Aminolevulinic acid
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Patients with Renal Impairment Because approximately one third of the ALA dose is excreted in urine as parent drug, ALA clearance may be reduced in patients with renal impairment; it is not known if dose adjustment is needed [see Clinical Pharmacology ] .
Dosing in liver impairment
Patients with Hepatic Impairment The contribution of the liver to the elimination of ALA following Gleolan dosing is unknown. ALA clearance may be reduced in patients with hepatic impairment; it is not known if dose adjustment is needed [see Clinical Pharmacology ] .
Preparation and administration
Recommended Dose For oral use only The recommended oral dose of reconstituted Gleolan is 20 mg / kg body weight. More than 1 vial may be required.
Reconstitution of Gleolan Gleolan powder must be reconstituted prior to administration by a healthcare provider according to the following instructions: Determine the total number of vials needed to achieve the intended dose for the patient according to the equation below (rounded up to the nearest whole vial): # of vials = Patient Body Weight (kg) 75 kg / vial Completely remove the white cap and aluminum crimp seal from each vial.
Remove and retain the rubber stopper from the vial. Using an appropriate volumetric measuring device (e.g., flask, graduated cylinder, dosing syringe), measure 50 mL of drinking water and add to each vial containing 1,500 mg of Gleolan. Gently swirl the vial to completely dissolve the powder. The resulting reconstituted solution (30 mg of Gleolan per mL) is clear and colorless to slightly yellowish.
If required, replace the stopper and store reconstituted solution for up to 24 hours at room temperature prior to administration.
Gleolan Administration Gleolan is for ORAL USE ONLY. The reconstituted Gleolan solution is administered according to the following steps: Calculate the administration volume, in mL, to achieve the intended dose according to the following equation: Administration Volume (mL) = Patient Body Weight (kg) * 20 mg/kg 30 mg/mL Transfer the entire contents of the prepared vial(s) into an appropriate dosing container (e.g., oral medicine bottle); ensure the entire contents of the vials are transferred.
After transfer, discard the empty vial(s). Using a disposable volumetric syringe, remove the administration volume of reconstituted Gleolan solution from the dosing container and transfer to a separate oral dosing container. Discard unneeded volume of Gleolan solution. Administer orally 3 hours (range 2 to 4 hours) prior to induction of anesthesia.
| Administration Volume (mL) = | Patient Body Weight (kg) * 20 mg/kg |
| 30 mg/mL |
Drug interactions
Check aminolevulinic acid against a medication listLabel text (1 paragraph)
Phototoxic Drugs Patients exposed to a photosensitizing agent may experience a phototoxic skin reaction (severe sunburn). Due to the risk of possible phototoxic reactions, avoid administering phototoxic drugs such as St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines, and topical preparations containing ALA for 24 hours before and after administration of Gleolan.
Contraindications
Hypersensitivity to the aminolevulinic acid (ALA) or porphyrins. [see Warnings and Precautions (5.3) ] Acute or chronic types of porphyria, due to potential ineffectiveness of the drug in these patients. Hypersensitivity to aminolevulinic acid (ALA) or porphyrins. ( 4 , 5.3 , 6.2 ) Acute or chronic types of porphyria. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available human data on Gleolan in pregnant women to inform a drug associated risk of adverse developmental outcomes. In animal reproduction studies, no adverse developmental effects were observed with oral ALA HCl administration to pregnant rabbits during organogenesis at doses 3 times the maximum recommended human oral dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Animal data ALA HCl was administered to rabbits at oral doses of 15, 50 and 150 mg/kg/day [approximately 0.1, 0.6, and 3 times the maximum human recommended dose (MHRD), respectively based on AUC comparisons] from gestation days 6-18. The no-observed-adverse-effect level (NOAEL) for maternal toxicity was 50 mg/kg/day and the NOAEL for embryo-fetal developmental toxicity was 150 mg/kg/day.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.