Anifrolumab

Intravenous
Systemic lupus erythematosus

Withdraw and discard 2 mL of fluid from a 50 or 100 mL NaCl 0.9% infusion bag, then add 2 mL of anifrolumab solution for infusion to the infusion bag. Gently invert the bag to mix. Do not shake. Instructions for reconstitution may vary between countries (refer to specific product guidelines).

Hypersensitivity. Concomitant use with live or live attenuated vaccines.

Patient with chronic or recurrent infections or with a predisposition for infection; active or predisposition for the development or reoccurrence of malignancy. Not recommended for use in patients with severe active lupus nephritis or severe active CNS lupus; active TB; in combination with other biologic therapies (e.g. B-cell-targeted therapies). Pregnancy and lactation.

Significant: Infusion-related reactions, severe hypersensitivity reactions (e.g. anaphylaxis, angioedema), respiratory tract infection, herpes zoster infection (e.g. cutaneous and disseminated herpes zoster). Rarely, malignant neoplasm (e.g. malignant neoplasm of the breast, squamous cell carcinoma).
Respiratory, thoracic and mediastinal disorders: Cough.
Potentially Fatal: Severe infections.

IV: Z (No congenital abnormalities or adverse effects based on inadvertent pregnancies in clinical trials. However, not recommended unless benefits outweigh risks due to limited information.)

Monitor for signs and symptoms of infection, hypersensitivity, and infusion-related reactions.

Potentially Fatal: May enhance the adverse effects of live or live attenuated vaccines.

Description:
Mechanism of Action: Anifrolumab, an immunosuppressive agent, is an IgG₁-kappa human monoclonal antibody that has high specificity and affinity for binding to the subunit 1 of the type 1 interferon receptor (IFNAR). It prevents type I interferon (IFN) signalling, thus blocking its biological activity. Consequently, this blockage inhibits IFN responsive gene expression and reduces inflammatory and immunological processes. Additionally, it induces IFNAR1 internalisation, causing reduced levels of cell surface IFNAR1 available for receptor assembly.
Pharmacokinetics:
Metabolism: Metabolised via the reticuloendothelial system and target IFNAR-mediated elimination pathway by proteolytic enzymes into small peptides and individual amino acids.

Intact vial: Store between 2-8°C. Do not freeze or shake. Protect from light. Diluted solution for infusion: Store between 2-8°C for 24 hours or at 25°C for 4 hours. Do not freeze. Protect from light.

Thuốc ức chế miễn dịch

L04AG11 - anifrolumab ; Belongs to the class of monoclonal antibodies. Used as immunosuppressants.

Anon. Anifrolumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 01/08/2023.

Anon. Anifrolumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/08/2023.

Buckingham R (ed). Anifrolumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/08/2023.

Saphnelo (AstraZeneca). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 01/08/2023.

Saphnelo 300 mg Concentrate for Solution for Infusion (Astrazeneca Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/08/2023.

Saphnelo 300 mg Concentrate for Solution for Infusion (AstraZeneca UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/08/2023.

Saphnelo Injection, Solution (AstraZeneca Pharmaceuticals LP). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/08/2023.