Ruxolitinib (Oral)

Ruxolitinib is used to treat intermediate or high-risk myelofibrosis, which includes primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis. Myelofibrosis is a serious bone marrow condition that can cause symptoms such as an enlarged spleen (splenomegaly), severe itching, fever, night sweats, weight loss, bone pain, or unusual tiredness or weakness. It is also used to treat polycythemia vera in patients who have already tried hydroxyurea but did not respond well.

Ruxolitinib is also used to treat acute graft-versus-host disease (aGVHD) in patients who have been treated with other medications (for example, steroids) that did not work well. It is also used for chronic graft-versus-host disease (cGVHD) in patients who have received 1 or 2 previous treatments that did not work well.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood tests will be needed to check for unwanted effects.

If your condition does not improve within 6 months, or if it gets worse, check with your doctor.

This medicine lowers the number of certain types of blood cells in your body. Because of this, you may bleed or get infections (such as herpes, tuberculosis, hepatitis B, progressive multifocal leukoencephalopathy, fungal infections). Avoid being around people who are sick or have infections while you are using this medicine. Wash your hands often. Stay away from rough sports or other situations where you could get bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may increase your risk of a serious brain infection called progressive multifocal leukoencephalopathy (PML). Call your doctor right away if you experience weakness on one side of your body, loss of coordination, clumsiness, memory problems, trouble thinking clearly, or loss of interest in things.

Check with your doctor right away if you have burning or stinging of the skin, or painful cold sores or blisters on the lips, nose, eyes, genitals, or on your body. These may be symptoms of herpes simplex or herpes zoster (shingles).

Do not stop using this medicine suddenly without asking your doctor. You may need to gradually decrease your dose before stopping it completely. This may help prevent a possible worsening of your condition and reduce the risk of withdrawal symptoms such as fever, chest tightness, trouble breathing, lightheadedness, dizziness, or fainting.

This medicine may increase your risk of cancer (such as lymphoma, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, a general feeling of illness, swollen glands, weight loss, yellowing of the skin and eyes, a persistent non-healing sore, a reddish patch or irritated area, a shiny bump, a pink growth, or a white, yellow or waxy scar-like area on the skin.

This medicine may increase your risk of serious heart or blood vessel problems, including heart attack or stroke. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty speaking, double vision, headache, inability to move your arms, legs, or facial muscles, nausea, pain or discomfort in your arms, jaw, back, or neck, sweating, trouble breathing, or vomiting.

Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, a fast heartbeat, pain, redness, or swelling in your arm or leg, chest pain, groin pain, or leg pain, especially in your calf, severe headaches, sudden loss of coordination, sudden slurred speech, sudden vision changes, or trouble breathing. These may be symptoms of serious blood clots (such as deep vein thrombosis, pulmonary embolism, arterial thrombosis).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will need to consider the risks and benefits. For this medicine, think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

There are no appropriate studies on how ruxolitinib affects children when treating myelofibrosis and polycythemia vera or in children under 12 years old for steroid-refractory acute graft-versus-host disease (aGVHD) and chronic graft-versus-host disease (cGVHD). Safety and effectiveness have not been established.

Geriatric

Studies so far have not shown any geriatric-specific problems that would limit the usefulness of ruxolitinib in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor may adjust the dose, or other precautions might be necessary. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions have been selected based on their potential importance and are not all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Abatacept
• Apalutamide
• Azathioprine
• Baricitinib
• Boceprevir
• Carbamazepine
• Clarithromycin
• Cobicistat
• Conivaptan
• Cyclophosphamide
• Daridorexant
• Enzalutamide
• Fedratinib
• Fluconazole
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Lumacaftor
• Mitotane
• Nefazodone
• Nelfinavir
• Phenytoin
• Posaconazole
• Rifampin
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Tocilizumab
• Tofacitinib
• Upadacitinib
• Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about using food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

Other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Anemia (low number of red blood cells) or
• Heart or blood vessel disease or
• Herpes simplex, history of or
• Herpes zoster (shingles), history of or
• Liver disease (e.g., hepatitis B) or
• Neutropenia (low number of white blood cells) or
• Skin cancer, history of or
• Thrombocytopenia (low number of platelets) or
• Tuberculosis, or history of—Use with caution. May worsen these conditions.

• Infection—May reduce your body's ability to fight infection.

• Kidney disease, moderate or severe or
• Liver disease—Use with caution. Effects may be stronger because the medicine is removed from the body more slowly.

• Kidney disease, requiring dialysis—This medicine should be taken after your dialysis treatment.

• Smoker, current or past—May increase the risk for serious side effects.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools
• Bladder pain
• Bleeding gums
• Blood in the urine or stools
• Blurred vision
• Bruising
• Chest tightness
• Chills
• Cloudy urine
• Collection of blood under the skin
• Cough
• Coughing up blood
• Deep, dark purple bruise
• Difficult, burning, or painful urination
• Difficulty in breathing or swallowing
• Dizziness
• Fever
• Frequent urge to urinate
• Headache
• Hoarseness
• Increased menstrual flow or vaginal bleeding
• Itching, pain, redness, or swelling
• Large, flat, blue or purplish patches in the skin
• Lower back or side pain
• Nervousness
• Nosebleeds
• Painful or difficult urination
• Pale skin
• Paralysis
• Pinpoint red spots on the skin
• Pounding in the ears
• Prolonged bleeding from cuts
• Pus in the urine
• Red or dark brown urine
• Small, red or purple spots on the skin
• Slow or fast heartbeat
• Sore throat
• Swelling
• Tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• Trouble breathing
• Ulcers, sores, or white spots in the mouth
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Less common

• Painful blisters on the trunk of the body

Incidence not known

• Anxiety
• Burning or stinging of the skin
• Chest pain
• Fainting
• Pain, redness, or swelling in the arm or leg
• Painful cold sores or blisters on the lips, nose, eyes, or genitals
• Pains in the chest, groin, or legs, especially calves of the legs
• Persistent non-healing sore
• Pink growth
• Reddish patch or irritated area
• Severe headaches of sudden onset
• Sudden loss of coordination
• Sudden onset of slurred speech
• Sudden vision changes
• Shiny bump
• White, yellow, or waxy scar-like area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bloated or full feeling
• Diarrhea
• Excess air or gas in the stomach or bowels
• Feeling of constant movement of self or surroundings
• Passing gas
• Sensation of spinning
• Skin rash
• Weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Jakafi

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Take this medicine only as directed by your doctor. Your dose depends on your platelet count and needs to be changed several times in order to find out what works best for you. Do not use more medicine, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Keep using this medicine for as long as your doctor has told you to. Do not change your dose or stop taking this medicine without first talking with your doctor.

Take this medicine with or without food.

If you cannot swallow the tablet whole, you may dissolve it in about 40 milliliters (mL) of water, with stirring, for about 10 minutes. Take the mixture using a nasogastric tube within 6 hours. Then, rinse the tube with about 75 mL of water.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For acute graft-versus-host disease: Adults and children 12 years of age and older—At first, 5 milligrams (mg) 2 times a day, depending on your blood test results. Your doctor will adjust your dose as needed and tolerated. Children younger than 12 years of age—Use and dose must be determined by your doctor. For chronic graft-versus-host disease: Adults and children 12 years of age and older—At first, 10 milligrams (mg) 2 times a day, depending on your blood test results. Your doctor will adjust your dose as needed and tolerated. Children younger than 12 years of age—Use and dose must be determined by your doctor. For myelofibrosis: Adults—At first, 5 to 20 milligrams (mg) 2 times a day, depending on your blood test results. Your doctor will adjust your dose as needed and tolerated. However, the dose is usually not more than 25 mg 2 times a day. Children—Use and dose must be determined by your doctor. For polycythemia vera: Adults—At first, 10 milligrams (mg) 2 times a day, depending on your blood test results. Your doctor will adjust your dose as needed and tolerated. However, the dose is usually not more than 25 mg 2 times a day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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