BASAGLAR: Uses, Side Effects, and Important Information

BASAGLAR is a medication praised for its effectiveness and safety in managing diabetes across various types, including type 1, type 2, and gestational diabetes. It is often highly rated by healthcare providers for its role in controlling high blood sugar levels.

What is BASAGLAR?

BASAGLAR contains insulin glargine as its active ingredient, which is a long-acting human insulin analog. It is designed to provide a steady level of insulin over an extended period, typically 24 hours, to help manage blood sugar levels between meals and during the night.

Available Forms

BASAGLAR is available as a sterile, clear solution for subcutaneous injection. It comes in two forms:

  • A 10 mL vial
  • A 3 mL prefilled pen (Insulin Glargine Solostar or KwikPen)

Each mL of BASAGLAR contains 100 units of insulin glargine, along with other ingredients like glycerol, m-cresol, zinc, and water. The vial also contains polysorbate 20. The BASAGLAR KwikPen is a disposable, prefilled insulin pen.

Intended Use

BASAGLAR is a long-acting insulin indicated to control high blood sugar in adults and children with type 1 diabetes and adults with type 2 diabetes. It is not intended for the treatment of diabetic ketoacidosis.

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How to Use BASAGLAR

Administration

BASAGLAR is administered via subcutaneous injection, meaning it is injected under the skin. It is crucial to follow the directions provided by your healthcare team. They will guide you on how to adjust doses for activity and illness.

Important Instructions

  • Check the Label: Always ensure you have the correct insulin and supplies.
  • Inspect the Insulin: Before each use, check the appearance of the insulin. It should be clear and colorless, like water. Do not use it if it is thick, cloudy, or colored.
  • Injection Site: Choose an injection site on the stomach, upper arms, or upper legs (thighs). Avoid injecting into skin that is thickened, irritated, or has pits or lumps.
  • Rotate Injection Sites: Keep a chart of the areas you have injected and rotate your injection site to prevent skin changes.
  • Needle Disposal: Dispose of used needles and syringes in a special sharps container. Do not discard them in a regular trash can.
  • Instructions for Use: This medication comes with detailed INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication and read the information carefully.

Dosage and Timing

BASAGLAR should be taken once a day at the same time every day. It starts to work several hours after injection and keeps working evenly for 24 hours. Test your blood sugar levels while using insulin. Do not make any changes to your dose or type of insulin without talking to your healthcare provider.

Important Considerations

  • Do NOT dilute or mix BASAGLAR with any other insulin or solution. It will not work as intended, and you may lose blood sugar control, which could be serious.
  • BASAGLAR must only be used if the solution is clear and colorless with no particles visible.
  • Never share insulin pens or cartridges with anyone, even if the needle is changed. Each pen should only be used by one person to prevent the risk of infection.
  • Do not use a syringe to take insulin out of an insulin pen, as this may result in an incorrect dose.

Missed Dose

It is important to follow your insulin routine as directed. If you miss a dose, talk to your care team. They can help you adjust your dosing routine. Do not take double doses.

Overdosage

If you think you have taken too much of this medicine, contact a poison control center or emergency room at once.

Storage

Proper storage of BASAGLAR is essential to maintain its effectiveness.

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Unopened (Not In-Use) Pens

  • Store at room temperature up to 30 degrees C (86 degrees F) for up to 28 days or refrigerated until the expiration date.

Opened (In-Use) Pens

  • Store at room temperature up to 30 degrees C (86 degrees F) for up to 28 days. Do not refrigerate.

General Storage Guidelines

  • Keep out of the reach of children and pets.
  • Do not freeze.
  • Protect from direct light and heat.
  • Do not use insulin if it is exposed to temperatures above 37 degrees C (98.6 degrees F).
  • Do not use insulin if it has been frozen.
  • Do not store an injection pen with the needle attached.

Disposal

To get rid of medications that are no longer needed or have expired:

  • Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
  • If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

Potential Side Effects

Like all medications, BASAGLAR can cause side effects. It is important to be aware of these and to discuss any concerns with your healthcare provider.

Common Side Effects

Some of the more common side effects reported by people who took BASAGLAR in clinical trials include:

  • Injection site reactions, such as pain, itching, swelling, or irritation where you inject the drug
  • Swelling in the feet or lower legs due to fluid buildup
  • Low blood sugar (hypoglycemia)
  • Skin rash
  • Weight gain
  • Skin changes at injection sites (lipodystrophy)

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Serious Side Effects

Serious side effects are less common but require immediate medical attention. These include:

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  • Allergic Reactions: Symptoms include skin rash, itching, hives, swelling of the face, lips, tongue, or throat. Anaphylaxis has been reported.
  • Low Blood Sugar (Hypoglycemia): Symptoms include tremors or shaking, anxiety, sweating, cold or clammy skin, confusion, dizziness, rapid heartbeat. Severe hypoglycemia can lead to seizures, loss of consciousness, or coma.
  • Low Potassium Level (Hypokalemia): Symptoms include muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation.
  • Heart Failure: Can occur if you are taking insulin together with medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems.

