SEMGLEE (insulin glargine-yfgn)

SEMGLEE is man-made insulin used to control high blood sugar in adults with diabetes mellitus.

• SEMGLEE should not be used to treat diabetic ketoacidosis.

• It is not known if SEMGLEE is safe to use in children less than 6 years of age with type 1 diabetes

• It is not known if SEMGLEE is safe to use in children with type 2 diabetes.

Do not use SEMGLEE if you:

• are having an episode of low blood sugar (hypoglycemia).

• have an allergy to insulin glargine products or any of the ingredients in SEMGLEE.

Before using SEMGLEE, tell your doctor about all your medical conditions including if you:

• have liver or kidney problems.

• take other medicines, especially ones called thiazolidinediones (TZDs).

• have heart failure or heart problems. If you have heart failure, it may get worse while you take TZDs with SEMGLEE.

• are pregnant or planning to become pregnant. It is not known if SEMGLEE can harm your unborn baby.

• are breastfeeding or planning to breastfeed. It is not known if SEMGLEE can pass into your breast milk.

Tell your doctor about all the medicines you take including prescriptions, over-the-counter medicines, vitamins, and herbal supplements.

Before you start using SEMGLEE, talk to your doctor about low blood sugar and how to manage it.

• Use SEMGLEE exactly as your doctor tells you to. Your doctor should tell you how much SEMGLEE to use and when to use it.

• Know the amount of SEMGLEE you use. Do not change the amount of SEMGLEE you use unless your doctor tells you to.

• Check your insulin label each time you give yourself an injection to make sure you are using the correct insulin.

• Do not re-use needles.

• You may take SEMGLEE at any time during the day but take it at the same time every day.

• Only use SEMGLEE if it is clear and colorless. If your SEMGLEE is cloudy or slightly coloured, return it to your pharmacy for a replacement.

• SEMGLEE is injected under the skin of your upper legs (thighs), upper arms, or stomach area (abdomen).

• Do not use SEMGLEE in an insulin pump or inject SEMGLEE into your vein.

• Change injection sites within the area you chose with each dose to reduce your risk of getting lipodystrophy (pits in the skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
  • Do not use the exact same spot for each injection.
  • Do not inject where the skin has lumps or pits.
  • Do not inject where the skin is bruised, scaly, tender, or hard, or into scars or damaged skin.

• Do not mix SEMGLEE with any other type of insulin or liquid medicine.

• Check your blood sugar levels. Ask your doctor what your blood sugar should be and when you should check your blood sugar levels.

Your dose of SEMGLEE may need to change because of:

a change in the level of exercise or physical activity, weight gain or loss, illness, increased stress, change in diet, or because of the medicines you take.

While using SEMGLEE do not:

• drive or operate heavy machinery, until you know how SEMGLEE affects you.

• drink alcohol or use over-the-counter medicines that contain alcohol.

The most common side effects of SEMGLEE include:

low blood sugar, allergic reactions, weight gain, including reactions at your injection site, skin thickening, or pits at the injection site.

SEMGLEE may cause serious side effects that can lead to death, including:

• Low blood sugar or hypoglycemia: Signs and symptoms that may indicate low blood sugar include:
  • dizziness or light-headedness, sweating, fast heartbeat, anxiety, confusion, headache, blurred vision, irritability or mood change, slurred speech, shakiness, and hunger.

• Severe allergic reaction: Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
  • a rash over your whole body, a fast heartbeat, trouble breathing, or sweating.

• Hypokalemia (low potassium in your blood): SEMGLEE may cause hypokalemia.

• Heart failure: Taking certain diabetes pills called thiazolidinediones with SEMGLEE may cause heart failure in some people. This can also happen even if you have never had heart failure or heart problems. Your doctor should monitor you closely while you are taking TZDs with SEMGLEE. Tell your doctor if you have any new or worse symptoms of heart failure including:
  • shortness of breath, swelling of your ankles or feet, sudden weight gain.

• Treatment with TZDs and SEMGLEE may need to be changed or stopped by your doctor if you have new or worse heart failure.

• Get emergency medical help if you have:
  • trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, and confusion.

Antidiabetic agents, ACE inhibitors, disopyramide, angiotensin II receptor blocking agents, fibrates, fluoxetine, pentoxifylline, pramlintide, monoamine oxidase inhibitors, salicylates, somatostatin analogs, and sulfonamide antibiotics

Atypical antipsychotics, corticosteroids, protease inhibitors, somatropin, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, danazol, diuretics, progestogens (e.g., in oral contraceptives), sympathomimetic agents, and thyroid hormones.

clonidine, alcohol, beta-blockers, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

Clonidine, beta-blockers, guanethidine, and reserpine.

Excess insulin administration may cause hypoglycemia and hypokalemia.

Do not freeze SEMGLEE. Discard SEMGLEE if it has been frozen. Protect SEMGLEE from direct heat and light.

Active ingredient: insulin glargine-yfgn
10 mL vial inactive ingredients: glycerol, polysorbate-20, metacresol, zinc chloride, and Water for Injection. Hydrochloric acid and sodium hydroxide may be added to adjust the pH