Darunavir Tablets and Idelalisib

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Idelalisib may cause serious and life-threatening liver problems, and using it with other medications that can also affect the liver such as darunavir may increase that risk. Darunavir can also increase the blood levels of idelalisib. In addition to liver problems, this may increase the risk and/or severity of other side effects such as diarrhea, intestinal wall perforation, lung or breathing problems, and low white blood cell and platelet counts. You may need a dose adjustment or more frequent monitoring by your doctor to safely use both medications. Call your doctor immediately if you have 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, as these may be signs and symptoms of liver damage. Also let your doctor know if the number of bowel movements per day increases by six or more, or if you experience other potentially serious side effects such as infection, coughing, difficulty breathing, and shortness of breath. 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.

GENERALLY AVOID: Coadministration of idelalisib with other agents known to induce hepatotoxicity may potentiate the risk of liver injury. The use of idelalisib has been associated with elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 5 times the upper limit of normal. Serious and fatal hepatotoxicity occurred in 14% of patients treated with idelalisib in premarketing trials. Liver enzyme elevations were generally observed within the first 12 weeks of treatment and were reversible with dose interruption. Following treatment resumption at a lower dose, 26% of patients had recurrence of ALT and AST elevations.

MONITOR: Coadministration with inhibitors of CYP450 3A4 and/or P-glycoprotein (P-gp) may increase the plasma concentrations of idelalisib, which is a substrate of both the isoenzyme and efflux transporter. In healthy volunteers, administration of a single 400 mg dose of idelalisib with the potent CYP450 3A4 and P-gp inhibitor ketoconazole (400 mg daily for 4 days) resulted in a 1.8-fold increase in mean idelalisib systemic exposure (AUC). No change was observed in mean peak plasma concentration (Cmax).

MANAGEMENT: The use of idelalisib with other potentially hepatotoxic agents such as azole antifungal agents, macrolide antibiotics, nefazodone, ritonavir, and telithromycin should be avoided whenever possible. In addition, these agents are potent CYP450 3A4/P-gp inhibitors and may increase the toxicity of idelalisib. Caution is advised if coadministration is required. Patients should be closely monitored for hepatotoxicity and other toxicities of idelalisib such as diarrhea, colitis, intestinal perforation, pneumonitis, neutropenia and thrombocytopenia, and the dosing adjusted or interrupted as necessary. Patients should have serum ALT, AST, and bilirubin measured prior to initiation of treatment and regularly during treatment in accordance with the product labeling. Permanent discontinuation of idelalisib is recommended in those who experience recurrent hepatotoxicity following dosage reduction. Patients should be advised to seek medical attention if they experience potential signs and symptoms of hepatotoxicity such as fever, rash, itching, anorexia, nausea, vomiting, fatigue, malaise, right upper quadrant pain, dark urine, pale stools, and jaundice.

Darunavir Tablets

Generic Name: darunavir

Brand name: Prezista

Synonyms: Darunavir

What is Darunavir Tablets?

Idelalisib

Generic Name: idelalisib

Brand name: Zydelig

Synonyms: n.a.

What is Idelalisib?