Hold the FASENRA PEN with 1 hand. between the needle guard activation clips. General information about the safe and effective use of FASENRA. Do not give FASENRA to other people, even if they have the same symptoms you have. Clara Health is a patient-centric healthcare platform that was founded to assist patients in finding relevant research studies & clinical trials. The adverse event profile in adolescents was generally similar to the overall population in the Phase 3 studies [see ADVERSE REACTIONS]. Inject FASENRA by following the steps in figures a, b, c, and d. Hold the FASENRA PEN in place for the entire injection. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FASENRA during pregnancy. Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-15185 U.S. License Number 2059. 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. If any of these happen, throw away the FASENRA PEN in a puncture-resistant sharps disposal container and use a new FASENRA PEN. Do not try to inject yourself in the arm. 1 51% reduction in AER â¡ (0.74) vs placebo + SOC (1.52) in SIROCCO (Trial 1, 48 weeks). Fasenra is indicated for use as an add-on maintenance treatment. However, benralizumab is a humanized monoclonal antibody (IgG1/κ-class), and immunoglobulin G (IgG) is present in human milk in small amounts. FASENRA Savings Program 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. FASENRA may be left out of the refrigerator at room temperature for up to 14 days in the original carton 1 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. Do not expel the air bubble prior to administration. Therefore, diagnosis is usually confirmed via blood test. In Trial 2, the ACQ-6 responder rate for the FASENRA was 63% vs 59% placebo (odds ratio 1.16; 95% CI: 0.80, 1.68). 3"FASENRA FAQs | FASENRA® (benralizumab) for Severe ...." https://www.fasenra.com/faq.html. However, other reports indicate that eosinophil infiltration into tumors can promote tumor growth. It is unknown if FASENRA will influence a patient’s response against helminth infections. 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. Fasenra may be injected by a healthcare professional, or by the patient once training has been provided. Discard the used syringe
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. 1 puncture-resistant sharps disposal container. Fasenra should be administered as a 30 mg subcutaneous (SC) injection once every 4 weeks (Q4W) for the first three doses, followed by 30 mg SC once every 8 weeks (Q8W). In 2019, FASENRA was approved in the US for self-administration in a single dose prefilled autoinjector, the FASENRA ⦠See the end of section 4 for how to report side effects. Table 4). Revised: Oct 2019. Individuals taking Fasenra, who are also taking corticosteroids, should not discontinue or reduce the dose of their c⦠Do
If your headache or sore throat doesn’t go away or becomes more severe, consult your doctor to discuss potential treatments. Once removed from the refrigerator and brought to room temperature (up to 77°F [25°C]), the prefilled syringe and autoinjector must be used within 14 days or discarded. FASENRA is intended for use under the guidance of a healthcare provider. An effect of benralizumab on the pharmacokinetics of co-administered medications is not expected. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. The liquid should be clear and colorless to slightly yellow. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. What you need to know about navigating health, treatments, clinical trials, and more. are taking oral or inhaled corticosteroid medicines. Keep FASENRA and all medicines out of the sight and reach of children. 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. Healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting mothertobaby.org/Fasenra. Member is 12 years of age or older; and 2. This is necessary to activate
If you have the Medicare Advantage Plan, your insurance may include additional coverage. The prefilled syringe is for administration by a healthcare provider. 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. They may also perform diagnostic tests of your blood, sputum or respiratory tissues 15. Note: REQUIRES PRECERTIFICATION Precertification of benralizumab (Fasenra) is required of all Aetna participating providers and members in applicable plan designs. 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. Fasenra is intended for add-on maintenance treatment of patients with severe eosinophilic asthma over the age of 12 years 5. not re-cap the prefilled syringe. Do not dispose of your used sharps disposal container in your household trash unless your community
Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of benralizumab. yellow, and may contain a few translucent or white to off-white particles. You can help by reporting any side effects you may get. Patients were required treatment with daily OCS (7.5 to 40 mg per day) in addition to regular use of high-dose ICS and LABA with or without additional controller(s). The pharmacokinetics of benralizumab in adolescents 12 to 17 years of age were consistent with adults based on population pharmacokinetic analysis and the reduction in blood eosinophil counts was similar to that observed in adults following the same FASENRA treatment. https://www.medicalnewstoday.com/articles/fasenra. - Drugs.com." The following adverse reactions are described in greater detail in other sections: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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. Complete the following steps right away after removing the cap. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation. If needed, the prefilled syringe and autoinjector may be stored at room temperature up to 77°F (25°C) for a maximum of 14 days in the original carton to protect from light. FASENRA comes in a single dose prefilled syringe and in a single dose autoinjector. can be closed with a tight-fitting puncture-resistant lid, without sharps being able to come out. It is unknown if Fasenra passes into breast milk or how it would affect a nursing infant. side effects drug center fasenra (benralizumab for subcutaneous injection) drug. (benralizumab)
MedicalResearch.com: How is it administered? Since FASENRA is a protein, a few translucent or white to off-white particles may be present in the solution. There may be state or local laws about how you should throw away used needles and syringes. No formal drug-drug interaction studies have been conducted. Median blood eosinophil levels at baseline were 310, 280, 190 and 190 cells/μL in the 2, 20, and 100 mg benralizumab and placebo groups, respectively. Visually inspect FASENRA for particulate matter and discoloration
Eosinophilic asthma is characterised by large numbers of eosinophils, white blood cells that cause inflammation and can trigger asthmatic symptoms. Do not use FASENRA for a condition for which it was not prescribed. Trial 3 evaluated the effect of FASENRA on reducing the use of maintenance oral corticosteroids. You do not need to do anything about it. Call your doctor for medical advice about side effects. This Instructions for Use has been approved by the U.S. Food and Drug Administration. 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]. 20 Sep. 2017, https://www.medicalnewstoday.com/articles/319466. In the event of a hypersensitivity reaction, FASENRA should be discontinued [see CONTRAINDICATIONS]. 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). For these reasons, comparison of the incidence of antibodies to benralizumab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. The green needle guard is now exposed. FASENRA is clear to opalescent, colorless to slightly
Patients/caregivers may inject after proper training in subcutaneous injection technique, and after the healthcare provider determines it is appropriate. Check the expiration date on the
Carefully pull the cap straight off with your other hand. 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. Fasenra for provider administration, is medically necessary when allof the following criteria are met: The Phase 2 randomized, double-blind, placebo-controlled, 52-week dose-ranging trial, enrolled 609 asthmatic patients 18 years of age and older. Fasenra [package insert]. Based on population pharmacokinetic analysis, age did not affect benralizumab clearance. In this 28-week trial, patients receiving FASENRA had 1 event while those on placebo had 14 events (annualized rate 0.02 and 0.32, respectively; rate ratio of 0.07, 95% CI: 0.01, 0.63). The safety and efficacy in patients younger than 12 years of age has not been established. Do not
The safety exposure for FASENRA is derived from two Phase 3 placebo-controlled studies (Trials 1 and 2) from 48 weeks duration [FASENRA every 4 weeks (n=841), FASENRA every 4 weeks for 3 doses, then every 8 weeks (n=822), and placebo (n=847)]. It is there to prevent you from touching the needle. Table 1. Adverse reactions that occurred at greater than or equal to 3% incidence are shown in Table 1. No formal clinical studies have been conducted to investigate the effect of renal impairment on benralizumab. It may harm them. pressure on the plunger head to allow the needle guard to cover the needle. Benralizumab concentrations were approximately equal in mothers and infants on postpartum day 7, but were lower in infants at later time points. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Follow your healthcare providers instructions on how to inject. FASENRA demonstrated reductions in exacerbation rate in two phase 3 clinical trials. The primary endpoint was percent reduction from baseline of the final OCS dose during Weeks 24 to 28, while maintaining asthma control (see definition of asthma control in trial description). Do not change the position of the FASENRA PEN after the injection has started. Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a physician. How do I take it? Contact your health insurance provider for more information. Tell your healthcare provider if your asthma does not get better or if it gets worse after you start treatment with FASENRA. * Pharyngitis was defined by the following terms: ‘Pharyngitis’, ‘Pharyngitis bacterial’, ‘Viral pharyngitis’, ‘Pharyngitis streptococcal’. 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. 2. The primary endpoint was the annual exacerbation rate and forced expiratory volume in 1 second (FEV1) and ACQ-6 were key secondary endpoints. The annual exacerbation rate reduction for patients receiving benralizumab 2 mg, 20 mg, and 100 mg were -12% (80% CI: -52, 18), 34% (80% CI: 6, 54), 29% (80% CI: 10, 44), respectively, compared to placebo (rate 0.56). It is not a rescue medication; instead, it is an add-on treatment, and is used alongside other asthma treatments to control symptoms 1. 19 May. Important Safety Information & Side Effects: Fasenra contains benralizumab and other ingredients. FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Included as part of the "PRECAUTIONS" Section. Common Health Conditions Among Minorities. the syringe body and remove the needle cover by pulling straight off. Eosinophilic asthma is a rare subtype of severe asthma that is most commonly seen in adults 13. Asthma is a cluster of diseases characterized by the narrowing and swelling of the airways 9. # ¶ For people taking oral steroids daily. Kaplan-Meier Cumulative Incidence Curves for Time to First Exacerbation, Trial 1. Fasenra is administered via injection. 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 upper arm, thigh, or abdomen. Table 3. Consult your doctor before breastfeeding. Most people with the condition first start to notice symptoms between the ages of 35 and 50 years old, at which point they will often show elevated blood and tissue levels of eosinophils. Tell your healthcare provider if you become pregnant during your treatment with FASENRA. Do not touch the cleaned area before injecting. particles or foreign particulate matter. Change from Baseline in Mean Pre-Bronchodilator FEV1 (L) at End of Trial*. Benralizumab is a humanized IgG1 monoclonal antibody that is degraded by proteolytic enzymes widely distributed in the body and not restricted to hepatic tissue. 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. Sub group analyses also showed greater improvements in FEV1 in patients with higher baseline blood eosinophil counts and more frequent prior exacerbation history. FASENRA®
Change from baseline in mean FEV1 was assessed in Trials 1, 2, and 3 as a secondary endpoint. As is the case with all medications, Fasenra can cause side effects which may be mild or severe 6. 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. FASENRA is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients . Inflammation is an important component in the pathogenesis of asthma. FASENRA (n=267), Placebo (n=267) (P0.0001). FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype [see Clinical Studies]. Do not remove the cap until you have reached Step 6 of these instructions and are ready to inject FASENRA. Doses up to 200 mg were administered subcutaneously in clinical trials to patients with eosinophilic disease without evidence of dose-related toxicities. Copyright © 2021 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended [see WARNINGS AND PRECAUTIONS]. Itâs approved to treat severe eosinophilic asthma in adults as well as children ages 12 years and older. Immune System Disorders: Hypersensitivity reactions, including anaphylaxis. Figure 2. You and your healthcare provider should decide if you will use FASENRA and breastfeed. It is not known if FASENRA will harm your unborn baby. FASENRA is clear to opalescent, colorless to slightly yellow, and may contain a few translucent or white to off-white particles. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The median percent reduction in daily OCS dose from baseline was 75% in patients receiving FASENRA (95% CI: 60, 88) compared to 25% in patients receiving placebo (95% CI: 0, 33). Eosinophils are a type of white blood cell that may contribute to your asthma. are breastfeeding or plan to breastfeed. Prior to administration, warm FASENRA by leaving carton at room temperature for about 30 minutes. 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). 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 ⦠bubble; this is normal. In patients with eosinophilic asthma, the inflammation of their airways is caused by abnormally high levels of white blood cells called eosinophils 11. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., days). This is normal. Do not try to put the cap back on the FASENRA PEN. into a sharps container. FASENRA helps prevent severe asthma attacks (exacerbations) and may improve your breathing. A healthcare provider will inject FASENRA using the single-dose prefilled syringe. guidelines permit this. For a long time, asthma was thought to be a single condition, but we now know there are lots of different types of asthma. The pharmacokinetics of benralizumab was approximately dose-proportional in patients with asthma following subcutaneous administration over a dose range of 20 to 200 mg. Hold
