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Lantus

Last reviewed on RxList: 9/13/2016
Lantus Side Effects Center

Last reviewed on RxList 9/12/2016

Lantus (insulin glargine [rdna origin]) Injection is a man-made form of a hormone that is produced in the body used to treat type 1 (insulin-dependent) or type 2 (non insulin-dependent) diabetes. The most common side effects of Lantus is hypoglycemia, or low blood sugar. Symptoms include:

Other common side effects of Lantus include pain, redness, swelling, itching, or thickening of the skin at the injection site. These side effects usually go away after a few days or weeks.

Lantus should be administered subcutaneously (under the skin) once a day at the same time every day. Dose is determined by the individual and the desired blood glucose levels. Lantus may interact with albuterol, clonidine, reserpine, or beta-blockers. Many other medicines can increase or decrease the effects of insulin glargine on lowering your blood sugar. Tell your doctor all prescription and over-the-counter medications and supplements you use. Tell your doctor if you are pregnant before using Lantus. Discuss a plan to manage blood sugar with your doctor before becoming pregnant. Your doctor may switch the type of insulin you use during pregnancy. It is unknown if this drug passes into breast milk. Insulin needs may change while breastfeeding. Consult your doctor before breast-feeding.

Our Lantus (insulin glargine [rdna origin]) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Lantus Consumer Information

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.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin glargine. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin glargine.

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 Lantus (Insulin Glargine [rDNA origin] Injection)

Lantus Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

The data in Table 1 reflect the exposure of 2327 patients with type 1 diabetes to LANTUS or NPH. The type 1 diabetes population had the following characteristics: Mean age was 38.5 years. Fifty four percent were male, 96.9% were Caucasian, 1.8 % were Black or African American and 2.7 % were Hispanic. The mean BMI was 25.1 kg/m2 .

The data in Table 2 reflect the exposure of 1563 patients with type 2 diabetes to LANTUS or NPH. The type 2 diabetes population had the following characteristics: Mean age was 59.3 years. Fifty eight percent were male, 86.7% were Caucasian, 7.8 % were Black or African American and 9 % were Hispanic. The mean BMI was 29.2 kg/m2 .

The frequencies of adverse events during LANTUS clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Table 1: Adverse events in pooled clinical trials up to 28 weeks duration in adults with type 1 diabetes (adverse events with frequency ≥5%)

LANTUS, % (n=1257) NPH, % (n=1070)
Upper respiratory tract infection 22.4 23.1
Infection* 9.4 10.3
Accidental injury 5.7 6.4
Headache 5.5 4.7
*Body System not Specified

Table 2: Adverse events in pooled clinical trials up to 1 year duration in adults with type 2 diabetes (adverse events with frequency ≥ 5%)

LANTUS, % (n=849) NPH, %
(n=714)
Upper respiratory tract infection 11.4 13.3
Infection* 10.4 11.6
Retinal vascular disorder 5.8 7.4
*Body System not Specified

Table 3: Adverse events in a 5-year trial of adults with type 2 diabetes (adverse events with frequency ≥ 10%)

LANTUS, % (n=514) NPH, %
(n=503)
Upper respiratory tract infection 29.0 33.6
Edema peripheral 20.0 22.7
Hypertension 19.6 18.9
Influenza 18.7 19.5
Sinusitis 18.5 17.9
Cataract 18.1 15.9
Bronchitis 15.2 14.1
Arthralgia 14.2 16.1
Pain in extremity 13.0 13.1
Back pain 12.8 12.3
Cough 12.1 7.4
Urinary tract infection 10.7 10.1
Diarrhea 10.7 10.3
Depression 10.5 9.7
Headache 10.3 9.3

Table 4: Adverse events in a 28-week clinical trial of children and adolescents with type 1 diabetes (adverse events with frequency ≥ 5% )

LANTUS, % (n=174) NPH, %
(n=175)
Infection* 13.8 17.7
Upper respiratory tract infection 13.8 16.0
Pharyngitis 7.5 8.6
Rhinitis 5.2 5.1
*Body System not Specified

Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including LANTUS [see WARNINGS AND PRECAUTIONS]. Tables 5, and 6 and 7 summarize the incidence of severe hypoglycemia in the LANTUS individual clinical trials. Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose below 50 mg/dL (≤56 mg/dL in the 5-year trial and ≤36 mg/dL in the ORIGIN trial) or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.

