Tretiva is a prescription medication containing isotretinoin, a potent retinoid derived from vitamin A, specifically formulated for the treatment of severe, recalcitrant nodular acne that has proven unresponsive to conventional therapies. It represents a significant advancement in dermatological treatment, targeting the multifactorial pathogenesis of acne with a mechanism of action that addresses all major causative factors: sebum production, follicular hyperkeratinization, inflammation, and Cutibacterium acnes proliferation. This comprehensive approach offers the potential for long-term remission, making it a cornerstone therapy in medical dermatology for appropriate patient populations under strict medical supervision.

Features

• Contains isotretinoin as the active pharmaceutical ingredient (API)
• Available in multiple dosage strengths (e.g., 10 mg, 20 mg soft gelatin capsules)
• Formulated for optimized oral bioavailability
• Manufactured under strict Good Manufacturing Practice (GMP) guidelines
• Packaged with mandatory safety materials, including a patient information leaflet

Benefits

• Achieves profound and often permanent reduction in sebum production by inducing apoptosis in sebaceous glands.
• Effectively resolves severe, inflammatory, and nodular acne lesions, preventing scarring and improving skin texture.
• Addresses the root causes of acne pathogenesis, offering the potential for long-term remission rather than temporary suppression.
• Can significantly improve psychosocial well-being and quality of life by alleviating the burden of severe acne.
• Reduces the colonization of Cutibacterium acnes bacteria and comedone formation.
• Provides a finite treatment course, typically lasting 15-20 weeks, reducing long-term medication dependence.

Common use

Tretiva (isotretinoin) is indicated for the treatment of severe recalcitrant nodular acne in patients aged 12 years and older. It is reserved for cases where standard acne treatments, including systemic antibiotics and topical therapies, have failed to produce adequate clinical improvement. The diagnosis of severe nodular acne is a clinical one, characterized by the presence of numerous inflammatory nodules and cysts, which are often painful and carry a high risk of permanent scarring. Its use is not intended for mild or moderate acne vulgaris or for cosmetic purposes. Treatment is initiated and monitored exclusively by qualified healthcare professionals, typically dermatologists, who are experienced in the management of severe acne and the complex safety profile of systemic retinoids.

Dosage and direction

The dosage of Tretiva is highly individualized, based on patient body weight (mg/kg), the severity of the disease, and the patient’s response to and tolerance of the medication. The recommended cumulative dose range for a single course of therapy is 120 to 150 mg/kg.

• Initial Dosing: The standard starting dose is 0.5 mg/kg/day, administered in two divided doses with food to enhance absorption. This may be increased as tolerated.
• Maintenance Dosing: For most patients, the dose is gradually increased to approximately 1.0 mg/kg/day for the remainder of the treatment course, which typically spans 15 to 20 weeks.
• Administration: Capsules must be swallowed whole with a full glass of water. They should always be taken with a meal or large, high-fat snack to ensure maximum absorption. Dividing the daily dose (e.g., one capsule in the morning and one in the evening with meals) is recommended.
• Course Duration: A single course of therapy is often sufficient to induce prolonged remission. Treatment continues until the total cumulative dose is achieved or until the acne has cleared significantly. Retreatment is not recommended immediately after the first course; a period of observation is required.

Dosage adjustments are mandatory in cases of significant side effects (e.g., elevated serum triglycerides, elevated liver transaminases). Under no circumstances should the daily dose exceed 2 mg/kg/day.

Precautions

The use of Tretiva necessitates rigorous precautions due to its potent effects and serious potential risks.

• Pregnancy Prevention Program (PPP): Tretiva is a known teratogen (Category X) and can cause severe life-threatening birth defects. Female patients of childbearing potential MUST use two reliable forms of contraception simultaneously for at least one month before treatment, throughout treatment, and for one month after discontinuation. They must also comply with mandatory monthly pregnancy testing before, during, and after therapy.
• Psychiatric Effects: Patients should be monitored for symptoms of depression, mood changes, psychosis, aggression, and, in rare cases, suicidal ideation. Any history of psychiatric illness must be discussed prior to initiation.
• Hepatotoxicity: Baseline and periodic monitoring of liver function tests (LFTs) is required, as isotretinoin can cause elevated transaminases.
• Lipid Effects: Significant elevations in serum triglycerides and cholesterol can occur. Baseline fasting lipid profiles are required, with follow-up tests during treatment.
• Ocular Effects: May cause dry eyes, conjunctivitis, and night blindness. Contact lens wearers may experience intolerance. Patients should be cautioned about potential visual disturbances, particularly when driving at night.
• Musculoskeletal Effects: Can cause musculoskeletal symptoms (e.g., myalgia, arthralgia), hyperostosis, and premature epiphyseal closure in adolescents. Vigorous physical activity may exacerbate these symptoms.
• Pancreatitis: Discontinue immediately if symptoms of pancreatitis (e.g., severe abdominal pain, nausea, vomiting) occur, especially in the context of hypertriglyceridemia.
• Sun Sensitivity: Photosensitivity is increased. Patients must use sunscreen and protective clothing.

