodilator FEV1 below 80% in adults, and below 90% in adolescents] despite regular treatment with high dose inhaled corticosteroid (ICS) (Trial 1) or with medium or high dose ICS (Trial 2) plus a long-acting beta agonist (LABA) with or without oral corticosteroids (OCS) and additional asthma controller medications. Eosinophilic asthma is rare among the general population 12, and is only thought to affect around 5% of the estimated 25.7 million adults with asthma in the US. or abdomen). guidelines permit this. FASENRA may be left out of the refrigerator at room temperature for up to 14 days in the original carton 1 These are not all the possible side effects of FASENRA. Disease-associated Maternal and/or Embryo/fetal Risk: In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Inform patients that FASENRA does not treat acute asthma symptoms or acute exacerbations. It is unknown if FASENRA will influence a patient’s response against helminth infections. Reductions of 50% or higher in the OCS dose were observed in 48 (66%) patients receiving FASENRA compared to those receiving placebo 28 (37%). Fasenra is only administered once every 8 weeks after 2 months. You may report side effects to FDA at 1-800-FDA-1088. Do not warm the FASENRA PEN in any other way. It is not known if FASENRA is safe and effective in children under 12 years of age. Do Eosinophilic asthma is a rare subtype of asthma, and often causes severe symptoms. A population pharmacokinetics analysis indicated that there was no significant effect of gender and race on benralizumab clearance. In the 52-week Phase 2 dose-ranging trial, asthma patients received 1 of 3 doses of benralizumab [2 mg (n=81), 20 mg (n=81), or 100 mg (n=222)] or placebo (n=222). Similar results were seen in Trial 3. http://indianpharmanetwork.in/FASENRA.pdf. Included as part of the "PRECAUTIONS" Section. Fasenra is administered by subcutaneous injection. Fasenra comes in a single dose prefilled syringe and in a single dose autoinjector. Demographics and Baseline Characteristics of Asthma Trials. When used in combination with other asthma treatments, Fasenra has been clinically proven to improve lung function, prevent asthma attacks and reduce or even stop oral steroid use in asthma patients 3. Individuals taking Fasenra should be monitored for signs of hypersensitivity (allergic) reactions, such as rash or difficulty breathing. It is not to be self-administered. Inform patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. Compared with placebo, Carefully pull the cap straight off with your other hand. Benralizumab is a humanized afucosylated, monoclonal antibody (IgG1, kappa) that directly binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with a dissociation constant of 11 pM. Visually inspect FASENRA for particulate matter and discoloration prior to administration. All Right Reserved. FASENRA comes in a single dose prefilled syringe and in a single dose autoinjector. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended [see WARNINGS AND PRECAUTIONS]. Benralizumab did not elicit adverse effects on fetal or neonatal growth (including immune function) up to 6.5 months after birth. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Visually inspect FASENRA for particulate matter and discoloration 2.2 General Administration Instructions FASENRA is intended for use under the guidance of a healthcare provider. Do not give FASENRA to other people, even if they have the same symptoms you have. Based on population pharmacokinetic analysis, the estimated absolute bioavailability was approximately 59% and there was no clinically relevant difference in relative bioavailability in the administration to the abdomen, thigh, or arm. Fasenra for provider administration, is medically necessary when allof the following criteria are met: The asthma development program for FASENRA included one 52-week dose ranging exacerbation trial (NCT01238861) three confirmatory trials, (Trial 1 [NCT01928771], Trial 2 [NCT01914757], Trial 3 [NCT02075255]) and one 12-week lung function trial (NCT02322775). This will allow quick identification of new safety information. 6"Fasenra: Side effects, dosage, alternatives, and more." (benralizumab) Based on population pharmacokinetic analysis, baseline hepatic function biomarkers (ALT, AST, and bilirubin) had no clinically relevant effect on benralizumab clearance. Of these, 46 received placebo, 40 received FASENRA every 4 weeks for 3 doses, followed by every 8 weeks thereafter, and 22 received FASENRA every 4 weeks. Do not stop taking your other asthma medicines unless your healthcare provider tells you to. FASENRA Savings Program See additional information. Adverse reactions from Trial 3 with 28 weeks of treatment with FASENRA (n=73) or placebo (n=75) in which the incidence was more common in FASENRA than placebo include headache (8.2% compared to 5.3%, respectively) and pyrexia (2.7% compared to 1.3%, respectively) [see Clinical Studies]. If you miss a dose of FASENRA, call your healthcare provider. However, it is considered a leading cause of severe asthma, and is thought to affect 50 - 60% of people with a severe form of the condition. The FASENRA Pen is an injection administered under the skin (subcutaneously) by the patient or their caregiver. You may see small air bubbles in the liquid. by pushing in the plunger all the way until the plunger head is completely After injection, maintain can be closed with a tight-fitting puncture-resistant lid, without sharps being able to come out. Patients were required to have a history of 2 or more asthma exacerbations requiring