Jakafi® (ruxolitinib) - Incyte Corporation


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Indications & Usage

INDICATIONS AND USAGE

 

Jakafi is a kinase inhibitor indicated for treatment of:

  • intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults.
  • polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.
  • steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.
  • chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

 

 

Please click here for Full Prescribing Information for Jakafi.

Dosage & Administration

DOSAGE AND ADMINISTRATION

 

Doses should be individualized based on safety and efficacy. Starting doses per indication are noted below.

Myelofibrosis

  • The starting dose of Jakafi is based on patient’s baseline platelet count:
    • Greater than 200 × 109/L: 20 mg given orally twice daily
    • 100 × 109/L to 200 × 109/L: 15 mg given orally twice daily
    • 50 × 109/L to less than 100 × 109/L: 5 mg given orally twice daily
    • Monitor complete blood counts every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. Modify or interrupt dosing for thrombocytopenia.

Polycythemia Vera

  • The starting dose of Jakafi is 10 mg given orally twice daily.

Acute Graft-Versus-Host Disease

  • The starting dose of Jakafi is 5 mg given orally twice daily.

Chronic Graft-Versus-Host Disease

  • The starting dose of Jakafi is 10 mg given orally twice daily.

 

DOSAGE FORMS AND STRENGTHS

 

Tablets: 5 mg, 10 mg, 15 mg, 20 mg and 25 mg.

 

 

Please click here for Full Prescribing Information for Jakafi.

Contraindications

CONTRAINDICATIONS

 

None.

 

 

Please click here for Full Prescribing Information for Jakafi.

Warnings & Precautions

WARNINGS AND PRECAUTIONS

 

  • Thrombocytopenia, Anemia and Neutropenia: Manage by dose reduction, or interruption, or transfusion.
  • Risk of Infection: Assess patients for signs and symptoms of infection and initiate appropriate treatment promptly. Serious infections should have resolved before starting therapy with Jakafi.
  • Symptom Exacerbation Following Interruption or Discontinuation: Manage with supportive care and consider resuming treatment with Jakafi.
  • Risk of Non-Melanoma Skin Cancer: Perform periodic skin examinations.
  • Lipid Elevations: Assess lipid levels 8-12 weeks from start of therapy and treat as needed.
  • Major Adverse Cardiovascular Events (MACE): Monitor for development of MACE.
  • Thrombosis: Evaluate and treat symptoms of thrombosis promptly.
  • Secondary Malignancies: Monitor for development of secondary malignancies, particularly in patients who are current or past smokers.

 

 

Please click here for Full Prescribing Information for Jakafi.

Adverse Reactions

ADVERSE REACTIONS

 

  • In myelofibrosis and polycythemia vera, the most common hematologic adverse reactions (incidence > 20%) are thrombocytopenia and anemia. The most common nonhematologic adverse reactions (incidence ≥ 15%) are bruising, dizziness, headache, and diarrhea.
  • In acute graft-versus-host disease, the most common hematologic adverse reactions (incidence > 50%) are anemia, thrombocytopenia, and neutropenia. The most common nonhematologic adverse reactions (incidence > 50%) are infections (pathogen not specified) and edema.
  • In chronic graft-versus-host disease, the most common hematologic adverse reactions (incidence > 35%) are anemia and thrombocytopenia. The most common nonhematologic adverse reactions (incidence ≥ 20%) are infections (pathogen not specified) and viral infections.

 

To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

 

Please click here for Full Prescribing Information for Jakafi.

Drug Interactions

DRUG INTERACTIONS

 

  • Fluconazole: Avoid concomitant use with fluconazole doses greater than 200 mg. Reduce Jakafi dosage with fluconazole doses less than or equal to 200 mg.
  • Strong CYP3A4 Inhibitors: Reduce, interrupt, or discontinue Jakafi doses as recommended except in patients with acute or chronic graft-versus-host disease.

 

 

Please click here for Full Prescribing Information for Jakafi.

Use in Specific Populations

USE IN SPECIFIC POPULATIONS

 

  • Renal Impairment: Reduce Jakafi starting dose or avoid treatment as recommended.
  • Hepatic Impairment: Reduce Jakafi starting dose or avoid treatment as recommended.
  • Lactation: Advise not to breastfeed.

