Lutetium Lu 177-dotatate

What is Lutetium Lu 177-dotatate?

• Lutetium Lu 177-dotatate (Lutathera) is a radiolabeled somatostatin analog used to treat gastroenteropancreatic neuroendocrine tumors that are somatostatin receptor positive.
• These tumors form from cells that release hormones and can occur in the stomach, small and large intestines, rectum, and pancreas.
• Lutetium Lu 177-dotatate is also being studied in the treatment of other types of cancer.

Lutetium (177Lu) oxodotreotide

What are the uses of this medicine?

• Lutetium Lu 177-dotatate (Lutathera) 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?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take.
• 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?

• Lutetium Lu 177 dotatate was approved in the United States for the treatment of SSTR positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut and hindgut neuroendocrine tumors in adults, in January 2018.

How should this medicine be used?

• Verify pregnancy status of females of reproductive potential prior to initiating Lutathera.
• Administer antiemetics before recommended amino acid solution.
• Initiate recommended intravenous amino acid solution 30 minutes before Lutathera infusion; continue during and for at least 3 hours after Lutathera infusion. Do not decrease dose of amino acid solution if Lutathera dose is reduced.

Recommended dosage:

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

Administration:

• 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 with long-acting octreotide compared to patients receiving high-dose long-acting octreotide. Monitor blood cell counts. Withhold, reduce dose, or permanently discontinue based on severity.
• Secondary Myelodysplastic Syndrome and Leukemia may occur. Median time to onset of MDS is 29 months; acute leukemia is 55 months.
• Patients had underlying renal impairment or risk factors for renal failure (e.g., diabetes or hypertension) and required dialysis. Advise patients to urinate frequently during and after administration of Lutathera. Monitor serum creatinine and calculated creatinine clearance. Withhold, reduce dose, or permanently discontinue based on severity.
• Monitor transaminases, bilirubin and serum albumin. Withhold, reduce dose, or permanently discontinue Lutathera based on severity of hepatotoxicity.
• Hypersensitivity reactions, including angioedema, occurred in patients treated with Lutathera. Monitor patients closely for signs and symptoms of hypersensitivity reactions, including anaphylaxis. Permanently discontinue Lutathera based on severity.
• Neuroendocrine hormonal crises, manifesting with flushing, diarrhea, bronchospasm and hypotension, occurred in patients in ERASMUS and typically occurred during or within 24 hours following the initial Lutathera dose. Monitor for flushing, diarrhea, hypotension, bronchoconstriction or other signs and symptoms.
• Lutathera 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 in males and females.

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 when administered to a pregnant woman.
• 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?

Distributed by:

• Advanced Accelerator Applications USA, Inc., NJ
• Lutathera® is a registered trademark of Novartis AG and/or its affiliates.

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

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