Drug Information Summary: Lucius Ruxolitinib Tablets

Disclaimer: This is a synthesized summary based on the known pharmacological profile of Ruxolitinib. This is not the official manufacturer's leaflet and does not replace professional medical advice.Ruxolitinib is a potent prescription drug with serious risks and must only be prescribed and monitored by physicians experienced in the treatment of myeloproliferative disorders.

1. Brand and Generic Name

• Generic Name: Ruxolitinib

• Brand/Manufacturer: Lucius Pharmaceuticals (Laos) - Note: This is a generic/manufactured version. The original brand name is Jakafi®.

2. What is Ruxolitinib and what is it used for?

• Ruxolitinib is a kinase inhibitor. It works by inhibiting the Janus-associated kinases (JAK) JAK1 and JAK2.

• It is used for the treatment of:

  • Myelofibrosis: A type of bone marrow cancer, for patients with intermediate or high-risk disease.

  • Polycythemia Vera: A type of blood cancer, for patients who have had an inadequate response to or are intolerant of hydroxyurea.

  • Acute Graft-versus-Host Disease (aGVHD): For the treatment of steroid-refractory aGVHD in adult and pediatric patients 12 years and older.

3. Before you take Lucius Ruxolitinib
Do NOT take if you:

• Are allergic to ruxolitinib or any of its ingredients.

Warnings and Precautions:
Talk to your doctor about:

• Thrombocytopenia, Anemia, and Neutropenia: Ruxolitinib can cause low platelet, red blood cell, and white blood cell counts. Your blood counts will be monitored frequently, especially during the first few months of treatment. Dose adjustments may be necessary.

• Infection: May increase the risk of serious bacterial, fungal, viral, and opportunistic infections (e.g., tuberculosis, herpes zoster). Monitor for signs and symptoms of infection during and after treatment.

• Non-Melanoma Skin Cancer: An increased risk of basal cell and squamous cell carcinoma has been observed. Periodic skin examinations are recommended.

• Hypercholesterolemia: May increase cholesterol levels. Lipid parameters should be monitored during treatment.

• Pregnancy and Breastfeeding: Based on animal data, ruxolitinib may cause fetal harm. Discuss the potential risks with your doctor. Effective contraception is recommended. It is not known if it is excreted in human milk; a decision should be made to discontinue nursing or discontinue the drug.

4. How to take Lucius Ruxolitinib

• Dosage: The dosage is based on platelet count and the condition being treated. It must be carefully determined and adjusted by your doctor.

  • For Myelofibrosis: The starting dose is typically based on platelet count (e.g., 20 mg twice daily for platelets >200 x 10⁹/L, 15 mg twice daily for platelets 100-200 x 10⁹/L, etc.).

  • For Polycythemia Vera: The starting dose is 10 mg twice daily.

• Administration: Take with or without food. If you miss a dose, do not take an extra dose. Take your next dose at the usual time.

5. Possible Side Effects
Common side effects may include:

• Low platelet count (thrombocytopenia)

• Low red blood cell count (anemia)

• Bruising

• Dizziness

• Headache

• Increased cholesterol levels

• Serious Side Effects (Contact your doctor immediately):

  • Signs of infection: fever, chills, sore throat.

  • Signs of low blood counts: unusual bleeding or bruising, fatigue, shortness of breath.

  • Signs of skin cancer: new or changing skin lesions.

6. Drug Interactions
Inform your doctor about all medicines you are taking, especially:

• Strong CYP3A4 Inhibitors (e.g., fluconazole, ketoconazole): May increase ruxolitinib levels. Dose reduction may be required.

• Strong CYP3A4 Inducers (e.g., rifampin): May decrease ruxolitinib levels.

7. Storage

• Store below 30°C (86°F).

• Keep in the original container, tightly closed.

• Protect from moisture.

• Keep out of reach of children and pets.

8. Packaging

• Typically supplied in bottles or blister packs.

Final Crucial Advice:
Treatment with Ruxolitinib requires careful dose individualization based on platelet counts and frequent monitoring of blood counts and for signs of infection. Close and continuous communication with your hematology team is essential for managing side effects and ensuring the safe and effective use of this medication. Always follow your doctor's specific instructions.

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