March 25, 2017
Recommended Topic Related To:

Omnitrope

"An investigational long-acting form of recombinant human growth hormone (rhGH) given twice a month has achieved efficacy and safety at 2 years, new data show.

The novel long-acting recombinant human growth hormone fusion protein somav"...

A A A

Omnitrope




PATIENT INFORMATION

OMNITROPE® PEN 10 INSTRUCTIONS FOR USE

Omnitrope
(om-KNEE-trope)
(somatropin) injection, for subcutaneous use 10 mg/1.5 mL cartridges for use with Omnitrope Pen 10

Read these Instructions for Use before you start using Omnitrope Pen 10 and each time you get a refill. There may be new information. This information does not take the place of talking to the healthcare provider about the medical condition or the treatment.

Note:

  • Omnitrope is for use under the skin only (subcutaneous).
  • Do not share your Omnitrope Pen or needles with anyone else. You may give an infection to them or get an infection from them.
  • The “Start use by no later than” date, presented in year and month on the outer carton, indicates the date after which therapy should not be initiated with this pen.

Omnitrope Pen 10, cartridge containing Omnitrope, needle, alcohol swab and storage case:

Figure A

Supplies needed - Illustration

Supplies you will need to give an Omnitrope Injection. See Figure A.

  • Omnitrope Pen 10
  • 10 mg/1.5 mL cartridge containing Omnitrope
  • 1 new BD™ Pen needle (29G x 12.7 mm or 31G x 8 mm or 31G x 5 mm). Needles are not included with the Pen.
  • 1 alcohol swab
  • flat surface like a table
  • a sharps disposal container. See Step 6 for information on how to dispose of used needles and syringes.

Steps you should follow to give an Omnitrope injection:

Step 1. Placing the cartridge in the Omnitrope Pen 10

Step 2. Attaching the needle to the Omnitrope Pen 10

Step 3. Priming a new cartridge Step 4. Selecting the correct dose of Omnitrope Step 5. Selecting the injection site and injecting the dose of Omnitrope Step 6. Removing and throwing away the needle and empty cartridge

Step 1. Placing the cartridge in the Omnitrope Pen 10

  • Take an Omnitrope cartridge out of the refrigerator and leave at room temperature for about 30 minutes. Wash and dry your hands while you wait.
  • Assemble all of the supplies needed on a flat surface. Remove the Pen and cartridge from their cartons if you are preparing the injection for the first time.
  • Hold the body of the Pen with 1 hand and pull off the Pen cap with the other hand. See Figure B.

Figure B

Pull off the Pen cap - Illustration

  • Hold the body of the Pen with 1 hand and unscrew the cartridge holder in a clockwise direction until the Pen and cartridge holder are completely separated. See Figure C.

Figure C

Unscrew the cartridge holder - Illustration

  • Hold the cartridge in 1 hand with the metal cap end pointing down. Insert the cartridge into the cartridge holder. See Figure D.

Figure D

Insert the cartridge into the cartridge holder - Illustration

  • Lower the Pen body onto the cartridge holder so that the black rod presses against the cartridge plunger. Screw the cartridge holder onto the Pen body in a counterclockwise direction until the cartridge holder will not turn anymore. One of the blue arrows on the cartridge holder must line up with the white line mark on the Pen body. Do not over tighten the cartridge holder. See Figure E.

Figure E

Screw the cartridge holder onto the Pen body -  Illustration

Step 2. Attaching the needle to the Omnitrope Pen 10

  • Take a new disposable needle and tear off the paper tab. Do not touch the needle or lay it on a surface. See Figure F.

Figure F

tear off the paper tab -Tllustration

  • Holding the cartridge holder with 1 hand, firmly press the needle onto the cartridge holder end of the Pen. See Figure G. Screw the threaded hub of the needle onto the cartridge holder in a counterclockwise direction until the needle will not turn anymore. See Figure H.

Figure G

Screw the threaded hub of the needle onto the cartridge holder - Illustration

Figure H

Screw the threaded hub of the needle onto the cartridge holder - Illustration

  • Gently pull off the outer needle shield and put it on a flat surface. You will use the outer needle shield later to remove the needle from the Pen after the injection is finished. See Figure I.

Figure I

Gently pull off the outer needle shield -  Illustration

Note: Check that the cartridge holder is attached to the Pen body before each injection. One of the blue arrows on the cartridge should be lined up with the white mark on the Pen body. After you attach the needle, you may see a few drops of medicine at the tip of the needle.

