Lucius Ruxolitinib Patient Information Leaflet

Brand Name: Jakavi®
Generic Name: Ruxolitinib (ruk-soe-LI-ti-nib)
Manufacturer: Lucius Pharmaceuticals

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

Lucius Ruxolitinib is a prescription medication belonging to a class of drugs called kinase inhibitors. It works by blocking certain enzymes in the body that are involved in the overproduction of blood cells and inflammatory processes.

It is used to treat:

• Myelofibrosis: A rare bone marrow disorder that disrupts the body's normal production of blood cells, leading to scarring in the bone marrow, an enlarged spleen, and symptoms like fatigue, night sweats, and itching.

• Polycythemia Vera: A blood cancer where the bone marrow produces too many red blood cells, which can lead to blood clots, strokes, and an enlarged spleen.

• Acute Graft-versus-Host Disease (aGVHD): A serious complication that can occur after a stem cell or bone marrow transplant from a donor, where the donor cells attack the recipient's body.

2. Before you take Lucius Ruxolitinib

Do NOT take this medicine if you:

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

• Are taking any other strong medicines that affect your immune system.

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

• Infections: This drug can lower your ability to fight infections. Tell your doctor immediately if you have a fever, chills, or any signs of an infection.

• Low Blood Cell Counts: Ruxolitinib can cause low red blood cells (anemia), low platelets (thrombocytopenia), and low white blood cells (neutropenia). Your doctor will perform regular blood tests to monitor this.

• Shingles (Herpes Zoster): This medication can increase the risk of shingles. Your doctor may recommend a vaccine before you start treatment.

• Skin Cancer: There is an increased risk of non-melanoma skin cancer. Your doctor will perform skin exams, and you should protect your skin from the sun.

• High Cholesterol: Your cholesterol levels may increase and may need to be managed.

• Liver or Kidney Problems: Your doctor will adjust your dose based on how well your liver and kidneys are working.

• Tuberculosis (TB): Your doctor may test you for TB before starting treatment.

Pregnancy and Breastfeeding:

• Pregnancy: Do not take this medicine if you are pregnant unless specifically advised by your doctor. It may harm your unborn baby. Use effective contraception during treatment and for at least 1 week after your last dose.

• Breastfeeding: Do not breastfeed during treatment and for at least 1 week after your last dose, as the drug may pass into breast milk.

Other Medicines:
Tell your doctor about ALL the medicines you take, including prescription, over-the-counter, vitamins, and herbal supplements. Especially inform them about:

• Fluconazole (an antifungal)

• Other strong immunosuppressants

• Erythromycin (an antibiotic)

3. How to take Lucius Ruxolitinib

• Dosage: Your doctor will determine the exact dose based on your condition, blood test results, and other health factors. NEVER change your dose unless your doctor tells you to.

• Administration:

  • Take the tablet(s) by mouth, usually twice a day (approximately every 12 hours).

  • You can take it with or without food.

  • Swallow the tablet whole with a full glass of water. Do not crush, break, or chew the tablet.

• Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for 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.

• Overdose: In case of overdose, contact your doctor or poison control center immediately. Symptoms may include excessive bleeding, infection, or low blood counts.

4. Possible Side Effects

Common Side Effects (may affect up to 1 in 10 people):

• Low platelet count (bruising, bleeding)

• Low red blood cell count (anemia - fatigue, shortness of breath)

• Dizziness, headache

• High cholesterol levels

• Nausea, diarrhea

• Shortness of breath

• Weight gain (often due to fluid retention)

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

• Signs of infection: fever, chills, sweating, body aches

• Signs of bleeding: unusual bruising, blood in urine or stool, coughing up blood

• Signs of a blood clot: chest pain, sudden shortness of breath, pain or swelling in your leg

• Severe skin reactions: painful skin or mouth sores, blisters, peeling skin

• Signs of shingles: painful skin rash with blisters

• Signs of liver problems: yellowing of the skin or eyes (jaundice), dark urine, severe stomach pain

5. How to Store Lucius Ruxolitinib

• Store at room temperature (15°C to 30°C or 59°F to 86°F) in the original container.

• Keep the container tightly closed 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: Each tablet contains ruxolitinib (as ruxolitinib phosphate).

• Available Strengths: 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg tablets.

  
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