Sernivo

Name: Sernivo

Sernivo Drug Class

Sernivo is part of the drug class:

  • Glucocorticoids

Sernivo Precautions

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.

Sernivo Food Interactions

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.

Inform MD

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

What is the most important information I should know about Sernivo (betamethasone topical)?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I avoid while using Sernivo (betamethasone topical)?

Avoid getting this medicine in your eyes. If contact does occur, rinse with water. Do not use betamethasone topical on broken or infected skin. Also avoid using this medicine in open wounds.

Avoid applying betamethasone topical to the skin of your face, underarms, or groin area without your doctor's instruction.

Do not use betamethasone topical to treat any condition that has not been checked by your doctor.

How is this medicine (Sernivo) best taken?

Use this medicine 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).
  • 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.
  • Do not use coverings (bandages, dressings, make-up) 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.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • 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.

This information should not be used to decide whether or not to take Sernivo or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sernivo. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Sernivo - Clinical Pharmacology

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.

Pharmacodynamics

Vasoconstrictor studies performed with Sernivo Spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

The potential for HPA axis suppression by Sernivo Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. Sernivo Spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively. Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with Sernivo Spray for 15 days. No subjects (0 out of 24) treated with Sernivo Spray for 29 days had HPA axis suppression. In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Plasma concentrations of betamethasone dipropionate, betamethasone-17-propionate, and betamethasone were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [see Clinical Pharmacology (12.2)]. The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of betamethasone dipropionate, while the metabolites, betamethasone-17-propionate and betamethasone, were detected in the majority of subjects (Table 2). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.

Table 2: Mean (±SD) Maximum Plasma Concentrations (pg/mL) of Betamethasone Dipropionate Metabolites after 15 or 29 Days of Treatment with Sernivo Spray
Analyte (pg/mL) Sernivo Spray b.i.d.
(15 days)
Sernivo Spray b.i.d.
(29 days)
Betamethasone-17-propionate 120 ± 127 63.9 ± 52.6
Betamethasone 119 ± 176 57.6 ± 55.9

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.

In a 90-day repeat-dose toxicity study in rats, topical administration of betamethasone dipropionate spray formulation at dose concentrations of 0.05% and 0.1% (providing dose levels up to 0.5 mg/kg/day in males and 0.25 mg/kg/day in females) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including reduced body weight gain, adrenal atrophy, and histological changes in bone marrow, thymus and spleen indicative of severe immune suppression. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.

Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Inform patients of the following:

  • Discontinue therapy when control is achieved, unless directed otherwise by the physician.
  • Do not use for longer than 4 consecutive weeks.
  • Avoid contact with the eyes.
  • Avoid use of Sernivo Spray on the face, scalp, underarms, groin or other intertriginous areas, unless directed by the physician.
  • Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
  • Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215
Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Sernivo is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007465
140728

This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 02/2016
PATIENT INFORMATION
Sernivo™ (ser-ne-vo)
(betamethasone dipropionate)
Spray, 0.05%
Important: Sernivo Spray is for use on the skin only. Do not get Sernivo Spray near or in your eyes, mouth, or vagina.

What is Sernivo Spray?

  • Sernivo Spray is a prescription corticosteroid medicine used to treat mild to moderate plaque psoriasis in people 18 years of age and older.

It is not known if Sernivo Spray is safe and effective in children under 18 years of age. Sernivo Spray is not recommended for use in patients under 18 years of age.

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. See the end of this leaflet for a list of the ingredients in Sernivo Spray.
  • have thinning of the skin (atrophy) 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.

How should I use Sernivo Spray?

See the “Instructions for Use” for detailed information about the right way to apply Sernivo Spray.

  • 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.
  • Apply Sernivo Spray 2 times a day.
  • Use Sernivo Spray for the shortest amount of time needed to treat your plaque psoriasis. 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.
  • 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.

What are the possible side effects of Sernivo Spray?

  • Sernivo Spray can pass through your skin. Too much Sernivo Spray passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems.

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

These are not all the possible side effects of Sernivo Spray.

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

How should I store Sernivo Spray?

  • 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.

General information about the safe and effective use of Sernivo Spray.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Sernivo Spray for a condition for which it was not prescribed. Do not give Sernivo Spray to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Sernivo Spray that is written for health professionals.

What are the ingredients in Sernivo Spray?

Active ingredient: betamethasone dipropionate
Inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215
Distributed by: Promius Pharma, LLC., Princeton, NJ 08540
007465
140728

Instructions for Use
Sernivo™ (ser-ne-vo)
(betamethasone dipropionate)
Spray, 0.05%

Important: Sernivo Spray is for use on the skin only. Do not get Sernivo Spray near or in your eyes, mouth, or vagina.

Read this “Instructions for Use” before you start using Sernivo Spray and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

Parts of the Sernivo Spray bottle. (See Figure A)

Figure A

How to apply Sernivo Spray:

Step 1: Shake the Sernivo Spray bottle well. Remove the cap from the pump top.

Step 2: Hold the bottle in an upright position while pointing the opening of the pump top in the direction of the affected area. To spray, push down on the pump top. Apply Sernivo Spray to the affected area as instructed by your doctor. (See Figure B)

Figure B

Step 3: Spray only enough Sernivo Spray to cover the affected area, for example, the elbow (See Figure C). Rub in Sernivo Spray gently.

Figure C

Repeat Steps 2 and 3 to apply Sernivo Spray to other affected areas as instructed by your doctor.

Step 4: After applying Sernivo Spray, place the cap back onto the pump top. (See Figure D)

Figure D

How should I store Sernivo Spray?

  • 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 28 days.

Keep Sernivo Spray and all medicines out of the reach of children.

This “Instructions for Use” has been approved by the U.S. Food and Drug Administration.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215
Distributed by: Promius Pharma, LLC., Princeton, NJ 08540

Sernivo is a trademark of Promius Pharma, LLC.

Issued: 02/2016

007528
140693

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