Sernivo

What is Sernivo used for?

Sernivo is used to treat plaque psoriasis. Sernivo may be given to you for other reasons.

Description

SERNIVO Spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use.

The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C28H37FO7 and the molecular weight is 504.6. The structural formula is shown below.

Each gram of SERNIVO Spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. SERNIVO Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.

Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of SERNIVO Spray in psoriasis is unknown.

Before taking Sernivo, tell your doctor:

• If you are allergic to Sernivo; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have thinning of the skin where you are putting Sernivo.

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

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 Sernivo with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Sernivo?

• Tell all of your health care providers that you take Sernivo. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use longer than you have been told by the doctor.
• Use care when using on a large part of the skin. Talk with the doctor.
• Do not use to treat diaper rash or redness. Avoid putting Sernivo in the diaper area.
• This medicine may raise the chance of cataracts or glaucoma. Talk with the doctor.
• Do not give to a child younger than 18 years of age.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• If you are breast-feeding, do not put Sernivo right on the nipple or the area right around it.

How is Sernivo best taken?

Use Sernivo as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Do not take Sernivo by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not put on the face, underarms, or the groin area unless told to do so by the doctor.
• Shake well before use.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

What are the side effects of Sernivo that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing’s disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Skin irritation.
• Thinning of the skin.
• Change in eyesight.

What are some other side effects of Sernivo?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning or stinging.
• Dry skin.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Sernivo?

• Store at room temperature. Do not freeze.
• Protect from light.
• Throw away any part not used after 28 days.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – NDC: 69482-800-99 – 120 ML CARTON LABEL

PRINCIPAL DISPLAY PANEL – NDC: 69482-800-99 – 120 ML SPRAY BOTTLE LABEL