Cosentyx SENSOREADY PEN Скачать руководство пользователя страница 6

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CONSUMER BRIEF SUMMARY

How should I use COSENTYX®?
See the detailed “Instructions for Use” that comes with your 

COSENTYX for information on how to prepare and inject a  

dose of COSENTYX, and how to properly throw away (dispose 

of) used COSENTYX Sensoready® pens and prefilled syringes.

•  Use COSENTYX exactly as prescribed by your healthcare 

provider.

•  If your healthcare provider decides that you or a caregiver may 

give your injections of COSENTYX at home, you should receive 

training on the right way to prepare and inject COSENTYX. Do 

not try to inject COSENTYX yourself, until you or your caregiver 

has been shown how to inject COSENTYX by your healthcare 

provider.

•  COSENTYX comes in a Sensoready pen or prefilled syringe that 

you or your caregiver may use at home to give injections. Your 

healthcare provider will decide which type of COSENTYX is best 

for you to use at home.

•  Your healthcare provider will prescribe the dose of COSENTYX 

that is right for you.

  If your prescribed dose of COSENTYX is 

150 mg

, you must give 

1 injection

 of COSENTYX for each dose.

  If your prescribed dose of COSENTYX is 

300 mg

, you must give 

2 injections

 for each dose.

•  COSENTYX is given as an injection under your skin (subcutaneous 

injection), in your upper legs (thighs) or stomach-area (abdomen) 

by you or a caregiver. A caregiver may also give you an injection 

of COSENTYX in your upper outer arm.

• 

 Do  not

 give an injection in an area of the skin that is tender, 

bruised, red or hard, or in an area of skin that is affected by 

psoriasis.

•  Each injection should be given at a different site. 

Do not

 use the 

2-inch area around your navel (belly button).

•  If you inject more COSENTYX than prescribed, call your 

healthcare provider or go to the nearest emergency room right 

away.  

What are the possible side effects of COSENTYX?
See “What is the most important information I should know 

about COSENTYX?”

•  

Inflammatory bowel disease.

 New cases of inflammatory 

bowel disease or “flare-ups” can happen with COSENTYX, 

and can sometimes be serious. If you have inflammatory 

bowel disease (ulcerative colitis or Crohn’s disease), tell your 

healthcare provider if you have worsening disease symptoms 

during treatment with COSENTYX or develop new symptoms  

of stomach pain or diarrhea.

•  

Serious allergic reactions.

 Get emergency medical help right 

away if you get any of the following symptoms of a serious 

allergic reaction:

 

 feel faint  

 

  swelling of your face, 

eyelids, lips, mouth, tongue, 

or throat

 

  trouble breathing or throat 

tightness

 

 chest tightness

 

 skin rash

If you have a severe allergic reaction, do not give another 

injection of COSENTYX.
The most common side effects of COSENTYX include:

• cold symptoms

• diarrhea

• upper respiratory infections
These are not all of the possible side effects of COSENTYX.
Call your doctor for medical advice about side effects. You may 

report side effects to FDA at 1-800-FDA-1088.

Keep COSENTYX and all medicines out of the reach  

of children.

General information about the safe and effective use  

of COSENTYX

Medicines are sometimes prescribed for purposes other than 

those listed in a Medication Guide. Do not use COSENTYX for a 

condition for which it was not prescribed. Do not give COSENTYX 

to other people, even if they have the same symptoms you have. It 

may harm them.
You can ask your healthcare provider or pharmacist for 

information about COSENTYX that is written for health 

professionals.

What are the ingredients in COSENTYX?
Active ingredient:

 secukinumab

Inactive ingredients: Sensoready pen and prefilled syringe: 

L-histidine/histidine hydrochloride monohydrate, L-methionine, 

polysorbate 80, trehalose dihydrate, and sterile water for 

injection.

Vial:

 L-histidine/histidine hydrochloride monohydrate, polysorbate 

80, and sucrose.

Visit 

COSENTYX.com

 for more information.

Содержание SENSOREADY PEN

Страница 1: ...itis PsA with active ankylosing spondylitis AS IMPORTANT SAFETY INFORMATION Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX See the Medication Guide for a complete list of ingredients Please see Important Safety Information throughout this brochure Please see Consumer Brief Summary on pages 8 11 Visit COSENTYX com for more i...

