Utebzi

Utebzi (tebipenem pivoxil) is an antibiotic tablet used to treat complicated urinary tract infections (cUTIs), including pyelonephritis, in adults with limited or no alternative oral treatment options. It is the first and only oral carbapenem antibiotic to be FDA-approved.

Utebzi usual dose is two 300 mg tablets (600mg) every 6 hours for 7 to 10 days, taken with or without food. As an oral tablet, it provides an alternative to intravenous (IV) hospital treatments.

Utebzi is active against certain bacteria that cause cUTIs, including Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis.

Utebzi works by binding to penicillin-binding proteins (PBPs) in bacterial cell walls, disrupting cell wall biosynthesis and killing the bacteria. Utebzi contains tebipenem pivoxil, a prodrug that is converted in the gut to the active compound tebipenem.

Utebzi is a carbapenem antibiotic, a subclass of the broader penem antibacterial family.

Utebzi should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria to reduce the development of drug-resistant bacteria.

Utebzi is not approved for use in patients under 18 years of age.

Utebzi received FDA approval on June 17, 2026. It was granted Priority Review, Fast Track Designation, and Qualified Infectious Disease Product (QIDP) Designation for this indication. Spero Therapeutics developed Utebzi under a license agreement with GSK, which holds the New Drug Application sponsorship.

Read the medication guide provided with your prescription and follow your healthcare provider's instructions carefully. Do not take more or less than prescribed, or for longer than directed.

• The standard dose is 600 mg (two 300 mg tablets) taken by mouth every 6 hours for 7 to 10 days.
• Tablets can be taken with or without food. Swallow tablets whole.
• Your dose may be reduced if you have kidney problems.
• Do not use Utebzi beyond the recommended treatment duration due to the risk of carnitine depletion.
• Complete the full course of treatment, even if you start to feel better early.

Contraindications

Do not use Utebzi if you:

• Are allergic to Utebzi, carbapenems, penicillins, cephalosporins, or any other beta-lactam antibiotics.
• Have primary or secondary carnitine deficiency, or inborn errors of metabolism that may result in clinically significant carnitine deficiency.

Hypersensitivity reactions

Serious and occasionally fatal allergic (anaphylactic) reactions have been reported with beta-lactam and carbapenem antibiotics, including Utebzi. The risk is higher in people with a history of sensitivity to multiple allergens. Tell your healthcare provider about any previous allergic reactions to antibiotics before starting Utebzi. If an allergic reaction occurs, stop taking Utebzi immediately and seek emergency care.

Seizures and central nervous system (CNS) effects

Seizures and other CNS reactions have been reported with carbapenem antibiotics, including Utebzi. These are most likely in patients with brain disorders (such as a history of seizures or brain lesions) or kidney problems. Contact your healthcare provider if you experience seizures, tremors, confusion, or dizziness during treatment. If co-use is necessary, valproic acid levels should be monitored closely.

Carnitine depletion

Utebzi can cause reversible decreases in carnitine levels in the body. Carnitine deficiency can lead to low blood sugar, fatigue, muscle weakness, fainting, seizures, and confusion. Do not use Utebzi beyond the recommended treatment duration. Do not use if you already have carnitine deficiency. Patients with significant kidney problems or low muscle mass are at higher risk.

Symptoms of carnitine depletion to watch for include:

• Fainting or loss of consciousness
• Muscle aches and weakness
• Unexplained fatigue
• Low blood sugar (lightheadedness, shakiness, hunger)
• Confusion or seizures

Interaction with valproic acid

Using Utebzi together with valproic acid or divalproex sodium (medicines used to treat seizures or mood disorders) may reduce the levels of these medicines in your blood, increasing the risk of breakthrough seizures. Avoid this combination.

Clostridioides difficile (C. diff) Infection

C. difficile infection (CDI), ranging from mild diarrhea to life-threatening colitis, has been reported with almost all antibiotics, including Utebzi. CDI can occur more than two months after finishing antibiotic treatment. If you develop watery or bloody diarrhea, stomach cramps, or fever, contact your healthcare provider.

Newborn screening interference

If Utebzi is taken during pregnancy close to delivery, it may cause a false positive result on the newborn screening test for isovaleric acidemia. If you are pregnant, inform your healthcare provider. Prompt follow-up of any positive newborn screening result is recommended.

There is a pregnancy safety study for Utebzi. You or your healthcare provider can report a pregnancy exposure by contacting GlaxoSmithKline at 1-888-825-5249.

