tezepelumab drug interactions

Tezepelumab (Tezspire) for severe asthma Med Lett Drugs Ther. If you also use a steroid medication, you should not stop using it suddenly. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 29 There were no differences among the three drug administration strategies with regard to the PKs . Tezspire may cause serious side effects including: hives, difficulty breathing, swelling of your face, lips, tongue, or throat, severe dizziness, rash, and red, irritated, or itchy eyes Get medical help right away, if you have any of the symptoms listed above. Tezepelumab - Amgen/AstraZeneca Alternative Names: AMG 157; MEDI-9929; Tezepelumab-ekko; Tezspire Latest Information Update: 24 Oct 2022. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. Corticosteroids (Inhalers), long-acting and short-acting beta-agonists, leukotriene modifiers, etc are reported to be ineffective for the treatment of severe asthmatic patients. Tezepelumab-ekko is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody IgG2 that binds to human TSLP with a dissociation constant of 15.8 pM and blocks its interaction with the heterodimeric TSLP receptor. It is unknown if tezepelumab-ekko will influence a patients response against helminth infections. The most common side effects include arthralgia (joint pain) and pharyngitis (sore throat). Tezepelumab injection may cause side effects. Tezepelumab-ekko is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2). Tezepelumab is the first of a new kind of potential medicines targeting TSLP. Tezepelumab is in a Phase III clinical trial for nasal polyps and other indications. In . Inform patients that tezepelumab does not treat acute asthma symptoms or acute exacerbations. Written by Cerner Multum. WILMINGTON, Del., May 13, 2021 - Detailed results from the pivotal NAVIGATOR Phase III trial showed AstraZeneca and Amgen's tezepelumab, a potential first-in-class treatment, demonstrated superiority across every primary and key secondary endpoint in a broad population of severe asthma patients, compared to placebo when added to standard of . 210 mg subcutaneously every 4 weeks Comments:-This drug is not indicated for the relief of acute bronchospasm or status asthmaticus. Tezepelumab may also be used for purposes not listed in this medication guide. Because tezepelumab is a large protein molecule with a molecular weight of 147,000 Da, the amount in milk is likely to be very low. Tezepelumab is a first-in-class human monoclonal antibody that binds TSLP inhibiting its interaction with TSLP receptor complex. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. WebMD provides information about common drug or vitamin interactions for tezepelumab-ekko subcutaneous. Tezepelumab-ekko injection is used together with other medicines to treat severe asthma. 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED . This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Tezepelumab, a potential first-in-class medicine, when added to standard of care (SoC) achieved a 56% reduction (p<0.001) in AAER over 52 weeks in the overall patient population, compared to . Other drugs may affect tezepelumab, including prescription and over-the-counter medicines, vitamins, and herbal products. UseTezepelumab (Tezspire)exactly as directed on the label, or as prescribed by your doctor. Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE). Tezepelumab is a first-in-class human monoclonal antibody that binds to TSLP, thus inhibiting its interaction with TSLP receptor complex. Structural studies by X-ray crystallography showed that Tezepelumab competes against a critical part of the TSLPR binding site on TSLP. Recent findings In severe asthma and anaphylaxis, we found a . THOUSAND OAKS, Calif., July 7, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. 0% Migraine. Tezepelumab is injected under the skin, usually once every 4 weeks. The Breakthrough Therapy Designation will help us bring tezepelumab to patients as quickly as possible.". TSLP, a molecule involved in airway inflammation, is a cytokine mainly derived from epithelial cells and occupies an upstream position in the asthma inflammatory cascade. TSLP is involved in T2 inflammation within the airway, but also plays a role in the interactions between airway cells and immune cells, which doesn't rely only solely on T2 inflammation. TSLP has been implicated in asthma pathophysiology. Tezepelumab is a human monoclonal antibody (immunoglobulin [Ig] G2) that binds specifically to TSLP, preventing its interaction with its heterodimeric receptor. Tezepelumab (Tezspire) for severe asthma. Dosage form: subcutaneous solution (210 mg/1.91 mL) Importance of informing patients of other important precautionary information. Written by ASHP. Fig.1 Mechanism of Action of Tezepelumab Table 1. Tezepelumab-ekko was present in the milk of cynomolgus monkeys postpartum following dosing during pregnancy. What are the possible side effects of tezepelumab (Tezspire)? DOI: 10.1007/s40265-022-01679-2. Tezspire is a monoclonal antibody, or more specifically, a thymic stromal lymphopoietin (TSLP) blocker. "Tezepelumab is the first and only asthma biologic to consistently demonstrate in randomized trials clinically meaningful exacerbation reductions irrespective of key biomarkers, including blood . Blocking this inflammation leads to decreased airway restriction and improved breathing. PMID: 35184265. