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First Generic for Renova® 0.05% cream – available in 40 and 60 gm tubes

TRETINOIN CREAM, USP (EMOLLIENT) 0.05% is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs that includes the use of effective sunscreens (minimum SPF of 15) daily. Please see the package insert for details of Adverse reactions, Precautions, and Dosage and Administration.

The product should be used in the evening as tretinoin is sensitive to the light. During weeks 1-4 irritation of the skin with peeling and redness is common.⁽¹⁾ If mild, continue as prescribed by your doctor. If it becomes uncomfortable ask your doctor if you should reduce to every other night during the first 4 weeks, until your skin adapts to this prescription -strength form of vitamin A (tretinoin). If degree of irritation is still significant, discontinue. Daily sunscreen is required as you will be more sensitive to the sun especially during the first 4 weeks.

The clinical data in the package insert are from Ortho Pharmaceuticals original studies as required by the FDA labeling. Our bioequivalence study included 382 patients who completed the 6-month study, and the results revealed the Spear and Renova 0.05% products were bioequivalent. Spear's Tretinoin Cream, USP (Emollient) 0.05% and Renova 0.05% demonstrated no statistical difference from one another, neither product being superior to the other, but both were superior to placebo. Our product showed improvement as follows:

Improvement was based on a change in baseline of 1 or more units at week 24 as follows:

Fine wrinkling was scored at baseline and at week 24 by the investigator using a ten point scale, where 0 represents no damage, 2-3=mild, 4‑5=moderate, 6-7=moderate/severe, and grade 8-9=severe.

Mottled pigmentation was scored at baseline and at week 24 using a ten point scale, where 0 represents no damage, 2-3=mild, 4‑5=moderate, 6-7=moderate/severe, and grade 8-9=severe.

The change was calculated as baseline minus the Week 24 evaluation. ⁽²⁾

References:
⁽¹⁾ Weinstein et al. Topical Tretinoin for the Treatment of Photodamaged Skin. Arch. Derm 1991; 127: 659-665.
⁽²⁾ Data on file, Spear Pharmaceuticals. Spear performed a 382-patient double-blind bioequivalence study with the brand Renova .05%, our Tretinoin Emollient Cream .05%, and Placebo.

Package Insert: 

Tretinoin Insert

Tretinoin Patient Instructions

What is the Product indicated for?

Fluorouracil Cream, USP 5% (5-fluorouracil) is recommended for the topical treatment of actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. Please read the package insert for complete details

What are Actinic Keratoses?

Actinic Keratoses (AK’s) are also called solar keratoses and they are typically red, scaly patches that develop on sun exposed skin. These lesions tend to grow over time and some may become squamous cell carcinomas (skin cancer). The presence of AK’s is most likely the reason your Physician has recommended therapy with 5-flourouracil. You can typically tell by the look and feel of your skin whether the lesions have cleared, but a follow-up examination by your Physician is very important. ^{(2, 3)}

Will the Product work?

Spear performed large clinical studies to prove that its product is bioequivalent to the brand. The studies involved 297 patients evaluated on a per protocol basis following two weeks of treatment. Of the patients using Spear Fluorouracil Cream USP 5%, 87% had 100% clearing of their lesions after six weeks. When Spear evaluated the individual lesions: 96% of the lesions were cleared after six weeks following 2 weeks of treatment. ⁽¹⁾

5-flourouracil is a very effective treatment; however, the patient must overcome the irritation that occurs while killing the pre-cancer cells. This is a strong treatment and some form of irritation occurs in 94% of patients.

Patients may take comfort in knowing the irritation is a sign that the treatment is working. ⁽³⁾

How should the Product be used?

First and foremost, please follow whatever instructions your Physician gave you. You should receive instructions with your prescription that detail specifically when and where to apply, how much to use for each application and the length of therapy. You should be sure that these instructions are clear and that you or your caregiver will be able to follow them. Please alert your physician if you have any questions or if you feel you are unable to complete the therapy as prescribed. ⁽²⁾

The product should be applied with a non-metal applicator, or a gloved hand. It is possible to apply without an applicator or a glove, however, special caution should be used to wash hands immediately and thoroughly after application. Always keep the product away from the eyes, corners of the nose, and mouth.

There are two ways that Physicians usually recommend use of this product: One is to apply product to the lesions themselves and the other is to apply product to a whole area of sun damaged skin, like the forehead and cheeks. The benefit of the broad area of treatment is that early Actinic Keratoses, which are not seen by your physician, tend to "light up". When treatment is complete, the drug eliminates unhealthy cells, leaving you with fresh, healthier skin. The downside to treating large areas is that more severe irritation can occur. ^{(2, 4, 5)}

The usual treatment consists of application 2 times a day for a period of 2 weeks, but sometimes it is longer. Be sure to closely follow the directions given to you by your Physician.

Please note: after applying for 1 week, your skin will likely become very red, tender and swollen. Your physician may recommend an antihistamine or pain reliever to help reduce the severity or soothe any reaction which may occur. ⁽³⁾

5-fluorouracil is an anti-cancer chemical and there is a potential for systemic absorption (approximately 5.98% of topical dose-see package insert). Therefore, do not use on large areas (e.g., scalp, ears & face) at one time unless expressly recommended by your Physician. Treating different parts of the face or body at different times is one method of increasing a patient’s tolerance and comfort during the treatment. (3) This therapy is not indicated for women who are or may become pregnant. See our full prescribing information for Contraindications and Precautions.

Remember to wear your sunscreen and a hat, and see your Physician regularly (at least every 6 months or more if you have multiple lesions). ^{(2, 3, 5)}

References:
⁽¹⁾ Data on File, Spear Pharmaceuticals
⁽²⁾ Maibach et al, Treatment of Actinic Keratoses. Supplement to Skin & Allergy News, June 6, 1998.
⁽³⁾ Anderson, Jeffes, Supplement to Skin & Allergy News, Vol 34, No. 3, March 2003.
⁽⁴⁾ Dinehart SM. The treatment of actinic keratoses. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):25-8
⁽⁵⁾ ActinicKeratosesnet Website by American Academy of Dermatologists - Guidelines of Treatment; http://www.skincarephysicians.com/actinickeratosesnet

Please see full Prescribing Information

Package Insert: 

5298 Fluorouracil Pl HR.pdf