Opzelura (ruxolitinib)

Opzelura generic

Opzelura contains the active drug ruxolitinib. The drug is available only as a brand-name medication. It’s not currently available in a generic version.

A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics typically cost less than brand-name drugs.

Opzelura cost and coupons

As with all medications, the cost of Opzelura can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Opzelura. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor, pharmacist, or insurance company.

Before approving coverage for Opzelura, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide whether the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Opzelura, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Opzelura, or if you need help understanding your insurance coverage, help is available.

A copay savings program and a patient assistance program are available for Opzelura. For more information and to find out whether you’re eligible for support, text “SAVE” to 91830 or visit the program website.

To learn more about saving money on prescriptions, check out this article.

Mail-order pharmacies

Opzelura may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Opzelura, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor, pharmacist, or insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Opzelura is not available in a generic version. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Drug coupons

You can visit Optum Perks for price estimates of Opzelura. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

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Retail price refers to the manufacturer’s published list price and is up to date as of 3/2023. Retail and discounted prices are U.S.-only and can vary based on region and pharmacy. We cannot guarantee that the discounted price listed here will exactly match the price at your pharmacy. Please contact your pharmacy for the exact price.

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Opzelura side effects

Opzelura can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while using Opzelura. These lists do not include all possible side effects.

For more information about the possible side effects of Opzelura, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may concern or bother you.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Opzelura, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Opzelura. Side effects might differ slightly between people with atopic dermatitis and people with vitiligo. To learn about other mild side effects, talk with your doctor or pharmacist or view Opzelura’s prescribing information.

Mild side effects of Opzelura can include:

• diarrhea
• headache
• fever
• runny nose
• swollen hair follicles
• swollen tonsils
• high level of eosinophils (a type of white blood cell)
• reactions at the Opzelura application site, such as:
  • acne
  • itching
  • hives
  • warmth, discoloration, or deepening of skin color
• mild infection, such as:
  • ear infection
  • urinary tract infection (UTI)
  • the common cold
  • bronchitis (inflammation of the lungs’ bronchial tubes)
• mild allergic reaction*

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or do not go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Opzelura, see “Allergic reaction” below.

Serious side effects

Serious side effects from Opzelura aren’t common. However, they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Low level of platelets (a type of blood cell). Symptoms can include:
  • bleeding, such as having bleeding gums or nosebleeds
  • bruising more easily
• Anemia (low level of red blood cells). Symptoms can include:
  • fatigue
  • pale-looking skin
  • lightheadedness
  • shortness of breath
• Low level of neutrophils (a type of white blood cell). This condition may not cause symptoms, though a blood test can detect it.
• Serious infection.*
• Increased risk of death.*
• Cancer.*
• Serious cardiovascular problems.*
• Blood clots.*
• Severe allergic reaction.†

* Opzelura has a boxed warning for this side effect. This is a serious warning from the FDA. To learn more, see the “Opzelura precautions” section below.
† For details about allergic reaction and Opzelura, see “Allergic reaction” below.

Side effects in children

Opzelura is approved to treat atopic dermatitis and vitiligo in children ages 12 years and older. (Atopic dermatitis is a type of eczema. Vitiligo is a skin condition that causes patches of skin to lose color. To learn more, see the “Opzelura uses” section below.)

Opzelura’s side effects in children are similar to those in adults. For more information, see the “Mild side effects” and “Serious side effects” sections above.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after applying Opzelura. This side effect wasn’t reported in clinical trials of this drug. However, it can still occur.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare. However, it is possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Opzelura, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Common questions about Opzelura

Here are answers to some frequently asked questions about Opzelura.

Does Opzelura treat eczema?

Yes, Opzelura is used to treat eczema. Specifically, Opzelura is approved to treat a type of eczema called atopic dermatitis. With atopic dermatitis, you have itchy, cracked, and swollen patches of skin.

To learn more about atopic dermatitis and eczema, see the “Opzelura uses” section below.

Is Opzelura used for alopecia or hair loss?

