Rezvoglar

What is Rezvoglar?

• Rezvoglar is a long-acting man-made insulin used to control high blood sugar in adults with diabetes mellitus.
• Rezvoglar is not for use to treat diabetic ketoacidosis.
• It is not known if Rezvoglar is safe and effective in children less than 6 years of age with type 1 diabetes.
• It is not known if Rezvoglar is safe and effective in children with type 2 diabetes.

What is the most important thing I should know about Rezvoglar?

Do not share your Rezvoglar KwikPen 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.

Who should not use Rezvoglar?

Do not use Rezvoglar if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to insulin glargine products or any of the ingredients in Rezvoglar. See the end of this Patient Information guide for a complete list of ingredients in Rezvoglar.

What should I tell my healthcare provider before using Rezvoglar?

Before using Rezvoglar, tell your healthcare provider about all your medical conditions including if you:

• have liver or kidney problems.
• take other medicines, especially ones called TZDs (thiazolidinediones).
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Rezvoglar.
• are pregnant, planning to become pregnant, or are breastfeeding. It is not known if Rezvoglar may harm your unborn baby or breastfeeding baby.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements.
Before you start using Rezvoglar, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use Rezvoglar?

• Read the detailed Instructions for Use that come with your Rezvoglar KwikPen single-patient-use prefilled pen.
• Use Rezvoglar exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Rezvoglar to use and when to use it.
• Know the amount of Rezvoglar you use. Do not change the amount of Rezvoglar you use unless your healthcare provider tells you to.
• Check your insulin label each time you give your injection to make sure you are using the correct insulin.
• Rezvoglar comes in a KwikPen single-patient-use prefilled pen that you must use to give your Rezvoglar. The dose indicator on your pen shows your dose of Rezvoglar. Do not make any dose changes unless your healthcare provider tells you to.
• Do not use a syringe to remove Rezvoglar from your KwikPen disposable prefilled pen.
• Do not re-use needles. Always use a new needle for each injection. Re-use of needles increases your risk of having blocked needles, which may cause you to get the wrong dose of Rezvoglar. Using a new needle for each injection lowers your risk of getting an infection. If your needle is blocked, follow the instructions in Step 3 of the Instructions for Use.
• You may take Rezvoglar at any time during the day but you must take it at the same time every day.
• Rezvoglar is injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
• Do not use Rezvoglar in an insulin pump or inject Rezvoglar into your vein (intravenously).
• Change (rotate) your injection sites within area you chose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
  • Do not use the exact same spot for each injection.
  • Do not inject where the skin has pits, is thickened, or has lumps.
  • Do not inject where skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• Do not mix Rezvoglar with any other type of insulin or liquid medicine.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.

Keep Rezvoglar and all medicines out of the reach of children.

Your dose of Rezvoglar may need to change because of:

• change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of the medicines you take.

What should I avoid while using Rezvoglar?

While using Rezvoglar do not:

• drive or operate heavy machinery, until you know how Rezvoglar affects you.
• drink alcohol or use over-the-counter medicines that contain alcohol

What are the possible side effects of Rezvoglar?

Rezvoglar may cause serious side effects that can lead to death, including:

• low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
  • dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger.
• severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
  • a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
• low potassium in your blood (hypokalemia).
• heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Rezvoglar may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Rezvoglar. Your healthcare provider should monitor you closely while you are taking TZDs with Rezvoglar. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
  • shortness of breath, swelling of your ankles or feet, sudden weight gain.

Treatment with TZDs and Rezvoglar may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.
Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

The most common side effects of Rezvoglar include:

• low blood sugar (hypoglycemia), weight gain; allergic reactions, including reactions at your injection site, skin thickening or pits at the injection site (lipodystrophy).

These are not all the possible side effects of Rezvoglar. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Rezvoglar

General information about the safe and effective use of Rezvoglar.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Rezvoglar for a condition for which it was not prescribed. Do not give Rezvoglar to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information guide summarizes the most important information about Rezvoglar. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Rezvoglar that is written for healthcare professionals. For more information about Rezvoglar call 1-800-545-5979

How should I store Rezvoglar?

Storage conditions are summarized in the following table for Rexvoglar KwikPen:

If your Rezvoglar KwikPen is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject.

Keep Rezvoglar KwikPen out of the reach and sight of children.

Keep your Rezvoglar KwikPen in cool storage (36°F–46°F [2°C–8°C]) until first use. Do not allow it to freeze. Do not put it next to the freezer compartment of your refrigerator or next to a freezer pack.

