Important Safety Information for Adlyxin (lixisenatide) injection

Transcription

1 A GLP-1 receptor agonist (RA) Adlyxin (lixisenatide) injection 20 mcg Information To Help Answer Patients Questions This booklet contains information about Adlyxin to help you answer patients questions about their newly prescribed treatment and its administration: Product information Storage instructions How to get more information Indications and Limitations of Use for Adlyxin (lixisenatide) injection 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. Contraindications Adlyxin is contraindicated in patients with known hypersensitivity to lixisenatide or to any component of Adlyxin. Hypersensitivity including anaphylaxis have occurred with Adlyxin. reactions 1

2 What is Adlyxin? Adlyxin is the brand name for lixisenatide, a GLP-1 RA indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 1 Adlyxin comes in two pre-filled pens each with 14 doses. One 10 microgram (mcg) pen, each dose contains 10 mcg in 0.2 ml One 20 microgram (mcg) pen, each dose contains 20 mcg in 0.2 ml Adlyxin dosing 1 Adlyxin is administered subcutaneously once daily, within one hour before the first meal of the day. If a dose is missed, Adlyxin should be administered within one hour prior to the next meal. Step 1: Initiation Days 1-14: Patients administer 10 mcg subcutaneously once daily for the first 14 days Step 2: Maintenance Day 15+: Patients administer 20 mcg maintenance dose subcutaneously once daily Adlyxin packaging information 1 Adlyxin starter pack Adlyxin maintenance pack 1 pre-filled green pen of Adlyxin 10 mcg and 1 pre-filled burgundy pen of Adlyxin 20 mcg 2 pre-filled burgundy pens of Adlyxin 20 mcg 28-day supply NDC code: day supply NDC code: Patient must start treatment with the green 10 mcg Adlyxin pen and must use all 14 doses from this pen. Discard the used Adlyxin pen after 14 days, even if there is some medicine left in the pen. Then use the burgundy 20 mcg Adlyxin pen starting on day 15. Warnings and Precautions 2 Anaphylaxis and Serious Hypersensitivity Reactions: In clinical trials of Adlyxin there have been cases of anaphylaxis determined to be related to Adlyxin. Other serious hypersensitivity reactions including angioedema also occurred. If a hypersensitivity reaction occurs, patients must stop taking Adlyxin and promptly seek medical attention. Inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist for allergic reactions, because it is unknown whether such patients will be predisposed to anaphylaxis.

3 How should Adlyxin pens be stored?2 Adlyxin pens should be kept in a safe place out of the reach and sight of children The pen should be protected from dust and dirt The pen cap should be replaced after each use to protect container window from light. The entire Adlyxin pen should also be protected from light Adlyxin should not be used after the expiration date, which is stated on the label and on the carton. The expiration date refers to the last day of that month Adlyxin pens that have not yet been activated should be stored in the refrigerator at 36 to 46 F (2 to 8 C). Adlyxin pens should not be frozen, or used if they have been frozen Patients should allow the pen to warm at room temperature before using Once a pen has been activated, it should be stored at room temperature 86 F (30 C); it should not be stored in the refrigerator Adlyxin pens should not be stored with the needle attached Once activated, Adlyxin can be used for up to 14 days. A used Adlyxin pen should be discarded after 14 days, even if there is some medicine still left in the pen Which needles are compatible with Adlyxin? Length Manufacturers 8 mm Becton Dickinson (BD) Ypsomed Owen Mumford Only use needles that have been approved for use with ADLYXIN. The ADLYXIN pen may be used with certain pen needles from Becton Dickinson, Ypsomed and Owen Mumford that are 8 mm long or shorter. Ask your healthcare provider which needle gauge and length is best for you. Warnings and Precautions (cont d) Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists based on spontaneous postmarketing reports.in clinical trials of Adlyxin, there were cases of pancreatitis among some Adlyxin treated patients. After initiation of Adlyxin, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Adlyxin should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, do not restart Adlyxin. Never Share an Adlyxin Pen Between Patients, even if the needle is changed: Pen sharing poses a risk for transmission of blood-borne pathogens. 3