No, Opzelura is not approved to treat hair loss. This includes alopecia, which is a type of patchy hair loss that typically occurs on the scalp or face.

Currently, Opzelura is only approved to treat atopic dermatitis and vitiligo. (To learn about these conditions, see the “Opzelura uses” section below.)

Sometimes, doctors may prescribe Opzelura off-label for other conditions. Off-label drug use is when a drug approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.

However, doctors aren’t likely to prescribe Opzelura off-label for hair loss. This is because the drug may not be effective for this condition. For example, one study compared Opzelura with a placebo cream for the treatment of alopecia. (A placebo cream is a treatment with no active drug.) This study found that Opzelura was no more effective than the placebo at helping hair grow back.

If you’d like to know more about treatment options for alopecia or other types of hair loss, talk with your doctor.

Can Opzelura be prescribed to treat psoriasis?

It’s possible for doctors to prescribe Opzelura off-label for psoriasis. (With psoriasis, you have thick, scaly, and itchy patches of skin. These patches typically occur on your scalp, elbows, torso, or knees.)

Opzelura is not currently approved to treat psoriasis. However, doctors may prescribe the drug off-label for this condition. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

In this case, your doctor can prescribe Opzelura to treat psoriasis. This is because the FDA regulates the testing and approval of drugs. However, the FDA does not regulate how doctors prescribe drugs for people. So your doctor can still prescribe Opzelura for psoriasis if they think doing so is best for your care.

If you’d like to know more about using Opzelura for psoriasis, talk with your doctor.

What are Opzelura’s ingredients?

Opzelura comes as a topical cream, which means you apply it to your skin. The cream contains several ingredients.

The active ingredient in Opzelura is ruxolitinib. An active ingredient is what makes a drug work.

In addition to its active ingredient, Opzelura also contains several inactive ingredients. These are ingredients that do not work to treat a specific condition. However, inactive ingredients may still help the medication work well.

For example, Opzelura contains dimethicone and methylparaben as inactive ingredients, among others. Dimethicone helps give Opzelura a creamy texture so you can more easily apply the drug to your skin. And methylparaben is a preservative (a substance that helps prevent the growth of bacteria). This ingredient helps Opzelura remain safe to use over a long period of time.

For a complete list of Opzelura’s ingredients, see the drug’s prescribing information. You can also talk with your doctor or pharmacist.

Opzelura uses

The Food and Drug Administration (FDA) approves prescription drugs such as Opzelura to treat certain conditions. Opzelura may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Note: Opzelura has a limitation of use. The drug’s manufacturer advises against prescribing the drug with certain other medications. Examples include cyclosporine (Gengraf, Neoral, Sandimmune) and azathioprine (Azasan, Imuran). For more information, see the “Opzelura interactions” section below.

Opzelura for atopic dermatitis

Opzelura is FDA-approved to treat atopic dermatitis. The drug can be prescribed for adults and children ages 12 years and older who do not have a weak immune system.

Doctors prescribe Opzelura as a short-term treatment for mild to moderate atopic dermatitis that either:

• does not respond to treatment with other topical medications, which are ones you apply to the skin, or
• where other topical medications do not manage the condition

Atopic dermatitis explained

Atopic dermatitis is a type of eczema that’s commonly triggered by certain factors.

With atopic dermatitis, you have itchy, cracked, and swollen patches of skin. These patches may occur on the face, neck, elbows, or knees.

With atopic dermatitis, you may have episodes of flares (active symptoms) and remission (no symptoms). The following factors can trigger flares:

• stress
• substances that irritate your skin, such as household cleaners, soaps, or fabrics
• hot baths or showers
• hot, humid, dry, or cold weather

You can learn more about atopic dermatitis and eczema by visiting our eczema hub.

Effectiveness for atopic dermatitis

Clinical trials have shown Opzelura to be effective for treating atopic dermatitis. For information about how the drug performed in clinical trials, see Opzelura’s prescribing information.

Opzelura for vitiligo

Opzelura is FDA-approved to treat nonsegmental vitiligo in adults and children ages 12 years and older.

