Vabomere

Generic name: meropenem and vaborbactam
Drug class: Carbapenems / beta-lactamase inhibitors

Medically reviewed by  A Ras MD.

What is Vabomere used for?

Vabomere is a prescription medicine that is used to treat a urinary tract infection (UTI).

Description

VABOMERE (meropenem and vaborbactam) for injection is a combination product that contains meropenem, a synthetic penem antibacterial drug and vaborbactam, a cyclic boronic acid beta-lactamase inhibitor, for intravenous administration.

Meropenem, present as a trihydrate, is a white to light yellow crystalline powder, with a molecular weight of 437.52. The chemical name for meropenem trihydrate is (4R,5S,6S)-3-[[(3S,5S)-5-(dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, trihydrate. The empirical formula of meropenem trihydrate is C17H25N3O5S∙3H2O and its chemical structure is:

Figure 1: Structure of Meropenem Trihydrate

Vaborbactam is a white to off-white powder, with a molecular weight of 297.14. The chemical name for vaborbactam is (3R,6S)-2-hydroxy-3-[[2-(2-thienyl)acetyl]amino]-1,2-oxaborinane-6-acetic acid. Its empirical formula is C12H16BNO5S and its chemical structure is:

Figure 2: Structure of Vaborbactam

VABOMERE is supplied as a white to light yellow sterile powder for constitution that contains meropenem trihydrate, vaborbactam, and sodium carbonate. Each 50 mL glass vial contains 1 gram of meropenem (equivalent to 1.14 grams of meropenem trihydrate), 1 gram of vaborbactam, and 0.575 gram of sodium carbonate. The total sodium content of the mixture is approximately 0.25 grams (10.9 mEq)/vial.

Each vial is constituted and further diluted with 0.9% Sodium Chloride Injection, USP. Both the constituted solution and the diluted solution for intravenous infusion should be a colorless to light yellow solution.

Before taking Vabomere, tell your doctor:

• If you are allergic to Vabomere; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Divalproex or valproic acid.
• If you are taking probenecid.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Vabomere with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Vabomere?

• Tell all of your health care providers that you take Vabomere. This includes your doctors, nurses, pharmacists, and dentists.
• Severe and sometimes deadly allergic side effects have rarely happened with drugs like this one.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Vabomere affects you.
• Do not use longer than you have been told. A second infection may happen.
• If you are 65 or older, use Vabomere with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Vabomere while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Vabomere best taken?

Use Vabomere as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Vabomere that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Seizures.
• Stiff muscles, shakiness, or muscle movements that are not normal.
• A burning, numbness, or tingling feeling that is not normal.
• Feeling confused.
• Diarrhea is common with antibiotics. Rarely, a severe form called C diff–associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen during or a few months after taking antibiotics. Call your doctor right away if you have stomach pain, cramps, or very loose, watery, or bloody stools. Check with your doctor before treating diarrhea.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Vabomere?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Irritation where Vabomere is given.
• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Vabomere?

• If you need to store Vabomere at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – 2 G VIAL CARTON

• Rx only
  NDC 70842-120-06
• VABOMERE®
  (meropenem and vaborbactam)
  for injection
• 2 g per vial*
• *Meropenem 1 gram (equivalent
  to 1.14 g meropenem trihydrate)
  and vaborbactam 1 g
• For Intravenous Infusion Only
  Single Dose Only
  Discard Unused Portion After Use
• MUST BE CONSTITUTED THEN DILUTED
  See prescribing information for constitution
  and dilution instructions and complete
  directions for use.
• Each vial contains meropenem 1 g,
  vaborbactam 1 g, and sodium carbonate
  0.575 g. The total sodium content of the
  mixture is approximately 0.25 g (10.9 mEq).
• Storage:
  Store at 20°C to 25°C (68°F to 77°F);
  excursions are permitted to 15°C to 30°C
  (59°F to 86°F) [See USP Controlled
  Room Temperature]
• MEL042-R002
• Contains 6 single dose 2 g vials

SRC: NLM .