Pronunciation:

eye-del-a-LIS-ib

Brand Names:

• Zydelig

Dosage Forms:

• Tablet

Warnings:

Serious hepatotoxicity, including fatalities, has been reported in 16% of patients administered idelalisib. Fatal and/or serious diarrhea and colitis has also been reported in 20% of idelalisib patients. Monitor hepatic function before and during treatment and monitor for the development of diarrhea or colitis. Fatal and/or serious pneumonitis occurred in 4% of idelalisib patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Serious infections, including fatalities, have been reported in 48% of idelalisib patients. Monitor for signs and symptoms of infection. Fatal and serious intestinal perforation may occur. Interrupt, reduce dose, or discontinue treatment with idelalisib as recommended. Discontinue use if intestinal perforation occurs .

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Idelalisib is used in combination with rituximab to treat chronic lymphocytic leukemia (CLL) that has come back after other treatment. Idelalisib interferes with the growth of cancer cells, which are eventually destroyed by the body. It is an antineoplastic agent (cancer medicine).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of idelalisib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of idelalisib in the elderly. However, elderly patients are more likely to have unwanted effects, which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin
• Alprazolam
• Colchicine
• Conivaptan
• Dihydroergotamine
• Dronedarone
• Eletriptan
• Eliglustat
• Eplerenone
• Ergotamine
• Finerenone
• Gepirone
• Isavuconazonium Sulfate
• Ivabradine
• Lomitapide
• Lovastatin
• Lurasidone
• Maraviroc
• Mavacamten
• Naloxegol
• Pacritinib
• Pimozide
• Ranolazine
• Silodosin
• Simvastatin
• Tolvaptan
• Triazolam
• Ubrogepant
• Venetoclax
• Voclosporin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Acalabrutinib
• Adagrasib
• Ado-Trastuzumab Emtansine
• Alfentanil
• Amiodarone
• Apalutamide
• Aprepitant
• Aripiprazole
• Atogepant
• Avacopan
• Avanafil
• Avapritinib
• Bedaquiline
• Benzhydrocodone
• Boceprevir
• Bosutinib
• Brigatinib
• Bromocriptine
• Budesonide
• Buprenorphine
• Buspirone
• Cabazitaxel
• Cabozantinib
• Calcifediol
• Carbamazepine
• Cariprazine
• Ceritinib
• Cilostazol
• Clarithromycin
• Clozapine
• Cobicistat
• Cobimetinib
• Codeine
• Copanlisib
• Crizotinib
• Dabrafenib
• Daclatasvir
• Daridorexant
• Darifenacin
• Darunavir
• Dasatinib
• Deflazacort
• Delamanid
• Dexamethasone
• Dihydrocodeine
• Docetaxel
• Domperidone
• Duvelisib
• Efavirenz
• Elacestrant
• Elagolix
• Elexacaftor
• Encorafenib
• Entrectinib
• Enzalutamide
• Erlotinib
• Eszopiclone
• Everolimus
• Fedratinib
• Felodipine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Fluticasone
• Fosaprepitant
• Fosphenytoin
• Gilteritinib
• Glasdegib
• Hydrocodone
• Ibrexafungerp
• Ibrutinib
• Ifosfamide
• Iloperidone
• Indinavir
• Infigratinib
• Irinotecan
• Irinotecan Liposome
• Istradefylline
• Itraconazole
• Ivacaftor
• Ivosidenib
• Ixabepilone
• Ketoconazole
• Lapatinib
• Larotrectinib
• Lefamulin
• Lemborexant
• Leniolisib
• Levoketoconazole
• Levomilnacipran
• Lopinavir
• Lorlatinib
• Lumacaftor
• Lumateperone
• Lurbinectedin
• Macitentan
• Manidipine
• Meperidine
• Methadone
• Midazolam
• Midostaurin
• Mifepristone
• Mirtazapine
• Mirvetuximab Soravtansine-gynx
• Mitapivat
• Mitotane
• Mobocertinib
• Nefazodone
• Nelfinavir
• Neratinib
• Nifedipine
• Nilotinib
• Olaparib
• Omaveloxolone
• Osilodrostat
• Oxycodone
• Palbociclib
• Palovarotene
• Panobinostat
• Pazopanib
• Pemigatinib
• Pentazocine
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pirtobrutinib
• Ponatinib
• Posaconazole
• Pralsetinib
• Primidone
• Quetiapine
• Quizartinib
• Reboxetine
• Regorafenib
• Ribociclib
• Rifabutin
• Rifampin
• Rimegepant
• Ritonavir
• Rivaroxaban
• Romidepsin
• Ruxolitinib
• Salmeterol
• Saquinavir
• Selpercatinib
• Selumetinib
• Sildenafil
• Simeprevir
• Sirolimus
• Sirolimus Protein-Bound
• Sonidegib
• Sparsentan
• St John's Wort
• Sufentanil
• Sunitinib
• Suvorexant
• Tacrolimus
• Tadalafil
• Tamsulosin
• Tazemetostat
• Telaprevir
• Telithromycin
• Temsirolimus
• Tezacaftor
• Thiotepa
• Ticagrelor
• Toremifene
• Trabectedin
• Tramadol
• Trazodone
• Upadacitinib
• Valbenazine
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vorapaxar
• Voriconazole
• Zanubrutinib
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amlodipine
• Aripiprazole Lauroxil

