Precautions
In these two Phase 3 studies, patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 89% of patients treated for more than 6 months and 25% treated for more than 12 months.
What is the duration of Jakafi treatment?
For dose reductions, patients who are currently receiving Jakafi 10 mg twice daily may have their dose reduced to 5 mg twice daily; patients receiving 5 mg twice daily may have their dose reduced to 5 mg once daily.
Can Jakafi be reduced from 10 mg to 5 mg?
Patients were randomized 2:1 to Jakafi versus best available therapy. Best available therapy was selected by the investigator on a patient-by-patient basis. In the best available therapy arm, the medications received by more than 10% of patients were hydroxyurea (47%) and glucocorticoids (16%).
What is the best available therapy for Jakafi?
If the bleeding event has resolved but the underlying cause persists, consider resuming treatment with Jakafi at a lower dose. The recommended starting dose of Jakafi is 10 mg twice daily.
What is the recommended starting dose of Jakafi for postoperative bleeding?
How long do you take Jakafi?
Jakafi is a long-term treatment. Your Healthcare Professional may allow up to 6 months to see if Jakafi is working for you. If you do not see an improvement after 6 months of treatment, your Healthcare Professional may have you stop taking Jakafi.
What happens when you stop taking Jakafi?
To help you remember, take it at the same times each day. Do not stop taking ruxolitinib without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as fever, trouble breathing, dizziness, and unusual bleeding/bruising.
How long does ruxolitinib take to work?
Ruxolitinib may take several weeks to begin having an effect on your cells, but often its effects on spleen and symptoms occur in 2-4 weeks. Your blood cell counts may not stabilise for up to 16 weeks.
How often do you take Jakafi?
Take Jakafi exactly as instructed by your Healthcare Professional. For most patients, the starting dose of Jakafi is one tablet taken twice a day by mouth. In certain cases, a Healthcare Professional may start a patient at a lower dose or temporarily reduce the dose of Jakafi to once a day.
Can Jakafi cause liver damage?
This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests.
Does Jakafi increase hemoglobin?
A total of 90 patients with MF and anemia defined as a hemoglobin <10 g/dL but with low platelet counts <100/nL were treated with 2 dose levels of Pomalyst combined with Jakafi. A subset of these patients had their average hemoglobin level improved from 8.7 g/dL to 9.6 g/dL and sustained.
How long does Jakafi work for myelofibrosis?
Median overall survival time was 5.3 years for patients treated with Jakafi, compared with 3.8 years for patients treated with BAT or receiving placebo.
How effective is Jakafi?
99% of people on Jakafi had some response to therapy. This means that they had a reduction in spleen size even if it was less than the 35% goal achieved by some patients. In contrast, most patients receiving placebo experienced an increase in spleen size.
What happens if you stop taking ruxolitinib?
Ruxolitinib discontinuation syndrome (RDS) occurs within 21 days of treatment stop and is characterized by an acute relapse of disease symptoms, accelerated splenomegaly, worsening of cytopenias, and occasional hemodynamic decompensation, including acute respiratory distress syndrome and shock.
Does Jakafi reduce platelets?
Jakafi appeared to effectively reduce platelet levels, as well as white blood cell counts and enlarged spleen, in patients with ET who had progressed on or couldn't tolerate Hydrea.
How much does Jakafi cost per month?
Your monthly Jakafi cost savings if eligibleStrengthAvg. monthly price at a US pharmacyNiceRx monthly price5mg 10 tablets$2,300.00$49.0010mg 30 tablets$6,900.00$49.0015mg 30 tablets$6,900.00$49.0020mg 30 tablets$6,900.00$49.001 more row
When is the best time to take Jakafi?
Take Jakafi exactly as instructed by your Healthcare Professional. For most patients, the starting dose of Jakafi is 1 tablet taken twice a day by mouth. In certain cases, a Healthcare Professional may start a patient at a lower dose or temporarily reduce the dose of Jakafi to once a day.
Before Taking This Medicine
You should not use Jakafi if you are allergic to it.Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosi...
How Should I Take Jakafi?
Take Jakafi exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose t...