oral or systemic corticosteroid treatment in the past 12 months and reduced lung function at baseline (pre-bronchodilator FEV1<90%) despite regular treatment with medium or high dose ICS and LABA with or without OCS or other controller therapy. Do not expel the air bubble prior to administration. Read this Instructions for Use before you start using your FASENRA PEN and each time you get a refill. Gently pinch the skin and insert the needle at the This triggers an asthma ‘attack’ (or flare-up) and causes shortness of breath, wheezing, coughing and difficulty breathing. In an in vitro setting, the absence of fucose in the Fc domain of benralizumab facilitates binding (45.5 nM) to FcɣRIII receptors on immune effector cells, such as natural killer (NK) cells, leading to apoptosis of eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity (ADCC). (fas-en-rah) side effects drug center fasenra (benralizumab for subcutaneous injection) drug. For the purposes of the OCS dose titration, asthma control was assessed by the investigator based on a patient’s FEV1, peak expiratory flow, nighttime awakenings, short-acting bronchodilator rescue medication use or any other symptoms that would require an increase in OCS dose. Eosinophils may be involved in the immunological response to some helminth infections. Clean the injection site with an alcohol wipe in a circular motion. As with all therapeutic proteins, there is potential for immunogenicity. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. are pregnant or plan to become pregnant. No formal clinical studies have been conducted to investigate the effect of hepatic impairment on benralizumab. Once removed from the refrigerator and brought to room temperature FASENRA must be used within 14 days or thrown away. Medicines such as FASENRA reduce blood eosinophils. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Overall, treatment-emergent anti-drug antibody response developed in 13% of patients treated with FASENRA at the recommended dosing regimen during the 48 to 56 week treatment period. pressure on the plunger head and remove the needle from the skin. Prior to administration, warm FASENRA by leaving carton at room temperature for about 30 minutes. 8"Does Medicare Cover Fasenra? Page 5of 39 3.2 Recommended Dose and Dosage Adjustment The recommended dose of FASENRA is 30 mg administered once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter by subcutaneous injection into the thigh, or In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during post approval use of FASENRA. The FASENRA pre-filled syringe is an injection administered under the skin (subcutaneously) by a healthcare provider. # ¶ For people taking oral steroids daily. FASENRA (benralizumab) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution and may contain a few translucent or white to off-white particles, for subcutaneous injection supplied as a single-dose prefilled syringe or single-dose autoinjector. Patients/caregivers may inject after proper training in subcutaneous injection technique, and after the healthcare provider determines it is appropriate. Do not change the position of the FASENRA PEN after the injection has started. Published with, https://www.drugs.com/medical-answers/fasenra-work-3541067/, https://www.ema.europa.eu/documents/overview/fasenra-epar-medicine-overview_en.pdf, https://www.ncbi.nlm.nih.gov/books/NBK541777/, http://indianpharmanetwork.in/FASENRA.pdf, https://www.medicalnewstoday.com/articles/fasenra, https://www.medicare.org/articles/does-medicare-cover-fasenra/, https://www.mayoclinic.org/diseases-conditions/asthma/symptoms-causes/syc-20369653, https://www.webmd.com/asthma/eosinophilic-asthma-causes, https://www.medicalnewstoday.com/articles/319466, https://apfed.org/about-ead/eosinophilic-asthma/, COVID-19 & Decentralization of Clinical Trials In 2020, Patients Have Power Twitter Chat: Fears, Hopes & Realities for Chronic Illness Patients During COVID-19, Injection site reactions (such as pain, redness, itching or a small lump), Low blood pressure (causing fainting, dizziness and light-headedness), We are available to offer you personal support in finding the best and latest clinical studies that fit your needs. Only patients with an optimized baseline OCS dose of 12.5 mg or less were eligible to achieve a 100% reduction in OCS dose during the study. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with FASENRA. Anti-benralizumab antibodies were associated with increased clearance of benralizumab and increased blood eosinophil levels in patients with high anti-drug antibody titers compared to antibody negative patients. Benralizumab is a humanized IgG1 monoclonal antibody that is degraded by proteolytic enzymes widely distributed in the body and not restricted to hepatic tissue. use. or give the injection without pinching the skin. Trial 3 was a randomized, double-blind, parallel-group, OCS reduction trial in 220 asthma patients. FASENRA may be stored at room temperature between 68°F to 77°F (20°C to 25°C). Fasenra 30 mg solution for injection in pre-filled syringe benralizumab This medicine is subject to additional monitoring. See additional information. Do not use FASENRA if you are allergic to benralizumab or any of the ingredients in FASENRA. Benralizumab is produced in Chinese hamster ovary cells by recombinant DNA technology. Do not expose to heat. Patients were required to have blood eosinophil counts greater than or equal to 150 cells/μL and a history of at least one exacerbation in the past 12 months.
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