Levemir FlexTouch 100 (Insulin Detemir)

Levemir (insulin detemir)

Levemir is a long-acting insulin injection prescribed to improve blood sugar levels in patients with diabetes mellitus. Levemir is prescribed to be used once or twice daily. Levemir will start working within 4 hours of the injection lasting up to 24 hours.

Levemir belongs to the drug class of antidiabetics, insulin. Insulin medications work by mimicking human insulin, which helps control blood sugar levels. When insulin made by the body decreases, blood sugar levels will rise to high levels. Very high blood sugar levels can be dangerous and life-threatening.

What are the Indications for Levemir?

Levemir is prescribed as part of a treatment plan to manage blood sugar levels consisting of exercise, diet changes, and regular blood sugar testing. Any change in diet and activity can affect blood sugar levels.

Levemir may also be prescribed to treat type 1 diabetes and type 2 diabetes in both adults and children.

Levemir is not recommended:

• For treatment of diabetic ketoacidosis.
• If you are allergic or have had an allergic reaction to Levemir or ingredients in Levemir.

How is Levemir used?

Levemir should be used as prescribed by your doctor by injecting the medication under your skin through a needle and syringe, infusion pump, or injection pen.

Storage

Levemir that has not been opened should be stored in the refrigerator between 36° to 46°F or 2° to 8°C. Levemir should not be stored in the freezer.

Levemir that has been opened and is currently in use should be stored at room temperature between under 86°F or 30°C. Levemir should be kept away from direct light and heat.

Once you’ve opened Levemir, it must be used within 42 days. After 42 days, any opened remaining medication must be thrown away even if there is still some medication left.

• Levemir FlexTouch pens should not be refrigerated and should be stored at room temperature without the needle.
• Levemir vials may be refrigerated or stored at room temperature.

Instructions

Follow the patient information pamphlet that comes with your medication. Levemir needs to be injected under the skin of your upper leg, stomach, thigh, buttocks, or upper arm. Levemir should never be injected into a vein or muscle.

1. Select your injection site and clean with an alcohol swab. The injection site should be rotated so as not to be in the exact same location as the last injection.

• Do not inject in areas with scars, stretch marks, bruises, or where the skin is tender, hard, or red.

1. Inject the medication as directed in the patient information pamphlet.
2. After the injection, dispose of the needle in an FDA-cleared sharps disposal container immediately. Do not reuse or share your needles with other people. You can create a sharps disposable container by using any heavy-duty plastic household container that you have that:

• Is leak-resistant
• Has a tight-fitting, puncture-proof lid so sharps such as needles cannot escape
• Has a label warning there are hazardous materials inside the container

Dosage

Levemir is a clear, colorless solution available in one strength, 100-unit per mL (U-100). Levemir is available as a 3 mL single-use prefilled pen and a 10 mL multiple-use vial.

Levemir may be administered once or twice daily as directed by your doctor.

• Once daily dosing: Levemir should be injected with your last meal of the day or before bedtime.
• Twice daily dosing: Levemir should be injected in the morning then 12 hours later, with the last meal, or before bedtime.

The specific unit dose for each person will vary and can change depending on several factors; weight, current blood sugar level, activity levels, and how well you respond to insulin.

If you have never taken insulin before, your doctor may start your dose on a titration schedule working your way up to the full recommended unit dose.

If you are switching from a different insulin to Levemir, you may be able to continue taking the same unit dose as you did with the previous insulin medication.

Side Effects

It’s important to understand that although Levemir is FDA approved, it comes with side effects that may or may not affect you.

Before starting Incruse Ellipta, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Incruse Ellipta, side effects may go away.

Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:

• Reaction at the injection site (e.g. tenderness and redness)
• Congestion
• Runny or stuffy nose, sneezing
• Weight gain
• Tender or swollen glands
• Swelling of the hands, feet, or lower legs
• Body aches

Serious Side Effects

Severe adverse reactions while taking Levemir can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
• Low blood sugar: headache, irritability, confusion, blurred vision, slurred speech, dizziness or light-headedness, shakiness, fast heartbeat, mood change, anxiety, or excessive hunger.

