Lantus

Generic name: insulin glargine · Brand names: Lantus (Lantus SoloStar prefilled pen)

Quick facts

Drug class
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a Highlights, Indications and Usage
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Also
MedlinePlus: Insulin glargine is in a class of medications called long-acting insulin.
Also url
https://medlineplus.gov/druginfo/meds/a600027.html
Source text (exact source wording)
LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
Rx or otc
Rx (prescribing information label with separate Patient Information and Instructions for Use)
Forms and strengths
  • Injection: 100 units/mL (U-100) a clear and colorless solution available as: 10 mL multiple-dose vial; 3 mL single-patient-use LANTUS SoloStar prefilled pen (section 3)
Generic available
Source
https://dailymed.nlm.nih.gov/dailymed/services/v2/spls.json?drug_name=insulin%20glargine ; https://medlineplus.gov/druginfo/meds/a600027.html
Common use one line
Long-acting insulin used to improve blood sugar control in adults and children with diabetes.

What it is used for

Lantus is used to improve blood sugar control in adults and children with diabetes. It is not recommended for treating diabetic ketoacidosis.
Section
1 INDICATIONS AND USAGE
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Confidence
high
Source text (exact source wording)
LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use: LANTUS is not recommended for the treatment of diabetic ketoacidosis.

How it works

Insulin lowers blood sugar by helping muscle and fat take up sugar and by stopping the liver from making sugar.
Section
12.1 Mechanism of Action
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Confidence
high
Source text (exact source wording)
The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

Dosage: adults

Lantus is injected under the skin once a day at the same time each day, and the dose is set for each person. People with type 1 diabetes also need short-acting insulin, and the starting dose is about one-third of total daily insulin needs. For type 2 diabetes not already on insulin, the starting dose is 0.2 units/kg or up to 10 units once daily. It must not be given into a vein or in an insulin pump, or mixed with other insulin. When switching from other insulins, the label gives starting doses of 80% of Toujeo, the same as once-daily NPH, or 80% of total twice-daily NPH.
Section
2.1, 2.2, 2.3, 2.4 (Dosage and Administration)
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Confidence
high
Source text (exact source wording)
2.1: Administer LANTUS subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not administer intravenously or via an insulin pump. Do not dilute or mix LANTUS with any other insulin or solution. 2.2: Administer LANTUS subcutaneously once daily at any time of day but at the same time every day. Individualize and adjust the dosage of LANTUS based on the patient's metabolic needs, blood glucose monitoring results and glycemic control goal. In patients with type 1 diabetes, LANTUS must be used concomitantly with short-acting insulin. 2.3: The recommended starting dosage of LANTUS in patients with type 1 diabetes is approximately one-third of the total daily insulin requirements. Use short-acting, premeal insulin to satisfy the remainder of the daily insulin requirements. The recommended starting dosage of LANTUS in patients with type 2 diabetes who are not currently treated with insulin is 0.2 units/kg or up to 10 units once daily. 2.4: Once-daily TOUJEO (insulin glargine 300 units/mL) to once-daily LANTUS (100 units/mL), the recommended starting LANTUS dosage is 80% of the TOUJEO dosage that is being discontinued. Once-daily NPH insulin to once-daily LANTUS, the recommended starting LANTUS dosage is the same as the dosage of NPH that is being discontinued. Twice-daily NPH insulin to once-daily LANTUS, the recommended starting LANTUS dosage is 80% of the total NPH dosage that is being discontinued.

Dosage: children

Lantus is established as safe and effective for children with diabetes. The main study had 174 children aged 6 to 15 years with type 1 diabetes. These children had more severe low blood sugar than adults did in the type 1 diabetes studies.
Section
8.4 Pediatric Use
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Confidence
high
Source text (exact source wording)
The safety and effectiveness of LANTUS to improve glycemic control in pediatric patients with diabetes mellitus have been established. Use of LANTUS for this indication is supported by evidence from an adequate and well-controlled study (Study D) in 174 LANTUS-treated pediatric patients aged 6 to 15 years with type 1 diabetes mellitus, and from adequate and well-controlled studies of LANTUS in adults with diabetes mellitus. In the pediatric clinical study, pediatric patients with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in studies with type 1 diabetes.