Step 3. Priming a new cartridge

  • Priming is not needed for a cartridge you have used before. If the cartridge has already been primed, go to Step 4.
  • Before you use a new cartridge you must first prepare it for use. Hold the Pen with the needle pointing upwards. Gently tap the cartridge holder with your finger to help air bubbles rise to the top of the cartridge. See Figure J.

Figure J

Gently tap the cartridge holder - Illustration

  • Hold the pen with the needle pointing up and the dose window facing you and you will see the numbers in the dose window at the bottom of the Pen body. Using the dose knob on the bottom of the Pen, slowly turn the dose knob in a clockwise direction as shown in Figure K until you hear 1 “click”. The arrow on the Pen body will then be lined up with the small line between “0” and “0.2” (0.1 mg). See Figure K.

Figure K

Dose window -  Illustration

  • Remove the inner needle shield. See Figure L.
  • With the needle pointing up, firmly turn the dose knob in a counterclockwise direction and back to the “0” position.

Figure L

Remove the inner needle shield - Illustration

At least 2 drops of medicine must flow out of the needle for the Pen to be properly primed. See Figure M.

Figure M

Properly primed pen -  Illustration

  • If at least 2 drops of medicine do not flow out, set the dose to 0.1 mg and repeat this step until at least 2 drops of medicine appear at the tip of the needle.
  • When you see 2 drops of medicine flow out of the needle, the Pen is correctly primed and ready to use.

Step 4. Selecting the correct dose of Omnitrope

  • Hold the pen with the needle pointing up and the dose window facing you and turn (dial) the dose knob in a clockwise direction until you see the number of mg for the prescribed dose in the middle of the dose window. The dose should be lined up with the arrow on the Pen body. You will hear 1 click for every single unit you dial. See Figure N.

Do not count the clicks to measure the correct dose of medicine.

Figure N

You will hear 1 click for every single unit you dial - Illustration

  • If you turn the dose knob past the correct dose, do not dial counterclockwise.

Instead, hold the Pen body with the needle pointing up and turn the dose knob in a clockwise direction until you see a bent arrow (↓) in the dose dialing window. See Figure O. Now continue to turn the dose knob in a clockwise direction until you hear a click and the entire Pen body is fully extended.

The injection button can now be fully pressed, resetting the dial to “0” without giving medicine. The correct dose can now be redialed.

Figure O

Redialling the correct dose - Illustration

  • Check that the cartridge holder is still attached to the Pen body, with the blue arrow lined up with the white mark on the Pen body.

Step 5. Selecting the injection site and injecting the dose of Omnitrope

Change the injection site every day. See Figure P.

Figure P

Injection site - Illustration

  • Select the injection site and wipe the skin with an alcohol pad as your healthcare provider showed you.
  • Insert the needle under the skin as your healthcare provider showed you. See Figure Q.

Figure Q

Insert the needle under the skin - Illustration

  • After inserting the needle into the skin, push the injection button as far in as it will go and press the button firmly. A clicking sound will be heard while the dose is being injected. Continue to press firmly on the injection button for 5 seconds before you remove the needle from the skin. See Figure R.

Figure R

Press firmly on the injection button for 5 seconds - Illustration

  • Stop pressing the injection button before you carefully remove the needle from the skin.
  • If the injection button cannot be pushed in completely or stops during the injection, and the cartridge is empty, then the full dose has not been given. The dose indicator window will show the amount of medicine still needed. Reset the dose knob to “0” as described in Step 4. Remove the needle as described in Step 6. Replace the empty cartridge with a new cartridge as described in Step 1. Prime the new cartridge as described in Step 3. Set the dose, which you noted, and inject. This completes your dose.

Step 6. Removing and throwing away the needle and empty cartridge

  • Carefully replace the outer needle shield. See Figure S.

Figure S

Carefully replace the outer needle shield - Illustration

  • Hold the Pen by the cartridge holder and carefully remove the needle from the Pen by turning the needle in a clockwise direction. See Figure T. Recap the pen.

Figure T

Remove the needle from the Pen - Illustration

  • Put your used needles and cartridges in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and cartridges in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information 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.

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store Omnitrope Pen 10?

  • Store Omnitrope cartridges in the refrigerator between 36°F and 46°F (2°C and 8°C).
  • When the Omnitrope Pen 10 contains a cartridge, do not remove the cartridge from the Pen in between injections. Store the Pen containing the cartridge in the storage case provided and place in the refrigerator.
  • When the Pen does not contain a cartridge, you may store the Pen at room temperature.
  • Do not freeze Omnitrope cartridges.
  • Protect the Omnitrope Pen 10 and cartridge from light by storing in their cartons or the storage case.
  • The Omnitrope cartridge must be thrown away 28 days after the first injection. The Omnitrope Pen 10 can be reloaded with a new cartridge and can be used multiple times.