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. Medicines such as FASENRA reduce blood eosinophils. It is given once every 4 weeks for the first 3 doses, then once every 8 weeks. 30 mg administered subcutaneously every 4 weeks for the first three doses and then once every 8 weeks thereafter. Wash your hands well with soap and water. You can either gently pinch at the injection site
Based on population pharmacokinetic analysis, baseline hepatic function biomarkers (ALT, AST, and bilirubin) had no clinically relevant effect on benralizumab clearance. The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Advise patients to follow sharps disposal recommendations [see Instructions for Use]. FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. 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 upper arm, thigh, or abdomen. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. FASENRA was studied in a robust clinical trial program for severe eosinophilic asthma. In the Phase 2 dose-ranging trial, blood basophil counts were measured by flow cytometry. Trial 3 was a randomized, double-blind, parallel-group, OCS reduction trial in 220 asthma patients. 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. Do not warm the FASENRA PEN in any other way. FASENRA® Product Monograph. Following subcutaneous administration, the elimination half-life was approximately 15.5 days. Fasenra comes in a single dose prefilled syringe and in a single dose autoinjector. 1"What is Fasenra used for and how does it work? This magnitude of reduction was seen at the first observed time point, 4 weeks of treatment, and was maintained throughout the treatment period. These reactions generally occurred within hours of FASENRA administration, but in some instances had a delayed onset (i.e., days). Do not try to touch the needle or push on the needle guard with your finger. Method of administration Fasenra is administered as a subcutaneous injection. FASENRA may cause serious side effects, including: The most common side effects of FASENRA include headache and sore throat. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Reductions in exacerbation rates were observed irrespective of baseline peripheral eosinophil counts; however, patients with a baseline blood eosinophil count ≥300 cells/μL showed a numerically greater response than those with counts <300 cells/μL. Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred following administration of FASENRA. 4"Discussion - Clinical Review Report: Benralizumab (Fasenra ...." https://www.ncbi.nlm.nih.gov/books/NBK541777/. Administer FASENRA into the thigh or abdomen. Do not use FASENRA if you are allergic to benralizumab or any of the ingredients in FASENRA. For each injection, choose a different site that is at least 1-inch (3-cm) away from where you last injected. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Based on the population analysis, commonly co-administered medications had no effect on benralizumab clearance in patients with asthma. Compared to placebo, patients receiving FASENRA achieved greater reductions in daily maintenance oral corticosteroid dose, while maintaining asthma control. 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]. Benralizumab (Fasenra) is considered medically necessary for the treatment of asthma when all of the following criteria are met: 1. Benralizumab has a molecular weight of approximately 150 kDa. Along with Nucala and Cinqair, severe asthma patients can also be treated with Novartisâ older drug Xolair (omalizumab), although that is indicated for allergic asthma and doesnât specifically address eosinophilic inflammation. Fasenra is injected under your skin (subcutaneously) one time every 4 weeks for the first 3 doses, and then every 8 weeks. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with FASENRA. 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. The responder rate for both measures was defined as improvement in score of 0.5 or more as threshold at the end of Trials 1, 2, and 3 (48, 56, and 28 weeks, respectively). Patients were stratified by eosinophilic status. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If you miss a dose of FASENRA, call your healthcare provider. Fasenra is a brand-name prescription medication. dropped without needle cover in place), discard and use a new prefilled
