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Levemir

  • Generic Name: insulin detemir
  • Brand Name: Levemir

Levemir(Insulin Detemir) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Levemir Side Effects Center

What Is Levemir?

Levemir (insulin detemir [rDNA origin] injection) is a man-made form of a hormone that is produced in the body used to treat diabetes in adults and children.

What Are Side Effects of Levemir?

Common side effects of Levemir include:

  • injection site reactions (e.g., pain, redness, irritation),
  • swelling of the hands/feet,
  • thickening of the skin where you inject Levemir,
  • weight gain,
  • headache,
  • back pain,
  • stomach pain,
  • flu symptoms, or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

Tell your doctor if you experience serious side effects of Levemir including:

Dosage for Levemir

Levemir is for once- or twice-daily subcutaneous (under the skin) administration. Patients treated with Levemir once-daily should administer the dose with the evening meal or at bedtime. Patients requiring twice-daily dosing can administer the evening dose with the evening meal, at bedtime, or 12 hours after the morning dose.

What Drugs, Substances, or Supplements Interact with Levemir?

Levemir may interact with albuterol, clonidine, reserpine, guanethidine, or beta-blockers. Other medicines can increase or decrease the effects of insulin Levemir on lowering your blood sugar. Tell your doctor all prescription and over-the-counter medications you use.

Levemir During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before using Levemir. Discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. It is not known if this medication passes into breast milk. Consult your doctor before breastfeeding. Insulin needs may change while breastfeeding.

Additional Information

Our Levemir (insulin detemir [rDNA origin] injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Levemir Consumer Information

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

  • fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or
  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • low blood sugar;
  • weight gain;
  • swelling in your hands and feet;
  • rash, itching; or
  • thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Levemir (Insulin Detemir)

 

Levemir Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere:

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 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 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 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 LEVEMIR® (n=767) or NPH (n=388). The mean duration of exposure to LEVEMIR® was 153 days, and the total exposure to 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%)

  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 LEVEMIR® (n=161) or insulin glargine (n=159). The mean duration of exposure to LEVEMIR® was 176 days, and the total exposure to 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 + LEVEMIR® to insulin aspart + insulin glargine in adults with type 1 diabetes (adverse reactions with incidence ≥ 5%)

  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 Levemir® (n=432) or NPH (n=437). The mean duration of exposure to LEVEMIR® was 157 days, and the total exposure to 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%)

  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 LEVEMIR® (n=232) or NPH (n=115). The mean duration of exposure to LEVEMIR® was 180 days, and the total exposure to 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%)

  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. [see Use in Specific Populations]

Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including LEVEMIR® [see WARNINGS AND PRECAUTIONS].

Tables 5 and 6 summarize the incidence of severe and non-severe hypoglycemia in the 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 LEVEMIR® clinical trials (see Clinical Studies) were comparable between LEVEMIR®-treated patients and non-LEVEMIR®-treated patients (see Tables 5 and 6).

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 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 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 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 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 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 LEVEMIR® Twice-Daily NPH Once- or Twice Daily LEVEMIR® Once- or Twice Daily NPH Once Daily 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 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 [see DOSAGE AND ADMINISTRATION].

Weight Gain

Weight gain can occur with insulin therapy, including LEVEMIR®, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria [see Clinical Studies].

Peripheral Edema

Insulin, including 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 LEVEMIR® may experience injection site reactions, including localized erythema, pain, pruritus, urticaria, edema, and inflammation. In clinical studies in adults, three patients treated with 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, hypoten­sion, and shock may occur with any insulin, including LEVEMIR®, and may be life-threatening [see WARNINGS AND PRECAUTIONS].

Antibody Production

All insulin products can elicit the formation of insulin antibodies. These insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose. In phase 3 clinical trials of LEVEMIR®, antibody development has been observed with no apparent impact on glycemic control.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of LEVEMIR®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Medication errors have been reported during post-approval use of LEVEMIR® in which other insulins, particularly rapid-acting or short-acting insulins, have been accidentally administered instead of LEVEMIR® [see PATIENT INFORMATION]. To avoid medication errors between LEVEMIR® and other insulins, patients should be instructed always to verify the insulin label before each injection.

Read the entire FDA prescribing information for Levemir (Insulin Detemir)

&Copy; Levemir Patient Information is supplied by Cerner Multum, Inc. and Levemir Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.