Important information about possible problems you may have with the Omnitrope Pen 10

Problem Possible cause How to fix
Dial unit does not turn easily. Dust or dirt Turn the dial beyond the highest setting on the scale. Wipe all exposed surfaces with a clean, damp cloth.
The injection button cannot be pushed or stops during injection. The dose knob does not return to “0”. Cartridge is empty and full dose has not been given. Remove the needle as described in Step 6. Replace the empty cartridge with a new cartridge as described in Step 1. Prime the new cartridge as described in Step 3.
Clogged needle. Remove the needle as described in Step 6. Replace with a new needle as described in Step 2.
No clicking is heard during the injection and dose knob moves freely. Pen is in dose correction mode. Remove the needle from skin. Press injection button all the way in so the dial returns to zero and repeat Step 2, Step 4 and Step 5 to give the injection.
Medicine continues to drip from the needle before injection. Cartridge holder is not properly attached to the Pen body. Line up blue arrow on cartridge holder with white mark on Pen body.
Medicine continues to drip from the needle after injection. Needle was removed from the skin too early. Hold the needle in the skin for 5 seconds to complete the injection, before you carefully remove the needle from the skin. For the next injection, make sure that you hold the needle in the skin for 5 seconds.
Cartridge holder is not properly attached to the Pen body. Line up blue arrow on cartridge holder with white mark on Pen body.
The needle is left on the Pen after injection. Carefully remove the needle from the Pen right after the injection.

If the Omnitrope Pen 10 is damaged or does not work, call the pharmacy where you got the Omnitrope Pen 10. If you got your Omnitrope Pen 10 from OmniSource, call 1-877-456-6794.

For other questions or additional information, call OmniSource at 1-877-456-6794. Do not try to repair the Pen yourself.

Your Omnitrope Pen 10 is covered by a 2 year guarantee. Contact your Omnitrope Pen 10 provider after you have used the pen for 2 years to have it replaced by a new one. This guarantee is invalid if your Omnitrope Pen 10 has not been used in accordance with the manufacturer's instruction leaflet or if the defect has been caused by neglect, misuse or accident.

These Instructions for Use have been approved by the U.S. Food and Drug Administration.

Instructions For Use

OMNITROPE® PEN 5 INSTRUCTIONS FOR USE

Omnitrope
(om-KNEE-trope)
(somatropin) injection, for subcutaneous use 5 mg/1.5 mL cartridges for use with Omnitrope Pen 5

Read these Instructions for Use before you start using Omnitrope Pen 5 and each time you get a refill. There may be new information. This information does not take the place of talking to the healthcare provider about the medical condition or the treatment.

Note:

  • Omnitrope is for use under the skin only (subcutaneous).
  • Do not share your Omnitrope Pen or needles with anyone else. You may give an infection to them or get an infection from them.
  • The “Start use by no later than” date, presented in year and month on the outer carton, indicates the date after which therapy should not be initiated with this pen.

Omnitrope Pen 5, cartridge containing Omnitrope, needle, alcohol swab and storage case:

Figure A

Supplies needed - Illustration

Supplies you will need to give an Omnitrope Injection. See Figure A.

  • Omnitrope Pen 5
  • 5 mg/1.5 mL cartridge containing Omnitrope
  • 1 new BD™ Pen needle (29G x 12.7 mm or 31G x 8 mm or 31G x 5 mm). Needles are not included with the Pen.
  • 1 alcohol swab
  • flat surface like a table
  • a sharps disposal container. See Step 6 for information on how to dispose of used needles and syringes.

Steps you should follow to give an Omnitrope injection:

Step 1. Placing the cartridge in the Omnitrope Pen 5

Step 2. Attaching the needle to the Omnitrope Pen 5 Step 3. Priming a new cartridge Step 4. Selecting the correct dose of Omnitrope Step 5. Selecting the injection site and injecting the dose of Omnitrope Step 6. Removing and throwing away the needle and empty cartridge

Step 1. Placing the cartridge in the Omnitrope Pen 5

  • Take an Omnitrope cartridge out of the refrigerator and leave at room temperature for about 30 minutes. Wash and dry your hands while you wait.
  • Assemble all of the supplies needed on a flat surface. Remove the Pen and cartridge from their cartons if you are preparing the injection for the first time.
  • Hold the body of the Pen with 1 hand and pull off the Pen cap with the other hand. See Figure B.

