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RX ITEM-Trulicity Pen 0.75Mg 0.5 Inj 4X0.5Ml By Lilly Eli & Co

NDC 00002-1433-80 UPC/GTIN No.3-00021-43380-2 Mfg.Part No.143380BRAND: TRULICITY  NDC: 00002-1433-80,2143380 UPC: 3-00021-43380-2,300021433802 Lilly Eli & CoOnly 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.

RX ITEM-Trulicity Pen 0.75Mg 0.5 Inj 4X0.5Ml By Lilly Eli & Co

$911.28$859.99

item No.:RX351163 NDC No.2143380 UPC No.:300021433802 NDC No.00002-1433-80 UPC/GTIN No.3-00021-43380-2 MPN 143380 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx351163 Trulicity Pen 0.75mg/0.5 Inj 4X0.5ml by Lilly Eli & Co Item No.3351163 NDC No.00002143380 UPC No.300021433802 Other Name Trulicit

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TRULICITY- dulaglutide injection, solution
Eli Lilly and Company
WARNING: RISK OF THYROID C-CELL TUMORS

In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions (5.1), and Nonclinical Toxicology (13.1)].
TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of TRULICITY and inform them of symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with TRULICITY [see Contraindications (4.1) and Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

TRULICITY™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1.1 Limitations of Use

​ TRULICITY is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe TRULICITY only to patients for whom the potential benefits outweigh the potential risk [see Warnings and Precautions (5.1)].
TRULICITY has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)]. Consider other antidiabetic therapies in patients with a history of pancreatitis.
TRULICITY should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. TRULICITY is not a substitute for insulin.
TRULICITY has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. The use of TRULICITY is not recommended in patients with pre-existing severe gastrointestinal disease [see Warnings and Precautions (5.6)]
The concurrent use of TRULICITY and basal insulin has not been studied.

2 DOSAGE AND ADMINISTRATION
2.1 Dosage

The recommended initiating dose of TRULICITY is 0.75 mg once weekly. The dose may be increased to 1.5 mg once weekly for additional glycemic control. The maximum recommended dose is 1.5 mg once weekly.

Administer TRULICITY once weekly, any time of day, with or without food. TRULICITY should be injected subcutaneously in the abdomen, thigh, or upper arm.

If a dose is missed, instruct patients to administer as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. If less than 3 days remain before the next scheduled dose, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.

The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.
DRUG INTERACTIONS
7.1 Oral Medications

TRULICITY slows gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with TRULICITY. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with TRULICITY. In clinical pharmacology studies, TRULICITY did not affect the absorption of the tested, orally administered medications to a clinically relevant degree [see Clinical Pharmacology (12.3)].
Pregnancy

Pregnancy Category C
DESCRIPTION

TRULICITY contains dulaglutide, a human GLP-1 receptor agonist. The molecule is a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker and is produced using mammalian cell culture. The GLP-1 analog portion of dulaglutide is 90% homologous to native human GLP-1 (7-37). Structural modifications were introduced in the GLP-1 part of the molecule responsible for interaction with the enzyme dipeptidyl-peptidase IV (DPP-4). Additional modifications were made in an area with a potential T-cell epitope and in the areas of the IgG4 Fc part of the molecule responsible for binding the high-affinity Fc receptors and half-antibody formation. The overall molecular weight of dulaglutide is approximately 63 kilodaltons.

TRULICITY is a clear, colorless, sterile solution. Each 0.5 mL of TRULICITY solution contains 0.75 mg or 1.5 mg of dulaglutide. Each single-dose pen or prefilled syringe contains 0.5 mL of solution and the following excipients: citric acid anhydrous (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg), trisodium citrate dihydrate (1.37 mg), in water for injection.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action

TRULICITY contains dulaglutide, which is a human GLP-1 receptor agonist with 90% amino acid sequence homology to endogenous human GLP-1 (7-37). Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.
HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied

Each TRULICITY single-dose pen or prefilled syringe is packaged in a cardboard outer carton.

Carton of 4 Single-Dose Pens

0.75 mg/0.5 mL solution in a single-dose pen (NDC 0002-1433-80)
1.5 mg/0.5 mL solution in a single-dose pen (NDC 0002-1434-80)
16.2 Storage and Handling

Store TRULICITY in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not use TRULICITY beyond the expiration date.
If needed, each single-dose pen or prefilled syringe can be kept at room temperature, not to exceed 86°F (30°C) for a total of 14 days.
Do not freeze TRULICITY. Do not use TRULICITY if it has been frozen.
TRULICITY must be protected from light. Storage of TRULICITY in the original carton is recommended until time of administration.
Discard the TRULICITY single-dose pen or prefilled syringe after use in a puncture-resistant container.

NDC 00002-1433-80 UPC/GTIN No.3-00021-43380-2 Mfg.Part No.143380
RX ITEM-Trulicity Pen 0.75Mg 0.5 Inj 4X0
NDC 00002-1433-80 UPC/GTIN No.3-00021-43380-2 Mfg.Part No.143380

BRAND: TRULICITY  NDC: 00002-1433-80,2143380 UPC: 3-00021-43380-2,300021433802 Lilly Eli & Co
Trulicity Pen 0.75Mg 0.5 Inj 4X0.5Ml By
BRAND: TRULICITY NDC: 00002-1433-80,2143380 UPC: 3-00021-43380-2,300021433802 Lilly Eli & Co

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
DULAGLUTIDE SUB-Q PEN INJ
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

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.