NOW APPROVED
FOR
3
INDICATIONS
Visit ZYDELIG.com for more information.
ANNOUNCING
3 INDICATIONS FOR ZYDELIG®:
Relapsed CLL in combination with rituximab where rituximab alone is appropriate
due to comorbidities
Relapsed FL after 2 prior systemic therapies
Relapsed SLL after 2 prior systemic therapies
The FL and SLL indications were granted accelerated approval based on overall response rate;
improvement in patient survival or disease-related symptoms has not been established.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: FATAL AND SERIOUS TOXICITIES:
HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS,
AND INTESTINAL PERFORATION
• Fatal and/or serious hepatotoxicity occurred in 14% of
ZYDELIG-treated patients. Monitor hepatic function prior
to and during treatment. Interrupt and then reduce or
discontinue ZYDELIG as recommended
• Fatal and/or serious and severe diarrhea occurred in 14% of
ZYDELIG-treated patients. Monitor for the development
of severe diarrhea or colitis. Interrupt and then reduce or
discontinue ZYDELIG as recommended
• Fatal and serious pneumonitis can occur. Monitor for pulmonary
symptoms and bilateral interstitial infiltrates. Interrupt or
discontinue ZYDELIG as recommended
• Fatal and serious intestinal perforation can occur in ZYDELIGtreated patients. Discontinue ZYDELIG for intestinal perforation
Contraindications
• History of serious allergic reactions, including anaphylaxis
and toxic epidermal necrolysis (TEN)
Warnings and Precautions
• Hepatotoxicity: Findings were generally observed within the first
12 weeks of treatment and reversed with dose interruption. Upon
rechallenge at a lower dose, ALT/AST elevations recurred in 26% of
patients. In all patients, monitor ALT/AST every 2 weeks for the first
3 months, every 4 weeks for the next 3 months, and every 1 to 3
months thereafter. If ALT/AST is >3x upper limit of normal (ULN),
monitor for liver toxicity weekly. If ALT/AST is >5x ULN, withhold
ZYDELIG and monitor ALT/AST and total bilirubin weekly until
resolved. Discontinue ZYDELIG for recurrent hepatotoxicity. Avoid
concurrent use with other hepatotoxic drugs
• Severe diarrhea or colitis: Grade 3+ diarrhea can occur at any time
and responds poorly to antimotility agents. Avoid concurrent use
with other drugs that cause diarrhea
• Pneumonitis: Evaluate for pneumonitis in patients presenting with
pulmonary symptoms such as cough, dyspnea, hypoxia, interstitial
infiltrates on radiologic exam, or oxygen saturation decline by ≥5%
• Intestinal perforation: Advise patients to promptly report any new
or worsening abdominal pain, chills, fever, nausea, or vomiting
• Severe cutaneous reactions: One case of TEN occurred in a study
of ZYDELIG in combination with rituximab and bendamustine.
Other severe or life-threatening (grade ≥3) cutaneous reactions
have been reported. Monitor patients for the development of
severe cutaneous reactions and discontinue ZYDELIG if a
reaction occurs
• Anaphylaxis: Serious allergic reactions including anaphylaxis have
been reported. Discontinue ZYDELIG permanently and institute
appropriate supportive measures if a reaction occurs
• Neutropenia: Treatment-emergent grade 3-4 neutropenia occurred
in 31% of ZYDELIG-treated patients in clinical trials. I