What is the purpose of Claravis (isotretinoin)?

From the Guidelines

Claravis (isotretinoin) is a powerful medication primarily used to treat severe, recalcitrant nodular acne that has not responded to other treatments like antibiotics. The purpose of Claravis is to reduce oil production in the skin, decrease bacteria, prevent clogged pores, and reduce inflammation, as stated in the guidelines of care for the management of acne vulgaris 1.

Key Points

• Typically prescribed for a 15-20 week course at doses of 0.5-1 mg/kg/day divided into two daily doses, Claravis is highly effective but carries significant risks.
• Due to its severe potential for birth defects, female patients must participate in the iPLEDGE program, use two forms of birth control, and undergo monthly pregnancy testing.
• Common side effects include dry skin, lips, and eyes, while serious side effects may include elevated triglycerides, liver enzyme abnormalities, and rarely, psychiatric issues.
• Patients should avoid vitamin A supplements, waxing, and sun exposure during treatment.
• Monthly blood tests are required to monitor for side effects, and the medication should only be taken under close medical supervision due to its significant risk profile, as outlined in the guidelines 1.

Important Considerations

• The medication is highly lipophilic and is best absorbed when taken with food, as noted in the guidelines 1.
• The most prevalent side effects involve the mucocutaneous, musculoskeletal, and ophthalmic systems, generally mimicking symptoms of hypervitaminosis A.
• Inflammatory bowel disease, depression/anxiety/mood changes, cardiovascular risk factors, bone mineralization, concerns regarding scarring, and S aureus colonization are potential adverse effects of interest.
• Routine monitoring of serum lipid profiles and liver function studies should continue, as recommended by the work group 1.

From the FDA Drug Label

INDICATIONS AND USAGE Severe Recalcitrant Nodular Acne Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. The purpose of Claravis (isotretinoin) is to treat severe recalcitrant nodular acne. The medication is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics, and are not pregnant due to the risk of life-threatening birth defects 2.

• Key points:
  • Treats severe recalcitrant nodular acne
  • Reserved for patients unresponsive to conventional therapy
  • Not for pregnant patients due to risk of birth defects

From the Research

Purpose of Claravis (Isotretinoin)

The purpose of Claravis, also known as isotretinoin, is to treat severe acne and other skin disorders.

• It is primarily used for the treatment of severe refractory nodulocystic acne, reducing sebaceous gland size and sebum production, and altering skin surface lipid composition 3.
• Isotretinoin has also been used to treat other skin conditions such as rosacea, Gram-negative folliculitis, Darier's disease, ichthyosis, and pityriasis rubra pilaris 3.
• It is effective in treating severe and mild-to-moderate acne lesions, reducing scarring damage, and is considered a valid therapeutic alternative for acne treatment 4.

Treatment Guidelines

Guidelines for the optimal use of isotretinoin in acne recommend:

• A dose of 0.5 to 1.0 mg/kg/day for patients with acne who fail to respond to other forms of treatment 5.
• The administration of a higher dose of 1 mg/kg/day to achieve a significant cumulative dose of > 120 mg/kg, especially for young patients and men with truncal acne and more severe disease 5.
• A treatment duration of 4 months, with some patients requiring longer treatment, up to 10 months 5.

Efficacy and Safety

The efficacy and safety of isotretinoin have been studied in various clinical trials:

• Isotretinoin has been shown to be effective in reducing acne lesion counts, with a response rate of 60-95% in patients with severe acne 3, 5.
• The drug has also been associated with side effects, including mucocutaneous system effects and raised serum triglyceride levels 3.
• The use of isotretinoin is strictly contraindicated in women of childbearing potential due to its severe teratogenic properties, unless an effective form of contraception is used 3.

Comparison with Other Treatments

Isotretinoin has been compared with other treatments for acne, including:

• Topical therapies such as retinoids, benzoyl peroxide, and azelaic acid 6.
• Systemic agents such as oral antibiotics and hormonal therapies 6.
• Low-dose oral isotretinoin has been shown to be effective in treating mild-to-moderate acne, but the conventional dose is more effective in achieving prolonged remission 7.