PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

1 ShingrixNovember 22, 2021 Shingrix, Herpes Zoster vaccinePage 1 of 36 PRODUCT MONOGRAPHINCLUDING PATIENT MEDICATION INFORMATIONSHINGRIXH erpes Zoster vaccine (non-live recombinant, AS01 Badjuvanted)Suspension for injection, 50 mcg Varicella Zoster Virus (VZV) glycoprotein E (gE), Intramuscular InjectionActive Immunizing AgentGlaxoSmithKline RoadMississauga, OntarioL5N 6L4 Date of Initial Authorization:October13, 2017 Date of Revision:November 24, 2021 Submission Control Number: 246933 2021 GSK group of companies or its licensorTrademarks are owned by or licensed to theGSK group of companiesShingrixNovember 22, 2021 Shingrix, Herpes Zoster vaccinePage 2 of 36 RECENTMAJOR LABEL CHANGESS ectionDate1 INDICATIONS11/20214 DOSAGE AND ADMINISTRATION, Recommended Dose andDose Adjustment11/20217 WARNINGSAND PRECAUTIONS11/2021 TABLE OF CONTENTSS ections orsubsections that are not applicable at the time of authorization are MAJOR LABEL OF 44 DOSAGE AND Dose and Dosage FORMS, STRENGTHS, COMPOSITION AND 57 WARNINGS AND Reaction 22, 2021 Shingrix, Herpes Zoster vaccinePage 3 of Trial Adverse Adverse Interactions Test of.

2 STABILITY AND HANDLING II: SCIENTIFIC Trials by Zoster (HZ) in Adults aged 50 years and Zoster (HZ) in Immunocompromised (IC) adults 18 years and 3116 NON-CLINICAL MEDICATION 22, 2021 Shingrix, Herpes Zoster vaccinePage 4 of 36 PARTI: HEALTH PROFESSIONAL INFORMATION1 INDICATIONSSHINGRIX is indicated for theprevention of herpes zoster (HZ, or shingles) in: adults 50 years of age or older; adults 18 years of age or older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or (<18 years of age): The safety and efficacy of SHINGRIX in individuals youngerthan 18 years have not been Geriatrics ( 60years of age): The efficacy and safety inindividuals60 years and older were assessed in clinical trials (see 14 CLINICAL TRIALS).

3 2 CONTRAINDICATIONSI ndividualswith a known hypersensitivity to the active substance or to any component of the vaccine. For a complete listing,see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND DOSAGE AND ConsiderationsThis medicinal PRODUCT must not be mixed with other medicinal Dose and Dosage AdjustmentThe primary vaccination schedule consists of two doses of mL each; an initial dose at Month 0 followed by a second doseadministered anytime between2 and 6 months later. Administration of the second dose of SHINGRIX is important to ensure maximum vaccine efficacy and duration of protection against HZ individuals who areor will be immunodeficient, or immunosuppressed and whowould benefit from a shorter vaccination schedule, the second dose can be given 1 to 2 months after the initialdose (see14 CLINICAL TRIALS).

4 The need for booster doses following the primary vaccination schedule has not been can be given with the same vaccination schedule in individuals previously vaccinated with live attenuatedHZ vaccine (see14 CLINICAL TRIALS). is to be reconstituted only with the accompanying adjuvant powder and suspension should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not reconstitute the 22, 2021 Shingrix, Herpes Zoster vaccinePage 5 of is for intramuscular injection only, preferably in the deltoid toprepare SHINGRIX:SHINGRIX must be reconstituted prior to administration. Withdraw the entire contents of the vialcontaining the suspension into a sterilesyringe.

5 Add the entire contents ofthe syringe into the vial containing the lyophilized powder. Shake gently until the lyophilized powder is completely reconstituted vaccineis an opalescent,colourless to pale brownish reconstituted vaccine should be inspectedvisuallyfor any foreign particulate matter and/or variation of appearance. If either is observed, do not administer the reconstitution, the vaccine should be usedpromptly; if this is not possible, the vaccine should be stored in a refrigerator (2 C to 8 C). If not used within 6hours itshould be administration: Withdraw the entire contents of the vial containing the reconstituted vaccineinto a sterilesyringe. Change the needle so that you are using a new needle to administer the unused medicinal PRODUCT or waste material should be disposed of in accordance with local DoseIf you miss a scheduled injection, it is important that you make another OVERDOSAGENo cases of overdosage have been management of a suspected drugoverdose, contact your regional poison control DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGINGTo help ensure the traceability of vaccines for PATIENT immunization record-keeping aswell as safetymonitoring, health professionals should record the time and date of administration, quantity of administered dose(if applicable)

