Jakafi (ruxolitinib) is a JAK inhibitor. It's used to treat adults with certain blood conditions called myelofibrosis (MF) and polycythemia vera (PV). This medication can also treat graft-versus-host disease (GVHD) in people 12 years and older. Jakafi (ruxolitinib) comes as a tablet that's taken by mouth twice a day. There's also Jakafi XR (ruxolitinib), the extended-release version that's taken once a day. Side effects can include low blood cell counts, infection, and dizziness.
Jakafi (ruxolitinib) is a JAK inhibitor. It works by blocking JAK1 and JAK2 proteins in the body.
In myelofibrosis and polycythemia vera, these JAK signals are too active. This can cause the body to make too many blood cells. By blocking these signals, Jakafi (ruxolitinib) helps control blood cell production.
In graft-versus-host disease, JAK signals can turn on immune cells that attack healthy tissue after a donor stem cell transplant. Jakafi (ruxolitinib) blocks these signals. This helps calm the immune system and lessen damage to healthy tissue.
| Common Brands | Jakafi, Jakafi XR |
|---|---|
| Drug Class | JAK inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Note: Side effects are from adults with myelofibrosis. Side effects might differ slightly for people with other conditions and for children.
Contact your healthcare provider immediately if you experience any of the following.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Black, tarry stools
bladder pain
bleeding gums
blood in the urine or stools
blurred vision
bruising
chills
cloudy urine
collection of blood under the skin
coughing up blood
deep, dark purple bruise
difficult, burning, or painful urination
difficulty in breathing or swallowing
dizziness
frequent urge to urinate
headache
hoarseness
increased menstrual flow or vaginal bleeding
itching, pain, redness, or swelling
large, flat, blue or purplish patches in the skin
lower back or side pain
nervousness
nosebleeds
painful or difficult urination
pale skin
paralysis
pinpoint red spots on the skin
pounding in the ears
prolonged bleeding from cuts
pus in the urine
red or dark brown urine
small, red or purple spots on the skin
slow or fast heartbeat
swelling
tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
tightness in the chest
troubled breathing with exertion
ulcers, sores, or white spots in the mouth
unusual bleeding or bruising
unusual tiredness or weakness
Less common
Painful blisters on the trunk of the body
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Jakafi (ruxolitinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Jakafi (ruxolitinib) can cause low blood cell counts. It can lower your red blood cells, white blood cells, and platelets. Low red blood cells can cause anemia and make you feel tired, weak, or short of breath. Low white blood cells can put you at risk of infection. And low platelets can make you bruise or bleed more easily.
Your care team will check your blood cell counts every 2 to 4 weeks at first and then as needed. Tell your care team if you have unusual tiredness, weakness, easy bruising, or bleeding. If your blood counts get too low, your prescriber might lower your dose or pause Jakafi (ruxolitinib) until your labs improve. Some people might also need a blood transfusion of red blood cells or platelets to help.
Jakafi (ruxolitinib) can raise your risk of infection. These can include bacterial, fungal, and viral infections, which can sometimes be serious. Infections have included tuberculosis (TB) and shingles. Rarely, a serious brain infection called progressive multifocal leukoencephalopathy (PML) has also happened.
Before starting Jakafi (ruxolitinib), tell your prescriber about any infections you have now or had in the past. You shouldn’t start the medication if you have a serious infection. During treatment, your prescriber might give you an antibiotic or antiviral medication to help prevent certain infections.
Call your care team right away if you have signs of an infection. This can include fever, chills, cough, trouble breathing, or feeling very tired. A painful or blistering rash can be a sign of shingles.
PML can cause different symptoms. Tell your care team right away if you have new confusion, weakness, vision changes, or trouble with balance or coordination.
Some people who stopped Jakafi (ruxolitinib) for myelofibrosis or polycythemia vera had their symptoms come back. Some also had other serious problems. This can include fever, trouble breathing, low blood pressure, blood-clotting problems, or organ failure.
Don’t suddenly stop taking Jakafi (ruxolitinib) without talking to your prescriber first. Usually, they'll slowly lower the dose before stopping treatment to help lower the risk. Tell your prescriber right away if your symptoms come back while your dose is being lowered or after you stop.
Some people taking Jakafi (ruxolitinib) have had higher cholesterol and triglyceride levels. Your care team will check these levels with a blood test about 8 to 12 weeks after you start treatment. If your levels are too high, they might recommend ways to help manage your cholesterol.
