ZYDELIG- idelalisib tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IDELALISIB (UNII: YG57I8T5M0) (IDELALISIB - UNII:YG57I8T5M0)

Available from:

Gilead Sciences, Inc.

INN (International Name):

IDELALISIB

Composition:

IDELALISIB 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Zydelig is contraindicated in patients with a history of serious hypersensitivity reactions to idelalisib, including anaphylaxis, or patients with a history of toxic epidermal necrolysis with any drug [see Warnings and Precautions (5.6, 5.7)] . Risk Summary Based on findings in animal studies and the mechanism of action [see Clinical Pharmac

Product summary:

Zydelig tablets supplied as follows: Store between 20–30 °C (68–86 °F) with excursions permitted 15–30 °C (59–86 °F).

Authorization status:

New Drug Application

Patient Information leaflet

Gilead Sciences, Inc.
----------
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Revised: 2/2022
MEDICATION GUIDE
ZYDELIG® (zye-DEL-ig)
(idelalisib)
tablets
What is the most important information I should know about Zydelig?
Zydelig can cause serious side effects that can lead to death,
including:
•
Liver problems. Abnormal liver blood test results are common during
treatment with Zydelig.
Zydelig can cause severe liver problems. Your healthcare provider will
do blood tests before and
during your treatment with Zydelig to check for liver problems. Tell
your healthcare provider right
away if you get any of the following symptoms of liver problems:
•
yellowing of your skin or the white part of your eyes (jaundice)
•
dark or brown (tea colored) urine
•
pain in the upper right side of your stomach area (abdomen)
•
bleeding or bruising more easily than normal
•
Severe diarrhea. Diarrhea is common during treatment with Zydelig and
can sometimes be severe.
Tell your healthcare provider right away if the number of bowel
movements you have in a day
increases by six or more. Ask your healthcare provider about medicines
you can take to treat your
diarrhea.
•
Lung problems (pneumonitis). Your healthcare provider may do tests to
check your lungs if you have
breathing problems during treatment with Zydelig. Tell your healthcare
provider right away if you
get new or worsening cough, shortness of breath, difficulty breathing,
or wheezing. Your healthcare
provider may treat you with a corticosteroid medicine if you develop
lung problems.
•
Infections. Zydelig can cause serious infections that may lead to
death. Tell your healthcare provider
right away if you have a fever or any signs of an infection during
treatment with Zydelig.
•
Tear in intestinal wall (perforation). Tell your healthcare provider
or get medical help right away if
you get new or worsening stomach area (abdomen) pain, chills, fever,
nausea, or vomiting.
•
Severe skin reactions. Tell your healthcare provider

Summary of Product characteristics

ZYDELIG- IDELALISIB TABLET, FILM COATED
GILEAD SCIENCES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZYDELIG SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZYDELIG.
ZYDELIG® (IDELALISIB) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
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 ZYDELIG-TREATED
PATIENTS.
MONITOR HEPATIC FUNCTION PRIOR TO AND DURING TREATMENT. INTERRUPT AND
THEN REDUCE OR
DISCONTINUE ZYDELIG. (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. (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. (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.
(5.4)
FATAL AND SERIOUS INTESTINAL PERFORATION CAN OCCUR IN ZYDELIG-TREATED
PATIENTS ACROSS
CLINICAL TRIALS. DISCONTINUE ZYDELIG IF INTESTINAL PERFORATION IS
SUSPECTED. (5.5)
RECENT MAJOR CHANGES
Indications and Usage, Relapsed Follicular B-cell non-Hodgkin Lymphoma
– Accelerated Approval
Indication Removed (1)
2/2022
Indications and Usage, Relapsed Small Lymphocytic Lymphoma –
Accelerated Approval Indication
Removed (1)
2/2022
INDICATIONS AND USAGE
Zydelig 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. (1)
Limitations of use:
Zydelig is not indicated and i