Drug Detail:Sernivo spray (Betamethasone diproprionate 0.05%)
Drug Class: Topical steroids
1. How it works
- Sernivo is a brand (trade) name for nonaugmented betamethasone dipropionate.
- Experts aren't sure exactly how betamethasone dipropionate, the active ingredient in Sernivo, works, but they believe it may be inducing phospholipase A2 inhibitory proteins, collectively called lipocortins. These proteins are thought to control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
- Sernivo belongs to the class of medicines known as topical steroids.
2. Upsides
- May be used to treat mild-to-moderate plaque psoriasis in adults aged 18 years or older.
- Effective at treating inflammation and itching
- Sernivo is available as a convenient 0.05% spray.
- Sernivo is a medium-potency steroid.
- Sernivo is usually applied twice daily for no more than 4 weeks.
3. Downsides
If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:
- Burning, itching, stinging, pain, and atrophy (skin thinning) are the most common side effects reported. Less commonly, stretch marks, rash or hives, folliculitis, loss of taste, and high blood sugar levels have been reported. Sernivo spray may increase the risks of glaucoma and posterior subcapsular cataracts.
- Using Sernivo for longer than 4 weeks is not recommended.
- Sernivo may increase the risk of developing an infection. In people with a pre-existing infection, consider the concomitant administration of an appropriate antifungal or antibacterial agent. If no improvement is seen or the infection worsens, discontinue Sernivo until the infection has been adequately controlled.
- Allergic contact dermatitis, manifesting as irritation can develop and Sernivo should be discontinued and appropriate therapy be given. Symptoms usually include a failure of the skin to heal rather than an exacerbation of psoriasis.
- Rarely, Sernivo may cause an allergic reaction. Seek emergency medical help if you develop hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.
- Doctors should monitor people administering Sernivo for possible signs of absorption through their skin. Symptoms may include weight gain in the face and shoulders, slow wound healing, skin discoloration, thinning skin, increased body hair, tiredness, mood changes, menstrual changes, and sexual changes.
- Sernivo spray should not be used in children and adolescents younger than 18 years of age because children can absorb larger amounts of this medicine through the skin and there is a high risk of hypothalamic-pituitary-adrenal (HPA) axis suppression.
- Sernivo may not be suitable for people with any type of skin infection, a history of skin reactions to steroid medications, liver disease, or an adrenal gland disorder.
- Sernivo may increase levels of blood glucose (sugar) in the blood or urine. People with diabetes may need to monitor their blood sugar levels more carefully. Symptoms include increased thirst, increased urination, dry mouth, or fruity breath odor.
- There is not enough data to know whether using Sernivo applied to the skin will harm an unborn baby. Women who are pregnant should only use Sernivo if the risks outweigh the benefits and only under a doctor's advice.
- It may not be safe to breastfeed while using this medicine. If breastfeeding and your doctor has advised you to use Sernivo do not apply to any areas of the chest likely to come into contact with the baby's mouth.
- There is no generic version of Sernivo spray currently available.
Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects
4. Tips
- Shake Sernivo spray well before use. Hold the bottle upright and spray onto the affected areas of the skin by pushing down on the pump top. Rub in gently. Sernivo is usually applied twice a day but talk to your doctor if he/she has prescribed a different dosage for you.
- You can stop using Sernivo once your skin symptoms have cleared up. Do not use Sernivo for more than 4 consecutive weeks unless your doctor has advised you otherwise. Throw away any unused Sernivo spray after 4 weeks.
- Do not apply to broken or infected areas of skin or if skin thinning (atrophy) is present. Do not use on the face, scalp, groin, or other intertriginous areas (areas where two areas of skin touch such as behind the knees, front of the elbows, or the breast folds). Sernivo should only be applied to the skin, do not attempt to take it orally.
- Do not spray Sernivo near your eyes and always wash your hands after rubbing into other areas of your skin. Sernivo can increase your risk of developing glaucoma or cataracts. Report any visual symptoms or changes in eyesight to a doctor or optometrist immediately.
- Do not bandage, cover, or wrap the treated skin area unless directed by a physician.
