Jakavi

The recommended starting dose of Jakavi (Ruxolitinib) depends on the condition being treated and baseline levels of certain blood cells (e.g., platelets, hemoglobin, neutrophils). Your doctor will adjust your dose based on how you respond to and tolerate Jakavi (Ruxolitinib). Doses range between 5 mg and 20 mg taken twice daily. The maximum dose of Jakavi (Ruxolitinib) is 25 mg taken twice daily.

This medication can be taken with or without food. Swallow the tablets whole with a glass of water. Do not break, cut, crush, or chew the tablets. It is important to take Jakavi (Ruxolitinib) around the same time every day.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Jakavi (Ruxolitinib) exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Jakavi (Ruxolitinib) in its original package at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause anemia (low red blood cells); it may cause headaches; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may lower your white blood cell count, which can lead to fever, chills, sore throat or infections - if you experience any of these symptoms, contact your doctor right away; it may cause weight gain, mostly with prolonged use; it can lower blood platelet count, which could lead to increased bleeding. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

5 mg
Each round, white-to-almost-white tablet, with "NVR" debossed on one side and "L5" debossed on the other side, contains 5 mg of Jakavi (Ruxolitinib). Nonmedicinal ingredients: hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate (Type A), and povidone.

10 mg
Each round, curved, white-to-almost-white tablet with "NVR" debossed on one side and "L10" debossed on the other side contains 10 mg of Jakavi (Ruxolitinib). Nonmedicinal ingredients: hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate (Type A), and povidone.

15 mg
Each ovaloid, curved, white-to-almost-white tablet, with "NVR" debossed on one side and "L15" debossed on the other side, contains 15 mg of Jakavi (Ruxolitinib). Nonmedicinal ingredients: hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate (Type A), and povidone.

20 mg
Each elongated, curved, white-to-almost-white tablet with "NVR" debossed on one side and "L20"debossed on the other side, contains 20 mg of Jakavi (Ruxolitinib). Nonmedicinal ingredients: hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate (Type A), and povidone.

Do not take Jakavi (Ruxolitinib) if you:

• are allergic to Jakavi (Ruxolitinib) or any ingredients of the medication
• have a history of an illness called progressive multifocal leukoencephalopathy

There may be an interaction between Jakavi (Ruxolitinib) and any of the following:

• Amiodarone
• Apalutamide
• Aprepitant
• azole antifungals (e.g., ketoconazole, itraconazole, posaconazole, and Voriconazole)
• bacillus Calmette-Guérin (BCG)
• beta-adrenergic blockers (e.g., Atenolol, Metoprolol, Propranolol)
• Bicalutamide
• Carbamazepine
• Cimetidine
• Clonidine
• Clozapine
• Cobicistat
• conivaptan
• Cyclosporine
• Deferiprone
• Denosumab
• Digoxin
• Diltiazem
• Donepezil
• Dronedarone
• echinacea
• Enzalutamide
• Fingolimod
• Galantamine
• Guanfacine
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Lanreotide
• Leflunomide
• Lomitapide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• Mitotane
• methyldopa
• Natalizumab
• nefazodone
• Nivolumab
• Octreotide
• Pasireotide
• Phenobarbital
• Phenytoin
• Pimecrolimus
• primidone
• Propafenone
• rifabutin
• rifampin
• Rivastigmine
• Roflumilast
• St. John's wort
• simeprevir
• Stiripentol
• Tacrolimus
• Tizanidine
• Tofacitinib
• Trastuzumab
• certain tyrosine kinase inhibitors (e.g., Ceritinib, Crizotinib, Dabrafenib, imatinib, Nilotinib)
• vaccines
• Verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Jakavi (Ruxolitinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Jakavi (Ruxolitinib).

Anemia: Jakavi (Ruxolitinib) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the amounts of specific types of blood cells in your blood.

Bleeding: Jakavi (Ruxolitinib) can reduce the number of platelet cells in the blood. Platelets help the blood to clot and if there aren't enough, you may bleed more easily. If you notice signs of unusual bruising or bleeding (e.g., blood in urine, cuts that won't stop bleeding, black stools, bleeding gums), contact your doctor.

Grapefruit juice: Grapefruit juice affects how Jakavi (Ruxolitinib) is removed from the body. It may cause too much of the medication to build up in the body and cause possibly harmful side effects. People should not drink grapefruit juice or eat grapefruit at any time while taking Jakavi (Ruxolitinib) for treatment.

Heart rhythm: Jakavi (Ruxolitinib) can cause changes to the normal rhythm of the heart, including a decrease in heart rate and an irregular heartbeat.

If you are at risk for heart rhythm problems (e.g., have a slow heart rate, an abnormal heart rhythm, heart failure, or heart disease), discuss with your doctor how Jakavi (Ruxolitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Jakavi (Ruxolitinib), and whether any special monitoring is needed.

Infection: Jakavi (Ruxolitinib) can reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: Decreased kidney function or Kidney Disease may cause Jakavi (Ruxolitinib) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Jakavi (Ruxolitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Jakavi (Ruxolitinib), and whether any special monitoring is needed.

Lactose intolerance: Jakavi (Ruxolitinib) contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency), you should not take Jakavi (Ruxolitinib).

Liver function: Decreased liver function or liver disease causes Jakavi (Ruxolitinib) to build up in the body and may cause side effects. If you have liver problems, discuss with your doctor how Jakavi (Ruxolitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Jakavi (Ruxolitinib), and whether any special monitoring is needed. Jakavi (Ruxolitinib) can affect your liver function. Your doctor may want to regularly test your liver function with blood tests while you are taking Jakavi (Ruxolitinib). If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using Jakavi (Ruxolitinib). PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision loss, trouble thinking, or difficulty walking, contact your doctor immediately.

Skin Cancer: People taking this mediation have reported certain types of skin cancer. Report any skin changes or sores that do not heal to your doctor.

Pregnancy: Jakavi (Ruxolitinib) should not be used during pregnancy. If you become pregnant while taking Jakavi (Ruxolitinib), contact your doctor immediately. Men and women taking Jakavi (Ruxolitinib) should use an effective method of birth control (e.g., birth control pill, condoms) during treatment.

Breast-feeding: It is not known if Jakavi (Ruxolitinib) passes into breast milk. Women taking Jakavi (Ruxolitinib) should not breast-feed.

Children: The safety and effectiveness of Jakavi (Ruxolitinib) have not been clearly established for children less than 18 years of age.

To fully benefit from the effect of this medication, and to limit any adverse reactions, make sure that the health care facility overseeing your treatment has provided you with all the information needed to properly administer this drug. This medication is typically used twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. This medication should be swallowed whole. It should not be split, crushed or chewed. If you forget a dose, simply skip it and then take the next dose at the regularly scheduled time. This medication may be taken with or without food. Avoid grapefruit and grapefruit juice during your treatment. Grapefruit can seriously affect how this medication works.