Lucius Abemaciclib Patient Information Leaflet

Brand Name: Verzenio®
Generic Name: Abemaciclib (a-be-ma-SYE-klib)
Manufacturer: Lucius Pharmaceuticals
Dosage: This leaflet covers common strengths like 50 mg, 100 mg, 150 mg, and 200 mg tablets.

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

Lucius Abemaciclib is a prescription medicine belonging to a class of drugs called cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors. It works by blocking certain proteins inside cells that promote cancer cell growth.

It is used to treat Hormone Receptor (HR)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced or metastatic breast cancer in adults.

It can be used:

• In combination with an endocrine therapy (like fulvestrant or an aromatase inhibitor) or

• Alone, if the cancer has progressed after endocrine therapy and prior chemotherapy.

2. Before you take Lucius Abemaciclib

Do NOT take this medicine if you:

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

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

• Low White Blood Cell Counts (Neutropenia): This is very common and can increase your risk of serious infections. Your doctor will perform regular blood tests to monitor your blood counts.

• Liver Problems: Abemaciclib can cause liver injury. Your doctor will perform blood tests to monitor your liver function.

• Blood Clots: This drug can increase the risk of serious blood clots in your veins (venous thromboembolism). Report immediately any signs of pain or swelling in your legs, shortness of breath, or chest pain.

• Digestive Problems: Diarrhea is very common and can sometimes be severe, leading to dehydration or infection. It is crucial to manage diarrhea early.

Pregnancy and Breastfeeding:

• Pregnancy: This drug may harm an unborn baby. Use effective contraception during treatment and for at least 3 weeks after your last dose.

• Breastfeeding: Do not breastfeed during treatment and for at least 3 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. It is important to inform them about drugs that are:

• Strong CYP3A Inhibitors: Ketoconazole, itraconazole, clarithromycin, etc. (Your doctor may need to adjust your dose).

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

3. How to take Lucius Abemaciclib

• Dosage: Your doctor will determine your exact dose and schedule based on whether you are taking it alone or with other therapies. Doses are typically taken twice daily.

• 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, take it as soon as you remember, unless it is less than 6 hours until your next dose.

  • If it is less than 6 hours until your next dose, 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

Very Common Side Effects (may affect more than 1 in 4 people):

• Diarrhea (Very common; can be severe. See management tips below*)

• Infections (due to low white blood cells)

• Nausea

• Decreased appetite

• Abdominal pain

• Fatigue

• Low red blood cell count (anemia)

• Low white blood cell count (neutropenia)

• Vomiting

• Headache

• Hair thinning or hair loss (alopecia)

Diarrhea Management:

• Start an anti-diarrheal medicine (like loperamide) at the first sign of loose stools.

• Drink plenty of fluids to avoid dehydration.

• Contact your doctor immediately if you have severe diarrhea, diarrhea with fever or dizziness, or if it does not get better within 24 hours.

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

• Signs of infection: fever (100.4°F or 38°C or higher), chills, cough, pain when urinating.

• Signs of liver problems: yellowing of the skin or eyes (jaundice), dark urine, severe nausea, pain on the right side of your stomach.

• Signs of blood clots: swelling or pain in an arm or leg, chest pain, sudden shortness of breath.

• Severe or persistent diarrhea.

5. How to Store Lucius Abemaciclib

• 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: Abemaciclib.

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