Ordering

Gleolan (aminolevulinic acid HCl) Authorized Distribution Network

NX Development Corp. (NXDC) Distribution offers easy ordering by email, fax, or phone.

NXDC 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.

Is your center interested in ordering Gleolan for the first time?

Gleolan Ordering Information:
Item Order Number Telephone Fax Email
71469-0231-01 1-833-GLEOLAN
(453-6526)
1-833-471-3382 orders@nxdevcorp.com

Gleolan Ordering Information:

NDC: 71469-231-01

Supplied: 1,500 mg/50 mL Vial

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

Terms: Contact NXDC 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 NXDC. The dispensing pharmacist must confirm that the requesting neurosurgeon is an Approved User prior to Gleolan being ordered.

 

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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