 

 

Please click here for Full Prescribing Information for Jakafi.

ICD Codes

ICD Codes

 

D75.81  Myelofibrosis
D45 Polycythemia vera
D89.810 Acute Graft-Versus-Host Disease
D89.811 Chronic Graft-Versus-Host Disease
D89.812 Acute on Chronic Graft-Versus-Host Disease
D89.813 Graft-Versus-Host Disease, Unspecified

 

Sponsored by Incyte Corporation

 

MAT-JAK-03734    03/22

Full Prescribing Information


INDICATIONS AND USAGE

Jakafi is a kinase inhibitor indicated for treatment of:

  • intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults
  • polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea
  • steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older
  • chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older

IMPORTANT SAFETY INFORMATION

  • Treatment with Jakafi® (ruxolitinib) can cause thrombocytopenia, anemia and neutropenia, which are each dose-related effects. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated
  • Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary
  • Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi
  • Severe neutropenia (ANC <0.5 × 109/L) was generally reversible by withholding Jakafi until recovery
  • Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting Jakafi until active serious infections have resolved. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines
  • Tuberculosis (TB) infection has been reported. Observe patients taking Jakafi for signs and symptoms of active TB and manage promptly. Prior to initiating Jakafi, evaluate patients for TB risk factors and test those at higher risk for latent infection. Consult a physician with expertise in the treatment of TB before starting Jakafi in patients with evidence of active or latent TB. Continuation of Jakafi during treatment of active TB should be based on the overall risk-benefit determination
  • Progressive multifocal leukoencephalopathy (PML) has occurred with Jakafi treatment. If PML is suspected, stop Jakafi and evaluate
  • Advise patients about early signs and symptoms of herpes zoster and to seek early treatment
  • Increases in hepatitis B viral load with or without associated elevations in alanine aminotransferase and aspartate aminotransferase have been reported in patients with chronic hepatitis B virus (HBV) infections. Monitor and treat patients with chronic HBV infection according to clinical guidelines
  • When discontinuing Jakafi, myeloproliferative neoplasm-related symptoms may return within one week. After discontinuation, some patients with myelofibrosis have experienced fever, respiratory distress, hypotension, DIC, or multi-organ failure. If any of these occur after discontinuation or while tapering Jakafi, evaluate and treat any intercurrent illness and consider restarting or increasing the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi without consulting their physician. When discontinuing or interrupting Jakafi for reasons other than thrombocytopenia or neutropenia, consider gradual tapering rather than abrupt discontinuation
  • Non-melanoma skin cancers (NMSC) including basal cell, squamous cell, and Merkel cell carcinoma have occurred. Perform periodic skin examinations
  • Treatment with Jakafi has been associated with increases in total cholesterol, low-density lipoprotein cholesterol, and triglycerides. Assess lipid parameters 8-12 weeks after initiating Jakafi. Monitor and treat according to clinical guidelines for the management of hyperlipidemia
  • Another JAK-inhibitor has increased the risk of major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, and stroke (compared to those treated with tumor TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Jakafi particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur
  • Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. In patients with myelofibrosis (MF) and polycythemia vera (PV) treated with Jakafi in clinical trials, the rates of thromboembolic events were similar in Jakafi and control treated patients. Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately
  • Another JAK-inhibitor has increased the risk of lymphoma and other malignancies excluding NMSC (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Jakafi, particularly in patients with a known secondary malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers
  • In myelofibrosis and polycythemia vera, the most common nonhematologic adverse reactions (incidence ≥15%) were bruising, dizziness, headache, and diarrhea. In acute graft-versus-host disease, the most common nonhematologic adverse reactions (incidence >50%) were infections (pathogen not specified) and edema. In chronic graft-versus-host disease, the most common nonhematologic adverse reactions (incidence ≥20%) were infections (pathogen not specified) and viral infections
  • Avoid concomitant use with fluconazole doses greater than 200 mg. Dose modifications may be required when administering Jakafi with fluconazole doses of 200 mg or less, or with strong CYP3A4 inhibitors, or in patients with renal or hepatic impairment. Patients should be closely monitored and the dose titrated based on safety and efficacy
  • Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus. Women taking Jakafi should not breastfeed during treatment and for 2 weeks after the final dose

 

 

Please click here for Full Prescribing Information for Jakafi.