Basaglar

Basaglar is a prescription medication used to improve blood sugar control in people with type 1 and type 2 diabetes. Basaglar belongs to a group of drugs called long-acting insulins. These work by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy.

This medication is available in an injectable from to be given directly under the skin (subcutaneously) once a day.

Common side effects of Basaglar include hypoglycemia (low blood sugar), allergic reactions, and injection site reactions.

Basaglar is a prescription medication used to improve blood sugar control in people with type 1 and type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Eli Lilly and Company

Serious side effects have been reported with Basaglar. See the "Drug Precautions" section.

Common side effects of Basaglar include the following:

• hypoglycemia (low blood sugar)
• allergic reactions
• injection site reactions
• lipodystrophy (pitting at the injection site)
• itching
• rash
• edema (fluid retention)
• weight gain

This is not a complete list of Basaglar side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antidiabetic medication
• angiotensin-converting enzyme (ACE) blockers such as
  • benazepril (Lotensin, Lotensin HCT)
  • captopril (Capoten, Capozide)
  • enalapril (Vasotec, Vaseretic)
  • fosinopril (Monopril, Monopril HCT)
  • lisinopril (Prinivil, Prinzide, Zestril, Zestoretic)
  • moexipril (Univasc, Uniretic)
  • quinapril (Accupril, Accuretic, Quinaretic)
  • ramipril (Altace)
  • trandolapril (Mavik, Tarka)
• angiotensin receptor II blockers such as
  • azilsartan (Edarbi)
  • candesartan (Atacand)
  • irbesartan (Avapro)
  • losartan (Cozaar)
  • olmesartan (Benicar)
  • telmisartan (Micardis, Twynsta)
  • valsartan (Diovan)
• disopyramide (Norpace)
• fibrates such as  gemfibrozil (Lopid) and  fenofibrate (TriCor)
• fluoxetine (Prozac)
• monoamine oxidase inhibitors such as
  • isocarboxazid (Marplan)
  • phenelzine (Nardil)
  • tranylcypromine (Parnate)
  • selegiline (Emsam, Eldepryl, Zelapar)
  • rasagiline (Azilect)
• pentoxifylline (Pentoxil)
• pramlintide (Symlin)
• propoxyphene (Darvon)
• salicylates such as aspirin (Bayer Aspirin) and diflunisal (Dolobid)
• octreotide (Sandostatin)
• sulfonamides such as trimethoprim/sulfamethoxazole (Septra, Bactrim), sulfasalazine (Azulfidine), dapsone (DDS), hydrochlorothiazide (Microzide), sumatriptan (Imitrex, Sumavel Dosepro), zonisamide (Zonegran), acetazolamide (Diamox), and celecoxib (Celebrex)
• atypical antipsychotics (olanzapine and clozapine)
• steroids such as prednisone (Cortan, Deltasone, Orasone, Sterapred), budesonide (Entocort), dexamethasone (Decadron), triamcinolone (Kenacort, Aristocort), flunisolide (AeroBid. Aerospan), ciclesonide (Alvesco), mometasone (Asmanex, Dulera), fluticasone (Flovent), methylprednisolone (Medrol, Solu-Medrol), fludrocortisone (Florinef), and hydrocortisone (Cortef, Cortril, Hydrocortone)
• danazol (Danocrine)
• diuretics such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), torsemide (Demadex), triamterene (Dyrenium)
• estrogens
• glucagon
• isoniazid
• niacin
• oral contraceptives
• phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), fluphenazine (Prolixin), perphenazine (Triavil), prochlorperazine (Compazine), and trifluoperazine (Stelazine)
• progestogens (e.g., in oral contraceptives)
• protease inhibitors
• somatropin (Genotropin)
• sympathomimetic agents such as albuterol, epinephrine, and terbutaline
• thyroid hormones such as levothyroxine (Synthroid, Levothroid, Levoxyl)
• alcohol
• beta blockers such as
  • metoprolol (Toprol XL, Lopressor)
  • carvedilol (Coreg)
  • bisoprolol (Zebeta)
  • betaxolol (Kerlone)
  • nebivolol (Bystolic)
  • propranolol (Inderal, Pronol)
• clonidine (Catapres)
• lithium salts
• pentamidine
• guanethidine (Ismelin)
• reserpine

