Lucius Acalabrutinib Patient Information Leaflet

Brand Name: Calquence®
Generic Name: Acalabrutinib (a-ka-la-BRU-ti-nib)
Manufacturer: Lucius Pharmaceuticals
Dosage: This leaflet primarily covers the 100 mg capsule strength.

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

Lucius Acalabrutinib is a prescription medicine belonging to a class of drugs called Bruton's tyrosine kinase (BTK) inhibitors. It works by blocking a specific protein (BTK) that helps cancer cells, particularly certain blood cancer cells, to survive and multiply.

It is used to treat adults with:

• Mantle Cell Lymphoma (MCL): A type of non-Hodgkin's lymphoma, often after at least one prior therapy.

• Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL): A type of cancer that affects white blood cells.

2. Before you take Lucius Acalabrutinib

Do NOT take this medicine if you:

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

Warnings and Precautions:
Talk to your doctor before taking Lucius Acalabrutinib if you have or have had:

• Bleeding Problems: This drug can increase the risk of bleeding and bruising. Report any unusual bleeding or bruising to your doctor.

• Infections: Acalabrutinib can lower your immune system's ability to fight infections. Tell your doctor immediately if you have a fever, chills, flu-like symptoms, or any signs of an infection.

• Heart Rhythm Problems (Atrial Fibrillation/Flutter): This medication can cause irregular heartbeats. Tell your doctor if you feel your heart is pounding, beating irregularly, or if you have dizziness, shortness of breath, or chest discomfort.

• Second Primary Cancers: There is a risk of developing other cancers, including skin cancer. Your doctor may perform skin exams, and you should use sunscreen and protective clothing.

• Cytopenias: The drug can cause low blood cell counts (white blood cells, platelets, red blood cells). Your doctor will perform regular blood tests to monitor this.

Pregnancy and Breastfeeding:

• Pregnancy: This drug may harm an unborn baby. Use effective contraception during treatment and for at least 1 week after your last dose. Inform your doctor immediately if you become pregnant.

• Breastfeeding: Do not breastfeed during treatment and for at least 2 weeks after your last dose, as the drug may pass into breast milk.

Other Medicines and Supplements:
Tell your doctor about ALL the medicines you take, including prescription, over-the-counter, vitamins, and herbal supplements. This is extremely important for drugs that affect liver enzymes, such as:

• Strong CYP3A inhibitors: Ketoconazole, itraconazole, clarithromycin, ritonavir, etc. (Your doctor may tell you to avoid these or adjust your dose).

• Strong CYP3A inducers: Rifampin, carbamazepine, St. John's Wort, etc. (These may make acalabrutinib less effective).

3. How to take Lucius Acalabrutinib

• Dosage: The typical dose is one 100 mg capsule, taken approximately every 12 hours (twice daily).

• Administration:

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

  • Do not open, break, or chew the capsules.

  • You can take it with or without food.

• Timing: Try to take your doses at the same times each day (e.g., 8 AM and 8 PM) to maintain a constant level of the drug in your body.

• Missed Dose:

  • If you miss a dose by less than 3 hours, take it as soon as you remember.

  • If you miss a dose by more than 3 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.

• Overdose: In case of overdose, contact your doctor or go to the nearest emergency room immediately.

4. Possible Side Effects

Common Side Effects (may affect many people):

• Headache (very common)

• Diarrhea

• Muscle and joint pain (arthralgia, myalgia)

• Rash

• Nausea

• Bruising easily

• Fatigue

• Low blood cell counts (neutrophils, platelets, red blood cells)

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

• Signs of serious bleeding: unusual bleeding from gums, nose, or wounds; blood in urine, stool, or vomit (may look like coffee grounds); severe headaches; dizziness or weakness.

• Signs of infection: fever of 100.4°F (38°C) or higher, chills, cough, shortness of breath, night sweats.

• Signs of heart rhythm problems: feeling your heart beat irregularly or rapidly (palpitations), dizziness, fainting, lightheadedness, shortness of breath.

• Severe skin reactions: painful red or purple skin rash with blisters or peeling.

5. How to Store Lucius Acalabrutinib

• Store at room temperature (20°C to 25°C or 68°F to 77°F). Brief excursions permitted between 15°C and 30°C (59°F to 86°F).

• Keep in the original container to protect from moisture and light.

• 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: Acalabrutinib (100 mg per capsule).

• Inactive Ingredients: The capsule shell contains gelatin, titanium dioxide, and other ingredients. The internal contents include microcrystalline cellulose, etc.

  
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