Jakafi Dosing Information
Usual Adult Dose for Myeloproliferative Disorders:Initial Dose:-Platelets greater than 200 x 10(9)/L: 20 mg orally twice a day-Platelets 100 to 200...
What Happens If I Miss A Dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to...
What Should I Avoid While Taking Jakafi?
Grapefruit and grapefruit juice may interact with ruxolitinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking...
What Other Drugs Will Affect Jakafi?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Jakafi, especially: 1. an antibiotic; 2....
How long does Jakafi last?
The median duration of treatment with Jakafi was 46 days (range, 4‑382 days).
How often should I take Jakafi?
A complete blood count (CBC) and platelet count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [ see Warnings and Precautions ( 5.1) ].
How much Jakafi should I take?
The recommended starting dose of Jakafi is 5 mg given orally twice daily. Consider increasing the dose to 10 mg twice daily after at least 3 days of treatment if the ANC and platelet counts are not decreased by 50% or more relative to the first day of dosing with Jakafi.
What happens after Jakafi is discontinued?
Some patients with MF have experienced one or more of the following adverse events after discontinuing Jakafi: fever, respiratory distress, hypotension , DIC, or multi-organ failure. If one or more of these occur after discontinuation of, or while tapering the dose of Jakafi, evaluate for and treat any intercurrent illness and consider restarting or increasing the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi therapy without consulting their physician. When discontinuing or interrupting therapy with Jakafi for reasons other than thrombocytopenia or neutropenia [ see Dosage and Administration ( 2.6) ], consider tapering the dose of Jakafi gradually rather than discontinuing abruptly.
What is Jakafi used for?
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.
What is the effect of Ruxolitinib on Janus Associated Kinases?
Ruxolitinib, a kinase inhibitor, inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression.
Is Jakafi safe for children?
The safety and effectiveness of Jakafi for treatment of myelofibrosis or polycythemia vera in pediatric patients have not been established. The safety and effectiveness of Jakafi for treatment of steroid-refractory acute graft-versus-host disease (GVHD) have been established for treatment of children 12 years and older.
How often should I take Jakafi?
A complete blood count (CBC) and platelet count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [ see Warnings and Precautions ( 5.1) ].
How much Jakafi should I take?
The recommended starting dose of Jakafi is 5 mg given orally twice daily. Consider increasing the dose to 10 mg twice daily after at least 3 days of treatment if the ANC and platelet counts are not decreased by 50% or more relative to the first day of dosing with Jakafi. .
How often should I increase my meds?
If the response is insufficient and platelet, hemoglobin, and neutrophil counts are adequate, doses may be increased in 5 mg twice daily increments to a maximum of 25 mg twice daily. Doses should not be increased during the first 4 weeks of therapy and not more frequently than every two weeks.
Can Jakafi be titrated?
After restarting Jakafi following treatment interruption, doses may be titrated, but the maximum total daily dose should not exceed 5 mg less than the dose that resulted in the dose interruption. An exception to this is dose interruption following phlebotomy-associated anemia, in which case the maximal total daily dose allowed after restarting Jakafi would not be limited.
What else should I communicate to my Transplant Team?
It is important for you and your caregiver to talk to your Transplant Team about how you are feeling and how your condition is affecting you, even if you’re not sure that how you are feeling is caused by your condition. Talking to your Transplant Team helps you both:
How long will I need to take Jakafi?
How long you continue to take Jakafi depends on your unique situation and how you and your Healthcare Professional decide to move your treatment forward.
How often should I take Jakafi?
For most patients, the starting dose of Jakafi is one tablet taken twice a day by mouth. In certain cases, a Healthcare Professional may start a patient at a lower dose or temporarily reduce the dose of Jakafi to once a day. It is important to take each dose of Jakafi as prescribed.
How many mg of Jakafi is there?
The results of your blood work. Certain other medical conditions you may have. Other medications you may be taking. Jakafi comes in different dosage strengths— 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg —as shown below. This is because different people need different doses and dosing may change during treatment.
How much Jakafi should I take for polycythemia?
For most adults with polycythemia vera (PV) who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it, the recommended starting dose of Jakafi is 10 mg, taken twice daily by mouth.