- Topical corticosteroids are grouped by their potency. Group 1 is the most potent group of all seven topical corticosteroid potency groups, and Group 7 is the least potent. Sernivo spray belongs in Group 4. Do not apply other topical corticosteroids while you are using Sernivo unless your doctor has told you to do so.
- See your doctor if you develop redness, warmth, swelling, oozing, or severe irritation of any treated skin. If your skin condition worsens while using Sernivo spray, also talk with your doctor. You may have developed allergic contact dermatitis to Sernivo and you might need to try another type of treatment.
- Do not use Sernivo on your face. Sernivo is classed as a medium-potency topical corticosteroid and lower-potency corticosteroids, such as hydrocortisone are more appropriate to use on the face if one is deemed necessary. You should always use the lowest potency corticosteroid that is effective for your skin condition for the shortest possible time.
- Sernivo should not be used to treat acne; bacterial, fungal, or viral skin infections (such as herpes simplex, shingles, or chickenpox); bites or stings; eyelid conditions; mild dermatitis; perioral dermatitis; phimosis (a tight foreskin of the penis); rosacea; scabies; skin conditions caused by vaccinations, tuberculosis, or syphilis.
- Using more spray than recommended, or applying Sernivo for longer than two weeks can lead to side effects such as skin thinning, growth retardation in children, cataracts, glaucoma, or suppression of the hypothalamic-pituitary-adrenal axis.
- If you have surgery scheduled, tell your doctor you are using Sernivo.
- Keep your Sernivo spray at room temperature of 20°C to 25°C (68°F to 77°F), although the occasional increase or decrease in temperature to 15°C to 30°C (59°F to 86°F) is allowed. The contents are slightly thickened, white to off-white liquid. Your pharmacist should install the manual spray pump for you before dispensing.
- If you are pregnant or breastfeeding, tell your doctor. If you are advised to use Sernivo, apply it to the smallest area of skin and for the shortest duration possible. If you are breastfeeding do not apply Sernivo Spray directly to the nipple and areola or any area of your skin your baby may come into contact with.
5. Response and effectiveness
- Some improvements in the symptoms of plaque psoriasis such as inflammation (redness) and itching, should be noticed within one to two weeks but it may take up to four weeks for the full effects to be seen.
- 19% to 21.5% of people reported treatment success (which was defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline) in their skin after 15 days of Sernivo treatment. 34.5% to 42.7% reported treatment success after 29 days of Sernivo.
- Sernivo is absorbed through normal intact skin. Inflammation and other skin states (such as thinned or broken skin) can increase absorption.
- Sernivo is not effective against other types of skin rashes caused by fungi, viruses, scabies, acne, rosacea, or other conditions.
- If no improvement is seen after four weeks, then your doctor should reassess your condition, because there may be another reason for your rash other than what has been initially diagnosed.
- The effect of Sernivo Spray 0.05% on HPA axis suppression was evaluated in 48 subjects with psoriasis. 5 out of 24 people with psoriasis covering 29% of their body area on average who applied Sernivo twice daily for 15 days demonstrated HPA axis suppression compared with 0 subjects out of 24 that had psoriasis that covered 26.5% of their body and who applied Sernivo for 29 days. HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL, 30-minutes post-cosyntropin stimulation. All subjects available at follow-up had normal ACTH stimulation tests.
- Each gram of Sernivo Spray contains 0.643 mg betamethasone dipropionate which is equivalent to 0.5 mg betamethasone. This makes the concentration 0.05%.
6. Interactions
Sernivo is unlikely to interact with any other drugs that are taken orally because it is applied topically to the skin. However, excessive use of Sernivo may increase the risk of absorption of Sernivo, and possible interactions.
The product information for Sernivo lists only minor interactions. These include:
- acid suppressants, such as famotidine, or omeprazole (corticosteroids can increase irritation of the stomach)
- diabetic medications, such as insulin, glyburide, glimepiride, or glipizide (Sernivo may increase blood sugar levels)
- oral or topical corticosteroids, such as prednisone (may increase the risk of HPA suppression).
Note that this list is not all-inclusive and includes only common medications that may interact with Sernivo. You should refer to the prescribing information for Sernivo for a complete list of interactions. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.