A Comprehensive Guide to Ozempic and the Recent FDA Label Update

Understanding Ozempic and the Recent FDA Label Update

Ozempic is an injectable prescription medication used to improve blood sugar levels in adults with type 2 diabetes. It contains semaglutide and belongs to a class of drugs called GLP-1 receptor agonists.

The FDA recently approved an update to Ozempic's label regarding dosage information. This came amidst shortages of the drug due to off-label use for weight loss.

Here is a comprehensive look at what Ozempic is, how it works, the recent label change, who should use caution with it, and how it differs from related diabetes drugs.

What is Ozempic?

Ozempic is the brand name for semaglutide injection, a prescription medication used to improve blood sugar levels in adults with type 2 diabetes. It is manufactured by Novo Nordisk.

Ozempic was initially approved by the FDA in 2017 as an adjunct treatment to diet, exercise and other diabetes medications. It is taken as a once-weekly subcutaneous injection.

How Does Ozempic Work?

Ozempic works by mimicking incretin hormones in the body that regulate blood sugar. It binds to GLP-1 receptors in the pancreas, stimulating the release of insulin when blood sugar is high.

It also decreases the amount of glucose released by the liver and slows digestion to help control blood sugar after meals. The combined effect is lower fasting blood sugar and A1C levels.

Recent FDA Label Update for Ozempic

In August 2022, the FDA approved an update to the Ozempic label regarding its dosage information. The change was based on clinical trials showing the 0.5 mg and 1 mg doses were not meaningfully different in A1C reduction.

Previously, the label stated to start at 0.25 mg weekly for 4 weeks, then increase to 0.5 mg, and finally to 1 mg if needed. Now, the label states any of the three doses (0.25 mg, 0.5 mg or 1 mg) can be used initially and adjusted based on the patient’s response and tolerability.

Reason for the Label Change

The label update for Ozempic was intended to provide more dosing flexibility right away rather than gradually titrating up. This could help address shortages of the drug.

Ozempic and Wegovy, a higher dose of semaglutide for weight loss, have been in short supply due to heavy off-label use for weight management. The label change allows quicker access to the 1 mg dose found beneficial for weight loss.

Who is Ozempic For?

Ozempic is approved by the FDA for use in adults with type 2 diabetes to improve blood sugar control along with diet and exercise. It can be used:

• As a stand-alone treatment
• In combination with metformin
• With other diabetes medications
• For patients with renal or cardiovascular disease

By lowering blood sugar and A1C, Ozempic reduces the risk of diabetes complications but is not a cure. It complements other diabetes treatment efforts.

Off-Label Use of Ozempic

While only approved for type 2 diabetes, Ozempic is also being prescribed off-label for:

• Weight loss
• Type 1 diabetes
• Non-alcoholic fatty liver disease (NAFLD)
• Polycystic ovary syndrome (PCOS)

When used off-label, Ozempic is typically dosed at 1 mg to maximize weight loss benefits. However, this contributes to shortages for diabetes patients.

Benefits of Ozempic

Here are some of the benefits Ozempic offers:

• Lowers A1C by up to 2%
• Does not increase risk of hypoglycemia
• Promotes weight loss of 5-10%
• Once weekly dosing
• Improves cholesterol and blood pressure
• May protect kidneys and heart
• Well-tolerated with few side effects

Clinical studies show Ozempic is safe and effective for managing type 2 diabetes. It offers convenience with injection just once per week.

Weight Loss Benefits

Although not its intended use, Ozempic does lead to weight loss as a side effect. By controlling appetite and slowing digestion, it typically results in 5-10% body weight reduction.

This weight loss effect has made it popular off-label for obesity treatment. However, the 1 mg dose used off-label for this purpose further limits supply.

Side Effects of Ozempic

Like any medication, Ozempic can cause certain side effects. Common ones may include:

• Nausea
• Vomiting
• Diarrhea
• Decreased appetite
• Stomach pain or discomfort
• Constipation
• Heartburn
• Headache
• Fatigue

These gastrointestinal side effects are usually mild to moderate and diminish over time. Taking Ozempic with food may help.

Rare But Serious Side Effects

In rare cases, Ozempic may cause:

• Gallbladder problems
• Severe allergic reaction
• Low blood sugar (hypoglycemia)
• Kidney problems
• Pancreatitis
• Thyroid tumors

Patients should seek medical care if they experience severe side effects. The risks versus benefits of continuing Ozempic can be evaluated.

