Opzelura

Generic name: Ruxolitinib
Dosage form: cream for topical use
Drug class: Topical antineoplastics

Usage of Opzelura

Opzelura is a prescription medicine used on the skin (topical) for:

short-term and non-continuous treatment of mild to moderate eczema (atopic dermatitis) in non-immunocompromised people 12 and older whose disease:

is not well controlled with topical prescription therapies or

when those therapies are not recommended.

the treatment of a type of vitiligo called nonsegmental vitiligo in adults and children 12 years of age and older.

The use of Opzelura along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended.

It is not known if this medicine is safe and effective in children less than 12 years of age with atopic dermatitis or nonsegmental vitiligo.

Opzelura side effects

Opzelura may cause serious side effects, including:

See Important information.

Low blood cell counts. Opzelura may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment, and may stop your treatment if signs or symptoms of low blood cell counts happen. Tell your healthcare provider right away if you develop or have worsening of any of these symptoms:

unusual bleeding

bruising

tiredness

shortness of breath

fever

Cholesterol increases. Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high levels of fat in your blood (high cholesterol or triglycerides).

The most common side effects in people treated for atopic dermatitis include:

common cold (nasopharyngitis)

diarrhea

bronchitis

ear infection

increase in a type of white blood cell (eosinophil) count

hives

inflamed hair pores (folliculitis)

swelling of the tonsils (tonsillitis)

runny nose (rhinorrhea)

The most common side effects in people treated for nonsegmental vitiligo include:

acne at the application site

itching at the application site

common cold (nasopharyngitis)

headache

urinary tract infection

redness at the application site

fever

These are not all of the possible side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.

Before taking Opzelura

Before using Opzelura, tell your healthcare provider about all of your medical conditions, including if you:

See Important information

have an infection

have or had tuberculosis (TB), or have been in close contact with someone who has TB

have had shingles (herpes zoster)

have or had hepatitis B or C

have had skin cancer in the past

are a current or past smoker

have or have had low white or red blood cell counts

have high levels of fat in your blood (high cholesterol or triglycerides)

are pregnant or plan to become pregnant. It is not known if Opzelura will harm your unborn baby.

Pregnancy Exposure Registry. There is a pregnancy exposure registry for individuals who use Opzelura during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become exposed to Opzelura during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463.

are breastfeeding or plan to breastfeed. It is not known if Opzelura passes into your breast milk. Do not breastfeed during treatment, and for about 4 weeks after the last dose.

Relate drugs

How to use Opzelura

Usual Adult Dose for Atopic Dermatitis

-Apply a thin layer twice daily to affected areas of up to 20% body surface area. Do not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks. For topical use only. Not for ophthalmic, oral, or intravaginal use.

Use: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Usual Adult Dose for Nonsegmental Vitiligo

-Apply a thin layer twice daily to affected areas of up to 10% body surface area. Do not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks. For topical use only. Not for ophthalmic, oral, or intravaginal use.

Use: the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older

Warnings

Opzelura cream is for use on the skin only. Do not use Opzelura cream, in your eyes, mouth or vagina.

Opzelura may cause serious side effects, including:

Serious Infections. Opzelura contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking Opzelura.

Your healthcare provider should watch you closely for signs and symptoms of TB during treatment.

Opzelura should not be used in people with an active, serious infection, including localized infections. You should not start treatment if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using Opzelura.

What other drugs will affect Opzelura

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Opzelura with certain other medicines could increase the risk of side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Especially tell your doctor if you take the following medicines:

antibiotics - clarithromycin

antifungal medicines - itraconazole, ketoconazole, posaconazole, voriconazole

HIV medicines containing atazanavir, darunavir, indinavir, nelfinavir, ritonavir, saquinavir, cobicistat

mifepristone

nefazodone

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.