Soliqua Solostar

The recommended starting dose of insulin glargine-lixisenatide depends on your previous dose of insulin. Starting doses are usually either 15 units (15 units insulin glargine/5 µg lixisenatide) or 30 units (30 units insulin glargine/10 µg lixisenatide) injected once daily.

Insulin glargine-lixisenatide should be injected subcutaneously (under the skin) of the thigh, upper arm, or abdomen, once daily within 1 hour before your first meal of the day. Do not inject it into a vein or muscle. Do not use Soliqua Solostar in an insulin pump.

Depending on your body's needs and blood glucose monitoring, your doctor or diabetes educator will help you adjust your dose until your fasting blood glucose is appropriate for you. Your doctor or diabetes educator will determine the appropriate dose for you according to various lifestyle factors and the blood glucose values obtained while monitoring your blood glucose. The maximum daily dose is 60 units of insulin glargine/20 µg of lixisenatide daily.

If you need less than 15 units or more than 60 units of Soliqua Solostar to control your blood glucose, contact your doctor.

If you are unsure how to use the prefilled injection pen or Soliqua Solostar, ask your doctor, pharmacist, or diabetes educator to show you. Don't use Soliqua Solostar until you know how to administer it.

Insulin glargine-lixisenatide should be clear and colourless. Do not use Soliqua Solostar if you notice anything unusual in the appearance of the solution, such as cloudiness, discolouration, or clumping. It is not necessary to shake or rotate the vial before use. It should not be mixed with any other insulins or solutions.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Soliqua Solostar exactly as prescribed by your doctor. If you miss a dose, inject within the hour before your next meal and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store unopened prefilled pens in the original cartons, in the refrigerator. Protect from light and do not allow to freeze. Once a pen has been opened, keep it at room temperature and protect it from light. After first use, a pen may be used for 28 days. Discard any solution that remains in the pen after this time, or if the pen is frozen or exposed to excessive heat.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause diarrhea; it may cause nausea or, rarely, vomiting; it may cause low blood sugar levels, which could make you feel dizzy, shaky or weak. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

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.

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Use it regularly and continuously to maintain its beneficial effects. Insulin users should be aware of the symptoms of low blood sugar, which include confusion, headache, hunger, mood changes, palpitations, rapid breathing, cold sweats and shakiness. These symptoms require immediate treatment, to bring your blood sugar back up to a safe level. This can be done with a quick source of sugar, such as: 4 or 5 glucose tablets 59 to 79 mL of liquid glucose 15 to 20 mL (3 or 4 teaspoons) of honey, maple syrup or corn syrup 6 to 8 LifeSavers type candies 150 to 200 mL (2/3 to 3/4 cup) of fruit juice or regular soft drink (not a diet soft drink) 4 or 5 packets of white sugar (3 or 4 teaspoons) dissolved in water Inform your health care professional if these symptoms have occurred, as it may mean that your diet and/or medication needs to be adjusted.<br/><br/>Insulin users must check their blood sugar levels regularly using an appropriate device. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this. This medication must be taken within 60 minutes prior to a meal. If a dose is missed, the injection should be administered within one hour prior to the next meal. Do not administer more than one dose daily. In order not to cause hypoglycemia, avoid excessive alcohol consumption. Do not drink alcohol on an empty stomach.