Wynzora Topical Cream 60gm
It is used to treat plaque psoriasis. It may be given to you for other reasons. Talk with the doctor.
Drug Class
Topical Psoriasis Treatment
Pharmacologic Class
Vitamin D Analog; Corticosteroid, Topical
Pregnancy Category
Category C
FDA Approved
Jul 2021
DEA Schedule
Not Controlled
Overview
What is this medicine?
Wynzora is a cream that combines two medicines, a form of vitamin D (calcipotriene) and a strong steroid (betamethasone). It's used to treat plaque psoriasis by helping to slow down skin cell growth and reduce inflammation, redness, and itching.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
Apply this medication only to your skin, as instructed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to your face, underarms, groin area, or skin that is thinning.
Do not insert the medication into your vagina.
Before and after applying the medication, wash your hands thoroughly. If you are treating a skin condition on your hand, do not wash your hand after application.
Application Instructions
Apply a thin layer of the medication to the affected skin area and gently rub it in.
Unless instructed by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storage and Disposal
Store the medication at room temperature, away from heat and light.
Keep the lid tightly closed and do not freeze the medication.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
Apply this medication only to your skin, as instructed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to your face, underarms, groin area, or skin that is thinning.
Do not insert the medication into your vagina.
Before and after applying the medication, wash your hands thoroughly. If you are treating a skin condition on your hand, do not wash your hand after application.
Application Instructions
Apply a thin layer of the medication to the affected skin area and gently rub it in.
Unless instructed by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storage and Disposal
Store the medication at room temperature, away from heat and light.
Keep the lid tightly closed and do not freeze the medication.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer to affected areas only, as directed by your doctor. Do not apply to the face, groin, or armpits, or if skin atrophy is present.
- Wash hands thoroughly after applying the cream, unless treating hands.
- Do not cover the treated area with bandages or other occlusive dressings unless directed by your doctor, as this can increase absorption.
- Avoid excessive exposure to natural or artificial sunlight (tanning beds, sunlamps) while using this medication, as calcipotriene can increase sensitivity to UV light.
- Do not use for longer than 8 weeks without consulting your doctor.
- Avoid contact with eyes, mouth, and other mucous membranes.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas once daily for up to 8 weeks. Do not exceed 100 grams per week.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply a thin layer to affected areas once daily for up to 8 weeks. Treatment beyond 8 weeks should be re-evaluated by a physician.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients under 18 years of age).
Adolescent:
Not established (Safety and efficacy not established in pediatric patients under 18 years of age).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to limited systemic absorption.
Moderate:
No specific adjustment recommended due to limited systemic absorption.
Severe:
No specific adjustment recommended due to limited systemic absorption. Use with caution if extensive application or prolonged use due to potential for systemic effects.
Dialysis:
Considerations: Use with caution if extensive application or prolonged use due to potential for systemic effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended due to limited systemic absorption.
Moderate:
No specific adjustment recommended due to limited systemic absorption.
Severe:
No specific adjustment recommended due to limited systemic absorption. Use with caution if extensive application or prolonged use due to potential for systemic effects.
Confidence:
Medium
Pharmacology
Mechanism of Action
Wynzora Cream combines calcipotriene and betamethasone dipropionate. Calcipotriene is a synthetic vitamin D3 analog that regulates cell proliferation and differentiation, inhibiting keratinocyte proliferation and promoting normal keratinocyte differentiation. Betamethasone dipropionate is a potent corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. The combination provides synergistic effects in treating psoriasis.
Pharmacokinetics
Absorption:
Bioavailability:
Limited systemic absorption; varies with skin integrity, site of application, and use of occlusive dressings.
Tmax:
Not precisely defined for topical application due to variable absorption.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely defined for topical application.
ProteinBinding:
Betamethasone: approximately 64% bound to plasma proteins. Calcipotriene: approximately 60% bound to plasma proteins.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely defined for topical application due to variable absorption and local retention.
Clearance:
Not precisely defined for topical application.
ExcretionRoute:
Calcipotriene: Primarily fecal excretion. Betamethasone: Primarily renal excretion.
Unchanged:
Minimal systemic excretion of unchanged drug.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2 weeks.
PeakEffect:
Maximal clinical effect often observed by 8 weeks.
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur upon discontinuation.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation where the medication was applied
Skin breakdown where the medication is used
Change in skin color
Change in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Itching
Signs of a common cold
* Headache
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation where the medication was applied
Skin breakdown where the medication is used
Change in skin color
Change in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Itching
Signs of a common cold
* Headache
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased skin irritation, redness, burning, or itching at the application site.
- Signs of skin thinning, such as easy bruising, stretch marks (striae), or spider veins (telangiectasias).
- Signs of systemic steroid absorption: unusual weight gain, swelling in ankles/feet, increased thirst/urination, muscle weakness, fatigue, mood changes.
- Signs of high calcium levels (hypercalcemia): nausea, vomiting, constipation, muscle weakness, confusion, excessive thirst, increased urination.
- Any signs of infection at the application site (pus, worsening redness, fever).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have elevated calcium levels in your blood.
If you are currently experiencing a skin infection.
If the skin area where you will be applying this medication is thinning.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have elevated calcium levels in your blood.
If you are currently experiencing a skin infection.
If the skin area where you will be applying this medication is thinning.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
Before using any other medications or skin products, including soaps, consult with your doctor to ensure safe use. If you are undergoing light therapy, notify your doctor to avoid any potential interactions.
When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. Exercise caution when applying it to large areas of skin or near open wounds, and consult with your doctor if you have any concerns.