Figure B

Pull off the Pen cap - Illustration

  • Hold the body of the Pen with 1 hand and unscrew the cartridge holder in a clockwise direction until the Pen and cartridge holder are completely separated. See Figure C.

Figure C

Unscrew the cartridge holder - Illustration

  • Hold the cartridge in 1 hand with the metal cap end pointing down. Insert the cartridge into the cartridge holder. See Figure D.

Figure D

Insert the cartridge into the cartridge holder - Illustration

  • Lower the Pen body onto the cartridge holder so that the black rod presses against the cartridge plunger. Screw the cartridge holder onto the Pen body in a counterclockwise direction until the cartridge holder will not turn anymore. One of the blue arrows on the cartridge holder must line up with the yellow line mark on the Pen body. Do not over tighten the cartridge holder. See Figure E.

Figure E

Screw the cartridge holder onto the Pen body - Illustration

Step 2. Attaching the needle to the Omnitrope Pen 5

  • Take a new disposable needle and tear off the paper tab. Do not touch the needle or lay it on a surface. See Figure F.

Figure F

Tear off the paper tab - Illustration

  • Holding the cartridge holder with 1 hand, firmly press the needle onto the cartridge holder end of the Pen. See Figure G. Screw the threaded hub of the needle onto the cartridge holder in a counterclockwise direction until the needle will not turn anymore. See Figure H.

Figure G

Screw the threaded hub of the needle onto the cartridge holder - Illustration

Figure H

Screw the threaded hub of the needle onto the cartridge holder - Illustration

  • Gently pull off the outer needle shield and put it on a flat surface. You will use the outer needle shield later to remove the needle from the Pen after the injection is finished. See Figure I.

Figure I

Gently pull off the outer needle shield - Illustration

Note: Check that the cartridge holder is attached to the Pen body before each injection. One of the blue arrows on the cartridge should be lined up with the yellow mark on the Pen body. After you attach the needle, you may see a few drops of medicine at the tip of the needle.

Step 3. Priming a new cartridge

  • Priming is not needed for a cartridge you have used before. If the cartridge has already been primed, go to Step 4.
  • Before you use a new cartridge you must first prepare it for use. Hold the Pen with the needle pointing upwards. Gently tap the cartridge holder with your finger to help air bubbles rise to the top of the cartridge. See Figure J.

Figure J

Gently tap the cartridge holder - Illustration

  • Hold the pen with the needle pointing up and the dose window facing you and you will see the numbers in the dose window at the bottom of the Pen body. Using the dose knob on the bottom of the Pen, slowly turn the dose knob in a clockwise direction as shown in Figure K until you hear 1 “click”. The arrow on the Pen body will then be lined up with the small line between “0” and “0.1” (0.05 mg). See Figure K.

Figure K

Dose window - Illustration

  • Remove the inner needle shield. See Figure L.
  • With the needle pointing up, firmly turn the dose knob in a counterclockwise direction and back to the “0” position.

Figure L

Remove the inner needle shield - Illustration

  • At least 2 drops of medicine must flow out of the needle for the Pen to be properly primed. See Figure M.

Figure M

Properly primed pen - Illustration

  • If at least 2 drops of medicine do not flow out, set the dose to 0.05 mg and repeat this step until at least 2 drops of medicine appear at the tip of the needle.
  • When you see 2 drops of medicine flow out of the needle, the Pen is correctly primed and ready to use.

Step 4. Selecting the correct dose of Omnitrope

  • Hold the pen with the needle pointing up and the dose window facing you and turn (dial) the dose knob in a clockwise direction until you see the number of mg for the prescribed dose in the middle of the dose window. The dose should be lined up with the arrow on the Pen body. You will hear 1 click for every single unit you dial. See Figure N.

Do not count the clicks to measure the correct dose of medicine.

Figure N

Selecting the correct dose - Illustration

  • If you turn the dose knob past the correct dose, do not dial counterclockwise.

Instead, hold the Pen body with the needle pointing up and turn the dose knob in a clockwise direction until you see a bent arrow (↓) in the dose dialing window. See Figure O. Now continue to turn the dose knob in a clockwise direction until you hear a click and the entire Pen body is fully extended.

The injection button can now be fully pressed, resetting the dial to “0” without giving medicine. The correct dose can now be redialed.

Figure O

Redialling the dose - Illustration

  • Check that the cartridge holder is still attached to the Pen body, with the blue arrow lined up with the yellow mark on the Pen body.

