Zydelig: Package Insert and Label Information (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Zydelig tablets supplied as follows:

Tablet Strength	Package Configuration	NDC No.	Description of Tablet; Debossed on Tablet
150 mg	High density polyethylene (HDPE) bottle with a polyester fiber coil, capped with a child-resistant closure. Each bottle contains 60 film-coated tablets.	61958-1702-1	Oval shaped; pink; “150” on one side and “GSI” on the other side
100 mg		61958-1701-1	Oval-shaped; orange; “100” on one side and “GSI” on the other side

Store between 20–30 °C (68–86 °F) with excursions permitted 15–30 °C (59–86 °F).

• Dispense only in original container.
• Do not use if seal over bottle opening is broken or missing.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Hepatotoxicity

Advise patients that Zydelig can cause significant elevations in liver enzymes, and that serial testing of serum liver tests (ALT, AST, and bilirubin) are recommended while taking Zydelig [see Warnings and Precautions (5.1)]. Advise patients to report symptoms of liver dysfunction including jaundice, bruising, abdominal pain, or bleeding.

Severe Diarrhea or Colitis

Advise patients that Zydelig may cause severe diarrhea or colitis and to notify their healthcare provider immediately if the number of bowel movements in a day increases by six or more [see Warnings and Precautions (5.2)].

Pneumonitis

Advise patients of the possibility of pneumonitis, and to report any new or worsening respiratory symptoms including cough or dyspnea [see Warnings and Precautions (5.3)].

Infections

Advise patients that Zydelig can cause serious infections that may be fatal. Advise patients to immediately report symptoms of infection (e.g. pyrexia) [see Warnings and Precautions (5.4)].

Intestinal Perforation

Advise patients of the possibility for intestinal perforation and to notify their healthcare provider immediately if they experience severe abdominal pain [see Warnings and Precautions (5.5)].

Severe Cutaneous Reactions

Advise patients that Zydelig may cause severe cutaneous reactions and to notify their healthcare provider immediately if they develop a severe skin reaction [see Warnings and Precautions (5.6)].

Hypersensitivity Reactions

Advise patients that anaphylaxis can occur during treatment with Zydelig and to notify their healthcare provider immediately if they experience a hypersensitivity reaction, including anaphylaxis [see Warnings and Precautions (5.7)].

Neutropenia

Advise patients of the need for periodic monitoring of blood counts. Advise patients to notify their healthcare provider immediately if they develop a fever or any signs of infection [see Warnings and Precautions (5.8)].

Embryo-Fetal Toxicity

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.9), Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment with Zydelig and for 1 month after the last dose [see Use in Specific Populations (8.3)].

Advise males with female partners of reproductive potential to use effective contraception during treatment with Zydelig and for 3 months after receiving the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment with Zydelig and for 1 month after the last dose [see Use in Specific Populations (8.2)].

Instructions for Taking Zydelig

Advise patients to take Zydelig exactly as prescribed and not to change their dose or to stop taking Zydelig unless they are told to do so by their healthcare provider. Zydelig may be taken with or without food. Zydelig tablets should be swallowed whole. Advise patients that if a dose of Zydelig is missed by less than 6 hours, to take the missed dose right away and take the next dose as usual. If a dose of Zydelig is missed by more than 6 hours, advise patients to wait and take the next dose at the usual time [see Dosage and Administration (2.1)].

Manufactured and distributed by:

Gilead Sciences, Inc.

Foster City, CA 94404

GSI and Zydelig are trademarks or registered trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.

© 2022 Gilead Sciences, Inc. All rights reserved.