Percentages of LANTUS-treated adult patients experiencing severe symptomatic hypoglycemia in the LANTUS clinical trials [see Clinical Studies] were comparable to percentages of NPH-treated patients for all treatment regimens (see Tables 5 and 6). In the pediatric phase 3 clinical trial, children and adolescents with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia in the two treatment groups compared to the adult trials with type 1 diabetes.

Table 5: Severe Symptomatic Hypoglycemia in Patients with Type 1 Diabetes

Study A
Type 1 Diabetes 
Adults
 28 weeks In combination with regular insulin
Study B
Type 1 Diabetes
Adults 
28 weeks In combination with regular insulin
Study C
Type 1 Diabetes
Adults 
16 weeks In combination with insulin lispro
Study D
Type 1 Diabetes
Pediatrics 
26 weeks In combination with regular insulin
LANTUS N=292 NPH
N=293
LANTUS N=264 NPH
N=270
LANTUS N=310 NPH
N=309
LANTUS N=174 NPH
N=175
Percent of patients 10.6 15.0 8.7 10.4 6.5 5.2 23.0 28.6

Table 6: Severe Symptomatic Hypoglycemia in Patients with Type 2 Diabetes

Study E
Type 2 Diabetes
Adults 
52 weeks In combination with oral agents
Study F
Type 2 Diabetes
Adults 
28 weeks In combination with regular insulin
Study G
Type 2 Diabetes
Adults 
5 years In combination with regular insulin
LANTUS N=289 NPH
N=281
LANTUS N=259 NPH
N=259
LANTUS N=513 NPH
N=504
Percent of patients 1.7 1.1 0.4 2.3 7.8 11.9

Table 7 displays the proportion of patients experiencing severe symptomatic hypoglycemia in the Lantus and Standard Care groups in the ORIGIN Trial [see Clinical Studies].

Table 7: Severe Symptomatic Hypoglycemia in the ORIGIN trial

ORIGIN Trial
Median duration of follow-up: 6.2 years
LANTUS
N=6231
Standard Care
N=6273
Percent of patients 5.6 1.8

Peripheral Edema

Some patients taking LANTUS have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Lipodystrophy

Administration of insulin subcutaneously, including LANTUS, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients [see DOSAGE AND ADMINISTRATION].

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.

Weight Gain

Weight gain has occurred with some insulin therapies including LANTUS and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Allergic Reactions

Local Allergy

As with any insulin therapy, patients taking LANTUS may experience injection site reactions, including redness, pain, itching, urticaria, edema, and inflammation. In clinical studies in adult patients, there was a higher incidence of treatment-emergent injection site pain in LANTUS-treated patients (2.7%) compared to NPH insulin-treated patients (0.7%). The reports of pain at the injection site did not result in discontinuation of therapy.

Systemic Allergy

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including LANTUS and may be life threatening.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. All insulin products can elicit the formation of insulin antibodies. The presence of such insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose. In phase 3 clinical trials of LANTUS, increases in titers of antibodies to insulin were observed in NPH insulin and LANTUS treatment groups with similar incidences.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of LANTUS. 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 in which other insulins, particularly rapid-acting insulins, have been accidentally administered instead of LANTUS [see PATIENT INFORMATION]. To avoid medication errors between LANTUS and other insulins, patients should be instructed to always verify the insulin label before each injection.

Read the entire FDA prescribing information for Lantus (Insulin Glargine [rDNA origin] Injection)

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