The FDA has approved Levemir FlexTouch (insulin detemir [rDNA origin] injection), the newest insulin delivery pen by Novo Nordisk, which contains a longacting human insulin analogue indicated to improve glycemic control in adults and children with diabetes mellitus. The approval carries the limitation that Levemir FlexTouch is not recommended for diabetic ketoacidosis and that intravenous rapidacting or short-acting insulin should be used instead.1
In traditional prefilled pen devices, the push button extends as the dose is dialed. At larger doses, this extension may present delivery challenges for the patient. Levemir FlexTouch is the first and only prefilled insulin device without a push button extension, allowing insulin to be administered by pressing the low injection force button, which utilizes a spring-loaded mechanism.2
Levemir received its original FDA approval in 2005 and was subsequently available as a 10-mL multidose vial or as Levemir FlexPen, a prefilled pen device.1 Levemir FlexPen is expected to be discontinued and replaced by Levemir FlexTouch; however, the FlexPen device will still be available for Novo Nordisk’s Novolog and Novolog Mix 70/30.3 Levemir FlexTouch has already been launched in United Kingdom, Canada, Denmark, and Japan.2
Dosage and Administration
Levemir FlexTouch is a prefilled pen containing 300 U (3 mL of 100 U/mL) of insulin detemir. The pen allows for doses in 1-U increments, from a minimum of 1 U to a maximum of 80 U per dose. Needles are sold separately and may require a prescription in some states.2
When Levemir FlexTouch is used, the dose button must be pressed and held until the dose counter shows “0,” and then the needle must be kept in the skin for a slow count to 6, as the prescribed dose is not completely delivered until 6 seconds after the dose counter returns to 0. If the needle is removed earlier, the patient may see a stream of insulin coming from the needle, which may result in a possible underdosage of up to 20%. If this occurs, the patient should be instructed to increase the frequency of blood glucose monitoring, and additional insulin administration may be required.1,3
The starting dose of Levemir FlexTouch should be individualized for each patient. It should be administered subcutaneously once or twice daily. Injection sites should be rotated to reduce the risk for lipodystrophy. Converting from other insulin therapies may require adjustments in the timing and dose of Levemir FlexTouch.1
Contraindications, Warnings, and Precautions
Levemir FlexTouch is contraindicated in patients with a hypersensitivity to Levemir or any of its excipients.
Patients should never share Levemir FlexTouch with another person, even if the needle has been changed. Sharing devices may increase the risk for transmission of infection. Blood glucose should be monitored in all patients using insulin. Insulin regimens should be modified cautiously and only under medical supervision. The solution should not be diluted or mixed with any other insulin or solution. It should not be given subcutaneously via an insulin pump, intramuscularly, or intravenously, as severe hypoglycemia may occur. Severe, life-threatening, generalized allergy, including anaphylaxis, may occur. A dose adjustment may be required during renal or hepatic impairment. Fluid retention and heart failure can occur when Levemir is coadministered with thiazolidinediones. Levemir has not been studied in children with type 2 diabetes mellitus or children with type 1 diabetes mellitus who are younger than 2 years. Levemir is a Pregnancy Category B medication. Caution should be used when Levemir is administered to a patient who is breast-feeding. Certain medications may alter glucose metabolism; concurrent use of Levemir with these medications may require Levemir dose adjustment and close blood glucose monitoring. Patients using antiadrenergic medications may not experience the signs and symptoms of hypoglycemia.
Adverse reactions include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash, and pruritus.1
Dr. Holmberg earned her PharmD from the University of Connecticut and completed an ambulatory care residency at the Phoenix VA Healthcare System. Her practice has also included pediatrics and inpatient mental health. She resides in Phoenix, Arizona.
1. Levemir [package insert]. www.novo-pi.com/levemir.pdf. Accessed September 2014.
2. Novo Nordisk announces US launch of new insulin device Levemir FlexTouch: latest delivery device advancement in the basal insulin category. http://press.novonordisk-us.com/2014-06-19-Novo-Nordisk-Announces-U-S-Launch-of-New-Insulin-Device-Levemir-FlexTouch. Accessed September 2014.
3. Levemir FlexTouch FAQ. www.levemirpro.com/content/dam/novonordisk/levemirpro/general/generaldocuments/Levemir_FlexTouch_HCP_FAQ.pdf. Accessed September 2014.