Dosage adjustments

Drug interaction caps
The label does not give fixed dose limits for interactions. Doses may need to go down or up, with more blood sugar checks, depending on the other drug.
Section
7 DRUG INTERACTIONS (Table 8)
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Confidence
high
Source text (exact source wording)
Drugs that May Increase the Risk of Hypoglycemia. Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of LANTUS. Intervention: Dosage increases and increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs.
Kidney
Lantus has not been studied in kidney problems. Frequent glucose checks and dose changes may be needed.
Section
8.6 Renal Impairment
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Confidence
high
Source text (exact source wording)
The effect of kidney impairment on the pharmacokinetics of LANTUS has not been studied. Some studies with human insulin have shown increased circulating levels of insulin in patients with kidney failure. Frequent glucose monitoring and dosage adjustment may be necessary for LANTUS in patients with kidney impairment [see Warnings and Precautions (5.3)].
Liver
Lantus has not been studied in liver problems. Frequent glucose checks and dose changes may be needed.
Section
8.7 Hepatic Impairment
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Confidence
high
Source text (exact source wording)
The effect of hepatic impairment on the pharmacokinetics of LANTUS has not been studied. Frequent glucose monitoring and dosage adjustment may be necessary for LANTUS in patients with hepatic impairment [see Warnings and Precautions (5.3)].
Elderly
No overall differences were seen in people 65 and older, but caution is advised. Starting doses, dose increases, and maintenance doses should be conservative to avoid low blood sugar, which can be hard to recognize in older adults.
Section
8.5 Geriatric Use
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Confidence
high
Source text (exact source wording)
Of the total number of subjects in controlled clinical studies of patients with type 1 and type 2 diabetes who were treated with LANTUS, 15% (n=316) were ≥65 years of age and 2% (n=42) were ≥75 years of age. No overall differences in safety or effectiveness of LANTUS have been observed between patients 65 years of age and older and younger adult patients. Nevertheless, caution should be exercised when LANTUS is administered to geriatric patients. In geriatric patients with diabetes, the initial dosing, dosage increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in geriatric patients.

Missed dose

Label
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Medlineplus
The label gives no missed-dose rule. MedlinePlus says to ask your doctor before you start what to do if you forget a dose or take an extra dose, and to write the directions down.
Source
MedlinePlus Insulin Glargine (rDNA origin) Injection
Url
https://medlineplus.gov/druginfo/meds/a600027.html
Section
What should I do if I forget a dose?
Source text (exact source wording)
Before you start using insulin glargine, ask your doctor what to do if you forget to use a dose or if you accidentally use an extra dose. Write these directions down so you can refer to them later.
Confidence
medium

Overdose

Too much insulin can cause low blood sugar and low potassium. Mild low blood sugar is usually treated with carbohydrates by mouth. Severe episodes with coma or seizure may be treated with glucagon or intravenous glucose. After recovery, continued observation and extra carbohydrate may be needed. Low potassium must be corrected. For overdose, call poison control at 1-800-222-1222 (MedlinePlus lists this number).
Section
10 OVERDOSAGE
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Confidence
high
Source text (exact source wording)
Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.6)]. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Lowering the insulin dosage, and adjustments in meal patterns or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with glucagon for emergency use or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia. Hypokalemia must be corrected appropriately.
Medlineplus source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Storage

Keep unused Lantus in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze it, and discard it if it was frozen. Protect it from heat and light. Unopened vials and pens can be kept at room temperature (up to 86°F [30°C]) for 28 days. An opened vial lasts 28 days at room temperature or in the fridge. An opened pen lasts 28 days at room temperature only and must not be refrigerated.
Section
16.2 Storage
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Confidence
high
Source text (exact source wording)
Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused LANTUS in a refrigerator between 36°F and 46°F (2°C and 8°C). Do not freeze. Discard LANTUS if it has been frozen. Protect LANTUS from direct heat and light. Storage table: 10 mL multiple-dose vial: not in-use refrigerated until expiration date; not in-use room temperature (up to 86°F [30°C]) 28 days; in-use (opened) 28 days, refrigerated or room temperature. 3 mL single-patient-use SoloStar prefilled pen: not in-use refrigerated until expiration date; room temperature 28 days; in-use (opened) 28 days, room temperature only (Do not refrigerate).

