Ruxolitinib Phosphate Cream

What is Ruxolitinib Phosphate Cream?

• Ruxolitinib Phosphate Cream (Opzelura) is a Janus kinase (JAK) inhibitor used for the treatment of mild to moderate atopic dermatitis (AD), topical treatment of nonsegmental vitiligo.

Ruxolitinib

Ruxolitinib Structural formula V1

What are the uses of this medicine?

Ruxolitinib Phosphate Cream (Opzelura) is a prescription medicine used on the skin (topical) for: short-term and non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) in non‑immunocompromised adults and children 12 years of age 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.

Limitation of Use:

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

How does this medicine work?

• A topical cream formulation containing the phosphate salt form of ruxolitinib, a bioavailable Janus-associated kinase (JAK) inhibitor, with potential immunomodulating activity.
• Upon topical administration of the ruxolitinib phosphate cream, ruxolitinib specifically binds to and inhibits the protein tyrosine kinases JAK 1 and 2; this inhibits signal transduction pathways of various cytokines and reduces inflammation.
• The JAK-STAT (signal transducer and activator of transcription) pathway plays a key role in the signaling pathways initiated by many cytokines and growth factors
• JAK kinases are upregulated in various inflammatory and autoimmune diseases, including alopecia areata.
• Ruxolitinib Phosphate Cream, Pharmacologic Substance

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following:

• antifungal medications including itraconazole (Sporanox), ketoconazole, and voriconazole (Vfend)
• carbamazepine (Carbatrol, Equetro, Tegretol, others)
• clarithromycin
• efavirenz (Sustiva, in Atripla, Symfi)
• erythromycin (E.E.S, Eryc, Ery-tab); fluconazole (Diflucan)
• HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, Viekira Pak), and saquinavir (Invirase)
• nefazodone
• nevirapine (Viramune)
• phenytoin (Dilantin, Phenytek)
• pioglitazone (Actos, in Oseni, Duetact)
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rimactane, in Rifamate, Rifater)
• telaprevir (Incivik)
• Tell your doctor what herbal products you are taking, especially St. John's wort.

Is this medicine FDA approved?

• In September 2021, ruxolitinib cream (sold under the brand name Opzelura) was approved for medical use in the United States for the treatment of mild to moderate atopic dermatitis (AD).
• It is the first topical janus kinase inhibitor approved in the United States.
• In July 2022, ruxolitinib cream (sold under the brand name Opzelura) was approved for medical use in the United States for the treatment of vitiligo.

How should this medicine be used?

Recommended dosage:

Atopic Dermatitis:

• Apply a thin layer twice daily to affected areas of up to 20% body surface area.

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.

Administration:

• For topical use only.
• Not for intraocular, oral, or intravaginal use.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cream: 1.5% ruxolitinib

This medicine is available in fallowing brand namesː

• Opzelura

What side effects can this medication cause?

The most common side effects of Opzelura 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 of Opzelura 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

Opzelura may cause serious side effects, including:

• Serious Infections
• Increased risk of death due to any reason
• Cancer and immune system problems
• Increased risk of major cardiovascular events
• Low blood cell counts
• Cholesterol increases

What special precautions should I follow?

• Serious bacterial, mycobacterial, fungal and viral infections have occurred. Regularly monitor patients for infection and manage it promptly.
• Basal cell and squamous cell carcinoma have occurred. Perform periodic skin examinations during treatment and following treatment as appropriate.
• Malignancies, including lymphomas, were observed in clinical trials of oral JAK inhibitors used to treat inflammatory conditions. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Opzelura.
• Thromboembolic events have occurred. Avoid Opzelura in patients who may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue Opzelura and evaluate and treat patients appropriately.
• Thrombocytopenia, anemia, and neutropenia have occurred. Perform CBC monitoring as clinically indicated. If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue Opzelura.
• Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active ingredient: ruxolitinib phosphate
• Inactive ingredients: cetyl alcohol, dimethicone 350, edetate disodium, glyceryl stearate SE, light mineral oil, medium chain triglycerides, methylparaben, phenoxyethanol, polyethylene glycol 200, polysorbate 20, propylene glycol, propylparaben, stearyl alcohol, purified water, white petrolatum, and xanthan gum.

Who manufactures and distributes this medicine?

Manufactured for:

• Incyte Corporation, 1801 Augustine Cut-off, Wilmington, DE
• Opzelura is a trademark of Incyte.

What should I know about storage and disposal of this medication?

• Store Opzelura at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Ruxolitinib Phosphate Cream
• FDA Ruxolitinib Phosphate Cream

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