Wynzora is a once-daily, topical, fixed-dose combination cream containing calcipotriene 0.005% (a vitamin D analog) and betamethasone dipropionate 0.064% (a corticosteroid) that may be used to treat plaque psoriasis in adults 18 years of age or older.

The cream uses PAD™ Technology, which enables the mixing of oil and water using just a fraction of the emulsifier required in conventional creams and lotions. This improves the penetration, solubility, and stability of the active ingredients, the tolerability of the product, and makes it more convenient to use.

Wynzora was approved on July 22, 2020.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Hypercalcemia and hypercalciuria have been observed with the use of topical calcipotriene. If either occurs, discontinue Wynzora until laboratory values of calcium normalize.

Endocrine effects

The use of high-potency steroid creams such as betamethasone dipropionate can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroids, use over a large surface area, or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age. Modify use should HPA axis suppression develop.

Ophthalmic Adverse Reactions

May increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist.

Allergic contact dermatitis

May occur with either calcipotriene or betamethasone dipropionate topical use. May be observed as a failure to heal. Confirm with diagnostic patch testing.

Pregnancy

Use of high-potency topical steroid medicine during pregnancy may increase the risk of a low birth weight in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Lactation

It may not be safe to breastfeed while using Wynzora. Ask your doctor about any risks. If you apply betamethasone and calcipotriene to your chest, avoid areas that may come into contact with the baby's mouth.

Children

Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects. Wynzora is not approved for use by anyone younger than 18 years old.

Wynzora should be applied once daily to the plaques for up to 8 weeks. Rub in gently to ensure the plaques are saturated.

• Discontinue treatment once control has been achieved.
• Do not use more than 100 g per week.
• Do not apply an occlusive dressing over the top of Wynzora unless directed by a physician.
• Do not use it on your face, groin, or armpit, or if skin thinning is present at the treatment site.
• Not for oral, ophthalmic, or intravaginal use.

You should not use Wynzora cream if you are allergic to calcipotriene, betamethasone dipropionate, or any other components of the cream.

Tell your doctor if you have ever had:

• too much calcium in your blood or urine
• an adrenal gland disorder
• cataracts or glaucoma
• liver disease
• severe forms of psoriasis (with pus, skin peeling, severe redness)
• have thinning skin at the treatment site
• a skin infection or
• if you are receiving UV light treatments (phototherapy).

Apply the cream as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medicine.

High doses or long-term use of Wynzora can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Avoid using other skin medications that contain betamethasone or calcipotriene. Do not use Wynzora to treat any skin condition that has not been checked by your doctor.

Avoid getting the cream in your eyes or on your face, underarms, groin area, or areas of thin skin.

Betamethasone and calcipotriene could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Side effects can occur if your skin absorbs topical steroid medicine. Tell your doctor if you have:

• swelling, weight gain (especially in your face or your upper back and torso);
• thinning skin, stretch marks, acne, increased facial hair;
• irregular menstrual periods, changes in sexual function; or
• memory problems, and feeling irritable.

Also, tell your doctor if you have:

• worsening of your skin condition;
• redness, warmth, swelling, oozing, or severe irritation of any treated skin;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• high calcium levels--confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss; or
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.

The most common side effects reported with Wynzora include upper respiratory tract infections, headaches, and irritation at the application site.

Postmarketing studies with topical corticosteroids have reported atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria.

Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure, have been reported during the use of topical corticosteroids, including topical betamethasone products.

Tell your doctor about all your other medicines, especially:

• any other steroid medicine (such as dexamethasone, fludrocortisone, hydrocortisone, prednisone, triamcinolone, and others); or
• any other medicine to treat psoriasis.

This list is not complete. Other drugs may affect betamethasone and calcipotriene, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed.