Recarbrio

Recarbrio is an antibacterial prescription medication used to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). Recarbrio is reserved for patients who have limited or no alternative treatment options.

Recarbrio is a three-drug combination product containing imipenem, cilastatin, which belongs to a group of drugs called renal dehydropeptidase inhibitors, and relebactam, a new beta-lactamase inhibitor. Imipenem belongs to a group of antibacterial drugs called carbapenem antibiotics which work by stopping the growth of bacteria by disrupting the bacterial cell wall synthesis. Cilastatin and relebactam help imipenem work more effectively by preventing the breakdown of the antibiotic.

This medication comes in an injectable form to be given directly into a vein (IV) by your healthcare provider in a clinical center.

The most common adverse reactions included nausea, diarrhea, headache, fever and increased liver enzymes.

Recarbrio is a prescription medication used to treat patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of the following infections caused by susceptible gram-negative bacteria: 

• Complicated urinary tract infections, including pyelonephritis (cUTI) 
• Complicated intra-abdominal infections (cIAI)

This medication may be prescribed for other uses.

Serious side effects may occur. See "Recarbrio Precautions" section.

Common side effects include:

• diarrhea
• nausea
• vomiting
• headache
• elevated liver enzymes
• fever
• high blood pressure
• pain, bruising, swelling, or irritation at the injection site

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Recarbrio. For more information, ask your healthcare provider or pharmacist.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ganciclovir
• valproic acid or divalproex sodium

Recarbrio should not be used in patients taking ganciclovir unless the benefits outweigh the risks as generalized seizures have been reported. Patients should also avoid using Recarbrio when taking valproic acid or divalproex sodium, drugs used to manage seizures, as a reduction in valproic acid level may lead to seizures.

This is not a complete list of Recarbrio drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported including:

Hypersensitivity Reactions: Hypersensitivity reactions have been reported in patients receiving beta lactam drugs. Stop taking Recarbrio immediately if a hypersensitivity reaction occurs. Tell your healthcare provider if you have ever had a hypersensitivity reactions to Recarbrio (imipenem, cilastatin, and relebactam), carbapenems, penicillins, cephalosporins, other beta lactams, or other allergens.

Seizures and Central Nervous System Adverse Reactions: CNS adverse reactions such as seizures have been reported with imipenem/cilastatin, a component of Recarbrio. Tell your healthcare provider if you have central nervous system disorders, such as stroke or history of seizures.

Increased Seizure Potential Due to Interaction with Valproic Acid: Recarbrio use in combination with valproic acid or divalproex sodium may reduce the amount of valproic acid in the blood which may increase the risk of breakthrough seizures. If you are taking valproic acid or divalproex sodium and treatment with Recarbrio is necessary, supplemental anti-convulsant medication to prevent and/or treat seizures may be needed. Talk to your healthcare provider.

Clostridium difficile-Associated Diarrhea (CDAD): Diarrhea is a common problem caused by antibacterial drugs, including Recarbrio and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection that may require treatment. If severe watery or bloody diarrhea develops, contact your healthcare provider right away.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Recarbrio there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Recarbrio, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Recarbrio or to any of its ingredients
• have a history of seizures
• have had a stroke
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you are pregnant or planning to become pregnant. Recarbrio may cause fetal harm. You and your doctor should decide if this medication is safe for you to use during pregnancy.

In animal studies, pregnant animals were given some components of this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. 

Tell your healthcare provider if you are breastfeeding or planning to breastfeed.

It is not known if any of the 3 components of Recarbrio can cross into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Recarbrio.

Take Recarbrio exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by Recarbrio or other antibacterial drugs in the future.

Recarbrio comes in an injectable form to be given by intravenous (IV) infusion over 30 minutes every 6 hours.

Treatment usually lasts 4 to 14 days.

Take this medication exactly as prescribed by your doctor. If you are administering this medication at home, follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dosage of Recarbrio is 1.25 grams (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) administered by intravenous (IV) infusion over 30 minutes every 6 hours in patients 18 years of age and older with normal kidney function (creatinine clearance (CLcr) of 90 mL/min or greater). A dose reduction is recommended for patients with CLcr less than 90 mL/min.

The recommended duration of treatment with Recarbrio is 4 days to 14 days.

If you take too much Recarbrio, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Recarbrio is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.