Rhofade 1% Cream 30gm
It is used to treat redness of the face caused by rosacea.
Drug Class
Alpha-adrenergic agonist
Pharmacologic Class
Selective alpha-1A adrenergic receptor agonist
Pregnancy Category
Not available
FDA Approved
Jan 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
RHOFADE is a cream used to treat the persistent facial redness (erythema) of rosacea. It works by narrowing the tiny blood vessels in your skin, which helps to reduce the redness.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vagina.
If you're using the pump, prime it before the first use by pressing it three times. Discard any product that comes out during priming. Always wash your hands before and after applying the medication. Clean the affected area before use and make sure it's completely dry. Apply a thin layer to the affected skin and gently rub it in. Avoid applying the medication to open wounds, cuts, or irritated skin.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it's 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 one.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vagina.
If you're using the pump, prime it before the first use by pressing it three times. Discard any product that comes out during priming. Always wash your hands before and after applying the medication. Clean the affected area before use and make sure it's completely dry. Apply a thin layer to the affected skin and gently rub it in. Avoid applying the medication to open wounds, cuts, or irritated skin.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it's 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 one.
Lifestyle & Tips
- Apply the cream thinly and evenly to the entire face (forehead, nose, cheeks, chin) once daily. Avoid applying to eyes, lips, or inside the nose.
- Wash hands immediately after applying the cream.
- Do not apply to irritated skin or open wounds.
- Avoid triggers that worsen rosacea, such as sun exposure, hot beverages, spicy foods, alcohol, and extreme temperatures.
- Use gentle skin care products and a broad-spectrum sunscreen daily.
- If you miss a dose, apply it as soon as you remember, unless it's almost time for your next dose. Do not apply more than once a day.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount once daily to the entire face (forehead, nose, cheeks, chin)
Condition-Specific Dosing:
rosacea_erythema:
Apply a pea-sized amount once daily to the entire face (forehead, nose, cheeks, chin), avoiding the eyes and lips.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
No specific adjustment recommended due to minimal systemic absorption.
Severe:
No specific adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
No specific adjustment recommended due to minimal systemic absorption.
Severe:
No specific adjustment recommended due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Oxymetazoline is a selective alpha-1A adrenergic receptor agonist. It works by causing vasoconstriction of the dermal blood vessels, thereby reducing the erythema (redness) associated with rosacea.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (mean Cmax 1.1 ng/mL after 24 hours of daily application for 29 days)
Tmax:
6 hours (systemic)
FoodEffect:
Not applicable for topical administration
Distribution:
Vd:
Not extensively characterized due to minimal systemic absorption
ProteinBinding:
Not extensively characterized due to minimal systemic absorption
CnssPenetration:
Limited
Elimination:
HalfLife:
Not extensively characterized due to minimal systemic absorption (systemic half-life estimated to be 10-12 hours based on nasal spray data)
Clearance:
Not extensively characterized due to minimal systemic absorption
ExcretionRoute:
Not extensively characterized due to minimal systemic absorption; likely renal for systemically absorbed drug.
Unchanged:
Not extensively characterized
Pharmacodynamics
OnsetOfAction:
Within 30 minutes to 3 hours
PeakEffect:
3 to 6 hours
DurationOfAction:
Up to 12 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency 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 or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Changes in skin color, such as pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensations in hands or feet
Changes in eyesight, eye pain, or severe eye irritation
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 unusual symptoms, contact your doctor for advice:
Irritation at the site where the medication was applied
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to contact 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency 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 or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Changes in skin color, such as pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensations in hands or feet
Changes in eyesight, eye pain, or severe eye irritation
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 unusual symptoms, contact your doctor for advice:
Irritation at the site where the medication was applied
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to contact 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:
- Severe burning, stinging, or itching at the application site.
- Worsening of facial redness or development of new inflammatory lesions (papules/pustules).
- Significant rebound redness or flushing that occurs or worsens after stopping the medication.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If this drug is accidentally swallowed, it can be harmful, so it is crucial to contact a doctor or a poison control center immediately. If you are pregnant, planning to become pregnant, or are breast-feeding, you must discuss this with your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe skin irritation
- Systemic effects (rare due to minimal absorption) could include: dizziness, lightheadedness, slow heart rate, low blood pressure, or central nervous system depression (especially in children if ingested).
