Brand Name

Steglatro

Generic Name
Ertugliflozin
View Brand Information
FDA approval date: December 19, 2017
Form: Tablet

What is Steglatro (Ertugliflozin)?

Steglatro (Ertugliflozin): An SGLT2 Inhibitor for Type 2 Diabetes

Living with type 2 diabetes means managing a condition that affects nearly every part of your day, from what you eat to how you feel. It can be a constant balancing act, and finding the right tools to help you manage your blood sugar is a critical part of staying healthy and feeling your best. When diet and exercise alone aren’t enough to reach your goals, your doctor may prescribe medication to help.

Steglatro (ertugliflozin) is a prescription medicine used to help control blood sugar levels in adults with type 2 diabetes. It is not for type 1 diabetes. Steglatro belongs to a class of drugs known as **sodium-glucose co-transporter 2 (SGLT2) inhibitors**. It is an oral medication that works alongside your diet and exercise plan to help lower your blood sugar and improve your A1C.


What does Steglatro do?

Steglatro is approved by the U.S. Food and Drug Administration (FDA) to improve glycemic control in adults with type 2 diabetes, in addition to diet and exercise. This means its primary job is to help lower high blood sugar (**hyperglycemia**) (FDA, 2024).

By helping to keep your blood sugar levels in a healthier range, Steglatro can be an important part of your diabetes management plan. Effectively managing blood sugar is key to preventing or delaying the serious long-term complications of diabetes, such as nerve damage, kidney problems, vision loss, and heart disease. While Steglatro helps lower blood sugar, it is **not approved to reduce the risk of heart attack or stroke**.


How does Steglatro work?

The mechanism of Steglatro is unique and does not depend on your body’s insulin production. Instead, it works directly with your kidneys.

Your kidneys act as your body’s filters. As blood passes through them, they filter out waste products while also reabsorbing essential substances back into the bloodstream, including sugar (glucose). In people with type 2 diabetes, the body often reabsorbs too much sugar, even when blood sugar levels are already high.

Steglatro works by blocking a specific protein in the kidneys called **SGLT2**. This SGLT2 protein is the main pathway responsible for pulling sugar back into the body. By inhibiting SGLT2, Steglatro prevents the kidneys from reabsorbing excess sugar. As a result, that extra sugar is **removed from your body through your urine** (U.S. National Library of Medicine, 2022).


Steglatro Side Effects and Warnings

Like any medication, Steglatro can cause side effects. Because it works by removing sugar through your urine, the most common side effects are related to the genital and urinary tracts. These include:

Common Side Effects:

  • Female genital yeast infections
  • Male yeast infections (balanitis or balanoposthitis)
  • Urinary tract infections (UTIs)
  • Increased urination or urinating more often

It is important to practice good hygiene and drink plenty of fluids to help prevent these. Contact your doctor if you experience symptoms like itching, unusual discharge, pain or burning when urinating, or a frequent urge to go.

Serious Side Effect Warnings (Seek immediate medical help or call your doctor for):

  • Ketoacidosis: High blood acids (ketones) causing nausea, vomiting, stomach pain, fatigue, and trouble breathing, even with normal blood sugar.
  • Serious UTIs: Infections potentially spreading to kidneys or bloodstream.
  • Fournier’s Gangrene: Rare, life-threatening bacterial infection of the perineum. Seek emergency care for tenderness, redness, swelling, fever, or feeling unwell in that area.
  • Lower Limb Amputation: Increased risk, mainly of the toe. Daily foot checks for pain, sores, ulcers, or infections are crucial; report immediately.
  • Dehydration (Volume Depletion): Increased urination can lead to dizziness, fainting, or weakness, especially when standing (orthostatic hypotension) (FDA, 2024).

Steglatro is not for everyone. You should not take it if you have **severe kidney problems** or are on dialysis, or if you have had a serious allergic reaction to it.


Steglatro Dosage and Monitoring

Steglatro comes as an oral tablet, available in 5 mg and 15 mg strengths. It is typically taken **once per day, in the morning, with or without food.**

The starting dose is usually 5 mg once daily. Your doctor may increase your dose to 15 mg once daily if you tolerate the medication well but need additional blood sugar control (FDA, 2024). The specific dose prescribed for you depends on your medical history, kidney function, and other medications you may be taking.

