Zydelig

ZYDELIG- idelalisib tablet, film coated
Gilead Sciences, Inc.

WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION

Fatal and/or serious hepatotoxicity occurred in 16% of Zydelig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Zydelig as recommended [see Dosage and Administration (2.2), Warnings and Precautions (5.1)].

Fatal and/or serious and severe diarrhea or colitis occurred in 20% of Zydelig-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue Zydelig as recommended [see Dosage and Administration (2.2), Warnings and Precautions (5.2)].

Fatal and/or serious pneumonitis occurred in 4% of Zydelig-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Zydelig as recommended [see Dosage and Administration (2.2), Warnings and Precautions (5.3)].

Fatal and/or serious infections occurred in 48% of Zydelig-treated patients. Monitor for signs and symptoms of infection. Interrupt Zydelig if infection is suspected [see Dosage and Administration (2.2), Warnings and Precautions (5.4)].

Fatal and serious intestinal perforation can occur in Zydelig-treated patients across clinical trials. Discontinue Zydelig for intestinal perforation [see Warnings and Precautions (5.5)].

1 INDICATIONS AND USAGE

Zydelig 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.

Limitations of Use

Zydelig 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.

Zydelig 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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosage of Zydelig is 150 mg administered orally twice daily with or without food until disease progression or unacceptable toxicity. The optimal and safe dosing regimen for patients who receive treatment longer than several months is unknown.

Swallow tablets whole.

If a planned dose of Zydelig is missed by less than 6 hours, take the missed dose as soon as possible and take the next dose as usual. If a dose of Zydelig is missed by more than 6 hours, skip the missed dose and take the next dose at the usual time.

2.2 Dosage Modifications for Adverse Reactions

Table 1 presents the dosage modification for specific adverse reactions.

For other severe or life-threatening adverse reactions, withhold Zydelig until resolution. If resuming Zydelig after interruption for other severe or life-threatening toxicities, reduce the dosage to 100 mg orally twice daily. Permanently discontinue Zydelig for recurrence of other severe or life-threatening Zydelig-related toxicity upon rechallenge.

Table 1 Dosage Modifications for Adverse Reactions
Abbreviations: ANC: absolute neutrophil count; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; ULN, upper limit of normal; CMV, cytomegalovirus; DRESS, drug reaction with eosinophilia and systemic symptoms; PCR: polymerase chain reaction; PJP: Pneumocystis jirovecii pneumonia; SJS: Stevens-Johnson syndrome; TEN: toxic epidermal necrolysis
*
Moderate diarrhea: increase of 4–6 stools per day over baseline; severe diarrhea: increase of ≥7 stools per day over baseline.
ALT/AST >3–5 × ULN >5–20 × ULN >20 × ULN
[see Warnings and Precautions (5.1)] Maintain Zydelig dose. Monitor at least weekly until ≤1 × ULN. Withhold Zydelig.Monitor at least weekly until ALT/AST are ≤1 × ULN, then may resume Zydelig at 100 mg BID. Discontinue Zydelig permanently.
Bilirubin >1.5–3 × ULN >3–10 × ULN >10 × ULN
[see Warnings and Precautions (5.1)] Maintain Zydelig dose. Monitor at least weekly until ≤1 × ULN. Withhold Zydelig.Monitor at least weekly until bilirubin is ≤1 × ULN, then may resume Zydelig at 100 mg BID. Discontinue Zydelig permanently.
Diarrhea * Moderate diarrhea Severe diarrhea or hospitalization Life-threatening diarrhea
[see Warnings and Precautions (5.2)] Maintain Zydelig dose. Monitor at least weekly until resolved. Withhold Zydelig.Monitor at least weekly until resolved, then may resume Zydelig at 100 mg BID. Discontinue Zydelig permanently.
Pneumonitis Any symptomatic pneumonitis
[see Warnings and Precautions (5.3)] Discontinue Zydelig in patients with any severity of symptomatic pneumonitis.
Infections Grade 3 or higher sepsis or pneumonia
[see Warnings and Precautions (5.4)] Interrupt Zydelig until infection has resolved.
Evidence of CMV infection or viremia
Interrupt Zydelig in patients with evidence of active CMV infection of any grade or viremia (positive PCR or antigen test) until the viremia has resolved. If Zydelig is resumed, monitor patients by PCR or antigen test for CMV reactivation at least monthly.
Evidence of PJP infection
Interrupt Zydelig in patients with suspected PJP infection of any grade.Permanently discontinue Zydelig if PJP infection is confirmed.
Intestinal Perforation Evidence of intestinal perforation
[see Warnings and Precautions (5.5)] Permanently discontinue Zydelig in patients who experience intestinal perforation.
Severe Cutaneous Reactions Suspected/Confirmed SJS, TEN, DRESS, or other severe or life-threatening (Grade ≥3) cutaneous reactions
[see Warnings and Precautions (5.6)] Interrupt Zydelig in patients with suspected SJS, TEN, or DRESS until the etiology of the reaction has been determined.Permanently discontinue Zydelig in patients with confirmed SJS, TEN, or DRESS, or other severe or life-threatening (Grade ≥3) cutaneous reactions.
Hypersensitivity Reactions Evidence of hypersensitivity reactions
[see Warnings and Precautions (5.7)] Permanently discontinue Zydelig in patients who develop serious hypersensitivity reactions.
Neutropenia ANC 1.0 to <1.5 Gi/L ANC 0.5 to <1.0 Gi/L ANC <0.5 Gi/L
[see Warnings and Precautions (5.8)] Maintain Zydelig dose. Maintain Zydelig dose. Monitor ANC at least weekly. Interrupt Zydelig. Monitor ANC at least weekly until ANC ≥0.5 Gi/L, then may resume Zydelig at 100 mg BID.
Thrombocytopenia Platelets 50 to <75 Gi/L Platelets 25 to <50 Gi/L Platelets <25 Gi/L
[see Adverse Reactions (6.1)] Maintain Zydelig dose. Maintain Zydelig dose. Monitor platelet counts at least weekly. Interrupt Zydelig. Monitor platelet count at least weekly. May resume Zydelig at 100 mg BID when platelets ≥25 Gi/L.

No dosage modification is recommended for lymphocytosis, which has been observed in some patients taking Zydelig. This observed lymphocytosis is a pharmacodynamic effect and should not be considered progressive disease in the absence of other clinical findings.

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