Lutetium Lu 177 dotatate

What is Lutetium Lu 177 dotatate?

• Lutetium Lu 177 dotatate (LUTATHERA) is a radiolabeled somatostatin analog used in the treatment of cancers which express somatostatin receptors.

What are the uses of this medicine?

This medicine is used for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

How does this medicine work?

• Lutetium Lu 177 dotatate binds to somatostatin receptors with highest affinity for subtype 2 receptors (SSRT2).
• Upon binding to somatostatin receptor expressing cells, including malignant somatostatin receptor-positive tumors, the compound is internalized.
• The beta emission from Lu 177 induces cellular damage by formation of free radicals in somatostatin receptor-positive cells and in neighboring cells.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each LUTATHERA dose. Avoid repeated administration of high-doses of glucocorticosteroids during treatment with LUTATHERA.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

• Verify pregnancy status of females of reproductive potential prior to initiating LUTATHERA.

Recommended Dosage

• The recommended LUTATHERA dosage is 7.4 GBq (200 mCi) every 8 weeks for a total of 4 doses.

Premedication and Concomitant Medications

• Administer long-acting octreotide 30 mg intramuscularly 4 to 24 hours after each LUTATHERA dose and short-acting octreotide for symptomatic management.
• Continue long-acting octreotide 30 mg intramuscularly every 4 weeks after completing LUTATHERA until disease progression or for up to 18 months following treatment initiation.
• Administer antiemetics before recommended amino acid solution.
• Initiate recommended intravenous amino acid solution 30 minutes before LUTATHERA infusion; continue during and for 3 hours after LUTATHERA infusion. Do not reduce dose of amino acid solution if LUTATHERA dose is reduced.

Administration

• Use aseptic technique and radiation shielding when administering the LUTATHERA solution. Use tongs when handling vial to minimize radiation exposure.
• Do not inject LUTATHERA directly into any other intravenous solution.
• Confirm the amount of radioactivity of LUTATHERA in the radiopharmaceutical vial with an appropriate dose calibrator prior to and after LUTATHERA administration.
• Inspect the product visually for particulate matter and discoloration prior to administration under a shielded screen.
• Discard vial if particulates or discoloration are present.
• Dispose of any unused medicinal product or waste material in accordance with local and federal laws.
• The gravity method or infusion pump method may be used for administration of the recommended dosage.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 370 MBq/mL (10 mCi/mL) in single-dose vial.

This medicine is available in fallowing brand namesː

• LUTATHERA

What side effects can this medication cause?

The most common side effects of this medicine include:

• lymphopenia
• increased GGT
• vomiting
• nausea
• increased AST
• increased ALT
• hyperglycemia
• hypokalemia

What special precautions should I follow?

• LUTATHERA contributes to a patient’s overall long-term radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Minimize radiation exposure during and after treatment with LUTATHERA consistent with institutional good radiation safety practices and patient management procedures.
• Myelosuppression occurred more frequently in patients receiving LUTATHERA. Monitor blood cell counts. Withhold, reduce dose, or permanently discontinue based on severity.
• Advise patients of the potential for secondary cancers, including myelodysplastic syndrome and acute leukemia.
• Advise patients to hydrate and urinate frequently during and after administration of LUTATHERA. Monitor serum creatinine and calculated creatinine clearance. Withhold, reduce dose, or permanently discontinue based on severity.
• This medicine may cause hepatotoxicity. Monitor transaminases, bilirubin and albumin.
• Advise patients to contact their health care provider for signs or symptoms that may occur following tumor-hormone release, including severe flushing, diarrhea, bronchospasm, and hypotension.
• This medicine Can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus and to use effective contraception.
• LUTATHERA may cause infertility.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action, LUTATHERA can cause fetal harm .
• There are no available data on LUTATHERA use in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of LUTATHERA have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• LUTETIUM OXODOTREOTIDE LU-177

Inactive ingredients:

• ACETIC ACID
• SODIUM ACETATE
• GENTISIC ACID
• SODIUM HYDROXIDE
• PENTETIC ACID
• SODIUM CHLORIDE
• ASCORBIC ACID
• WATER

Who manufactures and distributes this medicine?

• Packager: Advanced Accelerator Applications USA, Inc

What should I know about storage and disposal of this medication?

• Store below 25 °C (77 °F).
• Do not freeze LUTATHERA.
• Store in the original package to protect from ionizing radiation.
• The shelf life is 72 hours.
• Discard appropriately at 72 hours.

• Dailymed label info on Lutetium Lu 177 dotatate
• FDA Lutetium Lu 177 dotatate

Lutetium Lu 177 dotatate Resources
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