Jakafi

Generic name: ruxolitinib [RUX-oh-LI-ti-nib]
Drug Class: Multikinase inhibitors are a type of drug.

What is Jakafi?

Jakafi works by stopping the body from making some enzymes that change how blood cells are made.

Jakafi works by stopping the body from making some enzymes that change how blood cells are made.

Some kinds of myelofibrosis in adults are treated with Jakafi.

Jakafi is used to treat people with polycythemia vera who have already tried hydroxyurea and either didn’t like it or it didn’t work well enough.

Jakafi is used to treat acute graft-versus-host disease (aGVHD) in adults and children older than 12 who have already tried corticosteroids and they didn’t work well enough.

Jakafi is also used to treat chronic graft-versus-host disease (cGVHD) in adults and children 12 years old and older who have already tried one or two other medicines that did not work well enough.

Warnings

If you are allergic to ruxolitinib or have severe kidney problems, you shouldn’t use Jakafi.

Tell your doctor if you have liver or kidney disease, are on dialysis, or are pregnant before you take this medicine.

While you are taking this medicine, you shouldn’t breastfeed.

Your blood will need to be checked often to make sure that Jakafi is helping your situation and not making it worse. This will help your doctor figure out how much medicine you should take. When you start taking this medicine for the first time, your blood will need to be checked every two to four weeks. Don’t forget to see your doctor for follow-up care.

Grapefruit and grapefruit juice may have an effect on how much of the drug is in your blood. Talk to your doctor about how to use grapefruit goods.

Follow all of the advice on the label and package of your medicine. Tell each health care worker about all of your health problems, allergies, and medicines.

Drugs that are similar

prednisone, methotrexate, mycophenolate mofetil, Deltasone, imatinib, Imbruvica, ibrutinib

Before you take this drug,

If you are allergic to ruxolitinib, you shouldn’t use Jakafi.

Tell your doctor if you’ve ever had tuberculosis or if anyone else in your family does. Tell your doctor if you’ve ever had tuberculosis or been around someone who did, or if you’ve just returned from a trip. Some illnesses are more common in some parts of the world, and you may have been exposed to them while traveling.

To make sure you can take Jakafi safely, tell your doctor if you have ever:

• any type of infection;

• shingles (herpes zoster);

• a blood clot, stroke, heart attack, or other heart problems;

• low white or red blood cell counts;

• any type of cancer;

• are a current or former smoker;

• have kidney disease (or are on dialysis);

• have liver disease (especially hepatitis B); or

• have high cholesterol or triglycerides (types of fat in the blood).

It is not known if ruxolitinib will hurt a baby that is still in the womb. If you are pregnant or want to get pregnant, you should tell your doctor.

Do not breastfeed while taking Jakafi and for at least two weeks after your last dose.

No one younger than 18 is allowed to take Jakafi to treat myelofibrosis or polycythemia vera.

What do I do with Jakafi?

Take Jakafi just as your doctor told you to. Follow all of the rules on the label of your prescription, and read any guides or instruction sheets that come with it.

Your doctor may change your dose from time to time. Your doctor will need to do tests on you often to figure out the best dose.

You can take Jakafi with food or on an empty stomach. A nasogastric (NG) tube can also be used to give a Jakafi pill.

Read and carefully follow any directions that come with the medicine on how to use it. If you don’t understand what to do, talk to your doctor or pharmacy.

If you get dialysis, take Jakafi after your treatment.

Using Jakafi may make you more likely to get other types of cancer. Talk to your doctor about this possibility.

Keep at room temperature and away from heat and moisture.

Don’t stop using Jakafi all of a sudden. Follow your doctor’s advice about how to cut down your dose.

You might be given other medicines to help keep you from getting sick. Take these drugs for as long as your doctor tells you to.

Information dosage

For Myeloproliferative Disorder, the usual dose of Jakafi for adults is:

Doses should be changed based on how safe and effective they are. A complete blood count (CBC) and platelet count should be done every 2 to 4 weeks until doses are stable, and then as clinically suggested.

First dose based on the number of platelets:

-Platelets over 200 x 109/L: Take 20 mg by mouth twice a day.
-Platelets 100 x 10(9)/L to 200 x 109/L: 15 mg by mouth twice a day
-Platelets 50 x 109/L to less than 100 x 109/L: 5 mg by mouth twice a day

Comments:
-Based on limited clinical data, long-term maintenance at 5 mg twice a day has not shown to be helpful. This dose should only be given to people for whom the benefits outweigh the risks.
-Stop treatments if the size of the spleen doesn’t go down or symptoms don’t get better after 6 months.

Uses:
For the treatment of myelofibrosis (MF) with intermediate or high risk, such as main MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.

Normal dose of Jakafi for adults with Graft vs. Host disease:

Before starting treatment, monitor complete blood counts (CBC), including platelet count and ANC, and bilirubin every 2 to 4 weeks until doses are stable, and then as clinically indicated:

Acute Graft-Versus-Host Disease (GVHD): Initial dose: 5 mg orally twice a day. Dose titration: consider increasing dose to 10 mg orally twice a day after at least 3 days if the absolute neutrophil count (ANC) and platelet count have not dropped by 50% or more compared to the first day of dosing.

