Adlyxin

Name: Adlyxin

What Is Adlyxin (Lixisenatide)?

Adlyxin is the brand name of the injectable medicine lixisenatide, which is used to treat type 2 diabetes — a disease in which the body doesn't make or use the hormone insulin properly, so it can't adequately control the amount of sugar in the blood.

This prescription medicine is a glucagon-like peptide-1 (GLP-1). It works by helping to normalize blood sugar levels.

Using Adlyxin, along with adopting a healthy lifestyle, may reduce your risk of developing serious or life-threatening complications from diabetes — including heart disease, stroke, nerve damage, kidney problems, or eye problems.

The Food and Drug Administration (FDA) approved Adlyxin in 2016. It's marketed by Sanofi-Aventis.

Adlyxin Warnings

Adlyxin shouldn't be used by people with type 1 diabetes — a disease in which the body doesn't produce any insulin — or diabetic ketoacidosis, a dangerous condition that can occur if high blood sugar goes untreated.

It's not known whether this medicine is safe or effective in children.

Adlyxin isn't a type of insulin, and it shouldn't be used in place of a long-acting insulin.

Before starting on treatment with Adlyxin, tell your doctor if you have, or have ever had:

  • Gastroparesis (a condition in which there is a delay in stomach emptying)
  • Problems digesting food
  • Gallbladder stones
  • A history of alcoholism
  • Kidney problems
  • Allergies to any medication

Adlyxin helps control type 2 diabetes, but it doesn't cure the condition.

Continue to take this medicine even if you feel well. Don't stop using Adlyxin without first talking to your doctor.

This medicine may cause hypoglycemia (low blood sugar), which is often characterized by symptoms such as:

  • Hunger
  • Dizziness
  • Confusion
  • Irritability
  • Drowsiness
  • Headache
  • Weakness
  • Fast heartbeat
  • Sweating
  • Feeling jittery or having tremors

Monitor your blood sugar levels carefully while using Adlyxin. Talk to your doctor about what to do if you have a low blood sugar episode.

Illness, injury, or unusual stress can affect your blood sugar levels. They may also affect how much Adlyxin you need to take. Talk to your doctor if you experience any of these conditions while taking this medicine.

Always wear a diabetic ID bracelet to be sure you get proper treatment in case of an emergency.

Your doctor will probably want to check your blood sugar and urine sugar levels often while you're using this medication. Keep all appointments with your healthcare provider and laboratory.

Adlyxin should be used along with a program that includes diet, exercise, and weight control. Follow your doctor's recommendations carefully.

Pregnancy and Adlyxin

It's not known whether Adlyxin could harm an unborn baby if used during pregnancy.

Tell your doctor if you're pregnant, or might become pregnant, during your treatment.

It's also not known whether Adlyxin passes into breast milk. Don't breastfeed a baby while taking this medicine without first talking to your doctor.

What other drugs will affect lixisenatide?

Other drugs may interact with lixisenatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Introduction

Lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist (incretin mimetic), is an antidiabetic agent.

Uses for Adlyxin

Lixisenatide has the following uses:

Lixisenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.1

Lixisenatide has the following limitations of use:

Has not been studied in patients with chronic pancreatitis or a history of unexplained pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.1

Not for treatment of type 1 diabetes or diabetic ketoacidosis.1

Has not been studied in combination with short acting insulin.1

Has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis.1

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Lixisenatide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for subcutaneous use only

100 mcg/mL (3 mL)

Adlyxin Maintenance Pack (contains 2 prefilled, single-patient use pens [for 14 doses; 20 mcg/dose])

Sanofi-Aventis U.S. LLC

Starter Pack

50 mcg/mL (3 mL) and 100 mcg/mL (3 mL)

Adlyxin Starter Pack (contains 2 prefilled, single-patient use pens [for 14 doses; 10 or 20 mcg/dose])

Sanofi-Aventis U.S. LLC

Uses For Adlyxin

Lixisenatide injection is used to treat type 2 diabetes mellitus. Lixisenatide is used together with diet and exercise to help control your blood sugar. This medicine is a glucagon-like peptide-1 (GLP-1) receptor agonist.