To minimize the risk of severe side effects, adhere to your doctor's instructions regarding dosage and frequency of application. Do not exceed the recommended amount or use it for an extended period beyond what your doctor has prescribed.
As this medication may increase your susceptibility to sunburn, take precautions to protect your skin from the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to minimize your risk.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
This medication is not approved for use in children, so it is crucial to consult with your doctor if you have any questions or concerns.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or surrounding area to prevent any potential harm to your baby.
Before using any other medications or skin products, including soaps, consult with your doctor to ensure safe use. If you are undergoing light therapy, notify your doctor to avoid any potential interactions.
When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. Exercise caution when applying it to large areas of skin or near open wounds, and consult with your doctor if you have any concerns.
To minimize the risk of severe side effects, adhere to your doctor's instructions regarding dosage and frequency of application. Do not exceed the recommended amount or use it for an extended period beyond what your doctor has prescribed.
As this medication may increase your susceptibility to sunburn, take precautions to protect your skin from the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to minimize your risk.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
This medication is not approved for use in children, so it is crucial to consult with your doctor if you have any questions or concerns.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or surrounding area to prevent any potential harm to your baby.
Overdose Information
Overdose Symptoms:
- Excessive systemic absorption of calcipotriene can lead to hypercalcemia (high blood calcium levels), characterized by nausea, vomiting, constipation, muscle weakness, confusion, and increased urination.
- Excessive systemic absorption of betamethasone can lead to Cushing's syndrome (moon face, buffalo hump, central obesity, skin thinning, easy bruising) and HPA axis suppression (fatigue, weakness, nausea, vomiting, low blood pressure).
What to Do:
Discontinue use and seek immediate medical attention. Symptomatic and supportive treatment should be initiated. For hypercalcemia, hydration and calcium-lowering measures may be necessary. For HPA axis suppression, gradual withdrawal of the corticosteroid may be required. Call 1-800-222-1222 for poison control.
Drug Interactions
Moderate Interactions
- Other topical corticosteroids (increased risk of HPA axis suppression)
- Other topical vitamin D analogs (increased risk of hypercalcemia)
Monitoring
Baseline Monitoring
Extent and severity of psoriasis
Rationale: To establish baseline for efficacy assessment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical signs of HPA axis suppression (e.g., fatigue, weakness, nausea)
Frequency: Periodically, especially with extensive or prolonged use.
Target: Not applicable
Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels. Discontinue drug if confirmed.
Signs of hypercalcemia (e.g., nausea, vomiting, constipation, muscle weakness)
Frequency: Periodically, especially with extensive or prolonged use.
Target: Not applicable
Action Threshold: If suspected, check serum calcium levels. Discontinue drug if confirmed.
Skin integrity and local adverse reactions (e.g., atrophy, striae, irritation)
Frequency: At each follow-up visit.
Target: Not applicable
Action Threshold: If severe or persistent, discontinue use.
Symptom Monitoring
- Skin irritation, redness, burning, itching
- Skin thinning, striae, telangiectasias
- Acne-like eruptions
- Folliculitis
- Signs of systemic corticosteroid absorption (e.g., weight gain, moon face, easy bruising, fatigue)
- Signs of hypercalcemia (e.g., nausea, vomiting, constipation, muscle weakness, confusion)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with both calcipotriene and betamethasone.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects; systemic absorption, though limited, can occur.
Second Trimester:
Potential for teratogenic effects; systemic absorption, though limited, can occur.
Third Trimester:
Potential for teratogenic effects; systemic absorption, though limited, can occur. Risk of HPA axis suppression in the neonate if used extensively near term.
Lactation
Caution is advised. It is not known whether calcipotriene or betamethasone are excreted in human milk following topical application. Systemic absorption is limited, but potential for infant exposure exists. Avoid applying to areas that may come into direct contact with the infant's skin or mouth.
Infant Risk:
Low risk with limited, short-term use on small areas. Higher risk with extensive application, prolonged use, or application to the breast area due to potential for systemic absorption and infant exposure.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 18 years of age. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids and calcipotriene due to a larger skin surface area to body weight ratio and immature skin barrier function, leading to increased systemic absorption. Risk of HPA axis suppression and hypercalcemia is higher.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. However, caution should be exercised in elderly patients who may have thinner skin or comorbidities that increase susceptibility to systemic effects.
Clinical Information
Clinical Pearls
- Wynzora is a fixed-dose combination, offering convenience and potentially improved adherence compared to separate applications.
- It is designed for once-daily application, which can improve patient compliance.
- The cream formulation may be preferred for dry, scaly lesions.
- Advise patients to use the smallest amount necessary to cover the affected areas and to avoid applying to healthy skin.
- Patients should be educated on the signs of HPA axis suppression and hypercalcemia, especially if using on large body surface areas or for prolonged periods.
- Not for use on the face, groin, or axillae due to increased risk of local adverse effects (e.g., skin atrophy) in these sensitive areas.
- Rebound phenomenon (worsening of psoriasis after discontinuation) can occur with topical corticosteroids; gradual tapering may be considered for prolonged use, though not explicitly stated for this product.
Alternative Therapies
- Topical corticosteroids (e.g., clobetasol, fluocinonide)
- Topical vitamin D analogs (e.g., calcipotriene, calcitriol)
- Topical retinoids (e.g., tazarotene)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - off-label for psoriasis)
- Systemic therapies (e.g., methotrexate, cyclosporine, biologics, oral small molecules) for moderate to severe psoriasis
- Phototherapy (UVB, PUVA)
Cost & Coverage
Average Cost:
Highly variable, typically $800 - $1200+ per 60gm tube
Insurance Coverage:
Specialty Tier or Non-Preferred Brand Tier, often requiring prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.