CABTREO Dosage & Rx Info | Uses, Side Effects

Cabtreo Generic Name & Formulations

Legal Class

General Description

Clindamycin phosphate 1.2%, adapalene 0.15%, benzoyl peroxide 3.1%; gel.

Pharmacological Class

Lincosamide + retinoid + antibacterial/keratolytic.

How Supplied

Gel (tubes, pumps)—20g, 50g

Storage

Prior to Dispensing:

Store Cabtreo in a refrigerator between 2° to 8°C (36° to 46°F) until dispensed to the patient.
Dispense Cabtreo with a 10-week expiration date.

After Dispensing:

Store Cabtreo at room temperature at or below 25°C (77°F).

Do not freeze.

Keep away from heat.

Store pump upright.

Manufacturer

Bausch Health Companies Inc.

Generic Availability

Mechanism of Action

Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing bacterial protein synthesis.

Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes.

Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects but the precise mechanism of action is unknown.

Cabtreo Indications

Indications

Acne vulgaris.

Cabtreo Dosage and Administration

Adult

Apply thin layer to affected area once daily. Wash hands thoroughly after application.

Children

<12yrs: not established.

Cabtreo Contraindications

Contraindications

History of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

Cabtreo Boxed Warnings

Not Applicable

Cabtreo Warnings/Precautions

Warnings/Precautions

Not for oral, ophthalmic, or intravaginal use. Discontinue if serious hypersensitivity reaction or diarrhea occurs. Photosensitivity. Avoid or minimize sun exposure (including tanning beds, sun lamps). Reduce the frequency or discontinue if skin irritation and allergic contact dermatitis occurs. Avoid eyes, mouth, paranasal creases, mucous membranes, and areas of broken, eczematous or sunburned skin. Increased irritation in extreme weather. Pregnancy. Nursing mothers: avoid direct infant exposure.

Cabtreo Pharmacokinetics

See Literature

Cabtreo Interactions

Interactions

Concomitant antiperistaltic agents (eg, opiates, diphenoxylate with atropine) may prolong and/or worsen severe colitis. Avoid concomitant potentially irritating topical agents (eg, peeling, desquamating, or abrasive agents) and products with high concentrations of alcohol, astringents, spices, or limes. Concomitant other topical acne therapy: not evaluated. May potentiate other neuromuscular blockers; caution. Concomitant erythromycin topical or oral products may reduce the efficacy of Cabtreo.

Cabtreo Adverse Reactions

Adverse Reactions

Application site reactions, pain, erythema, dryness, irritation, exfoliation, dermatitis; colitis, allergic contact dermatitis.

Cabtreo Clinical Trials

Clinical Trials

The approval of Cabtreo was based on data from 2 placebo-controlled phase 3 studies (Trial 1; ClinicalTrials.gov Identifier: NCT04214639 and Trial 2; ClinicalTrials.gov Identifier: NCT04214652) that included 363 patients 10 years of age and older with facial acne vulgaris.

Study participants were randomly assigned to receive Cabtreo (n=122) or vehicle (n=61) applied once daily for 12 weeks. At baseline, 91% of patients had moderate acne, based on Evaluator’s Global Severity Score (EGSS). The coprimary endpoints were success on the EGSS (defined as at least a 2-grade improvement from baseline and an EGSS score of clear [0] or almost clear [1]), absolute change in noninflammatory lesion count, and absolute change in inflammatory lesion count.

Results from Trial 1 showed that 49.6% of patients treated with Cabtreo achieved EGSS success at week 12 compared with 24.9% of those who received vehicle (treatment difference, 24.7% [95% CI, 10.7-38.7]). In the Cabtreo arm, the mean percent reduction in inflammatory lesions was 75.7% (27.7 mean absolute reduction) vs 59.6% (21.7 mean absolute reduction) in the vehicle arm. Mean percent reduction in noninflammatory lesions was 72.7% (35.4 mean absolute reduction) with Cabtreo and 47.6% (23.5 mean absolute reduction) with vehicle.

Similar results were seen in Trial 2, with 50.5% of Cabtreo-treated patients achieving EGSS success vs 20.5% of the vehicle group (treatment difference, 30% [95% CI, 16.4-43.6]). Mean percent reduction in inflammatory lesions was 80.1% (30.1 mean absolute reduction) with Cabtreo and 56.2% (20.8 mean absolute reduction) with vehicle. Mean percent reduction for noninflammatory lesions was 73.3% (35.2 mean absolute reduction) with Cabtreo and 49.0% (22.0 mean absolute reduction) with vehicle.

Cabtreo Note