Gleolan (aminolevulinic acid HCl) Authorized Distribution Network
Medexus Pharma, Inc. Distribution offers easy ordering by email, fax, or phone.
Medexus Pharma, Inc. recommends pharmacies maintain a minimum two (2) vial inventory as patients weighing over 75 kg will require more than one vial to complete a procedure.
All orders are shipped via overnight service with free shipping upon ordering of ten (10) vials.
|Gleolan Ordering Information:|
|Item Order Number||Telephone||Fax|
59137-231-01 or 59137-0231-01
Gleolan Ordering Information:
NDC: 59137-231-01 or 59137-0231-01
Supplied: 1,500 mg/50 mL Vial
Hours of Operation: 9:00 AM to 6:00 PM ET
Terms: Contact Medexus Pharma, Inc. for more information
Order Policy: Minimum order quantity is 2 vials
Gleolan is available to order for delivery to centers from which at least one neurosurgeon has successfully completed the Gleolan Neurosurgeon Training Program and is on the current Gleolan Approved User List. The Gleolan Approved User List is maintained, monitored, and updated by Medexus Pharma, Inc. The dispensing pharmacist must confirm that the requesting neurosurgeon is an Approved User prior to Gleolan being ordered.
Do not use Gleolan in patients with:
Due to the risk of phototoxic reactions, do not administer phototoxic drugs and topical preparations containing ALA for 24 hours during the perioperative period. Reduce exposure to sunlight or room lights for 48 hours after administration of Gleolan.
Errors may occur with the use of Gleolan 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 seen in areas of inflammation or metastases from other tumor types.
Hypersensitivity reactions, including serious hypersensitivity reactions have occurred; these reactions include anaphylactic shock, swelling, and urticaria. Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions.
Adverse reactions occurring in >1% of patients in the week following surgery were pyrexia, hypotension, nausea, and vomiting.
Nervous system disorders occurred in 29% of patients within the first week after surgery and events occurring in >1% of patients included: aphasia (8%), hemiparesis (7.8%), hemianopsia (3.2%), headache (2.7%), seizure (1.9%), hemiplegia (1.9%), monoparesis (1.3%) and hypoesthesia (1.1%). Brain edema occurred in <1% of patients in the first 6 weeks after surgery. In a randomized clinical trial, the numbers of serious neurologic adverse events in the post operative period were higher in patients randomized to ALA fluorescence arm compared to the control arm. An imbalance was notable for the adverse events aphasia, ataxia, convulsion and hemianopsia and is likely related to the higher amount of brain resection performed in the ALA arm. At longer follow up periods, the numbers between the two arms appeared similar.
Worsening of >2 Common Toxicity Criteria grades in alanine aminotransferase and gamma-glutamyl transferase occurred in 15.8% and 11.6% of patients, respectively, within the first week after surgery. Absolute levels ranged from 2 times to greater than 10 times the upper limit of normal for each parameter. At 6 weeks, these measurements remained elevated in 2.9% and 7.5% of patients, respectively. There were no cases of liver failure.
See information under Warnings and Precautions regarding phototoxic reactions.
Please see Full Prescribing Information
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