Wynzora

Plaque Psoriasis Treatment

Wynzora is used for the topical treatment of plaque psoriasis. This is a chronic autoimmune condition that causes skin cells to build up rapidly, resulting in thick, red patches covered with silvery scales. These patches can be itchy, sore, or prone to cracking.

Target Areas and Patient Population

This medication is approved for use in adults 18 years of age and older. It is intended for application to affected skin areas on the body and the scalp. It works by combining two different types of medicine to address the condition in multiple ways:

• A vitamin D analog helps slow down the overproduction of skin cells.
• A corticosteroid helps reduce the inflammation, swelling, and itching associated with psoriasis flares.

Wynzora is typically prescribed when a combination of these two ingredients is necessary to control symptoms that have not responded well to other treatments.

How Wynzora Works

Wynzora is a combination medication containing calcipotriene and betamethasone dipropionate. Each ingredient targets a different aspect of plaque psoriasis to help clear the skin.

• Calcipotriene: This ingredient is a synthetic form of vitamin D. In plaque psoriasis, skin cells grow and multiply much faster than normal, which creates thick, scaly patches. Calcipotriene works by slowing down the excessive production of these skin cells, helping the skin return to a more normal growth cycle.
• Betamethasone dipropionate: This is a potent corticosteroid. It works by suppressing the immune response in the skin to reduce inflammation. This helps relieve the redness, swelling, and itching often experienced with psoriasis plaques.

Together, these two components address both the rapid cell turnover and the inflammatory response that characterize the condition.

Common Side Effects

The most frequently reported side effects of Wynzora include:

• Upper respiratory tract infections
• Headache
• Irritation, itching, or redness at the application site

Serious Side Effects

While less common, some side effects can be serious and may require medical attention:

• High calcium levels: Excessive absorption of calcipotriene can lead to elevated calcium levels in the blood or urine.
• Adrenal gland suppression: The steroid component can be absorbed through the skin and affect how the adrenal glands produce hormones, particularly if used over large areas or for extended periods.
• Vision problems: Use of topical corticosteroids may increase the risk of developing cataracts or glaucoma.
• Skin changes: Prolonged use may cause the skin to become thin, bruised, or develop stretch marks (atrophy).
• Folliculitis: Inflammation of the hair follicles may occur at the site of application.
• Allergic reactions: Seek immediate medical help for signs of a severe reaction, such as hives, swelling of the face or throat, or difficulty breathing.

Hormonal and Metabolic Effects

Wynzora contains betamethasone dipropionate, a corticosteroid that can be absorbed through the skin into the bloodstream. Systemic absorption may lead to hypothalamic-pituitary-adrenal (HPA) axis suppression, a condition where the adrenal glands do not produce enough hormones. This risk is higher with prolonged use or application over large surface areas. Other potential systemic effects include Cushing's syndrome, high blood sugar (hyperglycemia), and glucose in the urine.

The calcipotriene component of the medication may cause elevated calcium levels in the blood (hypercalcemia) or urine (hypercalciuria). If calcium levels become too high, treatment is usually discontinued until levels stabilize.

Eye-Related Risks

Exposure to topical corticosteroids can increase the risk of posterior subcapsular cataracts and glaucoma. Care should be taken to avoid contact with the eyes. If vision changes, blurred vision, or eye pain occur, a healthcare provider should be consulted for evaluation.

Skin and Application Precautions

Local side effects may occur at the site of application, such as skin thinning (atrophy), stretch marks (striae), or redness. To reduce the risk of adverse reactions, the following precautions are typically advised:

• Avoid using the medication on the face, groin, or armpits unless specifically directed by a healthcare provider.
• Do not cover the treated area with bandages, dressings, or tight clothing (occlusion) unless instructed to do so, as this increases absorption.
• Discontinue use if severe irritation, skin infections, or an allergic reaction develops.

Ultraviolet Light Exposure

Calcipotriene may increase the skin's sensitivity to light. It is recommended to limit or avoid exposure to natural or artificial sunlight, including tanning booths and sunlamps, during treatment. Healthcare providers may advise patients to avoid Wynzora if they are also undergoing phototherapy.

Pregnancy

There is limited data regarding the use of Wynzora in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies involving the systemic administration of the active ingredients, calcipotriene and betamethasone dipropionate, have shown potential for developmental toxicity when given at high doses. However, topical application generally results in lower systemic absorption than oral or injectable forms of these medications.

Pregnant individuals should discuss the potential risks and benefits with their healthcare provider before starting treatment. It is generally recommended to use the smallest amount of the medication for the shortest duration possible if treatment is necessary during pregnancy.

Breastfeeding

It is not known if the active ingredients in Wynzora are present in human milk, or if they affect milk production or the nursing infant. Because many medications can be passed through breast milk, caution is advised when using this product while nursing.

To reduce the risk of exposure to a nursing infant, consider the following precautions:

• Do not apply the cream directly to the breast or nipple area to prevent the infant from accidentally swallowing the medication or coming into direct contact with it.
• Wash your hands thoroughly after applying the medication if you will be handling your baby.
• Speak with a healthcare professional to evaluate the risks and benefits of using this medication while breastfeeding.

Dosage Forms

Wynzora is supplied as a cream for topical application to the skin. It is a combination medication that contains both a vitamin D analog and a corticosteroid.

Available Strengths

Wynzora cream is available in one strength:

• Calcipotriene 0.005% and betamethasone dipropionate 0.064%

FDA Approval and Indication

The U.S. Food and Drug Administration (FDA) approved Wynzora in July 2020. It is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

Regulatory Status

Wynzora is a fixed-dose combination product containing calcipotriene, which is a vitamin D analog, and betamethasone dipropionate, a corticosteroid. It is classified as a prescription-only medication. There are currently no boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) associated with this drug.

Insurance Coverage

The cost of Wynzora varies based on your insurance provider and the specific details of your prescription drug plan. Some plans may require prior authorization before they will cover the medication.

Financial Assistance

Manufacturer savings cards or copay coupons may be available for eligible patients with commercial insurance to help reduce out-of-pocket expenses. Patients without insurance or those with limited coverage may qualify for patient assistance programs based on financial need.

Generic Availability

While the combination of calcipotriene and betamethasone dipropionate is available as a generic in other topical forms, such as ointments or suspensions, Wynzora is a branded cream. Generic medications typically cost less than brand-name drugs, but the specific formulation of Wynzora may be necessary for your condition as determined by a healthcare professional.