It is used to treat certain kinds of bacterial infections in the bowel. We cover dificid fidaxomicin for the treatment of clostridium difficile when all of the following criteria are met1. It has a narrow spectrum of antimicrobial activity against most clostridial spp, including clostridium difficile, against which it is bactericidal. Fidaxomicin and its main metabolite, op1118, are pgp substrates, but not significantly affected by pgp inhibitors. If you believe that you meet the eligibility criteria for the merck patient assistance program and you have received a prescription for a merck product, call tollfree 8007275400 8 am to 8 pm et to obtain a. In selected patients n8 treated with fidaxomicin 200 mg twice daily for 10 days from controlled trials, fecal concentrations of fidaxomicin and op1118 obtained within 24 hours of the last dose ranged from 6392710. Key points fidaxomicin dificid is a macrolide antibiotic that inhibits the rna polymerase sigma subunit in susceptible organisms, which results in the inhibition of protein synthesis and cell death. Fidaxomicin is in a class of medications called macrolide antibiotics. Fidaxomicin medicare coverage and copay details goodrx. Department of health and human services silver spring md 20993.
Nov 09, 2018 fidaxomicin is an antibiotic that fights bacteria. It will not work for colds, flu, or other viral infections. Current health protection agency hpa guidance recommends metronidazole as firstline therapy in mild to moderate cdi, but vancomycin in severe cases. Fidaxomicin may cause live bacterial vaccines such as typhoid vaccine to not work as well. Background fidaxomicin is an antibiotic belonging to the macrocyclic class of antibacterials. Fidaxomicin for the treament of clostridium difficile infection cdi had entered phase iii trials 2. Fidaxomicin is mainly confined to the gastrointestinal tract following oral administration. Feb 20, 2020 effect of pgp inhibitors on fidaxomicin. Hypersensitivity reactions associated with fidaxomicin use. Key points fidaxomicin dificid is a macrolide antibiotic that inhibits the rna polymerase sigma subunit in susceptible organisms, which results in the inhibition of protein synthesis and cell death only indicated for the treatment of diarrhea due to clostridium difficile infection not for use with systemic infection and has minimal systemic absorption has a narrow spectrum activity. Patients on oral vancomycin or oral fidaxomicin could have also received intravenous metronidazole. Feb 01, 20 fidaxomicin dificid is an oral macrolide antibiotic labeled for the treatment of clostridium difficile associated diarrhea in adults. Also, fidaxomicin preserved the intestinal microbiome during the treatment of cdi 3.
In more serious cases, oral administration of, first, oral metronidazole and if that fails. It is bactericidal, and its mechanism of action relates to inhibition of a rna polymerase at a site distinct from where rifamycins interact. Although the exact mechanism of action has yet to be fully elucidated, fidaxomicin may bind to and inhibit bacterial dnadependent rna polymerase, thereby. Dificid is a macrolide antibacterial indicated in adultand pediatric patients 6monthsof ageand olderfor the treatment of c. Dailymed zinplava bezlotoxumab injection, solution. Dificid fda prescribing information, side effects and uses. Eligible, privately insured patients may save on a qualifying prescription with the savings coupon for dificid.
Based on results of studies coadministered with cyclosporine, fidaxomicin may be co. Dificid should only be used to treat infections that are proven or strongly suspected to be caused by clostridium difficile also called c. Get emergency medical help if you have any of these signs of an allergic reaction. Optimer pharmaceuticals 2011 dificid fidaxomicin package insert. Fidaxomicin is used to treat diarrhea caused by infection with clostridium difficile. It is a fermentation product obtained from the actinomycete dactylosporangium aurantiacum subspecies hamdenesis. Jul, 2012 fidaxomicin dificlir is the first in a new class of macrocylic antibiotics and has recently been licensed by the european medicines agency ema for the treatment of clostridium difficile infection cdi. A pharmacokinetic study with coadministration of fidaxomicin and a potent pgp inhibitor, cyclosporine, was conducted. Requests based exclusively on the use of samples will not meet coverage criteria for exception. Fidaxomicin is a topically acting drug that cannot be used to treat systemic infections. Antiinfective pregnancy risk category b action bactericidal against clostridium difficile in vitro, inhibiting rna synthesis by rna polymerases availability tablets. Fidaxomicin is marketed as a 200 mg tablet and is recommended to be administered orally twice daily for 10 days. Safety and efficacy of fidaxomicin in the treatment of. Fidaxomicin may also be used for purposes not listed in.
