Sustained clinical response in adults

In the same studies, DIFICID demonstrated superior sustained response rate vs vancomycin through 25 days after end of treatment

DIFICID® (fidaxomicin) Sustained Clinical Response Rate vs Vancomycin

^aSustained response was defined as clinical response at the end of treatment and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment.

^bCI was derived using Wilson's score method. Approximately 5% to 9% of the data in each trial and treatment arm were missing sustained response information and were imputed using multiple imputation method.

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Since clinical success at the end of treatment and mortality rates were similar across treatment arms (approximately 6% in each group), differences in sustained response were due to lower rates of proven or suspected CDAD during the follow-up period in DIFICID patients.

Efficacy in BI isolates: In patients infected with a BI isolate, similar rates of clinical response at the end of treatment and during the follow-up period were seen in fidaxomicin-treated and vancomycin-treated patients. However, DIFICID did not demonstrate superiority in sustained response when compared with vancomycin in these patients.

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Initial Clinical Response

Indication

DIFICID is a macrolide antibacterial drug indicated in adult and pediatric patients 6 months of age and older for treatment of Clostridioides difficile-associated diarrhea (CDAD).

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

Selected Safety Information

DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID.
Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema of the mouth, throat, and face have been reported with DIFICID. If a severe hypersensitivity reaction occurs, DIFICID should be discontinued and appropriate therapy should be instituted.
DIFICID is not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin. DIFICID has not been studied for the treatment of infections other than CDAD. DIFICID should only be used for the treatment of CDAD.
Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.
The most common adverse reactions in adults reported in clinical trials are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%).
Among adult patients receiving DIFICID, 33 (5.9%) withdrew from trials as a result of adverse reactions. Vomiting was the primary adverse reaction leading to discontinuation of dosing (incidence of 0.5% for both DIFICID and vancomycin patients).
The most common adverse reactions in pediatric patients treated with DIFICID are pyrexia (13.3%), abdominal pain (8.2%), vomiting (7.1%), diarrhea (7.1%), constipation (5.1%), increased aminotransferases (5.1%), and rash (5.1%).
The safety and effectiveness of DIFICID in patients <6 months of age have not been established.
The recommended dose of DIFICID for adults and pediatric patients weighing at least 12.5 kg and able to swallow tablets is one 200 mg tablet orally twice daily for 10 days, with or without food. The recommended weight-based dosage of the oral suspension in pediatric patients (weighing at least 4 kg) is twice daily for 10 days.
No dose adjustment is recommended for patients ≥ 65 years of age.
No dose adjustment is recommended for patients with renal impairment.
No dosage adjustments are recommended when co-administering fidaxomicin with substrates of P-gp or CYP enzymes.
The impact of hepatic impairment on the pharmacokinetics of fidaxomicin has not been evaluated; however, because fidaxomicin and its active metabolite (OP-1118) do not appear to undergo significant hepatic metabolism, elimination of fidaxomicin and OP-1118 is not expected to be significantly affected by hepatic impairment.

Before prescribing DIFICID® (fidaxomicin), please read the Prescribing Information. The Patient Information also is available.

Indication

DIFICID is a macrolide antibacterial drug indicated in adult and pediatric patients 6 months of age and older for treatment of Clostridioides difficile-associated diarrhea (CDAD).

Selected Safety Information

DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID.
Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema of the mouth, throat, and face have been reported with DIFICID. If a severe hypersensitivity reaction occurs, DIFICID should be discontinued and appropriate therapy should be instituted.
DIFICID is not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin. DIFICID has not been studied for the treatment of infections other than CDAD. DIFICID should only be used for the treatment of CDAD.
Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.
The most common adverse reactions in adults reported in clinical trials are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%).
Among adult patients receiving DIFICID, 33 (5.9%) withdrew from trials as a result of adverse reactions. Vomiting was the primary adverse reaction leading to discontinuation of dosing (incidence of 0.5% for both DIFICID and vancomycin patients).
The most common adverse reactions in pediatric patients treated with DIFICID are pyrexia (13.3%), abdominal pain (8.2%), vomiting (7.1%), diarrhea (7.1%), constipation (5.1%), increased aminotransferases (5.1%), and rash (5.1%).
The safety and effectiveness of DIFICID in patients <6 months of age have not been established.
The recommended dose of DIFICID for adults and pediatric patients weighing at least 12.5 kg and able to swallow tablets is one 200 mg tablet orally twice daily for 10 days, with or without food. The recommended weight-based dosage of the oral suspension in pediatric patients (weighing at least 4 kg) is twice daily for 10 days.
No dose adjustment is recommended for patients ≥ 65 years of age.
No dose adjustment is recommended for patients with renal impairment.
No dosage adjustments are recommended when co-administering fidaxomicin with substrates of P-gp or CYP enzymes.
The impact of hepatic impairment on the pharmacokinetics of fidaxomicin has not been evaluated; however, because fidaxomicin and its active metabolite (OP-1118) do not appear to undergo significant hepatic metabolism, elimination of fidaxomicin and OP-1118 is not expected to be significantly affected by hepatic impairment.

Before prescribing DIFICID® (fidaxomicin), please read the Prescribing Information. The Patient Information also is available.

US-DIF-0100707/21