4 What do patients need to know about the Adlyxin pen? 2 NOTE: Instructions for use are applicable to both the green 10-mcg Starter Pen (shown) and the burgundy 20-mcg Maintenance Pen. Components of the Adlyxin pen Pen cap Rubber seal Expiration date on the back Activation window Pen shown is not actual size. Container window Arrow window Injection button Black plunger The plunger will move along the dose scale after each injection. In this example, the dose number shows that there are 13 injections left. Instruct your patients not to share their Adlyxin pens with other people. Pen-sharing poses a risk for transmission of serious infections, even if the needle is changed. How to attach the needle 2 Instruct patients to: Remove the protective seal from the outer needle cap Line up the needle with the pen Keep the needle straight until secured When the needle is securely attached to the pen, pull off (do not unscrew) the outer and inner needle caps. Keep the outer needle cap to remove the needle later. Care should be taken to prevent injury from the exposed needle. Components of the needle Needle Outer needle cap Inner needle cap Protective seal The pen does not come with a needle. Needles are supplied separately. 4 Attach the needle. 1 When attaching 2 the needle, it should be kept straight and screwed onto the pen. Instruct your patients to inject the medication ONLY with the pen injector. Patients should never use a syringe to withdraw or inject the medication. Warnings and Precautions (cont d) Hypoglycemia with Concomitant Use of Sulfonylurea or Basal Insulin: Patients receiving Adlyxin in combination with basal insulin or a sulfonylurea have an increased risk of hypoglycemia. Reduction of the dose of the sulfonylurea or basal insulin may be necessary. Acute Kidney Failure: There have been postmarketing reports of acute kidney injury and worsening of chronic Remove the needle caps. Keep Discard renal failure, which may sometimes require hemodialysis in patients treated with GLP-1 receptor agonists. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Adlyxin in patients with renal impairment reporting severe gastrointestinal reactions. Adlyxin is not recommended for patients with end stage renal disease.

5 Getting started Activation of the Adlyxin pen Each new pen must be activated the day it is going to be used for the first time, before the first injection. 3 Activation is done to make sure the pen is working correctly and that the dose for the first injection is correct. 2 Pen activation should be done only once; the process should not be repeated or patients will not obtain the full 14 doses. The graphic at right shows how the window on the injection button changes after activation. PENS REQUIRE ACTIVATION BEFORE FIRST USE 2 Not activated (orange window) Activated (white window) How to activate a new pen 2 The new pen set-up is only for the first time the pen is used. 1 Pull off the cap and check the pen. 4 Firmly press and hold the injection button to remove the liquid, pointing the needle into a suitable container. They may hear or feel a click. The injection button should be fully depressed for 2 seconds after hearing the click. click The container window shows the liquid, which should be checked to make sure it is clear and colorless with no particles. If it is not, the pen should not be used. Check that the activation window is orange. 2 2 seconds 2 Attach the needle (see How to attach the needle section on previous page). 3 Activate the Pen. The arrow in the window will be pointing toward the injection button when the pen is not activated. 5 Check that the activation window is white. When the pen is activated and ready for injections, the window will be white, as shown. Pull the injection button firmly until it stops. Check that the arrow is pointing toward the needle. 5

6 How to inject Adlyxin 2 NOTE: These steps should be taken ONLY when the activation window is white. Only one dose should be injected each day. How to inject a daily dose 4 Choose the injection site. Adlyxin must be injected under the skin into any of the areas shown in orange thigh, abdomen, or upper arm. 1 Pull off the cap and check the pen. Instruct patients to check the label to make sure they have the correct medication and that it has not passed the expiration date. The liquid should be clear and colorless with no particles. If it is not, the pen should not be used. The black plunger should be checked to find out how many doses remain. The label should be checked to ensure that the pen contains the correct medicine. The activation window should be white. 5 To inject Adlyxin, the patient grasps a fold of skin and inserts the needle. 2 Attach a new needle and remove the needle caps. A new needle should be used for each injection. The needle does not need to be replaced between activation of a new pen and the first injection as long as the patient administers the injection immediately after activating the pen. 3 Pull the injection button out firmly until it stops. 2 2 seconds 6 Press and hold the injection button all the way in to inject the dose. After feeling or hearing a click, keep the injection button pressed in, hold the pen in place and count to 2 before pulling the needle out of the skin. Failing to hold down the injection button, or removing the injector too soon, can prevent the full dose from being administered. 7 Remove the needle and discard after each injection (see How to remove the needle section ). The arrow will now be pointing toward the needle. Discard the pen 14 days after activation, even if there is some medicine left. 6

7 How to remove a needle 2 1 The widest part of the outer needle cap is grasped and guided firmly and straight back onto the needle. 3 The cap is replaced on the pen. The needle can puncture the cap if it is recapped at an angle 2 To grip the needle, the outer needle cap is squeezed and the pen is turned several times with the other hand. This procedure should be tried again if the needle does not come off the first time Patients should safely dispose of the needle in a punctureresistant container How should the Adlyxin pen be maintained? 2 The outside of the pen can be cleaned by wiping it with a damp cloth. The pen should not be soaked, washed, or have liquid placed on the outside, as this may damage it. If you are a patient experiencing problems with a Sanofi US product, please contact Sanofi US at If an Adlyxin pen appears to be damaged, it should not be used; the prescriber should be contacted to arrange for a new prescription. 7 Warnings and Precautions (cont d) Immunogenicity: Patients may develop antibodies to lixisenatide following treatment with Adlyxin. A higher incidence of allergic reactions and injection site reactions occurred in antibody positive patients. If there is worsening glycemic control or failure to achieve targeted glycemic control, significant injection site reactions, or allergic reactions then alternative antidiabetic therapy should be considered. Macrovascular Outcomes: Clinical studies have not shown macrovascular risk reduction with Adlyxin or any other antidiabetic drug. Most Common Adverse Reactions ( 5%) The most common adverse reactions associated with Adlyxin include nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia. Drug Interactions 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 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. 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.

