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Starting a Patient on Jakafi

Dose optimization is key to maintaining the balance between safety and efficacy.

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START with the appropriate dose

A complete blood count (CBC) and platelet (PLT) count must be performed before initiating therapy.1

A complete blood count (CBC) and platelet (PLT) count must be performed before initiating therapy.1

Image of 10 mg bottle of JakafiImage of 10 mg bottle of Jakafi

Jakafi is also available in tablets of

Image of 5 mg, 15 mg, 20mg, 25mg bottles of Jakafi
Image of 5 mg bottle of Jakafi
Image of 15 mg bottle of Jakafi
Image of 20 mg bottle of Jakafi
Image of 25 mg bottle of Jakafi
 
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MONITOR: Monitoring patients after initiation of Jakafi is essential

MONITOR: Monitoring patients after initiation of Jakafi is essential

A CBC and PLT count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated.1

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…of patients treated with Jakafi in the RESPONSE* trial had dose adjustments from the recommended starting dose by week 322

 
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OPTIMIZE: Individualize dosing of Jakafi to optimize the balance between safety and efficacy1

OPTIMIZE: Individualize dosing of Jakafi to optimize the balance between safety and efficacy1

Image with an arrow pointing downDECREASING DOSE FOR ANEMIA OR THROMBOCYTOPENIA
Image showing 2 groups of people – 1st group WEEK 8 - 5% (6/110); 2nd group WEEK 32 – 13% (14/110) – Percent of patients randomized to Jakafi in the phase 3 RESPONSE trial who decreased from starting doseImage showing 2 groups of people – 1st group WEEK 8 - 5% (6/110); 2nd group WEEK 32 – 13% (14/110) – Percent of patients randomized to Jakafi in the phase 3 RESPONSE trial who decreased from starting dose
Image with an arrow pointing upINCREASING DOSE FOR INSUFFICIENT RESPONSE
Image showing 2 groups of people – 1st group WEEK 8 - 37% (41/110); 2nd group WEEK 32 – 54% (59/110) – Percent of patients randomized to Jakafi in the phase 3 RESPONSE trial who increased from starting doseImage showing 2 groups of people – 1st group WEEK 8 - 37% (41/110); 2nd group WEEK 32 – 54% (59/110) – Percent of patients randomized to Jakafi in the phase 3 RESPONSE trial who increased from starting dose

A CBC and PLT count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated.1

Image that says 66% – 73 out of 110

…of patients randomized to Jakafi discontinued treatment due to an adverse event1,3

Image shows a hand in a 'stop' signINTERRUPTING/RESTARTING DOSING
Special populations:

Dosing in patients with renal or hepatic impairment, or when coadministered with strong CYP3A4 inhibitors or fluconazole1

DOSE MODIFICATIONS FOR SPECIAL POPULATIONS

For further information and to download the Jakafi dosing guide, click here.

Video

Dosing of Jakafi® (ruxolitinib) in Patients With Polycythemia Vera Who Have Had an Inadequate Response to or Are Intolerant of Hydroxyurea

Hematology specialist Dr Harry Erba discusses the appropriate dosing of Jakafi® (ruxolitinib) in patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Dr Erba addresses the recommended starting dose, dose reductions based on hemoglobin levels and/or platelet counts, and dose modifications because of insufficient response in PV.

WATCH NOW

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*The RESPONSE (Randomized study of Efficacy and Safety in POlycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care) trial was a randomized, open-label, active-controlled phase 3 trial comparing Jakafi with best available therapy (BAT) in 222 patients with polycythemia vera. BAT included hydroxyurea (60%), interferon/pegylated interferon (12%), anagrelide (7%), pipobroman (2%), lenalidomide/thalidomide (5%), and observation (15%). Patients enrolled in the study had been diagnosed with polycythemia vera for at least 24 weeks, had an inadequate response to or were intolerant of hydroxyurea, required phlebotomy for hematocrit (Hct) control, and exhibited splenomegaly. All patients were required to demonstrate Hct control between 40% and 45% prior to randomization. After week 32, patients were able to cross over to Jakafi treatment. The composite primary endpoint was defined as Hct control without phlebotomy eligibility and a ≥35% spleen volume reduction as measured by CT or MRI. To achieve the Hct control endpoint, patients could not become eligible for phlebotomy between weeks 8 and 32. Phlebotomy eligibility was defined as Hct >45% that is ≥3 percentage points higher than baseline or Hct >48% (lower value). 23% of patients receiving Jakafi achieved the composite primary endpoint at week 32 vs <1% for BAT (P <0.0001).1,3

References

  1. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.
  2. Data on file. Incyte Corporation. Wilmington, DE.
  3. Vannucchi AM, Kiladjian JJ, Griesshammer M, et al. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med. 2015;372(5):426-435.

Indications and Usage

Jakafi is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.

Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults.

Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.

Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) 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 see Full Prescribing Information for Jakafi.

Jakafi and the Jakafi logo are registered trademarks of Incyte. All other trademarks are the property of their respective owners.
© 2014-2021, Incyte Corporation. MAT-JAK-02777  09/21

Jakafi and the Jakafi logo are registered trademarks of Incyte. All other trademarks are the property of their respective owners.
© 2014-2021, Incyte Corporation. MAT-JAK-02777  09/21