Boxed warning

Lantus has no boxed warning.
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Confidence
high
Source text (exact source wording)
NONE (no boxed warning appears in the label's Highlights or full prescribing information)

Contraindications

Do not use during an episode of low blood sugar.
Section
4 CONTRAINDICATIONS
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
During episodes of hypoglycemia [see Warnings and Precautions (5.3)]
Do not use if allergic to insulin glargine or any ingredient in Lantus.
Section
4 CONTRAINDICATIONS
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
In patients with hypersensitivity to insulin glargine or any of the excipients in LANTUS [see Warnings and Precautions (5.5)]

Warnings and precautions

Never share a pen, needle, or syringe, even if the needle is changed. Sharing can spread blood-borne infections.
Heading
5.1 Never Share a LANTUS SoloStar Prefilled Pen, Insulin Syringe, or Needle Between Patients
Section
5.1 Never Share a LANTUS SoloStar Prefilled Pen, Insulin Syringe, or Needle Between Patients
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
LANTUS SoloStar prefilled pens must never be shared between patients, even if the needle is changed. Patients using LANTUS vials must never re-use or share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
Changes in insulin strength, maker, type, or injection site can cause low or high blood sugar. Make changes only with close medical supervision and more blood sugar checks.
Heading
5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Section
5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.3)] or hyperglycemia. Make any changes to a patient's insulin regimen under close medical supervision with increased frequency of blood glucose monitoring.
Low blood sugar is the most common side effect of insulin. Severe lows can cause seizures and can be life-threatening. It can affect concentration and reaction time, such as when driving. Lantus's long action may slow recovery. Kidney or liver problems raise the risk.
Heading
5.3 Hypoglycemia
Section
5.3 Hypoglycemia
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
Hypoglycemia is the most common adverse reaction associated with insulins, including LANTUS. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place the patient and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). The long-acting effect of LANTUS may delay recovery from hypoglycemia. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations (8.6, 8.7)].
Insulin products have been mixed up by mistake. Always check the insulin label before each injection.
Heading
5.4 Hypoglycemia Due to Medication Errors
Section
5.4 Hypoglycemia Due to Medication Errors
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
Accidental mix-ups among insulin products have been reported. To avoid medication errors between LANTUS and other insulins, instruct patients to always check the insulin label before each injection [see Adverse Reactions (6.3)].
Severe, life-threatening allergy, including anaphylaxis, can occur. If it happens, stop Lantus and get treatment.
Heading
5.5 Hypersensitivity Reactions
Section
5.5 Hypersensitivity Reactions
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including LANTUS [see Adverse Reactions (6.1)]. If hypersensitivity reactions occur, discontinue LANTUS; treat per standard of care and monitor until symptoms and signs resolve. LANTUS is contraindicated in patients who have had hypersensitivity reactions to insulin glargine or one of the excipients.
Insulin can lower blood potassium. Untreated low potassium may cause respiratory paralysis, dangerous heart rhythms, and death. Potassium is monitored in people at risk.
Heading
5.6 Hypokalemia
Section
5.6 Hypokalemia
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
All insulins, including LANTUS, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia, if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).
Thiazolidinedione diabetes pills used with insulin can cause fluid retention that may cause or worsen heart failure. Watch for heart failure signs.
Heading
5.7 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists
Section
5.7 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including LANTUS, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure.

Pregnancy and breastfeeding

Published studies have not shown a clear link between insulin glargine in pregnancy and harm to the baby. Poorly controlled diabetes in pregnancy carries risks for mother and baby. There is little or no data on insulin glargine in breast milk. Weigh the benefits of breastfeeding with the mother's need for Lantus.
Section
8.1 Pregnancy; 8.2 Lactation
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Confidence
high
Source text (exact source wording)
8.1: Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). 8.2: There are either no or only limited data on the presence of insulin glargine in human milk, the effects on breastfed infant, or the effects on milk production. Endogenous insulin is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LANTUS, and any potential adverse effects on the breastfed child from LANTUS or from the underlying maternal condition.

