Trim Bleed SHINGRIX RECONSTITUTION - GSKpro · adverse reactions, contraindications and drug...

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SHINGRIX is indicated for the prevention of herpes zoster (HZ, or shingles) in adults 50 years of age or older. 1 SHINGRIX, ADMINISTERED AS 2 DOSES, CAN HELP PROTECT YOUR PATIENTS AGED 50+ FROM SHINGLES 1 1 4 2 5 3 6 Withdraw the entire contents of the vial containing the suspension into a sterile syringe. AS01B Adjuvant Lyophilized VZV gE Inspect the vaccine for any foreign particulate matter and/or variation of appearance. If either is observed, do not administer the vaccine. Add the entire contents of the syringe into the vial containing the lyophilized powder. Withdraw the entire contents of the vial containing the reconstituted vaccine into a sterile syringe. Shake gently until the lyophilized powder is completely dissolved. It should be an opalescent, colourless to pale brownish liquid. Change the needle so you are using a new needle to administer the vaccine. SHINGRIX RECONSTITUTION 1 SHINGRIX is to be reconstituted only with the accompanying adjuvant suspension Refer to product monograph for complete dosing and administrative information. DIN: 02468425 RECOMMEND SHINGRIX TO HELP PROTECT YOUR PATIENTS AGED 50+ FROM SHINGLES 04/18 02608 Most serious warnings and precautions: Administration: Do not administer the vaccine intravascularly, intradermally or subcutaneously Other relevant warnings and precautions: • A protective immune response may not be elicited in all vaccinees Not for prevention of primary varicella infection or treatment of HZ or postherpetic neuralgia • Postpone in those with acute severe febrile illness Use with caution in those with thrombocytopenia or any coagulation disorder • Syncope following or before any vaccination as a psychogenic response Use in special populations such as pregnant or nursing women or pediatrics (<18 years of age) has not been established Limited data in immunocompromised adults 50 years of age or older Adverse events: Solicited local and general adverse reactions that occurred in clinical trials within 7 days of vaccination in subjects aged 50–69 and ≥70 years respectively were: pain (85.6%, 69.2%), redness (38.5%, 37.7%), swelling at the injection site (28.5%, 23.0%), myalgia (53.0%, 35.1%), fatigue (51.3%, 36.6%), headache (45.2%, 29.0%), shivering (33.1%, 19.5%), fever (25.9%, 14.3%), gastrointestinal symptoms (20.5%,13.5%) Unsolicited adverse reactions that occurred in clinical trials within 30 days of vaccination in ≥1% of subjects and ≥2-fold higher than placebo recipients included chills (3.5%), injection site pruritus (2.2%), and malaise (1.7%) For more information: Please consult the product monograph at gsk.ca/SHINGRIX/PM for important information relating to dosing and administration, adverse reactions, contraindications and drug interactions which have not been discussed in this piece. To request a product monograph, or to report an adverse event please call 1-800-387-7374. Reference: 1. SHINGRIX Product Monograph, GlaxoSmithKline Inc., October 13, 2017. Trademarks are owned by or licensed to the GSK group of companies. ©2018 GSK group of companies or its licensor. Learn more at ThinkSHINGRIX.ca FPO

Transcript of Trim Bleed SHINGRIX RECONSTITUTION - GSKpro · adverse reactions, contraindications and drug...

Page 1: Trim Bleed SHINGRIX RECONSTITUTION - GSKpro · adverse reactions, contraindications and drug interactions which have not been discussed in this piece. To request a product monograph,

SHINGRIX is indicated for the prevention of herpes zoster (HZ, or shingles) in adults 50 years of age or older.1

SHINGRIX, ADMINISTERED AS 2 DOSES, CAN HELP PROTECT YOUR PATIENTS AGED 50+ FROM SHINGLES1

1

4

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6

Withdraw the entire contents of the vial containing the suspension into a sterile syringe.

AS01B Adjuvant Lyophilized VZV gE

Inspect the vaccine for any foreign particulate matter and/or variation of appearance. If either is observed, do not administer the vaccine.

Add the entire contents of the syringe into the vial containing the lyophilized powder.

Withdraw the entire contents of the vial containing the reconstituted vaccine into a sterile syringe.

Shake gently until the lyophilized powder is completely dissolved. It should be an opalescent, colourless to pale brownish liquid.

Change the needle so you are using a new needle to administer the vaccine.

SHINGRIX RECONSTITUTION1 SHINGRIX is to be reconstituted only with the accompanying adjuvant suspension

Refer to product monograph for complete dosing and administrative information.

