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Rx Item-Lutathera Lutetium Lu 177 Dotatate Inj SDV Vial by Advanced Accelerator

Lutathera (lutetium Lu 177 dotatate) for the Treatment of Gastroenteropancreatic Neuroendocrine TumoursAvion Pharmaceuticals LlcOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.NDC No.69488-003-01 69488-0003-01 UPC/GTIN No..369488003010 MPN 301 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, Np, Optometrist, PharmacistGeneric Name:	LEVONORGEST/ETH.ESTRADIOL/IRON	
Description:	BALCOLTRA TB 0.1-0.02-36.5MG 3X28	
NDC:	75854-0602-03	75854-602-03 75854060203 7585460203 
UPC:	375854-602039

Rx Item-Lutathera Lutetium Lu 177 Dotatate Inj SDV Vial by Advanced Accelerator

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Lutathera Lutetium Lu 177 Dotatate Inj SDV Vial by Advanced Accelerator NDC No.69488-003-01 69488-0003-01 6948800301 69488000301 UPC/GTIN No..369488003010 3-69488-00301-0 369488-003010 MPN 301 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, Np, Optometrist, Pharmacist, Pa, Physical Therapist, Podiatrist, Research Co., Uni., Va, Vet & Wholesalers In Scope Of Practice Can Order This Rx Item. Rx Item No.Rx744488 Rx Item-Lutathera Lutetium L

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For: Gastroenteropancreatic Neuroendocrine Tumors

Lutathera (lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. 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
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 in females of reproductive potential prior to initiating LUTATHERA. ( 2.1)
Administer 7.4 GBq (200 mCi) every 8 weeks 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 up to 18 months following treatment initiation. ( 2.3)
Premedicate with antiemetics 30 minutes before recommended amino acid solution. ( 2.3)
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. ( 2.3)
Modify LUTATHERA dose based on adverse reactions. ( 2.4)
Prepare and administer as recommended. ( 2.5)
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 management procedures ( 2.1, 5.1)
Myelosuppression: Monitor blood cell counts. Withhold, reduce dose, or permanently discontinue based on severity. ( 2.4, 5.2)
Secondary Myelodysplastic Syndrome (MDS) and Leukemia: Median time to development: MDS is 28 months; acute leukemia is 55 months. ( 5.3)
Renal Toxicity: 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. ( 2.3, 2.4, 5.4)
Hepatotoxicity: Monitor transaminases, bilirubin and albumin. Withhold, reduce dose, or permanently discontinue based on severity. ( 2.4, 5.5)
Neuroendocrine Hormonal Crisis: Monitor for flushing, diarrhea, hypotension, bronchoconstriction or other signs and symptoms. ( 5.6)
Embryo-Fetal Toxicity: LUTATHERA can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus and to use effective contraception ( 5.7, 8.1, 8.3)
Risk of Infertility: LUTATHERA may cause infertility. ( 8.3)
ADVERSE REACTIONS
Most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in LUTATHERA arm) are lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia and hypokalemia. ( 6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Advanced Accelerator Applications USA, Inc. at 1-844-863-1930 or us-pharmacovigilance@adacap.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
Somatostatin Analogs: Discontinue long-acting analogs for at least 4 weeks and short-acting octreotide at least 24 hours prior to each LUTATHERA dose. ( 2.3, 7.1)

USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. ( 8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2018

Lutathera (lutetium Lu 177 dotatate) for the Treatment of Gastroenteropancreatic Neuroendocrine Tumours
Lutathera
Lutathera (lutetium Lu 177 dotatate) for the Treatment of Gastroenteropancreatic Neuroendocrine Tumours

Avion Pharmaceuticals Llc
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Avion Pharmaceuticals Llc

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
HYDROCORTISONE/LIDOCAINE/
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

NDC No.69488-003-01 69488-0003-01 UPC/GTIN No..369488003010 MPN 301 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, Np, Optometrist, Pharmacist
Lutathera
NDC No.69488-003-01 69488-0003-01 UPC/GTIN No..369488003010 MPN 301 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, Np, Optometrist, Pharmacist

Generic Name:	LEVONORGEST/ETH.ESTRADIOL/IRON	
Description:	BALCOLTRA TB 0.1-0.02-36.5MG 3X28	
NDC:	75854-0602-03	75854-602-03 75854060203 7585460203 
UPC:	375854-602039
BALCOLTRA TAB 3X28 BP by Avion
Generic Name: LEVONORGEST/ETH.ESTRADIOL/IRON Description: BALCOLTRA TB 0.1-0.02-36.5MG 3X28 NDC: 75854-0602-03 75854-602-03 75854060203 7585460203 UPC: 375854-602039