Patient Medication Information: uses, side effects, how to take - Zydelig

What is ZYDELIG used for?

ZYDELIG is used in adults to treat the following types of cancers:

Chronic Lymphocytic Leukemia (CLL): ZYDELIG is used in combination with rituximab to treat a blood and bone marrow cancer. It is called chronic lymphocytic leukemia (CLL). ZYDELIG is used when you have been previously treated for your cancer.
Follicular Lymphoma (FL): ZYDELIG is used alone to treat a blood cancer. It is called follicular lymphoma (FL). ZYDELIG is used when your cancer did not respond to at least two previous treatments, including rituximab and an alkylating agent.

ZYDELIG is NOT for use in children under the age of 18 years.

How does ZYDELIG work?

ZYDELIG blocks a specific protein in the body that helps cancer cells live and grow. This protein is called “PI3 Kinase”. By blocking this protein, ZYDELIG may help kill and reduce the number of cancer cells and slow the spread of the cancer in your body.

What are the ingredients in ZYDELIG?

Medicinal ingredients: idelalisib.

Serious Warnings and Precautions

Take ZYDELIG only under the care of a qualified doctor who knows how to use drugs to treat cancer.

During treatment and for 2 to 6 months after you stop taking ZYDELIG:

take antibiotics to prevent a type of pneumonia called Pneumocystis.
continue to be monitored for a viral infection called cytomegalovirus.

Hepatotoxicity (liver damage) is a serious side effect.

Serious side effects that can lead to death include:

Serious infections.
Severe diarrhea and colitis (digestive disease).
Pneumonitis (severe lung problems).
Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (severe skin reactions).

Non-medicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, and sodium starch glycolate, talc, and titanium dioxide.

100 mg orange tablets also have: FD&C Yellow #6/Sunset Yellow, and FCF Aluminum Lake.

150 mg pink tablets also have: red iron oxide

ZYDELIG comes in the following dosage forms:

Tablets: 100 mg, 150 mg

Do not use ZYDELIG if:

if you are allergic to idelalisib or any of the other ingredients in this product.

ZYDELIG should not be prescribed by your healthcare professional as the first medicine to treat CLL or as the first or second medicine to treat FL.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ZYDELIG. Talk about any health conditions or problems you may have, including if you:

have an infection from any cause such as bacteria, fungus or virus. Serious infections can happen while taking ZYDELIG. Your doctor will prescribe a medicine and check your blood to reduce the risk of getting certain infections.
have liver damage, hepatitis or liver disease. Before and while taking ZYDELIG, you will have regular blood tests to check your liver. Your doctor may decide to stop treatment, or briefly stop treatment to let your liver get better, before starting the treatment again at a lower dose.
have severe diarrhea. Diarrhea is common while taking ZYDELIG and can sometimes be severe. Tell your doctor right away if the number of bowel movements you have in a day increases to four or more times. Ask your doctor about medicines you can take to treat your diarrhea.
have breathing or severe lung problems. Your doctor may do tests to check your lungs if you have breathing problems while taking ZYDELIG.
have severe skin reactions.

Pregnancy, birth control and breastfeeding:

ZYDELIG should not be used during pregnancy. While on ZYDELIG do NOT get pregnant. ZYDELIG can harm your unborn baby.
Use a reliable method of birth control while taking ZYDELIG and for 1 month after you stop taking ZYDELIG. Talk to your doctor about the birth control you may use.
ZYDELIG may make the birth control pill or oral contraceptive not work as well. You must also add a barrier method to be sure you do not get pregnant while taking ZYDELIG and for 1 month after your last treatment.
Tell your doctor right away if you become pregnant while taking ZYDELIG.
Do not breastfeed while taking ZYDELIG. If you are currently breastfeeding, talk to your doctor before starting treatment. It is not known if ZYDELIG passes into human milk.

Other warnings you should know about:

Progressive Multifocal Leukoencephalopathy (PML):

Cases of PML have been reported following ZYDELIG use. PML is a rare brain infection that can be fatal. Tell your doctor right away if you notice or someone notices in you: progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, changes in thinking, memory and orientation, confusion, personality changes. Your doctor may request further testing if PML is suspected. Your doctor should stop treatment if PML is confirmed.

Serious Allergic Reactions:

Serious allergic reactions can occur while taking ZYDELIG. Get medical help right away if you experience symptoms of an allergic reaction. These include rash, hives, swelling of the face, lips, tongue or throat or difficulty swallowing or breathing. Be sure to tell your doctor if this has happened to you. Your doctor may decide to stop treatment.

Sensitivity to Sunlight:

You may become sensitive to the sun while taking ZYDELIG. You should stay out of the sun or wear sunscreen.

