Sernivo Spray is a moderate to high potency corticosteroid that can be sprayed directly onto the skin to treat inflammation and itching caused by mild to moderate plaque psoriasis in adults aged 18 years and older. Although it is a spray, it feels like a lotion. Sernivo Spray contains betamethasone diproprionate 0.05% and should not be used for longer than 4 consecutive weeks.

Betamethasone dipropionate contains two esters - this makes it more fat soluble and increases its ability to penetrate the skin better. This makes it more potent than betamethasone valerate, which only contains one ester. Potency can also be increased by augmentation – this is when a substance, such as propylene glycol, is added to allow the active ingredient to penetrate the skin more quickly and work faster. Sernivo is a non-augmented betamethasone dipropionate cream.

Sernivo was FDA-approved on February 5, 2016.

Do not use it for longer than 4 consecutive weeks. Use care when using on a large part of the skin. Talk with your doctor.

Sernivo Spray contains betamethasone diproprionate which can be absorbed through the skin into the bloodstream and cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency, including Cushing’s syndrome, hyperglycemia, and glucosuria. Do not use for longer than 4 weeks and do not exceed the recommended dose. Periodic monitoring for HPA suppression may be required.

Occlusive dressings should not be used unless under the advice of the doctor because these increase the risk of side effects.

Spray Sernivo onto the affected areas twice daily. Rub in gently, then wash your hands after use, unless you have psoriasis on your hands.

• Stop using Sernivo Spray when your psoriasis is controlled but do not use it for longer than 4 weeks. If 2 weeks have passed and your psoriasis has not got any better, stop applying the spray and contact your doctor.
• If your psoriasis gets better earlier than 4 weeks, stop using Sernivo.
• Do not use it if your skin is thin where you want to apply it.
• Do not bandage, cover, or wrap your skin where you have applied Sernivo unless your doctor has told you to do so.
• Do not use it on your face, scalp, armpits, groin, or skin folds.
• Do not use other corticosteroid products while using Sernivo Spray.
• Apply only to the skin. Do not take by mouth, apply near your eyes, or insert it.

You should not use Sernivo Spray if you are allergic to it or any of the inactive ingredients contained in the spray.

Tell your doctor if you have ever had:

• any type of skin infection
• cataracts or glaucoma
• diabetes
• a skin reaction to any steroid medicine
• thinning of the skin after applying a corticosteroid product
• liver disease or
• an adrenal gland disorder.

Topical corticosteroids can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

Children are more susceptible to systemic absorption of topical corticosteroids and Sernivo Spray is not for use in children or young adults under the age of 18.

It is not known whether Sernivo Spray will harm an unborn baby. Tell your doctor if you are pregnant. If you are instructed to use the spray, use only a small amount and for the shortest time possible.

It may not be safe to breastfeed while using this medicine. If you are instructed to use Sernivo Spray, use only a small amount and for the shortest time possible. Do not apply to the breasts.

The most common side effects of Sernivo Spray include itching, burning, stinging, pain, and thinning of the skin (atrophy) at the treated site.

Topical corticosteroids can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency.

Other side effects reported with topical corticosteroids include:

• acne
• allergic contact dermatitis
• burning, itching, swelling, or irritation of treated skin
• dry or cracking skin
• redness or crusting around your hair follicles
• spider veins
• stretch marks, thinning skin
• rash or hives.

Possible signs that you may be absorbing this medicine through your skin include weight gain in your face and shoulders, increased body hair, tiredness, mood changes, menstrual changes, and sexual changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sprays applied to the skin such as Sernivo are not likely to be affected by other drugs you use. But you should not use Sernivo with other topical or oral corticosteroids, because they may have an additive effect.

Tell your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.