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. 

Sernivo is a prescription medication used to treat mild to moderate plaque psoriasis in those 18 years of age and older. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Promius Pharma, LLC

Serious side effects have been reported with Sernivo. See the “Sernivo Precautions” section.

Common side effects of Sernivo include skin reactions at the application site which include:

• itching
• burning
• stinging
• pain
• thinning of skin

This is not a complete list of Sernivo side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Sernivo including the following:

• Allergic skin reaction. This is commonly seen as failure to heal but can also present as a worsening of the skin condition.
• HPA axis suppression. Sernivo Spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment.
• Sernivo can pass through your skin. Too much Sernivo passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems. Tell your healthcare provider right away if you have some or all of the following symptoms of adrenal gland problems:
  • severe fatigue
  • loss of appetite
  • weight loss
  • nausea and vomiting
  • diarrhea
  • muscle weakness
  • irritability
  • depression
• Cushing's syndrome
  • Weight gain and fatty tissue deposits on face or trunk
  • Pink or purple stretch marks on the skin
  • Thinning skin that bruises easily
  • Slow healing of cuts, insect bites, and infections
  • Acne
• High blood sugar or unmasking of latent diabetes mellitus
  • excessive thirst
  • excessive urination
  • increased urination at night
  • blurry vision
  • sores that won’t heal
  • fatigue
• Pediatric patients may be more susceptible to systemic toxicity when treated with topical corticosteroids. 

Do not use Sernivo if you are allergic to Sernivo or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sernivo, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you use Sernivo Spray, tell your doctor about all of your medical conditions, including if you:

• are allergic to any of the ingredients in Sernivo Spray. 
• have thinning of the skin at the treatment site
• are pregnant or plan to become pregnant. It is not known if Sernivo Spray will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Sernivo Spray passes into breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Sernivo falls into category C. No well-controlled studies have been done in humans. Sernivo should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn child.

In animal studies, pregnant animals were given this medication and had some babies born with problems when given a particular dose. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

When corticosteroids are taken by mouth or injected, they can appear in the milk and therefore may cause problems to your baby. 

However, it is not known if applying a corticosteroid such as Sernivo spray can lead to so much absorption through the skin that it ends up in the breast milk. Because many drugs are excreted in human milk, caution should be taken when Sernivo Spray is administered to a nursing woman.

Use Sernivo Spray exactly as your doctor tells you to use it.

• Your doctor should tell you how much Sernivo Spray to use and where to apply it.
• Shake well before use.
• Apply Sernivo Spray to the affected skin areas twice daily and rub in gently.
• Use Sernivo Spray for the shortest amount of time needed to treat your plaque psoriasis.
• Discontinue Sernivo Spray when control is achieved unless your doctor tells you otherwise. 
• Tell your doctor if your skin condition is not getting better after 4 weeks of using Sernivo Spray. Do not use Sernivo Spray for longer than 4 weeks.
• Wash your hands after applying Sernivo Spray.
• Sernivo Spray is for topical use only.
• Do not use Sernivo Spray on your face, scalp, underarms (armpits), groin, or areas where your skin may touch or rub together.
• Do not bandage, cover, or wrap the treated skin area, unless your doctor tells you to.

Apply this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Sernivo Spray (betamethasone) for the treatment of plaque psoriasis is twice daily.

If you apply too much Sernivo  Spray, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• 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.