SAFETY SUMMARY
Warnings -
Do not take REZVOGLAR if you have:
- symptoms of low blood sugar (hypoglycemia)
- an allergy to REZVOGLAR or any of its ingredients
Do not reuse needles or share your REZVOGLAR™ KwikPen® with other people. You or the other person can get a serious infection. This can happen even if you change the needle.
Do not change the insulin you use or your dose, unless your doctor tells you to. This could cause low or high blood sugar, which could be serious.
REZVOGLAR may cause serious side effects. Some of these can lead to death. The possible serious side effects of REZVOGLAR are:
- Low blood sugar. This can lead to:
- dizziness or light-headedness
- headache
- shakiness
- irritability
- sweating
- blurred vision
- fast heartbeat
- mood change
- confusion
- slurred speech
- anxiety
- hunger
- Severe allergic reaction.
Get emergency help right away if you have:- a rash over your whole body
- swelling of your face, tongue, or throat
- extreme drowsiness, dizziness, or confusion
- trouble breathing
- sweating
- a fast heartbeat
- shortness of breath
- Low potassium in your blood (hypokalemia). This can lead to severe breathing problems, irregular heartbeat, and death.
- Heart failure. Taking diabetes pills called thiazolidinediones /thIE-uh-zOH-li-dEEn-dIE-OHns/(TZDs) with REZVOGLAR may cause heart failure in some people. This includes people who do not have any heart problems. If you have heart failure, it may get worse if you take TZDs with REZVOGLAR. Tell your doctor if you have any new symptoms of heart failure, or if they get worse. These are: shortness of breath, swelling of the ankles or feet, and sudden weight gain. Your doctor may need to change or stop treatment with TZDs and REZVOGLAR.
Common side effects
The most common side effects of REZVOGLAR are:
- low blood sugar
- minor reactions where you have injected REZVOGLAR
- itching
- swelling
- allergic reactions
- changes in fat tissue where you have injected REZVOGLAR
- rash
- weight gain
These are not all of the possible side effects. Tell your doctor if you have any side effects. You can report side effects at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
Before using
Talk with your doctor about low blood sugar and how to manage it. Tell your doctor:
- about all of the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.
- about any other prescription medicines you take, especially ones called TZDs.
- about all of your medical conditions, including if you have heart failure or other heart, liver, or kidney problems. If you have heart failure, it may get worse while you take TZDs with REZVOGLAR.
- if you are pregnant, breastfeeding, or plan to become pregnant. It is not known if REZVOGLAR may harm your unborn or breastfeeding baby.
How to take
The REZVOGLAR KwikPen is a disposable insulin delivery device for use by a single patient to inject REZVOGLAR. Read the Instructions for Use that come with your REZVOGLAR single-patient-use prefilled KwikPen. These instructions provide details on how to prepare and inject a dose of REZVOGLAR, and how to throw away used REZVOGLAR prefilled pens and needles.
Be sure to check your blood sugar levels and use REZVOGLAR exactly as your doctor tells you to. Your doctor may tell you to change your dose because of illness, increased stress, or changes in your weight, diet, or level of physical activity or exercise. He or she may also tell you to change your dose because of other medicines you take.
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 needle for each injection lowers your risk of getting infection. If your needle is blocked, follow the instructions in Step 3 of the Instructions for Use.
Before injecting your REZVOGLAR
You can inject REZVOGLAR yourself, or you can have a trained caregiver inject it for you. Make sure you or your caregiver:
- Check your insulin label each time you give your injection. This will help you make sure that you are using the correct insulin.
- Use a new needle for each injection. You can get a serious infection or the wrong dose of insulin if you re-use needles.
When you are ready to inject
- Take REZVOGLAR once a day, at the same time each day.
- Change (rotate) where you inject your insulin with each dose. This can help reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin. Do not inject your insulin into the exact same spot or where the skin has pits or lumps. Avoid injecting into thickened, tender, bruised, scaly, hard, scarred, or damaged skin.
Staying safe while taking your REZVOGLAR
To stay safe while taking REZVOGLAR, be sure you only use REZVOGLAR that is clear and colorless and does not have any particles.
Be sure you do not:
- mix REZVOGLAR with any other type of insulin or solution.
- drive or use heavy machinery until you know how REZVOGLAR affects you.
- drink alcohol or use other medicines that contain alcohol when taking REZVOGLAR.
- use REZVOGLAR in an insulin pump or inject REZVOGLAR into your vein (intravenously).
Learn more
REZVOGLAR is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about REZVOGLAR but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other health care provider about REZVOGLAR and how to take it. Your doctor is the best person to help you decide if REZVOGLAR is right for you.
RV CON BS 17NOV2022
REZVOGLAR™ is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.