What important information is included in the instructions for ruxolitinib tablets/ruxolitinib

Ruxolitinib tablets/ruxolitinib (JAKAVI), trade name Jakavi, is an oral Janus kinase (JAK) 1 and JAK2 inhibitor, mainly used to treat myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD). Its mechanism of action regulates blood cell production and immune response by inhibiting the JAK-STAT signaling pathway, thereby improving the symptoms and progression of related diseases.

1. Indications

1. Myelofibrosis (MF): Applicable to medium- and high-risk patients with primary myelofibrosis, secondary to polycythemia vera or essential thrombocythemia.

2. Polycythemia vera (PV): Suitable for PV patients who are resistant or intolerant to hydroxyurea treatment.

3. Graft-versus-host disease (GVHD): Applicable to acute or chronic GVHD patients 12 years old and above who do not respond to corticosteroid treatment.

2. Usage and dosage

1. Myelofibrosis (MF):

Platelet count >200×10^9/L: The starting dose is 20mg, twice daily.

Platelet count 100–200×10^9/L: Starting dose is 15 mg twice daily.

Platelet count 50–100×10^9/L: Starting dose is 5 mg twice daily.

Blood cell counts should be monitored regularly during treatment and dosage adjusted as needed.

2. Polycythemia vera (PV):

The starting dose is10 mg twice daily. The dose may be gradually increased based on the patient's hematological parameters and clinical response, with the maximum dose not exceeding 25 mg twice daily.

3. Graft versus host disease (GVHD):

AcuteGVHD: Starting dose is 5 mg twice daily.

ChronicGVHD: Starting dose is 10 mg twice daily.

Dosage may be adjusted based on patient response and tolerability.

4. Dosage adjustment

During treatment, if thrombocytopenia, anemia or neutropenia occurs, the dose should be adjusted or the medication should be suspended according to the specific situation. In patients with impaired hepatic or renal function, it is recommended that the starting dose be reduced by half and monitored closely. The dose of ruxolitinib needs to be adjusted when used concomitantly with strong CYP3A4 inhibitors (such as ketoconazole) or fluconazole (daily dose ≤200 mg); avoid coadministration with fluconazole (daily dose >200 mg).

3. Adverse reactions

Common adverse reactions include:

Hematological abnormalities: anemia, thrombocytopenia, neutropenia.

Increased risk of infections: such as shingles, urinary tract infections, etc.

Others: headache, dizziness, high blood pressure, elevated liver enzymes, etc.

4. Precautions

A comprehensive hematological examination should be performed before starting treatment and monitored regularly during treatment.

Avoid co-administration with otherJAK inhibitors or immunosuppressants to reduce the risk of infection.

Pregnant or breastfeeding women should avoid using this drug.

If a dose is missed, the dose should be skipped and the next dose should be taken at the regular time. The missed dose should not be made up. 5. Storage and disposal

Store medication at room temperature, away from moisture and heat.

Keep medicine out of the reach of children.

Unused medicines should be disposed of properly in accordance with local regulations to avoid contaminating the environment.

Reference materials:https://www.jakavi.com/