[Posted 03/06/2014]ISSUE: The FDA has concluded that Doribax (doripenem), an antibacterial drug used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (marketed in the U.S. under the name Primaxin). Based on an FDA analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, FDA approved changes to the Doribax drug label that describe these risks. The revised label includes a new warning about this unapproved use. Doribax is not approved to treat any type of pneumonia.
BACKGROUND: In the clinical trial that was stopped early, patients with ventilator-associated bacterial pneumonia received either 7-day Doribax treatment or 10-day treatment with imipenem and cilastatin. In the intent-to-treat population, the 28-day all-cause mortality was higher in the Doribax arm (23.0%; n=31/135) than in the imipenem and cilastatin arm (16.7%; n=22/132). Clinical cure rates were also lower in the Doribax arm.
RECOMMENDATION: Health care professionals should consider whether the benefits of Doribax treatment are likely to exceed its potential risks in patients who develop pneumonia while on ventilators. Doribax is still considered safe and effective for its FDA-approved indications - treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections (pyelonephritis).
For more information visit the FDA website at: Web Siteand Web Site.
Doripenem injection is used to treat serious infections of the urinary tract, kidney, and abdomen that are caused by bacteria. Doripenem injection is in a class of medications called carbapenem antibiotics. It works by killing bacteria. Antibiotics will not work for colds, flu, or other viral infections.
Doripenem injection comes as a liquid to be injected intravenously (into a vein). It is usually given every 8 hours. The length of your treatment depends on the type of infection being treated. 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 doripenem injection in a hospital or you may administer the medication at home. If you are using doripenem injection at home, use it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use doripenem injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
You should begin to feel better during the first few days of treatment with doripenem injection. If your symptoms do not improve or get worse, call your doctor.
Use doripenem injection until you finish the prescription, even if you feel better. If you stop using doripenem injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before using doripenem injection, tell your doctor and pharmacist if you are allergic to doripenem injection; other carbapenem antibiotics such as imipenem/cilastatin (Primaxin) or meropenem (Merrem); penicillins; cephalosporin antibiotics such as cefaclor (Ceclor), cefadroxil (Duricef), cefuroxime (Ceftin), or cephalexin (Keflex); aztreonam (Azactam); or any other medications.tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the following: probenecid (Probalan) and valproic acid (Depakene, Myproic Acid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.tell your doctor if you have any allergies and if you have or have ever had seizuresor kidney disease.tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using doripenem injection, call your doctor.
Unless your doctor tells you otherwise, continue your normal diet.
Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.
Doripenem injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: headachenauseadiarrhearedness, pain, or swelling at the injection site
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately: hivesitchingrashblisters on the skin, mouth, nose, and eyessloughing (shedding) of skinfeverdifficulty breathing or swallowingseizureswatery or bloody stools (up to 2 months after your treatment)excessive tirednessweaknessshortness of breath
Doripenem 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 [at Web Site] or by phone [1-800-332-1088].
If you will be injecting doripenem injection at home, your health care provider will tell you where you should store it and how long you may keep it. Follow these directions carefully. Be sure to store doripenem injection in the container it came in and out of reach of children. Throw away any medication that is outdated or no longer needed. Talk to your health care provider about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local 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 doripenem injection.
Do not let anyone else take your medication. If you still have symptoms of infection after you finish doripenem injection, talk to your doctor.
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.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: March 15, 2014.