Pronunciation:

mer-oh-PEN-em, va-bor-BAK-tam

Brand Names:

• Vabomere

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antibiotic

Pharmacologic—

Beta-Lactam

Chemical—

Carbapenem

Uses of This Medicine:

Meropenem and vaborbactam combination injection is used to treat complicated urinary tract infections (cUTI), including pyelonephritis (kidney infection).

Meropenem and vaborbactam are antibiotics that belong to the group of medicines known as beta-lactams and beta-lactamase inhibitors. They work by killing the bacteria and preventing their growth. However, these medicines will not work for colds, flu, or other virus infections.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of meropenem and vaborbactam combination injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of meropenem and vaborbactam combination injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine and are more likely to have age-related kidney problems, which may require caution in the dose for patients receiving meropenem and vaborbactam combination injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Cholera Vaccine, Live
• Desogestrel
• Dienogest
• Drospirenone
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Gestodene
• Levonorgestrel
• Medroxyprogesterone
• Mestranol
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Segesterone
• Ulipristal
• Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Probenecid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to cephalosporins, beta-lactams, or penicillins, known or history of—Should not be used in patients with this condition.

• Brain infection (eg, meningitis) caused by bacteria or
• Brain lesions or
• Kidney problems or
• Seizures, history of—Use with caution. May increase the risk for seizures.

• Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given through an IV catheter placed into one of your veins. This medicine must be given slowly, so the needle will have to stay in place for at least 3 hours.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause a serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Some patients may develop tremors or seizures while receiving this medicine. If you already have a history of seizures and you are taking medicine for seizures, you should continue unless otherwise directed by your doctor. Tell your doctor if you are taking divalproex sodium (Depakote®) or valproic acid (Depakene®).

Meropenem and vaborbactam combination injection may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop receiving this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

This medicine may cause confusion, headaches, or numbness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Bluish color

changes in skin color

decreased urine

diarrhea

dry mouth

increased thirst

irregular heartbeat

loss of appetite

mood changes

muscle pain or cramps

nausea

numbness or tingling in the hands, feet, or lips

seizures

swelling of the foot or leg

unusual tiredness or weakness

vomiting

Rare

Anxiety

black, tarry stools

bloody or cloudy urine

blurred vision

body aches or pain

chest discomfort

chest pain

chills

cold sweats

confusion

cool, pale skin

cough

depression

difficulty breathing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dryness or soreness of the throat

fast heartbeat

fever

flushed, dry skin

fruit-like breath odor

headache

hoarseness

increased hunger

increased urination

itching of the vagina or genitals

loss of consciousness

nervousness

nightmares

pain in the lower back or side

pain, redness, or swelling in the arm or leg

painful or difficult urination

runny nose

seeing, hearing, or feeling things that are not there

shakiness

slurred speech

sore mouth, throat, or tongue

sores, ulcers, or white spots on the lips or in the mouth

stomach pain

sweating

tender, swollen glands in the neck

thick, white vaginal discharge with mild or no odor

trouble in swallowing

unexplained weight loss

unusual bleeding or bruising

voice changes

weakness or heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

decreased appetite

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.