Страница 2: ...f your doctor feels that you are at risk for TB you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX Your doctor should watch you closely for signs and symptoms of TB during treatment with COSENTYX Do not take COSENTYX if you have an active TB infection This brochure contains photos of actual patients who have been compensated for thei...

Страница 3: ...for Use on pages 8 17 keep these tips in mind Take COSENTYX out of the refrigerator 15 30 minutes before injecting to allow it to come to room temperature Setting a timer after you remove it from the fridge may be helpful Clean the skin where you plan to inject with an alcohol wipe before using the Sensoready Pen When injecting with your Sensoready Pen remember to Click Watch Click Wait STEP 1 CLI...

Страница 4: ...onstration Video at YouTube com COSENTYX NEED A REFRESHER ON HOW TO INJECT Our team of dedicated support specialists is here to help Call 1 844 267 3689 between 8 AM and 8 PM ET to schedule live virtual injection training get your questions about using the Sensoready Pen answered and more A FEW THINGS TO CONSIDER These are just some of the Sensoready Pen instructions Keep the following in mind Use...

Страница 5: ...r healthcare provider See What are the possible side effects of COSENTYX for more information about side effects What is COSENTYX COSENTYX is a prescription medicine used to treat adults with moderate to severe plaque psoriasis that involves large areas or many areas of the body and who may benefit from taking injections or pills systemic therapy or phototherapy treatment using ultraviolet or UV l...

Страница 6: ...ffects of COSENTYX See What is the most important information I should know about COSENTYX Inflammatory bowel disease New cases of inflammatory bowel disease or flare ups can happen with COSENTYX and can sometimes be serious If you have inflammatory bowel disease ulcerative colitis or Crohn s disease tell your healthcare provider if you have worsening disease symptoms during treatment with COSENTY...

Страница 7: ...ns for Use before injecting COSENTYX Your healthcare provider should show you how to prepare and inject COSENTYX properly using the Sensoready Pen before you use it for the first time Talk to your healthcare provider if you have any questions Important Do not use the COSENTYX Sensoready Pen if either the seal on the outer carton or the seal on the pen is broken Keep the COSENTYX Sensoready Pen in ...

Страница 8: ...ch is normal Look at the expiration date EXP on your Sensoready Pen Do not use your COSENTYX Sensoready Pen if the expiration date has passed Contact your pharmacist if the COSENTYX Sensoready Pen fails any of these checks Figure D VIEWING WINDOW WHAT YOU NEED FOR YOUR INJECTION Included in the carton A new COSENTYX Sensoready Pen see Figure B Each COSENTYX Sensoready Pen contains 150 mg of COSENT...

Страница 9: ...on of the arrow see Figure H Throw away the cap Do not try to re attach the cap Use the COSENTYX Sensoready Pen within 5 minutes of removing the cap Figure H Figure G STEP 2 Choose your injection site The recommended site is the front of the thighs You may also use the lower abdomen but not the area 2 inches around your navel belly button see Figure E Choose a different site each time you give you...

Страница 10: ...k This indicates the injection is almost complete Check the green indicator fills the window and has stopped moving see Figure K The COSENTYX Sensoready Pen can now be removed Figure K Figure J STEP 5 Holding your COSENTYX Sensoready Pen Hold the COSENTYX Sensoready Pen at 90 degrees to the cleaned injection site see Figure I IMPORTANT During the injection you will hear 2 loud clicks The 1st click...

Страница 11: ...n about safe sharps disposal and for specific information about sharps disposal in the state that you live in go to the FDA s website at http www fda gov safesharpsdisposal Figure M INSTRUCTIONS FOR USE AFTER YOUR INJECTION STEP 8 Check the green indicator fills the window see Figure L This means the medicine has been delivered Contact your healthcare provider if the green indicator is not visible...

Страница 12: ...e see Important Safety Information throughout this brochure Please see Consumer Brief Summary on pages 8 11 Visit COSENTYX com for more information Once I learned how to use the pen I was on my way MARK ACTUAL PATIENT WITH AS ...

Страница 13: ... TAKING COSENTYX AT YOUTUBE COM COSENTYX Please see Important Safety Information throughout this brochure Please see Consumer Brief Summary on pages 8 11 VISIT COSENTYX COM FOR MORE INFORMATION Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936 1080 2018 Novartis Printed in USA 6 18 COS 1358660 ...

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