DIN: 02468425

RECOMMEND SHINGRIX TO HELP PROTECT YOUR PATIENTS AGED 50+ FROM SHINGLES

04/18 02608

Most serious warnings and precautions:• Administration: Do not administer the vaccine intravascularly,

intradermally or subcutaneously

Other relevant warnings and precautions:• A protective immune response may not be elicited in all vaccinees• Not for prevention of primary varicella infection or treatment of HZ

or postherpetic neuralgia• Postpone in those with acute severe febrile illness• Use with caution in those with thrombocytopenia or any

coagulation disorder• Syncope following or before any vaccination as a psychogenic response• Use in special populations such as pregnant or nursing women or

pediatrics (<18 years of age) has not been established• Limited data in immunocompromised adults 50 years of age or older

Adverse events:• Solicited local and general adverse reactions that occurred in clinical

trials within 7 days of vaccination in subjects aged 50–69 and ≥70 years

respectively were: pain (85.6%, 69.2%), redness (38.5%, 37.7%), swelling at the injection site (28.5%, 23.0%), myalgia (53.0%, 35.1%), fatigue (51.3%, 36.6%), headache (45.2%, 29.0%), shivering (33.1%, 19.5%), fever (25.9%, 14.3%), gastrointestinal symptoms (20.5%,13.5%)

• Unsolicited adverse reactions that occurred in clinical trials within 30 days of vaccination in ≥1% of subjects and ≥2-fold higher than placebo recipients included chills (3.5%), injection site pruritus (2.2%), and malaise (1.7%)

For more information:Please consult the product monograph at gsk.ca/SHINGRIX/PM for important information relating to dosing and administration, adverse reactions, contraindications and drug interactions which have not been discussed in this piece. To request a product monograph, or to report an adverse event please call 1-800-387-7374.

Reference: 1. SHINGRIX Product Monograph, GlaxoSmithKline Inc., October 13, 2017.

Trademarks are owned by or licensed to the GSK group of companies.©2018 GSK group of companies or its licensor.

Learn more at ThinkSHINGRIX.ca

FPO HELP PROTECT YOUR PATIENTS FPO

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Page 2: Trim Bleed SHINGRIX RECONSTITUTION - GSKpro · adverse reactions, contraindications and drug interactions which have not been discussed in this piece. To request a product monograph,

Supplied as 2 vials for reconstitution:SHINGRIX is to be reconstituted only with the accompanying adjuvant suspension.

Refrigerate, do NOT freeze:Prior to reconstitution, the vaccine should be stored between 2°C and 8°C.

After reconstitution, the vaccine should be used promptly. If not possible, the vaccine is stable for 6 hours after reconstitution when refrigerated, after which it should be discarded.

Intramuscular (IM) injection only:Preferably in the deltoid muscle.

SHINGRIX STORAGE AND ADMINISTRATION1

Refer to the product monograph for complete dosing and administration information.

MAKE SURE YOUR PATIENTS GET BOTH DOSES OF SHINGRIX1 Steps to consider to ensure your patients complete the 2-dose series

* Pooled data on solicited local and general adverse events were collected using standardized diary cards for 7 days following each vaccine dose or placebo (i.e., day of vaccination and the next 6 days) in a subset of subjects (n=4,884 receiving SHINGRIX, n=4,880 receiving placebo with at least one documented dose in the ZOE-50 and ZOE-70 studies).

† Fever defined as ≥37.5ºC/99.5ºF for oral, axillary, or tympanic route, or ≥38ºC/100.4ºF for rectal route.‡ Gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.

Schedule the second dose immediately:Patients can receive the second dose in as soon as 2 months (and any time between 2–6 months).1

Reminders:Set a date, provide an appointment card, and encourage your patients to visit SHINGRIX.ca to sign up to receive text or email reminders.

Set expectations:• Patients may experience local adverse reactions after receiving SHINGRIX.

In clinical trials, the most common adverse reactions were pain, redness, swelling at the injection site, myalgia, fatigue, headache, fever† and gastrointestinal symptoms.‡1*

• The majority of solicited local adverse reactions and general adverse events seen with SHINGRIX were mild to moderate and were not long-lasting (median duration of 3 days).1

SHINGRIX IS GIVEN AS A 2-DOSE SERIES:1 Timing of the second dose can provide flexibility for you and your patients

The second dose of SHINGRIX is important to ensure maximum vaccine efficacy and duration of protection.1

The need for booster doses following the primary vaccination schedule has not been established.

0 1 2 3 4 5 6

1st Dose 2nd Dose

Initial dose: 0.5 mL at month 0

2nd dose: 0.5 mL anytime between 2 and 6 months later

MONTHS

Recommended dosing1

Explain the importance of 2 doses to your patient1

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April 24/18 Cindy 10897212

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