Refissa

Refissa is a prescription medication used to reduce fine facial wrinkles and darkening of skin (hyperpigmentation). Refissa belongs to a group of drugs called retinoids. It is not known exactly how it works to reduce fine facial wrinkles. 

Refissa comes in a cream and is applied to the face once a day at bedtime. 

Common side effects of Refissa include peeling, dry skin, and redness of the skin.

Refissa is part of the drug class:

• OTHER ANTINEOPLASTIC AGENTS

Do not use Refissa if:

• you are pregnant or plan to become pregnant
• you are sunburned or your skin is irritated
• you are highly sensitive to sunlight
• have eczema or other skin conditions
• you are allergic to any of the ingredients in the Refissa

Exposure to sunlight (including sunlamps) should be avoided or minimized during use of Refissa use because of heightened sunburn susceptibility.

Refissa has been reported to cause severe irritation to patients with eczema and should be used only with caution if you have this particular skin condition.

Avoid contact with the eyes, ears, nostrils, angles of the nose, and mouth. Refissa may cause severe redness, itching, burning, stinging, and peeling if used on these areas.

Avoid excessive exposure to wind or cold. Extremes of climate tend to dry or burn normal skin. Skin treated with Refissa may be more vulnerable to these extremes. Your physician can recommend ways to manage your acne treatment under such conditions.

Store Refissa at 20-25˚C (68-77˚F).

Tretinoin is a form of vitamin A that helps the skin renew itself.

Tretinoin topical (for the skin) is used to treat acne, to smooth rough facial skin, and to reduce the appearance of fine wrinkles and mottled skin discoloration.

Tretinoin topical may also be used for purposes not listed in this medication guide.

Do not take by mouth. Tretinoin topical is for use only on the skin. Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects.

Wash your hands before and after applying tretinoin topical. Before applying, clean and dry the skin area to be treated.

Applying tretinoin topical to wet skin may cause skin irritation. If you use Renova, wait at least 20 minutes after washing your face before applying a thin layer of the medication.

Do not wash the treated area for at least 1 hour after applying tretinoin topical. Avoid the use of other skin products on the treated area for at least 1 hour following application of tretinoin topical.

Applying an excessive amount of tretinoin gel may result in "pilling" of the medication. If this occurs, use a thinner layer of gel with the next application.

Tretinoin topical should be used as part of a complete skin care program that includes avoiding sunlight and using an effective sunscreen and protective clothing.

Use this medication for the full prescribed length of time, even if you think it is not working.

It may take up to several weeks before you notice improvement in your skin. Keep using the medication as directed and tell your doctor if your symptoms do not improve. If you are using tretinoin topical to treat acne, your condition may get slightly worse for a short time when you first start using the medication.

Call your doctor if skin irritation becomes severe or if your acne does not improve within 8 to 12 weeks.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Tretinoin topical gel is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Two adequate and well-controlled trials were conducted involving a total of 161 evaluable patients (under 50 years of age) treated with Tretinoin Cream, USP (Emollient) 0.05% and 154 evaluable patients treated with the vehicle emollient cream on the face for 24 weeks as an adjunct to a comprehensive skin care and sun avoidance program, to assess the effects on fine wrinkling, mottled hyperpigmentation, and tactile skin roughness. Patients were evaluated at baseline on a 10-point scale, and changes from that baseline rating were categorized as follows:

In these trials, the fine wrinkles, mottled hyperpigmentation, and tactile roughness of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sun exposure.

The results of these assessments are as follows:

Most of the improvement in these signs was noted during the first 24 weeks of therapy. Thereafter, therapy primarily maintained the improvement realized during the first 24 weeks.

A majority of patients will lose most mitigating effects of Refissa on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin with discontinuation of a comprehensive skin care and sun avoidance program including Refissa; however, the safety and effectiveness of using Refissa daily for greater than 48 weeks have not been established.

Applies to tretinoin topical: topical cream, topical gel/jelly, topical liquid, topical solution

In some animal studies, tretinoin has been shown to cause skin tumors to develop faster when the treated area is exposed to ultraviolet light (sunlight or artificial sunlight from a sunlamp). Other studies have not shown the same result and more studies need to be done. It is not known if tretinoin causes skin tumors to develop faster in humans.

Along with its needed effects, tretinoin topical (the active ingredient contained in Refissa) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking tretinoin topical:

• Burning feeling or stinging skin (severe)
• lightening of skin of treated area, unexpected
• peeling of skin (severe)
• redness of skin (severe)
• unusual dryness of skin (severe)

• Darkening of treated skin

Some side effects of tretinoin topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning feeling, stinging, or tingling of skin (mild)lasting for a short time after first applying the medicine
• chapping or slight peeling of skin (mild)
• redness of skin (mild)
• unusual dryness of skin (mild)
• unusually warm skin (mild)

The side effects will go away after you stop using tretinoin. On the rare chance that your skin color changes, this effect may last for several months before your skin color returns to normal.

Applies to tretinoin topical: topical cream, topical gel, topical kit, topical liquid

Dermatologic

Cream:
Very common (10% or more): Severe skin irritation (Up to 32%)
Frequency not reported: Mild irritation, peeling/skin exfoliation, erythema, pruritus, blistering, pain, crusting, tenderness, dry skin, burning/warmth/stinging, photosensitivity/increased sensitivity to light
Postmarketing reports: Temporary hyper/hypopigmentation, rash, skin atrophy

Gel:
Very common (10% or more): Dry skin (Up to 16%), peeling/scaling/flaking skin (Up to 12%)
Common (1% to 10%): Burning sensation, erythema, pruritus, skin pain, sunburn
Frequency not reported: Blistering/crusting skin
Postmarketing reports: Temporary hypo/hyperpigmentation, increased susceptibility to sunlight

Microsphere Gel:
Common (1% to 10%): Skin irritation, skin burning, erythema, dermatitis
Frequency not reported: Peeling, dryness, stinging, itching
Postmarketing reports: Temporary hypo/hyperpigmentation[Ref]

Erythema, peeling, dryness, burning/stinging, and/or itching occurred most frequently during the first 2 weeks of therapy.

Most of the dermatologic side effects were mild in severity (approximately 63%), and approximately 34% were of moderate severity.

Dry, peeling, scaling, and/or flaking skin occurred most often in the gel formulation.[Ref]

Hepatic

Cream:
Frequency not reported: Reversible liver function test changes (bilirubin, alkaline phosphatase, ALT, AST)[Ref]

Metabolic

Cream:
Frequency not reported: Thymol turbidity elevations, increased flocculation[Ref]

Cardiovascular

Cream:
Postmarketing reports: Edema/swelling of application site[Ref]

Hypersensitivity

Cream:
Frequency not reported: Allergic contact dermatitis
Postmarketing reports: Allergic reaction[Ref]

Some side effects of Refissa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.