5 WARNINGS AND PRECAUTIONS

5.1 Never Share a LEVEMIR FlexPen, Needle, or Insulin Syringe between

Patients

LEVEMIR FlexPen prefilled pens must never be shared between patients, even if the needle is changed. Patients using LEVEMIR vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.4)] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6)].

Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant antidiabetic products may be needed [see Dosage and Administration (2.4)].

5.3 Hypoglycemia

Hypoglycemia is the most common adverse reaction of insulin, including LEVEMIR [see Adverse Reactions (6.1)]. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place the patient and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). LEVEMIR, or any insulin, should not be used during episodes of hypoglycemia [see Contraindications (4)].

Hypoglycemia can happen suddenly and symptoms may differ in each patient and change over time in the same patient. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy, using drugs that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7)], or who experience recurrent hypoglycemia.

Risk Factors for Hypoglycemia

The risk of hypoglycemia generally increases with intensity of glycemic control. The risk of hypoglycemia after an injection is related to the duration of action of the insulin [see Clinical Pharmacology (12.2)] and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of LEVEMIR may vary among different patients or at different times in the same patient and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature.

Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to concomitant drugs [see Drug Interactions (7)]. When a GLP-1 receptor agonist is used in combination with LEVEMIR, the LEVEMIR dose may need to be lowered or more conservatively titrated to minimize the risk of hypoglycemia [see Adverse Reactions (6.1)]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations (8.6, 8.7)].

Risk Mitigation Strategies for Hypoglycemia

Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.

5.4 Hypoglycemia Due to Medication Errors

Accidental mix-ups between insulin products have been reported. To avoid medication errors between LEVEMIR and other insulins, instruct patients to always check the insulin label before each injection.

5.5 Hypersensitivity Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including LEVEMIR [see Adverse Reactions (6.1)]. If hypersensitivity reactions occur, discontinue LEVEMIR; treat per standard of care and monitor until symptoms and signs resolve. LEVEMIR is contraindicated in patients who have had hypersensitivity reactions to insulin detemir or any of the excipients.

5.6 Hypokalemia

All insulins, including LEVEMIR, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).

5.7 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma

Agonists

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including LEVEMIR, and a PPAR- gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere:

•

Hypoglycemia [see Warnings and Precautions (5.3)]

•

Hypoglycemia Due to Medication errors [see Warnings and Precautions (5.4)]

•

Hypersensitivity Reactions [see Warnings and Precautions (5.5)]

•

Hypokalemia [see Warnings and Precautions (5.6)]

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

The frequencies of adverse reactions (excluding hypoglycemia) reported during LEVEMIR clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in Tables 1-4 below. See Tables 5 and 6 for the hypoglycemia findings.

In two pooled trials, adults with type 1 diabetes were exposed to individualized doses of LEVEMIR (n=767) or NPH (n=388). The mean duration of exposure to LEVEMIR was 153 days, and the total exposure to LEVEMIR was 321 patient-years. The most common adverse reactions are summarized in Table 1.

Adults with type 1 diabetes were exposed to LEVEMIR (n=161) or insulin glargine (n=159). The mean duration of exposure to LEVEMIR was 176 days, and the total exposure to LEVEMIR was 78 patient-years. The most common adverse reactions are summarized in Table 2.

In two pooled trials, adults with type 2 diabetes were exposed to LEVEMIR (n=432) or NPH (n=437). The mean duration of exposure to LEVEMIR was 157 days, and the total exposure to LEVEMIR was 186 patient-years. The most common adverse reactions were comparable to that observed in adult patients with type 1 diabetes mellitus; see Table 1.

Pediatric patients with type 1 diabetes were exposed to individualized doses of LEVEMIR (n=232) or NPH (n=115). The mean duration of exposure to LEVEMIR was 180 days, and the total exposure to LEVEMIR was 114 patient-years. The most common adverse reactions are summarized in Table 3.

Hypoglycemia

Hypoglycemia was the most commonly observed adverse reaction in patients treated with LEVEMIR. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for LEVEMIR with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice.

Table 4 (type 1 diabetes) and Table 5 (type 2 diabetes) summarize the incidence of severe and non-severe hypoglycemia in the LEVEMIR clinical trials.