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before using Levemir, tell your doctor or pharmacist:

• If you are allergic to any medications such as Levemir
• If you have or have had low levels of potassium such as hypokalemia
• If you are pregnant or plan to become pregnant
• If you are breastfeeding

Hypoglycemia or Low Blood Sugar

The risks of having low blood sugar levels increase:

• If there is a change in your diet and exercise
• If you consume alcohol
• If you take medications for diabetes such as Levemir
• If you are over 65 years of age
• If you have liver or kidney problems

Symptoms include the inability to concentrate, irritability, shakiness, fast heartbeat, unusual weakness or tiredness, excessive hunger, and confusion.

Severe low blood sugar may become life-threatening, cause seizures, or result in death. Your doctor will create a treatment plan that includes monitoring your blood sugar level to determine if a change in treatment is necessary.

Hypokalemia

Taking Levemir can result in low potassium levels, especially if you are taking another medication that may also lower potassium levels. Low potassium levels can be dangerous, resulting in ventricular arrhythmia, respiratory paralysis, or death. Your doctor may monitor your potassium levels to determine if a change in treatment is necessary.

Mixing Insulins

Take precautions such as carefully reviewing labels to ensure you use the correct insulin before making an injection. Using the wrong insulin and/or dose may lead to overdose and severe high blood pressure. There have been reports of accidental insulin mix-ups of patients using different insulins in the incorrect amount.

Pregnant or Plan to Become Pregnant

Having high blood sugar during pregnancy may cause complications during the pregnancy and delivery for both mother and baby. Complications include premature birth, low birth weight, and breathing problems. There is also an increased risk of miscarriage or stillborn. Your doctor will create a treatment plan to monitor your blood sugar levels.

Sharing of Needles, Pens, and Vials

Needles, pens, and vials should never be reused or shared with anyone else. Doing so creates risks of dangerous diseases spread through blood transmission.

Interactions & Contraindications

Before using Levemir, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Increased Risk of Low Blood Sugar

Taking Levemir with the following types of medications may increase your risk of low blood sugar. Your doctor will monitor your treatment plan and make changes as necessary.

• Salicylates
• Angiotensin II receptor blocking agents
• Somatostatin analogs (e.g., Sandostatin and Mycapssa)
• Antidiabetic agents (e.g. metformin, glyburide, and glipizide)
• Sulfonamide antibiotics
• Fluoxetine
• Disopyramide
• Pramlintide
• Fibrates
• Pentoxifylline
• Monoamine oxidase inhibitors (e.g., Azilect and Marplan)
• ACE inhibitors (e.g., Benazepril and Lisinopril)

Taking Levemir with the following types of medications may weaken the signs and symptoms of low blood sugar. Check your blood sugar regularly and contact your doctor with any concerns.

• Beta-blockers (e.g., Atenolol and Metoprolol)
• Clonidine
• Guanethidine
• Reserpine

Effectiveness of Blood Sugar Lowering Ability

Taking Levemir with the following types of medications may decrease the effectiveness of Levemir to lower blood sugar levels. Your doctor will monitor your treatment plan and make changes as necessary.

• Corticosteroids (e.g., betamethasone, prednisone, and prednisolone).
• Isoniazid
• Niacin
• Estrogens (e.g., Estradiol and Imvexxy)
• Oral contraceptives
• Phenothiazines (e.g., prochlorperazine and promethazine)
• Danazol
• Diuretics
• Sympathomimetic agents (e.g., albuterol inhalers and EpiPen)
• Somatropin (e.g., Humatrope and Omnitrope)
• Atypical antipsychotics (e.g., risperidone and aripiprazole)
• Glucagon
• Protease inhibitors (e.g., Reyataz and Norvir)
• Thyroid hormones (e.g., Synthroid)

Taking Levemir with the following medications can either decrease or increase the effectiveness of Levemir to lower blood sugar levels. Your doctor will monitor your treatment plan and make changes as necessary.

• Beta-blockers (e.g., Atenolol, Metoprolol, Nadolol, and Propranolol)
• Clonidine
• Lithium salts
• Alcohol
• Pentamidine

Frequently Asked Questions