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Lixisenatide (Adlyxin)

Trade Name : ADLYXIN

Sanofi-Aventis U.S. LLC

KIT

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Lixisenatide (Adlyxin) which is also known as ADLYXIN and Manufactured by Sanofi-Aventis U.S. LLC. It is available in strength of per ml. Read more

Lixisenatide (Adlyxin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • ADLYXIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • ADLYXIN 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 ().
  • 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.
  • Not for treatment of type 1 diabetes or diabetic ketoacidosis.
  • Has not been studied in combination with short acting insulin.
  • Has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis.
  • No data
  • Initiate at 10 mcg once daily for 14 days. On Day 15, increase dosage to 20 mcg once daily ().
  • Administer once daily within one hour before the first meal of the day ().
  • Inject subcutaneously in the abdomen, thigh or upper arm ().
  • ADLYXIN is a clear solution for subcutaneous injection available as:
  • Injection: 50 mcg/mL in 3 mL in green prefilled pen (for 14 pre-set doses; 10 mcg per dose) ().
  • Injection: 100 mcg/mL in 3 mL in burgundy prefilled pen (for 14 pre-set doses; 20 mcg per dose) ().
  • ADLYXIN is contraindicated in patients with known hypersensitivity to lixisenatide or to any component of ADLYXIN. Hypersensitivity reactions including anaphylaxis have occurred with ADLYXIN n
  • Hypersensitivity to ADLYXIN or any product components. Hypersensitivity reactions including anaphylaxis have occurred with ADLYXIN ().
  • No data
  • Anaphylaxis and Serious Hypersensitivity Reactions: Discontinue ADLYXIN and promptly seek medical advice ().
  • Pancreatitis: Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis ().
  • Never share ADLYXIN pen between patients, even if the needle is changed ().
  • Hypoglycemia with Concomitant use of Sulfonylurea or Basal Insulin: When ADLYXIN is used with a sulfonylurea or basal insulin, consider lowering the dose of the sulfonylurea or basal insulin to reduce the risk of hypoglycemia. ().
  • Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. ADLYXIN is not recommended in patients with end stage renal disease ().
  • Immunogenicity: Patients may develop antibodies to lixisenatide. If there is worsening glycemic control or failure to achieve targeted glycemic control, significant injection site reactions or allergic reactions, alternative antidiabetic therapy should be considered ().
  • Macrovascular Outcomes: Clinical studies have not shown macrovascular risk reduction with ADLYXIN or any other antidiabetic drug ().
  • The following serious reactions are described below or elsewhere in the prescribing information:
  • The most common adverse reactions (u22655%) of patients treated with ADLYXIN are nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia ().
  • To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or n
  • No data
  • ADLYXIN delays gastric emptying which may impact absorption of concomitantly administered oral medications. 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 1 hour before ADLYXIN (,).
  • Oral contraceptives should be taken at least 1 hour before ADLYXIN administration or 11 hours after the dose of ADLYXIN (,).
  • Pregnancy: ADLYXIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus ().
  • 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.
  • ADLYXIN contains lixisenatide, which acts as a GLP-1 receptor agonist. Lixisenatide is a peptide containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44). The order of the amino acids is given in the figure below. Its molecular weight is 4858.5 and its molecular formula is CHNOS. Lixisenatide has the following chemical structure:
  • ADLYXIN injection is a sterile, clear, colorless aqueous solution for subcutaneous administration. ADLYXIN is supplied in two single-patient use prefilled pens. Each green prefilled pen contains 3 mL solution and each mL contains 50 mcg lixisenatide. Each burgundy prefilled pen contains 3 mL solution, and each mL contains 100 mcg lixisenatide. Inactive ingredients for both prefilled pens are glycerol 85% (54 mg), sodium acetate trihydrate (10.5 mg), methionine (9.0 mg), metacresol (8.1 mg), and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.
  • No data
  • No data
  • ADLYXIN has been studied as monotherapy, in combination with oral antidiabetic medications, and in combination with basal insulin (with or without oral antidiabetic medications). The efficacy of ADLYXIN was compared with placebo, exenatide, and insulin glulisine.
  • In patients with type 2 diabetes, ADLYXIN produced reductions from baseline in HbA1c compared to placebo.
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
  • sanofi-aventis U.S. LLCBridgewater, NJ 08807A SANOFI COMPANY
  • u00a92019 sanofi-aventis U.S. LLC
  • No data
  • INSTRUCTIONS FOR USEADLYXIN (ad-LIX-in)(lixisenatide)Injection, for subcutaneous use
  • Starter pack - Contains two pre-filled pens each with doses.
  • One pen, each dose contains .
  • One pen, each dose contains .
  • Section 1 - Important Information
  • Read these instructions carefully before using your ADLYXIN pens.