What to Do:
If accidental ingestion or excessive application occurs, contact a poison control center immediately. For severe skin reactions, wash the area thoroughly with water. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Monoamine oxidase inhibitors (MAOIs)
- Tricyclic antidepressants (TCAs)
- Other alpha-adrenergic agonists (e.g., systemic decongestants, other topical vasoconstrictors)
- Beta-blockers (systemic)
Monitoring
Baseline Monitoring
Assessment of baseline facial erythema
Rationale: To establish a starting point for evaluating treatment efficacy.
Timing: Prior to initiation of therapy.
Skin integrity assessment
Rationale: To identify any pre-existing skin irritation or lesions that may be exacerbated by treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Facial erythema (redness)
Frequency: Daily by patient, periodically by clinician (e.g., at follow-up visits)
Target: Reduction in redness
Action Threshold: Lack of improvement or worsening of erythema may indicate need for re-evaluation.
Application site reactions (e.g., dermatitis, pruritus, pain, burning, stinging)
Frequency: Daily by patient, periodically by clinician
Target: Absence or mildness of reactions
Action Threshold: Persistent or severe reactions may require discontinuation or dose adjustment.
Rebound erythema or flushing
Frequency: Upon discontinuation or during therapy
Target: Absence
Action Threshold: Significant rebound may necessitate re-evaluation of treatment strategy.
Symptom Monitoring
- Reduction in facial redness
- Application site irritation (e.g., burning, stinging, itching)
- Application site pain
- Contact dermatitis
- Worsening of inflammatory lesions of rosacea
- Rebound erythema or flushing upon discontinuation
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Rhofade in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal.
Trimester-Specific Risks:
First Trimester:
Risk unknown; minimal systemic absorption suggests low risk.
Second Trimester:
Risk unknown; minimal systemic absorption suggests low risk.
Third Trimester:
Risk unknown; minimal systemic absorption suggests low risk.
Lactation
It is not known whether oxymetazoline is excreted in human milk. Due to minimal systemic absorption, the risk to a breastfed infant is considered low. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Rhofade and any potential adverse effects on the breastfed infant from Rhofade or from the underlying maternal condition.
Infant Risk:
Low risk (L3 - Moderately safe)
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use is not recommended.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. No dosage adjustment is needed based on age. However, caution is advised in elderly patients with severe cardiovascular disease, cerebral or coronary insufficiency, Raynaud's phenomenon, or orthostatic hypotension.
Clinical Information
Clinical Pearls
- RHOFADE is specifically for the persistent facial erythema of rosacea, not for inflammatory lesions (papules/pustules).
- Apply a pea-sized amount to the entire face, not just the reddened areas, to ensure even coverage and avoid demarcation lines.
- Patients should be advised about the potential for rebound erythema or flushing upon discontinuation, which is a common issue with topical vasoconstrictors.
- Onset of action is relatively quick, often within hours, but consistent daily use is needed for sustained effect.
- Avoid contact with eyes, lips, and mucous membranes. If accidental contact occurs, rinse thoroughly with water.
- Some patients may experience worsening of inflammatory lesions (papules/pustules) or application site reactions; monitor for these effects.
Alternative Therapies
- Brimonidine topical gel (Mirvaso) - another alpha-adrenergic agonist for rosacea erythema.
- Metronidazole topical (cream, gel, lotion) - for inflammatory lesions of rosacea.
- Azelaic acid topical (gel, foam, cream) - for inflammatory lesions and erythema of rosacea.
- Ivermectin topical cream (Soolantra) - for inflammatory lesions of rosacea.
- Oral medications (e.g., doxycycline, isotretinoin) for severe inflammatory rosacea.
- Laser and light therapies (e.g., pulsed dye laser, IPL) for persistent erythema and telangiectasias.
Cost & Coverage
Average Cost:
$500 - $650 per 30gm tube
Insurance Coverage:
Tier 3 or higher (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.