Tell your healthcare provider if you:

• Have a history of seizures, brain lesions, or other brain disorders
• Have kidney problems or are on dialysis
• Take valproic acid, divalproex sodium, probenecid, or other pivalate-containing drugs
• Are pregnant, plan to become pregnant, or are breastfeeding
• Have had previous allergic reactions to antibiotics

Common side Effects

The most common Utebzi side effects include:

• Diarrhea (8%)
• Headache (3%)
• Nausea (1%)
• Abdominal pain (1%)
• Increased liver enzymes (1%)
• Clostridioides difficile infection (1%)

Diarrhea was the most notable common side effect, occurring more frequently with Utebzi (8%) than with intravenous imipenem-cilastatin (3%) in clinical trials.

Less Common Side Effects (Less Than 1%)

Side effects occurring in fewer than 1% of patients include:

• Vomiting and indigestion (dyspepsia)
• Candida infections (vaginal, urinary, or oral thrush)
• Skin rash, itching, or hives (urticaria)

Serious side effects requiring immediate medical attention include:

• Severe allergic reactions (anaphylaxis): swelling of the face, lips, tongue, or throat; difficulty breathing; severe rash. Stop Utebzi and seek emergency care right away.
• Seizures and CNS reactions: tremors, confusion, dizziness. Contact your healthcare provider promptly.
• Signs of carnitine deficiency: fainting, muscle weakness, fatigue, low blood sugar, or seizures. Contact your healthcare provider right away.
• Severe or persistent diarrhea that may indicate C. difficile infection, including watery, bloody, or mucus-containing stools, accompanied by fever or stomach cramping.

Talk to your healthcare provider if you have any side effects that bother you or do not go away. These are not all the possible side effects of Utebzi. You may report side effects to the FDA at 1-800-FDA-1088.

Utebzi Standard Dosage (Adults with eGFR 60 to 150 mL/min)

600 mg (two 300 mg tablets) orally every 6 hours for 7 to 10 days.

Dosage Adjustment for Kidney Problems

Note: Utebzi is not recommended in patients with eGFR above 150 mL/min, as reduced drug exposure may lower effectiveness. There are insufficient data to recommend dosing in hemodialysis patients.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double up doses to make up for a missed one.

In the event of an overdose, call the Poison Help line at 1-800-222-1222 or go to the nearest emergency room. Tebipenem can be partially removed by hemodialysis.

Tell your healthcare provider and pharmacist about all prescription and over-the-counter medicines, vitamins, nutritional supplements, and herbal products you are taking before starting Utebzi.

Valproic Acid and Divalproex Sodium

Avoid using Utebzi together with valproic acid or divalproex sodium. Carbapenems including Utebzi can lower the blood levels of these seizure medicines, potentially causing breakthrough seizures. If co-use is unavoidable, valproic acid levels should be monitored and supplemental anticonvulsant therapy should be considered.

Probenecid (OAT1/OAT3 Inhibitors)

Probenecid and other OAT1/OAT3 transporter inhibitors can increase tebipenem levels in the blood. If you need to take these together, your healthcare provider should monitor you more closely for Utebzi side effects such as diarrhea and headache.

Other Pivalate-Containing Drugs

Using Utebzi with other pivalate-generating medicines (for example, adefovir dipivoxil, pivmecillinam, or cefditoren pivoxil) is generally not recommended, as it may increase the risk of carnitine depletion. If combined use is necessary, watch for signs of carnitine deficiency such as muscle aches, fatigue, and low blood sugar.

This list is not complete. Many other drugs may interact with Utebzi, including prescription and over-the-counter medicines, vitamins, and herbal products.

Available data on Utebzi use in pregnant women are insufficient to fully assess the risk of birth defects, miscarriage, or other adverse outcomes. Animal studies did not show harm at exposures similar to those in humans at the recommended dose.

Taking Utebzi close to delivery may cause a false positive newborn screening result for isovaleric acidemia. If you are pregnant and need to take Utebzi, report the exposure to GlaxoSmithKline at 1-888-825-5249 as part of an ongoing pregnancy safety study.

It is not known whether tebipenem passes into human breast milk. Tebipenem and its metabolites were detected in the milk of lactating rats. Talk to your healthcare provider about the safest way to feed your baby if you need to take Utebzi.

Store at room temperature between 68°F to 77°F (20°C to 25°C). Excursions are permitted between 59°F and 86°F (15°C to 30°C).

Do not freeze. Keep all medicines out of the reach of children. Store in the original packaging.

Active ingredient: tebipenem pivoxil (present as tebipenem pivoxil hydrobromide)

Inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide.

Tablet film-coating: FD&C blue 1, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.