JAKAVI Application Scope

Treatment of myelofibrosis (MF) in adult patients: for disease‑related splenomegaly or symptoms in:
- Primary (chronic idiopathic) myelofibrosis,
- Post-polycythemia vera MF,
- Post-essential thrombocythemia MF.
Polycythemia vera (PV) in adult patients who are resistant to or intolerant of hydroxyurea.
Graft-versus-host disease (GvHD):
- Acute GvHD: in adults (and pediatric in some regions) with inadequate response to corticosteroids or other systemic therapies.
- Chronic GvHD (in some approvals)—see clinical data (e.g., REACH3 trial)
  
  jakavi ruxolitinib

JAKAVI Characteristics

Ingredients: Ruxolitinib
Properties: Film-coated tablet
Packaging Specification: Are available in multiple strengths (e.g., 5 mg, 15 mg, 20 mg)
Storage: Store below 30°C (86°F)
Expiry Date: As stated on the packaging
Executive Standard: Approved and regulated by local health authorities
Approval Number: Varies by country and region (e.g., EU/1/12/791/001-013)
Date of Revision: This is product-specific and should be checked on the latest package insert
Manufacturer: Novartis Pharma Stein AG, Switzerland, or other licensed facilities

Guidelines for the Use of JAKAVI

Dosage and Administration:
- Recommended Dose:
  
  The starting dose is individualized based on platelet count and the condition being treated.
  - Myelofibrosis: Starting dose typically ranges from 15 mg twice daily to 20 mg twice daily.
  - Polycythemia Vera: Starting dose is typically 10 mg twice daily.
  - GVHD: Starting dose is typically 10 mg twice daily.
- Administration: Taken orally with or without food. Tablets should be swallowed whole with water.
- Missed Dose: If a dose is missed, it should be taken as soon as it is remembered unless it is less than 6 hours until the next dose. Do not take a double dose to make up for a forgotten dose.
Adverse Reactions:
- Common Adverse Reactions:
  - Thrombocytopenia (low platelet count), anemia (low red blood cell count).
  - Bruising, dizziness, headache.
  - Increased blood cholesterol and liver enzymes (ALT/AST).
  - Bacterial infections, herpes zoster (shingles), and urinary tract infections.
- Serious Adverse Reactions:
  - Severe infections (e.g., tuberculosis, sepsis).
  - Progressive Multifocal Leukoencephalopathy (PML).
  - New non-melanoma skin cancers.
  - Major adverse cardiovascular events (MACE).
  - Severe hepatic toxicity.
Contraindications:
- Hypersensitivity to ruxolitinib or any of the excipients.
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) in patients with renal or hepatic impairment.
Precautions:
- Complete Blood Counts (CBC): Must be monitored frequently as thrombocytopenia, anemia, and neutropenia are common. Dose adjustments or interruptions may be necessary.
- Infections: Active serious infections should be resolved before starting treatment. Patients should be monitored for signs and symptoms of infection and treated promptly.
- Lipids: Lipid parameters should be monitored approximately 8-12 weeks after initiation.
- Hepatotoxicity: Liver function should be monitored periodically.
- Non-Melanoma Skin Cancer: Periodic skin examinations are recommended.
- Pregnancy & Lactation: Not recommended during pregnancy unless clearly necessary. Breastfeeding is not recommended during treatment.

JAKAVI Interactions

Strong CYP3A4 Inhibitors (e.g., ketoconazole, fluconazole, clarithromycin): Significantly increase ruxolitinib exposure. Concomitant use is not recommended, or a dose reduction of JAKAVI is required.
Immunosuppressants: May increase the risk of infection.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.