Duration of therapy: Consider tapering after 6 months for people who got better after they quit taking corticosteroids at therapeutic doses; taper by one dose level every 8 weeks (see comments); If signs or symptoms of GVHD come back during or after tapering, a second treatment may be needed.

Long-term GVHD: Initial dose: 10 mg orally twice a day. Duration of therapy: Consider tapering after 6 months for those who have responded and have stopped taking therapeutic amounts of corticosteroids; taper by one dose level every 8 weeks (see comments); If signs or symptoms of GVHD come back during or after tapering, a second treatment may be needed.

Comments:
-The dose goes from 10 mg twice a day to 5 mg twice a day to 5 mg once a day.
-Check the Dose Adjustment part for advice on how to change the dose for side effects.

Uses: To treat acute GVHD that doesn’t respond to steroids and to treat chronic GVHD after 1 or 2 lines of systemic therapy have failed.

For Polycythemia Vera, the usual dose of Jakafi for an adult is:

Doses should be changed based on how safe and effective they are. A complete blood count (CBC) and platelet count should be done every 2 to 4 weeks until doses are stable, and then as clinically suggested.

Initial amount: 10 mg twice a day by mouth. The dose can be changed based on how safe and effective it is.

Use: To treat polycythemia vera (PV) in people who did not respond well to hydroxyurea or who can’t take it.

For Graft Versus Host Disease, the usual dose of Jakafi for children 12 years or higher is:

Before starting treatment, monitor complete blood counts (CBC), including platelet count and ANC, and bilirubin every 2 to 4 weeks until doses are stable, and then as clinically indicated:

Acute Graft-Versus-Host Disease (GVHD): Initial dose: 5 mg orally twice a day. Dose titration: consider increasing dose to 10 mg orally twice a day after at least 3 days if the absolute neutrophil count (ANC) and platelet count have not dropped by 50% or more compared to the first day of dosing.

Duration of therapy: Consider tapering after 6 months for people who got better after they quit taking corticosteroids at therapeutic doses; taper by one dose level every 8 weeks (see comments); If signs or symptoms of GVHD come back during or after tapering, a second treatment may be needed.

Long-term GVHD: Initial dose: 10 mg orally twice a day. Duration of therapy: Consider tapering after 6 months for those who have responded and have stopped taking therapeutic amounts of corticosteroids; taper by one dose level every 8 weeks (see comments); If signs or symptoms of GVHD come back during or after tapering, a second treatment may be needed.

Comments:
-The dose goes from 10 mg twice a day to 5 mg twice a day to 5 mg once a day.
-Check the Dose Adjustment part for advice on how to change the dose for side effects.

Uses: To treat acute GVHD that doesn’t respond to steroids and to treat chronic GVHD after 1 or 2 lines of systemic medicine have failed in children 12 years or older.

What will happen if I don’t take a dose?

Take the medicine as soon as you can, but skip the dose you missed if your next dose is almost due. Take only one amount at a time.

What happens if I overdose?

Get help from a doctor right away or call 1-800-222-1222 to reach the Poison Help line.

What should I stay away from while I’m on Jakafi?

Grapefruit may cause side effects when taken with ruxolitinib. Don’t eat anything with grapefruit in it.

Jakafi side effects

Get emergency medical help if you have hives, trouble breathing, or swelling of your face, lips, tongue, or throat after taking Jakafi.

Some side effects may be the same as myelofibrosis signs. Call your doctor at once if you have:

• changes in the size, shape, or color of a mole or skin lesion;

• problems with speech, thought, vision, or muscle movement (these symptoms may start gradually and get worse quickly);

• nausea, vomiting, weakness, general ill feeling;

• cold sores around your mouth, skin sores or blisters, itching, tingling, skin rash, burning pain in your thigh or lower back;

• pain in your arms, back, neck, jaw, or stomach;

• >b>signs of a stroke – sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung – chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;

• signs of a blood clot deep in the body – pain, swelling, or warmth in one leg;

• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;

• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or

• signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Some of the most common side effects of Jakafi are low numbers of blood cells, swelling, infection, bruises, diarrhea, dizziness, or headache.

This isn’t a full list of all possible side effects, and there may be others. You should talk to your doctor about any side effects. You can call 1-800-FDA-1088 to tell the FDA about side affects.

What effects will other drugs have on Jakafi?

Using some drugs at the same time is not always safe. Some medicines can change how much of another medicine is in your blood, which can make side effects worse or make the medicine less effective.

Tell your doctor about all the other drugs you take, especially fluconazole.

This list is not full, and ruxolitinib may also interact with many other drugs. This includes medicines you get from a doctor or buy over the counter, vitamins, and herbal goods. Not every drug combination that could happen is on this list.

For more details

Remember to keep this and all other medicines away from children, never give your medicines to other people, and only use Jakafi for what it was given for.

Talk to your doctor or other healthcare source to make sure that the information on this page applies to your situation.

Medical Disclaimer Use Copyright 1996–2023 Cerner Multum, Inc. Version: 7.02.

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