Ruxolitinib (Topical application)

Medically reviewed by Drugs.com. Last updated on Feb 20, 2023.

Topical application route(Cream)

Warning: Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and ThrombosisSerious InfectionsPatients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalizations or death.Reported infections include: active tuberculosis, which may present with pulmonary or extrapulmonary disease; invasive fungal infections, including cryptococcosis, and pneumocystosis; and bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.Avoid use of ruxolitinib in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt ruxolitinib until the infection is controlled.The risks and benefits of treatment with ruxolitinib should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ruxolitinib.MortalityIn a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.MalignanciesMalignancies were reported in patients treated with ruxolitinib. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.Major Adverse Cardiovascular Events (MACE)In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE)(defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue ruxolitinib in patients who have experienced a myocardial infarction or stroke.ThrombosisThromboembolic events were observed in trials with ruxolitinib. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid ruxolitinib in patients at risk. If symptoms of thrombosis occur, discontinue ruxolitinib and treat appropriately.

Available Dosage Forms:

Cream

Therapeutic Class: Dermatological Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses for ruxolitinib

Ruxolitinib topical is used to treat mild to moderate atopic dermatitis (eczema) in non-immunocompromised patients whose condition is not well controlled with other topical treatments or when these treatments are not recommended.

Ruxolitinib topical is also used to treat a skin disease called nonsegmental vitiligo.

Ruxolitinib is available only with your doctor's prescription.

Before using ruxolitinib

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 ruxolitinib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ruxolitinib 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 topical in children younger than 12 years of age. 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 topical in the elderly.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper use of ruxolitinib

It is very important that you use ruxolitinib only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Ruxolitinib should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Ruxolitinib is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. If it does get on these areas, rinse it off right away with water.

To use the cream:

Wash your hands with soap and water before and after using ruxolitinib.
Apply a thin layer of ruxolitinib to the affected area of the skin. Rub it in gently.

Dosing

The dose of ruxolitinib 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 ruxolitinib. 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 topical dosage form (cream):
- For mild to moderate atopic dermatitis and nonsegmental vitiligo:
  - Adults and children 12 years of age and older—Apply to the affected area of the skin 2 times a day. Do not use more than 1 tube (60 grams) per week or 1 tube (100 grams) of ruxolitinib per 2 weeks.
  - Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of ruxolitinib, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

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.

Precautions while using ruxolitinib

It is very important that your doctor check your or your child's progress at regular visits to make sure ruxolitinib is working properly. Blood tests may be needed to check for any unwanted effects.

Ruxolitinib should not be used together with azathioprine or cyclosporine.

If your condition does not improve within 8 weeks for atopic dermatitis or 24 weeks for nonsegmental vitiligo, or if it become worse, check with your doctor.

Ruxolitinib 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 or C, fungal infection) more easily. To help with these problems, avoid being near people who are sick or have infections. 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.

Ruxolitinib 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.

Ruxolitinib may increase your risk of serious heart or blood vessel problems, including heart attack or stroke, especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. 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.

Ruxolitinib may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Ruxolitinib may increase your risk of developing blood clots (eg, arterial thrombosis, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. 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.

Ruxolitinib may increase the level of cholesterol and fat in your blood. Talk to your doctor if you have concerns.

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.

Ruxolitinib 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:

Less common

Black, tarry stools
bladder pain
bloody or cloudy urine
chest pain
chills
cough
difficult, burning, or painful urination
fever
frequent urge to urinate
lower back or side pain
sore throat
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
trouble breathing
unusual bleeding or bruising
unusual tiredness or weakness

Rare

Painful blisters on the trunk of the body
pale skin

Incidence not known

Anxiety
bleeding gums
blood in the urine or stools
chest discomfort
coughing or spitting up blood
dizziness or lightheadedness
fainting
general feeling of illness
muscle aches
nausea
night sweats
pain, redness, or swelling in the arm or leg
pain or discomfort in the arms, jaw, back, or neck
pains in the chest, groin, or legs, especially calves of the legs
persistent non-healing sore
pink growth
pinpoint red spots on the skin
reddish patch or irritated area
severe headaches of sudden onset
shiny bump
sudden loss of coordination
sudden onset of slurred speech
sudden vision changes
sweating
vomiting
weight loss
white, yellow or waxy scar-like area
yellow skin and eyes

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

Blemishes, itching, flushing, redness at the application site

Less common

Burning, itching, and pain in the hairy areas, pus at the root of hair
change in hearing
chest tightness
cough producing mucus
diarrhea
earache
ear drainage
headache
hives, itching, skin rash
stuffy or runny nose

Rare

Burning, dry, or itching eyes
discharge, excessive tearing
itching ears
redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Drug Status

Availability Prescription only Rx

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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