August 24, 2016
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Lantus

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Lantus




Lantus Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/15/2015

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. Common side effects of Lantus include pain, redness, swelling or itching at the injection site. These effects usually go away after a few days or weeks. Hypoglycemia, or low blood sugar, is the most common side effect of Lantus (insulin glargine). Tell your doctor if you experience symptoms of hypoglycemia including headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal).

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 breast-feeding. 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lantus in Detail - Patient Information: Side Effects

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)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Lantus Overview - Patient Information: Side Effects

SIDE EFFECTS: Injection site reactions (such as pain, redness, irritation) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat).

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Lantus (Insulin Glargine [rDNA origin] Injection)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lantus FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 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
LANTUS
N=292
NPH
N=293
LANTUS
N=264
NPH
N=270
LANTUS
N=310
NPH
N=309
Percent of patients 10.6 15.0 8.7 10.4 6.5 5.2

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)

Lantus - User Reviews

Lantus User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Lantus sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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