"Miriam E. Tucker
Medscape Medical News
The U.S. Food and Drug Administration (FDA) will now require a "for single patient use only" warning on all multidose pen devices used for injectable diabetes medications.
(insulin detemir [rDNA origin]) Injection
LEVEMIR® (insulin detemir [rDNA origin] injection) is a sterile solution of insulin detemir for use as a subcutaneous injection. Insulin detemir is a long-acting (up to 24-hour duration of action) recombinant human insulin analog. LEVEMIR® is produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification.
Insulin detemir differs from human insulin in that the amino acid threonine in position B30 has been omitted, and a C14 fatty acid chain has been attached to the amino acid B29. Insulin detemir has a molecular formula of C267H402O76N64S6 and a molecular weight of 5916.9. It has the following structure:
Figure 1: Structural Formula of insulin detemir
LEVEMIR® is a clear, colorless, aqueous, neutral sterile solution. Each milliliter of LEVEMIR® contains 100 units (14.2 mg/mL) insulin detemir, 65.4 mcg zinc, 2.06 mg m-cresol, 16.0 mg glycerol, 1.80 mg phenol, 0.89 mg disodium phosphate dihydrate, 1.17 mg sodium chloride, and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. LEVEMIR® has a pH of approximately 7.4.
What are the possible side effects of insulin detemir (Levemir, Levemir FlexPen)?
Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.
Call your doctor at once if you have a serious side effect such as:
- itching, swelling, or redness where you inject insulin detemir;
- swelling in your hands or feet; or
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).
What are the precautions when taking insulin detemir (Levemir)?
Before using insulin detemir, tell your doctor or pharmacist if you are allergic to it; or to other types of insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Do not use this medication when you have low blood sugar (hypoglycemia).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal/pituitary gland problems, kidney disease, liver disease, thyroid problems.
You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can...
Last reviewed on RxList: 2/3/2016
This monograph has been modified to include the generic and brand name in many instances.
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