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Opzelura Ruxolitinib 1.5 % Cream Tube 60 Gram

  • Manufacturer Name : INCYTE CORPORATION/FLW
  • MFG # : 50881000705
  • NDC : 50881000705
  • Distributor Name : AmeriSource Bergen
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Description

Indications and Usage:

1.1 Atopic Dermatitis

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

1.2 Nonsegmental Vitiligo

OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

1.3 Limitations of Use

Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category S
Drug Type Code 1
FDA Approval Date 09/21/2021
FDA Therap Equiv NR
HCPCS -
Market Entry Date 10/04/2021
Medical Coverage -
Termination Date -
Unit GM
Units Per Pkg 60
Active Ingredients 14041 ruxolitinib phosphate
AHFS Class 84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.
DEA Class NC
Dose Form CREAM (GRAM)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 82689 ruxolitinib phosphate TOPICAL CREAM (G) 1.5 %
Inactive Ingredients 2468 propylene glycol 57556; 3203 paraben 99967; 3785 edetic acid 60004
OMP Family -
Product Category RX Pharmaceuticals
Strength 1.5%
Common Brand Name COMMON BRAND NAME(S): Opzelura
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Case Quantity 24
Drug Form Pack Size 60
Form CREAM
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 60
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using ruxolitinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Wash your hands with soap and water before using this medication. Apply a thin layer to the affected areas of skin as directed by your doctor, usually twice daily. Rub the medication into the skin gently and completely. Wash your hands after using this product unless your hands are being treated. If your doctor recommends a moisturizer, apply it after this medication. This product is for use on the skin only. Avoid getting this medication in your eyes or on the inside of your nose or mouth. If you do get the medication in those areas, flush with plenty of water. Do not apply this medication to open wounds or infected areas. Do not cover the treated area with plastic or waterproof bandages unless directed to do so by your doctor. Use this medication exactly as directed. For treating eczema, your doctor may instruct you to stop using this product once your eczema has cleared and to start using it again if symptoms reappear. Consult your doctor for details. Do not use more than 60 grams of this medication per week or 100 grams every 2 weeks unless directed to do so by your doctor. Tell your doctor if your condition does not get better (after 8 weeks of treatment for eczema or after 24 weeks of treatment for vitiligo) or if your condition gets worse.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as complete blood counts, cholesterol/triglyceride levels, skin exams) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details. This medication has been prescribed for your current condition only. Do not use it later for another skin condition unless your doctor tells you to. If you have eczema, talk with your doctor about other ways to manage your eczema, such as using moisturizers and taking shorter baths/showers.
Overdose OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (RUX-oh-LI-ti-nib)
Precautions PRECAUTIONS: See also Warning section. Before using ruxolitinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer (such as skin cancer), current/past/returning infections (such as tuberculosis, hepatitis B and C), weakened immune system (for example, following an organ transplant). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication may increase your risk of getting skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication and for 4 weeks after stopping treatment is not recommended. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also Warning section. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: signs of anemia (such as unusual tiredness, pale skin), easy bleeding/bruising. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: The cream form of ruxolitinib is used to treat certain skin conditions such as eczema (atopic dermatitis) and vitiligo. Eczema is an allergic-type condition that causes red, irritated, and itchy skin. Vitiligo is a condition where the immune system attacks skin cells that make the color in your skin. This drug works by weakening the skin's defense (immune) system, which can help relieve symptoms of the skin conditions. Ruxolitinib belongs to a class of drugs known as kinase inhibitors.

Frequently Asked Questions(FAQs)

The cost of Opzelura Ruxolitinib 1.5 % Cream Tube 60 Gram is available for registerd members only .
Opzelura Ruxolitinib 1.5 % Cream Tube 60 Gram is manufactured by INCYTE CORPORATION/FLW.
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