This medicine is available only with your doctor's prescription.

Before Using Adlyxin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lixisenatide injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lixisenatide injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acetohexamide
  • Chlorpropamide
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Estradiol
  • Ethinyl Estradiol
  • Ethynodiol
  • Etonogestrel
  • Gestodene
  • Gliclazide
  • Glimepiride
  • Glipizide
  • Gliquidone
  • Glyburide
  • Lanreotide
  • Levonorgestrel
  • Mestranol
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Octreotide
  • Pasireotide
  • Thioctic Acid
  • Tolazamide
  • Tolbutamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Acetaminophen
  • Atenolol
  • Betaxolol
  • Bisoprolol
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Esmolol
  • Insulin
  • Insulin Aspart, Recombinant
  • Insulin Bovine
  • Insulin Degludec
  • Insulin Detemir
  • Insulin Glargine, Recombinant
  • Insulin Glulisine
  • Insulin Lispro, Recombinant
  • Labetalol
  • Levobunolol
  • Metipranolol
  • Metoprolol
  • Nadolol
  • Nebivolol
  • Oxprenolol
  • Penbutolol
  • Pindolol
  • Practolol
  • Propranolol
  • Sotalol
  • Timolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetic ketoacidosis (ketones in the blood) or
  • Type 1 diabetes—Should not be used in patients with these conditions. Insulin is needed to control these conditions.
  • Gastroparesis (stomach does not empty food normally), severe—Should not be used in patients with this condition.
  • Kidney disease or
  • Pancreatitis (inflammation of the pancreas), history of—Use with caution. May make these conditions worse.

Uses of Adlyxin

  • It is used to lower blood sugar in patients with high blood sugar (diabetes).

What are some other side effects of Adlyxin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Headache.
  • Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Drug Interactions

Delayed Gastric Emptying Effects on Oral Medications

Adlyxin delays gastric emptying which may reduce the rate of absorption of orally administered medications. Use caution when coadministering oral medications that have a narrow therapeutic ratio or that require careful clinical monitoring. These medications should be adequately monitored when concomitantly administered with Adlyxin. If such medications are to be administered with food, patients should be advised to take them with a meal or snack when Adlyxin is not administered.

Oral medications that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, or medications for which a delay in effect is undesirable, such as acetaminophen, should be administered at least 1 hour before Adlyxin injection [see Clinical Pharmacology (12.3)].

Patients taking oral contraceptives should be advised to take them at least 1 hour before Adlyxin administration or at least 11 hours after the dose of Adlyxin [see Clinical Pharmacology (12.3)].

Dosage Adjustment of Sulfonylurea or Basal Insulin with Concomitant Use with Adlyxin

When Adlyxin is added to a sulfonylurea or basal insulin, there is a potential risk of hypoglycemia. A reduction of the concomitantly administered sulfonylurea or basal insulin may be necessary. [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].

Overdosage

During clinical studies, doses up to 30 mcg of lixisenatide twice daily (3 times the daily recommended dose) were administered to type 2 diabetic patients in a 13-week study. The 30 mcg dose of lixisenatide is not an approved dose. An increased incidence of gastrointestinal disorders was observed.

In case of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Carcinogenicity studies of 2-years durations were conducted in CD-1 mice and Sprague-Dawley rats with twice daily subcutaneous doses of 40, 200, or 1,000 mcg/kg. A statistically significant increase in thyroid C-cell adenomas was observed in male mice at 2,000 mcg/kg/day, resulting in systemic exposures that are >180-times the human exposure achieved at 20 mcg/day based on plasma AUC.

