Components:
Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 26.06.2023
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One unit (u) of Insulina Levemir rDNA (produced by recombinant DNA technology in Saccharomyces cerevisiae) 100 u contains salt-free anhydrous Insulina Levemir 0.142 mg. One unit of Insulina Levemir corresponds to 1 iu of human insulin. Insulina Levemir also contains the following excipients: Mannitol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, water for injections.
Insulina Levemir is a clear, colorless neutral solution for injection in a pre-filled pen.
Subcutaneous
Diabetes mellitus
Adult: In insulin-naive patients with type 2 DM who are not well controlled on oral antidiabetic drugs: Initial dosage of 0.1-0.2 units/kg given once daily in the evening or 10 units given once or twice daily, with subsequent dosage adjusted based on glycaemic control. In patients on basal insulin only: Insulina Levemir may be substituted on a unit-for-unit basis for the basal insulin currently in use, adjust dose to achieve glycaemic targets. Inj may be given once daily at evening meal or at bedtime or twice daily in the morning and the second dose admin after the evening meal, at bedtime, or 12 hr after the morning dose.
Renal impairment: Dose adjustment may be needed.
Hepatic impairment: Dose adjustment may be needed.
Insulina Levemir is a long-acting type of insulin. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have diabetes mellitus (sugar diabetes), your body cannot make enough insulin or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health.
Insulina Levemir is a long-acting insulin that works slowly over 24 hours. You may have to use Insulina Levemir in combination with another type of insulin or with oral diabetes medicine to keep your blood sugar under control.
Insulina Levemir is available only with your doctor's prescription.
Dosing
Insulina Levemir® is a recombinant human insulin analog for once- or twice-daily subcutaneous administration.
Patients treated with Insulina Levemir® once-daily should administer the dose with the evening meal or at bedtime.
Patients who require twice-daily dosing can administer the evening dose with the evening meal, at bedtime, or 12 hours after the morning dose.
The dose of Insulina Levemir® must be individualized based on clinical response. Blood glucose monitoring is essential in all patients receiving insulin therapy.
Patients adjusting the amount or timing of dosing with Insulina Levemir® should only do so under medical supervision with appropriate glucose monitoring.
In patients with type 1 diabetes, Insulina Levemir® must be used in a regimen with rapid-acting or short-acting insulin.
As with all insulins, injection sites should be rotated within the same region (abdomen, thigh, or deltoid) from one injection to the next to reduce the risk of lipodystrophy.
Insulina Levemir® can be injected subcutaneously in the thigh, abdominal wall, or upper arm. As with all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables, such as stress, intercurrent illness, or changes in co-administered medications or meal patterns.
When using Insulina Levemir® with a glucagon-like peptide (GLP)-1 receptor agonist, administer as separate injections. Never mix. It is acceptable to inject Insulina Levemir® and a GLP-1 receptor agonist in the same body region but the injections should not be adjacent to each other.
Initiation Of Insulina Levemir® Therapy
The recommended starting dose of Insulina Levemir® in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Rapid-acting or short-acting, pre-meal insulin should be used to satisfy the remainder of the daily insulin requirements.
The recommended starting dose of Insulina Levemir® in patients with type 2 diabetes inadequately controlled on oral antidiabetic medications is 10 Units (or 0.1-0.2 Units/kg) given once daily in the evening or divided into a twice daily regimen.
The recommended starting dose of Insulina Levemir® in patients with type 2 diabetes inadequately controlled on a GLP-1 receptor agonist is 10 Units given once daily in the evening.
Insulina Levemir® doses should subsequently be adjusted based on blood glucose measurements. The dosages of Insulina Levemir® should be individualized under the supervision of a healthcare provider.
Converting To Insulina Levemir® From Other Insulin Therapies
If converting from insulin glargine to Insulina Levemir®, the change can be done on a unit-to-unit basis.
If converting from NPH insulin, the change can be done on a unit-to-unit basis. However, some patients with type 2 diabetes may require more Insulina Levemir® than NPH insulin, as observed in one trial.
As with all insulins, close glucose monitoring is recommended during the transition and in the initial weeks thereafter. Doses and timing of concurrent rapid-acting or short-acting insulins or other concomitant antidiabetic treatment may need to be adjusted.
How supplied
Dosage Forms And Strengths
Insulina Levemir® solution for injection 100 Unit per mL is available as:
- 3 mL Insulina Levemir® FlexTouch®
- 10 mL vial
Storage And Handling
Insulina Levemir® is available in the following package sizes: each presentation containing 100 Units of Insulina Levemir per mL (U-100).
