Jakafi (ruxolitinib) is a prescription kinase inhibitor that is manufactured by Incyte Corporation. It is indicated to treat adults with certain bone marrow disorders such as myelofibrosis or polycythemia vera. Jakafi is also used in pediatric patients 12 years of age and older with acute or chronic graft-versus-host disease (GVHD).
What is Jakafi used for?
Jakafi (ruxolitinib) is a prescription Janus Associated Kinase (JAK) inhibitor that is indicated by the U.S. Food and Drug Administration (FDA) for the treatment of:
- intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults.
- polycythemia vera in adults who did not respond or are intolerant to hydroxyurea.
- steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years of age and older.
- chronic graft-versus-host disease (GVHD) after the failure of other systemic therapies in adult and pediatric patients 12 years of age and older.
How does Jakafi work?
Jakafi inhibits the JAK1 and JAK2 protein kinases which disrupts the signaling of cytokine and growth factors that are important for immune system function and the production of blood cells. This disruption leads to a decrease in inflammatory cytokines, which are usually increased in myelofibrosis and other inflammatory medical conditions. Blocking these signaling pathways also slows the growth of malignant cells.
What are the most commonly prescribed doses of Jakafi?
- 5mg tablet
- 10mg tablet
- 15mg tablet
- 20mg tablet
- 25mg tablet
Before taking Jakafi
Before starting Jakafi, tell your healthcare provider if you have ever had:
- Chronic infections
- Kidney disease or if you are currently on dialysis
- Hepatitis B
- Skin cancer
- Elevated cholesterol or triglyceride levels
How to take Jakafi
- Read the Full Prescribing Information and Medication Guide that comes with Jakafi.
- Take Jakafi exactly as your healthcare provider tells you. Do not change the dose or stop taking it without first discussing it with your healthcare provider.
- Jakafi is usually taken by mouth with or without food. If you cannot take oral medications, you can take Jakafi through certain nasogastric (NG) tubes.
- If you miss a dose of Jakafi, skip the missed dose and take it at your regular time. Do not take an extra dose to make up for your missed dose.
- If you think you have taken too much Jakafi, call your healthcare provider or go to the nearest emergency room immediately.
- While taking Jakafi, your healthcare provider will perform regular blood tests. Your dose of Jakafi may be changed or treatment stopped based on the results of these blood tests.
- There are no studies on the use of Jakafi during pregnancy so it is not known if there are any risks to the fetus.
- There is no data available in regards to the presence of Jakafi in breast milk or the effects it would have on a breastfed child. It was found in the milk of lactating rats during animal studies. Because of the potential for adverse events, you should discontinue breastfeeding while taking Jakafi and for 2 weeks after your final dose.
- Store Jakafi at room temperature between 68°F to 77°F (20°C to 25°C). Keep all medications, including Jakafi out of the reach of children.
Jakafi is contraindicated in:
- Patients who have had an allergic reaction to Jakafi or any of its inactive ingredients.
- Jakafi can cause low platelet, red blood cell, and white blood cell counts. If you develop any unusual bleeding, stop this medication and call your doctor immediately.
- Increased risk of infection. Notify your doctor if you have any signs of infection including chills, fever, night sweats, nausea, vomiting, or muscle aches. You should contact your doctor immediately if you develop a painful skin rash or blisters on the trunk of your body as these may be symptoms of shingles (herpes zoster). Serious infections should be treated and resolved before starting Jakafi.
- Increased risk of non-melanoma skin cancer. Your doctor may perform periodic skin exams.
- Increase in cholesterol levels. You should have your lipid levels checked 8 to 12 weeks from the start of Jakafi treatment.
- Following discontinuation or interruption of Jakafi treatment, myelofibrosis symptoms may worsen and return to pretreatment levels after 1 week.
- Increased risk of major adverse cardiovascular events (MACE) including cardiovascular death, myocardial infarction, and stroke. Get emergency help immediately if you have any symptoms of a heart attack or stroke including, chest pain or tightness, shortness of breath, breaking out in a cold sweat, nausea, vomiting, lightheadedness, slurred speech, or weakness on one side of your body.
- Increased risk of thrombosis (blood clot).
- increased risk of lymphoma and other malignancies, particularly in patients who are current or past smokers.
Jakafi drug interactions
When Jakafi is taken with other medicines, they may interact and change how those work. It may also increase the severity and frequency of certain side effects. Make sure your healthcare professional is aware of all the medications you take, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements. Some possible drug interactions of Jakafi include:
- Fluconazole: Your Jakafi dosage should be reduced with fluconazole doses less than or equal to 200 mg. You should not take Jakafi if you are taking more than 200mg of fluconazole.
- Strong CYP3A4 Inhibitors: Your dose should be reduced, interrupted, or discontinued if taking it with CYP3A4 inhibitors such as clarithromycin, erythromycin, diltiazem, ketoconazole, and grapefruit juice. This is not necessary for patients with acute or chronic graft-versus-host disease (cGVHD).
- Strong CYP3A4 Inducers: Your dose may need to be increased if Jakafi is taken with inducers such as phenobarbital, phenytoin, rifampin, and St. John’s Wort.
Side effects of Jakafi
Some common side effects of Jakafi may include:
- Anemia (low red blood cell count)
- Neutropenia (low white blood cell count)
- Thrombocytopenia (low platelet count)
- High cholesterol levels
Jakafi can cause some serious side effects including:
- Low blood cell counts
- Increased risk of certain cancers
- Increased risk of blood clots
- Major cardiovascular events including heart attack and stroke
- Hypersensitivity reactions, including anaphylaxis.
Contact your doctor for medical advice about any side effects you experience while taking Jakafi. You can report your side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
There are other medications that your healthcare professional can prescribe if Jakafi is not the right medication for you. Some alternative FDA-approved treatment options include:
How does Jakafi compare with Vonjo (pacritinib)?
Jakafi and Vonjo are both JAK inhibitors that are indicated to treat myelofibrosis in adults.
Data from a study showed that while Vonjo had a higher rate of overall adverse events when compared to Jakafi, it had a lower rate of fatal complications. Vonjo had fewer bleeding or heart-related events, with no fatal cardiac events than Jakafi. The incidence of blood clots and secondary disease was the same between these medications.
There are currently no generic alternatives available for Jakafi or Vonjo. Jakafi is very expensive and costs over $17,000 for #60, 10mg tablets. Vonjo is even more expensive and costs over $22,000 for #120, 100mg capsules.
How long does Jakafi stay in your system?
Jakafi and its active metabolites have a half-life of up to 6 hours so it will stay in your bloodstream for approximately 30 hours.
How do I store Jakafi?
Store Jakafi at room temperature between 68°F to 77°F (20°C to 25°C). Keep all medications, including Jakafi out of the reach of children.
How long does it take for Jakafi to start working?
Your doctor may give Jakafi up to 6 months to see if it will work for you. After 6 months, your doctor may discontinue Jakafi if you have not seen any improvement.
Does Jakafi cause withdrawal?
Stopping Jakafi can cause symptoms from myelofibrosis to return to pretreatment levels over the course of 1 week. Some patients have experienced adverse events after stopping Jakafi such as fever, shortness of breath, hypotension (low blood pressure), blood clots, or organ failure. Do not interrupt or stop Jakafi without talking with your healthcare provider.
Is there a generic for Jakafi?
Currently, there is not a generic for Jakafi available on the market. However, you can still save on brand-name drugs like Jakafi with the help of NiceRx.