Some people have developed new skin cancers while taking Jakafi (ruxolitinib). Different types of skin cancer have been reported. Regularly check your skin and tell your prescriber if you notice any new or unusual skin changes.
In a study of people with rheumatoid arthritis (RA), a different JAK inhibitor was linked to a higher risk of serious health problems compared with a TNF inhibitor. These problems included heart-related death, heart attack, and stroke. Jakafi (ruxolitinib) wasn't studied in this trial and isn't approved for RA.
Tell your prescriber about all your medical conditions and if you smoke or have smoked in the past. They can consider these risks when deciding if Jakafi (ruxolitinib) is safe for you.
Call 911 right away if you have any signs of a heart attack or stroke. Signs of a heart attack can include sudden chest pain, nausea, or sweating. Signs of a stroke can include a droopy face, sudden weakness on one side of the body, severe headache, or trouble walking or talking.
In a study of people with rheumatoid arthritis (RA), a different JAK inhibitor was linked to a higher risk of blood clots compared with a TNF inhibitor. These clots included deep vein thrombosis (DVT) and pulmonary embolism (PE). Jakafi (ruxolitinib) wasn't studied in this trial and isn't approved for RA.
Get medical help right away if you have signs of a blood clot. These can include swelling or pain in one arm or leg, sudden chest pain, or sudden trouble breathing.
In a study of people with rheumatoid arthritis (RA), a different JAK inhibitor was linked to a higher risk of new cancers compared with a TNF inhibitor. These cancers included lymphoma and other types of cancer. The risk was higher in people who smoke or have smoked in the past. Jakafi (ruxolitinib) wasn't studied in this trial and isn't used for RA.
Tell your cancer care team if you smoke or have smoked in the past. Talk to them if you're concerned about the risk of developing a new cancer while taking Jakafi (ruxolitinib).
Myelofibrosis
Polycythemia vera
Acute graft-versus-host disease
Chronic graft-versus-host disease
Your prescriber might adjust your dose based on your blood counts, side effects, and how well the medication is working.
Your dose might be different if you have liver or kidney problems. It can also be different if you take certain medications that can interact with Jakafi (ruxolitinib).
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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No, Jakafi isn’t traditional chemotherapy. It's a type of targeted therapy called a JAK inhibitor. Jakafi blocks specific JAK signals involved in making blood cells and regulating the immune system. This is different from traditional chemotherapy, which broadly affects fast-growing cells in the body.
You can take Jakafi for as long as it's working for you and your prescriber says it's safe for you. How long you need treatment depends on your condition and how you respond. For some conditions, your prescriber might check how well Jakafi is working after several months and decide if you should keep taking it. Don't stop Jakafi suddenly on your own. If you need to stop, your prescriber might slowly lower your dose.
Some people might consider Jakafi as an immunosuppressant because it can weaken your immune system. It works as a JAK inhibitor, which blocks signals involved in immune system activity. This can make it harder for your body to fight infections. Tell your care team right away if you have signs of an infection. This can include fever, chills, cough, trouble breathing, or a painful rash.
After a single dose, it takes about 15 hours for most of Jakafi to leave your body. For Jakafi XR, it takes about 1 day. This is estimated using the medication’s half-life, or how long it takes for your body to remove half of the medication. This timing can be different depending on the other medications you take with Jakafi. Some medications can interact with Jakafi and affect how long it stays in your system. Ask your prescriber if you have questions about how long Jakafi stays in your body.
The manufacturer doesn't say if regular Jakafi tablets can be cut in half. Jakafi XR tablets shouldn't be cut because of the way they work. To be safe, swallow regular Jakafi tablets and Jakafi XR tablets whole. If you have trouble swallowing either medication, tell your care team.
It's best to avoid alcohol while taking Jakafi. Drinking alcohol can raise your risk of liver problems and make it harder for your body to fight infections. These are also possible risks with Jakafi. Long-term alcohol use can also raise the risk of certain cancers. Talk to your prescriber about how much alcohol you drink and whether it's safe during treatment.
Weight gain can happen with Jakafi, but it isn't a common side effect. In studies, some people taking Jakafi for myelofibrosis or polycythemia vera gained weight. Talk to your care team if you notice a large or unexpected change in your weight.
Stopping Jakafi can cause symptoms of your condition to come back or get worse. This can happen if you have myelofibrosis or polycythemia vera. With graft-versus-host disease (GVHD), symptoms can also come back while your dose is being lowered or after you stop. Don't stop Jakafi suddenly without talking to your prescriber. If it's the right choice for you, your prescriber can help you lower your dose safely.