If you develop serious side effects while taking BASAGLAR, call your doctor right away. If the side effects seem life-threatening, immediately call 911 or your local emergency number.

Other Possible Side Effects

  • Lipodystrophy-hardening or scarring of tissue at injection site
  • Pain, redness, or irritation at injection site
  • Weight gain
  • Localized cutaneous amyloidosis at the injection site has occurred and hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis.
  • Insulin may cause sodium retention and edema, especially as metabolic control is improving.

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.

Side Effects in Children

BASAGLAR is approved for use in children ages 6 years and older with type 1 diabetes. The side effects of the drug in children are similar to those in adults. However, children are more likely to have hypoglycemia (low blood sugar) with BASAGLAR, and this side effect is more likely to be severe in children.

Precautions

Before taking BASAGLAR, inform your healthcare team about any existing medical conditions and medications you are taking.

Medical Conditions

They need to know if you have any of these conditions:

  • Kidney disease
  • Liver disease
  • Frequent episodes of low blood sugar
  • Vision problems
  • An unusual or allergic reaction to insulin, other medications, foods, dyes, or preservatives

Pregnancy and Breastfeeding

Inform your healthcare provider if you are pregnant, trying to get pregnant, or breastfeeding.

Interactions

Some medications may affect your blood sugar levels or hide the symptoms of low blood sugar (hypoglycemia). Talk with your care team about all of the medications you take. They may suggest changes to your insulin dose or checking your blood sugar levels more often.

Medications That May Affect Blood Sugar Levels

  • Alcohol
  • Certain antibiotics, such as ciprofloxacin, levofloxacin, sulfamethoxazole; trimethoprim
  • Certain medications for blood pressure or heart disease, such as benazepril, enalapril, lisinopril, losartan, valsartan
  • Certain medications for mental health conditions, such as fluoxetine or olanzapine
  • Diuretics, such as hydrochlorothiazide (HCTZ)
  • Estrogen and progestin hormones
  • Other medications for diabetes
  • Steroid medications, such as prednisone or cortisone
  • Testosterone
  • Thyroid hormones

Medications That May Mask Symptoms of Low Blood Sugar

  • Beta blockers, such as atenolol, metoprolol, propranolol
  • Clonidine
  • Guanethidine
  • Reserpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Monitoring and Follow-Up

Regular health checks are essential while using BASAGLAR.

Blood Work

You may need blood work done while you are taking this medication. Your care team will monitor your HbA1C (A1C). This test shows what your average blood sugar level was over the past 2 to 3 months.

Important Reminders

  • This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you.
  • Learn how to check your blood sugar. Know the symptoms of low and high blood sugar and how to manage them.
  • Always carry a source of quick sugar with you. Examples include hard sugar candy or glucose tablets.
  • Tell your care team if you have high blood sugar. Your medication dose may change if your body is under stress.
  • Do not skip meals. Ask your care team if you should avoid alcohol.
  • Do not change the brand or type of insulin unless your care team tells you to.
  • Always keep an extra supply of insulin and related supplies on hand.
  • Wear a medical ID bracelet or chain. Carry a card that describes your condition.

Additional Information

Basaglar vs. Lantus

BASAGLAR is a follow-on insulin to Lantus®. It is a long-acting insulin with an amino acid sequence identical to Lantus, another U-100 insulin glargine. While both contain insulin glargine, BASAGLAR is not a biosimilar, according to the FDA. This means your doctor will need to write a prescription for one or the other, as they cannot be substituted at the pharmacy.

Injection Sites

Insulin can be injected into the stomach area (except for a 2-inch circle around the navel), the top and outer part of your thighs (but not your inner thighs or anywhere close to your knee), and the outer back of your upper arm where there is a pocket of fatty tissue.

Travel Tips

Keep a recent prescription and your medical history with you when you travel. Be prepared for emergencies and make allowances for changing time zones. Keep your meal times as close as possible to your usual meal times.

Emergency Preparedness

Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines. Keep an extra supply of insulin glargine and syringes with needles or injection devices on hand in case high blood sugar occurs. Keep some kind of quick-acting sugar handy to treat low blood sugar. Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

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