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ZYDELIG is a brand name for Idelalisib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ....................................................................................... 3 CONTRAINDICATIONS ........................................................................................................ 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Carcinogenesis and Mutagenesis The carcinogenicity potential of idelalisib was evaluated in a 26-week transgenic RasH2 mouse study and a 2-year rat study. A small increase in pancreatic islet cell tumors was noted in male rats (see TOXICOLOGY, Carcinogenesis).
ZYDELIG demonstrated no significant mutagenicity or genotoxicity in vitro, but demonstrated genotoxicity in vivo at a high dose (see TOXICOLOGY, Mutagenesis). Drug Interactions Cytochrome P450 (CYP) interactions ZYDELIG is a strong CYP3A inhibitor.
Coadministration of ZYDELIG with CYP3A substrates may increase their systemic exposures. Caution is recommended if ZYDELIG is coadministered with narrow therapeutic index CYP3A substrates (see DRUG INTERACTIONS).
Gastrointestinal Diarrhea/Colitis:
Cases of severe diarrhea/colitis were reported commonly and occurred relatively late (months) after the start of therapy with ZYDELIG. Severe diarrhea due to ZYDELIG responds poorly to antimotility agents. , anti-inflammatory corticosteroid Serious Warnings and Precautions ZYDELIG® should only be prescribed by a qualified physician who is experienced in the use of anti-cancer agents.
Prophylaxis for Pneumocystis carinii/jirovecii pneumonia (PCP/PJP) and monitoring for cytomegalovirus (CMV) are required during treatment with ZYDELIG. The following are clinically significant adverse events: Serious infections, including fatal cases (see Serious Infections below) Hepatotoxicity (see Hepatic below) Severe diarrhea/colitis, including fatal cases (see Gastrointestinal below) Pneumonitis, including fatal cases (see Respiratory below) Severe cutaneous reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), and fatal cases of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (see Skin below) ZYDELIG (idelalisib) tablets Product Monograph Page 6 agents such as enteric budesonide) but some had a fatal outcome (see DOSAGE AND ADMINISTRATION, Dose Modification).
Severe diarrhea/colitis occurring with administration of ZYDELIG has been associated with dehydration which has responded to intravenous fluid and electrolyte replacement. Causes of diarrhea related to gastrointestinal infection should be ruled out.
, loperamide) and maintain ZYDELIG dose. For Grade 2 diarrhea/colitis, withhold ZYDELIG and monitor at least weekly until resolved to Grade ≤1. For CTCAE Grade 3 or 4 diarrhea/colitis, withhold ZYDELIG. , sulfasalazine, budesonide). Monitor at least weekly until resolved to Grade ≤1, then may resume ZYDELIG at 100 mg BID.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Treatment of patients with ongoing inflammatory bowel disease is not recommended.
Hematologic Neutropenia:
Treatment-emergent Grade 3 or 4 neutropenia and cases of febrile neutropenia, some which have been fatal, have occurred in patients treated with ZYDELIG. 0 x 109/L (see DOSAGE AND ADMINISTRATION, Dose Modification).
Hepatic Hepatotoxicity:
Elevations in ALT and AST Grade 3 or 4 (greater than 5 times the upper limit of normal) have been observed in clinical trials of ZYDELIG. These laboratory findings were generally observed within the first 12 weeks of treatment, asymptomatic, and reversible within 3-4 weeks with dose interruption.
While most patients resumed treatment at a lower dose, recurrence of ALT and AST elevations were common (see DOSAGE AND ADMINISTRATION, Dose Modification). Monitor ALT, AST, and total bilirubin in all patients every 2 weeks for the first 3 months of treatment, then every 1 to 3 months thereafter, and as clinically indicated.
For CTCAE Grade 1 (ALT/AST ≤3 x ULN) or Grade 2 (ALT/AST > 3-5 x ULN), maintain ZYDELIG dose. Monitor at least weekly until ALT/AST are ≤1 x ULN. ZYDELIG (idelalisib) tablets Product Monograph Page 7 For CTCAE Grade 3 (ALT/AST >5-20 x ULN) or Grade 4 (ALT/AST >20 x ULN), withhold ZYDELIG.
Monitor at least weekly until ALT/AST are ≤1 x ULN, then may resume ZYDELIG at 100 mg BID. Discontinue ZYDELIG for recurrent hepatotoxicity. Treatment of patients with active hepatitis or liver disease is not recommended.
Immune Anaphylaxis:
Serious allergic reactions, including anaphylaxis, have been reported in patients on ZYDELIG. In patients who develop serious allergic reactions, discontinue ZYDELIG permanently and institute appropriate supportive measures.
Serious Infections:
Treatment with ZYDELIG should not be initiated in patients with any evidence of ongoing systemic bacterial, fungal or viral infection. Serious and fatal infections have occurred with ZYDELIG, including opportunistic infections such as Pneumocystis carinii/jirovecii pneumonia (PCP/PJP) and cytomegalovirus (CMV).
An increase in serious adverse events and deaths, primarily due to infections, was observed in patients receiving ZYDELIG compared with the control arms in a first-line study of CLL and two studies of relapsed early-line iNHL. Based on these findings, and the unfavourable benefit/risk assessment at interim analysis, these studies and all first-line studies in patients with CLL or iNHL were terminated.
ZYDELIG is contraindicated in first-line CLL and early-line iNHL outside a clinical trial. Administer prophylaxis for PCP/PJP to all patients throughout ZYDELIG treatment and for a period of 2 to 6 months after discontinuation. The duration of post-treatment prophylaxis should be based on clinical judgment and may take into account a patient’s risk factors such as concomitant corticosteroid treatment and prolonged neutropenia.
Regular clinical and laboratory monitoring for CMV infection should be conducted. Treatment with ZYDELIG should be permanently discontinued if there […]