205858-GS-006-PI

This Medication Guide has been approved by the U.S. Food and Drug Administration.		Revised: 2/2022
MEDICATION GUIDEZYDELIG® (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 right away if you get any of the following symptoms during treatment with Zydelig: painful sores or ulcers on your skin, lips, or in your mouth severe rash with blisters or peeling skin rash with itching fever enlarged lymph nodes If you have any of the above serious side effects during treatment with Zydelig, your healthcare provider may completely stop your treatment, stop your treatment for a period of time, or change your dose of Zydelig. See “What are the possible side effects of Zydelig?“ for more information about side effects.
What is Zydelig? Zydelig is a prescription medicine used to treat people with chronic lymphocytic leukemia (CLL), in combination with rituximab, when CLL comes back after prior cancer treatment and when rituximab treatment alone may be used due to other health problems.Zydelig should not be used as the first medicine to treat anyone, including people with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other slow growing (indolent) non-Hodgkin lymphomas.Zydelig should not be used in combination with bendamustine and rituximab, or in combination with rituximab to treat people with FL, SLL, and other indolent non-Hodgkin lymphomas.It is not known if Zydelig is safe and effective in children.
Do not take Zydelig if you: have had a serious allergic reaction to idelalisib. have had a severe skin reaction called toxic epidermal necrolysis (TEN) to any drug.
Before taking Zydelig, tell your healthcare provider about all of your medical conditions, including if you: have liver problems have lung problems have an infection are pregnant or plan to become pregnant. Zydelig may harm your unborn baby. Females who are able to become pregnant should have a pregnancy test before starting treatment with Zydelig. Females who are able to become pregnant should use effective birth control (contraception) during treatment with Zydelig and for 1 month after the last dose of Zydelig. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Zydelig. Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with Zydelig and for 3 months after the last dose. are breastfeeding or plan to breastfeed. It is not known if Zydelig passes into your breast milk. Do not breastfeed during your treatment with Zydelig and for 1 month after the last dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Zydelig and certain other medicines may affect each other. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take Zydelig? Take Zydelig exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose of Zydelig or tell you to stop taking Zydelig. Do not change your dose or stop taking Zydelig without first talking to your healthcare provider. Take Zydelig 2 times a day. You may take Zydelig with or without food. Take Zydelig tablets whole. Do not miss a dose of Zydelig. If you miss a dose of Zydelig by less than 6 hours, take the missed dose right away. Then take your next dose as usual. If you miss a dose of Zydelig by more than 6 hours, wait and take the next dose of Zydelig at your usual time.
What are the possible side effects of Zydelig?Zydelig can cause serious side effects, including: See “What is the most important information I should know about Zydelig?“ Serious allergic reactions, including a severe reaction known as anaphylaxis. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a serious allergic reaction during treatment with Zydelig, including:
	swelling of the face, lips, or tongue trouble breathing or swallowing feeling dizzy or faint	rash or hives cough a fast heartbeat
Low white blood cell count (neutropenia). Neutropenia is common during treatment with Zydelig and can sometimes be severe. Your healthcare provider will check your blood counts regularly during treatment with Zydelig. Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with Zydelig.
The most common side effects of Zydelig when used in combination with rituximab include:
pneumonia fever tiredness		rash cough nausea
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of Zydelig. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Zydelig? Store Zydelig between 68°F to 86°F (20°C to 30°C). Keep Zydelig in its original container. Do not use Zydelig if the seal over the bottle opening is broken or missing. Keep Zydelig and all medicines out of reach of children.
General information about the safe and effective use of Zydelig. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Zydelig for a condition for which it was not prescribed. Do not give Zydelig to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Zydelig that is written for health professionals.
What are the ingredients in Zydelig? Active ingredient: idelalisib Inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, sodium starch glycolate, and magnesium stearate. The tablet coating contains polyethylene glycol, talc, polyvinyl alcohol, titanium dioxide and FD&C Yellow #6 or Sunset Yellow FCF Aluminum Lake (for the 100 mg tablet) and red iron oxide (for the 150 mg tablet).Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404©2022 Gilead Sciences, Inc. All rights reserved For more information, call 1-800-445-3235 or go to www.Zydelig.com.205858-GS-005-MG

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

NDC 61958-1701 -1
60 tablets

Zydelig^®
(idelalisib) Tablets

100 mg

DISPENSER: Each time Zydelig^® is dispensedgive the patient the attached Medication Guide.

PRINCIPAL DISPLAY PANEL — 150 mg Tablet Bottle Label

NDC 61958-1702 -1
60 tablets

Zydelig^®
(idelalisib) Tablets

150 mg

DISPENSER: Each time Zydelig^® is dispensedgive the patient the attached Medication Guide.

ZYDELIG idelalisib tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61958-1701 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IDELALISIB (IDELALISIB) IDELALISIB 100 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE HYDROXYPROPYL CELLULOSE (1600000 WAMW) SODIUM STARCH GLYCOLATE TYPE A POTATO CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED TALC FD&C YELLOW NO. 6 ALUMINUM OXIDE

Product Characteristics Color orange Score no score Shape OVAL Size 10mm Flavor Imprint Code GSI;100 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:61958-1701-1 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205858 07/23/2014

ZYDELIG idelalisib tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61958-1702 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IDELALISIB (IDELALISIB) IDELALISIB 150 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE HYDROXYPROPYL CELLULOSE (1600000 WAMW) SODIUM STARCH GLYCOLATE TYPE A POTATO CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED TALC FERRIC OXIDE RED

Product Characteristics Color pink Score no score Shape OVAL Size 10mm Flavor Imprint Code GSI;150 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:61958-1702-1 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205858 07/23/2014

Labeler — Gilead Sciences, Inc. (185049848)

Revised: 03/2022 Gilead Sciences, Inc.