Instructions for Use
OZEMPIC® (oh-ZEM-pick)
(semaglutide) injection
0.25 mg or 0.5 mg doses
(pen delivers doses in 0.25 mg or 0.5 mg increments only)
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Read these instructions carefully before using your OZEMPIC® pen.
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Do not use your pen without proper training from your healthcare provider. Make sure that you know how to give yourself an injection with the pen before you start your treatment.
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Do not share your OZEMPIC pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the OZEMPIC pen.
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Start by checking your pen to make sure that it contains OZEMPIC, then look at the pictures below to get to know the different parts of your pen and needle.
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Your pen is a prefilled, single-patient-use, dial-a-dose pen. It contains 2 mg of semaglutide, and you can select doses of 0.25 mg or 0.5 mg. Your pen is made to be used with NovoFine® Plus or NovoFine®
disposable needles up to a length of 8 mm.
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•NovoFine® Plus 32G 4 mm disposable needles are included with your OZEMPIC pen.
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Always use a new needle for each injection.
Supplies you will need to give your OZEMPIC injection:
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•OZEMPIC pen
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•a new NovoFine Plus or NovoFine needle
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•1 alcohol swab
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•1 gauze pad or cotton ball
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•1 sharps disposal container for throwing away used OZEMPIC pens and needles. See “Disposing of used OZEMPIC pens and needles” at the end of these instructions.
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Step 1.
Prepare your pen with a new needle
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Wash your hands with soap and water.
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Check the name and colored label of your pen, to make sure that it contains OZEMPIC.
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This is especially important if you take more than 1 type of medicine.
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Pull off the pen cap.
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Check that the OZEMPIC medicine in your pen is clear and colorless.
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Look through the pen window. If OZEMPIC looks cloudy or contains particles, do not use the pen.
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Take a new needle, and tear off the paper tab. Do not attach a new needle to your pen until you are ready to give your injection.
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Push the needle straight onto the pen. Turn until it is on tight.
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Pull off the outer needle cap. Do not throw it away.
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Pull off the inner needle cap and throw it away.
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A drop of OZEMPIC may appear at the needle tip. This is normal, but you must still check the OZEMPIC flow if you use a new pen for the first time.
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Always use a new needle for each injection. This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose.
Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.
Never use a bent or damaged needle.
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Step 2.
Check the OZEMPIC flow with each new pen
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•Check the OZEMPIC flow before your first injection with each new pen.
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If your OZEMPIC pen is already in use, go to Step 3 “Select your dose”.
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•Turn the dose selector until the dose counter shows the flow check symbol (
).
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•Hold the pen with the needle pointing up.
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Press and hold in the dose button until the dose counter shows 0. The 0 must line up with the dose pointer.
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A drop of OZEMPIC will appear at the needle tip.
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If no drop appears, repeat Step 2 above as shown in Figure G and Figure H up to 6 times. If there is still no drop, change the needle and repeat Step 2 as shown in Figure G and Figure H 1 more time.
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Do not use the pen if a drop of OZEMPIC still does not appear.
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Contact Novo Nordisk at 1-888-693-6742.
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Always make sure that a drop appears at the needle tip before you use a new pen for the first time. This makes sure that OZEMPIC flows.
If no drop appears, you will not inject any OZEMPIC, even though the dose counter may move. This may mean that there is a blocked or damaged needle.
A small drop may remain at the needle tip, but it will not be injected.
Only check the OZEMPIC flow before your first injection with each new pen.
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Step 3.
Select your dose
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Turn the dose selector until the dose counter shows your dose (0.25 mg or 0.5 mg).
The dashed line in the dose counter () will guide you to your dose.
Make sure you know the dose of OZEMPIC you should use. If you select the wrong dose, you can turn the dose selector forward or backwards to the correct dose.
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Always use the dose counter and the dose pointer to see how many mg you select.
You will hear a “click” every time you turn the dose selector. Do not set the dose by counting the number of clicks you hear.
Only doses of 0.25 mg or 0.5 mg can be selected with the dose selector. The selected dose must line up exactly with the dose pointer to make sure that you get a correct dose.
The dose selector changes the dose. Only the dose counter and dose pointer will show how many mg you select for each dose.
You can select 0.25 mg or 0.5 mg for each dose. When your pen contains less than 0.5 mg or 0.25 mg, the dose counter stops before 0.5 mg or 0.25 mg is shown.
The dose selector clicks differently when turned forward or backward. Do not count the pen clicks.
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How much OZEMPIC is left?
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To see how much OZEMPIC is left in your pen, use the dose counter:
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Turn the dose selector until the dose counter stops.
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•If it shows 0.5, at least 0.5 mg is left in your pen. If the dose counter stops before 0.5 mg, there is not enough OZEMPIC left for a full dose of 0.5 mg.