For the adult trials and one of the pediatric trials (Study D), severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring assistance of another person and associated with either a plasma glucose value below 56 mg/dL (blood glucose below 50 mg/dL) or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. For the other pediatric trial (Study I), severe hypoglycemia was defined as an event with semi-consciousness, unconsciousness, coma and/or convulsions in a patient who could not assist in the treatment and who may have required glucagon or intravenous glucose.

For the adult trials and pediatric trial (Study D), non-severe hypoglycemia was defined as an asymptomatic or symptomatic plasma glucose <56 mg/dL (or equivalently blood glucose <50 mg/dL as used in Study A and C) that was self- treated by the patient. For pediatric Study I, non-severe hypoglycemia included asymptomatic events with plasma glucose <65 mg/dL as well as symptomatic events that the patient could self-treat or treat by taking oral therapy provided by the caregiver.

 Hypersensitivity Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock have occurred with insulin, including LEVEMIR, and may be life-threatening.

Insulin Initiation and Intensification of Glucose Control

Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long- term glycemic control decreases the risk of diabetic retinopathy and neuropathy.

Lipodystrophy

Long-term use of insulin, including LEVEMIR, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption [see Dosage and Administration (2.1)].

Weight Gain

Weight gain can occur with insulin therapy, including LEVEMIR, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria [see Clinical Studies (14)]. In the clinical program, the mean change in body weight from baseline in adult patients with type 1 diabetes (Study A, B, and C) treated with LEVEMIR ranged from -0.3 kg to 0.5 kg. The mean change in body weight from baseline in adult patients with type 2 diabetes (Study E, F, and H) treated with LEVEMIR ranged from 0.5 kg to 1.2 kg.

Peripheral Edema

Insulin, including LEVEMIR, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Injection Site Reactions

Patients taking LEVEMIR may experience injection site reactions, including localized erythema, pain, pruritus, urticaria, edema, and inflammation. In clinical studies in adults, three patients treated with LEVEMIR reported injection site pain (0.25%).

Immunogenicity

All insulin products can elicit the formation of insulin antibodies. These insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose. In clinical trials of LEVEMIR, antibody development has been observed with no apparent impact on glycemic control.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of LEVEMIR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Medication errors have been reported in which rapid-acting or short-acting insulins and other insulins, have been accidentally administered instead of LEVEMIR.

Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.

7 DRUG INTERACTIONS

Table 6 includes clinically significant drug interactions with LEVEMIR.

Table 6: Clinically Significant Drug Interactions with LEVEMIR

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Standard 2-year carcinogenicity studies in animals have not been performed. Insulin detemir tested negative for genotoxic potential in the in vitro reverse mutation study in bacteria, human peripheral blood lymphocyte chromosome aberration test, and the in vivo mouse micronucleus test.

In a fertility and embryonic development study, insulin detemir was administered to female rats before mating, during mating, and throughout pregnancy at doses up to 300 nmol/kg/day (3 times a human dose of 0.5 units/kg/day, based on plasma AUC ratio). There were no effects on fertility in the rat.

Patient Information

LEVEMIR is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

LEVEMIR is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).

are having an episode of low blood sugar (hypoglycemia).

have an allergy to LEVEMIR or any of the ingredients in LEVEMIR. See the end of this Patient Information leaflet for a complete list of ingredients in LEVEMIR.

take any other medicines, especially medicines commonly called TZDs (thiazolidinediones).

are pregnant, planning to become pregnant, or are breastfeeding.

**Read the Instructions for Use**that comes with your LEVEMIR.

Take LEVEMIR exactly as your healthcare provider tells you to.

Know the type and strength of insulin you take.**Do not** change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.

**Check your blood sugar levels.**Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

**Do not reuse or share your needles or syringes with other people.**You may give other people a serious infection or get a serious infection from them.

LEVEMIR is injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).

**Do not**inject LEVEMIR into a vein or muscle.

**Change (rotate) your injection sites within the area you choose 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 the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

Drive or operate heavy machinery, until you know how LEVEMIR affects you.

Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

**low blood sugar (hypoglycemia).**Low blood sugar can be a serious, but common side effect of LEVEMIR. 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 changes

hunger

**severe allergic reactions**. Severe allergic reactions are a potential side effect of LEVEMIR. Get emergency medical help if you have:

trouble breathing

shortness of breath

fast heartbeat

swelling

swelling of your face, tongue, or throat

sweating

extreme drowsiness

dizziness

confusion

**low potassium in your blood (hypokalemia).**

**heart failure.** Taking certain diabetes pills called TZDs (thiazolidinediones) with LEVEMIR 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 LEVEMIR. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:

shortness of breath

swelling of ankles or feet

sudden weight gain

injection site reactions

skin thickening or pits at the injection site (lipodystrophy)

weight gain

swelling of your hands and feet

rash

itching

change in level of physical activity or exercise

weight gain or loss

increased stress

illness

change in diet

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

Revised: 12/2022

INSTRUCTIONS FOR USE

LEVEMIR®** (LEV-uh-mere)**

injection, for subcutaneous use

10 mL multiple-dose vial

Please read the following Instructions for use carefully before using your LEVEMIR® vial and each time you get a refill. You should read the instructions in this manual even if you have used an insulin vial before.

How should I use the LEVEMIR vial?

Using the vial:

How should I inject LEVEMIR with a syringe?

If you clean your injection site with an alcohol swab, let the injection site dry before you inject. Talk with your healthcare provider about how to rotate injection sites and how to give an injection.

**Do not** freeze LEVEMIR.**Do not** use LEVEMIR if it has been frozen.

Keep LEVEMIR away from heat or light.

**All unopened vials:**

Store unopened LEVEMIR vials in the refrigerator at 36°F to 46°F (2°C to 8°C). 

Unopened vials may be used until the expiration date printed on the label, if they have been stored in the refrigerator. 

Unopened vials should be thrown away after 42 days, if they are stored at room temperature up to 86°F (30°C).

**After vials have been opened:**

Opened LEVEMIR vials can be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) or at room temperature up to 86°F (30°C). 

Throw away all opened LEVEMIR vials after 42 days, even if they still have insulin left in them. 

Revised: 07/2022

Novo Nordisk® and LEVEMIR® are registered trademarks of Novo Nordisk A/S.

PATENT Information: https://www.novonordisk-us.com/products/product- patents.html

© 2005-2022 Novo Nordisk

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

U.S. License Number 1261

INSTRUCTIONS FOR USE

Levemir**®**** (LEV–uh-mere)**

(insulin detemir)

injection, for subcutaneous use

FlexTouch**®**Pen

Please read the following instructions carefully before using your Levemir FlexTouch Pen.

•

**Do not share your Levemir FlexTouch 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.**

•

**Levemir FlexTouch Pen (“Pen”) is a prefilled disposable, single-patient-use insulin pen**containing 300 units insulin detemir. You can inject from 1 to 80 units in a single injection.

•

**People who are blind or have vision problems should not use this Pen without help from a person trained to use the Pen.**

Supplies you will need to give your Levemir injection:

•

Levemir FlexTouch Pen

•

a new NovoFine, NovoFine Plus or NovoTwist needle

•

alcohol swab

•

1 sharps container for throwing away used Pens and needles.**See “Disposing of used Levemir FlexTouch Pens and needles” at the end of these instructions.**

Preparing your Levemir FlexTouch Pen:

•

Wash your hands with soap and water.

•

**Before you start to prepare your injection, check the Levemir FlexTouch Pen label to make sure you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin.**

•

Levemir should look clear and colorless.**Do not** use Levemir if it is thick, cloudy, or is colored.

•

**Do not** use Levemir past the expiration date printed on the label or 42 days after you start using the Pen.

•

**Always**use a new needle for each injection to help ensure sterility and prevent blocked needles.**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.**

Pull Pen cap straight off (See Figure B).

**Check the liquid in the Pen** (See Figure C). Levemir should look clear and colorless.**Do not** use it if it looks cloudy or colored.

**Select a new needle.**

Pull off the paper tab from the outer needle cap (See Figure D).

Push the capped needle straight onto the Pen and twist the needle on until it is tight (See Figure E).

Pull off the outer needle cap.**Do no**t throw it away (See Figure F).

Pull off the inner needle cap and throw it away (See Figure G).

Priming your Levemir FlexTouch Pen:

Turn the dose selector to**select 2 units** (See Figure H).

Hold the Pen with the needle pointing up. Tap the top of the Pen gently a few times to let any air bubbles rise to the top (See Figure I).

