Adlyxin Starter Pack

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

Use Adlyxin Starter Pack as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Take Adlyxin Starter Pack within the hour before the first meal every day.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Wash your hands before and after use.
• Prepare pen before first use.
• Move site where you give the shot each time.
• Put the cap back on after you are done using your dose.
• Attach new needle before each dose.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Take a missed dose within the hour before your next meal.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Adlyxin Starter Pack, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Adlyxin Starter Pack. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Adlyxin Starter Pack.

Review Date: October 4, 2017

Applies to lixisenatide: subcutaneous solution

Along with its needed effects, lixisenatide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lixisenatide:

• Anxiety
• bloating
• bluish or pale skin
• blurred vision
• chills
• cold sweats
• confusion
• constipation
• cough
• darkened urine
• depression
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• fever
• headache
• hives, itching, redness, skin rash
• increased hunger
• indigestion
• loss of appetite
• nausea
• nervousness
• nightmares
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness
• shortness of breath
• slurred speech
• tightness in the chest
• troubled breathing
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

• Agitation
• decreased urine output
• hostility
• irritability
• lethargy
• muscle twitching
• rapid weight gain
• stupor
• swelling of the face, ankles, or hands

Get emergency help immediately if any of the following symptoms of overdose occur while taking lixisenatide:

• Diarrhea
• loss of appetite
• nausea or vomiting
• stomach pain, fullness, or discomfort
• indigestion
• passing of gas

Some side effects of lixisenatide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea

• Acid or sour stomach
• belching
• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• heartburn
• pressure in the stomach
• stomach discomfort, upset, or pain

Applies to lixisenatide: subcutaneous kit, subcutaneous solution

General

The most frequently reported adverse reactions were nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 26.5%), vomiting (up to 10.5%)
Common (1% to 10%): Dyspepsia, diarrhea, constipation, abdominal distension, abdominal pain, upper abdominal pain
Frequency not reported: Pancreatitis[Ref]

Gastrointestinal adverse reactions including nausea and vomiting were responsible for discontinuation of treatment in 4.3% of patients. During clinical trials, the severity of gastrointestinal adverse reactions were graded as mild, moderate or severe in 64.2%, 32.3%, and 3.5% of cases, respectively. The majority of reactions occurred during the first 3 weeks of treatment.

During clinical trials, 21 cases of pancreatitis were reported including acute pancreatitis (n=3), pancreatitis (n=12), chronic pancreatitis (n=5), and edematous pancreatitis (n=1). Of these cases, some had risk factors such as a history of cholelithiasis or alcohol abuse. Fourteen cases of pancreatitis were reported in the comparator-treated.[Ref]

Immunologic

Very common (10% or more): Development of anti-lixisenatide antibodies (69.8%)[Ref]

Pooled analysis of drug-treated patients has found that almost 70% were antibody positive at 24 weeks. Of the antibody positive patients, those with the highest antibody concentrations (greater than 100 nmol/L) had attenuated glycemic responses. Additionally, a higher incidence of allergic reactions and injection site reactions occurred in antibody positive patients.[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (in combination with a sulfonylurea and/or a basal insulin)
Common (1% to 10%): Hypoglycemia (in combination with metformin alone)[Ref]

Nervous system

Very common (10% or more): Headache
Common (1% to 10%): Dizziness, somnolence[Ref]

Cardiovascular

Common (1% to 10%): Palpitations
Uncommon (0.1% to 1%): Tachycardia[Ref]

Genitourinary

Common (1% to 10%): Cystitis[Ref]

Local

Common (1% to 10%): Injection site reactions including pain, pruritus, erythema[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Other

Common (1% to 10%): Viral infection[Ref]

Respiratory

Common (1% to 10%): Influenza, upper respiratory tract infection[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic reaction, angioedema, pruritus[Ref]

Some side effects of lixisenatide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

-Mild to severe renal impairment (eGFR 15 to 89 mL/min/1.73 m2): Use caution; no dose adjustment required; however closely monitor for gastrointestinal adverse reactions and changes in renal function
-ESRD (eGFR less than 15 mL/min/1.73 m2): Use is not recommended