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•If it stops at 0.25, then 0.25 mg is left in your pen. If the dose counter stops before 0.25 mg, there is not enough OZEMPIC left for a full dose of 0.25 mg.
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If there is not enough OZEMPIC left in your pen for a full dose, do not use it. Use a new OZEMPIC pen.
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Step 4.
Inject your dose
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•Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure K).
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Insert the needle into your skin as your healthcare provider has shown you.
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Make sure you can see the dose counter. Do not cover it with your fingers. This could stop the injection.
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Press and hold down the dose button until the dose counter shows 0.
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The 0 must line up with the dose pointer. You may then hear or feel a click.
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Keep the needle in your skin after the dose counter has returned to 0 and count slowly to 6.
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•If the needle is removed earlier, you may see a stream of OZEMPIC coming from the needle tip. If this happens, the full dose will not be delivered.
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Remove the needle from your skin.
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If blood appears at the injection site, press lightly with a gauze pad or cotton ball. Do not rub the area.
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Always watch the dose counter to make sure you have injected your complete dose. Hold the dose button down until the dose counter shows 0.
How to identify a blocked or damaged needle?
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•If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
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•If this happens you have not received any OZEMPIC even though the dose counter has moved from the original dose that you have set.
How to handle a blocked needle?
Change the needle as described in Step 5, and repeat all steps starting with Step 1: “Prepare your pen with a new needle”.
Never touch the dose counter when you inject. This can stop the injection.
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You may see a drop of OZEMPIC at the needle tip after injecting. This is normal and does not affect your dose.
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Step 5.
After your injection
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Carefully remove the needle from the pen. Do not put the needle caps back on the needle to avoid needle sticks.
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Place the needle in a sharps disposal container right away to reduce the risk of needle sticks. See “Disposing of used OZEMPIC pens and needles” below for more information about how to dispose of used pens and needles the right way.
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Put the pen cap on your pen after each use to protect OZEMPIC from light.
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•If you do not have a sharps disposal container, follow a 1-handed needle recapping method.
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Carefully slip the needle into the outer needle cap. Dispose of the needle in a sharps disposal container as soon as possible.
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Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Always remove the needle from your pen.
This will reduce the risk of contamination, infection, leakage of OZEMPIC, and blocked needles leading to the wrong dose. If the needle is blocked, you will not inject any OZEMPIC.
Always dispose of the needle after each injection.
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Disposing of used OZEMPIC pens and needles:
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•Put your used OZEMPIC pen and needle in a FDA-cleared sharps disposal container right away after use.
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•If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
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omade of a heavy-duty plastic
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ocan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
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oupright and stable during use
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oleak-resistant
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oproperly labeled to warn of hazardous waste inside the container
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•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 syringes. For more information about the 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
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•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.
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•Safely dispose of OZEMPIC that is out of date or no longer needed.
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Important
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•Caregivers must be very careful when handling used needles to prevent accidental needle stick injuries and prevent passing (transmission) of infection.
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•Never use a syringe to withdraw OZEMPIC from your pen.
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Always carry an extra pen and new needles with you, in case of loss or damage.
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•Always keep your pen and needles out of reach of others, especially children.
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Always keep your pen with you. Do not leave it in a car or other place where it can get too hot or too cold.
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Caring for your pen
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Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the OZEMPIC flow before you inject.
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Do not try to repair your pen or pull it apart.
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Do not expose your pen to dust, dirt or liquid.
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Do not wash, soak, or lubricate your pen. If necessary, clean it with mild detergent on a moistened cloth.
How should I store my OZEMPIC pen?
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•Store your new, unused OZEMPIC pens in the refrigerator between 36°F to 46°F (2°C to 8°C).
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Store your pen in use for 56 days at room temperature between 59°F to 86°F (15°C to 30°C) or in a refrigerator between 36°F to 46°F (2°C to 8°C).
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•The OZEMPIC pen you are using should be disposed of (thrown away) after 56 days, even if it still has OZEMPIC left in it. Write the disposal date on your calendar.
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Do not freeze OZEMPIC. Do not use OZEMPIC if it has been frozen.
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•Unused OZEMPIC pens may be used until the expiration date (“EXP”) printed on the label, if kept in the refrigerator.
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•When stored in the refrigerator, do not store OZEMPIC pens directly next to the cooling element.
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•Keep OZEMPIC away from heat and out of the light.
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Keep the pen cap on when not in use.
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Keep OZEMPIC and all medicines out of the reach of children.
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For more information go to www.OZEMPIC.com
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd
Denmark
For information about OZEMPIC contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-888-693-6742
Revised: 3/2022
Version: 4
OZEMPIC® and NovoFine® are registered trademarks of Novo Nordisk A/S.
PATENT Information: http://novonordisk-us.com/patients/products/product-patents.html
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
© 2022 Novo Nordisk
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