ALAONCO 1.5g Granules

What is ALAONCO 1.5g

ALAONCO is a prescription‑only (POM) medicinal product comprising **1.5 g of 5‑Aminolevulinic Acid Hydrochloride (5‑ALA HCl)** in granule form, produced by SBI Neopharma. Each single‑use sachet is designed for oral reconstitution prior to administration.

• Therapeutic use: Employed as a **photosensitising agent** in **photodynamic therapy (PDT)** or fluorescence-guided procedures for dermatological and oncological indications :contentReference[oaicite:1]{index=1}.
• Primary indications include: Treatment of minimally to moderately thick actinic keratoses on the face or scalp under blue light PDT; and visualization of malignant tissues—e.g., in bladder cancer or gliomas—via fluorescence-guided resection :contentReference[oaicite:2]{index=2}.
• Pharmacological class: A porphyrin precursor that increases **protoporphyrin IX (PpIX)** levels in targeted tissues, acting as a prodrug in PDT :contentReference[oaicite:3]{index=3}.
• Clinical approval: Approved for dermatologic PDT in the UAE and similar formulations (e.g., Gliolan, Alaglio) are approved in the EU and Japan for tumor visualization during surgery :contentReference[oaicite:4]{index=4}.
• Dosage form benefits: Single-dose granule sachet ensures consistent dosing, precise administration, and aligns with scheduled treatment protocols.

How to use ALAONCO 1.5g

Proper use of ALAONCO optimizes photosensitisation and minimizes adverse effects. Below is a general, structured protocol:

• Reconstitution: Dissolve the entire 1.5 g sachet in a glass of water (typically ~100 mL) according to local product guidelines.
• Timing before procedure:
  • For dermatologic PDT: Administer 14–18 hours before blue light exposure (per local protocol).
  • For tumor visualization (e.g., bladder cancer or glioma): Administer typically **2–8 hours** before procedure :contentReference[oaicite:5]{index=5}.
• With or Without Food: Can be taken irrespective of meals; water-based hydration aids absorption.
• Pre-treatment precautions: Shield eyes and skin from strong light sources post-dose; avoid bright indoor and outdoor light for up to 24 hours :contentReference[oaicite:6]{index=6}.
• Hydration: Encourage fluid intake to facilitate renal excretion of excess ALA or PpIX.
• Compliance: Single-dose regimen aids adherence and avoids dosing errors relative to multi-step treatments.
• Missed dose: If planned procedure is delayed beyond 12 hours, administer a fresh dose **2–4 hours** before rescheduled time; do *not* redose beyond that window :contentReference[oaicite:7]{index=7}.

Mode of Action ALAONCO 1.5g

ALAONCO acts by selectively localizing phototoxic protoporphyrin IX (PpIX) in diseased tissues:

• 5‑ALA → PpIX biosynthesis: Orally administered ALA is metabolized through the **heme biosynthesis pathway**, where it is converted to PpIX in epithelial or neoplastic cells :contentReference[oaicite:8]{index=8}.
• PpIX accumulation: Cancerous or dysplastic cells have reduced ferrochelatase activity, leading to **preferential accumulation of PpIX** compared to normal tissue :contentReference[oaicite:9]{index=9}.
• Light absorption: PpIX absorbs specific wavelengths (e.g., 410 nm violet-blue, 630 nm red), entering an excited state.
• Reactive oxygen generation: Excited PpIX transfers energy to oxygen, producing **singlet oxygen** and ROS that destroy cellular components and vasculature, inducing targeted cell death :contentReference[oaicite:10]{index=10}.
• Dual clinical effect:
  • In PDT: Enables selective cytotoxicity of superficial lesions (e.g., actinic keratosis).
  • In fluorescence-guided surgery: PpIX fluorescence delineates tumor margins for enhanced surgical resection accuracy :contentReference[oaicite:11]{index=11}.
• Endogenous metabolic pathway: Aligns with normal heme synthesis, allowing rapid clearance and reduced systemic toxicity :contentReference[oaicite:12]{index=12}.

