Pronunciation:

rux-oh-LI-ti-nib

Dosage Forms:

• Cream

Warnings:

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.

Classifications:

Therapeutic—

Dermatological Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

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.

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

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Other 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.

Other interactions—

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.

Other medical problems—

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

• Anemia (low number of red blood cells) or
• Diabetes or
• Heart or blood vessel disease or
• Hepatitis B, history of or
• Hepatitis C, history of or
• Herpes zoster (shingles), history of or
• High cholesterol or fats in the blood
• HIV infection or
• Lung disease, chronic or
• Neutropenia (low number of white blood cells) or
• Skin cancer, history of or
• Thrombocytopenia (low number of platelets) or
• Tuberculosis, or history of or
• Weakened immune system—Use with caution. May make these conditions worse.

• Liver disease (eg, hepatitis B or C), active or
• Serious infections, active—Use is not recommended in patients with these conditions.

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

Proper Use of This Medicine:

It is very important that you use this medicine 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.

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

This medicine 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 this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.

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 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 this medicine 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 this medicine, 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 This Medicine:

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

This medicine 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.

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 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.

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, 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.

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

This medicine 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.

This medicine 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.

Side Effects of This Medicine:

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.