Step 5. Selecting the injection site and injecting the dose of Omnitrope

Change the injection site every day. See Figure P.

Figure P

Selecting the injection site - Illustration

  • Select the injection site and wipe the skin with an alcohol pad as your healthcare provider showed you.
  • Insert the needle under the skin as your healthcare provider showed you. See Figure Q.

Figure Q

Insert the needle under the skin - Illustration

  • After inserting the needle into the skin, push the injection button as far in as it will go and press the button firmly. A clicking sound will be heard while the dose is being injected. Continue to press firmly on the injection button for 5 seconds before you remove the needle from the skin. See Figure R.

Figure R

Press firmly on the injection button for 5 seconds -  Illustration

  • Stop pressing the injection button before you carefully remove the needle from the skin.
  • If the injection button cannot be pushed in completely or stops during the injection, and the cartridge is empty, then the full dose has not been given. The dose indicator window will show the amount of medicine still needed. Reset the dose knob to “0” as described in Step 4. Remove the needle as described in Step 6. Replace the empty cartridge with a new cartridge as described in Step 1. Prime the new cartridge as described in Step 3. Set the dose, which you noted, and inject. This completes your dose.

Step 6. Removing and throwing away the needle and empty cartridge

  • Carefully replace the outer needle shield. See Figure S.

Figure S

Replace the outer needle shield - Illustration

  • Hold the Pen by the cartridge holder and carefully remove the needle from the Pen by turning the needle in a clockwise direction. See Figure T. Recap the pen.

Figure T

Remove the needle from the Pen - Illustration

  • Put your used needles and cartridges in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and cartridges in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information 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.
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store Omnitrope Pen 5?

  • Store Omnitrope cartridges in the refrigerator between 36°F and 46°F (2°C and 8°C).
  • When the Omnitrope Pen 5 contains a cartridge, do not remove the cartridge from the Pen in between injections. Store the Pen containing the cartridge in the storage case provided and place in the refrigerator.
  • When the Pen does not contain a cartridge, you may store the Pen at room temperature.
  • Do not freeze Omnitrope cartridges.
  • Protect the Omnitrope Pen 5 and cartridge from light by storing in their cartons or the storage case.
  • The Omnitrope cartridge must be thrown away 28 days after the first injection. The Omnitrope Pen 5 can be reloaded with a new cartridge and can be used multiple times.

Important information about possible problems you may have with the Omnitrope Pen 5

Problem Possible cause How to fix
Dial unit does not turn easily. Dust or dirt Turn the dial beyond the highest setting on the scale. Wipe all exposed surfaces with a clean, damp cloth.
The injection button cannot be pushed or stops during injection. The dose knob does not return to “0”. Cartridge is empty and full dose has not been given. Remove the needle as described in Step 6. Replace the empty cartridge with a new cartridge as described in Step 1. Prime the new cartridge as described in Step 3.
Clogged needle. Remove the needle as described in Step 6. Replace with a new needle as described in Step 2.
No clicking is heard during the injection and dose knob moves freely. Pen is in dose correction mode. Remove the needle from skin. Press injection button all the way in so the dial returns to zero and repeat Step 2, Step 4 and Step 5 to give the injection.
Medicine continues to drip from the needle before injection. Cartridge holder is not properly attached to the Pen body. Line up blue arrow on cartridge holder with yellow mark on Pen body.
Medicine continues to drip from the needle after injection. Needle was removed from the skin too early. Hold the needle in the skin for 5 seconds to complete the injection, before you carefully remove the needle from the skin. For the next injection, make sure that you hold the needle in the skin for 5 seconds.
Cartridge holder is not properly attached to the Pen body. Line up blue arrow on cartridge holder with yellow mark on Pen body.
The needle is left on the Pen after injection. Carefully remove the needle from the Pen right after the injection.

If the Omnitrope Pen 5 is damaged or does not work, call the pharmacy where you got the Omnitrope Pen 5. If you got your Omnitrope Pen 5 from OmniSource, call 1-877-456-6794.

For other questions or additional information, call OmniSource at 1-877-456-6794. Do not try to repair the Pen yourself.

Your Omnitrope Pen 5 is covered by a 2 year guarantee. Contact your Omnitrope Pen 5 provider after you have used the pen for 2 years to have it replaced by a new one. This guarantee is invalid if your Omnitrope Pen 5 has not been used in accordance with the manufacturer's instruction leaflet or if the defect has been caused by neglect, misuse or accident.

These Instructions for Use have been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 3/3/2017
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.