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Reducing risk of Shingles disease in adults aged ≥ 501 97% Vaccine efficacy1 97.2% (95% CI: 93.7-99.0) Adults 50 years of age or older2 Adults 18 years of age or older at increased risk of HZ . ≥50 ≥18 2 INDICATIONS Shingrix is indicated for the prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in *Results from a randomized, placebo-controlled, phase 3 study to evaluate the efficacy and safety of HZ in older adults ≥50 years of age who received two intramuscular doses of the vaccine or placebo 2 months apart: a total of 15,411 participants who could be evaluated received either the vaccine (7698 participants) or placebo (7713 participants; the mean followup period was 3.2 years1 . PM-TH-SGX-EPNL-230001 Date of approval: August 2023 ©2023 GSK group of companies or its licensor. Further distribution in any manner including screen capture, photo taking, or any similar kind of actions are legally prohibited. Trademarks are owned by or licensed to the GSK group of companies. References: 1) Lal H, Cunningham AL, Godeaux O, et al, for the ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087-96. 2) GSK Shingles vaccine IM GDS07/IPI02 TH 01/23. Abbreviated Prescribing Information: Shingrix. Qualitative and quantitative composition: After reconstitution, 1 dose (0.5 ml) contains 50 micrograms of gE antigen1 adjuvanted with AS01B2. 1 Varicella Zoster Virus (VZV) glycoprotein E (gE) produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells 2 The GlaxoSmithKline proprietary AS01B Adjuvant System is composed of the plant extract Quillaja saponaria Molina, fraction 21 (QS-21) (50 micrograms) and 3-O-desacyl4’-monophosphoryl lipid A (MPL) from Salmonella minnesota (50 micrograms) The powder is white. The suspension is an opalescent, colourless to pale brownish liquid. Therapeutic Indications: prevention of herpes zoster (HZ) and HZ-related complications, such as postherpetic neuralgia (PHN), in: • adults 50 years of age or older; • adults 18 years of age or older at increased risk of HZ. Method of administration: Shingrix is for intramuscular injection only, preferably in the deltoid muscle. Contraindications: Hypersensitivity to the active substances or to any component of the vaccine. Special Warnings and Precautions for Use: Prior to immunization: It is good clinical practice to precede vaccination by a review of the medical history and a clinical examination. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. As with other vaccines, vaccination with Shingrix should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination. As with any vaccine, a protective immune response may not be elicited in all vaccinees. In a post-marketing observational study in individuals aged 65 years or older, an increased risk of Guillain-Barré syndrome (estimated 3 excess cases per million doses administered) was observed during the 42 days following vaccination with Shingrix. Available information is insufficient to determine a causal relationship with Shingrix. Precautions for use: Do not administer the vaccine intravascularly, intradermally or subcutaneously. Maladministration via the subcutaneous route may lead to an increase in transient local reactions. As with other vaccines administered intramuscularly, Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints. Interaction with Other Medicinal Products and Other Forms of Interactions. Use with other vaccines: Shingrix can be given concomitantly with unadjuvanted seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23), pneumococcal conjugate vaccine (PCV) or reduced antigen diphtheria-tetanus-acellular pertussis vaccine (dTpa). The adverse reactions of fever and shivering were more frequent when PPV23 vaccine was co-administered with Shingrix compared to when Shingrix was given alone. If Shingrix is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites. Pregnancy and Lactation: Fertility. Animal studies indicate no effects of Shingrix on male or female fertility. Pregnancy. There are no data on the use of Shingrix in pregnant women. Animal studies performed with Shingrix administered to female rats do not indicate any harmful effects with respect to pregnancy. Lactation. The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied. Undesirable Effects: Very common (≥1/10): headache, gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), myalgia, injection site reactions (such as pain, redness, swelling), fatigue, chills, fever. Common (≥1/100 to <1/10): injection site pruritus, malaise. Uncommon (≥1/1,000 to <1/100): arthralgia. Rare (≥1/10,000 to <1/1,000) from post-marketing data: hypersensitivity reactions including rash, urticaria, angioedema. Overdose: Insufficient data are available. List of excipients: Powder (gE antigen): Sucrose, Polysorbate 80, Sodium dihydrogen phosphate dihydrate, Dipotassium phosphate. Suspension (AS01B Adjuvant System): Dioleoyl phosphatidylcholine, Cholesterol, Sodium chloride, Disodium phosphate anhydrous, Potassium dihydrogen phosphate, Water for injections. Version number: IM GDS07/IPI02 TH 01/23 (P). Full Prescribing Information is available upon request. Please read the full prescribing information prior to administration, available fromGlaxoSmithKline(Thailand)Ltd., 12thfloor,Wave Place 55Wireless Road,Lumpini, Pathum Wan, Bangkok 10330. GSK is committed to the effective collection and management of human safety information relating to our products and we encourage HCPs to report adverse events to us on [email protected]. Abb RZV IM GDS07/IPI02 TH 01/23 (P). เป็นยาใหม่ ใช้เฉพาะสถานพยาบาล แพทย์ควรติดตามผลการใช้ยา เลขทะเบียนยา 1C 9/66 (NBC) | ใบอนุญาตโฆษณาเลขที่ ฆศ. 2-xxx/2566 | ความถูกต้องของโฆษณานี้เป็นความรับผิดชอบของผู้โฆษณา มิได้ด�ำเนินการ โดยส�ำนักงานคณะกรรมการอาหารและยา