Sumatriptan: Package Insert and Label Information (Page 4 of 4)

Sumatriptan Injection, USP (autoinjector) Instructions for use of Disposable Sumatriptan Injection (autoinjector)

These instructions apply to both the 4 mg and 6 mg dose Sumatriptan Injection (autoinjector). Make sure that you have the dose that has been prescribed for you (the 4 mg autoinjector safety cap is yellow, the 6 mg autoinjector safety cap is blue).

Read this Patient Instructions for Use before you start to use your autoinjector. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about sumatriptan injection when you start taking it and at regular checkups.

Each autoinjector is a single dose, disposable device.

Important things that you need to know:

  • Use the autoinjector immediately once the cap has been removed; it is advised not to postpone the injection.
  • Keep the autoinjector out of reach of children.
  • If you have any further questions, ask your doctor or pharmacist.
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Getting ready for the injection:

  • Wash your hands thoroughly.
  • Before injecting, identify an area with an adequate fatty tissue layer on the outer thigh or back of the arm.
  • Do not inject into areas where the skin is tender, bruised, red, or hard.
  • Ask your healthcare provider if you have a question about where to inject your medicine.
  • Clean the skin area to be injected with alcohol and cotton wipe. Do not touch this area again before giving the injection.

STEP 1: INSPECT VIEWING WINDOW

  • Check the viewing window; make sure the window is clear. See Figure B.
  • Do not inject the solution if it looks discolored or cloudy or contains lumps, flakes, or particles.
  • Do not remove safety cap until you are ready to give an injection.
  • Do not touch the blue injection button on top of the autoinjector until ready to inject.
  • A tamper-evident seal can be found on the flat side of the autoinjector at the safety cap. DO NOT use the autoinjector if this safety seal is broken.
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STEP 2: REMOVE SAFETY CAP

  • Twist and remove the safety cap. See Figure C.
  • The autoinjector is ready only when the safety cap is removed.
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STEP 3: INSERT THE NEEDLE

  • Without pressing the blue button , place the needle guard against the injection site at a 90° angle. See Figure D.
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  • To insert the needle, firmly push the autoinjector against the skin until the needle guard is pushed in as far as it will go. See Figure E. You may feel the needle being inserted as you push .
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Figures F or G: injection sites.

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STEP 4: INJECT THE DRUG

  • While holding the autoinjector firmly against the skin, push the Blue Button until you hear an audible “click” signaling the start of the injection. Hold the Blue Button for 5 seconds to complete the injection. See Figure H.
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STEP 5: CONFIRM SUCCESSFUL INJECTION

  • After 5 seconds , carefully remove the autoinjector from the injection site.
  • The needle guard should automatically cover the needle and lock in this position. See Figure I.
  • The viewing window will be blue confirming the injection is complete. See Figure I.
  • If the viewing window is not blue, DO NOT try to use the autoinjector again.
  • DO NOT repeat the injection using a new autoinjector.
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STEP 6: Dispose of Sumatriptan Injection (autoinjector)

  • ​Discard the whole autoinjector after use.
  • DO NOT attempt to reuse the autoinjector

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured In Israel For:
Antares Pharma, Inc.
Ewing, NJ 08628

Distributed by: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

05/2018

LB-0065 V03

PRINCIPAL DISPLAY PANEL — 6 mg/0.5 mL Syringe

SUMATRIPTAN 6 MG 0.5 ML AUTOINJECT -- 06-04-2018 APPROVED -- PO 21460 -- 60429-994-01OL.jpg
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PRINCIPAL DISPLAY PANEL — 6 mg/0.5 mL Carton

SUMATRIPTAN 60 MG-0.5ML AUTO INJECT REV MAR 2016.jpg
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SUMATRIPTAN sumatriptan succinate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-994(NDC:0093-2014)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN SUCCINATE (SUMATRIPTAN) SUMATRIPTAN 6 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 3.5 mg in 0.5 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-994-02 2 SYRINGE in 1 CARTON contains a SYRINGE (60429-994-01)
1 NDC:60429-994-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (60429-994-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078319 12/10/2015
Labeler — Golden State Medical Supply Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply Inc. 603184490 repack (60429-994), relabel (60429-994)

Revised: 09/2019 Golden State Medical Supply Inc.

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