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Zydelig

(idelalisib)

How does this medication work? What will it do for me?

Idelalisib belongs to the group of cancer-fighting medications known as antineoplastics and more specifically to a class of medications called kinase inhibitors. These medications slow the reproduction of cancerous cells and kills cancerous cells.

Idelalisib is used in combination with another medication, rituximab, to treat a certain type of cancer of the blood (called chronic lymphocytic leukemia [CLL]) that has been previously treated and then returned (relapsed).

Idelalisib is also used to treat follicular lymphoma that has been previously treated unsuccessfully at least twice. Idelalisib has been granted a notice of compliance with conditions (NOC/c) by Health Canada for the treatment of follicular lymphoma. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended adult dose of idelalisib is 150 mg taken by mouth 2 times a day. Idelalisib may be taken with food or on an empty stomach.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose and it is more than 6 hours until your next dose, take it as soon as possible and continue with your regular schedule. If it is less than 6 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

100 mg
Each orange, oval-shaped, film-coated tablet debossed with “GSI” on one side and the number “100” on the other contains 100 mg of idelalisib. Nonmedicinal ingredients: microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, sodium starch glycolate, and magnesium stearate; film coating: Sunset Yellow FCF Aluminum Lake (FD&C Yellow No. 6), polyethylene glycol, talc, polyvinyl alcohol, and titanium dioxide.

150 mg
Each pink, oval-shaped, film-coated tablet debossed with “GSI” on one side and the number “150” on the other contains 150 mg of idelalisib. Nonmedicinal ingredients: microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, sodium starch glycolate, and magnesium stearate; film coating: red iron oxide, polyethylene glycol, talc, polyvinyl alcohol, and titanium dioxide.

Who should NOT take this medication?

Do not take this medication if you are allergic to idelalisib or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • cold symptoms (e.g., stuffy nose, cough)
  • decreased appetite
  • diarrhea (mild)
  • fatigue
  • headache
  • heartburn
  • mouth sores
  • nausea
  • night sweats
  • stomach pain
  • sun sensitivity
  • trouble sleeping
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • fever or chills
  • muscle pain
  • rash
  • severe diarrhea
  • signs of breathing problems (e.g., shortness of breath, troubled breathing, wheezing, or tightness in chest, fast or irregular breathing)
  • signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of a severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

May 3, 2016

Health Canada has issued new restrictions concerning the use of Zydelig (idelalisib). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Birth control: Women who may become pregnant should use effective birth control while taking idelalisib and for at least one month after stopping treatment. Because idelalisib may reduce the effectiveness of birth control pills, a barrier form of birth control should also be used.

Diarrhea: People receiving idelalisib have experienced severe diarrhea or inflammation of the bowel. If you have a history of inflammatory bowel disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Gastrointestinal problems can cause diarrhea that may lead to dehydration (loss of too much water from the body). If you experience severe diarrhea for more than a day, or if you have diarrhea along with fever, decreased urination, dizziness, or a fast heartbeat, contact your doctor immediately.

Infection: As well as killing cancer cells, idelalisib can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. Idelalisib may also reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor will want to test your liver function regularly with blood tests while you are taking this medication.

This medication is not recommended for people with hepatitis or active liver disease.

Lung inflammation: Lung inflammation (pneumonitis) causing difficulty breathing has occurred on rare occasions in some people taking this medication. This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking idelalisib, contact your doctor immediately.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if idelalisib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between idelalisib and any of the following:

  • almotriptan
  • alpha blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
  • amiodarone
  • anti-cancer medications (e.g., cabazitaxel, docetaxel, doxorubicin, etoposide, ifosfamide, irinotecan, vincristine)
  • aprepitant
  • aripiprazole
  • “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • bacillus Calmette-Guérin (BCG)
  • benzodiazepines (e.g., chlordiazepoxide, clonazepam, diazepam, lorazepam)
  • bisoprolol
  • bosentan
  • brentuximab
  • brinzolamide
  • bromocriptine
  • buprenorphine
  • buspirone
  • calcitriol
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • cannabis
  • carbamazepine
  • chloroquine
  • cilostazol
  • colchicine
  • conivaptan
  • inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
  • oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • cyclosporine
  • dantrolene
  • dapsone
  • darifenacin
  • deferasirox
  • denosumab
  • disopyramide
  • dofetilide
  • domperidone
  • dronedarone
  • drospirenone
  • dutasteride
  • echinacea
  • eletriptan
  • enzalutamide
  • eplerenone
  • ergot-containing medications (e.g., dihydroergotamine, ergotamine, or methysergide)
  • eslicarbazepine
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • ethosuximide
  • everolimus
  • fingolimod
  • flutamide
  • “gliptin” diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)
  • guanfacine
  • haloperidol
  • hepatitis C protease inhibitors (e.g., boceprevir, simeprevir, telaprevir)
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)
  • lacosamide
  • leflunomide
  • levomilnacipran
  • lidocaine
  • lomitapide
  • losartan
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • maraviroc
  • mefloquine
  • mestranol
  • methadone
  • mifepristone
  • mirtazapine
  • modafinil
  • montelukast
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • naloxegol
  • nateglinide
  • nefazodone
  • nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
  • ondansetron
  • oxybutynin
  • perampanel
  • phenobarbital
  • phenytoin
  • phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • pimecrolimus
  • pimozide
  • prasugrel
  • praziquantel
  • primidone
  • primaquine
  • progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
  • propafenone
  • protein kinase inhibitors (e.g., bosutinib, dabrafenib, dasatinib, erlotinib, imatinib, lapatinib, nilotinib, pazopanib)
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • quetiapine
  • quinidine
  • quinine
  • ramelton
  • repaglinide
  • rifabutin
  • rifampin
  • rilpivirine
  • rivaroxaban
  • roflumilast
  • romidepsin
  • St. John's wort
  • salmeterol
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • sildenafil
  • simeprevir
  • sirolimus
  • solifenacin
  • "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
  • tacrolimus
  • temsirolimus
  • teniposide
  • tetracycline
  • tetrahydrocannabinol
  • theophylline
  • ticagrelor
  • ticlopidine
  • tocilizumab
  • tolterodine
  • tolvaptan
  • tramadol
  • trazodone
  • tricyclic antidepresssants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • trimethoprim
  • ulipristal
  • vaccines
  • venlafaxine
  • zolpidem
  • zonisamide
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Zydelig

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