Driving and Using Machines:

ZYDELIG is not likely to affect you being able to drive or use any tools or machines. Use caution until you know how ZYDELIG affects you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ZYDELIG:

alfentanil, fentanyl (used for pain relief).
amiodarone, disopyramide, lidocaine, quinidine (used to treat heart problems).
amlodipine, diltiazem, felodipine, nifedipine (used to treat high blood pressure and heart problems).
atorvastatin, lovastatin, simvastatin (used to lower cholesterol).
buspirone, clorazepate, diazepam, flurazepam, zolpidem (used to treat nervous system disorders).
carbamazepine, phenytoin, S-mephenytoin (used to prevent seizures).
cyclosporine, sirolimus, tacrolimus (used to control your body’s immune response after a transplant).
dihydroergotamine, ergotamine (used to treat migraines or headaches).
ketoconazole (used to treat fungal infections).
midazolam, triazolam (used to help you sleep and/or relieve anxiety).
pimozide (used to treat illnesses affecting the way you think, feel or behave).
quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder).
quinidine (used to treat irregular heartbeats).
raloxifene (used to treat or prevent bone loss).
repaglinide (used to lower blood sugar).
rifampicin (used to prevent and treat tuberculosis and other infections).
St. John’s wort (Hypericum perforatum, an herbal product used for anxiety or depression).
sildenafil, tadalafil (used to treat impotence and pulmonary hypertension, a lung disease that
- makes breathing difficult).
oral or implanted hormonal contraceptives (used to prevent pregnancy).
warfarin (used to thin the blood).

How to take ZYDELIG:

Take ZYDELIG every day. Follow the instructions from your doctor, exactly as it says on the label. Set up a dosing schedule and follow it carefully. Talk to your healthcare professional if you have any questions.
Take this medicine with or without food.
Your doctor will tell you the dose of rituximab that is right for you.
Do not change or stop your treatment without first talking with your doctor. Take ZYDELIG every day until your doctor tells you to stop. This happens if your cancer no longer responds to the drug or you have unacceptable side effects.

It is important to see your doctor regularly while taking ZYDELIG. Only take medicine that has been prescribed to you. Do not give ZYDELIG to others.

Recommended Adult Dose: one 150 mg tablet twice a day.

Your doctor may reduce your dose of ZYDELIG to 100 mg twice a day if you experience side effects.

Overdose:

If you think you have taken too much ZYDELIG, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

It is important to take ZYDELIG each day.

If you miss a dose of ZYDELIG and it is less than 6 hours from the time you usually take ZYDELIG, take the dose right away.
If more than 6 hours has passed from the time you usually take ZYDELIG, wait and take the next dose at your usual time. Do NOT take a double dose (two doses close together).

What are possible side effects from using ZYDELIG?

These are not all the possible side effects you may feel when taking ZYDELIG. If your side effect is not listed here, contact your doctor. Side effects may occur at any time, even months or a year after starting or stopping ZYDELIG.

Side effects may include:

diarrhea, nausea, vomiting.
heartburn, stomach pain, decreased appetite.
sores/ulcers in the mouth and/or on the lips.
headache.
fatigue, feeling tired.
trouble sleeping.
stuffy nose, colds, sinus infections, bronchitis, cough.
rash.
chills.
night sweats.
muscle pain.
joint pain.

ZYDELIG can cause abnormal blood test results, including, but not limited to, high and low blood sugar. Your doctor will decide when to perform blood tests and will read the results. You will need a blood test at least every 2 weeks for the first 6 months on ZYDELIG.

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional			Stop taking drug and get immediate medical help
	Only if severe		In all cases
VERY COMMON
Hepatotoxicity (liver damage): yellowing of your skin or eyes, dark urine, pain in your abdomen, nausea, vomiting, loss of appetite			✓
Fever		✓
Severe diarrhea and colitis (digestive disease): increased number of bowel movements, watery or bloody stool, stomach pain and/or cramps			✓
Neutropenia (low numbers of white blood cells): fever, chills or sweating, or any signs of infection			✓
Serious infections: fever, sweats, or chills, cough or flu-like symptoms like rapid breathing, shortness of breath, blood in your phlegm, muscle aches, pain in your stomach					✓
COMMON
Pneumonitis or pneumonia (severe lung problems caused by a fungus called Pneumocystis or a virus called cytomegalovirus): new or worsening cough, shortness of breath, difficult or painful breathing, wheezing, pain in chest when breathing, fever			✓

Severe skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms [DRESS]): skin rash that spreads quickly, redness, fever, enlarged lymph nodes, blistering and peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals		✓
Peripheral edema: swelling, especially of the ankles and feet	✓
Urinary tract infection: strong and frequent urge to urinate, cloudy, bloody or strong smelling urine, pain or burning sensation when urinating	✓
UNCOMMON
Serious allergic reactions: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing		✓
Progressive multifocal leukoencephalopathy (PML) (a rare brain infection): progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, changes in thinking, memory and orientation, confusion, personality changes		✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store below 30 °C (86 °F).
Do not use ZYDELIG if the seal over the bottle opening is broken or missing.
Keep out of reach and sight of children.

If you want more information about ZYDELIG:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.gilead.ca), or by calling 1-800-207-4267.

Revised: August 18, 2020

Gilead Sciences, Inc.

Foster City, CA 94404

USA

Gilead Sciences Canada, Inc.

Mississauga, ON L5N 2W3 ZYDELIG^®is a trademark of Gilead Sciences, Inc. or its related companies.

All other marks referenced herein are property of their respective owners.

e165440-GS-006

Zydelig: Uses, Side Effects and Dosage