Opzelura dosage, forms, and strengths

Opzelura (ruxolitinib) is a prescription topical cream used to treat nonsegmental vitiligo, or mild to moderate atopic dermatitis, a type of eczema. Opzelura reduces itching and other skin symptoms of atopic dermatitis in a few weeks, but it is only prescribed when other drugs don’t work. For nonsegmental vitiligo—characterized by the loss of pigmentation in patches across the body—Opzelura serves as a longer-term treatment to restore pigment in affected areas. In both cases, doses are applied to the affected skin twice daily. Ruxolitinib is a powerful immunosuppressant, but it primarily affects the immune system on the skin where it’s applied. Still, there are significant risks when using this drug.

Opzelura forms and strengths

Opzelura is applied as a cream to the skin. It is prescribed in only one dosage strength:

• Cream: 1.5% (15 mg/gram)

Opzelura dosage for adults

Opzelura treats mild to moderate atopic dermatitis and helps recover pigment in skin affected by vitiligo in adults and adolescents 12 years of age and older. Doses are administered twice daily by spreading a thin film of the cream over the affected skin.

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Opzelura dosage for mild to moderate atopic dermatitis

Atopic dermatitis is a complex and chronic form of eczema that involves environmental triggers, skin health, and the immune system. Ruxolitinib, the active ingredient in Opzelura, is a Janus kinase (JAK) inhibitor. It suppresses the immune system by shutting down the release of chemicals that alert the immune system. The U.S. Food and Drug Administration (FDA) has approved Opzelura for use in adults and children 12 years and older for mild to moderate dermatitis, but only if other drugs aren’t working. Treatment can last up to eight weeks but should stop once symptoms have resolved.

• Standard Opzelura dosage for mild to moderate atopic dermatitis: Apply a thin layer of ruxolitinib cream to the affected skin twice daily for up to eight weeks (do not apply to more than 20% of the body surface area)

Opzelura dosage for nonsegmental vitiligo

Vitiligo is an autoimmune disease in which the immune system attacks the skin’s pigment cells (melanocytes). Flare-ups leave patches of skin without pigment cells, so the skin turns pale. Nonsegmental vitiligo is the most common type of vitiligo. In these cases, the depigmented areas appear in various places on the body. 

Opzelura works by blocking the immune system in depigmented areas to allow pigment cells to re-establish themselves, even without phototherapy. The FDA has approved Opzelura for skin repigmentation therapy in adults and children 12 and older. Doses are applied twice a day to the affected skin. Treatment may need to last for as long as 24 weeks. If sufficient progress hasn’t been made by that point, the doctor may continue treatment for longer after re-evaluating the situation. 

• Standard Opzelura dosage for nonsegmental vitiligo: Apply a thin layer of ruxolitinib cream to the affected skin twice daily for up to 24 weeks (do not apply to more than 10% of the body surface area).

Opzelura dosage for children

Opzelura is FDA-approved for use in children 12 years and older for atopic dermatitis and nonsegmental vitiligo. Dosages are identical to adult dosages. 

• Standard Opzelura dosage for children age 12 and older to treat mild to moderate atopic dermatitis: Apply a thin layer of cream to the affected skin twice daily for up to eight weeks (do not apply to more than 20% of the body’s skin area).

• Standard Opzelura dosage for children age 12 and older to treat nonsegmental vitiligo: Apply a thin layer of cream to the affected skin twice daily for up to 24 weeks (do not apply to more than 10% of the body’s skin area).

Opzelura dosage restrictions

Opzelura has no dosage restrictions for people with liver impairment or kidney disease.

Opzelura dosage for pets 

While veterinarians may prescribe any human drug for use in pets, they are unlikely to prescribe Opzelura because of the cost, the difficulty of applying a topical cream on an animal, and the lack of animal studies. Instead of Opzelura, veterinarians are more likely to use the JAK inhibitor Apoquel (oclacitinib). It is the only JAK inhibitor FDA-approved for use in dogs with chronic itching or atopic dermatitis. It is not FDA-approved for use in cats. Unlike Opzelura, Apoquel is an oral JAK inhibitor, so there is a greater risk of serious adverse reactions. Other therapies may be safer.

How to take Opzelura

Opzelura is applied to the affected skin twice per day.

• Apply this medication as instructed. Do not use Opzelura too much or too often.

• Read the Medication Guide that comes in the Opzelura package. In particular, read the section titled “What is the most important information I should know about OPZELURA?”

• Only apply Opzelura cream to the skin. 

  • Do not let it get in the eyes or mouth. 

  • Opzelura is not for intravaginal use.

• Apply a thin film to the affected skin twice a day.

• Immediately wash your hands after applying the cream unless the skin on the hands is being treated.

