Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Soliqua Solostar. If you are concerned about side effects, discuss the risks and benefits of Soliqua Solostar with your doctor.

The following side effects have been reported by at least 1% of people taking Soliqua Solostar. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• back pain
• bruising, itching, redness, or pain at the injection area
• cough
• Diarrhea
• dizziness
• headache
• mild Hypoglycemia (e.g., fast heartbeat, feeling faint, hunger, sweating)
• nausea
• runny nose or nasal congestion
• sore throat
• toothache
• vomiting
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• falls
• flu-like symptoms (e.g., Fever, tiredness, body aches)
• muscle pain
• nervousness
• pain with urination
• respiratory tract infections or inflammation (e.g., cough with mucous, fatigue, chest discomfort/pain, fever and chills, sweating, shortness of breath)
• skin changes at the injection site (lumps or small dents in the skin)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of severe hypoglycemia (low blood sugar; mood changes, vision changes, confusion, dizziness, loss of consciousness)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Soliqua Solostar.

Each 1 mL of clear and colourless, preservative free, sterile solution, contains 100 units insulin glargine and 33 µg of lixisenatide. Each unit dialed on the prefilled pen contains 1 unit of insulin glargine and 0.33 µg of lixisenatide. Nonmedicinal ingredients: glycerol, methionine, metacresol (2.7 mg/mL), zinc chloride, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injection.

Do not take Soliqua Solostar if you:

• are allergic to insulin glargine, lixisenatide, or any ingredients of the medication
• have a personal or family history of medullary Thyroid cancer
• have a condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• are experiencing low blood glucose
• are pregnant
• are breastfeeding

There may be an interaction between insulin glargine-lixisenatide and any of the following:

• Acarbose
• Acetaminophen
• acetylsalicylic acid (Asa)
• alcohol
• androgens (e.g., testosterone)
• angiotensin converting enzyme inhibitors (ACEIs; Ramipril, Lisinopril)
• antiarrhythmics (e.g., Amiodarone, Disopyramide, procainamide, quinidine)
• antibiotics
• Atorvastatin
• atypical antipsychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• Basiliximab
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• birth control pills
• fast acting bronchodilators (e.g., salbutamol, terbutaline)
• long acting bronchodilators (e.g., formoterol, salmeterol)
• Buserelin
• caffeine
• chloroquine
• clarithromycin
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Danazol
• decongestant cold medications (e.g., phenylephrine, Pseudoephedrine)
• other diabetes medications (e.g., Canagliflozin, Glyburide, insulin, Linagliptin, Liraglutide, Rosiglitazone)
• Digoxin
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Epinephrine
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• Fenofibrate
• Gemfibrozil
• glucagon
• Goserelin
• Hepatitis C antivirals (e.g., elbasvir, grazoprevir, ledipasvir, sofosbuvir, velpatasvir)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hydroxychloroquine
• isoniazid
• Lanreotide
• lithium
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Niacin
• Nilotinib
• Octreotide
• Pasireotide
• Pegvisomant
• pentamidine
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Sirolimus
• Somatropin
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• Sunitinib
• Tacrolimus
• Tramadol
• Venetoclax
• Vorinostat
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Soliqua Solostar. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Soliqua Solostar.

Allergic reactions: In rare cases, some people may develop an allergic reaction to Soliqua Solostar. Signs of an allergic reaction include a severe rash, Hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately.

Blood glucose monitoring: It is important for anyone using insulin to monitor their blood glucose levels regularly, as recommended by their doctor or diabetes educator. It is especially important to test blood glucose more often when your insulin dose or schedule changes, or when you are ill or under stress. If blood tests consistently show high or low blood glucose levels, contact your doctor or diabetes educator.

Diabetes identification: It is important to either wear a bracelet (or necklace) or carry a card indicating you have diabetes and are taking medication to manage your blood glucose levels.