Before starting Steglatro, your doctor will check your kidney function (**eGFR**) and monitor it periodically. Steglatro is not recommended for severely reduced kidney function. Take as prescribed.


Does Steglatro have a generic version?

No, Steglatro does not currently have a generic version available in the United States. It is a brand-name medication, and its active ingredient is **ertugliflozin**. However, international versions may exist in other markets.

When a drug is first approved by the FDA, it is protected by patents that prevent other companies from manufacturing generic versions for a certain period. Once these patents expire, other manufacturers can apply to the FDA to sell generic versions. Generics must be proven to be just as safe and effective as the brand-name drug, offering the same active ingredient, strength, and dosage form (FDA, 2023).


Conclusion

Steglatro is an effective once-daily medication that offers a unique way to help manage type 2 diabetes. By working with your kidneys to remove excess sugar from your body, it can be a valuable tool, alongside diet and exercise, to help you reach your blood sugar targets.

Steglatro offers benefits but carries risks like genital infections, UTIs, and rarely, more serious issues. Safe use requires close partnership with your doctor, including regular check-ups, kidney function monitoring, and diligent foot care. Stay informed, take medication as prescribed, and discuss any concerns with your doctor.


References

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Brand Information

STEGLATRO (ertugliflozin)
1INDICATIONS AND USAGE
STEGLATRO
2DOSAGE FORMS AND STRENGTHS
  • Tablets: 5 mg, pink, triangular-shaped debossed with "701" on one side and plain on the other side.
  • Tablets: 15 mg, red, triangular-shaped debossed with "702" on one side and plain on the other side.
3CONTRAINDICATIONS
STEGLATRO is contraindicated in patients with hypersensitivity to ertugliflozin or any excipient in STEGLATRO. Reactions such as angioedema have occurred
4ADVERSE REACTIONS
The following important adverse reactions are described elsewhere in the labeling:
  • Diabetic Ketoacidosis in Patients with Type 1 Diabetes and Other Ketoacidosis
  • Lower Limb Amputation
  • Volume Depletion
  • Urosepsis and Pyelonephritis
  • Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues
  • Necrotizing Fasciitis of the Perineum (Fournier's Gangrene)
  • Genital Mycotic Infections
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4.2Postmarketing Experience
Additional adverse reactions have been identified during postapproval use of STEGLATRO. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Infections: necrotizing fasciitis of the perineum (Fournier's Gangrene)
  • Skin and Subcutaneous Tissue Disorders: angioedema, rash
5OVERDOSAGE
In the event of an overdose with STEGLATRO, contact the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Employ the usual supportive measures as dictated by the patient's clinical status. Removal of ertugliflozin by hemodialysis has not been studied.
6DESCRIPTION
STEGLATRO (ertugliflozin) tablets for oral use contain ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor.
The chemical name of ertugliflozin L-pyroglutamic acid is (1
The chemical structure is:
Chemical Structure
Ertugliflozin L-pyroglutamic acid is a white to off-white powder that is soluble in ethyl alcohol and acetone, slightly soluble in ethyl acetate and acetonitrile and very slightly soluble in water.
STEGLATRO is supplied as film-coated tablets, containing 6.48 or 19.43 mg of ertugliflozin L-pyroglutamic acid, which is equivalent to 5 and 15 mg of ertugliflozin.
Inactive ingredients are microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, and magnesium stearate.
The film coating contains: hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide and iron oxide red.
7HOW SUPPLIED/STORAGE AND HANDLING
STEGLATRO (ertugliflozin) tablets are available as follows:
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
9PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label
NDC 0006-5363-03
Steglatro
5 mg
Dispense the accompanying Medication Guide
Each tablet contains 6.48 mg ertugliflozin L-pyroglutamic
Rx only
30 Tablets
PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label
10PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Label
NDC 0006-5364-03
Steglatro
15 mg
Dispense the accompanying Medication Guide
Each tablet contains 19.43 mg ertugliflozin L-pyroglutamic
Rx only
30 Tablets
PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Label