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Lung or breathing problems (eg, pneumonitis) or
• Neutropenia (low number of white blood cells) or
• Stomach or bowel problems (eg, perforation)—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infection.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Serious skin reactions (eg, toxic epidermal necrolysis) to any medicine, history of—Should not be used in patients with this condition.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For chronic lymphocytic leukemia:
    • Adults—At first, 150 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 6 hours from your usual dose, take the missed dose and go back to your regular schedule. If you miss a dose and it is more than 6 hours from your usual dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use effective birth control during treatment with this medicine and for at least 1 month after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Idelalisib may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Idelalisib may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

This medicine may cause serious infections (eg, pneumonia, sepsis). Check with your doctor right away if you have chest pain or tightness, cough, fever or chills, confusion, dizziness, lightheadedness, or fainting, fast heartbeat, sneezing, or trouble breathing.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem called pneumonitis.

Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause serious bowel problems, including perforation (hole). Check with your doctor right away if you have black, tarry stools, diarrhea, fever, severe vomiting, sometimes with blood, or stomach cramps or pain.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

body aches or pain

chest tightness

chills

clay colored stools

confusion

cough

cough producing mucus

dark urine

decreased appetite

difficulty with breathing

dizziness

ear congestion

fainting

fast heartbeat

fever

headache

itching or skin rash

lightheadedness

loss of appetite

loss of voice

lower back or side pain

nausea and vomiting

pain

pain or tenderness around the eyes and cheekbones

painful or difficult urination

pale skin

rapid, shallow breathing

sneezing

sore throat

stomach cramps, pain, or tenderness

stuffy or runny nose

swelling of the feet or lower legs

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

watery or bloody diarrhea

yellow eyes or skin

Less common

Bladder pain

bloody or cloudy urine

difficult, burning, or painful urination

frequent urge to urinate

lower back or side pain

Incidence not known

Blistering, peeling, or loosening of the skin

chest pain

cracks in the skin

difficulty with swallowing

general feeling of discomfort or illness

heartburn

hives

indigestion

joint or muscle pain

loss of heat from the body

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

red, swollen skin

scaly skin

severe abdominal or stomach pain, cramping, or burning

thickening of bronchial secretions

vomiting of material that looks like coffee grounds, severe and continuing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

decreased appetite

difficulty with moving

muscle pain or stiffness

night sweats

pain in the joints

rapid weight gain

tingling of the hands or feet

trouble sleeping

unusual weight gain or loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.