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

$881.99$792.99

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 [email protected], 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
Buy more Save More! Just change the quan
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
Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

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

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

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