Heart problems: Insulin glargine-lixisenatide may increase heart rate and may affect how electrical impulses travel through the heart muscle, causing changes to heart rhythm. It can cause fluid to build up in the body and can contribute to heart failure. If you have heart disease (e.g., recent Heart Attack, Angina, heart failure) or an abnormal heart rhythm (e.g., heart block or fast heart rate), discuss with your doctor how Soliqua Solostar may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Soliqua Solostar, and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

Changes at injection site: Fatty tissue under the skin at the injection site may shrink or thicken if you inject yourself too often at the same site. To help avoid this effect, change the site with each injection. Talk to your doctor or diabetes educator if you notice your skin pitting or thickening at the injection site.

Intestinal problems: The safety and effectiveness of using Soliqua Solostar for people with inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or who have slowed movement through the intestinal tract due to diabetes have not been established. If you have digestive system problems, discuss with your doctor how Soliqua Solostar may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Soliqua Solostar, and whether any special monitoring is needed.

Dehydration: Medications like lixisenatide can cause digestive system upset such as nausea, vomiting, and diarrhea. These effects can increase the risk of becoming dehydrated. If you experience digestive system side effects with insulin glargine - lixisenatide, make sure to drink enough fluids to replace what you are losing, to prevent dehydration. If you experience symptoms of dehydration, such as thirst, decreased urine or tear production, dizziness, or Headaches, contact your doctor.

Drowsiness/reduced alertness: Insulin glargine-lixisenatide may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how Soliqua Solostar affects you.

Kidney function: The safety and effectiveness of using Soliqua Solostar for people with reduced kidney function has not been studied. Ensure that you are drinking enough water to prevent dehydration if you experience nausea or vomiting with Soliqua Solostar. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Soliqua Solostar may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Soliqua Solostar, and whether any special monitoring is needed.

Liver function: People with decreased liver function or liver disease may require lower doses of insulin to control blood glucose. If you have reduced liver function or liver disease, discuss with your doctor how Soliqua Solostar may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Soliqua Solostar, and whether any special monitoring is needed.

Low blood glucose (hypoglycemia): People who use insulin are more at risk of experiencing hypoglycemia (low blood sugar). Symptoms of mild-to-moderate hypoglycemia may occur suddenly and can include cold sweat, nervousness or shakiness, fast heartbeat, headache, hunger, confusion, lightheadedness, weakness, and numbness or tingling (tongue, lips, or fingers).

Mild-to-moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. You should always carry a quick source of sugar, such as hard candies, glucose tablets, juice, or regular soft drinks (not diet soft drinks). If you experience symptoms of hypoglycemia, eat one of these sources of sugar and then rest. If you feel symptoms of hypoglycemia coming on, don't take insulin.

Signs of severe hypoglycemia can include disorientation, loss of consciousness, and seizures. People who are unable to take sugar by mouth or who are unconscious may require an injection of Glucagon or treatment with intravenous (into the vein) glucose.

Pancreatitis (inflammation of the pancreas): Pancreatitis has been associated with the medication lixisenatide. If you experience symptoms of pancreatitis such as severe and persistent abdominal pain that may move to the back with or without vomiting, contact your doctor immediately. If you have previously had pancreatitis, discuss with your doctor how Soliqua Solostar may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Soliqua Solostar, and whether any special monitoring is needed.

Risk of thyroid cancer: In rare cases, people have developed thyroid cancer while using medications similar to lixisenatide. People with a personal or family history of thyroid cancer or people who have multiple endocrine neoplastic syndrome type 2 (a disease where people have tumors in more than one gland in their body) should not use Soliqua Solostar.

Pregnancy: Soliqua Solostar should not be used during pregnancy. If you become pregnant while taking Soliqua Solostar, contact your doctor immediately.

Breast-feeding: It is not known if insulin glargine-lixisenatide passes into breast milk. If you are breast-feeding and are taking Soliqua Solostar, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Soliqua Solostar have not been established for children.

Seniors: People over the age of 65 are more likely to experience side effects of taking insulin glargine-lixisenatide. Doses for seniors may need to be lower and increased more slowly than for other adults.