8 Contraindications Adlyxin is contraindicated in patients with known hypersensitivity to lixisenatide or to any component of Adlyxin. Hypersensitivity reactions including anaphylaxis have occurred with Adlyxin. Warnings and Precautions Anaphylaxis and Serious Hypersensitivity Reactions: In clinical trials of Adlyxin there have been cases of anaphylaxis determined to be related to Adlyxin. Other serious hypersensitivity reactions including angioedema also occurred. If a hypersensitivity reaction occurs, patients must stop taking Adlyxin and promptly seek medical attention. Inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist for allergic reactions, because it is unknown whether such patients will be predisposed to anaphylaxis. Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists based on spontaneous postmarketing reports. In clinical trials of Adlyxin, there were cases of pancreatitis among some Adlyxin treated patients. After initiation of Adlyxin, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Adlyxin should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, do not restart Adlyxin. Never Share an Adlyxin Pen Between Patients, even if the needle is changed: Pen sharing poses a risk for transmission of blood-borne pathogens. Hypoglycemia with Concomitant Use of Sulfonylurea or Basal Insulin: Patients receiving Adlyxin in combination with basal insulin or a sulfonylurea have an increased risk of hypoglycemia. Reduction of the dose of the sulfonylurea or basal insulin may be necessary. Acute Kidney Failure: There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis in patients treated with GLP-1 receptor agonists. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Adlyxin in patients with renal impairment reporting severe gastrointestinal reactions. Adlyxin is not recommended in patients with end stage renal disease. Immunogenicity: Patients may develop antibodies to lixisenatide following treatment with Adlyxin. A higher incidence of allergic reactions and injection site reactions occurred in antibody positive patients. If there is worsening glycemic control or failure to achieve targeted glycemic control, significant injection site reactions, or allergic reactions then alternative antidiabetic therapy should be considered. Macrovascular Outcomes: Clinical studies have not shown macrovascular risk reduction with Adlyxin or any other antidiabetic drug. Most Common Adverse Reactions ( 5%) The most common adverse reactions associated with Adlyxin include nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia. Drug Interactions 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 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. 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. Use in Specific Populations Pregnancy and Nursing Women: The limited available data with lixisenatide in pregnant women are not sufficient to inform a drug-associated risk of major birth defects and miscarriage. Adlyxin should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. There is no information regarding the presence of Adlyxin in human milk, the effects on the breastfed infant, or the effects on milk production. Pediatric Use: Safety and effectiveness of Adlyxin have not been established in pediatric patients below 18 years of age. 8

9 How to prescribe a 1-month (28 days) supply of Adlyxin 1 INITIATION OF THERAPY MAINTENANCE THERAPY Rx: Administer Adlyxin 10 mcg subcutaneously once daily within one hour before the first meal of the day preferably the same meal each day for 14 days* Starting on Day 15, administer 20 mcg subcutaneously once daily Rx: Administer Adlyxin 20 mcg subcutaneously once daily within one hour before the first meal of the day preferably the same meal each day* DISP: Adlyxin Maintenance Pack (two 20-mcg pens) DISP: Adlyxin Starter Pack (one 10-mcg pen and one 20-mcg pen) *If a dose is missed, administer Adlyxin within one hour prior to the next meal. For additional information or to speak with a medical affairs specialist, please call sanofi-aventis at Contraindications Adlyxin is contraindicated in patients with known hypersensitivity to lixisenatide or to any component of Adlyxin. Hypersensitivity reactions including anaphylaxis have occurred with Adlyxin. Use in Specific Populations Pregnancy and Nursing Woman: The limited available data with lixisenatide in pregnant women are not sufficient to inform a drug-associated risk of major birth defects and miscarriage. Adlyxin should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. There is no information regarding the presence of Adlyxin in human milk, the effects on the breastfed infant, or the effects on milk production. Pediatric Use: Safety and effectiveness of Adlyxin have not been established in pediatric patients below 18 years of age. References: 1. Adlyxin (lixisenatide) injection, for subcutaneous use. Prescribing Information. July Instructions for Use. Adlyxin Starter Pack. July Instructions for Use. Adlyxin Maintenance Pack. July sanofi-aventis U.S. LLC. All rights reserved. SAUS.ADL /17