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Tezepelumab is a humanized monoclonal antibody, . Purpose of review The relationship between asthma and anaphylaxis is not completely defined, and it is necessary to establish their association and find out the influence of factors contributing to their development. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes, ILC2 cells) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in airway inflammation. Version: 1.02. Available for Android and iOS devices. Xolair, Nucala, Tezspire, prednisone, Breo Ellipta, Atrovent, Xopenex, Dulera. Tezepelumab is being developed by AstraZeneca in collaboration with Amgen and is under Priority Review for patients with asthma in the US. Tezepelumab-ekko should not be used to treat acute asthma symptoms or acute exacerbations. Common side effects of tezepelumab may include: This is not a complete list of side effects and others may occur. Tezepelumab is not a fast-acting rescue medicine for asthma attacks or bronchospasms. Tezepelumab targets and blocks thymic stromal lymphopoietin (TSLP), an epithelial cell-derived cytokine that plays a role in a wide range of asthma inflammatory pathways. [3] Tezepelumab - Last updated on October 9, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Tezepelumab is injected under the skin, usually once every 4 weeks. Tezepelumab is a fully human monoclonal IgG2 antibody that specifically ligates TSLP at the level of its binding site for TSLPR, thereby impeding the human TSLP-TSLPR interaction . Tezspire (tezepelumab)." Tezepelumab is not a fast-acting rescue medicine for asthma attacks or bronchospasms. Tezepelumab is used together with other medicines for the maintenance treatment of severe asthma in people 12 years and older and whose asthma is not controlled with their current medication. A healthcare provider will give you this injection. Highly clinically significant. The efficacy and safety of . Interactions are not expected. The safety and effectiveness in patients younger than 12 years of age have not been established. Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. Not for relief of acute bronchospasm or status asthmaticus. Price : $50 * Buy Profile. What are some other side effects of this drug? Tezepelumab-ekko helps prevent severe asthma attacks (exacerbations) and can improve your breathing. Applicable conditions: Infection - Bacterial/Fungal/Protozoal/Viral. Tezepelumab-ekko helps prevent severe asthma attacks (exacerbations) and can improve your breathing. Brand name: Tezspire Animal Data: In a prenatal and postnatal development study in cynomolgus monkeys, tezepelumab-ekko concentrations in milk were up to 0.5% of the maternal serum concentrations after intravenous administration of tezepelumab-ekko up to 300 mg/kg per week (168 times the exposures based on AUC achieved at MRHD). Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Medically reviewed by Drugs.com on Mar 30, 2022. Use of tezepelumab-ekko for this indication is supported by evidence from a total of 82 pediatric patients aged 12 to 17 years enrolled in NAVIGATOR and received treatment with tezepelumab-ekko 210 mg subcutaneously every 4 weeks (n=41) or placebo (n=41). Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Moderate Potential Hazard, Moderate plausibility. Everyday Health is among the federally registered trademarks of Everyday Health, Inc. and may not be used by third parties without explicit permission. Tell your doctor if you are pregnant, plan to get pregnant, or if you are breastfeeding or plan to breastfeed. The second late stage pipeline drug to discuss is Tezepelumab, an asthma drug being developed in collaboration with AstraZeneca. The concomitant use of tezepelumab-ekko and live attenuated vaccines has not been evaluated. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. We comply with the HONcode standard for trustworthy health information. Minimally clinically significant. Instruct patients to inform the healthcare provider that they are taking tezepelumab prior to a potential vaccination. Tezepelumab may also be used for purposes not listed in this medication guide. Available for Android and iOS devices. tezepelumab is a human monoclonal antibody (immunoglobulin g2) that binds specifically to thymic stromal lymphopoietin (tslp), preventing its interaction with the heterodimeric tslp receptor.1,2 tslp is an epithelial-derived cytokine that plays a key role in the initiation and persistence of airway inflammation in asthma by activating multiple Tezepelumab is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2), indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Thymic stromal lymphopoietin (TSLP) may be involved in the immunological response to some helminth infections. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Cerner Multum provides the data within some of the Overview, Uses, Warnings, Side Effects, Pregnancy, Interactions, Dosage, Overdose, and Images sections. You may report side effects to FDA at 1-800-FDA-1088. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Tezspire is a long-term maintenance treatment that helps prevent asthma attacks. Dosage summary: Recommended dosage in pediatric patients 12 years of age is 210 mg administered once every 4 weeks. if you are scheduled to receive or have received a live vaccine recently. Tezspire (tezepelumab-ekko) is a first-in-class human monoclonal antibody indicated for add-on maintenance treatment of severe asthma. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: The most reported adverse reactions have included pharyngitis, arthralgia, and back pain. 5. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment: rash hives 12 years or older: 210 mg subcutaneously every 4 weeks Comments:-This drug is not indicated for the relief of acute bronchospasm or status asthmaticus. By subscribing you agree to the Terms of Use and Privacy Policy. There are 19 drug interactions with Tezspire (tezepelumab). 0% Bronchial secretion retention. You will be watched closely for a short time after each injection, to make sure you do not have an allergic reaction. 3,10 tslp is If a patient becomes infected while on treatment and if they are not responding to treatment, discontinue tezepelumab until the infection resolves. In patients with asthma, the level of TSLP expression in airway tissue has been shown to correlate with airway obstruction and disease severity. Some side effects may not be reported. [5] [9] Contents 1 Medical uses 2 History 3 Society and culture 3.1 Legal status 4 Research 5 References 6 External links AstraZeneca and Amgen's recent discovery has made people optimistic about the antidote to severe asthma. . This medicine will not relieve an asthma attack that has already started. Known hypersensitivity to tezepelumab-ekko or excipients. Interaction highlights: No formal drug interaction studies have been performed with tezepelumab-ekko. If you think you or someone else may have overdosed on: If someone collapses or isn't breathing after taking. Tezepelumab is injected under the skin, usually once every 4 weeks. Overview tezepelumab TSLP antagonist Interaction Characteristics: immunosuppressive effects Avoid/Use Alternative adenovirus vaccine, live cholera vaccine, live dengue tetravalent vaccine, live ebola Zaire vaccine (recombinant), live influenza nasal vaccine, live measles/mumps/rubella vaccine, live rotavirus vaccine, live Does Tezepelumab-Ekko 210 Mg/1.91 Ml (110 Mg/Ml) Subcutaneous Syringe interact with other drugs you are taking? Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. tezepelumab specifically binds to tslp thus inhibiting its interaction with the tslp receptor complex and the consequent downstream activation of a signaling network including several pathways. Tezepelumab is a human monoclonal antibody that blocks thymic stromal lymphopoietin, an epithelial-cell-derived cytokine implicated in the pathogenesis of asthma. Tezepelumab-ekko is available in the following dosage form(s) and strength(s): Injection: 210 mg/1.91 mL (110 mg/mL) solution in a single-dose glass vial. Moderate Tezepelumab (applies to Tezspire) helminth infections Moderate Potential Hazard, Moderate plausibility. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Medically reviewed by Drugs.com on Dec 22, 2021. Despite an excellent safety profile, tezepelumab may be associated with hypersensitivity reactions and increased risk of infection, especially by parasitic helminths. Adis is an information provider. Avoid receiving a "live" vaccine. Final gross price and currency may vary according to local VAT and billing address. 2022 Feb 21;64(1644):25-26. This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT03406078) in the Tezepelumab ARM group. Preclinical data support the role of TSLP in both asthma and AD, indicating that tezepelumab may be effective as a treatment in both diseases. Call your doctor for instructions if you miss an appointment for your tezepelumab injection. You may report side effects to FDA at 1-800-FDA-1088. Also tell them if you smoke, drink alcohol, or use illegal drugs. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or. Applies to tezepelumab: subcutaneous solution. PMID: 35349238 Bookshelf ID: NBK579034 Excerpt No information is available . The FDA grants ODD status to medicines and . Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. No formal drug interaction studies have been performed with TEZSPIRE. Generic name: tezepelumab [TEZ-e-PEL-ue-mab] Follow your doctor's instructions about tapering your dose. A healthcare provider will give you this injection. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tezepelumab and any potential adverse effects on the breastfed infant from tezepelumab or from the underlying maternal condition. Xolair, Nucala, Tezspire, prednisone, Breo Ellipta, Atrovent, Xopenex, Dulera. Thymic stromal lymphopoietin (TSLP) is an innate cytokine, belonging to the group of alarmins, which plays a key pathogenic role in asthma by acting as an upstream activator of . Side effects requiring immediate medical attention Burning, dry, or itching eyes chest tightness discharge, excessive tearing fast heartbeat hives, itching, skin rash hoarseness irritation joint pain, stiffness, or swelling redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid . Tell your doctor if you are pregnant, plan to get pregnant, or if you are breastfeeding or plan to breastfeed. Globally, . You will be watched closely for a short time after each injection, to make sure you do not have an allergic reaction. What are the side effects of Tezepelumab (Tezspire)? Some items may interact with your medicine. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Tezepelumab for severe refractory asthma. Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE). Tezepelumab is used together with other medicines for the maintenance treatment of severe asthma in people 12 years and older and whose asthma is not controlled with their current medication. The rate of reduction is considered clinically meaningful. redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid, swelling of the eyelids, face, lips, hands, or feet, redness, pain, or itching at the injection site. AstraZeneca and Amgen's recent discovery has made people optimistic about the antidote to severe asthma. See Full Prescribing Information for important preparation and administration instructions. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The most common side effects of Tezspire include: sore throat , back pain , Compared with placebo, improvements in annualized asthma exacerbation (rate ratio 0.70; 95% CI 0.34, 1.46) and FEV1 (LS mean change versus placebo 0.17 L; 95% CI -0.01, 0.35) were observed in pediatric patients treated with tezepelumab-ekko. Call your doctor for medical advice about side effects. Xolair, Nucala, prednisone, Breo Ellipta, Atrovent, Xopenex, Dulera. Preliminary results of randomized clinical trials suggest that tezepelumab is characterized by a good safety and efficacy profile in patients with severe, uncontrolled asthma. . Tezepelumab is being developed by AstraZeneca in collaboration with Amgen and is under Priority Review for patients with asthma in the US. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. tezepelumab is a potential first-in-class human monoclonal antibody that inhibits the action of tslp, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma. We do not sell or distribute actual drugs. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working. We're hopeful that tezepelumab, with its unique mechanism of action that targets the top of the inflammatory cascade, could become a potential new medicine to improve outcomes for these patients." A decision on tezepelumab's Priority Review in patients with asthma in the US is expected in Q1 of 2022. Other Interactions Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Email this report to a friend, doctor, or patient. The results of a clinical trial demonstrated that tezepelumab compared to placebo reduced asthma exacerbations in adults with moderate-to-severe poorly controlled asthma. Blocking TSLP with tezepelumab-ekko reduces biomarkers and cytokines associated with inflammation including blood eosinophils, airway submucosal eosinophils, IgE, FeNO, IL-5, and IL-13; however, the mechanism of tezepelumab-ekko action in asthma has not been definitively established. Tezepelumab given as an add-on-therapy to patients with severe uncontrolled asthma has shown safety, tolerability and efficacy. Brand name: Tezspire This list may not describe all possible interactions. This is not a complete list of side effects and others may occur. The safety profile and pharmacodynamic responses in pediatric patients were generally similar to the overall study population. If patients become infected while receiving treatment with tezepelumab-ekko and do not respond to antihelminth treatment, discontinue treatment with tezepelumab-ekko until infection resolves. Initially tested in patients with mild allergic asthma, tezepelumab was shown to be capable of inhibiting several effects induced by an allergen challenge . Most common adverse reactions (incidence 3%) are pharyngitis, arthralgia, and back pain. Available for Android and iOS devices. Tezepelumab-ekko crossed the placenta in cynomolgus monkeys and tezepelumab-ekko serum concentrations were 0.5- to 6.7-fold higher in infants relative to maternal animals. Co-developed by Amgen and AstraZeneca, the drug is available as clear to opalescent, colourless to light yellow solution in a single-dose vial or a pre-filled syringe containing 210mg/1.91ml tezepelumab-ekko . Airway inflammation is an important component in the pathogenesis of asthma. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Weschsler said the. 1 It works by blocking the release of TSLP, a cytokine protein in your body that can cause inflammation. You may report them to the FDA. The benefits of tezepelumab were independent of type 2 status as assessed by blood eosinophil count and IgE level, implying either that these biomarkers are insufficient for assessing type 2 responses in the airway or that TSLP also plays an important role in type 2-low asthma. 2022 Mar;82(4):461-468. We comply with the HONcode standard for trustworthy health information. Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a healthcare provider. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. There were no tezepelumab-ekko related adverse effects on maternal health, pregnancy outcome, embryofetal development, or neonatal growth and development up to 6.5 months of age. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The concentration of tezepelumab-ekko in animal milk does not necessarily predict the concentration of drug in human milk. Amgen USA (2021): Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. TSLP is a cytokine mainly derived from epithelial cells and occupies an upstream position in the asthma inflammatory cascade. and efficacy in OCS-dependent patient with asthma and specific populations and interaction with the influenza vaccination. (2021). Applicable conditions: Infection - Bacterial/Fungal/Protozoal/Viral Patients with helminth infections should be treated prior to therapy with tezepelumab. In: Drugs and Lactation Database (LactMed) [Internet]. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with tezepelumab-ekko. Risk summary: There are no available data on tezepelumab use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.