LUTATHERA- lutetium lu 177 dotatate injection

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

LUTETIUM OXODOTREOTIDE LU-177 (UNII: AE221IM3BB) (LUTETIUM OXODOTREOTIDE LU-177 - UNII:AE221IM3BB)

Inapatikana kutoka:

Advanced Accelerator Applications USA, Inc

INN (Jina la Kimataifa):

LUTETIUM OXODOTREOTIDE LU-177

Tungo:

LUTETIUM OXODOTREOTIDE LU-177 10 mCi in 1 mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

LUTATHERA is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. None. Risk Summary Based on its mechanism of action, LUTATHERA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data on LUTATHERA use in pregnant women. No animal studies using lutetium Lu 177 dotatate have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, radioactive emissions, including those from LUTATHERA, can cause fetal harm. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary There are no data on the presence of lutetium Lu 177 dotatate in human milk, or its effects on the breastfed child or

Bidhaa muhtasari:

LUTATHERA Injection containing 370 MBq/mL (10 mCi/mL) of lutetium Lu 177 dotatate is a sterile, preservative-free and clear, colorless to slightly yellow solution for intravenous use supplied in a clear, colorless Type I glass 30 mL single-dose vial containing 7.4 GBq (200 mCi) ± 10% of lutetium Lu 177 dotatate at the time of injection (NDC# 69488-003-01). The solution volume in the vial ranges between 20.5 to 25 mL to provide a total of 7.4 GBq (200 mCi) of radioactivity. The product vial is enclosed within a lead shielded container (NDC# 69488-003-01) placed in a plastic sealed container. The product is shipped in a Type A package (NDC# 69488-003-70). Store below 25°C (77°F). Do not freeze LUTATHERA. Store in the original package to protect from ionizing radiation (lead shielding). The shelf life is 72 hours from the date and time of calibration. Discard appropriately at 72 hours.

Idhini hali ya:

New Drug Application

Tabia za bidhaa

LUTATHERA- LUTETIUM LU 177 DOTATATE INJECTION
ADVANCED ACCELERATOR APPLICATIONS USA, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LUTATHERA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LUTATHERA.
LUTATHERA (LUTETIUM LU 177 DOTATATE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2018
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.3, 2.4, 2.5, 2.6)
6/2022
Dosage and Administration (2.2, 2.3, 2.4, 2.5)
3/2023
Warnings and Precautions (5.3, 5.5, 5.6, 5.8)
6/2022
Warnings and Precautions (5.2, 5.4, 5.5)
3/2023
INDICATIONS AND USAGE
LUTATHERA is a radiolabeled somatostatin analog indicated for the
treatment of somatostatin receptor-
positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs),
including foregut, midgut, and
hindgut neuroendocrine tumors in adults. (1)
DOSAGE AND ADMINISTRATION
Verify pregnancy status of females of reproductive potential prior to
initiating LUTATHERA. (2.1)
Administer 7.4 GBq (200 mCi) every 8 weeks (± 1 week) for a total of
4 doses. (2.2)
Administer long-acting octreotide 30 mg intramuscularly 4 to 24 hours
after each LUTATHERA dose and
short-acting octreotide for symptomatic management. (2.3)
Continue long-acting octreotide 30 mg intramuscularly every 4 weeks
after completing LUTATHERA until
disease progression or for 18 months following treatment initiation.
(2.3)
Administer antiemetics before recommended amino acid solution. (2.3)
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. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 370 MBq/mL (10 mCi/mL) in single-dose vial. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Risk From Radiation Exposure: Minimize radiation exposure during and
after treatment with LUTATHERA
consistent with institutional good radiation safety practices and
patient ma