Product image of Opzelura (Ruxolitinib Phosphate) 1.5% X 60gm Cream supplied by GNH India

Opzelura

Active Ingredient:
Ruxolitinib Phosphate
Form:
Cream
Brand:
Opzelura
Origin:
US

Opzelura (Ruxolitinib Phosphate Cream) 1.5% X 60gm

Ruxolitinib, the active ingredient in Opzelura, is a Janus kinase (JAK) inhibitor presented as a 1.5% cream for topical use. It is used for the treatment of moderate to severe atopic dermatitis and vitiligo in specified patient populations.

GNH India supplies Opzelura as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

Strength

1.5% X 60gm

Pack Size

1s

Storage

15-25°

Manufacturer / TM Owner

Incyte Corporation

1
Pack/s
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Indications & Clinical Uses

Opzelura is a topical medication that acts on the immune system to manage specific skin conditions. It is used for the following indications:

  • Atopic Dermatitis: Treats mild to moderate eczema in non-immunocompromised adults and children 2 years and older when other topical therapies are not effective or advisable.
  • Vitiligo: Treats nonsegmental vitiligo in adults and children 12 years and older to restore skin pigmentation.

How It Works

  • Opzelura works by selectively inhibiting JAK1 and JAK2 enzymes, which are involved in the immune system's signaling pathways. This inhibition reduces cytokine signaling and decreases inflammation in the skin, thereby alleviating symptoms of atopic dermatitis and vitiligo.

Side Effects

Opzelura may cause various side effects, ranging from common to serious. Common Side Effects:

  • Acne at the application site
  • Itching or redness at the application site
  • Nasopharyngitis (common cold symptoms)
  • Headache
  • Urinary tract infection
  • Fever

Serious or Rare Side Effects

  • Serious infections, including tuberculosis and fungal or viral infections
  • Increased risk of certain cancers, such as lymphoma and lung cancer
  • Skin cancers, requiring regular skin checks and sun protection

Precautions & Warnings

Opzelura should be used with caution and under medical supervision. Key precautions include:

  • Avoid use in individuals with active or serious infections: Do not start treatment if any infection is present unless advised by a healthcare provider.
  • Monitor for signs of infection: Regularly check for symptoms of infection during treatment.
  • Limit sun exposure: Use protective clothing and broad-spectrum sunscreen to reduce the risk of skin cancer.
  • Avoid use with other immunosuppressants: Do not use with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants.
  • Store below 25°C: Keep in the original pack, protect from moisture.

Avoid Interactions

Opzelura may interact with other medications, necessitating careful monitoring. Major Interactions (Avoid):

  • Therapeutic biologics: Avoid concurrent use to prevent excessive immunosuppression.
  • Other JAK inhibitors: Avoid to prevent additive immune system effects.
  • Potent immunosuppressants (e.g., azathioprine, cyclosporine): Avoid to prevent severe immune suppression.

Moderate Interactions (Monitor Closely)

  • Other medications that affect the immune system: Monitor closely for signs of infection or other adverse effects.
  • Medications that increase the risk of infections: Monitor for signs of infection and adjust treatment as necessary.

Frequently Asked Questions

Opzelura is a topical cream used to treat mild to moderate atopic dermatitis (eczema) in non-immunocompromised adults and children 2 years and older, as well as nonsegmental vitiligo in adults and children 12 years and older. It is particularly useful when other topical therapies are ineffective or not advisable.

Ruxolitinib, the active ingredient in Opzelura, works by selectively inhibiting JAK1 and JAK2 enzymes. These enzymes are part of the immune system's signaling pathways. By inhibiting them, Ruxolitinib reduces cytokine signaling and decreases inflammation in the skin, which helps alleviate symptoms of atopic dermatitis and vitiligo.

The typical dosage of Opzelura is a thin layer applied to the affected areas twice daily. The maximum dosage is one 60-gram tube per week or one 100-gram tube once every two weeks. The exact dosage and duration of treatment should be determined by a healthcare provider based on the patient's condition and response to the medication.

The safety of Opzelura during pregnancy or breastfeeding has not been established. It is important to consult with a healthcare provider to discuss the potential risks and benefits before using Opzelura if you are pregnant, planning to become pregnant, or breastfeeding.

To order Opzelura from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets. The team will ask you to confirm your trade or institutional credentials and will then provide pricing, availability, shipping details, and the necessary import paperwork.

Opzelura is a non-steroidal topical treatment that works by inhibiting specific immune system pathways. Unlike corticosteroids, which are commonly used for eczema, Opzelura does not carry the same risks of skin thinning or other steroid-related side effects. It is particularly beneficial for patients who do not respond to other topical therapies or cannot use them.

Opzelura should be stored below 25°C, kept in the original pack, and protected from moisture. It is important to follow the storage instructions provided by the manufacturer to ensure the medication remains effective and safe to use.

Opzelura is applied as a thin layer to the affected areas of the skin twice daily. It is important to wash your hands after applying the cream, unless you are applying it to your hands. Do not cover the treated area with a bandage or other wrap unless instructed by your healthcare provider.

The most serious risks associated with Opzelura include serious infections, such as tuberculosis and fungal or viral infections, and an increased risk of certain cancers, including lymphoma and lung cancer. Regular monitoring by a healthcare provider is essential to manage these risks.

Opzelura should not be used by individuals with active or serious infections, those who are immunocompromised, or those who are allergic to ruxolitinib or any of the other ingredients in the cream. It is also not recommended for use in children under 2 years of age for atopic dermatitis or under 12 years of age for vitiligo.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

References

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