**Hold the Pen with the needle pointing up.**Press and hold in the dose button until the dose counter shows “0”. The “0” must line up with the dose pointer. 

A drop of insulin should be seen at the needle tip (See Figure J).

If you**do not** see a drop of insulin, repeat steps 7 to 9, no more than 6 times. 

If you**still do not** see a drop of insulin, change the needle and repeat steps 7 to 9. 

Selecting your dose:

**Turn the dose selector to select the number of units you need to inject.** The dose pointer should line up with your dose (See Figure K).

If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.

The**even** numbers are printed on the dial.

The**odd** numbers are shown as lines.

The Levemir FlexTouch Pen insulin scale will show you how much insulin is left in your Pen (See Figure L).

**To see how much insulin is left in your Levemir FlexTouch Pen:**

Turn the dose selector until it stops. The dose counter will line up with the number of units of insulin that is left in your Pen. If the dose counter shows 80, there are**at least 80** units left in your Pen. 

If the dose counter shows**less than 80,** the number shown in the dose counter is the number of units left in your Pen.

Giving your injection:

•

Inject your Levemir exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting. 

•

Levemir can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs) or upper arms.

•

For each injection, change (rotate) your injection site within the area of skin that you use 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 same injection site for each injection.**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.   

Choose your injection site (abdomen, thighs or upper arms) and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure M).

**Insert the needle into your skin** (See Figure N).

**Make sure you can see the dose counter. Do not** cover it with your fingers; this can stop your injection. 

**Press and hold down the dose button until the dose counter shows “0”** (See Figure O). 

The “0” must line up with the dose pointer. You may then hear or feel a click.

**Keep the needle in your skin after**the dose counter has returned to “0” and** slowly count to 6**(See Figure P).

**When the dose counter returns to “0”, you will not get your full dose until 6 seconds later.**

**If the needle is removed before you count to 6, you may see a stream of insulin coming from the needle tip.**

**If you see a stream of insulin coming from the needle tip you will not get your full dose. If this happens you should check your blood sugar levels more often because you may need more insulin.**

**Pull the needle out of your skin** (See Figure Q). 

If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab.**Do not** rub the area.

**Carefully remove the needle from the Pen and throw it away** (See Figure R). 

**Do not** recap the needle. Recapping the needle can lead to needle stick injury.

If you**do not** have a sharps container, carefully slip the needle into the outer needle cap (See Figure S). Safely remove the needle and throw it away as soon as you can. 

**Do not** store the Pen with the needle attached. Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.

Replace the Pen cap by pushing it straight on (See Figure T).

After your injection:

•

The used Levemir FlexTouch Pen may be thrown away in your household trash after you have removed the needle.

•

 You can put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash.

•

If you do not have a 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

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. Do not reuse or share your needles or syringes with other people. 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 my Levemir FlexTouch Pen?

•

Store unused Levemir FlexTouch Pens in the refrigerator at 36°F to 46°F (2°C to 8°C). 

•

Store the Pen you are currently using out of the refrigerator up to 86°F.

•

**Do not** freeze Levemir.**Do not** use Levemir if it has been frozen.

•

Keep Levemir away from heat or light.

•

Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator.

•

The Levemir FlexTouch Pen you are using should be thrown away after 42 days, even if it still has insulin left in it.

General Information about the safe and effective use of Levemir:

•

**Keep Levemir FlexTouch Pens and needles out of the reach of children.**

•

**Always** use a new needle for each injection.

•

**Do not** share your Levemir FlexTouch Pen or needles with other people. You may give other people a serious infection, or get a serious infection from them. 

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

U.S. License Number 1261

Revised: 07/2022

For more information go to

www.novotraining.com/levemirflextouch/us02

© 2005-2022 Novo Nordisk

Levemir**®**

FlexTouch®

Read before first use

Instructions For Use

LEVEMIR**®**** (LEV–uh-mere) FlexPen****®**

(insulin detemir)

injection, for subcutaneous use

Please read the following instructions carefully before using your LEVEMIR FlexPen.

Do not share your LEVEMIR FlexPen 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.

LEVEMIR FlexPen is a prefilled disposable, single-patient-use, insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. LEVEMIR FlexPen is designed to be used with NovoFine or NovoFine Plus needles.

