Patient information: uses, side effects, how to take - Insulin Glargine-aldy

What is LANGLARA?

LANGLARA is a long-acting man-made insulin used to control high blood sugar in adults and children with diabetes mellitus. LANGLARA is not for use to treat diabetic ketoacidosis.

Who should not use LANGLARA?

Do not use LANGLARA if you:

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

What should I tell my healthcare provider before using LANGLARA?

Before using LANGLARA, 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 LANGLARA.
are pregnant, planning to become pregnant, or are breastfeeding. It is not known if LANGLARA 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 LANGLARA, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use LANGLARA?

Read the detailed Instructions for Usethat come with your LANGLARA single-patient-use prefilled pen.
Use LANGLARA exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much LANGLARA to use and when to use it.
Know the amount of LANGLARA you use. Do not change the amount of LANGLARA 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.
The dose counter on your pen shows your dose of LANGLARA. Do not make any dose changes unless your healthcare provider tells you to.
Do not use a syringe to remove LANGLARA from your 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 LANGLARA. Using a new needle for each injection lowers your risk of getting an infection. If your needle is blocked, follow the instructions in Step 3B and Step 5F of the Instructions for Use.
You may take LANGLARA at any time during the day but you must take it at the same time every day.
LANGLARA is injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).

Do not use LANGLARA in an insulin pump or inject LANGLARA into your vein (intravenously).
Change (rotate) your injection sites within area you chose with each doseto 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 LANGLARA 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 LANGLARA and all medicines out of the reach of children.

Your dose of LANGLARA may need to change because of:

a 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 LANGLARA?

While using LANGLARA do not:

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

What are the possible side effects of LANGLARA and other insulins?

LANGLARA 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:
º 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:
º 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 LANGLARA 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 LANGLARA. Your healthcare provider should monitor you closely while you are taking TZDs with LANGLARA. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
º shortness of breath, swelling of your ankles or feet, sudden weight gain.
Treatment with TZDs and LANGLARA 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 LANGLARA 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 LANGLARA. 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 LANGLARA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do notuse LANGLARA for a condition for which it was not prescribed. Do notgive LANGLARA to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about LANGLARA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about LANGLARA that is written for healthcare professionals. For more information about LANGLARA call 1-267-383-3008 or go to the website Lanexabio.com.

What are the ingredients in LANGLARA?

Active ingredient: insulin glargine-aldy
Inactive ingredients: glycerin, metacresol, zinc oxide, and Water for injection, USP. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.

Manufactured by: Sunshine Lake Pharma Co., Ltd.

No.1, Northern Industry Road, Northern Industry Park of Song Shan Lake

Dongguan, Guangdong, China

At: YiChang HEC ChangJiang Pharmaceutical Co., Ltd., Hubei, China

U.S. License No. 2343

Distributed by: Lanexa Biologics, LLC, Langhorne, PA 19047

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 07/2026

INSTRUCTIONS FOR USE

LANGLARA™ (lan-GLAR-uh )

(insulin glargine-aldy)

injection, for subcutaneous use

3 mL Single-Patient-Use PREFILLED PEN: 100 units/mL (U-100)

Read these Instructions for Use before you start taking the LANGLARA pen and each time you get a new LANGLARA pen. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your LANGLARA 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.

People who are blind or have vision problems should not use the LANGLARA prefilled pen without help from a person trained to use the LANGLARA prefilled pen.

LANGLARA is a disposable prefilled pen used to inject LANGLARA. Each LANGLARA pen has 300 units of insulin which can be used for multiple injections. You can select doses from 1 to 80 units in steps of 1 unit. The pen plunger moves with each dose. The plunger will only move to the end of the cartridge when 300 units of LANGLARA have been given.

Important Information You Need to Know Before Injecting LANGLARA

Do notuse your pen if it is damaged or if you are not sure that it is working properly.
Do notuse a syringe to remove LANGLARA from your pen.
Do not reuse needles.If you do, you might get the wrong dose of LANGLARA or increase the chance of getting an infection.
Always perform a safety test (see Step 3).
Always carry a spare pen and spare needles in case they got lost or stop working.
Change (rotate) your injection sites within the area you choose for each dose. See “Places to inject”.

Learn to Inject

Talk with your healthcare provider about how to inject before using your pen.
Ask for help if you have problems handling the pen, for example if you have problems with your sight.
Read all these instructions before using your pen. If you do not follow all these instructions, you may get too much or too little insulin.

Need Help?

If you have any questions about your pen or about diabetes, ask your healthcare provider, or call Lanexa Biologics, LLC at 1-267-383-3008.

Extra Items You Will Need

a new sterile needle. See Step 2.
2 alcohol swabs. See figure below.

a puncture-resistant container for used needles and pens. See “Throwing y our pen away”.

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 notinject where the skin has pits, is thickened, or has lumps.
Do notinject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

Get to Know Your Pen

Step 1: Check your pen

Take a new pen out of the refrigerator at least 1 hour before you inject. Cold insulin is more painful to inject.

1A Check the name and expiration date on the label of your pen.

Make sure you have the correct insulin.
If you have other injector pens, it is especially important to check that you have the correct medicine.

Do notuse your pen after the expiration date.

1B Pull off the pen cap.

1C Check that the insulin is clear.

Do notuse the pen if the insulin looks cloudy, colored or contains particles.

1D Wipe the rubber seal with an alcohol swab.

