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DUOBRII is a brand name for Tazarotene, supplied as a lotion. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DUOBRII (halobetasol propionate and tazarotene lotion), is indicated for: • Improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe plaque psoriasis. 1.1 Pediatrics Pediatrics (under the age of 18 years) The safety and efficacy of DUOBRII in pediatric patients have not been…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Conditions which augment systemic absorption may increase the patient’s exposure to the drug (see WARNINGS AND PRECAUTIONS, Skin). ). ). 2 Recommended Dose and Dosage Adjustment DUOBRII should be applied in a thin layer to the affected area once a day.
Treatment should be discontinued when control has been achieved. Treatment may be reinitiated intermittently as necessary. The total dosage of DUOBRII should not exceed approximately 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Periodic evaluation for evidence of HPA axis suppression is recommended, particularly in patients who are using DUOBRII uninterrupted for more than 8 weeks (see WARNINGS AND PRECAUTIONS). The efficacy and safety of DUOBRII in patients with more than 12% of body surface area affected by plaque psoriasis has not been established (see CLINICAL TRIALS).
3 Administration Apply a thin layer of DUOBRII once daily to cover only affected areas and rub in gently. A QR link to a video is on the carton label to show patients how to apply DUOBRII lotion. If a bath or shower is taken prior to application, the skin should be dry before applying the lotion.
DUOBRII is not for oral, ophthalmic, or intravaginal use. In the event of contact with the eye, flush with cold water. DUOBRII is not recommended to be used on the face, scalp, axillae, or intertriginous areas. Application to normal skin should be avoided.
DUOBRII should not be used on eczematous skin, as it may cause severe irritation. DUOBRII should not be used with occlusive dressings due to risk of increasing systemic exposure and infection. 4 Missed Dose Apply the missed dose as soon as you remember.
Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.
1 Adverse Reaction Overview Across the 11 clinical studies that contributed to the evaluation of safety for DUOBRII, the most frequently reported events were generally associated with application site reactions and other related, topical skin events.
Most events were mild or moderate in severity. Few events across studies were serious and none of the serious adverse events (SAEs) were considered by the investigator to be treatment-related. 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. The safety of DUOBRII has been evaluated by monitoring ADRs occurring in the course of 2 randomized, placebo-controlled, Phase III studies of 8 weeks in duration (see CLINICAL TRIALS).
The studies in psoriasis patients involved a total of 270 patients who received DUOBRII. Adverse events occurring in ≥ 1% of the subjects treated with DUOBRII and more frequently than in vehicle-treated subjects are presented in Table 2.
4%). Other local adve rse reactions include atrophy, striae, telangiectasia, and folliculitis. In human dermal safety trials, DUOBRII did not induce allergic contact sensitization. It is not expected to induce any phototoxicity or photoallergy reactions.
7%) a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA. At each level of summarization (System Organ Class or Preferred Term) subjects are counted once. 0.
Note:
Treatment-emergent adverse events are those with an onset after the first application of study drug. During the 8 weeks of treatment in Studies V01-118A-301 and V01-118A-302 (combined data), most of the subjects experienced TEAEs that were mild or moderate in severity.
General Patients should be advised to inform physicians of current or prior use of corticosteroids (see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism). Cardiovascular Suitable precautions should be taken when using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation.
Use of corticosteroids around chronic leg ulcers may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection. Endocrine and Metabolism Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression, which can lead to secondary glucocorticosteroid insufficiency and adrenal hypercorticism including manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria (see ADVERSE REACTIONS, Clinical Trials Adverse Reactions).
Glucocorticoid insufficiency may also occur during treatment or upon withdrawal of treatment of the topical corticosteroid. Conditions that augment systemic absorption of DUOBRII may predispose a patient using a topical corticosteroid to HPA axis suppression (see WARNINGS AND PRECAUTIONS, Skin) If HPA axis suppression is documented, reduce the frequency of application or discontinue, as necessary.
Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Monitoring and Laboratory Tests Periodic evaluation for evidence of HPA axis suppression is recommended, particularly in patients who are using DUOBRII uninterrupted for more than 8 weeks.
An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA axis suppression. Hepatic There are no adequate and well controlled studies of DUOBRII use in patients with hepatic impairment. As corticosteroids undergo hepatic metabolism, DUOBRII should be used with caution in patients with hepatic impairment.
DUOBRII (halobetasol propionate and tazarotene lotion) is contraindicated in the following: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients who are hypersensitive to other corticosteroids or retinoic compounds. , herpes simplex, vaccinia and varicella) lesions of the skin, bacterial or fungal skin infections, parasitic infections, skin manifestations relating to tuberculosis or syphilis, eruptions following vaccinations.
• Patients with seborrheic dermatitis. • In women who are pregnant or may become pregnant (see WARNINGS AND PRECAUTIONS, Sexual Health, Reproduction; and Special Populations, Pregnant Women). PrDUOBRII™ Product Monograph Page 5 of 29
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1%) in the vehicle group experienced severe TEAEs. The long-term safety of DUOBRII was evaluated in a Phase III multi-center, open label study (V01-118A-303) (see CLINICAL TRIALS). The patient population included in the long-term safety study was similar to those in the placebo-controlled Phase III studies.