3 mL Insulina Levemir® FlexTouch® NDC 0169-6438-10 10 mL vial NDC 0169-3687-12
FlexTouch® can be used with NovoFine® or NovoTwist® disposable needles. Each FlexTouch® is for use by a single patient. Insulina Levemir® FlexTouch® must never be shared between patients, even if the needle is changed.
Storage
Unused (unopened) Insulina Levemir® should be stored in the refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. Do not use Insulina Levemir® if it has been frozen.
Unused (unopened) Insulina Levemir® can be kept until the expiration date printed on the label if it is stored in a refrigerator. Keep unused Insulina Levemir® in the carton so that it stays clean and protected from light.
If refrigeration is not possible, unused (unopened) Insulina Levemir® can be kept unrefrigerated at room temperature, below 30°C (86°F) as long as it is kept as cool as possible and away from direct heat and light. Unrefrigerated Insulina Levemir® should be discarded 42 days after it is first kept out of the refrigerator, even if the FlexTouch® or vial still contains insulin.
Vials
After initial use, vials should be stored in a refrigerator, never in a freezer. If refrigeration is not possible, the in-use vial can be kept unrefrigerated at room temperature, below 30°C (86°F) as long as it is kept as cool as possible and away from direct heat and light. Refrigerated Insulina Levemir® vials should be discarded 42 days after initial use. Unrefrigerated Insulina Levemir® vials should be discarded 42 days after they are first kept out of the refrigerator.
Insulina Levemir® FlexTouch®
After initial use, the Insulina Levemir® FlexTouch® must NOT be stored in a refrigerator and must NOT be stored with the needle in place. Keep the opened (in use) Insulina Levemir® FlexTouch® away from direct heat and light at room temperature, below 30°C (86°F). Unrefrigerated Insulina Levemir® FlexTouch® should be discarded 42 days after they are first kept out of the refrigerator.
Always remove the needle after each injection and store the Insulina Levemir® FlexTouch® without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.
The storage conditions are summarized in Table 13:
Table 13: Storage Conditions for Insulina Levemir® FlexTouch® and Vial
| Not in-use (unopened) Refrigerated | Not in-use (unopened) Room Temperature (below 30°C) | In-use (opened) | |
| 3 mL Insulina Levemir® FlexTouch® | Until expiration date | 42 days* | 42 days* Room Temperature (below 30°C) (Do not refrigerate) |
| 10 mL vial | Until expiration date | 42 days* | 42 days* Refrigerated or Room Temperature (below 30°C) |
| * The total time allowed at room temperature (below 30°C) is 42 days regardless of whether the product is in-use or not in-use. |
Preparation And Handling
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Insulina Levemir® should be inspected visually prior to administration and should only be used if the solution appears clear and colorless.
Mixing and diluting: Insulina Levemir® must NOT be mixed or diluted with any other insulin or solution.
Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark. Revised: Mar 2015
See also:
What is the most important information I should know about Insulina Levemir?
You should not use this medication if you are allergic to Insulina Levemir, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with a short-acting insulin).
Many other drugs can potentially interfere with the effects of Insulina Levemir. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. An insulin overdose can cause life-threatening hypoglycemia. Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Be sure your family and close friends know how to help you in an emergency.
Use Insulina Levemir cartridges as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Insulina Levemir cartridges. Talk to your pharmacist if you have questions about this information.
- Use Insulina Levemir cartridges at the same time each day, as directed by your doctor.
- If you will be using Insulina Levemir cartridges at home, a health care provider will teach you how to use it. Be sure you understand how to use Insulina Levemir cartridges. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Insulina Levemir cartridges should be clear and colorless. Do not use Insulina Levemir cartridges if it contains particles; is cloudy, discolored, or thickened; or if the vial or container is cracked or damaged.
- Do NOT dilute Insulina Levemir cartridges or mix it with other insulin. Do NOT use it in an insulin pump.
- Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle or a vein.
- Injection sites within an injection area (eg, abdomen, thigh, upper arm) must be rotated from one injection to the next. Do not inject insulin into skin that is red, swollen, or itchy.
- Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.
- The effect of Insulina Levemir cartridges may last for up to 24 hours.
- Do not share pen or cartridge devices with another person. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.
Ask your health care provider any questions you may have about how to use Insulina Levemir cartridges.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Insulina Levemir is used for the treatment of type 1 diabetes mellitus in adults and children (older than 2 years) and type 2 diabetes mellitus in adults.
See also:
What other drugs will affect Insulina Levemir?
A number of medications affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.
The following are examples of medications that may increase the blood-glucose-lowering effect of insulins including Insulina Levemir® and, therefore, increase the 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, and sulfonamide antibiotics.
