Ruxolitinib Topical

Ruxolitinib Topical is a prescription medication used for the treatment of atopic dermatitis and vitiligo. 

• Ruxolitinib Topical is available under the following different brand names: Opzelura.

Common side effects of Ruxolitinib Topical include:

• Pain or swelling in your nose or throat,
• Diarrhea,
• Bronchitis,
• Ear infection,
• Increase in a type of white blood cell (eosinophil) counts,
• Hives,
• Inflamed hair pores (folliculitis),
• Swelling of the tonsils (tonsillitis), and
• Runny nose

Serious side effects of Ruxolitinib Topical include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Severe dizziness,
• Abnormal lab results
• Unusual bleeding,
• Shortness of breath,
• Bruising,
• Fever, and
• Tiredness

Rare side effects of Ruxolitinib Topical include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Topical cream

• 1.5 % (15 mg/g)

Atopic Dermatitis

Adult dosage

• Apply a thin layer of cream to affected areas two times a day of up to 20% body surface area; not to exceed 60 g/week or one 100-gram tube per 2 weeks.
• Stop using when signs and symptoms (. g, itch, rash, redness) of atopic dermatitis resolve
• If signs and symptoms do not improve within 8 weeks, re-examine the patient.

Pediatric dosage

• Children below 12 years: Safety and efficacy not established.
• Children above 12 years:
  • Apply a thin layer of cream to affected areas two times a day of up to 20% of body surface area; not to exceed 60 g per week or one 100-gram tube per 2 weeks.
  • Stop using when signs and symptoms (. g, itch, rash, redness) of atopic dermatitis resolve
  • If signs and symptoms do not improve within 8 weeks, re-examine the patient.

Vitiligo

Adult dosage

• Apply a thin layer to affected areas two times a day of up to 10% body surface area; not to exceed 60 g per week or one 100-gram tube per 2 weeks.

Pediatric dosage

• Children below 12 years: Safety and efficacy not established.
• Children above 12 years:
  • Apply a thin layer to affected areas two times a day of up to 10% body surface area; not to exceed 60 g per week or one 100-gram tube per 2 weeks.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ruxolitinib Topical has severe interactions with no other drugs.
• Ruxolitinib Topical has serious interactions with at least 45 other drugs.
• Ruxolitinib Topical has moderate interactions with at least 52 other drugs.
• Ruxolitinib Topical has minor interactions with at least 114 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ruxolitinib Topical?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ruxolitinib Topical?”

Cautions

• Higher rate of all-cause mortality was observed with oral JAK inhibitors used for inflammatory conditions.
• Thromboses, including DVT, PE, and arterial thrombosis, were observed with oral JAK inhibitors for inflammatory conditions compared with patients treated with placebo; there was no clear relationship between platelet count elevations and thrombotic events; use with caution in patients who may be at increased risk of thrombosis.
• Oral Ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein cholesterol, and triglycerides.
• Major adverse cardiovascular events:
  • Major adverse cardiovascular events (MACE) such as cardiovascular death, nonfatal MI, and nonfatal stroke observed with JAK inhibitors used to treat inflammatory conditions; consider benefits and risks, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors.
  • Patients who are current or past smokers are at additional increased risk; discontinue therapy in patients who have experienced myocardial infarction or stroke.
  • Consider the benefits and risks for the individual patient before initiating or continuing therapy, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors; patients should be informed about symptoms of serious cardiovascular events and steps to take if they occur; discontinue therapy in patients that have experienced a myocardial infarction or stroke.
• Malignancies and lymphoproliferative disorders:
  • Malignancies, including lymphomas, are observed in clinical trials of oral JAK inhibitors used to treat inflammatory conditions; patients who are current or past smokers are at additional increased risk.
  • Consider benefits and risks for the individual patient before initiating or continuing therapy, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients who are current or past smokers.
  • Non-melanoma skin cancers including basal cell and squamous cell carcinoma reported; perform periodic skin examinations during treatment and following treatment as appropriate; exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen.
• Serious infections
  • Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens reported with oral JAK inhibitors.
  • Serious lower respiratory tract infections were reported in the clinical development program with topical Ruxolitinib.
  • Avoid use in patients with an active, serious infection, including localized infections.
  • Consider the risks and benefits of treatment before initiating in patients with or who have the following:
• Chronic or recurrent infection
  • A history of a serious or an opportunistic infection
• Previous exposure to tuberculosis
  • Resided or traveled in areas of endemic tuberculosis or endemic mycoses.
  • Underlying conditions that may predispose them to infection.
• Tuberculosis (TB)
  • No cases of active TB were reported with topical Ruxolitinib; however, active TB cases were reported with oral JAK inhibitors used to treat inflammatory conditions.
  • Consider evaluating for latent and active TB infection before administration.
  • During use, monitor for developing signs and symptoms of TB.
• Viral reactivation
  • Viral reactivation, including cases of herpes virus reactivation (. g, herpes zoster), was reported with JAK inhibitors used to treat inflammatory conditions.
  • If herpes zoster develops, consider interrupting treatment until the episode resolves.
• Hepatitis B and C
  • Impact of JAK inhibitors used to treat inflammatory conditions on chronic viral hepatitis reactivation is unknown.
  • Patients with a history of hepatitis B or C infection were excluded from clinical trials.
  • Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in ALT and AST, were reported in patients with chronic hepatitis B taking oral Ruxolitinib.
  • Do not initiate in patients with active hepatitis B or C
  • Thrombocytopenia, anemia, and neutropenia
  • Thrombocytopenia, anemia, and neutropenia were reported.
  • Avoid patients at increased risk of thrombosis.
  • Consider the benefits and risks for patients with a history of these events before initiating therapy.
  • Monitor complete blood cell count as clinically indicated.
  • Discontinue therapy if signs and/or symptoms of clinically significant thrombocytopenia, anemia, and/or neutropenia occur.
• Drug interaction overview
  • Drug interaction studies were not conducted.
  • Ruxolitinib is a substrate of CYP3A4.
  • Strong CYP3A4 inhibitors
  • Avoid coadministration.
    • Strong CYP3A4 inhibitors may increase Ruxolitinib systemic exposure and adverse reactions.

Pregnancy and Lactation

• There will be a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to Ruxolitinib during pregnancy. 
• Lactation
  • Advise a patient not to breastfeed during treatment with Ruxolitinib and for four weeks after the last dose.