What is Jakafi?
Jakafi can be used to treat some types of myelofibrosis among adults. Jakafi can also be used to treat polycythemia vera among adults who had previously taken hydroxyurea but it didn't work or they couldn't tolerate it. Jakafi can be used to treat acute Graft-versus-Host disease in adults and children aged 12 and older who have not responded well to corticosteroids. Jakafi blocks certain enzymes that are responsible for the production of blood cells.
Warnings
Jakafi should not be used if you're allergic to ruxolitinib or have severe kidney problems. Tell your doctor before taking this medication if any of the following conditions exist: liver or kidney disease; dialysis; or pregnancy. While using this medication, you should not breastfeed.
Blood tests are required to ensure that Jakafi does not cause harmful effects and is actually helping you. Your doctor can then determine the right dose to prescribe. You will need blood tests every two to four weeks when you first begin taking this medication. Do not skip any of your follow-up appointments with your doctor. Jakafi can interact with grapefruit or grapefruit juice, and this may affect the level of medication in your blood. Talk to your doctor about the use of grapefruit and grapefruit juice.
Please read all the instructions on the label or package of your medication. Inform your healthcare provider about your medical conditions, allergies, and medicines.
Before you take this drug
If you have an allergy to ruxolitinib, do not take Jakafi. Tell your doctor whether you or anyone else in your family has ever suffered from tuberculosis. Tell your doctor about any exposure to or experience with tuberculosis or recent travel. You may have come into contact with certain infections while travelling. Tell your doctor about any of the following to ensure that Jakafi will be safe for you:
- Shingles (herpes zoster);
- A blood clot or stroke, a heart attack, or other heart problems
- Low white or red cell counts
- Any type of cancer
- Are you a smoker, or have you been a smoker in the past?
- Kidney disease (or dialysis if you have it);
- Hepatitis b (specifically) is a liver disease.
- High cholesterol (or triglycerides) are types of fats in the blood.
There is no way to know if ruxolitinib can harm an unborn child. Inform your doctor if you are pregnant or planning to become pregnant.
Jakafi has not been approved to treat myelofibrosis or polycythemia vera in anyone under the age of 18.
Related drugs
Prednisone methotrexate mycophenolate Mofetil imatinib, Deltasone imbruvica imbrutinib
How to take Jakafi?
Follow the directions on your prescription label and read all medication guides or instructions sheets. Read all the instructions on the prescription label. Your doctor may change your dosage from time to time. Your doctor will need to perform frequent medical tests in order to determine the optimal dose. Jakafi can be taken with or without a meal. Jakafi can be administered through a nasogastric tube (NG).
Please read and follow all instructions for use that come with your medicine. If you don't understand the instructions, ask your doctor or pharmacist. Jakafi is best taken immediately after dialysis if you are on dialysis. Jakafi can increase your risk of developing other cancers. This is something you should discuss with your doctor.
Store away from heat and moisture at room temperature. Jakafi should not be stopped abruptly. You should follow your doctor's advice about reducing your dosage. Other medications may be prescribed to prevent infection. Continue to take these medications as prescribed by your doctor.
Details on dosage
Adult dose of Jakafi used for myeloproliferative disorder:
The dose should be titrated based on safety and effectiveness. CBC (complete blood count) and platelet counts are recommended every 2 to 4 weeks until the dose is stabilised, and then according to clinical indication.
Initial dose based on platelet count
Platelets exceeding 200 x 10 /L: 20 mg twice daily.
-Platelets from 100 x (10(9)/L up to 200 x 9/L: 15 mg twice daily.
Platelets less than 100 x 10 9/L or 50 x 10 9/L: Orally, 5 mg twice daily
Comments:
Based on limited clinical evidence, maintenance of 5 mg twice daily for long periods has not been beneficial. This dose should only be given to patients whose benefits outweigh their potential risks.
After 6 months, discontinue treatment if the spleen does not shrink or symptoms do not improve.
Uses:
For the treatment of myelofibrosis with intermediate or high risk, including primary MF and MF after polycythemia vera, as well as MF following essential thrombocythemia.
An adult dose of Jakafi is used for graft-versus-host disease.
Check complete blood counts, including platelet count, ANC, and bilirubin, before
Starting therapy every 2 to 4 weeks until the doses have stabilised, and then as clinically indicated:
Acute Graft Versus Host Disease (GVHD), initial dose: 5mg orally, 2 times a week
If the platelet count and ANC (absolute neutrophil count) have not fallen by at least 50% compared to the first dose day, consider increasing the dose to 10mg orally twice a day.