• Do not use more than one 60-gram tube weekly or more than one 100-gram tube every two weeks. 

• Stop using Opzelura for atopic dermatitis when the symptoms clear up.

• You can restart Opzelura treatment during flare-ups and use it for atopic dermatitis until the symptoms clear.

• Store the Opzelura tube at room temperature and keep it out of the reach of children.

Opzelura dosage FAQs

How long does it take Opzelura to work?

For atopic dermatitis, it should clear the skin and provide meaningful itch relief in about eight weeks. Some people may experience itch relief after the first few days of treatment. Vitiligo requires longer-term treatment. Clinical trials were carried out for an entire year, so it could take weeks or months before people noticed significant repigmentation in the affected areas.

How long does Opzelura stay in your system?

After applying Opzelura to the skin, the active ingredient has a half-life of 116 hours. That means the body will take about 25 days or more to clear the last dose applied. 

What happens if I miss a dose of Opzelura?

If you miss a dose, contact your healthcare provider. They can provide medical advice about applying the missed dose or skipping it.

How long can you take Opzelura?

Opzelura is not intended for chronic use. Short-term treatment for atopic dermatitis usually lasts eight weeks or less. The recommended treatment duration for vitiligo is 24 weeks (six months), though treatment could last longer after a doctor re-evaluates the case. Ruxolitinib is a risky medication, so long-term use increases the risk of developing serious adverse effects. 

How do I stop taking Opzelura?

Opzelura can be stopped without causing withdrawal symptoms or requiring a tapered dose. Twice-daily applications can be restarted for atopic dermatitis if eczema flares up again.

What is the maximum dosage for Opzelura?

The maximum dosage is two applications per day as long as these do not exceed a certain fraction of the body’s skin area. People can apply a thin film over the affected skin up to 20% of the body surface area for atopic dermatitis. For vitiligo, that upper limit is 10% of the body’s skin area. To make this easier, a single handprint represents about 1% of the body’s skin area. Ten percent is about the size of 10 hands. Twenty percent is about the size of 20 hands. 

Can you overdose on Opzelura?

It is possible to take too much Opzelura or misuse it, such as spreading the cream on an open wound or regularly covering too much skin with the cream. Additionally, Opzelura could be dangerous if it’s swallowed. Call a poison helpline or go to an emergency room if an overdose is suspected or the medicine has been swallowed.

What interacts with Opzelura?

Drug interactions with Opzelura have not been studied. Be sure to inform the prescribing healthcare provider about all the substances being taken, including prescription drugs, over-the-counter medicines, vitamins, and supplements. In particular, tell the doctor if you’re taking other JAK inhibitors, therapeutic biologics, or immunosuppressants such as cyclosporine or azathioprine.

What happens when you mix Opzelura and alcohol?

The FDA prescribing information lists no cautions about drinking alcohol while using Opzelura. 

Is it safe to take Opzelura during pregnancy?

Ask for medical advice from the prescribing healthcare professional if you are pregnant or planning to get pregnant. Opzelura has not been studied in pregnant women, so healthcare providers do not know if Opzelura can harm a fetus or cause a miscarriage.

Is it safe to take Opzelura while breastfeeding?

Women should avoid breastfeeding while using Opzelura. Healthcare professionals aren’t sure that the drug is present in human breast milk. They do know it is present in animal breast milk. 

What should I know about the side effects of Opzelura?

As an immunosuppressant, Opzelura increases the risk of infections. For this reason, the most common side effects are mild infections or symptoms of a mild infection such as nasal and throat swelling (nasopharyngitis), bronchitis, ear infections, and tonsillitis in people with atopic dermatitis and application site acne, nasopharyngitis, and urinary tract infection in people with vitiligo. Other possible side effects include itching, headache, and skin redness. 

What should I know about the risks of taking Opzelura?

Opzelura is a risky medication with several possible severe side effects, including serious infections, skin cancer, lymphoma, other types of cancer, major adverse cardiovascular events, blood clots (thrombosis), low blood cell counts, high cholesterol, high triglycerides, or death in older adults with risk factors for heart disease. Opzelura can also worsen existing or latent infections such as fungal infections, tuberculosis, herpes zoster infections, and hepatitis B infections.

Sources

• Atopic dermatitis, StatPearls

• Oclacitinib 10 years later: Lessons learned and directions for the future, Journal of the American Veterinary Medicine Association (AVMA)

• Oclacitinib maleate, Plumb’s Therapeutics Briefs

• Opzelura, Incyte Dermatology

• Opzelura HCP, Incyte Dermatology

• Opzelura ruxolitinib cream prescribing information, DailyMed (NIH National Library of Medicine)

• Vitiligo, StatPearls