Step 2: Attach a new pen needle

Do notreuse needles. This can cause blocked needles, germs, and infection. Always use a new sterile pen needle for each injection. Only use pen needles* that are compatible for use with LANGLARA, such as BD Ultra-Fine ^®.

2A Take a new pen needle and peel off the protective seal.

2B Keep the pen needle straight and screw it onto the pen until fixed.

Do notpush the pen needle onto the pen.
Do notover-tighten .

2C Pull off the outer needle cap. Keep this for later.

2D Pull off the inner needle cap and throw away in a puncture - resistant container. See “Throwing your pen away”.

Handling needles
º Take care when handling needles to prevent needle-stick injury and cross-infection.

Step 3: Do a safety test

Always do a safety test before each injection to:

Check your pen and the needle to make sure they are working properly.
Make sure that you get the correct LANGLARA dose.

3A Select 2 units by turning the dose selector until the dose pointer is at the 2 mark.

3B Press the injection button all the way in.

If you find it hard to press the injection button in, do notforce it as this may break your pen. See section “If you find it hard to press the injection button in” directly below Step 5F.
When insulin comes out of the needle tip, your pen is working correctly:

If no insulin appears:
º You may need to repeat this step up to 3 times before seeing insulin.
º If no insulin comes out after the third time, the needle may be blocked. If this happens:
♦ change the needle (see Step 6and Step 2),
♦ then repeat the safety test ( Step 3).
º Do notuse your pen if there is still no insulin coming out of the needle tip. Use a new pen.
º Do notuse a syringe to remove insulin from your pen.

If you see air bubbles:
º You may see air bubbles in the insulin. This is normal, they will not harm you.

Step 4: Select the dose

Do notselect a dose or press the injection button without a needle attached. This may damage your pen.

4A Make sure a needle is attached and the dose is set to “0.”

4B Turn the dose selector until the dose pointer lines up with your dose.

If you turn past your dose, you can turn back down.
If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
º If you cannot select your full prescribed dose, use a new pen or inject the remaining units and use a new pen to complete your dose.

How to read the dose window

Even numbers are shown in line with dose pointer.

Odd numbers are shown as a line between even numbers.

Units of LANGLARA in your pen:

Your pen contains a total of 300units of LANGLARA. You can select doses from 1to 80units in steps of 1unit. Each pen contains more than 1 dose.
You can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale.

Step 5: Injecting your LANGLARA dose

If you find it hard to press the injection button in, do notforce it as this may break your pen. See the section below 5Ffor help.

5A Choose a place to inject as shown in the picture above.

5B Clean your skin at the injection site with an alcohol swa b , then allow to dry for about 30 seconds.

5C Push the needle into your skin with the dose window in view as shown by your healthcare provider.

Do not touch the injection button yet.

5D Place your thumb on the injection button. Then press all the way in and hold.

Do notpress at an angle. Your thumb could block the dose selector from turning.

5E Keep the injection button held in and when you see "0" in the dose window, slowly count to 10.

This will make sure you get your full dose.

5F After holding and slowly counting to 10, release the injection button. Then remove the needle from your skin.

If you find it hard to press the injection button in:

Change the needle (see Step 6and Step 2) then do a safety test (see Step 3).
If you still find it hard to press in, get a new pen.
Do notuse a syringe to remove insulin from your pen.

Step 6: Remove the needle

Take care when handling needles to prevent needle-stick injury and cross-infection.
Do notput the inner needle cap back on.

6A Grip the widest part of the outer needle cap. Keep the needle straight and guide it into the outer needle cap. Then push firmly on.

The needle can puncture the cap if it is recapped at an angle.

6B Grip and squeeze the widest part of the outer needle cap. Turn your pen several times with your other hand to remove the needle.

Try again if the needle does not come off the first time.

6C Throw away the used needle in a puncture-resistant container.See “Throwing your pen away”at the end of this Instructions for Use.

6D Put your pen cap back on.

Do notput the pen back in the refrigerator.

Storing the LANGLARA Pen

Before first use
º Keep new pens in the refrigerator between 36°F to 46°F (2°C to 8°C).
º Do notfreeze. Do notuse LANGLARA if it has been frozen.

After first use
º Keep your pen at room temperature up to 86°F (30°C).
º Keep your pen away from heat or light.
º Store your pen with the pen cap on.
º Do notput your pen back in the refrigerator.
º Do notstore your pen with the needle attached.
º Only use your pen for up to 28 days after its first use. Throw away the LANGLARA pen you are using after 28 days, even if it still has insulin left in it.

Keep out of the reach of children.

Caring for Your LANGLARA Pen

Handle your pen with care
º Do not drop your pen or knock it against hard surfaces.
º If you think that your pen may be damaged, do nottry to fix it. Throw it away and use a new LANGLARA pen. See “Throwing Your Pen Away”at the end of this Instructions for Use. If you have questions, call Lanexa Biologics, LLC at 1-267-383-3008.

Protect your pen from dust and dirt
º You can clean the outside of your pen by wiping it with a damp cloth (water only).
º Do notsoak, wash or lubricate your pen. This may damage it.

Throwing Your Pen Away

The used LANGLARA pen may be thrown away in your household trash after you have removed the needle.
Put the used needle in an FDA-cleared sharps disposal container right away after use. Do notthrow away (dispose of) the used needles in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
º made of a heavy-duty plastic,
º can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
º upright and stable during use,
º leak-resistant, and
º 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 syringes. 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 notdispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do notrecycle your used sharps disposal container.

Manufactured by:

Sunshine Lake Pharma Co., Ltd.