Vitiligo explained

Vitiligo is a skin condition that causes patches of skin to lose color. This condition may affect the hair, eyes, and insides of the mouth. Sometimes, the patches may grow in size over a person’s lifetime.

With nonsegmental vitiligo, the patches appear on both sides of the body.

People with vitiligo have a higher risk of other conditions. Examples include painful sunburn, increased risk of skin cancer,* and vision changes.

Effectiveness for vitiligo

Clinical trials have shown Opzelura to be effective for treating nonsegmental vitiligo. For information about how the drug performed in clinical trials, see Opzelura’s prescribing information.

Opzelura and children

Opzelura is FDA-approved to treat atopic dermatitis and vitiligo in children ages 12 years and older. The drug is not typically prescribed for children younger than this age limit.

To learn more about these conditions, see “Opzelura for atopic dermatitis” and “Opzelura for vitiligo” above.

* Opzelura has a boxed warning for cancer. This is a serious warning from the FDA. To learn more, see the “Opzelura precautions” section below.

Opzelura dosage

The Opzelura dosing your doctor prescribes will depend on the type and severity of the condition you’re using Opzelura to treat.

The following information describes dosages that are commonly used or recommended. However, be sure to use the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Opzelura comes as a topical cream in a tube. (Topical means the drug is applied directly to the skin.) The cream is available in 60 grams (g) or 100 g tubes.

Opzelura comes in one strength: 1.5%.

Dosage for atopic dermatitis

The recommended dosage for atopic dermatitis is one application of Opzelura twice daily. You’ll apply the cream in a thin layer over the affected areas of skin.

For this use, you can apply Opzelura on up to 20% of your body. (For reference, one handprint is equal to about 1% of your body.)

The maximum dosage of Opzelura is either one 60-g tube per week or one 100-g tube per 2 weeks.

Dosage for vitiligo

The recommended dosage for vitiligo is one application of Opzelura twice daily. You’ll apply the cream in a thin layer over the affected areas of skin.

For this use, you can apply Opzelura on up to 10% of your body. (For reference, one handprint is equal to about 1% of your body.)

The maximum dosage of Opzelura is either one 60-g tube per week, or one 100-g tube per 2 weeks.

Children’s dosage

Opzelura is approved to treat atopic dermatitis and vitiligo in children ages 12 years and older.

The recommended dosage of Opzelura for children is the same for adults. For details, see the “Dosage for atopic dermatitis” and “Dosage for vitiligo” sections above.

What if I miss a dose?

The manufacturer of Opzelura hasn’t stated what to do about a missed dose. If you miss a dose of Opzelura, contact your doctor or pharmacist. They can tell you whether to apply the missed dose or skip it.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Will I need to use this drug long term?

No, Opzelura is not meant to be used as a long-term treatment.

For atopic dermatitis, you’ll use Opzelura for up to 8 weeks. For vitiligo, you’ll use Opzelura for up to 24 weeks or possibly longer. If the symptoms of your condition haven’t eased in these time periods, your doctor may prescribe a different treatment for your condition.

Alternatives to Opzelura

Other drugs that can treat your condition are available. Some may be a better fit for you than others. If you’re interested in finding an alternative to Opzelura, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.

Alternatives for atopic dermatitis

Examples of other drugs that may be used to treat atopic dermatitis (a type of eczema) include:

• topical medications (drugs that are applied to the skin), such as:
  • crisaborole (Eucrisa)
  • desonide (Desowen, Verdeso)
  • doxepin (Zonalon)
  • fluocinolone (Synalar)
  • pimecrolimus (Elidel)
  • tacrolimus (Protopic)
  • triamcinolone (Trianex, Triderm, others)
• injectable medications that are given subcutaneously, such as:
  • dupilumab (Dupixent)
  • tralokinumab-ldrm (Adbry)
• oral medications, such as:
  • abrocitinib (Cibinqo)
  • updacitinib (Rinvoq)

Alternatives for vitiligo

Examples of other drugs that may be used to treat vitiligo include:

• topical medications, such as:
  • calcipotriene (Dovonex)
  • pimecrolimus (Elidel)
  • tacrolimus (Protopic)
• oral medications, such as methoxsalen (Oxsoralen-Ultra)

How to use Opzelura

You should apply Opzelura according to the directions your doctor gives you.