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

Getting ready

Make sure you have the following items:

▪

LEVEMIR FlexPen

▪

NovoFine or NovoFine Plus disposable needles

▪

Alcohol swab

▪

Sharps disposal container (see**After the Injection**)

Preparing your LEVEMIR FlexPen

Wash your hands with soap and water. Before you start to prepare your injection, check the label to make sure that you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin. LEVEMIR should look clear and colorless.Do not use LEVEMIR if it is thick, cloudy, or is colored.

Always use a new needle for each injection to make sure the needle is free of germs (sterile) and to prevent blocked needles. 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.

Be careful not to bend or damage the needle before use.

To reduce the risk of needle sticks,** never put the inner needle cap back on the needle.**

Giving the airshot before each injection

Before each injection, small amounts of air may collect in the cartridge during normal use. To avoid injecting air and to ensure proper dosing:

Selecting your dose

Check and make sure that the dose selector is set at 0.

Giving the injection

Give the injection exactly as shown to you by your healthcare provider. Your healthcare provider should tell you if you need to pinch the skin before injecting. Wipe the skin with an alcohol swab and let the area dry.

LEVEMIR can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs), or upper arms.

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 use the same injection site for each injection.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.

After the injection

**Do not recap the needle.**Recapping can lead to a needle stick injury. Remove the needle from the LEVEMIR FlexPen after each injection and dispose of it. This helps to prevent infection, leakage of insulin, and will help to make sure you inject the right dose of insulin.

•

If you do not have a sharps container, carefully slip the needle into the outer needle cap using 1 hand. Use your other hand to pinch the base of the big outer needle cap and unscrew the used needle from the Pen and throw it away as soon as you can.

•

The used LEVEMIR FlexPen may be thrown away in your household trash after you have removed the needle.

•

Put your used needles in an FDA-cleared sharps disposal container right away after use.**Do not** throw away (dispose of) loose needles in your household trash. 

•

If you do not have a 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 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>.

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.

When there is not enough medicine left in your LEVEMIR FlexPen for your prescribed dose, the LEVEMIR FlexPen may be thrown away in your household trash after you have removed the needle.

The LEVEMIR FlexPen prevents the cartridge from being completely emptied. It is designed to deliver 300 units.

How should I store LEVEMIR FlexPen?

•

Store the unused (unopened) LEVEMIR FlexPen in the refrigerator between 36°F to 46°F (2°C to 8°C).

•

Store the LEVEMIR FlexPen you are currently using out of the refrigerator up to 86°F.

•

**Do not** freeze the LEVEMIR FlexPen.**Do not** use the LEVEMIR FlexPen if it has been frozen.

•

Keep the LEVEMIR FlexPen away from heat or light.

•

Unused LEVEMIR FlexPens may be used until the expiration date printed on the label, if kept in the refrigerator.

The LEVEMIR FlexPen you are using should be thrown away after 42 days, even if it still has insulin left in it.

Keep your LEVEMIR FlexPen and needles out of the reach of children.

Maintenance

For the safe and proper use of your LEVEMIR FlexPen be sure to handle it with care. Avoid dropping your LEVEMIR FlexPen as it may damage it. If you are concerned that your LEVEMIR FlexPen is damaged, use a new one. You can clean the outside of your LEVEMIR FlexPen by wiping it with a damp cloth.Do not soak or wash your LEVEMIR FlexPen as it may damage it.Do not refill your LEVEMIR FlexPen.

Remove the needle from the LEVEMIR FlexPen after each injection. This helps to ensure sterility, prevent leakage of insulin, and will help to make sure you inject the right dose of insulin for future injections.

Be careful when handling used needles to avoid needle sticks and transfer of infectious diseases.

Use the LEVEMIR FlexPen exactly as your healthcare provider tells you to.

** Do not** share your LEVEMIR FlexPen or needles with other people. You may give other people a serious infection, or get a serious infection from them.

Always use a new needle for each injection.

Novo Nordisk is not responsible for harm due to using this insulin pen with products not recommended by Novo Nordisk.

As a precautionary measure, always carry a spare insulin delivery device in case your LEVEMIR FlexPen is lost or damaged.

Remember to keep the disposable LEVEMIR FlexPen with you.Do not leave it in a car or other location where it can get too hot or too cold.

© 2022 Novo Nordisk

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

U.S. License Number 1261

Revised: 12/2022