Product image of Opzelura 1.5 % (Ruxolitinib (Ruxolitinib Phosphate)) 1.5 % CREAM supplied by GNH India

Opzelura 1.5 %

Active Ingredient:
Ruxolitinib (Ruxolitinib Phosphate)
Form:
CREAM
Brand:
OPZELURA
Origin:
UNITED STATES

Opzelura 1.5 % (Ruxolitinib (Ruxolitinib Phosphate) CREAM) 1.5 %

Ruxolitinib, the active ingredient in Opzelura 1.5%, is a Janus kinase (JAK) inhibitor presented as a 1.5% cream for topical use. It is used for the treatment of mild to moderate atopic dermatitis and nonsegmental vitiligo in specified patient groups. GNH India supplies Opzelura 1.5% as a licensed, GDP-compliant international pharmaceutical supplier serving pharmacies and clinics worldwide.

Opzelura 1.5% is a prescription medication that works by inhibiting specific enzymes involved in the immune response, thereby reducing inflammation and improving skin conditions. It is the first topical JAK inhibitor approved in the United States for its indicated uses.

Strength

1.5 %

Manufacturer / TM Owner

INCYTE CORPORATION

1
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Indications & Clinical Uses

Opzelura 1.5% is a topical medication used to manage specific skin conditions by modulating the immune response.

  • Atopic dermatitis (eczema): Reduces inflammation, itching, and rash severity in mild to moderate cases when other topical treatments are ineffective or inadvisable.
  • Nonsegmental vitiligo: Promotes repigmentation of the skin by targeting immune pathways involved in pigment loss.
  • Short-term and non-continuous treatment: Used for flare-ups or worsening symptoms, typically for a few weeks until symptoms improve.

How It Works

  • Opzelura 1.5% works by inhibiting Janus kinase (JAK) enzymes, specifically JAK1 and JAK2, which are involved in cytokine signaling pathways. By blocking these pathways, the cream reduces inflammation and immune responses in the skin, thereby alleviating symptoms of atopic dermatitis and vitiligo. This targeted inhibition helps to restore normal skin function and appearance.

Side Effects

Opzelura 1.5% may cause various side effects, ranging from common to serious.

Common Side Effects

  • Skin reactions: Acne, itching, and redness at the application site.
  • Upper respiratory infections: Common cold symptoms such as nasopharyngitis.
  • Headache: Mild to moderate headaches.
  • Urinary tract infection: Symptoms may include pain or burning during urination.
  • Fever: Mild to moderate increase in body temperature.

Serious or Rare Side Effects

  • Serious infections: Increased risk of infections, including tuberculosis and shingles.
  • Cancer: Potential risk of certain cancers, including lymphoma and skin cancers.
  • Immune system problems: May increase susceptibility to infections due to immune suppression.
  • Allergic reactions: Severe allergic reactions, though rare, can occur.

Precautions & Warnings

Opzelura 1.5% should be used with caution and under medical supervision.

  • Infection risk: Avoid use during active infections or in immunocompromised individuals.
  • Skin application: Do not apply to eyes, mouth, or vagina; use only on affected skin areas.
  • Body surface area: Limit use to no more than 20% of the body surface area.
  • Sun exposure: Limit sun exposure and use protective clothing and sunscreen.
  • Monitoring: Regularly check for signs of infection or skin changes.
  • Storage: Store at room temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Opzelura 1.5% may interact with other medications, requiring careful monitoring.

Major Interactions (Avoid)

  • Therapeutic biologics: Avoid concurrent use to prevent excessive immune suppression.
  • Other JAK inhibitors: Avoid to prevent additive immune suppression.
  • Strong immunosuppressants: Avoid to prevent severe immune system compromise.

Moderate Interactions (Monitor Closely)

  • Immunosuppressive drugs: Monitor for increased risk of infections or other immune-related side effects.
  • Medications affecting the immune system: Monitor for signs of immune suppression or other adverse effects.
  • Medications metabolized by CYP3A4: Monitor for potential changes in drug metabolism.

Frequently Asked Questions

Opzelura 1.5% is a topical cream used to treat mild to moderate atopic dermatitis (eczema) and nonsegmental vitiligo. It is applied to the affected areas of the skin to reduce inflammation, itching, and rash severity in eczema, and to promote repigmentation in vitiligo. The medication is typically used for short-term treatment during flare-ups or worsening symptoms.

Ruxolitinib, the active ingredient in Opzelura 1.5%, works by inhibiting Janus kinase (JAK) enzymes, specifically JAK1 and JAK2. These enzymes are involved in cytokine signaling pathways that drive inflammation and immune responses. By blocking these pathways, the cream reduces inflammation and immune activity in the skin, thereby alleviating symptoms of atopic dermatitis and vitiligo.

The usual dose of Opzelura 1.5% is applied as a thin layer to the affected areas of the skin twice a day, morning and evening. The duration of treatment is determined by a healthcare provider and is typically used for a few weeks until symptoms improve. The prescriber sets the exact dosage and treatment duration based on the patient's condition and response to the medication.

The safety of Opzelura 1.5% during pregnancy or breastfeeding has not been established. It is important to consult with a healthcare provider before using this medication if you are pregnant, planning to become pregnant, or breastfeeding. The healthcare provider will weigh the potential benefits and risks to determine the appropriate course of treatment.

To order Opzelura 1.5% 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 1.5% is a non-steroidal topical treatment that works by inhibiting the immune response, making it a suitable alternative for patients who do not respond well to other topical treatments or who cannot use steroids. Unlike corticosteroids, it does not carry the risk of skin thinning or other steroid-related side effects. It is the first topical JAK inhibitor approved for the treatment of atopic dermatitis.

Opzelura 1.5% should be stored at room temperature, protected from light and moisture. Keep the medication in its original packaging and out of reach of children. Do not use the cream if it appears discolored or if the consistency has changed. Always follow the storage instructions provided by the manufacturer to ensure the medication remains effective and safe to use.

Opzelura 1.5% is applied as a thin layer to the affected areas of the skin twice a day, morning and evening. Gently rub the cream into the skin, ensuring there is at least 8 hours between applications. Do not use more than 60 grams per week or 100 grams over 2 weeks. Avoid applying the cream to the eyes, mouth, or vagina, and do not cover the treated area with a bandage unless instructed by a healthcare provider.

The most serious risks associated with Opzelura 1.5% include serious infections, such as tuberculosis and shingles, and an increased risk of certain cancers, including lymphoma and skin cancers. Patients should be monitored closely for signs of infection or other concerning symptoms. Regular skin checks are recommended to detect any potential skin cancers early.

Opzelura 1.5% should not be used by individuals with an active, serious infection, including localized infections. It is also not recommended for immunocompromised individuals or those with a known hypersensitivity to ruxolitinib or any of the excipients in the cream. Patients should consult with a healthcare provider to determine if Opzelura 1.5% is appropriate for their specific condition and medical history.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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