Pronunciation:

IN-su-lin GLAR-jeen, ree-KOM-bi-nant, lix-i-SEN-a-tide

Brand Names:

• Soliqua 100/33

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antidiabetic

Pharmacologic—

Insulin, Long Acting

Uses of This Medicine:

Insulin glargine and lixisenatide combination is used to treat a type of diabetes mellitus (sugar diabetes) called type 2 diabetes.

Insulin glargine is a long-acting type of insulin that works slowly, over about 24 hours. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have diabetes mellitus, your body cannot make enough insulin or does not use insulin properly. This causes you to have too much sugar in your blood. Like other types of insulin, insulin glargine is used to keep your blood sugar level close to normal. Lixisenatide is to be used when diet and exercise do not result in good blood sugar control.

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

Before Using This Medicine:

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.

Children—

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

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Soliqua® in the elderly. However, elderly patients are more likely to have age-related hypoglycemia, which may require caution and an adjustment in the dose for patients receiving Soliqua®.

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.

Other 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.

• Abiraterone Acetate
• Acetohexamide
• Chloroquine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Ciprofloxacin
• Delafloxacin
• Desogestrel
• Dienogest
• Drospirenone
• Enoxacin
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Lanreotide
• Levofloxacin
• Levonorgestrel
• Liraglutide
• Lomefloxacin
• Mestranol
• Metoclopramide
• Metolazone
• Metreleptin
• Moxifloxacin
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Octreotide
• Ofloxacin
• Pasireotide
• Pioglitazone
• Polythiazide
• Pramlintide
• Rosiglitazone
• Somatrogon-ghla
• Sparfloxacin
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Triamterene
• Trovafloxacin

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
• Albiglutide
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Dulaglutide
• Esmolol
• Exenatide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lixisenatide
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Rasagiline
• Safinamide
• Selegiline
• Semaglutide
• Sotalol
• Timolol
• Tranylcypromine

Other interactions—

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:

• Alcohol abuse or
• Cholelithiasis (gallstones), history of—May increase risk for pancreatitis.

• Dehydration or
• Gastroparesis (stomach does not empty food normally) or
• Kidney disease (eg, chronic renal failure), severe or
• Pancreatitis (inflammation of the pancreas), history of—Use with caution. May make these conditions worse.

• Hypoglycemia (low blood sugar)—Should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.

• Hypokalemia (low potassium in the blood)—May make this condition worse and increase your chance of having serious side effects.

Proper Use of This Medicine:

When you start using this medicine, it is very important that you check your blood sugar often, especially before and after meals and at bedtime. This will help lower the chance of having very low blood sugar.

A nurse or other trained health professional may give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin.

Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Each package of Soliqua® contains a patient information sheet. Read this sheet carefully and make sure you understand:

• How to prepare the medicine.
• How to inject the medicine.
• How to dispose of syringes, needles, and injection devices.

This medicine is given as a shot under the skin of your stomach, thighs, or upper arm. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.

Since this medicine lowers the blood glucose over 24 hours, it is best to use it at about the same time every day, usually within the hour before the first meal of the day.

Check the liquid in the pen. it should be clear and colorless. Do not use it if it is discolored or has particles in it.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Use a new needle each time you inject your medicine.

Never share medicine pens with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of infection.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For Type 2 diabetes:
    • Adults—Dose is based on your blood sugar and must be determined by your doctor.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store your new, unused medicine pen in the refrigerator, in the original carton, and protect it from light. Do not freeze this medicine, and do not use the medicine if it has been frozen. You may store the opened medicine pen at room temperature for 28 days. Replace the pen cap after each use to protect from light. Throw away any unused medicine after 28 days.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor will want to check your progress at regular visits, to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are taking insulin glargine and lixisenatide combination unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

• Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
• Keep an extra supply of Soliqua® and syringes with needles or injection devices on hand in case high blood sugar occurs.
• Keep some kind of quick-acting sugar handy to treat low blood sugar.
• Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

This medicine can cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use Soliqua® with other medicines, including insulin or sulfonylureas, that can lower blood sugar. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.

• Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
• If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms including seizures or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.

This medicine can cause low blood sugar. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine or insulin, changes in insulin regimen, you overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

• Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, trouble breathing (rapid and deep), unconsciousness, or unusual thirst.
• If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive the medicine.

Check with your doctor right away if you have confusion, decreased urination, diarrhea, dizziness, dry mouth, fainting, increase in heart rate, lightheadedness, nausea, vomiting, rapid breathing, sunken eyes, thirst, unusual tiredness or weakness, or wrinkled skin. These may be symptoms of a kidney problem.

Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause low levels of potassium in your blood. Do not use medicines, supplements, or salt substitutes that contain potassium unless you have discussed this with your doctor.

Using this medicine together with other diabetes medicine (eg, pioglitazone, rosiglitazone, Actos®, Actoplus Met®, Avandia®) may cause serious heart problem or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

Check with your doctor right away if you have gaseous stomach pain, indigestion, recurrent fever, severe nausea or vomiting, stomach fullness, or yellow eyes or skin. These may be symptoms of gallbladder problems (eg, cholelithiasis, cholecystitis).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

Incidence not known

Agitation

bloating

blurred vision

chest tightness

chills

cold sweats

cold, clammy skin

coma

confusion

constipation

cool, pale skin

cough

decreased urine output

difficulty swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

fainting

fast heartbeat

fast, weak pulse

fever

flushed, dry skin

fruit-like breath odor

gaseous stomach pain

headache

hives, itching, or rash

hostility

increased hunger

increase in heart rate

increased thirst

increased urination

indigestion

irregular heartbeat

irritability

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lethargy

lightheadedness

loss of appetite

muscle pain or cramps

muscle twitching

nausea or vomiting

nightmares

noisy breathing

numbness or tingling in the hands, feet, or lips

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

rapid breathing

rapid weight gain

seizures

slurred speech

stomach pain or fullness

stupor

sunken eyes

sweating

thirst

trouble breathing

unexplained weight loss

unusual tiredness or weakness

wrinkled skin

yellow eyes or skin

Some side effects 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:

More common

Body aches or pain

diarrhea

ear congestion

loss of voice

muscle aches

sneezing

sore throat

stuffy or runny nose

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.