This is not a complete list of Basaglar drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Basaglar, including:

• transmission of diseases transmitted through blood when sharing the same Basaglar Kwikpen between patients. Never share a Basaglar KwikPen between patients.
• hyperglycemia (high blood sugar) with changes in insulin regimen. Tell your healthcare provider right away if you have some or all of the following symptoms of hyperglycemia:
  • excessive thirst
  • excessive urination
  • increased urination at night
  • blurry vision
  • sores that won’t heal
  • fatigue
  • difficulty concentrating
  • frequent urination
  • headaches
  • high blood glucose
  • high levels of sugar in the urine
  • increased fatigue
  • increased thirst
  • weight loss
• hypoglycemia (low blood sugar). Tell your healthcare provider right away if you have some or all of the following symptoms of hypoglycemia:
  • shakiness
  • nervousness or anxiety
  • sweating, chills and clamminess
  • irritability or impatience
  • confusion, including delirium
  • rapid/fast heartbeat
  • lightheadedness or dizziness
  • hunger and nausea
  • sleepiness
  • blurred/impaired vision
  • tingling or numbness in the lips or tongue
  • headaches
  • weakness or fatigue
  • anger, stubbornness, or sadness
  • lack of coordination
  • nightmares or crying out during sleep
  • seizures
  • unconsciousness
• medication errors. Take extra precautions against mixing up Basaglar with other insulin products.
• allergic reaction. Tell your healthcare provider right away if you have some or all of the following symptoms of an allergic reaction:
• hypokalemia (low potassium in the blood). Tell your healthcare provider right away if you have some or all of the following symptoms of hypokalemia:
  • constipation
  • feeling of skipped heart beats or palpitations
  • fatigue
  • muscle damage
  • muscle weakness or spasms
  • tingling or numbness
• fluid retention and heart failure when taken with PPAR-gamma Agonists. Tell your healthcare provider right away if you have some or all of the following symptoms of fluid retention or heart failure:
  • swollen ankles, legs, abdomen and weight gain.
  • increased need to urinate during the night.
  • loss of appetite or nausea
  • shortness of breath with exercise
  • difficulty breathing at rest or when lying flat in bed
  • dizziness, fatigue, and weakness
  • rapid or irregular heartbeats

Do not use Basaglar if you: 

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to insulin glargine or any of the ingredients in Basaglar. See the end of this Patient Information leaflet for a complete list of ingredients in Basaglar.

While using Basaglar do not: 

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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Basaglar, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Basaglar, tell your healthcare provider about all your medical conditions, especially if you: 

• have liver or kidney problems.
• take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Basaglar.
• are pregnant, planning to become pregnant, or are breastfeeding. It is not known if Basaglar may harm your unborn or breastfeeding baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Before you start using Basaglar, talk to your healthcare provider about low blood sugar and how to manage it.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Basaglar falls into category C.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Basaglar crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Basaglar.

• Inject Basaglar exactly as prescribed.
• Read the detailed Instructions for Use that come with your Basaglar.
• Use Basaglar exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Basaglar to use and when to use it.
• Know the amount of Basaglar you use. Do not change the amount of Basaglar you use unless your healthcare provider tells you to.
• Check your insulin label each time you give your injection to make sure you are using the correct insulin.
• Basaglar may be used at any time during the day, but Basaglar should be used at the same time each day.
• Only use Basaglar that is clear and colorless. If your Basaglar is cloudy or slightly colored, return it to your pharmacy for a replacement.
• Basaglar is injected under your skin (subcutaneously). Do not use Basaglar in an insulin pump or inject Basaglar into your vein (intravenously).
• Change (rotate) your injection sites within the area you chose with each dose. Do not use the exact spot for each injection.
• Do not mix Basaglar with any other type of insulin.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.
• Do not share your Basaglar with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose range of Basaglar for the treatment of diabetes is 1 to 80 units per injection into the abdominal area, thigh, or deltoid.

If you take too much Basaglar, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

When you get your prescription, store unused Pens in your fridge at 36°F to 46°F (2°C to 8°C). Don't freeze your Pen or use it if it's been frozen. Once you begin injecting with a Pen, store it at room temperature up to 86°F (30°C) and throw it away after 28 days.

Basaglar must be protected from direct heat and light.

Do not use after the expiration date