Jakavi 15 — Ruxolitinib 15 mg Tablets, 56 Tablets

Jakavi 15 mg is supplied as oral tablets[cite: 8].

Qualitative and Quantitative Composition per Tablet:

• • Active Ingredient: Ruxolitinib phosphate equivalent to ruxolitinib — 15 mg[cite: 8].
• • Excipients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, colloidal silicon dioxide.

Packaging Configuration: 15 mg tablets are packaged in blister strips containing 56 tablets per box (4 blisters of 14 tablets), providing a 28-day supply of standard twice-daily treatment[cite: 8]. The carton features official Novartis branding, dosage markings, language instructions ("Ağızdan kullanım içindir / For oral use"), and batch identification details[cite: 8].

Pharmacodynamics:
Ruxolitinib is a selective inhibitor of Janus Associated Kinases JAK1 and JAK2. These enzymes mediate the signaling of numbers of cytokines and growth factors vital for hematopoiesis and immune function. In myeloproliferative neoplasms, JAK-STAT signaling is hyperactive. Ruxolitinib inhibits STAT protein phosphorylation, decreasing cell proliferation and inducing apoptosis in malignant cells.

Pharmacokinetics:

• • Absorption: Rapidly absorbed following oral administration with peak plasma concentrations ($C_{max}$) reached within 1 hour post-dose. Food intake does not alter absorption to a clinically meaningful extent.
• • Distribution: Approximately 97% bound to human plasma proteins, predominantly albumin.
• • Metabolism: Extensively metabolized in the liver mainly by CYP3A4, with minor contribution from CYP2C9.
• • Elimination: Mean elimination half-life ($T_{1/2}$) is approximately 3 hours. Excreted mainly via urine (74%) and feces (22%) as metabolites.

Jakavi 15 mg is indicated for:

• • Myelofibrosis: Treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.
• • Polycythemia Vera: Treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.
• • Graft-versus-Host Disease (GvHD): Treatment of patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies.

Treatment with Jakavi 15 mg should be initiated and supervised by a physician experienced in managing hematologic malignancies[cite: 8].

Method of Administration:
For oral use. Take tablets twice daily (morning and evening) with or without food[cite: 8]. Swallow tablets whole with water. Do not chew, crush, or split tablets.

Standard Dosing Regimen in Myelofibrosis:
The starting dose depends on baseline platelet count:

• • Platelet count > 200 × 10⁹/L: Recommended starting dose is 20 mg twice daily.
• • Platelet count 100–200 × 10⁹/L: Recommended starting dose is 15 mg (1 tablet) twice daily[cite: 8].
• • Platelet count 50–100 × 10⁹/L: Maximum starting dose is 5 mg twice daily.

Dose Modifications: Complete blood counts must be monitored every 2–4 weeks during therapy. Doses should be interrupted or reduced in case of severe thrombocytopenia or neutropenia.

Missed Dose: If a dose is missed, skip the missed dose and resume the normal schedule. Do not take two doses at the same time.

Administration of Jakavi 15 mg is contraindicated in:

• • Hypersensitivity: Hypersensitivity to ruxolitinib or any inactive excipient[cite: 8].
• • Pregnancy and Lactation: Contraindicated during pregnancy and breastfeeding.
• • Severe Baseline Thrombocytopenia: Baseline platelet count under 50 × 10⁹/L (for initiation).
• • Pediatric Population: Patients under 18 years for myelofibrosis/PV, and under 12 years for GvHD.

Ruxolitinib is metabolized by CYP3A4, requiring care when co-administering CYP3A4 inhibitors or inducers.

Key Drug Interactions:

• • Strong CYP3A4 Inhibitors (ketoconazole, itraconazole, clarithromycin, grapefruit): Significantly increase ruxolitinib exposure. Reduce total daily dose of Jakavi by approximately 50%.
• • CYP3A4 Inducers (rifampin, carbamazepine, St. John's Wort): Decrease ruxolitinib exposure, potentially reducing therapeutic efficacy.
• • Dual CYP2C9 and CYP3A4 Inhibitors (fluconazole): Increase ruxolitinib exposure. Dose reduction is required.

Pregnancy:
Jakavi is contraindicated during pregnancy due to embryo-fetal toxicity risks. Females of childbearing potential must use effective contraception during treatment and for at least 1-2 weeks after the last dose.

Lactation:
It is unknown whether ruxolitinib is excreted in human milk. Breastfeeding must be discontinued during Jakavi therapy.

Treatment with Jakavi 15 mg requires close monitoring for hematologic toxicity and infectious complications.

Adverse Reactions:

• • Hematologic (Very Common): Thrombocytopenia, anemia, neutropenia, bleeding events (bruising, epistaxis).
• • Infections: Increased risk of serious bacterial, mycobacterial, fungal, and viral infections (herpes zoster, hepatitis B reactivation).
• • Metabolic & Laboratory Changes: Hypercholesterolemia, elevated AST/ALT levels, hypertriglyceridemia.
• • Neurologic & General: Dizziness, headache, weight gain, hypertension.

Symptoms:
Doses higher than recommended cause severe myelosuppression, leading to profound thrombocytopenia, anemia, and leukopenia.

Treatment:
No specific antidote exists. Treatment consists of drug withdrawal or dose reduction, supportive care, and blood transfusions if clinically indicated.

Storage Requirements for Jakavi 15 mg:[cite: 8]

• 🌡️ Temperature: Store below 30°C.
• ☀️ Moisture & Light Protection: Store in original package to protect from light and moisture[cite: 8].
• 👶 Safety: Keep out of reach of children[cite: 8].
• ⏳ Shelf Life: Stated on the side panel (Son kullanma tarihi / Exp)[cite: 8]. Rx Only.

To verify original Jakavi 15 mg manufactured by Novartis, check the following details[cite: 8]:

• ✅ Novartis Brand Logo: Official Novartis flame icon and wordmark on a dark blue top header[cite: 8].
• ✅ Dosage Accent: White "15 mg" lettering contained inside a bright orange oval badge[cite: 8]. Solid orange accent bar running along the bottom margin[cite: 8].
• ✅ Typography: Bold "JAKAVI®" product title with registered trademark ® symbol[cite: 8].
• ✅ Batch Identification: Printed Expiration Date (Son kullanma tarihi) and Batch Number (Parti no.) stamped on the side flap[cite: 8].