Version May 2024
Glioma (optical imaging agent): Oral: 20 mg/kg administered 3 hours (range: 2 to 4 hours) prior to the start of anesthesia.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling. Clearance may be reduced in patients with renal impairment; approximately one-third of a dose is excreted unchanged in the urine, however, it is not known if dosage adjustment is necessary.
There are no dosage adjustments provided in the manufacturer's labeling. Clearance may be reduced in patients with hepatic impairment, however, it is not known if dosage adjustment is necessary.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Aphasia (8%), hemiparesis (8%), headache (3%), hemiplegia (2%), seizure (2%), hypoesthesia (1%)
Endocrine & metabolic: Increased gamma-glutamyl transferase (grade ≥2: 8% to 12%)
Gastrointestinal: Nausea (>1%), vomiting (>1%)
Hepatic: Increased serum ALT (grade ≥2: 3% to 16%)
Neuromuscular & skeletal: Monoplegia (1%)
Ophthalmic: Hemianopia (3%)
Miscellaneous: Fever (>1%)
Frequency not defined:
Cardiovascular: Hypotension
Central nervous system: Ataxia
<1%, postmarketing, and/or case reports: Abnormal hepatic function tests, anaphylactic shock, angioedema, cerebral edema, chills, diarrhea, erythema, fixed drug eruption, metabolic acidosis, skin photosensitivity, solar dermatitis, urticaria
Hypersensitivity to aminolevulinic acid or any component of the formulation; hypersensitivity to porphyrins; acute or chronic types of porphyria
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions (including serious hypersensitivity) have occurred; these reactions include anaphylactic shock, swelling, and urticaria. Cardiopulmonary resuscitation personnel and equipment should be readily available. Monitor all patients for hypersensitivity.
• Photosensitivity: Reduce exposure to sunlight or room lights for 48 hours postoperatively. Due to the risk of phototoxic reactions, do not administer other phototoxic medications for 24 hours before and after systemic aminolevulinic acid administration.
Other warnings/precautions:
• Appropriate use: Should only be used by neurosurgeons who have completed a training program on use of fluorescence in surgery. Aminolevulinic acid must be used with a standard surgical operating microscope adapted with a blue light emitting light source (power density 40 to 80 mW/cm2) and ancillary excitation and emission filters to visualize fluorescence excitation in the wavelength of 375 to 440 nm and for observation from 620 to 710 nm (filters transmit porphyrin fluorescence as red-violet, as well as a fraction of backscattered blue excitation light necessary for distinguishing nonfluorescing tissue).
• Misinterpretation: Errors may occur with the use of systemic aminolevulinic acid for intraoperative visualization of malignant glioma (including false negatives and false positives). Non-fluorescing tissue in the surgical field does not rule out the presence of tumor in patients with glioma. Fluorescence may be observed in areas of inflammation or metastases due to other tumor types.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Oral:
Gleolan: 1.5 g (1 ea)
No
Solution (reconstituted) (Gleolan Oral)
1.5 g (per each): $3,346.80
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Oral:
Gleolan: 1.5 g (1 ea)
For oral administration only. Must be reconstituted by a health care provider prior to administration (see Preparation for Administration). Administer 3 hours (range 2 to 4 hours) prior to the start of anesthesia.
Glioma (optical imaging agent): Adjunct for visualization of malignant tissue during surgery in patients with glioma (suspected WHO grades III or IV on preoperative imaging)
Aminolevulinic acid (systemic) may be confused with aminolevulinic acid (topical), methyl aminolevulinate.
For oral use only. Inadvertent intravenous injection could occur due to packaging in what looks like a parenteral vial (ISMP 2018).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Photosensitizing Agents: May enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Adverse events were not observed in animal reproduction studies.
It is not known if aminolevulinic acid (systemic) is present in breast milk. The manufacturer recommends breastfeeding women pump and discard breast milk for 24 hours (5 to 6 half-lives) after aminolevulinic acid (systemic) administration to decrease exposure to the breastfed infant.
Monitor for signs/symptoms of hypersensitivity reactions.
Aminolevulinic acid (ALA) occurs endogenously as a metabolite formed in the mitochondria from succinyl-CoA and glycine. Exogenous administration of systemic ALA leads to accumulation of the ALA metabolite, PpIX in tumor cells. During glioma surgery, systemic ALA is used in conjunction with an operating microscope adapted with a blue emitting light source (power density 40 to 80 mW/cm2) and filters for excitation light of wavelength 375 to 440 nm, and observation at wavelengths of 620 to 710 nm, allowing tumor tissue to be visualized as red fluorescence (tissue lacking sufficient PpIX concentrations appear blue).
Metabolism: Metabolized to PpIX (actual fraction of administered aminolevulinic acid [ALA] that is metabolized to PpIX is unknown).
Bioavailability: Oral: 100% (range: 78.5% to 131.2%)
Half-life elimination: Oral: ALA: 0.9 ± 1.2 hours (range: 0.8 to 1.3 hours); PpIX: 3.6 ± 1.8 hours (range: 1.2 to 7.8 hours)
Time to peak: Oral: 0.8 hours (range: 0.5 to 1 hour); PpIX: 4 hours (range: 1.2 to 7.8 hours)
Excretion: Urine (27% to 57%; as parent drug)
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