Side effects

Common
Common effects are low blood sugar, allergic reactions, injection site reactions, skin thickening or dents (lipodystrophy), itching, rash, swelling (edema), and weight gain. In studies, colds and other upper respiratory infections were the most frequent events listed in the tables (22.4% in adults with type 1 diabetes on Lantus).
Threshold
The label does not give one threshold for its Highlights list; its tables use thresholds of 5% or more (Tables 1, 2 and 4) and 10% or more (Table 3).
Section
Highlights; 6.1 Clinical Trials Experience
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
Adverse reactions commonly associated with LANTUS include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain. (6.1) Hypoglycemia is the most common adverse reaction associated with insulins, including LANTUS. Table 1: Adverse Reactions Occurring ≥5% in Pooled Clinical Studies up to 28 Weeks Duration in Adults with Type 1 Diabetes (LANTUS n=1,257; NPH n=1,070): Upper respiratory tract infection 22.4 23.1; Infection 9.4 10.3; Accidental injury 5.7 6.4; Headache 5.5 4.7. Table 2: Adverse Reactions Occurring ≥5% in Pooled Clinical Studies up to 1 Year Duration in Adults with Type 2 Diabetes (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. Table 4: Adverse Reactions Occurring ≥5% in a 28-Week Clinical Study in Pediatric Patients with Type 1 Diabetes (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.
Less common
In a 5-year study of adults with type 2 diabetes, events at 10% or more on Lantus included upper respiratory infection (29.0%), peripheral edema (20.0%), and high blood pressure (19.6%), among others. Injection site pain was reported in 2.7% on Lantus versus 0.7% on NPH.
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Section
6.1 Table 3 (5-year type 2 study)
Source text (exact source wording)
Table 3: Adverse Reactions Occurring ≥10% in a 5-Year Study of Adults with Type 2 Diabetes (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. Also: In clinical studies in adult patients, there was a higher incidence of injection site pain in LANTUS-treated patients (2.7%) compared to NPH insulin-treated patients (0.7%).
Serious
Label
Serious effects include severe low blood sugar, severe allergic reactions including anaphylaxis, dangerously low potassium, insulin mix-ups, and a skin lump problem at injection sites (localized cutaneous amyloidosis).
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Section
6.1, 6.3; 5.3, 5.5, 5.6
Source text (exact source wording)
Severe hypoglycemia: Hypoglycemia was the most commonly observed adverse reaction in patients treated with LANTUS. Systemic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock have occurred with insulin, including LANTUS and may be life threatening. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Medication errors have been reported in which rapid-acting insulins and other insulins, have been accidentally administered instead of LANTUS. Localized cutaneous amyloidosis at the injection site has occurred.
Medlineplus
MedlinePlus says to call the doctor or get emergency care for body-wide rash or hives, wheezing, trouble breathing or swallowing, fast pulse, sweating, swelling of the face or throat, weakness, muscle cramps, abnormal heartbeat, sudden weight gain, swollen ankles or feet, shortness of breath, or vision changes.
Source
MedlinePlus Insulin Glargine (rDNA origin) Injection
Url
https://medlineplus.gov/druginfo/meds/a600027.html
Section
What side effects can this medication cause?
Source text (exact source wording)
Some side effects can be serious. If you experience these symptoms, call your doctor immediately or get emergency treatment: rash, hives, or itching all over the body; wheezing; difficulty breathing or swallowing; fast pulse; sweating; swelling of the eyes, face, lips, tongue, or throat; hoarseness; weakness; muscle cramps; abnormal heartbeat; sudden weight gain; swelling of ankles or feet; shortness of breath; vision changes
Led to discontinuation
Injection site pain did not lead people to stop therapy. The label gives no other discontinuation rates.
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Section
6.1
Source text (exact source wording)
The reports of pain at the injection site did not result in discontinuation of therapy.

Interactions

Drugs
These drugs can raise the chance of low blood sugar, so Lantus doses may need to be lowered with more glucose checks.
Name
Drugs that may increase the risk of hypoglycemia
Section
7 DRUG INTERACTIONS Table 8
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), sulfonamide antibiotics. GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors. Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs.
These drugs can weaken Lantus, so higher doses and more glucose checks may be needed.
Name
Drugs that may decrease the blood glucose lowering effect
Section
7 DRUG INTERACTIONS Table 8
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dosage increases and increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs.
Alcohol, beta-blockers, clonidine, and lithium can raise or lower the effect. Pentamidine can cause low blood sugar, sometimes followed by high blood sugar.
Name
Drugs that may increase or decrease the effect
Section
7 DRUG INTERACTIONS Table 8
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Intervention: Dosage adjustment and increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs.
These drugs can hide the warning signs of low blood sugar, so more frequent glucose checks may be needed.
Name
Drugs that may blunt signs of hypoglycemia
Section
7 DRUG INTERACTIONS Table 8
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
Drugs: Beta-blockers, clonidine, guanethidine, and reserpine. Intervention: Increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs.
Used with insulin, these pills can cause fluid retention and heart failure.
Name
Thiazolidinediones (PPAR-gamma agonists)
Section
5.7
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure.
Food and alcohol
Alcohol can raise or lower Lantus's effect on blood sugar.
Name
Alcohol
Section
7 DRUG INTERACTIONS Table 8
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. [Table 8: Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of LANTUS]
Ask your doctor about alcohol. It may cause low blood sugar and raise the chance of side effects.
Name
Alcohol (MedlinePlus)
Section
What special precautions should I follow?
Source
MedlinePlus Insulin Glargine (rDNA origin) Injection
Url
https://medlineplus.gov/druginfo/meds/a600027.html
Source text (exact source wording)
ask your doctor about the safe use of alcoholic beverages while you are using insulin glargine. Alcohol may cause low blood sugar and make the risk for side effects from insulin glargine more likely.
Skipping or delaying meals, or changing what you eat, can upset blood sugar control.
Name
Meals and diet (MedlinePlus)
Section
What special dietary instructions should I follow?
Source
MedlinePlus Insulin Glargine (rDNA origin) Injection
Url
https://medlineplus.gov/druginfo/meds/a600027.html
Source text (exact source wording)
Skipping or delaying meals or changing the amount or kind of food you eat can cause problems with your blood sugar control.