Opzelura comes as a cream that you apply twice daily. You’ll apply the cream in a thin layer over the affected areas of skin.

For atopic dermatitis, you can apply Opzelura on up to 20% of your body. For vitiligo, you can apply Opzelura on up to 10% of your body. (For reference, one handprint is equal to about 1% of your body.)

You should not apply Opzelura to your eyes, mouth, or vagina. Be sure to wash your hands after applying Opzelura. However, if you’re treating the skin on your hands, you do not need to wash them after applying the drug.

For detailed instructions on how to apply Opzelura, visit the manufacturer’s site for atopic dermatitis. You can also view the drug’s prescribing information.

When to use

You’ll use Opzelura twice a day. Try to apply the medication around the same time each day. Doing so helps keep a steady level of the drug in your body. This helps Opzelura work effectively.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Accessible labels and containers

If your prescription label is hard to read, talk with your doctor or pharmacist. Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist may be able to direct you to one that does.

Opzelura and alcohol

Opzelura isn’t known to interact with alcohol. If you drink alcohol and have questions about consuming it while you’re using Opzelura, talk with your doctor.

Opzelura interactions

Opzelura can interact with several other medications. It’s not known to interact with any supplements or foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe. Drug-condition interactions can also cause certain effects. For information about these interactions, see the “Opzelura precautions” section below.

Opzelura and other medications

Below is a list of medications that can interact with Opzelura. This list does not contain all drugs that may interact with Opzelura.

Before using Opzelura, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

The manufacturer of Opzelura advises against prescribing the drug with certain other medications. This is because Opzelura hasn’t been studied in combination with these drugs, so it is unknown whether it’s safe to take Opzelura with these medications. For this reason, doctors typically will not prescribe Opzelura with the following:

• other Janus kinase inhibitors, such as abrocitinib (Cibinqo) and updacitinib (Rinvoq)
• biologic drugs, such as dupilumab (Dupixent) and tralokinumab-ldrm (Adbry)
• immunosuppressant drugs, such as cyclosporine (Gengraf, Neoral, Sandimmune) and azathioprine (Azasan, Imuran)

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Opzelura and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Opzelura. However, you should still check with your doctor or pharmacist before using any of these products while using Opzelura.

Opzelura and foods

There aren’t any foods that have been specifically reported to interact with Opzelura. If you have any questions about eating certain foods with Opzelura, talk with your doctor.

How Opzelura works

Opzelura is approved to treat atopic dermatitis and vitiligo. (For details about these conditions, see the “Opzelura uses” section above.)

It is unknown exactly how Opzelura works to treat atopic dermatitis and vitiligo. The drug is thought to decrease the activity of a protein in your immune system. This protein is called Janus kinase (JAK). Reducing the activity of JAK may lead to fewer symptoms of atopic dermatitis and vitiligo.

How long does it take to work?

Opzelura starts working right away to treat your condition. However, it may take several weeks for your symptoms to start easing.

In clinical trials of Opzelura, people with atopic dermatitis took the drug for up to 8 weeks. And people with vitiligo took the drug for up to 24 weeks. Many people in these trials experienced fewer symptoms by the end of these time periods.

Opzelura and pregnancy

It is unknown whether Opzelura is safe to use during pregnancy.

There haven’t been enough clinical trials of Opzelura in people to know whether the drug is safe to use while pregnant.

If you use Opzelura during pregnancy, consider joining the drug’s pregnancy registry. A pregnancy registry helps collect information about the use of a drug during pregnancy. To learn more, talk with your doctor. You can also call 855-463-3463.

If you’re pregnant or planning a pregnancy, talk with your doctor. They’ll advise you on the risks and benefits of using Opzelura during pregnancy.

Opzelura and birth control

It is unknown whether Opzelura is safe to use during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Opzelura.

