REZVOGLAR (insulin glargine-aglr) for Diabetes

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

• REZVOGLAR should not be used to treat diabetic ketoacidosis.

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

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

Do not use REZVOGLAR if you:

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

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

Before using REZVOGLAR, 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 REZVOGLAR.

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

• are breastfeeding or planning to breastfeed. if REZVOGLAR 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 REZVOGLAR, talk to your doctor about low blood sugar and how to manage it.

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

• You should know the amount of REZVOGLAR you use. Do not change the amount of REZVOGLAR 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.

• REZVOGLAR comes in the form of a KwikPen single-patient-use prefilled pen that you must use to give your REZVOGLAR.

• The dose indicator on your KwikPen pen shows your dose of REZVOGLAR. Do not make any dose changes unless your doctor tells you to.

• Do not use a syringe to remove REZVOGLAR from your KwikPen disposable prefilled pen.

• Do not re-use needles.

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

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

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

• Change (rotate) your injection sites within area you chose with each dose to reduce your risk of getting lipodystrophy (pits in 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 pits, thickened, or lumps.
  • Do not inject where the skin is tender, bruised, scaly, or hard, or into scars or damaged skin.

• Do not mix REZVOGLAR 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.

• Keep REZVOGLAR out of the reach of children.

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

While using REZVOGLAR do not:

• drive or operate heavy machinery, until you know how REZVOGLAR affects you.
• drink alcohol or use over-the-counter medicines that contain alcohol.

The most common side effects of REZVOGLAR include:

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

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

• Low blood sugar (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): REZVOGLAR may cause hypokalemia.

• Heart failure: Taking certain diabetes pills called TZDs (thiazolidinediones) with REZVOGLAR 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 REZVOGLAR. 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 REZVOGLAR 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 REZVOGLAR.

• Discard REZVOGLAR if it has been frozen.

• Protect REZVOGLAR from direct heat and light.

Active ingredient: insulin glargine-aglr
Inactive ingredients: glycerin, m-cresol, Water for Injection, zinc, USP Hydrochloric acid, and/or sodium hydroxide may be added to adjust the pH.