Soliqua 100/33 (Subcutaneous)

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

Insulin glargine is a long-acting insulin that works slowly, for about 24 hours. Insulin is one of several hormones that help the body turn food into energy. It does this by using glucose (sugar) in the blood as quick energy. Insulin also helps store energy for later use. When you have diabetes mellitus, your body cannot make enough insulin or does not use insulin properly. This leads to high sugar levels in your blood. Like other types of insulin, insulin glargine is used to keep your blood sugar level close to normal. Lixisenatide is used when diet and exercise do not give good blood sugar control.

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

It is very important for your doctor to check your progress during regular visits to ensure that this medicine is working correctly. Blood and urine tests may be needed to look for any unwanted effects.

It is very important to carefully follow 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 while you are taking insulin glargine and lixisenatide combination unless your doctor has discussed them with you. 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 should learn how to prevent or help with side effects if they occur. Patients with diabetes may also need special counseling about changes in medicine dosing that might happen because of lifestyle changes, such as changes in exercise and diet. Additionally, counseling on contraception and pregnancy may be needed due to potential problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for emergencies as you normally would. Adjust 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 times when you need emergency help for a problem related to your diabetes. You need to be ready 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 states you have diabetes and lists all your medicines.
• Keep an extra supply of Soliqua® and syringes with needles or injection devices on hand in case of high blood sugar.
• Keep some quick-acting sugar available to treat low blood sugar.
• Have a glucagon kit along with a syringe and needle available in case of severe low blood sugar. Regularly check and replace any expired kits.

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

• Symptoms of low blood sugar include anxiety, behavior changes that resemble being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty thinking, drowsiness, excessive hunger, fast heartbeat, continuing headache, 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 drinks, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergencies when severe symptoms like seizures or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Family members 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, change your insulin regimen, overeat, 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, a fruity breath odor, increased urination (both frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea, vomiting, tiredness, rapid and deep breathing, 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 immediately if you have confusion, decreased urination, diarrhea, dizziness, dry mouth, fainting, increased 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 with other diabetes medicines (e.g., pioglitazone, rosiglitazone, Actos®, Actoplus Met®, Avandia®) may cause serious heart problems or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, experiencing chest pain or discomfort, extreme tiredness or weakness, trouble breathing, an uneven heartbeat, or excessive swelling of the hands, wrists, 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 yellowing of the eyes or skin. These may be symptoms of gallbladder problems (e.g., 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.

In deciding to use a medicine, you and your doctor should consider the risks and benefits. For this medicine, the following points should be thought about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have allergies to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on the effects of Soliqua® in children. Its safety and effectiveness are not known for this age group.

Geriatric

Studies so far have not shown any specific issues in older adults that would limit the usefulness of Soliqua®. However, older patients are more likely to experience age-related low blood sugar, which may require careful monitoring and possible dose adjustments for those using Soliqua®.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others can be used together even if there is a chance of interaction. In such cases, your doctor may adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are based on their potential importance and are not an exhaustive list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

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

Using this medicine with any of the following medicines may increase the risk of certain side effects, but both drugs may be necessary for the best treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

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

• Dehydration or
• Gastroparesis (slow stomach emptying) or
• Severe kidney disease (e.g., chronic renal failure) or
• Pancreatitis (pancreas inflammation), history of—Use with caution. May worsen these conditions.

• 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 drop to dangerously low levels.

• Hypokalemia (low potassium in the blood)—May worsen this condition and increase the risk of serious side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Soliqua 100/33

Available Dosage Forms:

• Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Long Acting

Find detailed information on biosimilars for this medication.

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.

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