Jakafi

The active ingredient in Jakafi is ruxolitinib phosphate, which is a JAK inhibitor. The mechanism of action involves inhibiting the activity of the JAK proteins (JAK1 and JAK2) in the body.

In myelofibrosis and polycythemia vera, JAK proteins convey signals that instruct blood cells to develop and divide too rapidly. Jakafi inhibits JAK activity, preventing blood cells from growing out of control.

In graft-versus-host disease, JAK proteins have a role in activating the immune system and destroying organs. Jakafi, which inhibits JAK, helps keep the immune system from being overly active.

Follow all directions provided by your doctor and read all documents carefully, including the full Prescribing Information, FDA-approved Product Labeling, Instructions for Use, and Medication Guide, before using Jakafi. However, the following is a synopsis of the general guidelines for the use of Jakafi:

• Jakafi is typically taken twice daily. You may take Jakafi with or without food.
• If you miss a dose of Jakafi, do not take any extra medication. Simply wait until the next planned time to take Jakafi at the customary dose.
• Your Jakafi treatment plan may need to be adjusted based on your blood counts. Make sure to attend your lab sessions so that your care team can monitor your blood counts and adjust your dose as necessary.
• Give your oncology or haematology care team an up-to-date list of medications you are taking. If you start or stop taking any new medications, make sure to update your list.

The most common side effects of Jakafi seen in clinical trials include:

• Muscle pain, stomach pain, or joint pain.
• Infections such as urinary tract infections.
• Bleeding.
• Anemia (low red blood cells).
• Low white blood cells.
• Nausea and vomiting.
• Dizziness or tiredness.
• Weight gain.
• High cholesterol/triglyceride levels - your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking Jakafi, and as needed.
• Higher liver enzyme levels.
• Lightheadedness.

Some individuals may experience serious side effects while using Jakafi. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Symptoms of a low white blood cell count and infection include fever, chills, extreme fatigue, body aches, coughing, and difficulty breathing.
• Low platelets and unexplained or unusual bleeding, bruising, nosebleeds, blood in urine, and blood in stool.
• Serious heart problems include chest pain, tightness, difficulty breathing, and passing out.
• Stroke symptoms include numbness or paralysis on one side of the body, a sudden headache, and shortness of breath, speaking, or walking.
• Blood clot symptoms include swelling in one arm or leg, sudden and severe chest discomfort, and difficulty breathing.
• Allergic reaction to the medication, such as skin rash, blisters, or hives.

These are not all of the possible side effects of Jakafi. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Jakafi, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Thrombocytopenia.
• Anemia.
• Shingles (herpes zoster).
• Neutropenia.
• Thrombosis.
• Viral infections.
• Increased risk of infections.
• Some people acquired new non-melanoma skin cancers after starting Jakafi, including basal cell carcinoma, squamous cell carcinoma, and Merkel cell carcinoma.
• People with rheumatoid arthritis who received a different JAK inhibitor than Jakafi experienced major heart issues, including heart attacks and strokes, and were more likely to acquire new malignancies, including lymphoma.

There are no contraindications with Jakafi.

Jakafi starts acting as soon as you take the first dose. However, you may not perceive the drug's effects in your body. During Jakafi treatment, your doctor can conduct tests to see whether the drug is effectively treating your illness.

When Jakafi is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Fluconazole.
• Ketoconazole.
• Rifampin.

Myelofibrosis: The initial dose is either 5 mg, 15 mg, or 20 mg taken orally twice a day. It will depend on your platelet count at the commencement of treatment. Your doctor may alter the dose during treatment based on your blood counts and condition.

Polycythaemia vera: The beginning dose is 10 mg orally twice a day. Your doctor may alter the dose during treatment based on your blood counts and condition.

Acute graft-versus-host disease: The initial dose is 5 mg orally twice daily for at least 3 days. Depending on your blood counts, your prescriber may increase the dose to 10 mg twice daily.

Chronic graft-versus-host disease: The beginning dose is 10 mg orally twice a day.

Store at room temperature and keep out of reach of children.

Incyte Corporation is the company that manufactures Jakafi.

There are no generic versions available of Jakafi.

You should not discontinue Jakafi abruptly unless your doctor advises you to. Otherwise, your symptoms can return. Your doctor will usually gradually reduce your dose until you can entirely discontinue the medicine.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

We don't know if Jakafi gets into human milk, but there is a risk of harm to breastfeeding infants. You should not breastfeed while using Jakafi and for two weeks following the last dose.