Who Should Not Take Ozempic?

Ozempic may not be appropriate for certain individuals, including:

• People with a personal or family history of medullary thyroid carcinoma
• Patients with Multiple Endocrine Neoplasia syndrome type 2
• People with severe gastrointestinal disease
• Those with a prior serious allergic reaction to semaglutide

It also lacks long-term safety data for use during pregnancy, so the risks versus benefits should be considered.

Cost and Availability of Ozempic

Ozempic is available only by prescription. The average retail cost is around $850 to $900 for a one month supply.

Many insurers cover Ozempic since it is FDA-approved for diabetes. Copay assistance programs are also available to lower out-of-pocket costs.

However, as of 2022, there are shortages of Ozempic due to heavy off-label use for weight loss. Securing a steady supply may require trying various pharmacies.

Ozempic vs Other Diabetes Drugs

Like other GLP-1 receptor agonists, Ozempic can lower blood sugar and A1C. Here’s how it compares to other type 2 diabetes medications:

Vs Metformin

Metformin is usually the first oral drug prescribed for diabetes. It works mainly by decreasing liver glucose production. Ozempic directly targets insulin production and appetite.

They have a synergistic effect and are often prescribed together. Ozempic also causes weight loss, unlike metformin.

Vs Januvia

Januvia (sitagliptin) is a DPP-4 inhibitor that prevents the breakdown of incretin hormones like GLP-1. Ozempic is a synthetic GLP-1 agonist.

Both modulate incretin activity but Ozempic is more potent. It results in greater A1C reductions than Januvia.

Vs Victoza

Victoza contains the same active drug as Ozempic, semaglutide, but at a lower dose (1.2 mg vs 1 mg for Ozempic).

Victoza is taken daily while Ozempic is a weekly injection. Ozempic results in slightly greater A1C reductions but otherwise they are very similar.

Vs Jardiance

Jardiance (empagliflozin) is an SGLT2 inhibitor that works by blocking reabsorption of glucose in the kidneys. This removes excess sugar through urine.

Ozempic and Jardiance complement each other’s mechanisms. They are often prescribed together for improved blood sugar control.

How to Take Ozempic

Ozempic is administered as a subcutaneous injection given once per week on the same day each week, any time of day with or without meals.

It is available as a pre-filled, single-dose pen injector. Patients should follow the instructions below:

1. Wash hands before handling the Ozempic pen
2. Inspect the pen to ensure the medication looks clear with no particles
3. Select an injection site - abdomen, thigh or upper arm
4. Pinch the skin and insert the needle at a 90 degree angle
5. Push the button on the pen to deliver the dose
6. Hold in place for 6 seconds then remove
7. Throw away pen immediately after use

Starting dosage is 0.25 mg or 0.5 mg. This can be increased to 1 mg if needed for optimal blood sugar control and tolerability.

Finding an Alternative

If Ozempic is out of stock, patients have some alternatives such as:

• Victoza - essentially same drug but requires daily dosing
• Trulicity - less weight loss but simpler dosing
• Rybelsus - oral semaglutide but not for people with food or drug allergies
• Metformin - very different mechanism but cheaper alternative

Talk to your doctor before switching medications. They can help find the most suitable Ozempic alternative during shortages.

The Future of Ozempic

Looking ahead, Novo Nordisk is working to ramp up Ozempic production to meet the high demand. Generic semaglutide products may also become available in coming years.

In the meantime, doctors are being advised to prescribe Ozempic primarily for diabetes rather than off-label uses until supply levels normalize.

The recent FDA label update provides more initial dosing flexibility for patients. But it remains to be seen if it will help stretch limited Ozempic supplies.

Key Takeaways

In summary, key points about Ozempic include:

• Ozempic is an injectable type 2 diabetes medication (semaglutide)
• It was approved by the FDA in 2017 to improve blood sugar control
• The FDA recently updated its label regarding dosage flexibility
• Shortages stem from heavy off-label use for weight loss
• Benefits include lower A1C and weight loss of 5-10%
• Potential side effects include GI issues like nausea or diarrhea
• It offers a convenient, once weekly dosing schedule
• Ozempic is not a substitute for diet, exercise and other diabetes treatment

Patients who are prescribed Ozempic should work closely with their doctor if they have trouble obtaining refills. But supply issues are expected to resolve in coming months.

Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a healthcare professional before starting any new treatment regimen.