Basaglar

Primary Uses

Basaglar is a long-acting (basal) insulin glargine used to manage blood sugar levels in patients with diabetes mellitus. It is typically prescribed for:

• Type 1 diabetes: For use in adults and pediatric patients (children aged 6 years and older).
• Type 2 diabetes: For use in adults to improve glycemic control.

Because it is a long-acting insulin, it provides a steady level of insulin in the body for about 24 hours. It is often used in combination with a shorter-acting insulin or other diabetes medications to provide comprehensive blood sugar management throughout the day.

Important Considerations

Basaglar is not used to treat diabetic ketoacidosis, which is a serious complication of diabetes that requires rapid-acting insulin treatment in a medical setting.

Regulating Blood Sugar

Basaglar works by replacing the insulin that the body would normally produce. Insulin is a hormone that allows sugar (glucose) in the blood to enter cells throughout the body, where it is used for energy. By facilitating this process, Basaglar helps lower blood sugar levels in people with diabetes.

Liver and Fat Regulation

In addition to helping cells absorb sugar, this medication also signals the liver to stop producing more sugar. It also helps prevent the breakdown of fat and protein, further stabilizing glucose levels in the bloodstream.

Long-Acting Mechanism

Basaglar is classified as a basal, or long-acting, insulin. Unlike rapid-acting insulins that work quickly around mealtimes, Basaglar is designed to be absorbed slowly into the bloodstream. This slow release provides a relatively constant level of insulin for about 24 hours, often referred to as a peakless profile. This helps maintain stable blood sugar levels between meals and overnight.

Common Side Effects

The most frequent side effect of Basaglar is low blood sugar (hypoglycemia). Other common side effects may include:

• Weight gain
• Swelling in the hands, ankles, or feet
• Injection site reactions, such as redness, itching, or pain
• Skin changes where the injection is given, such as thickening or pits (lipodystrophy)
• Symptoms of a cold or upper respiratory infection

Serious Side Effects

Some side effects can be severe and require immediate medical attention. These include:

• Severe low blood sugar, which can lead to confusion, dizziness, blurred vision, or fainting
• Severe allergic reactions, which may involve a widespread rash, trouble breathing, or swelling of the face, tongue, or throat
• Low potassium levels (hypokalemia), which can cause muscle weakness, cramps, or an irregular heartbeat
• Heart failure symptoms, such as shortness of breath, swelling of the ankles or feet, or sudden weight gain, especially when used with certain other diabetes drugs called thiazolidinediones (TZDs)

Never Share Injection Pens

Basaglar KwikPens or needles must never be shared between people, even if the needle has been changed. Sharing these devices poses a risk for transmitting blood-borne pathogens, such as hepatitis or HIV.

Hypoglycemia (Low Blood Sugar)

Low blood sugar is the most common side effect of insulin therapy and can be life-threatening if not managed. Changes in insulin regimen, strength, manufacturer, type, or method of administration may affect blood sugar control and increase the risk of hypoglycemia. Monitoring blood glucose is essential for all patients using insulin.

Hypokalemia (Low Potassium)

All insulin products, including Basaglar, cause a shift in potassium from the blood into the cells, which may lead to low potassium levels in the blood. If left untreated, this can cause respiratory issues, heart rhythm problems, and death. Monitoring potassium levels may be necessary for patients at risk.

Heart Failure Risk

Fluid retention and heart failure have been reported when using insulin together with certain oral diabetes medications called thiazolidinediones (TZDs). Patients should be observed for signs and symptoms of heart failure, such as shortness of breath or swelling of the ankles or feet.

Allergic Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products. If a serious allergic reaction occurs, the medication should be discontinued immediately and medical help should be sought.

Kidney and Liver Impairment

Patients with kidney or liver problems may require more frequent blood sugar monitoring and dose adjustments, as these conditions can change how the body processes insulin.

Pregnancy

Maintaining stable blood sugar levels is essential during pregnancy to reduce the risk of complications for both the parent and the developing baby. While studies in pregnant women have not shown that insulin glargine causes birth defects, insulin needs often fluctuate significantly during pregnancy.

Healthcare providers typically monitor blood sugar closely during this time and may adjust the dosage or type of insulin used. If you are pregnant or planning to become pregnant, discuss a management plan with your medical team to ensure blood sugar remains within a target range.

Breastfeeding

It is currently unknown whether insulin glargine passes into human breast milk. Because insulin is a naturally occurring hormone in the body, many forms of insulin are used during breastfeeding, but specific data for this long-acting version is limited.

If you are breastfeeding or planning to breastfeed, consider the following:

• Insulin requirements may change while nursing, often requiring a dosage adjustment.
• A healthcare provider can help determine if the benefits of using this medication outweigh any potential risks to the infant.
• Monitoring the infant for any unusual symptoms is recommended if you are using medication while nursing.

Available Forms

Basaglar is supplied as a sterile solution for subcutaneous injection. It is available in the following formats:

• Prefilled Pens: This medication is available in disposable, multi-dose delivery devices, such as the KwikPen and the Tempo Pen.

These devices are used to administer the medication into the layer of fat just under the skin.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Basaglar to manage blood glucose levels in specific patient populations. Its approved indications include:

• Adults and pediatric patients with type 1 diabetes mellitus.
• Adults with type 2 diabetes mellitus.

Basaglar is a long-acting insulin designed to provide a steady level of insulin in the body for approximately 24 hours.

Regulatory Classification

Basaglar was approved through an abbreviated regulatory pathway as a follow-on biologic product. This means it was demonstrated to be highly similar to an existing approved insulin glargine product. While it serves the same clinical purpose as other insulin glargine medications, it was not originally classified as an interchangeable biosimilar at the time of its initial approval.

Safety Monitoring and Communications

The FDA monitors the safety of Basaglar through the Adverse Event Reporting System (FAERS). In early 2018, the FDA identified a potential safety signal for the class of insulin glargine products regarding accidental lung exposure, also known as aspiration. The agency monitors these signals to determine if updates to prescribing information or other regulatory actions are required to ensure patient safety.

Insurance and Pharmacy Factors

The amount a patient pays for Basaglar is largely determined by their insurance provider. Most private insurance plans and Medicare Part D cover Basaglar, but the specific copay or coinsurance amount depends on the plan's drug list, also known as a formulary. Pharmacy prices can also vary between locations, so comparing costs at different pharmacies may be beneficial.

Financial Assistance

The manufacturer of Basaglar may offer savings cards or patient assistance programs to help reduce costs for eligible patients. These programs are often available to those with commercial insurance or those who meet specific income requirements. Patients may also explore state-sponsored programs or non-profit organizations that assist with the cost of diabetes medications.

Cost-Effectiveness

As a follow-on biologic medication, Basaglar is often a more affordable option compared to some other brand-name long-acting insulins. However, because it is not a generic, it may still carry a significant cost for those without adequate insurance coverage. It is important to consult with an insurance provider to determine which insulin products are most cost-effective under a specific plan.