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Idelalisib (Oral route)

Pronunciation:

eye-del-a-LIS-ib

Brand Names:

  • Zydelig

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Serious hepatotoxicity, including fatalities, has been reported in 11% to 18% of patients administered idelalisib. Serious and severe diarrhea and colitis, including fatalities, has also been reported in 14% to 19% of idelalisib patients. Monitor hepatic function before and during treatment and monitor for the development of diarrhea or colitis. Pneumonitis occurred in 4% of idelalisib patients, which may be serious or fatal. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Serious infections, including fatalities, has been reported in 21% to 36% 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). This medicine is also used to treat follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic lymphoma (SLL) in patients who have received at least two previous treatments. 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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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
  • Colchicine
  • Conivaptan
  • Dihydroergotamine
  • Dronedarone
  • Eletriptan
  • Eliglustat
  • Eplerenone
  • Isavuconazonium Sulfate
  • Ivabradine
  • Lomitapide
  • Lovastatin
  • Lurasidone
  • Maraviroc
  • Naloxegol
  • Ranolazine
  • Silodosin
  • Simvastatin
  • Tolvaptan
  • Triazolam
  • Venetoclax

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.

  • Ado-Trastuzumab Emtansine
  • Alfentanil
  • Alprazolam
  • Amiodarone
  • Amlodipine
  • Amprenavir
  • Apixaban
  • Aprepitant
  • Aripiprazole
  • Artemether
  • Astemizole
  • Atazanavir
  • Atorvastatin
  • Bedaquiline
  • Boceprevir
  • Bosutinib
  • Brentuximab Vedotin
  • Brigatinib
  • Brinzolamide
  • Bromocriptine
  • Budesonide
  • Buspirone
  • Cabazitaxel
  • Cabozantinib
  • Calcifediol
  • Carbamazepine
  • Cariprazine
  • Ceritinib
  • Cilostazol
  • Cisapride
  • Citalopram
  • Clarithromycin
  • Clonazepam
  • Clozapine
  • Cobicistat
  • Cobimetinib
  • Crizotinib
  • Cyclosporine
  • Dabrafenib
  • Daclatasvir
  • Darifenacin
  • Darunavir
  • Dasatinib
  • Deflazacort
  • Delamanid
  • Delavirdine
  • Dexamethasone
  • Diltiazem
  • Docetaxel
  • Domperidone
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Dutasteride
  • Efavirenz
  • Elvitegravir
  • Enzalutamide
  • Ergotamine
  • Erlotinib
  • Erythromycin
  • Eslicarbazepine Acetate
  • Estradiol
  • Eszopiclone
  • Ethinyl Estradiol
  • Everolimus
  • Exemestane
  • Felodipine
  • Fentanyl
  • Fluticasone
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Halofantrine
  • Haloperidol
  • Hydrocodone
  • Ibrutinib
  • Ifosfamide
  • Iloperidone
  • Imatinib
  • Indinavir
  • Irinotecan
  • Irinotecan Liposome
  • Isradipine
  • Itraconazole
  • Ivacaftor
  • Ketoconazole
  • Lapatinib
  • Letrozole
  • Levomilnacipran
  • Levonorgestrel
  • Lopinavir
  • Losartan
  • Lumefantrine
  • Macitentan
  • Manidipine
  • Mefloquine
  • Methadone
  • Midazolam
  • Midostaurin
  • Mifepristone
  • Mitotane
  • Nateglinide
  • Nefazodone
  • Nelfinavir
  • Nifedipine
  • Nilotinib
  • Nimodipine
  • Nisoldipine
  • Olaparib
  • Ondansetron
  • Ospemifene
  • Oxycodone
  • Paclitaxel
  • Palbociclib
  • Panobinostat
  • Pazopanib
  • Perampanel
  • Phenytoin
  • Pimavanserin
  • Pimozide
  • Ponatinib
  • Posaconazole
  • Prednisolone
  • Prednisone
  • Primidone
  • Propafenone
  • Quetiapine
  • Quinidine
  • Quinine
  • Reboxetine
  • Regorafenib
  • Ribociclib
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Rilpivirine
  • Riociguat
  • Ritonavir
  • Roflumilast
  • Romidepsin
  • Ruxolitinib
  • Salmeterol
  • Saquinavir
  • Sildenafil
  • Simeprevir
  • Sirolimus
  • Solifenacin
  • Sorafenib
  • St John's Wort
  • Sunitinib
  • Suvorexant
  • Tacrolimus
  • Tamoxifen
  • Tamsulosin
  • Telaprevir
  • Telithromycin
  • Temsirolimus
  • Terfenadine
  • Theophylline
  • Thiotepa
  • Ticagrelor
  • Tipranavir
  • Tofacitinib
  • Toremifene
  • Trabectedin
  • Tramadol
  • Trazodone
  • Triamcinolone
  • Valbenazine
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Verapamil
  • Vilanterol
  • Vilazodone
  • Vincristine
  • Vinflunine
  • Vorapaxar
  • Voriconazole
  • Zaleplon
  • Zileuton
  • Ziprasidone
  • Zolpidem

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.

  • 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.

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, follicular B-cell non-Hodgkin lymphoma, and small lymphocytic lymphoma:
      • Adults—At first, 150 milligrams (mg) two 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 of this medicine, you may still take it up to 6 hours after the time you normally take it. However, if it is more than 6 hours, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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. Use an effective form of birth control to keep from getting pregnant while you are using this medicine and for at least 1 month after stopping it. If you think you have become pregnant, tell your doctor right away.

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.

Check with your doctor right away if you have chest pain, cough, shortness of breath, or trouble breathing while using this medicine. Also, tell your doctor immediately if you have an abdominal or stomach pain, chills, fever, nausea, or vomiting.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, or sores or ulcers on the skin while you are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis 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.

Check with your doctor if you notice any signs of fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts.

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 (eg, St. John's wort) 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
Abdominal or stomach pain or tenderness
black, tarry stools
body aches or pain
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
stuffy or runny nose
swelling of the feet or lower legs
tightness in the chest
troubled 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.


Last Updated: 7/4/2017
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