Patient tips

Medlineplus
Inject once a day at the same time. Do not use it during low blood sugar. Check the label and make sure the insulin is clear and colorless. Never inject into a vein or muscle, and never reuse or share needles, syringes, or pens. Keep using it even when you feel well and do not stop without your doctor. Do not dilute or mix it.
Source
MedlinePlus Insulin Glargine (rDNA origin) Injection
Url
https://medlineplus.gov/druginfo/meds/a600027.html
Source text (exact source wording)
It is injected once a day. You should use insulin glargine at the same time every day. Never use insulin glargine products when you have symptoms of hypoglycemia (low blood sugar) or if you have checked your blood sugar and found it to be low. Always check your insulin glargine label to make sure you are using the correct insulin. Inspect your insulin glargine before you inject it. It should be clear and colorless. Never inject insulin glargine into a vein or muscle. Never reuse needles or syringes and never share needles, syringes, or pens. Continue to use insulin glargine even if you feel well. Do not stop using insulin glargine without talking to your doctor. Do not dilute insulin glargine and do not mix insulin glargine with any other type of insulin.
Confidence
medium

Alternatives

Pharmacologic class
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&type=display
Source text (exact source wording)
LANTUS is a long-acting human insulin analog
Note
No recommendation is made. These are separate products with separate labels.

Frequently asked questions

Question
What is Lantus used for?
Answer
Lantus is used to improve blood sugar control in adults and children with diabetes. It is not recommended for treating diabetic ketoacidosis.
Source section
1 INDICATIONS AND USAGE
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Question
How and when do I take Lantus?
Answer
It is injected under the skin of the abdominal area, thigh, or deltoid once daily at any time of day, but at the same time every day. Rotate injection sites. Do not give into a vein or in an insulin pump, and do not mix it with other insulin.
Source section
2.1, 2.2
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Question
What if I miss a dose of Lantus?
Answer
The Lantus label has no missed-dose rule. MedlinePlus says to ask your doctor before you start what to do if you forget a dose or take an extra dose, and to write down the directions.
Source section
MedlinePlus What should I do if I forget a dose?
Source
MedlinePlus Insulin Glargine (rDNA origin) Injection
Question
Can I drink alcohol with Lantus?
Answer
Ask your doctor. Alcohol may cause low blood sugar and make side effects more likely, and the label lists alcohol among drugs that can raise or lower Lantus's effect.
Source section
7 Table 8; MedlinePlus special precautions
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a; MedlinePlus Insulin Glargine (rDNA origin) Injection
Question
What are the most common side effects?
Answer
The label lists low blood sugar, allergic reactions, injection site reactions, lipodystrophy, itching, rash, edema, and weight gain. Hypoglycemia is the most common reaction.
Source section
Highlights; 5.3
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Question
Is Lantus safe in pregnancy or while breastfeeding?
Answer
Published studies have not shown a clear link between insulin glargine in pregnancy and harm to the baby, and poorly controlled diabetes in pregnancy carries risks. There is little or no data on breast milk. Talk to your doctor.
Source section
8.1; 8.2
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Question
What should I not combine with Lantus?
Answer
Do not mix or dilute Lantus with other insulin. Beta-blockers, clonidine, guanethidine, and reserpine can hide low blood sugar signs. Many other drugs can change Lantus's effect and may need dose changes and more glucose checks. Tell your doctor about everything you take.
Source section
2.1; 7 Table 8
Source
DailyMed label, LANTUS / LANTUS SoloStar, sanofi-aventis U.S. LLC, set ID d5e07a0c-7e14-4756-9152-9fea485d654a
Question
Should I stop Lantus when my blood sugar is normal?
Answer
No. MedlinePlus says insulin glargine controls diabetes but does not cure it. Continue to use it even if you feel well, and do not stop without talking to your doctor.
Source section
MedlinePlus How should this medicine be used?
Source
MedlinePlus Insulin Glargine (rDNA origin) Injection

Sources

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug