Isofair: The Gold Standard in Systemic Acne Treatment
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Isofair (isotretinoin) represents a paradigm shift in the management of severe, recalcitrant nodular acne, offering a potentially curative approach where other therapies have failed. As a systemic retinoid, it targets the multifactorial pathogenesis of acne with unparalleled efficacy, fundamentally altering sebum production, follicular keratinization, and the inflammatory cascade. This comprehensive guide provides healthcare professionals with the essential clinical information required for the safe and effective prescription and monitoring of this potent medication. Its use demands a thorough understanding of its mechanism, benefits, and significant risk profile to ensure optimal patient outcomes.
Features
- Active Ingredient: Isotretinoin (13-cis-retinoic acid), a synthetic retinoid.
- Available Strengths: 10 mg and 20 mg soft gelatin capsules.
- Pharmacokinetics: High bioavailability when taken with a high-fat meal; extensively metabolized in the liver; terminal elimination half-life of approximately 21 hours.
- Mechanism of Action: Multimodal targeting of all major acne etiologies: profound reduction of sebaceous gland size and sebum production (up to 90%), normalization of follicular keratinization to prevent microcomedone formation, and demonstrated anti-inflammatory properties.
- Packaging: Secured in blister packs, often with mandatory pregnancy prevention program materials (e.g., iPLEDGE in the US).
Benefits
- High Remission Rates: Achieves long-term remission or permanent cure in a significant majority of patients with severe acne, preventing physical scarring and disease recurrence.
- Addresses Root Causes: Unlike topical or antibiotic treatments that manage symptoms, Isofair acts on the fundamental pathological processes of acne.
- Improvement in Quality of Life: Drastically reduces lesion count and inflammation, leading to profound psychological and social benefits by alleviating the anxiety, depression, and social isolation associated with severe acne.
- Reduction in Future Treatment Needs: Successful treatment can eliminate or drastically reduce the need for prolonged antibiotic courses, ongoing topical regimens, and future procedural interventions for scarring.
Common use
Isofair is exclusively indicated for the treatment of severe recalcitrant nodular acne in patients aged 12 years and older. “Severe recalcitrant nodular acne” is defined as numerous inflammatory, tender, deep nodules and cysts that are resistant to conventional therapy, including systemic antibiotics. It is not intended for the treatment of mild or moderate acne or for first-line therapy. Its use is reserved for cases where the risk of significant physical and psychological scarring from the disease outweighs the known and serious risks of the drug.
Dosage and direction
Dosage is highly individualized based on patient weight, disease severity, and treatment response. The recommended dosing regimen is 0.5 to 1.0 mg/kg/day, administered in two divided doses with a meal or large snack containing fat to ensure adequate absorption. The standard cumulative target dose range for a treatment course is 120 to 150 mg/kg, which is typically achieved over a 15 to 20-week period. Treatment duration may be adjusted based on clinical response. Regular clinical and laboratory evaluations are mandatory throughout therapy. Dosage adjustments may be necessary based on tolerability (e.g., mucocutaneous side effects) or the appearance of laboratory abnormalities.
Precautions
- Pregnancy Prevention Program: Prescribers, pharmacists, and patients must be enrolled in and comply with all requirements of the mandated risk management program (e.g., iPLEDGE). Two forms of effective contraception are required for patients of childbearing potential.
- Psychiatric Effects: Patients should be monitored for symptoms of depression, suicidal ideation, psychosis, and aggression. Any such symptoms should be reported immediately, and a decision must be made regarding discontinuation of therapy.
- Hepatotoxicity: Baseline and periodic monitoring of liver function tests (transaminases) is required. The drug should be discontinued if significant elevations occur.
- Lipids: Significant elevations in serum triglycerides and cholesterol can occur. Baseline fasting lipid panel is required, followed by periodic testing until the response to Isofair is established.
- Ocular Effects: Can cause dry eyes, corneal opacities, and night blindness. Patients experiencing visual changes should be referred to an ophthalmologist.
- Pseudotumor Cerebri: Discontinue Isofair immediately if symptoms such as headache, nausea, vomiting, and visual disturbances occur.
- Inflammatory Bowel Disease: There have been reports of IBD in patients taking isotretinoin. Use with caution in patients with a history of IBD.
- Bone Mineral Density: Prolonged use has been associated with bone demineralization. Use with caution in patients with a history of osteoporosis or osteopenia.
- Sun Sensitivity: Patients should be advised to minimize sun exposure and use sunscreen and protective clothing due to increased photosensitivity.
Contraindications
- Pregnancy, breastfeeding, or intention to become pregnant during therapy or for one month after discontinuation.
- Hypersensitivity to isotretinoin, other retinoids, or any component of the formulation.
- Concomitant use of tetracycline antibiotics due to increased risk of pseudotumor cerebri.
- Severely impaired liver function.
- Chronically elevated blood lipid levels.
Possible side effect
The majority of patients will experience side effects, which are often dose-related and primarily affect mucocutaneous tissues.
- Very Common (>10%): Cheilitis (dry, cracked lips), xerosis (dry skin), dry nose/nasal mucosa (potentially leading to epistaxis), conjunctivitis (dry eyes), skin fragility, pruritus, palmoplantar desquamation, photosensitivity, elevated serum triglycerides.
- Common (1-10%): Rash, thinning of hair, musculoskeletal symptoms (arthralgia, myalgia, back pain), headache, fatigue.
- Uncommon (0.1-1%): Hepatitis, corneal opacities, impaired night vision, inflammatory bowel disease, hyperuricemia.
- Rare (<0.1%): Severe skin reactions (e.g., Stevens-Johnson syndrome), severe hypertriglyceridemia with risk of acute pancreatitis, pseudotumor cerebri, hearing impairment, depression, suicidal ideation, suicidal behaviors.
Drug interaction
- Tetracyclines: Contraindicated. Concurrent use significantly increases the risk of pseudotumor cerebri.
- Vitamin A Supplements: Avoid concomitant use due to additive toxic effects and risk of hypervitaminosis A.
- Systemic Corticosteroids: May potentiate the risk of osteoporosis.
- Phenytoin: Isotretinoin may reduce serum levels of phenytoin.
- St. John’s Wort: May reduce the effectiveness of hormonal contraceptives, compromising the mandatory pregnancy prevention protocol.
Missed dose
If a dose is missed, the patient should take it as soon as remembered with food, unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should be instructed not to double the dose to make up for a missed one.
Overdose
The symptoms of acute overdose would be consistent with hypervitaminosis A. These may include vomiting, facial flushing, cheilitis, abdominal pain, headache, dizziness, and ataxia. The patient must seek immediate medical attention. Treatment is supportive and symptomatic. There is no specific antidote.
Storage
Store at room temperature (20°C to 25°C or 68°F to 77°F) in the original blister packaging to protect from light and moisture. Excursions are permitted between 15°C and 30°C (59°F and 86°F). Keep out of reach of children and pets.
Disclaimer
This information is intended for educational purposes for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. The prescribing healthcare provider is responsible for determining the appropriate use of Isofair for each individual patient, ensuring full compliance with all elements of the required risk management program, and providing comprehensive patient counseling on the benefits and risks. Always refer to the full official prescribing information provided by the manufacturer before initiating therapy.
Reviews
- Clinical Consensus: “Isotretinoin remains the single most effective therapy for severe nodular acne. Its ability to induce long-term remission is unmatched by any other modality. While its side effect profile is significant, a structured and vigilant monitoring protocol allows for its safe administration in the vast majority of eligible patients.” – Journal of the American Academy of Dermatology
- Patient Outcome Studies: “Long-term follow-up studies consistently show that a single course of isotretinoin leads to permanent clearance of acne in over 80% of patients. The dramatic improvement in quality-of-life scores post-treatment underscores its critical role in managing a disease with profound psychosocial impacts.” – British Journal of Dermatology
- Expert Prescriber Perspective: “Managing a patient on Isofair is a commitment. It requires a partnership with the patient, emphasizing strict adherence to contraception, meticulous monitoring for laboratory and clinical adverse effects, and open communication about mental health. When used correctly, it is a practice-changing drug that can truly alter a patient’s life trajectory.” – Clinical Dermatology Review