The following are examples of medications that may reduce the blood-glucose-lowering effect of insulins including Insulina 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, and alcohol may either increase or decrease the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
The signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs such as beta-blockers, clonidine, guanethidine, and reserpine.
See also:
What are the possible side effects of Insulina Levemir?
The following adverse reactions are discussed elsewhere:
- Hypoglycemia
- Hypersensitivity and allergic reactions
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 Insulina 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 the Insulina Levemir® add-on to liraglutide+metformin trial, all patients received liraglutide 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with Insulina Levemir® or continued, unchanged treatment with liraglutide 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥ 5% of patients treated with liraglutide 1.8 mg + metformin (11.7%) and greater than in patients treated with liraglutide 1.8 mg and metformin alone (6.9%).
In two pooled trials, a total of 1155 adults with type 1 diabetes were exposed to individualized doses of Insulina Levemir® (n=767) or NPH (n=388). The mean duration of exposure to Insulina Levemir® was 153 days, and the total exposure to Insulina Levemir® was 321 patient-years. The most common adverse reactions are summarized in Table 1.
Table 1: Adverse reactions (excluding hypoglycemia) in two pooled clinical trials of 16 weeks and 24 weeks duration in adults with type 1 diabetes (adverse reactions with incidence ≥ 5%)
| Insulina Levemir®,% (n=767) | NPH, % (n=388) | |
| Upper respiratory tract infection | 26.1 | 21.4 |
| Headache | 22.6 | 22.7 |
| Pharyngitis | 9.5 | 8.0 |
| influenza-like illness | 7.8 | 7.0 |
| Abdominal Pain | 6.0 | 2.6 |
A total of 320 adults with type 1 diabetes were exposed to individualized doses of Insulina Levemir® (n=161) or insulin glargine (n=159). The mean duration of exposure to Insulina Levemir® was 176 days, and the total exposure to Insulina Levemir® was 78 patient-years. The most common adverse reactions are summarized in Table 2.
Table 2: Adverse reactions (excluding hypoglycemia) in a 26-week trial comparing insulin aspart + Insulina Levemir® to insulin aspart + insulin glargine in adults with type 1 diabetes (adverse reactions with incidence ≥ 5%)
| Insulina Levemir®,% (n=161) | Glargine, % (n = 159) | |
| Upper respiratory tract infection | 26.7 | 32.1 |
| Headache | 14.3 | 19.5 |
| Back pain | 8.1 | 6.3 |
| Influenza-like illness | 6.2 | 8.2 |
| Gastroenteritis | 5.6 | 4.4 |
| Bronchitis | 5.0 | 1.9 |
In two pooled trials, a total of 869 adults with type 2 diabetes were exposed to individualized doses of Insulina Levemir® (n=432) or NPH (n=437). The mean duration of exposure to Insulina Levemir® was 157 days, and the total exposure to Insulina Levemir® was 186 patient-years. The most common adverse reactions are summarized in Table 3.
Table 3: Adverse reactions (excluding hypoglycemia) in two pooled clinical trials of 22 weeks and 24 weeks duration in adults with type 2 diabetes (adverse reactions with incidence ≥ 5%)
| Insulina Levemir®,% (n =432) | NPH, % (n= 437) | |
| Upper respiratory tract infection | 12.5 | 11.2 |
| Headache | 6.5 | 5.3 |
A total of 347 children and adolescents (6-17 years) with type 1 diabetes were exposed to individualized doses of Insulina Levemir® (n=232) or NPH (n=115). The mean duration of exposure to Insulina Levemir® was 180 days, and the total exposure to Insulina Levemir® was 114 patient-years. The most common adverse reactions are summarized in Table 4.
Table 4: Adverse reactions (excluding hypoglycemia) in one 26-week clinical trial of children and adolescents with type 1 diabetes (adverse reactions with incidence ≥ 5%)
| Insulina Levemir®,% (n=232) | NPH, % (n=115) | |
| Upper respiratory tract infection | 35.8 | 42.6 |
| Headache | 31.0 | 32.2 |
| Pharyngitis | 17.2 | 20.9 |
| Gastroenteritis | 16.8 | 11.3 |
| Influenza-like illness | 13.8 | 20.9 |
| Abdominal pain | 13.4 | 13.0 |
| Pyrexia | 10.3 | 6.1 |
| Cough | 8.2 | 4.3 |
| Viral infection | 7.3 | 7.8 |
| Nausea | 6.5 | 7.0 |
| Rhinitis | 6.5 | 3.5 |
| Vomiting | 6.5 | 10.4 |
Pregnancy
A randomized, open-label, controlled clinical trial has been conducted in pregnant women with type 1 diabetes.
Hypoglycemia
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Insulina Levemir®.
Tables 5 and 6 summarize the incidence of severe and non-severe hypoglycemia in the Insulina 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 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.
The rates of hypoglycemia in the Insulina Levemir® clinical trials were comparable between Insulina Levemir®-treated patients and non-Insulina Levemir®-treated patients.
Table 5: Hypoglycemia in Patients with Type 1 Diabetes
| Severe Hypoglycemia | Non-Severe Hypoglycemia | ||||
| Percent of patients with at least 1 event (n/total N) | Event/ patient/ year | Percent of patients (n/total N) | Event/ patient/ year | ||
| Study A Type 1 Diabetes Adults 16 weeks In combination with insulin aspart | Twice-Daily Insulina Levemir® | 8.7 (24/276) | 0.52 | 88.0 (243/276) | 26.4 |
| Twice-Daily NPH | 10.6 (14/132) | 0.43 | 89.4 (118/132) | 37.5 | |
| Study B Type 1 Diabetes Adults 26 weeks In combination with insulin aspart | Twice-Daily Insulina Levemir® | 5.0 (8/161) | 0.13 | 82.0 (132/161) | 20.2 |
| Once-Daily Glargine | 10.1 (16/159) | 0.31 | 77.4 (123/159) | 21.8 | |
| Study C Type 1 Diabetes Adults 24 weeks In combination with regular insulin | Once-Daily Insulina Levemir® | 7.5 (37/491) | 0.35 | 88.4 (434/491) | 31.1 |
| Once-Daily NPH | 10.2 (26/256) | 0.32 | 87.9 (225/256) | 33.4 | |
| Study D Type 1 Diabetes Pediatrics 26 weeks In combination with insulin aspart | Once- or Twice Daily Insulina Levemir® | 159 (37/232) | 0.91 | 931 (216/232) | 31.6 |
| Once- or Twice Daily NPH | 20.0 (23/115) | 0.99 | 95 7 (110/115) | 37.0 | |
| Study I Type 1 Diabetes Pediatrics 52 weeks In combination with insulin aspart | Once- or Twice Daily Insulina Levemir® | 1.7 (3/177) | 0.02 | 949 (168/177) | 56.1 |
| Once- or Twice Daily NPH | 7.1 (12/170) | 0.09 | 97.6 (166/170) | 70.7 |
Table 6: Hypoglycemia in Patients with Type 2 Diabetes
| Study E Type 2 Diabetes Adults 24 weeks In combination with oral agents | Study F Type 2 Diabetes Adults 22 weeks In combination with insulin aspart | Study H Type 2 Diabetes Adults 26 weeks in combination with Liraglutide and Metformin | |||||
| Twice-Daily Insulina Levemir® | Twice-Daily NPH | Once- or Twice Daily Insulina Levemir® | Once- or Twice Daily NPH | Once Daily Insulina Levemir® + Liraglutide + Metformin | Liraglutide + Metformin | ||
| Severe hypoglycemia | Percent of patients with at least 1 event (n/total N) | 0.4 (1/237) | 2.5 (6/238) | 1.5 (3/195) | 4.0 (8/199) | 0 | 0 |
| Event/patient/year | 0.01 | 0.08 | 0.04 | 0.13 | 0 | 0 | |
| Non-severe hypoglycemia | Percent of patients (n/total N) | 40.5 (96/237) | 64.3 (153/238) | 32 3 (63/195) | 32.2 (64/199) | 9.2 (15/163) | 1.3 (2/158*) |
| Event/patient/year | 3.5 | 6.9 | 1.6 | 2.0 | 0.29 | 0.03 | |
| *One subject is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study |
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 Insulina 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. Rotate insulin injection sites within the same region to reduce the risk of lipodystrophy.
Weight Gain
Weight gain can occur with insulin therapy, including Insulina Levemir®, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Peripheral Edema
Insulin, including Insulina Levemir®, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Allergic Reactions
Local Allergy
As with any insulin therapy, patients taking Insulina Levemir® may experience injection site reactions, including localized erythema, pain, pruritus, urticaria, edema, and inflammation. In clinical studies in adults, three patients treated with Insulina Levemir® reported injection site pain (0.25%) compared to one patient treated with NPH insulin (0.12%). The reports of pain at the injection site did not result in discontinuation of therapy.
Rotation of the injection site within a given area from one injection to the next may help to reduce or prevent these reactions. In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique. Most minor reactions to insulin usually resolve in a few days to a few weeks.
Systemic Allergy
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypoten