Sernivo

Sernivo is a prescription medication used to treat plaque psoriasis. Sernivo belongs to a group of drugs called corticosteroids. These work to treat plaque psoriasis, because they reduce inflammation. 

This medication comes in a spray form. It is typically applied to the affected skin areas twice daily.

Common side effects of Sernivo include reactions at application site such as itching, burning, stinging, and pain. 

• Store Sernivo Spray at room temperature between 68°F to 77°F (20°C to 25°C)
• Throw away (discard) any unused Sernivo Spray after 4 weeks.
• Keep Sernivo Spray and all medicines out of the reach of children.
• Each unit is packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

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

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body. Stop using betamethasone topical and call your doctor if you have:

• blurred vision, or seeing halos around lights;

• uneven heartbeats;

• sleep problems (insomnia);

• weight gain, puffiness in your face; or

• tired feeling.

Also stop using betamethasone topical and call your doctor at once if you have:

• severe skin irritation where the medicine was applied; or

• signs of skin infection (swelling, redness, warmtth, oozing).

Common side effects may include:

• burning, stinging, or itching of treated skin;

• skin dryness, irritation, or reddish-purple discoloration;

• acne, skin rash;

• lightened color of treated skin; or

• folliculitis (redness or crusting around your hair follicles).

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.

In the U.S.

• Alphatrex
• Del-Beta
• Diprosone
• Sernivo

In Canada

• Dovobet
• Occlucort

Available Dosage Forms:

• Cream
• Lotion
• Spray
• Ointment

Therapeutic Class: Corticosteroid, Strong

Pharmacologic Class: Betamethasone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of betamethasone topical in children 13 years of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. Use in children 12 years of age and younger is not recommended.

Appropriate studies have not been performed on the relationship of age to the effects of betamethasone topical spray in the pediatric population. Safety and efficacy have not been established. Use is not recommended in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of betamethasone topical in the elderly.

Although appropriate studies on the relationship of age to the effects of betamethasone topical spray have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application or
• Liver failure—The chance of side effects may be increased.

• Perioral dermatitis (skin problem) or
• Rosacea (skin problem)—The gel should not be used in patients with these conditions.

• If you have an allergy to betamethasone or any other part of Sernivo (betamethasone spray).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have thinning of the skin where you are putting this medicine.

This is not a list of all drugs or health problems that interact with Sernivo.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied Sernivo Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied Sernivo Spray and 180 subjects applied vehicle spray.

Adverse reactions that occurred in at least 1% of subjects treated with Sernivo Spray for up to 28 days are presented in Table 1.

Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with Sernivo spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.

Postmarketing Experience

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Postmarketing reports for local adverse reactions to topical corticosteroids have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.

Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate).

Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-grade reduction from baseline). Table 3 presents the efficacy results at Day 15 and Day 29.