Ruxolitinib (Oral)

Generic name: Ruxolitinib
Drug class: Multikinase inhibitors

Usage of Ruxolitinib (Oral)

Ruxolitinib is used to treat intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. Myelofibrosis is a life-threatening bone marrow problem which is manifested by the following symptoms: 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 been previously treated with hydroxyurea that did not work well.

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

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

Ruxolitinib (Oral) side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they 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.

Before taking Ruxolitinib (Oral)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional 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 carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ruxolitinib in children to treat myelofibrosis and polycythemia vera or in children younger than 12 years of age to treat steroid-refractory acute graft-versus-host disease (aGVHD) and chronic graft-versus-host-disease (cGVHD). Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ruxolitinib in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use 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 eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of 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 the use of food, alcohol, or tobacco.

Grapefruit Juice

Relate drugs

How to use Ruxolitinib (Oral)

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.

Warnings

It is very important that your doctor check your progress at regular visits to make sure 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 becomes worse, check with your doctor.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections (eg, herpes, tuberculosis, hepatitis B, progressive multifocal leukoencephalopathy, fungal infection). Avoid being near 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 be 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 have 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 the trunk of the 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 slowly decrease your dose before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as a fever, chest tightness, trouble breathing, lightheadedness, dizziness, or fainting.

This medicine may increase your risk of cancer (eg, lymphoma, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or 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 in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the 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, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing. These may be symptoms of serious blood clots (eg, 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.

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