6 , anatomical site and route of administration, brand name and generic name of the vaccine, the PRODUCT lot number and expiry 22, 2021 Shingrix, Herpes Zoster vaccinePage 6 of 36 Table 1 Route of Administration,Dosage Form/Strength and Non-medicinal IngredientsDosage FormSHINGRIX is a suspension for injection supplied as a single-dose vial of lyophilized glycoprotein E (gE) to be reconstitutedwith the accompanying vial of adjuvant suspension. A single dose after reconstitution is lyophilizedpowder is suspension is an opalescent, colourless to pale brownish liquid. CompositionAfter reconstitution, one dose( mL) contains:Varicella Zoster Virus gE1 50 mcgQuillaja saponariaMolina fraction 21 (QS-21)2 50 mcg3-O-desacyl-4 -monophosphoryl lipid A (MPL)2 50 mcgAdditional Excipients Powder (gE):Dipotassium phosphatePolysorbate 80 Sodiumdihydrogen phosphate dihydrateSucroseSuspension (AS01 BAdjuvant System).

7 CholesterolDioleoyl phosphatidylcholineDisodium phosphate anhydrousPotassium dihydrogen phosphateSodium chlorideWater for injection1 Varicella Zoster Virus (VZV) glycoprotein E (gE) produced by recombinant DNA technology in Chinese Hamster Ovarycells2 The AS01 BAdjuvantSystem is composed of the plant extract Quillaja saponariaMolina, fraction 21 (QS-21) (50 mcg) and 3-O-desacyl-4 -monophosphoryl lipid A (MPL) from Salmonella minnesota(50 mcg) combined with dioleoyl phosphatidylcholine (DOPC) (1 mg) andcholesterol ( mg)Routeof AdministrationDosage Form / Strengthper mL doseNon-medicinal IngredientsIntramuscular injectionSuspension for injection/50 mcg Varicella Zoster Virus (VZV) glycoprotein E (gE) Cholesterol, dioleoyl phosphatidylcholine, dipotassiumphosphate, disodium phosphate anhydrous, polysorbate 80, potassium dihydrogen phosphate, Quillaja saponariaMolina, fraction 21 (QS-21), 3-O-desacyl-4 -monophosphoryllipid A (MPL), sodium chloride, sodium dihydrogen phosphate dihydrate,sucrose, water for injectionShingrixNovember 22, 2021 Shingrix, Herpes Zoster vaccinePage 7 of 36 PackagingSHINGRIX is available as two components.

8 Single dose lyophilized gE in a vial (type I glass) witha stopper (butyl rubber), with brown caps Single dose adjuvant suspension in a vial (type I glass) with a stopper(butyl rubber), with blue-green caps SHINGRIX is available in pack sizes (packaged without syringes or needles) of: 1 vial oflyophilized powder plus 1 vial of adjuvantsuspension 10 vials of lyophilized powder plus 10 vials of adjuvant suspensionDescriptionSHINGRIX is a sterile, non-live vaccine for intramuscular injection. The vaccine is supplied as a vialof lyophilized recombinant varicella zoster virus surface glycoprotein E (VZV gE) which is reconstituted at the time of use withthe accompanying vial of AS01 Badjuvant WARNINGSAND PRECAUTIONSG eneralPrior to immunizationIt is good clinicalpractice to precede vaccinationby areview ofthe medical history (especially with regards to previous vaccination and possibleoccurrence of undesirable events)

9 And a clinical 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 with any vaccine, a protective immune response may not be elicited in all vaccinees. Precautions for useDo not administer the vaccine intravascularly, intradermally or subcutaneously. Maladministration via thesubcutaneous route may lead to an increase in transient local is not indicated for prevention ofprimary varicella infection or for the treatment of herpes zoster (HZ) or postherpetic neuralgia (PHN).Concomitant use of vaccines Fever and shivering were more frequent when PPV23 vaccineis co-administered with IllnessAs with other vaccines, vaccination with SHINGRIX should be postponed in individualssuffering from an acute severefebrile illness.

10 The presence of aminor infection, such as a cold, should not result in the deferral of 22, 2021 Shingrix, Herpes Zoster vaccinePage 8 of 36 HematologicAs withother vaccines administered intramuscularly, SHINGRIX should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleedingmay occur following an intramuscular administrationto these a post-marketing observational study in individuals aged 65 years or older, an increased risk of Guillain-Barr 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.