Tezepelumab


Generic Medicine Info
Indications and Dosage
Subcutaneous
Severe asthma
Adult: As add-on maintenance therapy for patients who are inadequately controlled with standard treatment: 210 mg once every 4 weeks.
Child: ≥12 years Same as adult dose.
Contraindications
Hypersensitivity. Concomitant use with live attenuated vaccine.
Special Precautions
Patient with known parasitic (helminth) infection. Not indicated for the treatment of acute asthma symptoms or acute exacerbations, including status asthmaticus. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. anaphylaxis, allergic conjunctivitis, rash); risk of serious infections; serious cardiac events.
General disorders and administration site conditions: Local inj site reactions (e.g. erythema, pain, swelling).
Immune system disorders: Antibody development.
Infections and infestations: Pharyngitis.
Musculoskeletal and connective tissue disorders: Back pain, arthralgia.
SC: Z (Avoid unless benefits outweigh risks. Consult product literature for specific recommendations.)
Monitoring Parameters
Monitor forced expiratory volume in the 1st second (FEV1), peak flow, other pulmonary function tests. Monitor for signs and symptoms of hypersensitivity reactions, infections, uncontrolled or worsening asthma conditions, and cardiac events (e.g. dyspnoea, chest pain, feeling of fainting or being lightheaded, malaise).
Drug Interactions
May enhance the adverse effects of live vaccines.
Action
Description:
Mechanism of Action: Tezepelumab is a recombinant human monoclonal antibody IgG2 lambda. Its exact mechanism of action has not been fully established, but it is known to bind to human thymic stromal lymphopoietin (TSLP), preventing its interaction with heterodimeric TSLP receptor. TSLP inhibition leads to the reduction of inflammatory biomarkers and cytokines associated with airway inflammation (e.g. airway submucosal eosinophils, blood eosinophils, IgE, fraction of expired nitric oxide (FeNO), interleukin (IL)-5, and IL-13).
Onset: Approx 2 weeks.
Pharmacokinetics:
Absorption: Bioavailability: Approx 77%. Time to peak plasma concentration: Approx 3-10 days.
Distribution: Crosses the placenta. Volume of distribution: 3.9 L (central); 2.2 L (peripheral).
Metabolism: Metabolised via proteolytic degradation by enzymes widely distributed in the body.
Excretion: Via intracellular catabolism. Elimination half-life: Approx 26 days.
Storage
Store between 2-8°C. Do not freeze. Do not shake. May be stored between 20-25°C for up to 30 days; discard if unused after 30 days. Do not put back in the refrigerator. Protect from light. Do not expose to heat.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03DX11 - tezepelumab ; Belongs to the class of other systemic drugs used in the treatment of obstructive airway diseases.
References
Anon. Tezepelumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 01/04/2024.

Buckingham R (ed). Tezepelumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/04/2024.

Joint Formulary Committee. Tezepelumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/04/2024.

Paediatric Formulary Committee. Tezepelumab. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 01/04/2024.

Tezepelumab. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 01/04/2024.

Tezepelumab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 01/04/2024.

Tezspire 210 mg Solution for Injection in Pre-filled Syringe (AstraZeneca UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/04/2024.

Tezspire 210 mg Solution for Injection in Pre-filled Syringe or Pen (AstraZeneca AB). MIMS Singapore. http://www.mims.com/singapore. Accessed 01/04/2024.

Tezspire Injection, Solution (Amgen, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/04/2024.

Disclaimer: This information is independently developed by MIMS based on Tezepelumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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