injection, for subcutaneous
Look at the liquid in the FASENRA PEN through the viewing window. syringe. Clara Guides © 2021. 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. FASENRA should not be used to treat acute asthma symptoms or acute exacerbations. The IL-5 receptor is expressed on the surface of eosinophils and basophils. Patients were treated with placebo or benralizumab 30 mg SC every 4 weeks for 3 doses. Of those patients, 52% (22 of 42) receiving FASENRA and 19% (8 of 42) on placebo achieved a 100% reduction in OCS dose. Do not freeze. What might happen if I take too much FASENRA? Fasenra (Benralizumab) is a maintenance treatment given to people with eosinophilic asthma. Similar findings were seen in Trial 2. This is different to other forms of asthma, which are more commonly triggered by environmental factors, such as dust, pollen or animal hair. FASENRA is administered only once every 8 weeks after the first 2 months. It may contain small white particles. Two similarly-designed trials 4 (CALIMO and SIROCCA) compared the effects of Benralizumab with a placebo in eosinophilic asthma patients and found that lung function and symptoms were both improved by treatment with Benralizumab. The data reflect the percentage of patients whose test results were positive for antibodies to benralizumab in specific assays. Do not use FASENRA if the liquid is cloudy, discolored, or if it contains large particles or foreign particulate matter. Do not expose to heat. Trial 1 and Trial 2, were randomized, double-blind, parallel-group, placebo-controlled, exacerbation trials in patients 12 years of age and older and 48 and 56 weeks in duration, respectively. https://apfed.org/about-ead/eosinophilic-asthma/. The trial included an 8-week run-in period during which the OCS was titrated to the minimum effective dose without losing asthma control. Member has a baseline blood e⦠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. You may see small air bubbles in the liquid. by pushing in the plunger all the way until the plunger head is completely
Across Trials 1, 2, and 3, 1,808 patients received at least 1 dose of FASENRA [see Clinical Studies]. not use FASENRA if the liquid is cloudy, discolored, or if it contains large
Fasenra Financial Assistance. 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]. FASENRA may be kept at room temperature between 68°F to 77°F (20°C to 25°C) for a maximum of 14 days. The time to first exacerbation was longer for the patients receiving FASENRA compared with placebo in Trial 1 (Figure 2). For more information about safe sharps disposal, and for specific information about sharps disposal in the area that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. Administer FASENRA into the thigh or abdomen. Fasenrais administered as a subcutaneous injection. Once removed from the refrigerator and brought to room temperature FASENRA must be used within 14 days or thrown away. If patients become infected while receiving treatment with FASENRA and do not respond to anti-helminth treatment, discontinue treatment with FASENRA until infection resolves. or give the injection without pinching the skin. The Asthma Control Questionnaire-6 (ACQ-6) and Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) were assessed in Trials 1, 2 and 3. Read this Instructions for Use before you start using your FASENRA PEN and each time you get a refill. At Clara, it is our core belief that each and every patient should have the ability to access the most advanced healthcare treatments currently available and we are on a mission to make this process as seamless as possible. Dose-dependent reductions in blood eosinophils were observed. fainting, dizziness, feeling lightheaded (low blood pressure). Use FASENRA within 14 days of removing from the refrigerator. recommended injection site (i.e., upper arm, thigh,
Compared with placebo,
See additional information. FASENRA PEN is intended for administration by patients/caregivers. (fas-en-rah)
The single-dose prefilled syringe contains a 1 mL glass syringe with a staked 29 gauge ½ inch stainless steel needle. While a dosing regimen of FASENRA every 4 weeks was included in clinical trials, FASENRA administered every 4 weeks for 3 doses, then every 8 weeks thereafter is the recommended dose [see DOSAGE AND ADMINISTRATION]. There may be new information. All Right Reserved. Lung function, as measured by the change from baseline in FEV1 at Week 12 was improved in the benralizumab treatment group compared to placebo. The active ingredient in Fasenra (Benralizumab) attaches to receptors on the surface of eosinophils and triggers the body’s immune system to attack them. Eosinophilic asthma is a rare subtype of asthma, and often causes severe symptoms. Fasenra must be administered by a healthcare professional.