Meropenem and Vaborbactam Injection

Meropenem and vaborbactam injection is used to treat serious urinary tract infections, including kidney infections, that are caused by bacteria. Meropenem is in a class of medications called carbapenem antibiotics. It works by killing bacteria. Vaborbactam is in a class of medications called beta-lactamase inhibitors. It works by preventing bacteria from destroying meropenem.

Antibiotics such as meropenem and vaborbactam injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Meropenem and vaborbactam injection comes as a powder to be mixed with liquid and injected intravenously (into a vein). It is infused (injected slowly) intravenously over a period of 3 hours every 8 hours for up to 14 days. The length of treatment depends on your general health and how well you respond to the medication. Your doctor will tell you how long to use meropenem and vaborbactam injection. After your condition improves, your doctor may switch you to another antibiotic that you can take by mouth to complete your treatment.

You may receive meropenem and vaborbactam injection in a hospital, or you may administer the medication at home. If you will be receiving meropenem and vaborbactam injection at home, your healthcare provider will show you how to use the medication. Be sure that you understand these directions and ask your healthcare provider if you have any questions.

You should begin to feel better during the first few days of treatment with meropenem and vaborbactam injection. If your symptoms do not improve or if they get worse, call your doctor.

Use meropenem and vaborbactam injection until you finish the prescription, even if you feel better. If you stop using meropenem and vaborbactam injection too soon or if you skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using meropenem and vaborbactam injection,

• tell your doctor and pharmacist if you are allergic to meropenem, vaborbactam, other carbapenem antibiotics such as doripenem (Doribax), ertapenem (Invanz), or imipenem and cilastatin (Primaxin); cephalosporin antibiotics such as cefaclor, cefadroxil, cefuroxime (Ceftin, Zinacef), and cephalexin (Keflex); other beta-lactam antibiotics such as penicillin or amoxicillin (Amoxil, Trimox, Wymox); any other medications, or any of the ingredients in meropenem and vaborbactam injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving meropenem and vaborbactam injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• you should know that meropenem and vaborbactam injection may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, and injections). You will need to use another method of contraception to prevent pregnancy while receiving meropenem and vaborbactam injection. Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.
• tell your doctor if you have or have ever had seizures, brain lesions, or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving meropenem and vaborbactam injection, call your doctor.
• you should know that meropenem and vaborbactam injection may affect mental alertness or motor skills. Do not drive a car or operate machinery until you know how this medication affects you.

Unless your doctor tells you otherwise, continue your normal diet.

Meropenem and vaborbactam injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• diarrhea
• nausea
• redness, pain, or swelling at the injection site
• burning or tingling in the hands or feet
• confusion

Some side effects can be serious. If you experience any of these symptoms, stop using meropenem and vaborbactam injection and call your doctor immediately or get emergency medical treatment:

• seizures
• hives
• itching
• rash
• flushing
• swelling of the face, throat, tongue, lips, and eyes
• difficulty swallowing or breathing
• severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
• a return of fever or other signs of infection

Meropenem and vaborbactam injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to meropenem and vaborbactam injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Vabomere^®