Ordering

Gleolan™ Authorized Distribution Network NX Development Corp. Distribution offers easy ordering of Gleolan™ by email, fax or phone.

NX Development Corp. 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.

Gleolan is available on 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 and updated by NX Development Corp.

The dispensing pharmacist must confirm that the requesting neurosurgeon is a Gleolan Approved User prior to ordering.

Ordering Information

Item Order Number71469-231-01
Telephone1-833-GLEOLAN (453-6526)
Fax1-833-471-3382
Emailorders@nxdevcorp.com

NDC: 71469-231-01

Supplied: 1,500 mg of lyophilized ALA HCl powder (equivalent to 1,170 mg ALA), for oral solution in a 50-mL glass vial

Hours of Operation: 9:00 AM to 6:00 PM ET

Product Pricing: $2,789.00/Vial

Terms: Contact NX Development Corp. for more information.Order Policy: Minimum order quantity is 2 vials. Note any patient greater than 75kg (165 lbs) requires at least two (2) vials.

Medical Information Request Form

  1. Please complete all required fields (*).
  2. Include only one healthcare professional’s inquiry per form.

Please note that any requests for published literature or journal reprints may fall under the physician payment reporting provisions of Patient Protection and Affordable Care Act of 2010 (the “Sunshine Provisions”) or other applicable state laws. These provisions require that all applicable manufacturers track and report to the Centers for Medicare and Medicaid Services (CMS) or applicable state agency, all transfers of value to U.S. Physicians, specifically including the value or journal reprints.


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Important Safety Information

Contraindications

Do not use Gleolan in patients with:

  • hypersensitivity to aminolevulinic acid (ALA) or porphyrins
  • acute or chronic types of porphyria

Warnings and Precautions

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

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.

Drug-Drug Interactions

See information under Warnings and Precautions regarding phototoxic reactions.

Please see Full Prescribing Information

For medical inquires, please fill out our Medical Information Request Form.

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Important Safety Information

Contraindications

Do not use Gleolan in patients with:

  • hypersensitivity to aminolevulinic acid (ALA) or porphyrins
  • acute or chronic types of porphyria

Warnings and Precautions

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

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.

Drug-Drug Interactions

See information under Warnings and Precautions regarding phototoxic reactions.

Please see Full Prescribing Information

For medical inquires, please fill out our Medical Information Request Form.

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