ALTRENO

2 Recommended Dose and Dosage Adjustment Apply daily a pea-sized amount of ALTRENO to the affected areas after cleansing with a mild, non-medicated soap and water. A maintenance dose has not been studied or established with ALTRENO.

Application of ALTRENO may cause a transitory feeling of warmth or slight stinging. When administered according to recommended guidelines, ALTRENO may produce a slight erythema similar to that of mild sunburn. In cases where it is necessary to temporarily discontinue therapy or reduce the frequency of application, therapy should be resumed, or the frequency of application increased when the patient becomes able to tolerate the treatment .

Therapeutic effects may be noticed after two to three weeks of use, but more than six weeks of therapy may be required before definite beneficial effects are seen. During the early weeks of treatment, an apparent exacerbation of inflammatory lesions may occur.

This is due to the action of the medication on deep, previously unseen lesions and should not be considered a PrALTRENOTM – Product Monograph Page 5 of 28 reason to discontinue therapy. Once a satisfactory response has been obtained, it may be possible to maintain this improvement with less frequent applications.

Discontinue treatment if a severe local inflammatory response is experienced. Reinstitute therapy when the reaction has subsided and apply preparation every other day or less frequently. Should discomfort still be experienced, stop treatment completely.

Excess application of ALTRENO does not provide more rapid or better results. In fact, marked redness, peeling or discomfort can occur. If excess application occurs accidentally or through over-enthusiastic use, ALTRENO should be discontinued for several days before resuming therapy.

Health Canada has not authorized an indication for pediatric use of ALTRENO under the age of 9 years (see WARNINGS AND PRECAUTIONS, Special Populations Pediatrics). 4 Administration A pea-sized amount of ALTRENO should be squeezed onto a clean fingertip and a thin layer should be spread to the affected areas.

The treated area should be washed no more than twice per day. After washing, the skin should be dried gently and completely without rubbing it. Allow at least 20 to 30 minutes to dry before applying medication. Only a sufficient quantity of medication should be applied to cover the affected areas lightly, using a gauze swab, cotton wool or the tips of clean fingers.

1 Adverse Reaction Overview True contact allergy to topical tretinoin is rarely encountered. Changes in the skin may be anticipated, indicating an active effect of the medication. Expected changes include mild erythema and flaking or peeling of the stratum corneum.

In certain very sensitive patients, the skin may become very erythematous, edematous, blistered or crusted. In such cases, application of tretinoin should be discontinued until the skin has fully recovered. Further applications should be at a level that the individual can tolerate.

All adverse reactions observed are reversible when treatment is discontinued. Some degree of local irritation is expected. The following treatment-emergent adverse events have been reported with the use of ALTRENO. These reactions are listed in an approximately PrALTRENOTM – Product Monograph Page 9 of 28 decreasing order of occurrence: dryness, pain, erythema, photosensitivity reaction, pruritus, irritation, exfoliation, dermatitis rash, hypersensitivity, swelling, ulcer, malaise, pyrexia and burning.

These reactions were usually mild to moderate in severity, generally well-tolerated and self-limiting, occurred early during the course of therapy and generally decreased over time with the exception of dry skin, which tended to persist.

2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Integrated analysis of two Phase 3 studies was performed, which were both multi-centered, randomized, double-blinded, vehicle-controlled, 2-arm, parallel group comparison studies comparing the efficacy and safety of ALTRENO and a vehicle lotion.

General ALTRENO is for external use only. Not for ophthalmic use. Avoid contact with the eyes, eyelids, angles of the nose, lips, mucous membranes, severely inflamed skin or to open lesions or to other areas where treatment is not intended.

ALTRENO should be applied only to the affected areas. Excessive use should be avoided. Tretinoin may cause irritation of circumoral and other sensitive skin areas. Tretinoin should not be applied to severely inflamed skin or to open lesions.

Exposure to sunlight, including ultraviolet sunlamps, may provoke additional irritation. Therefore, exposure should be avoided or minimized during the use of tretinoin. A patient experiencing considerable sun exposure due to occupational duties, and/or any patient inherently sensitive to the sun, should exercise particular caution.

When exposure to sunlight cannot be avoided, use of sunscreen products and protective clothing over treated areas is recommended. Hyper- or hypopigmentation has occasionally been reported when the product is used to the point of producing severe irritation.

This is reversible when the medication is stopped. 05% w/w in a moisturizing lotion base with Sodium Hyaluronate, Glycerin and Collagen. Benzyl Alcohol, Butylated hydroxytoluene, Carbomer Copolymer Type B, Carbomer Homopolymer Type A, Glycerin, Methylparaben, Mineral Oil, Octoxynol-9, Purified Water, Sodium Hyaluronate, Soluble collagen and Trolamine PrALTRENOTM – Product Monograph Page 7 of 28 Cosmetics may be used, but the areas to be treated should be cleansed thoroughly before the medication is applied.

Astringent toiletries should be avoided. Simultaneous use of harsh abrasives and other skin treatments, including sun lamp, should be avoided if possible. g. plucking, electrolysis, depilatories) but should avoid these procedures at night before applying ALTRENO as they mig ht result in skin irritation.

ALTRENO is contraindicated in patients who have demonstrated a hypersensitivity to the drug or to any ingredient in the formulation, or any component of the container.