Once you take your Rezvoglar KwikPen out of cool storage, for use or as a spare, you can use it for up to 28 days. During this time it can be safely kept at room temperature up to 86°F (30°C). Do not use it after this time. Rezvoglar KwikPen in use must not be stored in a refrigerator.

Do not use Rezvoglar KwikPen after the expiration date printed on the Label of the Pen or on the carton.

Protect Rezvoglar KwikPen from heat and light.

Discard your used Rezvoglar KwikPen as required by your local authorities.

What are the ingredients in Rezvoglar?

Active ingredient: insulin glargine-aglr

Inactive ingredients: glycerin, m-cresol, zinc, and Water for Injection, USP

Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH.

Instructions for use for Rezvoglar

Rezvoglar KwikPen Single-Patient-Use Prefilled Pen
(insulin glargine-aglr)
injection for subcutaneous use
100 units/mL, 3 mL single-patient-use prefilled pen

Your healthcare professional has decided that Rezvoglar KwikPen is right for you. Talk with your healthcare professional about proper injection technique before using Rezvoglar KwikPen.

Read these instructions carefully before using your Rezvoglar KwikPen (“Pen”). If you are not able to follow all the instructions completely on your own, use Rezvoglar KwikPen only if you have help from a person who is able to follow the instructions.

Do not share your Rezvoglar KwikPen 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.

People who are blind or have vision problems should not use Rezvoglar KwikPen single-patient-use prefilled pen without help from a person trained to use Rezvoglar KwikPen single-patient-use prefilled pen.

Follow these instructions completely each time you use Rezvoglar KwikPen to ensure that you get an accurate dose. If you do not follow these instructions you may get too much or too little insulin, which may affect your blood glucose.

Rezvoglar KwikPen is a disposable pen for the injection of insulin. Each Rezvoglar KwikPen contains in total 300 units of insulin. You can give doses from 1 to 80 units in steps of 1 unit. If you need a dose greater than 80 units, you should give it as two or more injections. The Pen plunger moves with each injection, but you may not notice that it moves. The plunger will only move to the end of the cartridge when all 300 units of insulin have been given.

Keep this leaflet for future reference.

If you have any questions about Rezvoglar KwikPen or about diabetes, ask your healthcare professional, or call Eli Lilly and Company at 1-800-545-5979.

Important information for use of Rezvoglar KwikPen:

• Do not share your Rezvoglar KwikPen 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.
• Do not re-use needles. Always attach a new needle before each use.
• Use needles compatible with Rezvoglar KwikPen. Becton, Dickinson and Company (BD) Pen Needles are recommended. These are sold separately. Contact your healthcare professional for further information.
• Always perform the safety test (prime the Rezvoglar KwikPen) before each injection.
• Do not select a dose or press the Dose Knob without a needle attached.
• If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
• Never use Rezvoglar KwikPen if it is damaged or if you are not sure that it is working properly.
• Always have a spare Rezvoglar KwikPen in case your Pen is lost or damaged.
• Change (rotate) your injection sites within the area you choose for each dose (see “Places to inject” ).

Places to inject

• Inject your insulin exactly as your healthcare provider has shown you.
• Inject your insulin under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
• Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
• Do not inject where the skin has pits, is thickened, or has lumps.
• Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• Do not try to change your dose while injecting.

Step 1. Check the insulin

A. Check the Label on your Pen to make sure you have the correct insulin. The Rezvoglar KwikPen is light grey with a light grey Dose Knob that has a green ring on the end. The label on the Pen is light grey with green color bars.
B. Take off the Pen Cap.
C. Check the appearance of your insulin. Rezvoglar KwikPen contains a clear and colorless insulin. Do not use this Pen if the insulin is cloudy, colored or has particles or clumps in it.

Step 2. Attach the needle

Do not re-use needles. Always use a new sterile needle for each injection. This helps prevent contamination and potential needle blocks.

A. Wipe the Rubber Seal with alcohol.
B.Remove the Paper Tab from a new needle.
C. Line up the needle with the Pen, and keep it straight as you attach it. Push the capped needle straight onto the Rezvoglar KwikPen and twist the needle on until it is tight.

• If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.

Step 3. Perform a Safety test (Prime your Rezvoglar KwikPen)

Always perform the safety test (prime) before each injection.
Performing the safety test (priming) ensures that you get an accurate dose by:

• ensuring that Pen and needle work properly
• removing air bubbles

A. Select a dose of 2 units by turning the Dose Knob.

B. Take off the Outer Needle Shield and keep it to remove the used needle after injection. Take off the Inner Needle Shield and discard it.

