Lucius Idelalisib Patient Information Leaflet

Brand Name: Zydelig®
Generic Name: Idelalisib (eye-de-LAL-i-sib)
Manufacturer: Lucius Pharmaceuticals
Therapeutic Class: Phosphoinositide 3-Kinase (PI3K) Inhibitor
Dosage: This leaflet covers the 100 mg and 150 mg tablet strengths.

1. What is Lucius Idelalisib and what is it used for?

Lucius Idelalisib is a prescription medicine used to treat certain types of blood cancers in adults. It is a kinase inhibitor that works by blocking a specific protein that helps cancer cells survive and multiply.

It is used to treat:

• Relapsed Chronic Lymphocytic Leukemia (CLL): in combination with rituximab, for patients for whom rituximab alone would be considered appropriate therapy due to other existing health problems.

• Relapsed Follicular B-cell Non-Hodgkin Lymphoma (FL): in patients who have received at least two prior systemic therapies.

• Relapsed Small Lymphocytic Lymphoma (SLL): in patients who have received at least two prior systemic therapies.

2. Before you take Lucius Idelalisib

Do NOT take this medicine if you:

• Are allergic to idelalisib or any of the other ingredients in this medicine.

• Have a history of serious allergic reactions, including anaphylaxis or toxic epidermal necrolysis (TEN).

Warnings and Precautions (Boxed Warnings):
Idelalisib has serious side effects, which include:

• Fatal and/or serious hepatotoxicity (Liver Toxicity): Liver problems can be severe and lead to death. Your doctor will perform blood tests to check your liver function before and during treatment.

• Fatal and/or serious and severe diarrhea or colitis (Intestinal Inflammation): Severe diarrhea can lead to dehydration and infection.

• Fatal and/or serious pneumonitis (Lung Inflammation): Inflammation of the lung tissue can be life-threatening.

• Fatal and/or serious infections: Such as Pneumocystis jirovecii pneumonia (PJP) and cytomegalovirus (CMV) infection.

• Intestinal perforation: A hole or tear in the intestine, which can be fatal.

Other Warnings:

• Severe skin reactions: Such as toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS).

• Neutropenia: Low white blood cell count, increasing the risk of infection.

• Anaphylaxis: Severe allergic reactions.

Pregnancy and Breastfeeding:

• Pregnancy: Based on its mechanism, Idelalisib may harm an unborn baby. Use effective contraception during treatment and for at least 1 month after your last dose.

• Breastfeeding: Do not breastfeed during treatment and for at least 1 month after your last dose.

Other Medicines and Supplements:
Tell your doctor about ALL the medicines you take, especially:

• Other medications that can cause liver damage.

• Medications that can cause diarrhea or colitis.

3. How to take Lucius Idelalisib

• Dosage: The recommended dose is 150 mg taken twice daily (approximately every 12 hours).

• Administration:

  • Take the tablet(s) by mouth with a full glass of water.

  • You can take it with or without food.

  • Swallow the tablets whole; do not crush, chew, or split them.

• Timing: Try to take your doses at approximately the same times every day (e.g., 8 AM and 8 PM).

• Missed Dose:

  • If you miss a dose by less than 6 hours, take it as soon as you remember.

  • If you miss a dose by more than 6 hours, skip the missed dose and take your next dose at the regular time.

  • Do not take a double dose to make up for a missed one.

• Vomiting: If you vomit after taking a dose, do not take an extra dose. Continue with your next scheduled dose.

4. Possible Side Effects

Common Side Effects:

• Diarrhea

• Fever (pyrexia)

• Fatigue

• Nausea

• Cough

• Abdominal pain

• Pneumonia

• Rash

• Decreased appetite

• Chills

Serious Side Effects (Contact your doctor immediately if you experience any of these):

• Signs of Liver Problems: Yellowing of the skin or eyes (jaundice), dark urine, severe nausea or vomiting, pain on the right side of your stomach.

• Signs of Severe Diarrhea or Colitis: Severe or persistent diarrhea, abdominal pain or cramping, blood or mucus in your stool, fever.

• Signs of Lung Problems (Pneumonitis): New or worsening cough, shortness of breath, difficulty breathing, wheezing, chest pain.

• Signs of Infection: Fever (100.4°F or 38°C or higher), chills, cough, sore throat, pain during urination.

• Signs of Intestinal Perforation: Severe abdominal pain, chills, fever, nausea, vomiting.

• Signs of Severe Skin Reaction: Painful red or purple rash, skin blistering or peeling, sores in the mouth or eyes.

5. How to Store Lucius Idelalisib

• Store at room temperature in the original container to protect from moisture.

• Keep out of reach of children and pets.

• Do not use this medicine after the expiration date printed on the pack.

6. Contents of the Pack and Other Information

• Active Ingredient: Idelalisib.

• Inactive Ingredients: Includes microcrystalline cellulose, lactose, and other tablet-forming agents.

  
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