Ideenat Tablet

Idelalisib is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Idelalisib is a kinase inhibitor indicated for the treatment of patients with: Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Limitations of use: Idelalisib is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas. Idelalisib is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION Fatal and/or serious hepatotoxicity occurred in 16% of Idelalisib-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Idelalisib as recommended. Fatal and/or serious and severe diarrhea or colitis occurred in 20% of Idelalisib-treated patients. Monitor for the development of severe diarrhea or colitis. Fatal and/or serious pneumonitis occurred in 4% of Idelalisib-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Idelalisib as recommended. Fatal and/or serious infections occurred in 48% of Idelalisib-treated patients. Monitor for signs and symptoms of infection. Interrupt Idelalisib if infection is suspected. Fatal and serious intestinal perforation can occur in Idelalisib-treated patients across clinical trials. Discontinue Idelalisib for intestinal perforation. WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION See full prescribing information for complete boxed warning. Fatal and/or serious hepatotoxicity occurred in 16% of Idelalisib-treated patients. Interrupt and then reduce or discontinue Idelalisib. Interrupt or discontinue Idelalisib. Discontinue Idelalisib if intestinal perforation is suspected. Severe Cutaneous Reactions: Monitor patients for the development of severe cutaneous reactions. Permanently discontinue Idelalisib if confirmed. Hypersensitivity Reactions: Permanently discontinue Idelalisib and institute appropriate supportive measures. Neutropenia: Monitor blood counts. Interrupt Idelalisib until resolution and resume at reduced dose. Embryo-fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. Hepatotoxicity Fatal and/or serious hepatotoxicity occurred in 16% of patients treated with Idelalisib in combination with rituximab or with unapproved combination therapies. Elevations in ALT or AST greater than 5 times the upper limit of normal have occurred. These findings were generally observed within the first 12 weeks of treatment and were reversible with dose interruption. After resumption of treatment at a lower dose, 26% of patients had recurrence of ALT and AST elevations. Discontinue Idelalisib for recurrent hepatotoxicity. Avoid concurrent use of Idelalisib with other drugs that may cause liver toxicity. Monitor ALT and AST in all patients every 2 weeks for the first 3 months of treatment, every 4 weeks for the next 3 months, then every 1 to 3 months thereafter. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling. Hepatotoxicity Severe Diarrhea or Colitis Pneumonitis Infections Intestinal Perforation Severe Cutaneous Reactions Hypersensitivity Reactions Neutropenia The most common adverse reactions (incidence ≥30%) in patients treated with Idelalisib in combination trials are diarrhea, pneumonia, pyrexia, fatigue, rash, cough, and nausea. Common laboratory abnormalities are neutropenia, ALT elevations and AST elevations. at -5 or FDA Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to Idelalisib at a dosage of 150 mg twice daily in 110 patients administered in combination with rituximab in Study 312-0116, and in combination with other drugs in 380 patients. Among 490 patients who received Idelalisib, 74% were exposed for 6 months or longer and 50% were exposed for one year or longer. In this pooled safety population, the most common (> 30%) adverse reactions were diarrhea, pneumonia, pyrexia, fatigue, rash, cough, and nausea. Common laboratory abnormalities were neutropenia, ALT elevations and AST elevations. Summary of Clinical Trials in Chronic Lymphocytic Leukemia The safety data reflect exposure to Idelalisib from two randomized, double-blind clinical trials (Studies 312-0116 and 312-0115) in 634 patients with relapsed CLL and one randomized, open-label trial in 259 patients with relapsed CLL (Study 312-0119). Idelalisib with Rituximab (Study 312-0116) Patients with relapsed CLL received up to 8 doses of rituximab (R) with (n=110) or without Idelalisib (n=108)150 mg twice daily. The median duration of exposure to Idelalisib was 8 months. Serious adverse reactions were reported in 65 (59%) patients treated with Idelalisib + R The most frequent serious adverse reactions reported for patients treated with Idelalisib + R were pneumonia (23%), diarrhea (10%), pyrexia (9%), sepsis (8%), and febrile neutropenia (5%). Adverse reactions that led to discontinuation of Idelalisib occurred in 19 (17%) patients. The most common adverse reactions that led to treatment discontinuations were hepatotoxicity and diarrhea/colitis. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.