  • Keep this leaflet for future reference.
  • Do not share your ADLYXIN pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
  • ADLYXIN pen Information
  • About Your Starter Pack
  • The ADLYXIN Starter pack includes two different colored pens that contain different strengths of ADLYXIN. Both pens are used in the same way.
  • You must start your treatment with the green 10 microgram ADLYXIN pen. You must first use all 14 doses from this pen. Then use the burgundy 20 microgram ADLYXIN pen.
  • About Your ADLYXIN Pens
  • Green 10 microgram (mcg) ADLYXIN pen
  • The plunger will advance along the dose scale after each injection. In the example above, the dose number shows there are 13 injections left in the ADLYXIN pen.
  • Burgundy 20 microgram (mcg) ADLYXIN pen
  • About pen needles
  • Section 2 u2013 Getting Started
  • Begin with the green 10 mcg ADLYXIN pen.
  • First activate your new pen
  • The pictures below show how the activation window on the injection button of your pen changes after activation.
  • How to activate your new ADLYXIN pen
  • Step 1. Pull off cap and check pen
  • Step 2. Screw needle on and remove needle caps
  • Pull off
  • Take care not to injure yourself when the needle is exposed.
  • Step 3. Pull the injection button out
  • Pull the injection button out firmly until it stops.
  • The arrow will now be pointing towards the needle.
  • Step 4. Firmly press and hold the injection button to remove the liquid
  • Step 5. The pen is now ready for use.
  • For your first injection, go directly to Section 3 u2013 Step 3.
  • You need to replace the needle between activation and first injection if you inject yourself immediately after activation.
  • Section 3 - Daily use of pen
  • Inject only 1 dose each day.
  • Check to make sure the activation window is white before continuing in this section. tttttt
  • Step 1n- Pull off cap and check pen
  • Step 2n- Attach a new needle and remove needle caps
  • Step 3n- Pull the injection button out
  • The arrow in the window will be pointing towards the injection button.
  • Pull the injection button out firmly until it stops.
  • The arrow will now be pointing towards the needle.
  • Step 4. tChoosing Injection Sites
  • Injection sites
  • ADLYXIN must be injected under the skin and can be injected in any of the areas shown above in blue. These areas include the thigh, abdomen or upper arm. Ask your healthcare provider about how to inject correctly.
  • Step 5n- Press and hold the injection button to inject the dose
  • If you do not hold the injection button in or remove the injector too early you may not get the full dose.
  • Your dose has now been given. Pull out the needle from your skin
  • Step 6n- Remove and throw away needle after each injection
  • Step 7n- Repeat all steps in Section 3 for each injection.
  • Throw away a pen 14 days after activation, even if there is some medicine left.
  • Once the green pen is discarded continue to to begin using the burgundy pen.
  • Section 4 u2013 Moving to the burgundy pen
  • Completed use of the green 10 mcg pen
  • The green 10 mcg ADLYXIN pen is empty when the black plunger has reached '0' on the dose scale and the injection button cannot be pulled out fully.
  • Once the green 10 mcg ADLYXIN pen is empty you must continue your treatment the next day using the burgundy 20 mcg ADLYXIN pen. This is used in exactly the same way.
  • Use of burgundy 20 microgram pen
  • Burgundy 20 mcg pen activation
  • The burgundy 20 mcg ADLYXIN pen must also be activated before use. Follow all steps in Section 2.
  • Burgundy 20 mcg pen use
  • To inject a dose with the burgundy 20 mcg ADLYXIN pen, follow all steps in Section 3. Repeat Section 3 for your daily injections until your pen is empty.
  • Table of activation and disposal
  • In the table write the date when you activated your pen and the date to throw it away 14 days later.
  • Storage
  • General information
  • Before activation of the pen:
  • After activation of the pen:
  • Throwing your pen away
  • Maintenance
  • Questions and Answers
  • What do I do if I forget to activate the ADLYXIN Pen or inject myself before activation?
  • If you have injected yourself before activating the pen, do not correct this by giving yourself a second injection. Contact your healthcare provider for advice on checking your blood sugar.
  • What do I do if there are air bubbles in the container?
  • Small air bubbles in the container are normal and they will not harm you. Your dose will be correct and you can keep following the instructions. Contact your healthcare provider if you need help.
  • What do I do if no liquid comes out during activation?
  • The needle may be blocked or not properly attached. Remove the needle from the pen, attach a new one and repeat Steps 4 and 5 of Section 2 only. If still no liquid comes out, your ADLYXIN pen may be damaged. Do not use this ADLYXIN Starter pack. Contact your healthcare provider for help.
  • What do I do if it is hard to press the injection button all the way in?
  • The needle may be blocked or not properly attached. Pull the needle out of your skin and remove the needle from the pen. Attach a new needle and repeat Steps 5 and 6 of Section 3 only. If it is still hard to press in the injection button, your ADLYXIN pen may be damaged. Do not use this ADLYXIN starter pack. Contact your healthcare provider for help.
