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Aemcolo® (rifamycin)

Aemcolo® (rifamycin)

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RedHill announced in October 2019 that it had entered into an exclusive license agreement with Cosmo Pharmaceuticals N.V. for the U.S. rights to Aemcolo® (rifamycin). RedHill initiated promotion of Aemcolo® in December 2019.

Aemcolo® (rifamycin) is an orally administered, delayed release, minimally absorbed antibiotic approved for the treatment of travelers’ diarrhea caused by non-invasive strains of Escherichia coli (E.coli) in adults. Aemcolo® is the first antibiotic engineered with Cosmo Pharmaceuticals’ Multi Matrix Technology (MMX®). MMX technology allows the delivery of active pharmaceutical ingredients in a delayed and controlled manner to the full length of the colon.

INDICATION AND IMPORTANT SAFETY INFORMATION

Aemcolo® is indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli) in adults.

Limitations of Use

Aemcolo® is not indicated in patients with diarrhea complicated by fever or bloody stool or due to pathogens other than noninvasive strains of E. coli

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aemcolo® and other antibacterial drugs, Aemcolo® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

CONTRAINDICATION
Aemcolo® is contraindicated in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents, or any of the components in Aemcolo®.


WARNINGS AND PRECAUTIONS

Risk of Persistent or Worsening Diarrhea Complicated by Fever and/or Bloody Stool

Aemcolo® was not shown to be effective in patients with diarrhea complicated by fever and/or bloody stool or diarrhea caused by pathogens other than E. coli and is not recommended for use in such patients.

Discontinue Aemcolo® if diarrhea gets worse or persists more than 48 hours and consider alternative antibacterial therapy. 

Clostridium difficile-Associated Diarrhea (CDAD)

CDAD has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

Consider CDAD in all patients who present with diarrhea following antibacterial drug use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

Development of Drug-Resistant Bacteria

Prescribing Aemcolo® in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.


ADVERSE REACTIONS

Discontinuation of Aemcolo® due to adverse reactions occurred in 1% of patients. The most frequent adverse reactions were abdominal pain (0.5%) and pyrexia (0.3%).

Adverse reactions that occurred in at least 2% of Aemcolo®-treated patients and with a higher incidence than in the placebo or ciprofloxacin groups were constipation 3.5% and headache 3.3%, respectively.

USE IN SPECIFIC POPULATIONS

Pregnancy

There are no available data on AEMCOLO use in pregnant women to inform any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Lactation

There is no information regarding the presence of AEMCOLO in human milk, the effects on the breastfed infant, or the effects on milk production.

Pediatric Use

The safety and effectiveness of AEMCOLO has not been established in pediatric patients

See Full prescribing information for Aemcolo® is available at www.aemcolo.com  
 

To submit adverse event reports or product complaint reports, contact RedHill Biopharma, Inc. at 1(833)-ADR-HILL. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).