C. Hold the Pen with the needle pointing upwards.

D. Tap the insulin reservoir so that any air bubbles rise up towards the needle.

E. Press the Dose Knob all the way in. Hold the Dose Knob in and count to 5 slowly. Check if insulin comes out of the needle tip.

You may have to perform the safety test (prime) several times before insulin is seen.

• If no insulin comes out, check for air bubbles and repeat the safety test (prime) no more than 4 times.
• If still no insulin comes out, the needle may be blocked. Change the needle and try again.
• If no insulin comes out after changing the needle, your Rezvoglar KwikPen may be damaged. Do not use this Pen.

Step 4. Select the dose

You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.

A. Check that the dose window shows "0" following the safety test (priming).
B. Select your required dose (in the example below, the selected dose is 8 units). If you turn past your dose, you can turn back down. The Dose Knob clicks as you turn it. Do not dial your dose by counting the clicks because you may dial the wrong dose.

• Do not push the Dose Knob while turning, as insulin will come out.
• You cannot turn the Dose Knob past the number of units left in the Pen. Do not force the Dose Knob to turn. In this case, either you can inject what is remaining in the Pen and complete your dose with a new Pen or use a new Pen for your full dose.
  • Even numbers are printed on the dial.
  • Odd numbers, after the number 1, are shown as full lines.
• Always check the number in the Dose Window to make sure you have dialed the correct dose.

(Example: 12 units shown in the Dose Window)

(Example: 25 units shown in the Dose Window)

Step 5. Inject the dose

A. Use the injection method as instructed by your healthcare professional.
B. Insert the needle into the skin.

C. Deliver the dose by pressing the Dose Knob in all the way. The number in the Dose Window will return to "0" as you inject.
Do not try to inject your insulin by turning the Dose Knob. You will not receive your insulin by turning the Dose Knob.

D. Keep the Dose Knob pressed all the way in.

Slowly count to 5 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.
If you do not see “0” in the Dose Window, you did not receive your full dose. Do not redial. Insert the needle into your skin and finish your injection.
If you still do not think you received the full amount you dialed for your injection, do not start over or repeat the injection. Monitor your blood glucose and call your healthcare provider for further instructions.
If you normally need to give 2 injections for your full dose, be sure to give your second injection.

Step 6. Remove and discard the needle

Always remove the needle after each injection. Store Rezvoglar KwikPen without a needle attached. This helps prevent:

• Contamination and/or infection.
• Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.

A. Put the Outer Needle Shield back on the needle, and use it to unscrew the needle from the Pen.
To reduce the risk of accidental needle injury, never replace the Inner Needle Shield.

• If your injection is given by another person, special caution must be taken by this person when removing and disposing the needle. Follow recommended safety measures for removal and disposal of needles (e.g., a one-handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.

B. Dispose of the needle safely. Used needles should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.
If you are giving an injection to another person, you should remove the needle in an approved manner to avoid needle-stick injuries.

C. Always put the Pen Cap back on the Pen by lining up the Cap Clip with the Dose Indicator and pushing straight on. Store the Pen until your next injection.

Storage Instructions

Please check the leaflet for the insulin for complete instructions on how to store Rezvoglar KwikPen.

If your Rezvoglar KwikPen is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject.

Keep Rezvoglar KwikPen out of the reach and sight of children.

Keep your Rezvoglar KwikPen in cool storage (36°F–46°F [2°C–8°C]) until first use. Do not allow it to freeze. Do not put it next to the freezer compartment of your refrigerator or next to a freezer pack.

Once you take your Rezvoglar KwikPen out of cool storage, for use or as a spare, you can use it for up to 28 days. During this time it can be safely kept at room temperature up to 86°F (30°C). Do not use it after this time. Rezvoglar KwikPen in use must not be stored in a refrigerator.

Do not use Rezvoglar KwikPen after the expiration date printed on the Label of the Pen or on the carton.

Protect Rezvoglar KwikPen from heat and light.

Discard your used Rezvoglar KwikPen as required by your local authorities.

Maintenance

Protect your Rezvoglar KwikPen from dust and dirt.

You can clean the outside of your Rezvoglar KwikPen by wiping it with a damp cloth.

Do not soak, wash, or lubricate the Pen as this may damage it.

Your Rezvoglar KwikPen is designed to work accurately and safely. It should be handled with care. Avoid situations where Rezvoglar KwikPen might be damaged. If you are concerned that your Rezvoglar KwikPen may be damaged, use a new one.

Instructions for use approved 12/2021.