  • If you have any questions about ADLYXIN or about diabetes, ask your healthcare provider or call sanofi-aventis U.S. LLC at 1-800-633-1610.
  • Date of Revision: Jul/2016a
  • INSTRUCTIONS FOR USEADLYXIN (ad-LIX-in)(lixisenatide)Injection, for subcutaneous use
  • One pre-filled pen contains 14 doses, each dose contains .
  • Section 1 u2013 Important Information
  • Read these instructions carefully before using your ADLYXIN pen.
  • Keep this leaflet for future reference
  • Do not share your ADLYXIN pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
  • ADLYXIN pen Information
  • About Your ADLYXIN Pen
  • The plunger will move along the dose scale after each injection. In the example above the dose number shows there are 13 injections left in the ADLYXIN pen.
  • About your pen needles
  • Section 2 u2013 Getting Started
  • First activate your new pen
  • The pictures below show how the injection button of your pen changes after activation.
  • How to activate your new ADLYXIN pen
  • Step 1. Pull off the pen cap and check the pen
  • Step 2. Screw needle on and remove needle caps
  • Step 3. Pull injection button out
  • The arrow in the window will be pointing towards the injection button.
  • Pull the injection button out firmly until it stops.
  • The arrow will now be pointing towards the needle.
  • Step 4. Firmly press and hold injection button to remove the liquid
  • Step 5. The pen is now ready for use.
  • For your first injection, go directly to Section 3 - Step 3.
  • Section 3 - Daily use of pen
  • Inject only 1 dose each day.
  • Check to make sure the activation window is white before continuing in this section.
  • Step 1.tPull off pen cap and check pen
  • Step 2.tAttach a new needle and remove the needle caps
  • Step 3.tPull the injection button out
  • The arrow in the window will be pointing towards the injection button.
  • Pull the injection button out firmly until it stops.
  • The arrow will now be pointing towards the needle.
  • Step 4.tChoosing Injection Sites
  • Injection sites
  • ADLYXIN must be injected under the skin and can be injected in any of the areas shown above in blue. These areas include the thigh, abdomen or upper arm. Ask your healthcare provider about how to inject correctly.
  • Step 5.tPress and hold the injection button to inject the dose
  • If you do not hold the injection button in or remove the injector too early you may not get the full dose.
  • Your dose has now been given. Pull the needle out of your skin.
  • Step 6.tRemove and throw away needle after each injection
  • Step 7n- Repeat all steps in Section 3 for your each injection.
  • Throw away a pen 14 days after activation, even if there is some medicine left.
  • Table of activation and disposal
  • In the table, write the date when you activated your pen and the date to discard it 14 days later.
  • Storage
  • General information
  • Before activation of the pen:
  • After activation of the pen:
  • Throwing your pen away
  • Maintenance
  • Questions and Answers
  • What do I do if I forget to activate the ADLYXIN pen or inject myself before activation?
  • If you have injected yourself before activating the pen, do not correct this by giving yourself a second injection. Contact your healthcare provider for advice on checking your blood sugar.
  • What do I do if there are air bubbles in the container?
  • Small air bubbles in the container are normal and they will not harm you. Your dose will be correct and you can keep following the instructions. Contact your healthcare provider if you need help.
  • What do I do if no liquid comes out during activation?
  • The needle may be blocked or not properly attached. Remove the needle from the pen, attach a new needle and repeat Steps 4 and 5 of Section 2 only. If still no liquid comes out, your ADLYXIN pen may be damaged. Do not use this ADLYXIN pen. Contact your healthcare provider for help.
  • What do I do if it is hard to press the injection button all the way in?
  • The needle may be blocked or not properly attached. Pull the needle out of your skin and remove the needle from the pen. Attach a new needle and repeat Steps 5 and 6 of Section 3 only. If it is still hard to press in the injection button, your ADLYXIN pen may be damaged. Do not use this ADLYXIN pen. Contact your healthcare professional for help.
  • If you have any questions about ADLYXIN or about diabetes, ask your healthcare provider or call sanofi-aventis U.S. LLC at 1-800-633-1610.
  • Date of Revision: Jul/2016
  • NDC 0024-5745-02
  • Adlyxinu2122
  • 10n- PER DOSE
  • 20n- PER DOSE
  • Starter Pack
  • For Single Patient Use Only
  • 50 mcg/mL u2013 3 mL pen n 100 mcg/mL u2013 3 mL pen
  • For subcutaneous use only
  • CONTENTS:n- AND
  • Each prefilled pen will deliver 14 doses.
  • Dispense with the medication guide
  • Rx only
  • SANOFI
  • NDC 0024-5747-02
  • Adlyxinu2122
  • 20n- PER DOSE
  • MaintenancePack
  • For Single Patient Use Only
  • 100 mcg/mL u2013 3mL pen
  • For subcutaneous use only
  • CONTENTS:
  • Each prefilled pen will deliver 14 doses. Rx only
  • Dispense with the medication guide
  • SANOFI

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