Duration of treatment: If you have a response after stopping corticosteroids, taper your dose by one level every eight weeks. (See comments).
Chronic GVHD Initial dose: Orally, 10 mg twice a day.
Duration: taper after 6 months if you have a response and have stopped taking corticosteroids. Taper by one dose every 8 weeks.
Comments:
Dose levels decrease: from 10 mg twice daily to 5mg twice daily to 5mg once per day.
For dose modifications for adverse reactions, please refer to the section on dose adjustment.
Uses: Treatment of acute GVHD refractory to steroid therapy and chronic GVHD following failure of one or two lines of systemic treatment
Adult dose of Jakafi as usual for Polycythemia Vera:
The dose should be titrated based on safety and effectiveness. CBCs and platelet counts are recommended every 2 to 4 weeks until the dose is stabilised, and then according to clinical indication.
Initial dose: 10 mg twice daily.
The dose may be adjusted based on efficacy and safety.
Use: To treat polycythemia vera (PV) among adults who are not tolerant or have an insufficient response to hydroxyurea.
The usual paediatric dose of Jakafi to treat Graft Versus Host Disease
Twelve years of age or older
Check complete blood counts, including platelet count, ANC, and bilirubin, before
Starting therapy every 2 to 4 weeks until the doses have stabilised, and then as clinically indicated:
Acute Graft Versus Host Disease (GVHD), initial dose: 5mg orally, 2 times a week
If the platelet count and ANC (absolute neutrophil count) have not fallen by at least 50% compared to the first dose day, consider increasing the dose to 10mg orally twice a day.
Duration of treatment: If you have a response after stopping corticosteroids, taper your dose by one level every eight weeks. (See comments).
Chronic GVHD Initial dose: Orally, 10 mg twice a day.
Duration: taper after 6 months if you have a response and have stopped taking corticosteroids. Taper by one dose every 8 weeks.
Comments:
Dose levels decrease: from 10 mg twice daily to 5mg twice daily to 5mg once per day.
For dose modifications for adverse reactions, please refer to the section on dose adjustment.
Uses: Treatment of acute GVHD, steroid-refractory GVHD, and chronic GVHD following failure of one or two lines of systemic treatment in paediatric patients aged 12 years and older.
What happens if I miss the dose?
If you are almost due for your next dose, skip the missed one. Never take two doses of the same medicine at once.
What happens if I overdose?
Call 1-800-222-1222 for poison help or seek immediate medical attention.
Avoid this
Grapefruit can interact with ruxolitinib, causing side effects. Avoid consuming grapefruit products.
Side effects of Jakafi:
If you experience any of the following symptoms of an allergic reaction: difficulty breathing, swelling of the face,:lips, or tongue, or hives,
Some side effects can be similar to the symptoms of myelofibrosis. If you experience:
- Changes in the size, colour, or shape of a skin lesion or mole;
- These symptoms can start slowly and worsen over time.
- Nausea;
- Cold sores around the mouth, skin blisters or sores, itching or tingling in your lower back or thigh, and skin rash
- You may experience pain in your back, arms, jaw, or neck.
- Signs and symptoms of stroke include sudden numbness, weakness, or severe headaches. Other symptoms are slurred or shaky speech, vision or balance problems, or slurred or shaky speech.
- Signs that a blood clot is in the lung: chest pain, sudden hack, shortness of breath, dizziness, or coughing blood
- Signs of a Blood Clot Deep in the Body: Pain, swelling, or warmth in a leg;
- Heart attack symptoms: pain in the chest or pressure on your chest, pain that spreads to your shoulder or jaw, nausea, and sweating.
- Signs and symptoms of an infection include: fever; sore or dry throat; and body aches.
- Low blood cell counts: fever, chills, and tiredness; mouth sores or skin sores; easy bruising or bleeding; pale or cold skin, hands, or feet; feeling light-headed or short-of-breath.
- Signs of tuberculosis include fever, coughing, night sweats, and loss of appetite.
Jakafi may cause the following side effects:
- Low blood cell count.
- Diarrhoea.
There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.
Interaction with other drug
It is sometimes not safe to take certain medications at the same time. Some drugs may affect the blood levels of drugs that you are taking, causing side effects or making them less effective. Tell your doctor all of your medications, including fluconazole.
This list is incomplete, and other drugs can interact with ruxolitinib. These include prescription and over-the-counter medicines, vitamins, and herbal products. This list does not include all possible drug interactions.