What to do if you miss a dose of Jakafi?
If you miss a dose of Jakafi, take your next dose as scheduled. Do not take an additional dose. If you take too much Jakafi, call your Healthcare Professional or go to the nearest hospital emergency room right away. Take the bottle of Jakafi with you.
Can you take jakafi while pregnant?
Taking Jakafi with certain other medicines may affect how Jakafi works. Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Where can I get Jakafi?
Jakafi will come to you from a specialty pharmacy. It is important that you let your local pharmacist know that you are taking Jakafi, and it is also important to tell the specialty pharmacy about any other medicines, vitamins, and supplements you are taking.
Can you drink grapefruit juice while taking Jakafi?
It may help you remember to take your Jakafi if you take it at the same time as you perform another daily activity, like brushing your teeth. Do not drink grapefruit juice while taking Jakafi. Grapefruit juice can affect the amount of Jakafi in your blood.
How often should I take Jakafi?
For most patients, the initial dose will be taken twice a day by mouth. Some patients may take Jakafi once a day. During treatment, your Healthcare Professional may check your blood cell counts regularly to make sure they don’t become too low.
How much Jakafi should I take?
Your Healthcare Professional will determine the appropriate dose of Jakafi for you by taking several factors into account, including: Jakafi comes in different dosage strengths— 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg —as shown below. This is because different people need different doses and dosing may change during treatment.
How many mg of Jakafi is there?
This is because different people need different doses and dosing may change during treatment. Jakafi comes in different dosage strengths—5 mg, 10 mg, 15 mg, 20 mg, and 25 mg —as shown below. This is because different people need different doses and dosing may change during treatment. Be sure to take the dose you were prescribed ...
Where can I get Jakafi?
Jakafi will come to you from a specialty pharmacy. It is important that you let your local pharmacist know that you are taking Jakafi, and it is also important to tell the specialty pharmacy about any other medicines, vitamins, and supplements you are taking.
Can you take jakafi while pregnant?
Taking Jakafi with certain other medicines may affect how Jakafi works. Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Does Jakafi raise blood count?
Depending on how you respond to Jakafi, your Healthcare Professional may raise or lower the dose to help maintain appropriate blood count levels and/or treat your myelofibrosis. In some instances, your Healthcare Professional may have to temporarily stop your treatment with Jakafi.
Can you drink grapefruit juice with jakafi?
Do not drink grapefruit juice while taking Jakafi. Grapefruit juice can affect the amount of Jakafi in your blood. You can take Jakafi with or without food. If you miss a dose of Jakafi, take your next dose as scheduled. Do not take an additional dose.
What is Jakafi used for?
Jakafi is used to treat adults with intermediate or high-risk myelofibrosis (MF). Jakafi is the first medicine approved by the Food and Drug Administration (FDA) for the treatment of these patients. Jakafi is not chemotherapy.
How does jakafi work?
All people with MF are believed to have overactive JAK signaling even if they do not have a JAK mutation. Jakafi works by targeting JAKs, which control the production of blood cells.
What happens when a JAK sends too many signals?
When JAKs send too many signals, they cause the body to make the wrong number of blood cells. This chain of events is called overactive JAK signaling (B). As a result of overactive signaling in MF, scar tissue can build up in the bone marrow, preventing it from making enough blood cells.
Does Jakafi cause bruising?
These are not all the possible side effects of Jakafi .
Can Jakafi be changed?
Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.
Can Jakafi cause a fever?
Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.
Can I take jakafi while pregnant?
Do not change your dose or stop taking Jakafi without first talking to your healthcare provider. Women should not take Jakafi while pregnant or planning to become pregnant. Do not breastfeed during treatment with Jakafi and for 2 weeks after the final dose.
How often should I monitor CBCs for Jakafi?
Perform a pre-treatment 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.
What blood test is required for Jakafi?
A complete blood count (CBC) and platelet (PLT) count must be performed before initiating Jakafi. Jakafi is also available in 10 mg and 25 mg tablets. MONITOR: Monitoring patients after initiation of Jakafi is essential, especially during the first 12 weeks of therapy.
