What is the recommended dosage and administration protocol for Hipprex (Methoxsalen) in PUVA therapy?

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Methoxsalen (Hipprex) Dosing and Administration for PUVA Therapy

Oral Methoxsalen Dosing

For oral PUVA therapy, methoxsalen capsules should be taken 1.5 to 2 hours before UVA exposure with low-fat food or milk, dosed according to body weight. 1

Weight-Based Dosing Table

  • <30 kg (<66 lbs): 10 mg
  • 30-50 kg (66-110 lbs): 20 mg
  • 51-65 kg (112-143 lbs): 30 mg
  • 66-80 kg (146-176 lbs): 40 mg
  • 81-90 kg (179-198 lbs): 50 mg
  • 91-115 kg (201-254 lbs): 60 mg
  • >115 kg (>254 lbs): 70 mg 1

Critical Timing Considerations

The newer soft gelatin capsule formulation (Oxsoralen-Ultra) reaches peak photosensitivity at 1.5-2.1 hours post-ingestion, significantly earlier than older hard gelatin formulations (3.9-4.25 hours). 1 This formulation achieves twice the serum levels of hard gelatin capsules and requires substantially lower UVA doses. 1

An alternative formulation, 8-methoxypsoralen (8-MOP), requires 2 hours before UVA exposure. 2

Food Interaction Management

While it is preferred to avoid food for 1 hour before and after dosing (as food decreases absorption), if nausea necessitates food intake, maintain consistent timing and type of food with each dose to minimize pharmacokinetic variability. 2 Taking methoxsalen with milk or crackers can reduce nausea. 2

Initial UVA Exposure Protocol

Starting UVA doses are determined by Fitzpatrick skin type, NOT by arbitrary fixed doses. 1

Skin Type-Based Initial Dosing

  • Type I (Always burn, never tan; includes erythrodermic psoriasis): 0.5 J/cm²
  • Type II (Always burn, sometimes tan): 1.0 J/cm²
  • Type III (Sometimes burn, always tan): 1.5 J/cm²
  • Type IV (Never burn, always tan): 2.0 J/cm²
  • Type V (Moderately pigmented): 2.5 J/cm²
  • Type VI (Black skin): 3.0 J/cm² 1

If minimal phototoxic dose (MPD) testing is performed, start at ½ MPD. 1

Treatment Frequency and Escalation

Treatments should be administered 2-3 times weekly with at least 48 hours between sessions, as full phototoxic reactions may not manifest until 48 hours post-exposure. 2, 1

Clearance Phase Dose Escalation

For Skin Types I, II, III:

  • Increase UVA by up to 1.0 J/cm² per treatment based on response
  • Hold dose constant if erythema develops until resolution 1

For Skin Types IV, V, VI:

  • Increase UVA by up to 1.5 J/cm² per treatment unless erythema occurs
  • If erythema develops, follow Type I-III protocols 1

For Erythrodermic Psoriasis:

  • Treat as Type I patient (maximum 1.0 J/cm² increases) due to difficulty assessing treatment-related erythema against baseline erythema 1

Non-Response Protocol

After 10 treatments without response: Increase UVA by an additional 0.5-1.0 J/cm² above the standard incremental increases. 1

After 15 treatments with minimal/no response: Increase methoxsalen dose by 10 mg (one-time only). This increased dose may continue for the remainder of treatment but should not be exceeded. 1

Missed Treatment Adjustments

  • One missed treatment: Do not increase UVA exposure at next session
  • Multiple missed treatments: Reduce exposure by 0.5 J/cm² for each treatment missed 1

Topical PUVA Alternatives

Topical Application Method

For palmar-plantar psoriasis: Apply 0.1% 8-methoxypsoralen in emollient 30 minutes before UVA, treating 2-3 times weekly. Start at 0.25-0.5 J/cm² and increase by 0.25-0.5 J/cm² per session. 2

Bath PUVA Method

For generalized psoriasis (adults and children): Use 50 mg of 8-methoxypsoralen in 100 L of water with 20-30 minute pre-exposure immersion. Follow similar scheduling to oral PUVA. 2

A higher concentration (5 mg/L methoxsalen) is substantially more effective than 1 mg/L, achieving 87% reduction in PASI scores versus 72%, with median cumulative UVA dose of 25.4 J/cm² versus 71.9 J/cm² respectively. 3 However, mild-to-moderate adverse events are more common with the higher concentration. 3

Maintenance Phase Protocol

Once 95% clearing (Grade 4 response) is achieved, transition to sequential maintenance schedules:

  • M1: Once weekly
  • M2: Once every 2 weeks
  • M3: Once every 3 weeks
  • M4: As needed for flares 1

Each maintenance schedule should be maintained for at least 2 treatments before advancing. 1 Remission times typically range from 3-12 months. 2

Maximum Maintenance Doses by Skin Type

To prevent cumulative photocarcinogenesis risk, maximum UVA dosages during maintenance should not exceed:

  • Type I: 12 J/cm²/treatment
  • Type II: 14 J/cm²/treatment
  • Type III: 18 J/cm²/treatment
  • Type IV: 22 J/cm²/treatment 1

Critical Safety Monitoring

Absolute Contraindications

Do not use PUVA in patients with:

  • Lupus erythematosus
  • Porphyria
  • Xeroderma pigmentosum 2

High-Risk Populations Requiring Extreme Caution

  • Skin types I-II (burn easily)
  • History of arsenic exposure or ionizing radiation
  • History of melanoma or multiple non-melanoma skin cancers
  • Severe liver disease (risk of toxic psoralen levels)
  • Prior cyclosporine or methotrexate treatment
  • Pregnancy or nursing 2

Photocarcinogenesis Risk

Caucasians with skin types I-III face significantly increased risk of squamous cell carcinoma after 200 treatments or 2000 J/cm² cumulative exposure. 2 A 14-fold increased incidence of SCC occurs with high-dose PUVA (≥200 treatments) compared to low-dose (<100 treatments). 2 This risk is not present in non-Caucasian populations. 2

Male genitalia require shielding during all treatments due to particularly elevated SCC risk in this area. 2

Drug Interactions

If oral retinoids are initiated during PUVA therapy, decrease UVA dose by one-third. 2 Exercise caution with any photosensitizing medications. 2

Eye Protection Requirements

Patients must wear UVA-blocking eyewear during treatment and for the remainder of the day after psoralen ingestion. 2 However, a 25-year prospective study found no increased risk of cataract formation with proper eye protection compliance. 2

Nursing is contraindicated for 24 hours after psoralen ingestion. 2

Expected Treatment Course

Typical response occurs within 1 month of treatment initiation. 2 A single course usually requires 30-40 treatments for clearance, though noticeable response may take 30 treatments. 2 Historical data from 1,308 patients showed 88% clearance rate with oral PUVA. 4

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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