Levemir FlexTouch Pens 100 Units / mL

About Insulin Detemir

Insulin detemir, sold under the brand name Levemir, is a long-lasting insulin used by adults, adolescents and children (1 year and above) with diabetes mellitus for glycemic control.

Managing glucose levels is important for diabetics in order to prevent diabetes complications such as kidney damage, nerve problems, sexual function, blindness, loss of limbs or even death. The use of insulin can also reduce the risk of stroke and heart attacks.

Insulin detemir acts longer than regular insulin by providing a low, steady level of insulin that helps glucose enter the cells so that the body can use it for energy. It is often used in combination with a short-acting insulin or other diabetes drugs such as metformin or exenatide.

Levemir provides a long and stead glycemic control within 3-4 hours and up to 24 hours of basal insulin coverage.

What is the Levemir FlexPen?

Levemir is a modern insulin (insulin analogue) used for glycemic control that works better than human versions of insulin.

The Levemir FlexPen is an insulin pen that contains insulin detemir as its active ingredient.

Levemir is not meant to treat diabetic ketoacidosis.

How is Levemir FlexPen used?

A doctor or pharmacist should instruct you on how to properly use the Levemir FlexPen. Additionally, you should review the instructions that are included with your medication.

The Levemir FlexPen is taken as an injection under the skin (subcutaneously).

It is usually taken with meals, within 15-20 minutes before or within 20 minutes of starting a meal.

USAGE

• Never share your insulin with others even if you attach a new pen needle.
• Use a new pen needle for every injection.
• Remove pen needles after injection and discard into a sharps disposal container.
• Do not place a new needle into the FlexPen unless you are ready to use it.
• Review the patient instructions on how to perform a function check if your Levemir Flexpen is working correctly
• Use a new needle for every injection to prevent infection.

Remove the needle after every use and do not store with its needle in place to prevent contamination, leakage of insulin or infection.

Do not modify your insulin regimen without consulting your doctor first.

Part of your insulin treatment should be checking your blood glucose levels regularly. Speak to your doctor or diabetes educator on how to do this.

A modification may be required to dosage if patient has weight loss or gain, increased stress, change in diet or has become ill.

Speak to your pharmacist about how to properly dispose of medication. You can put pen and needles in an FDA-cleared sharps container after use. Do not dispose of medication, pens and needles in the house hold trash or down wastewater. If you do not have sharps container you can use a household container that is made from heavy-duty plastic, is puncture/leak resistant and label container as hazardous waste.

Levemir FlexTouch Storage

• After initialy use of the Levemir FlexTouch, it must not be stored in a refrigerator.
• Keep your FlexTouch at room temperature, below 86°F (30°C) once in use.
• Keep in use FlexTouch away from sunlight and direct heat.
• Do not freeze Levemir FlexTouch pen or use if it has been frozen.
• Unrefrigerated Levemir FlexTouch should be discarded after 42 days after it has been taken out of the refrigerator.

SIDE EFFECTS

As with taking any insulin, side effects may occur.

Hypoglycemia (low blood sugar) may happen. Symptoms may include:

• anxiety
• mood changes
• dizziness
• sweating
• confusion
• headache
• irritability

Hypoglycemia is a common side effect with most insulin treatments (including Levemir) and may be life threatening if not treated.

Common side effects may include:

• skin reactions at site of injection which may include itching, rash
• skin thickening or pitting at injection sites (lipodystrophy)
• weight gain
• swelling

If you are experiencing any of the following side effects get medical help immediately:

• trouble breathing
• shortness of breath
• rapid heartbeat
• dizziness
• confusion
• drowsiness
• sweating
• swelling of face, throat or tongue

DRUG INTERACTIONS

Several medications may affect blood glucose metabolism and require an adjustment to insulin dosage and close monitoring.

The following medications affect blood sugar levels and increase susceptibility to hypoglycemia:

• oral antidiabetic medications
• pramlintide acetate
• angiotensin converting enzyme (ACE) inhibitors
• disopyramide
• fibrates
• fluoxetine
• monoamine oxidase (MAO) inhibitors
• propoxyphene
• pentoxifylline
• salicylates
• somatostatin analogs
• sulfonamide antibiotics

The following are examples of medications that may reduce the blood-glucose-lowering effect of insulins including LEVEMIR®:

• corticosteroids
• niacin
• danazol
• diuretics
• sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline)
• glucagon
• isoniazid
• phenothiazine derivatives
• somatropin
• thyroid hormones
• estrogens
• progestogens (e.g., in oral contraceptives)
• protease inhibitors and atypical antipsychotic medications (e.g. olanzapine and clozapine)
• Beta-blockers
• clonidine
• lithium salts

The signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs such as beta-blockers, clonidine, guanethidine, and reserpine.

WARNINGS & PRECAUTIONS

Do not take Levmir FlexTouch if you have an allergy to any of the ingredients contained in Levemir.

Before taking Levemir®, inform your doctor about all your medical conditions including, if you are:

• if you have any pre-existing medical conditions such as heart, liver or kidney issues.
• if you are pregnant, planning on pregnancy or breastfeeding
• taking any other medications, over-the-counter medications, vitamins or herbal supplements

Do not share your FlexTouch pen with others as it may spread serious infections.

Do not skip meals when taking insulin.

It is important to rotate injection sites to avoid skin complications.

Do not inject into a muscle or vein.

Hypoglycemia is a common side effect for diabetics. To avoid hypoglycemia, keep a sugary snack, juice or pop (non-diet), glucose tablet available.

Do not mix or dilute Levemir with any other solution or insulin. Do not administer using an insulin pump, intravenously or intramuscularly as it may cause severe hypoglycemia.

FREQUENTLY ASKED QUESTIONS