idelalisib 100 mg tablet

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Medication name

Generic name:
Idelalisib - oral

Pronunciation
(eye-DEL-a-LIS-ib)

Brand name(s)
Zydelig

Warning

Idelalisib may cause serious (possibly fatal) liver disease. Your doctor will test your liver function while you are taking this medication. Tell your doctor right away if you have any symptoms of liver damage, including persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

This medication can cause severe diarrhea and a tear in the stomach/intestines (gastrointestinal perforation). Tell your doctor right away if you develop persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool, fever, nausea/vomiting, or dizziness/fainting.

Idelalisib can cause severe (possibly fatal) lung problems (pneumonitis). Tell your doctor right away if you have any symptoms of lung problems (such as worsening cough, shortness of breath, trouble breathing, wheezing).

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Your doctor may prescribe an antibiotic to help prevent serious infection during and after treatment with this medication. Carefully follow your doctor's instructions. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Uses

This medication is used to treat certain types of cancer (such as chronic lymphocytic leukemia-CLL, follicular B-cell non-Hodgkin's lymphoma, small lymphocytic lymphoma-SLL). Idelalisib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

How to use

See also Warning section.

Read the Medication Guide provided by your pharmacist before you start taking idelalisib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually twice daily. Swallow the tablets whole. Do not chew or crush the tablets.

The dosage is based on your medical condition and response to treatment.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Side effects

See also Warning section.

Diarrhea, headache, heartburn, mouth/throat sores, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

  • easy bruising/bleeding
  • swelling hands/ankles/feet
  • sudden vision changes

Idelalisib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, get medical help right away if you develop any rash.

This medication can weaken the immune system/increase the risk of infection, including a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects:

  • clumsiness
  • loss of coordination/balance
  • weakness
  • sudden change in your thinking (such as confusion, difficulty concentrating, memory loss)
  • difficulty talking/walking
  • seizure

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking idelalisib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • liver disease
  • lung problems
  • stomach/intestinal ulcers
  • current serious infection

Idelalisib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while taking idelalisib. Idelalisib may harm an unborn baby. Women should ask about reliable forms of birth control while taking this medication and for 1 month after stopping treatment. Men should ask about reliable forms of birth control while taking this medication and for 3 months after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 1 month after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

  • bendamustine
  • other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab)

Other medications can affect the removal of idelalisib from your body, which may affect how idelalisib works. Examples include rifampin, phenytoin, carbamazepine, St. John's wort, among others.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include domperidone, midazolam, among others.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as liver function tests, complete blood count) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

Missed dose

If you miss a dose, take it as soon as you remember unless it is more than 6 hours after the time you usually take the dose. In that case, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature in the original container away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised February 2018.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.