Statistically significant increases in thyroid C-cell adenomas were seen at all doses in rats, resulting in systemic exposures that are ≥15-times the human exposure achieved at 20 mcg/day based on plasma AUC. A numerical increase in thyroid C-cell carcinomas was observed in rats at ≥ 400 mcg/kg/day, resulting in systemic exposures that are >56-times the human exposure achieved at 20 mcg/day based on plasma AUC.

Mutagenesis

Lixisenatide was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), human lymphocyte chromosome aberration, mouse bone marrow micronucleus).

Impairment of Fertility

Studies in which male and female rats received twice daily subcutaneous doses of 2, 29, or 414 mcg/kg/dose prior to pairing through gestation day 6 did not indicate any adverse effects on male or female fertility in rats up to the highest dose tested, 414 mcg/kg/dose, which is approximately 400-times the clinical dose at 20 mcg/day based on mcg/m2.

PRINCIPAL DISPLAY PANEL - 20 mcg Maintenance Pack Carton

NDC 0024-5747-02

Adlyxin™
(lixisenatide) injection

20 mcg
PER DOSE

Maintenance
Pack

For Single Patient Use Only

100 mcg/mL – 3mL pen

For subcutaneous use only

CONTENTS:
2 prefilled pens containing 20 mcg per dose

Each prefilled pen will deliver 14 doses. Rx only

Dispense with the medication guide

SANOFI

Adlyxin 
lixisenatide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0024-5745
Packaging
# Item Code Package Description
1 NDC:0024-5745-02 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 SYRINGE 3 mL
Part 2 1 SYRINGE 3 mL
Part 1 of 2
Adlyxin 
lixisenatide injection, solution
Product Information
Item Code (Source) NDC:0024-5741
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lixisenatide (Lixisenatide) Lixisenatide 50 ug  in 1 mL
Inactive Ingredients
Ingredient Name Strength
glycerin  
sodium acetate  
methionine  
metacresol  
water  
hydrochloric acid  
sodium hydroxide  
Packaging
# Item Code Package Description
1 NDC:0024-5741-01 3 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208471 07/27/2016
Part 2 of 2
Adlyxin 
lixisenatide injection, solution
Product Information
Item Code (Source) NDC:0024-5740
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lixisenatide (Lixisenatide) Lixisenatide 100 ug  in 1 mL
Inactive Ingredients
Ingredient Name Strength
glycerin  
sodium acetate  
methionine  
metacresol  
water  
hydrochloric acid  
sodium hydroxide  
Packaging
# Item Code Package Description
1 NDC:0024-5740-00 3 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208471 07/27/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208471 07/27/2016
Adlyxin 
lixisenatide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0024-5747
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lixisenatide (Lixisenatide) Lixisenatide 100 ug  in 1 mL
Inactive Ingredients
Ingredient Name Strength
glycerin  
sodium acetate  
methionine  
metacresol  
water  
hydrochloric acid  
sodium hydroxide  
Packaging
# Item Code Package Description
1 NDC:0024-5747-02 2 SYRINGE in 1 CARTON
1 3 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208471 07/27/2016
Labeler - Sanofi-Aventis U.S. LLC (824676584)
Establishment
Name Address ID/FEI Operations
Sanofi-Aventis Deutschland GmbH 313218430 MANUFACTURE(0024-5747, 0024-5745), ANALYSIS(0024-5747, 0024-5745), LABEL(0024-5747, 0024-5745), PACK(0024-5747, 0024-5745)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 050424395 LABEL(0024-5747, 0024-5745), PACK(0024-5747, 0024-5745)
Revised: 08/2017   Sanofi-Aventis U.S. LLC

Adlyxin dosing information

Usual Adult Dose for Diabetes Type 2:

Initial dose: 10 mcg subcutaneously once a day for 14 days
Maintenance dose: Increase to 20 mcg subcutaneously once a day on day 15, and thereafter

Comments:
-This drug should be administered within 1 hour before the first meal of the day, preferably the same meal each day; if a dose is missed, administer within 1 hour prior to the next meal.
-Concurrent use with short acting insulin has not been studied and is not recommended.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

(web3)