Choice of soc was at the discretion of the health care provider. Fidaxomicin is a narrowspectrum, 18membered macrolide antibiotic isolated from the actinomycete dactylosporangium aurantiacum subsp. If the quantity dose requested exceeds the maximum fda labeled dose, when specified, or to the safest studied dose per the manufacturers product insert, then the. In selected patients n8 treated with dificid 200 mg twice daily for 10 days from controlled trials, fecal. Fidaxomicin use over time across included hospitals in the united. Fidaxomicin oral route description and brand names. Fidaxomicin and its main metabolite, op1118, are substrates of the efflux transporter, pglycoprotein pgp, which is expressed in the gastrointestinal tract. In patients with cdi, fidaxomicin exhibited a lower reappearance of toxin in fecal filtrates and inhibited recurrence of cdi. Only minimal systemic absorption occurs following oral administration. Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema of. Fidaxomicin use in realworld clinical practice, especially for severe clostridium difficile infection cdi, is mainly based on singlecenter observational studies. Based on results of studies coadministered with cyclosporine, fidaxomicin may be coadministered with pgp inhibitors and no dose adjustment is recommended. Dificid for oral suspension is supplied as granules in bottles containing 5. Each ml contains 40 mg fidaxomicin after reconstitution with ml purified.
Fidaxomicin dificlir is the first in a new class of macrocylic antibiotics and has recently been licensed by the european medicines agency ema for the treatment of clostridium difficile infection cdi. In selected patients n8 treated with dificid 200 mg twice daily for 10 days from controlled trials, fecal concentrations of fidaxomicin and op1118 obtained within 24 hours of the last dose ranged from 6392710 mcgg and 2 1210 mcgg, respectively. Fidaxomicin macroclide, hydrolyzed to active metabolite bactericidal. Fda in may 2011 for the treatment of clostridium difficileassociated diarrhea cdad, joining metronidazole and vancomycin as drugs recommended for treatment of c. Each ml contains 40 mg fidaxomicin after reconstitution with ml purified water. Fidaxomicin, sold under the brand name dificid among others, is the first member of a class of narrow spectrum macrocyclic antibiotic drugs called tiacumicins. Coadministration of single doses of the pgp inhibitor cyclosporine a and fidaxomicin in healthy. Patents listed in the fda orange book drug database of fidaxomicin with information and expiryexpiration dates. Dificid fidaxomicin is considered medically necessary. Since there is minimal systemic absorption of fidaxomicin, dificid is not effective for treatment of systemic infections. Highlights of prescribing information o for instructions. However, this medicine will not work for colds, flu, or other virus infections.
It works by killing bacteria or preventing their growth. Downloading fda package insert for fidaxomicin tablet. Antiinfective pregnancy risk category b action bactericidal against clostridium difficile in vitro, inhibiting rna synthesis by rna. If you believe that you meet the eligibility criteria for the merck patient assistance program and you have received a prescription for a merck product, call tollfree 8007275400 8 am to 8 pm et to obtain a brochure outlining the program and an enrollment application, or by clicking on the link on the right. If the quantity dose requested exceeds the maximum fda labeled dose, when specified, or to the safest studied dose per the manufacturers product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended. Drugs az pill identifier supplements symptom checker diseases dictionary media. Apr 07, 2020 see enclosed package insert for preparation instructions. And prior treatments or failures with metronidazole and vancomycin. Apr 01, 2020 dificid fidaxomicin for oral suspension. Fidaxomicin belongs to the class of medicines known as macrolide antibiotics. Fidaxomicin is used to treat diarrhea caused by clostridium difficile c.
Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for dificid fidaxomicin skip to. Dificid fidaxomicin tablets for oral administration. Fidaxomicin previously known as opt80, par101, tiacumicin b and difimicin received health canada approval dificid, merck and co, usa in june 2012 for the treatment of adults with a cdi dificid product monograph. Fidaxomicin dificid for clostridium difficile infection.
Fidaxomicin definition of fidaxomicin by medical dictionary. In patients with cdi, fidaxomicin exhibited a lower reappearance of toxin in fecal filtrates and inhibited. We acknowledge receipt of your amendments dated february 22, march 18 and march 29, 20. Dificid is not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicinsee clinical pharmacology 12. Nov 18, 2019 patients on oral vancomycin or oral fidaxomicin could have also received intravenous metronidazole. The 2 cases of positive rechallenge support this association. Fidaxomicin is a substrate of the pglycoprotein pgp efflux system.
Dificid fidaxomicin dosing, indications, interactions. And prior treatments or failures with metronidazole and. Fidaxomicin dificlir is the first in a new class of macrocylic antibiotics and has recently been licensed by the european medicines agency ema for the treatment of clostridium difficile. Dificid should only be used for the treatment ofcdad. In selected patients n8 treated with fidaxomicin 200 mg twice daily for 10 days from controlled trials, fecal. Dificid fidaxomicin is a macrolide antibacterial drug used to reduce the development of drugresistant bacteria and to treat clostridium difficileassociated diarrhea cdad in adults over the. Fidaxomicin side effects, dosage, interactions drugs. Fidaxomicin is minimally absorbed into the bloodstream when taken orally, is bactericidal, and selectively eradicates. Side effects of dificid fidaxomicin tablets for oral. A multicenter study of fidaxomicin use for clostridium. Difficile infection can often be cured by discontinuing the antibiotics responsible. For outlook, click inside of the body of an item, such as an email message or calendar event.
Fda in may 2011 for the treatment of clostridium difficileassociated diarrhea cdad, joining metronidazole and vancomycin as drugs recommended. See enclosed package insert for preparation instructions. The purpose of this pharmacoepidemiology study was to assess outcomes of patients given fidaxomicin based on episode number and use of concomitant antibiotics. In conclusion, the described events are consistent with hypersensitivity reactions associated with fidaxomicin use. It has a narrow spectrum of antimicrobial activity against most. Do not have any immunizations vaccinations while using this medication unless your doctor tells you to. Fidaxomicin belongs to a group of macrocyclic antibiotic drugs. This changes being effected supplemental new drug application provides for the following revisions to the package insert.
These particular pharmaceutical drugs have a molecular structure comprised of a large macrolide ring to which one or. Fidaxomicin supplier buy cas 873857626 api supplies. Fidaxomicin vs vancomycin for clostridium difficile. Fidaxomicin pharmacokinetics absorption bioavailability. Fidaxomicin plasma levels were increased, but not clinically significant. Dificid has not been studied for the treatment of infections other than cdad. Fidaxomicin, a nonabsorbed macrocyclic compound, is the first antimicrobial agent approved by the fda for the treatment of clostridium difficile infection cdi in adults over the last 25 years. Dificlir 200 mg filmcoated tablets summary of product. Coadministration of single doses of the pgp inhibitor cyclosporine a and fidaxomicin in healthy volunteers, resulted in a 4 and 2fold increase in fidaxomicin c max and auc, respectively and in a 9. The day of the infusion of zinplava or placebo in relation to the start of soc ranged from the day prior to the start of soc to 14 days after the start of soc with the median being.