非达霉素(Dificid)的注意事项及副作用详情

Fidaxomicin (Dificid) is a macrolide antimicrobial drug mainly used to treat Clostridium difficile-associated diarrhea (CDAD). The drug was first approved for marketing in the United States in 2011 and is suitable for adults and pediatric patients 6 months and older.

Fidaxomicin (Dificid) Indications and Applicable Populations

1. Indications

It is used to treat Clostridium difficile-associated diarrhea (CDAD) in adults and children 6 months and older.

2. Applicable groups

Adults and children from 6 months to 18 years old. It is only used for confirmed or highly suspected infections caused by Clostridium difficile.

The pictures come from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Precautions for fidaxomicin (Dificid)

1. Risk of allergic reactions

Such as rash, itching, difficulty breathing, facial swelling, etc. If an allergic reaction occurs, fidaxomicin should be stopped immediately and symptomatic treatment should be given according to the severity of the reaction.

2. Only suitable for Clostridium difficile infection

Due to its extremely low systemic absorption rate, fidaxomicin is not suitable for treating other types of systemic infections. Recommended only for diarrhea with culture or clinical suspicion of being caused by Clostridium difficile. Misuse for other infections is not only ineffective but may also increase the risk of developing drug-resistant bacteria.

3. Drug resistance issue

Use fidaxomicin only when it is confirmed or highly suspected that the infection is caused by Clostridium difficile, and avoid unindicated use of the drug; if the patient's symptoms do not improve or worsen, the pathogen needs to be re-evaluated in a timely manner and the treatment plan should be adjusted to reduce the risk of drug-resistant bacteria.

Side effects of fidaxomicin (Dificid)

1. Adverse reactions in adult patients

In clinical trials, adverse reactions reported by adult patients after taking fidaxomicin with an incidence rate of ≥2% include: nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal bleeding (4%), anemia (2%), and neutropenia (2%).

In addition, a small number of patients have gastrointestinal problems such as abdominal distension, indigestion, dysphagia, intestinal obstruction, and megacolon, as well as abnormal liver function indicators, thrombocytopenia, metabolic acidosis, and skin reactions (such as drug rash, itching, rash, etc.).

2. Adverse reactions in pediatric patients

Common adverse reactions reflected in pediatric clinical trials have an incidence rate of ≥5%, such as fever, abdominal pain, vomiting, diarrhea, constipation, elevated transaminases, rash, etc.

Special population use of fidaxomicin (Dificid)

1. Elderly patients

Elderly patients have higher plasma concentrations of fidaxomicin, but there is no need to adjust the dose, and the safety profile is not significantly different from that of younger patients.

2. Pregnant women

There is currently limited data on the use of fidaxomicin in pregnant women. Animal experiments have shown that no embryotoxicity was found at doses much higher than human exposure. However, there is insufficient human data and it should be used after weighing the pros and cons.

3. Patients with hepatic and renal insufficiency

The pharmacokinetics of fidaxomicin do not change significantly in patients with mild, moderate and severe renal insufficiency, and there is no need to adjust the dose of fidaxomicin.

Specific studies have not been conducted in patients with hepatic impairment, but since the drug is barely metabolized by the liver, hepatic impairment is not expected to significantly affect its clearance.