ALAONCO 1.5g Interactions ALAONCO 1.5g

Being a metabolic precursor rather than a classic drug, ALAONCO’s interaction profile is distinct:

• Photosensitizing agents: Co-administration with other photosensitisers—such as tetracyclines, sulfonamides, fluoroquinolones, or St. John’s wort—can amplify photosensitivity. Avoid for at least **2 weeks** post-treatment :contentReference[oaicite:13]{index=13}.
• Hepatotoxic medications: Concurrent hepatotoxic drugs during the 24‑hour post-dose window may potentiate liver injury risk; monitoring is advised :contentReference[oaicite:14]{index=14}.
• Porphyria concern: Contraindicated with porphyrin pathway disorders; may provoke acute attacks :contentReference[oaicite:15]{index=15}.
• Photosensitizing supplements: Avoid co-use with herbal extracts like hypericin that may increase photoreactivity :contentReference[oaicite:16]{index=16}.
• Light therapy devices: Strict adherence to timing protocols is essential; improper light timing may reduce efficacy or cause unintended tissue damage.

Dosage of ALAONCO 1.5g

Dosage depends on indication, patient weight, and timing requirements:

• Dermatologic PDT: A single **1.5 g sachet**, administered ~14–18 hours before blue light exposure, per approved local protocols :contentReference[oaicite:17]{index=17}.
• Bladder cancer visualization: Japan’s Alaglio regimen: **20 mg/kg orally (approx. 1.5 g)**, 2–8 hours prior to cystoscopy or TURBT :contentReference[oaicite:18]{index=18}.
• Glioma fluorescence (Gliolan): ~20 mg/kg administered 2–4 hours before induction of anesthesia :contentReference[oaicite:19]{index=19}.
• Pediatric use: Not established; current use is limited to adults :contentReference[oaicite:20]{index=20}.
• Renal/hepatic impairment: No formal dose adjustments established; use caution and monitor patients closely :contentReference[oaicite:21]{index=21}.
• Missed or delayed procedure: If >12 hours elapse, repeat dose 2–4 hours before rescheduled exposure; do **not** double the dose :contentReference[oaicite:22]{index=22}.

Possible side effects of ALAONCO 1.5g

Adverse effects primarily arise from phototoxicity and metabolic changes in porphyrin pathways:

• Photosensitivity reactions (very common): Burning or stinging sensations on exposed skin or eyes upon light exposure—avoid strong light for 24 hours post-dose :contentReference[oaicite:23]{index=23}.
• Gastrointestinal discomfort: Nausea, abdominal pain, diarrhea—generally mild, managed symptomatically.
• Headache/dizziness: Frequently reported; ensure hydration and rest.
• Hypotension: Transient drops in blood pressure may occur—monitor in patients with cardiovascular conditions :contentReference[oaicite:24]{index=24}.
• Allergic reactions: Rare rash or urticaria; treat as needed and consider discontinuation if severe.
• Liver enzyme elevations: Mild transaminase rises possible; monitor during the peri-dosing period.
• Serious reactions: Rare photosensitivity burns or ocular injury from premature light exposure—ensure patient education and adherence to light avoidance protocol.

ALAONCO 1.5g Contraindications ALAONCO 1.5g

Contraindications include:

• Hypersensitivity: To ALA, PpIX precursors, porphyrins, or excipients.
• Porphyria (acute or chronic): Contraindicated due to risk of triggering porphyrin pathway crises :contentReference[oaicite:25]{index=25}.
• Pediatric use (<18 years): Not established for children and adolescents :contentReference[oaicite:26]{index=26}.
• Pregnancy: Not recommended—animal studies show embryo/fetal risk under light exposure; human safety unknown :contentReference[oaicite:27]{index=27}.
• Lactation: Unknown transfer of ALA/PpIX in milk—avoid breastfeeding for 24 hours post-dose :contentReference[oaicite:28]{index=28}.
• Severe renal or hepatic impairment: Caution advised due to unknown pharmacokinetics; use only if benefits outweigh risks :contentReference[oaicite:29]{index=29}.

Storage of ALAONCO 1.5g

• Temperature: Store between 2–25 °C (36–77 °F); avoid excessive heat or freezing.
• Humidity and light protection: Keep sachets in original sealed packaging to protect from moisture and light.
• Expiry: Use before the printed expiration date; expired product may lose efficacy or stability.
• Post-opening: Open only immediately before reconstitution; discard unused granules.
• Children safety: Store out of reach to prevent accidental ingestion.
• Disposal: Follow local drug disposal regulations; do not dispose via sink or toilet to avoid environmental contamination.