Gleolan

What is Gleolan?

Gleolani s used in people with a type of brain tumor to help see the tumor better during surgery.

Description

Gleolan (aminolevulinic acid hydrochloride) is an optical imaging agent for oral solution. The 50-mL, clear vial contains 1,500 mg of lyophilized aminolevulinic acid hydrochloride powder (equivalent to 1,170 mg aminolevulinic acid). After reconstitution, the product has a concentration of 30 mg aminolevulinic acid hydrochloride per mL (equivalent to 23.4 mg aminolevulinic acid per mL). The chemical name is 5-amino-4-oxo-pentanoic acid hydrochloride. The chemical formula for aminolevulinic acid hydrochloride is C5H10ClNO3. Its molecular weight is 167.59 g/mol with the following structural formula:

Before taking Gleolan, tell your doctor:

• If you are allergic to porphyrins.
• If you are allergic to Gleolan; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have porphyria.
• If you are taking any drugs that may make your skin more sensitive to light. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Gleolan with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Gleolan?

• Tell all of your health care providers that you take Gleolan. This includes your doctors, nurses, pharmacists, and dentists.
• Your skin may be more sensitive to light after treatment with Gleolan. Follow what your doctor has told you to do with regard to sunlight and room lights.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Gleolan.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Gleolan while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Gleolan best taken?

Use Gleolan as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take by mouth only.
• Your doctor will give Gleolan.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Gleolan that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Fever.
• Change in speech.
• Weakness on 1 side of the body.

What are some other side effects of Gleolan?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Gleolan?

• If you need to store Gleolan at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

• NDC 59137-231-01
  Rx only
• Gleolan®
  (aminolevulinic
  acid hydrochloride)
• for oral solution
• 1,500 mg
• Reconstitute Prior To Use.
• For Oral Use Only
• SINGLE-DOSE VIAL.
• Discard Unused Portion
• One Vial
• MEDEXUS
  PHARMA

Patient Counseling

Advise patients that they may experience elevated liver enzymes (ALT and GGT) within the first week after surgery. This elevation may persist after 6 weeks.

Advise patients to reduce exposure to sunlight or room lights for 48 hours after administration of Gleolan due to risk of phototoxic reactions.