In Summary
Common side effects of Jakafi include: anemia, balance impairment, dizziness, headache, labyrinthitis, meniere's disease, neutropenia, thrombocytopenia, vertigo, and orthostatic dizziness. Other side effects include: weight gain, and flatulence. See below for a comprehensive list of adverse effects.
For the Consumer
Along with its needed effects, ruxolitinib (the active ingredient contained in Jakafi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
How often should I taper Jakafi?
Taper Jakafi by 1 dose level approximately every 8 weeks (10 mg twice daily to 5 mg twice daily to 5 mg once daily) If aGVHD signs or symptoms recur during or after the taper of Jakafi, consider retreatment.
How long does it take to taper Jakafi?
Patients who are unable to tolerate Jakafi at 5 mg once daily should have treatment interrupted until their clinical and/or laboratory parameters recover. Tapering may be considered after 6 months of treatment as clinically indicated in patients who have discontinued therapeutic doses of steroids.
Indications and Usage
This medication is used to treat certain bone marrow disorders (myelofibrosis, polycythemia vera).
May Treat: Graft versus host disease · Myelofibrosis · Polycythemia vera · Thrombocytosis in myeloproliferative disease
Drug Class: Antineoplastic - Janus Kinase (JAK) Inhibitors
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: This drug should not be given to breastfeeding mothers
May Treat: Graft versus host disease · Myelofibrosis · Polycythemia vera · Thrombocytosis in myeloproliferative disease
Drug Class: Antineoplastic - Janus Kinase (JAK) Inhibitors
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: This drug should not be given to breastfeeding mothers
Alcohol: Avoid intake while taking this medication
Driving: May cause drowsiness or dizziness. Use caution
Manufacturer: INCYTE CORPORAT
- If available, read the patient package insert
- Call MD for fever, chills or persistent sore throat
- Tell MD immediately of easy bruising or bleeding
- If available, read the patient package insert
- Call MD for fever, chills or persistent sore throat
- Tell MD immediately of easy bruising or bleeding
- May make you dizzy. Use caution when driving.
- Avoid taking grapefruit juice/grapefruit with med
- MD may need to reduce the dose before you stop it.
- Not recommended when breast feeding
- Lab tests may be ordered to monitor therapy
Dosage and Administration
Dosage Forms and Strengths
Warnings and Precautions
Adverse Reactions
Drug Interactions
- Myelofibrosis
The recommended starting dose of Jakafi is based on platelet count (Table 1). A complete blood count (CBC) and platelet count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [see Warnings and Precautions (5.1)]. … - Polycythemia Vera
The recommended starting dose of Jakafi is 10 mg twice daily. Doses may be titrated based on safety and efficacy. A complete blood count (CBC) and platelet count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [s…
Use in Specific Populations
- 5 mg tablets - round and white with "INCY" on one side and "5" on the other. 10 mg tablets - round and white with "INCY" on one side and "10" on the other. 15 mg tablets - oval and white with "INCY" on one side and "15" on the other. 20 mg tablets - capsule-shaped and white with "INCY" on one side and "20" on the other. 25 mg tablets - oval and white with "INCY" on one side and "25" on the …
Overdosage
- Thrombocytopenia, Anemia and Neutropenia
Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia [see Adverse Reactions (6.1)]. Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary [see Dosage and Administration (2)]. Patients de… - Risk of Infection
Serious bacterial, mycobacterial, fungal and viral infections have occurred [see Adverse Reactions (6.1)]. Delay starting therapy with Jakafi until active serious infections have resolved. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly. Use active …
Description
- The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: 1. Thrombocytopenia, Anemia and Neutropenia [see Warnings and Precautions (5.1)] 2. Risk of Infection [see Warnings and Precautions (5.2)] 3. Symptom Exacerbation Following Interruption or Discontinuation of Treatment with Jakafi [see Warnings a…
Clinical Pharmacology
- Effect of Other Drugs on Jakafi
Fluconazole Concomitant use of Jakafi with fluconazole increases ruxolitinib exposure [see Clinical Pharmacology (12.3)], which may increase the risk of exposure-related adverse reactions. Avoid concomitant use of Jakafi with fluconazole doses of greater than 200 mg daily. Reduce th…