Drug Interactions between fidanacogene elaparvovec and troleandomycin

After receiving fidanacogene elaparvovec, alcohol consumption should be limited for at least 1 year. Fidanacogene elaparvovec can cause liver problems, which may make the medication less effective in treating your condition. Consuming other substances that can also affect the liver such as alcohol after receiving fidanacogene elaparvovec may increase that risk. Symptoms of liver problems include fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, abdominal pain, dark urine, pale stools, and/or yellowing of the skin or eyes. Blood tests to monitor liver function should be performed before and after treatment with fidanacogene elaparvovec. Talk to your doctor if you have any questions or concerns. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Troleandomycin is primarily excreted by the liver and may accumulate in patients with impaired hepatic function. In addition, the use of troleandomycin has been associated with an allergic type of cholestatic hepatitis, particularly in patients receiving the drug for more than 2 weeks or given repeated courses. Therapy with troleandomycin should be administered cautiously in patients with liver and/or biliary disease. Liver function tests should be monitored during prolonged or repeated courses of therapy, and the drug discontinued if abnormalities develop.

Clostridioides difficile-associated diarrhea (CDAD), formerly pseudomembranous colitis, has been reported with almost all antibacterial drugs and may range from mild diarrhea to fatal colitis. The most common culprits include clindamycin and lincomycin. Antibacterial therapy alters the normal flora of the colon, leading to overgrowth of C difficile, whose toxins A and B contribute to CDAD development. Morbidity and mortality are increased with hypertoxin-producing strains of C difficile; these infections can be resistant to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea after antibacterial use. Since CDAD has been reported to occur more than 2 months after antibacterial use, careful medical history is necessary. Therapy with broad-spectrum antibacterials and other agents with significant antibacterial activity should be administered cautiously in patients with history of gastrointestinal disease, particularly colitis; pseudomembranous colitis (generally characterized by severe, persistent diarrhea and severe abdominal cramps, and sometimes associated with the passage of blood and mucus), if it occurs, may be more severe in these patients and may be associated with flares in underlying disease activity. Antibacterial drugs not directed against C difficile may need to be stopped if CDAD is suspected or confirmed. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C difficile, and surgical evaluation should be started as clinically indicated.

Troleandomycin is primarily excreted by the liver and may accumulate in patients with impaired hepatic function. In addition, the use of troleandomycin has been associated with an allergic type of cholestatic hepatitis, particularly in patients receiving the drug for more than 2 weeks or given repeated courses. Therapy with troleandomycin should be administered cautiously in patients with liver and/or biliary disease. Liver function tests should be monitored during prolonged or repeated courses of therapy, and the drug discontinued if abnormalities develop.

Fidanacogene elaparvovec, a liver-targeting gene therapy, may carry the theoretical risk of hepatocellular carcinoma development. Patients with risk factors for hepatocellular carcinoma (e.g., hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, non-alcoholic steatohepatitis, advanced age) should be monitored with regular liver ultrasound (e.g., annually) and alpha-fetoprotein testing for 5 years following treatment.

Fidanacogene elaparvovec, a liver-targeting gene therapy, may carry the theoretical risk of hepatocellular carcinoma development. Patients with risk factors for hepatocellular carcinoma (e.g., hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, non-alcoholic steatohepatitis, advanced age) should be monitored with regular liver ultrasound (e.g., annually) and alpha-fetoprotein testing for 5 years following treatment.

Fidanacogene elaparvovec, a liver-targeting gene therapy, may carry the theoretical risk of hepatocellular carcinoma development. Patients with risk factors for hepatocellular carcinoma (e.g., hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, non-alcoholic steatohepatitis, advanced age) should be monitored with regular liver ultrasound (e.g., annually) and alpha-fetoprotein testing for 5 years following treatment.

There is limited information on the safety and effectiveness of fidanacogene elaparvovec in patients with HIV infection. Perform HIV testing prior to infusion, and do not administer this product to patients with either CD4+ cell count less than 200 mm3 or viral load equal to or greater than 20 copies/mL in case of serological evidence of HIV-1 or HIV-2 infection.

Fidanacogene elaparvovec, a liver-targeting gene therapy, may carry the theoretical risk of hepatocellular carcinoma development. Patients with risk factors for hepatocellular carcinoma (e.g., hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, non-alcoholic steatohepatitis, advanced age) should be monitored with regular liver ultrasound (e.g., annually) and alpha-fetoprotein testing for 5 years following treatment.

Fidanacogene elaparvovec has not been studied in patients with liver dysfunction. Furthermore, administration of this product can lead to liver transaminase elevations and hepatocyte injury. Patients should undergo a liver health assessment prior to treatment, which includes liver function tests, screening for active hepatitis B or C, and elastography and/or ultrasound to assess liver fibrosis. This product should not be administered to patients with current liver-related coagulopathy, hypoalbuminemia, persistent jaundice, or cirrhosis, portal hypertension, splenomegaly, hepatic encephalopathy, hepatic fibrosis, or active viral hepatitis.

Fidanacogene elaparvovec has not been studied in patients with renal dysfunction.