All enrolled subjects received the treatment for 8 weeks and then as needed once daily as assessed in 4 -week periods for up to 1 year. The reported TEAEs in the long-term study were similarly consistent with those reported in the other studies.
Most of the TEAEs were reported as mild or moderate. 5%) using DUOBRII experienced severe TEAEs. The percentage of subjects with skin AEs peaked around Day 60 and remained relatively stable from Day 90 through Day 365. DUOBRII has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
The potential for HPA axis suppression was evaluated in a study (V01-118A-501) of 20 adult subjects with moderate to severe plaque psoriasis involving ≥20% of their body surface area. An approximate dose of 7 g DUOBRII was applied once daily (49 g/week) for 8 weeks and subjects were assessed for HPA axis suppression at Weeks 4 and 8.
0%) subjects at Week 4 and for 0% of subjects at Week 8. In this PrDUOBRII™ Product Monograph Page 13 of 29 study, the criteria for HPA axis suppression was a serum cortisol level of less than or equal to 18 mcg/dL 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone) (see WARNINGS AND PRECAUTIONS).
3 Less Common Clinical Trial Adverse Reactions (< 1% and More Frequent than the Vehicle in Pooled Pivotal Phase III Studies [V01-118A-301 and V01-118A-302]) General disorders and administration site conditions: pain, administration site pain, application site dermatitis, application site erosion.
Infections and infestations: cellulitis. Injury, poisoning and procedural complications: wound secretion, documented hypersensitivity to administered product. Investigations: staphylococcus test positive. Immune system disorders: hypersensitivity.
Skin and subcutaneous tissue disorders: blister, dermatitis, dry skin, ecchymosis, pruritus generalized, scab, skin sensitization, skin exfoliation, skin lesion, telangiectasia. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data There were no findings related to hematology or chemistry parameters that appeared to be treatment-related in any of the studies that included subjects with plaque psoriasis.
5 Clinical Trial Adverse Reactions (Pediatrics) No clinical trials were carried out in pediatric population.
Immune Medicinal products containing corticosteroids must be used with caution in patients with PrDUOBRII™ Product Monograph Page 8 of 29 impaired immune system function (T-lymphocytes) or in those being treated with immunosuppressive therapy.
Topical corticosteroids may increase the risk of infections including aggravation of cutaneous infection, masked infection and secondary infections. In particular, bacterial infection is encouraged by the warm, moist conditions within skin folds or caused by occlusive dressings.
If concomitant skin infections develop, DUOBRII should be discontinued and antimicrobial therapy administered. Renal There are no adequate and well controlled studies of DUOBRII use in patients with renal impairment. As corticosteroids undergo renal excretion, DUOBRII should be used with caution in patients with renal impairment.
Sensitivity/Resistance Local hypersensitivity reactions may resemble symptoms of the condition under treatment. If hypersensitivity reactions occur, DUOBRII should be discontinued and appropriate therapy initiated. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation.
Such an observation should be corroborated with appropriate diagnostic patch testing. Ophthalmologic Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Topical corticosteroids should be used with caution in patients with glaucoma.
Sexual Health Reproduction DUOBRII is contraindicated in women who are pregnant or may become pregnant (see Special Populations, Pregnant Women). Skin DUOBRII should be used with caution as topical corticosteroid use may lead to rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity.
Prolonged use of topical corticosteroid preparations may produce striae , telangiectasias, folliculitis, or atrophy of the skin or subcutaneous tissue. If these local adverse reactions are observed, treatment with DUOBRII should be discontinued.
PrDUOBRII™ Product Monograph Page 9 of 29 Use of topical tazarotene may produce contact dermatitis. If burning/stinging, itching, and dryness become more severe, the medication should either be discontinued until the integrity of the skin is restored or the dosing should be reduced to an interval the patient can tolerate.
Discontinue and do not resume treatment if allergic contact dermatitis is identified. Conditions which augment systemic absorption may increase the patient’s exposure to the drug. Such conditions include the formulation and potency of the topical corticosteroid, the application of topical corticosteroids over large body surface areas, application to intertriginous areas (such as the axillae and anogenital area), frequency of application, concomitant use of multiple corticosteroid-containing products, prolonged use, the addition of occlusive dressings, and/or liver failure.
Other risk factors for increased systemic effects include increasing hydration of the stratum corneum, use on thin skin areas (such as the face), and use on broken skin or in conditions where the skin barrier may be impaired. Weather extremes, such as wind or cold, may be more irritating to patients using DUOBRII.
Photosensitivity and Risk for Sunburn Topical administration of tazarotene has been shown to be associated with increased phototoxicity (see TOXICOLOGY, Phototoxicity). DUOBRII was not shown to induce phototoxicity. However, as tazarotene is a component of DUOBRII, exposure to sunlight (including sunlamps) should be avoided during the use of DUOBRII.
Patients should be instructed to use sunscreens (minimum SPF of 15) and protective clothing on areas treated with DUOBRII. Patients with sunburn should be advised not to use DUOBRII on the sunburnt areas until fully recovered. DUOBRII should be administered with caution if the patient is also taking drugs known to be photosensitizers […]