For more information about using Opzelura during pregnancy, see the “Opzelura and pregnancy” section above.

Opzelura and breastfeeding

It is unknown whether Opzelura passes into breast milk or whether the drug causes side effects in a child who is breastfed. So your doctor will likely recommend you do not use Opzelura while breastfeeding. And they may recommend you avoid breastfeeding for at least 4 weeks after your last dose of the drug.

If you’re breastfeeding or planning to do so, talk with your doctor. They can recommend alternative ways to feed your child.

Opzelura precautions

This drug comes with several precautions. These are considered drug-condition interactions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Serious infection

Opzelura may increase the risk of serious infection caused by bacteria, fungi, or viruses. Examples include serious lower respiratory tract infections, such as pneumonia, and shingles. In rare cases, infection with Opzelura may require treatment in the hospital or even be fatal.

Serious infections were rare in clinical trials of Opzelura.

Before starting treatment with Opzelura, your doctor may test you for tuberculosis (TB). This is because Opzelura may reactivate TB in people who already have TB in their body. (With reactivation, the bacteria that causes TB becomes active and causes symptoms of the condition.) If you have TB, your doctor will treat it before you start using this drug.

If you have an infection, talk with your doctor before using Opzelura. They’ll likely treat your infection before you start using this drug. If you develop a serious infection while using Opzelura, your doctor may have you stop using it until your infection is treated.

Increased risk of death

Janus kinase (JAK) inhibitors, such as Opzelura, may increase the risk of death in certain people. This risk affects adults ages 50 years and older who have at least one risk factor of heart disease. Examples of these risk factors include high blood pressure and high cholesterol.

This risk wasn’t reported in clinical trials of Opzelura. However, it’s been reported with oral JAK inhibitor drugs. (Opzelura is a topical cream, meaning it’s applied to the skin.) Still, it’s possible for Opzelura to increase this risk.

Your doctor can advise whether you have any factors that may increase the risk of death with Opzelura.

Cancer

Opzelura may raise the risk of certain cancers. This includes rare cases of skin cancers such as squamous cell carcinoma and basal cell carcinoma.

Due to this risk, your doctor may recommend you have regular skin checks with a dermatologist while using Opzelura. In addition, they may instruct you to limit your exposure to sunlight. This includes wearing sunscreen and protective clothing, such as wide-brimmed hats and long-sleeved shirts.

Before using Opzelura, talk with your doctor about your cancer risk.

Serious cardiovascular problems

JAK inhibitors, such as Opzelura, may increase the risk of serious cardiovascular problems. Examples include stroke, heart attack, and death due to a heart problem.

This risk wasn’t reported in clinical trials of Opzelura. However, it’s been reported with oral JAK inhibitor drugs. (Opzelura is a topical cream, meaning it’s applied to the skin.) It’s possible that Opzelura may lead to serious heart problems.

Your doctor can advise you on your risk of heart problems with Opzelura.

Blood clots

Opzelura may increase the risk of blood clots. This includes blood clots in a vein, artery, or lung artery, which may be fatal. Blood clots were rare in clinical trials of Opzelura.

While using Opzelura, watch for symptoms of a blood clot. Symptoms can vary depending on where the blood clot occurs. Examples include trouble breathing and warmth, pain, or swelling in the affected area.

Talk with your doctor about your risk of blood clots with Opzelura.

Other precautions

Before using Opzelura, talk with your doctor about your health history. Opzelura may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Allergic reaction: If you’ve had an allergic reaction to Opzelura or any of its ingredients, your doctor will likely not prescribe Opzelura. Ask your doctor what other medications may be better options for you.
• Pregnancy: It is unknown whether Opzelura is safe to use during pregnancy. For more information, see the “Opzelura and pregnancy” section above.
• Breastfeeding: It is unknown whether Opzelura passes into breast milk. To learn more, see the “Opzelura and breastfeeding” section above.

Note: For more details about the potential negative effects of Opzelura, see the “Opzelura side effects” section above.

Opzelura overdose

Do not use more Opzelura than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you use too much Opzelura

If you think you’ve used too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.