What are the risks and possible side effects of UTEBZI?

Do not take UTEBZI if you:

• are allergic to UTEBZI, similar antibiotics (like carbapenems, penicillins, cephalosporins), or any of the ingredients in UTEBZI.
• have low levels of a substance in the body called carnitine (carnitine deficiency) or have certain conditions that cause low levels of carnitine. UTEBZI can decrease the level of carnitine in your body.

 

Before you take UTEBZI, tell your healthcare provider about all your medical conditions, including if you:

• have a history of brain problems, such as seizures or tumors.
• have kidney problems or are on dialysis.
• are pregnant or plan to become pregnant. It is not known if UTEBZI can harm your unborn baby.
  Pregnancy Safety Study: There is a pregnancy safety study for women who are or become pregnant during treatment with UTEBZI. You or your healthcare provider can report your pregnancy by calling 1-888-825-5249.
• are breastfeeding or plan to breastfeed. It is not known if UTEBZI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take UTEBZI.

 

Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements. UTEBZI and certain other medicines may interact with each other. This may cause serious side effects.

 

Especially tell your healthcare provider if you take:

• probenecid
• valproic acid or divalproex sodium

 

UTEBZI can cause serious side effects, including:

• Allergic (hypersensitivity) reactions: Allergic reactions can happen after you take UTEBZI. Serious allergic reactions, including those leading to death, have happened with antibiotics similar to UTEBZI. Tell your healthcare provider if you have had an allergic reaction to antibiotics such as carbapenems, penicillins, cephalosporins, or other beta-lactam medicines in the past.
• Central Nervous System (CNS) problems: Seizures and other CNS problems have been reported in people who take UTEBZI or similar antibiotics, including carbapenems, penicillins, and cephalosporins. Tell your healthcare provider if you get any of the following side effects, or other changes in your brain function, mood or behavior during treatment with UTEBZI: seizures, confusion, tremors, feeling lightheaded or dizzy. Your healthcare provider may decide to stop treatment with UTEBZI.
• Carnitine deficiency: Levels of a substance in the body called carnitine may decrease while taking UTEBZI. Contact your healthcare provider right away if you have the following symptoms: fainting, confusion, worsening tiredness (fatigue), low blood sugar (hypoglycemia; lightheadedness, dizziness, shakiness, or hunger may happen if your blood sugar is too low), muscle aches and weakness, or seizures.
• Diarrhea: Diarrhea is a common side effect caused by antibiotics, including UTEBZI. The diarrhea usually stops after the antibiotic is stopped. In some cases, diarrhea may be caused by Clostridioides difficile infection (CDI). CDI is a severe infection of the intestines (bowels) that can happen over 2 months after finishing treatment with antibiotic medicines, including UTEBZI. CDI can be life‑threatening and can lead to death. Do not take medicines to treat diarrhea without checking first with your healthcare provider. Contact your healthcare provider right away if you have any of the following signs or symptoms: stomach cramps, fever, watery diarrhea, diarrhea that does not go away, or bloody stools.
• If you are pregnant and taking UTEBZI, this may cause a false-positive screening test result for a substance called isovaleric acid in your newborn baby.

 

The most common side effects of UTEBZI include diarrhea, headache, nausea, stomach pain, increased liver enzymes, and Clostridioides difficile infection (CDI).

 

These are not all the possible side effects of UTEBZI. Call your doctor for medical advice about side effects.

 

Please see full Prescribing Information, including Patient Information, for UTEBZI.