Contraindications

Tretiva is absolutely contraindicated in the following scenarios:

• Pregnancy, women who are or may become pregnant, and women who are breastfeeding.
• Hypersensitivity to isotretinoin, other retinoids, or any component of the formulation (e.g., soy, due to the capsule content).
• Patients with significantly impaired liver function or chronically elevated blood lipid levels.
• Concomitant use with tetracycline antibiotics (e.g., tetracycline, doxycycline, minocycline) due to the increased risk of pseudotumor cerebri (benign intracranial hypertension).
• Concomitant use with systemic corticosteroids (for acne) or drugs with a high potential for hepatotoxicity.
• Patients with a history of pancreatitis or hypertriglyceridemia.

Possible side effects

The majority of patients will experience some side effects, which are often dose-dependent and manageable. They are largely related to the mucocutaneous and systemic effects of decreased sebum production.

• Very Common (>10%): Cheilitis (dry, cracked lips); xerosis (dry skin); dry nose/nasal mucosa (potentially leading to epistaxis); conjunctivitis and dry eyes; skin fragility; pruritus; palmoplantar desquamation (peeling skin on palms/soles).
• Common (1-10%): Headache; epistaxis (nosebleeds); rash; myalgia and arthralgia (muscle and joint pain); hair thinning; increased susceptibility to sunburn; paronychia (nail inflammation).
• Uncommon (0.1-1%): Elevated liver enzymes; elevated blood triglycerides/cholesterol; corneal opacities; inflammatory bowel disease (IBD) flare-ups; hypergranulation tissue (pyogenic granuloma).
• Rare (<0.1%): Severe skin reactions (e.g., Stevens-Johnson Syndrome); hearing impairment; severe headache with nausea and vomiting (signs of pseudotumor cerebri); depression, mood changes, suicidal ideation; pancreatitis; aggressive behavior.

Drug interaction

Tretiva has several critical drug interactions that must be avoided or carefully managed.

• Tetracyclines: CONTRAINDICATED. Concurrent use dramatically increases the risk of pseudotumor cerebri.
• Vitamin A Supplements: AVOID. Concomitant use will result in additive toxic effects and hypervitaminosis A.
• Systemic Corticosteroids: Use with caution; may potentiate the risk of osteoporosis or pseudotumor cerebri.
• Hepatotoxic Drugs (e.g., methotrexate, azole antifungals): Increased risk of liver damage. Avoid or monitor LFTs closely.
• St. John’s Wort: May reduce the effectiveness of hormonal contraceptives, compromising the PPP. AVOID.
• Phenytoin: Isotretinoin may alter phenytoin levels. Monitor levels if co-administered.
• Alcohol: May exacerbate hypertriglyceridemia and potential hepatotoxicity. Consumption should be minimized or avoided.

Missed dose

If a dose of Tretiva is missed, the patient should take it as soon as they remember, provided it is not almost time for the next scheduled dose. Do not double the dose to make up for the missed one. Simply resume the normal dosing schedule with the next capsule. Maintaining a consistent daily intake with food is more important than precisely timing each dose. If unsure, the patient should contact their pharmacist or prescribing physician for guidance.

Overdose

Acute overdose with Tretiva would produce effects consistent with hypervitaminosis A. Symptoms may include severe headache, vertigo, drowsiness, irritability, pruritus, vomiting, abdominal pain, and cheilitis. The skin may peel extensively. Due to the drug’s long half-life (approximately 21 hours), symptoms may be prolonged. There is no specific antidote for isotretinoin overdose. Management is supportive and symptomatic. Gastric lavage may be considered if ingestion was very recent. The patient must be referred to emergency medical care immediately, and the prescriber and poison control center should be notified.

Storage

• Store Tretiva capsules at room temperature (15°-30°C or 59°-86°F).
• Protect from light and moisture. Keep the bottle tightly closed in its original packaging.
• Do not freeze.
• Keep out of reach of children and pets, preferably in a locked cabinet, to prevent accidental ingestion.
• Do not use after the expiration date printed on the packaging.
• Do not transfer capsules to another container.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is not exhaustive and may not include all possible uses, directions, precautions, interactions, or adverse effects. The manufacturer and publisher are not responsible for any errors or omissions or for any outcomes resulting from the use of this information.

Reviews

Clinical reviews and patient testimonials consistently highlight Tretiva’s efficacy in achieving transformative clearance of severe acne, often after years of unsuccessful treatments. Many users report a dramatic improvement in skin quality and a significant boost in self-confidence post-treatment. However, reviews universally emphasize the challenging side-effect profile, particularly intense dryness, and the critical importance of strict adherence to the Pregnancy Prevention Program. The treatment is widely regarded by dermatologists as a powerful, life-changing tool when used appropriately under expert supervision, with its benefits far outweighing the temporary difficulties for correctly selected patients.