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Rx Item-TOUJEO SOLOSTAR PEN 3X1.5ML BY AVENTIS SANOFI

NDC No.00024-5869-03 0024-5869-03 0024586903 00024586903 24586903 UPC No.:3-00245-869036-3  00245-869036 300245869036  NDC No.00024-5869-03 UPC/GTIN No.3-00245-86903-6 MPN 586903No.586903 insulin pen BRAND: TOUJEO NDC: 00024-5869-03,24586903 UPC: 3-00245-86903-6,300245869036 Aventis PharmaceuticalsOnly 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-TOUJEO SOLOSTAR PEN 3X1.5ML BY AVENTIS SANOFI

$466.46$423.82

TOUJEO SOLOSTAR PEN insulin glargine,hum.rec.anlog SUBCUT INSULN PEN 300/ML 3X1.5ML Item No.: RX381689 NDC No.00024-5869-03 0024-5869-03 0024586903 00024586903 24586903 UPC No.:3-00245-869036-3 00245-869036 300245869036 NDC No.00024-5869-03 UPC/GTIN No.3-00245-86903-6 MPN 586903 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

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TOUJEO- insulin glargine injection, solution
Sanofi-Aventis U.S. LLC

1. INDICATIONS AND USAGE

TOUJEO is indicated to improve glycemic control in adults with diabetes mellitus.

Limitations of Use

TOUJEO is not recommended for the treatment of diabetic ketoacidosis.

2. DOSAGE AND ADMINISTRATION

2.1 General Dosing Instructions
Inject TOUJEO subcutaneously once a day into the abdominal area, thigh, or deltoid at the same time each day.
Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy [See Adverse Reactions (6.1)].
Individualize and titrate the dosage of TOUJEO based on the individual's metabolic needs, blood glucose monitoring results, and glycemic control goal. The dosage of TOUJEO ranges from 1 to 80 units per one injection.
To minimize the risk of hypoglycemia titrate the dose of TOUJEO no more frequently than every 3 to 4 days.
Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions (5.2), and Use in Specific Populations (8.5, 8.6)].
To minimize the risk of hypoglycemia, do not administer TOUJEO intravenously, intramuscularly or in an insulin pump.
To minimize the risk of hypoglycemia, do not dilute or mix TOUJEO with any other insulin products or solutions.
2.2 Starting Dose in Insulin-Na�ve Patients


Type 1 Diabetes:

The recommended starting dose of TOUJEO in insulin na�ve patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be given as a short-acting insulin and divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin na�ve patients with type 1 diabetes.
The maximum glucose lowering effect of a dose of TOUJEO may take five days to fully manifest and the first TOUJEO dose may be insufficient to cover metabolic needs in the first 24 hours of use [See Clinical Pharmacology (12.2) ]. To minimize risks associated with insufficient insulinization when initiating TOUJEO, monitor glucose daily, titrate TOUJEO per instructions, and adjust co-administered glucose lowering therapies per standard of care.
Type 2 Diabetes:

The recommended starting dose of TOUJEO in insulin na�ve patients with type 2 diabetes is 0.2 units per kilogram of body weight once daily. The dosage of other anti-diabetic drugs may need to be adjusted when starting TOUJEO to minimize the risk of hypoglycemia [See Warnings and Precautions (5.3)].
2.3 Starting Dose in Patients with either Type 1 or Type 2 Diabetes Already on Insulin Therapy
To minimize the risk of hypoglycemia when changing patients from a once daily long-acting or intermediate acting insulin product to TOUJEO, the starting dose of TOUJEO can be the same as the once daily long-acting dose. For patients controlled on LANTUS (insulin glargine, 100 units/mL) expect that a higher daily dose of TOUJEO will be needed to maintain the same level of glycemic control [see Clinical Pharmacology (12.2) and Clinical Studies (14.1)].
To minimize the risk of hypoglycemia when changing patients from twice-daily NPH insulin to once-daily TOUJEO, the recommended starting TOUJEO dose is 80% of the total daily NPH dosage.
To minimize the risk of hyperglycemia when changing patients to TOUJEO, monitor glucose frequently in the first weeks of therapy titrate the dose of TOUJEO per instructions and the dose of other glucose lowering therapies per standard of care. [See Warning and Precautions (5.2) and Clinical Pharmacology Section (12.2)].
2.4 Important Administration Instructions
Prior to initiation of TOUJEO, patients should be trained by their healthcare professional on proper use and injection technique. Training reduces the risk of administration errors such as needle sticks and incomplete dosing.
Patient should follow the Instructions for Use to correctly use the pen device and administer TOUJEO.
Patients should be informed that the dose counter of the TOUJEO SoloStar disposable prefilled pen shows the number of units of TOUJEO to be injected. The TOUJEO SoloStar prefilled pen has been specifically designed for TOUJEO, therefore no dose conversion is required [Patient counseling information (17)].
Patients should be instructed to visually inspect the TOUJEO solution for particulate matter and discoloration prior to administration and only use if the solution is clear and colorless with no visible particles.
For single patient use only [see Warnings and Precautions (5.1)].
Refrigerate unused (unopened) TOUJEO SoloStar prefilled pens.
3. DOSAGE FORMS AND STRENGTHS

Injection: 300 units per mL of insulin glargine available as a clear, colorless, solution in a 1.5 mL TOUJEO SoloStar disposable prefilled pen (450 Units/1.5 mL).

4. CONTRAINDICATIONS

TOUJEO is contraindicated:

During episodes of hypoglycemia [See Warnings and Precautions (5.3)].
In patients with hypersensitivity to insulin glargine or one of its excipients [See Warnings and Precautions (5.5)].
5. WARNINGS AND PRECAUTIONS

5.1 Never Share a TOUJEO SoloStar pen Between Patients
TOUJEO SoloStar disposable prefilled pens must never be shared between patients, even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens.

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.3)] or hyperglycemia. These changes should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, dosage adjustments of concomitant oral anti-diabetic products may be needed.

On a unit to unit basis, TOUJEO has a lower glucose lowering effect than LANTUS [See Clinical Pharmacology (12.2)]. In clinical trials, patients who changed to TOUJEO from other basal insulins experienced higher average fasting plasma glucose levels in the first weeks of therapy compared to patients who were changed to LANTUS. To minimize the risk of hyperglycemia when initiating TOUJEO monitor glucose daily, titrate TOUJEO according to labeling instructions, and adjust co-administered glucose lowering therapies per standard of care [See Dosage and Administration (2.2, 2.3)]. Higher doses of TOUJEO were required to achieve similar levels of glucose control compared to LANTUS in clinical trials [ see Clinical Studies (14.1)].

The onset of action of TOUJEO develops over 6 hours following an injection. In type 1 diabetes patients treated with IV insulin, consider the longer onset of action of TOUJEO before stopping IV insulin. The full glucose lowering effect may not be apparent for at least 5 days [See Dosage and Administration (2.2) and Clinical Pharmacology (12.2)].

5.3 Hypoglycemia
Hypoglycemia is the most common adverse reaction associated with insulin, including TOUJEO. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving, or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [See Drug Interactions (7)] , or in patients who experience recurrent hypoglycemia.

Risk Factors for Hypoglycemia

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation.

As with all insulin preparations, the glucose lowering effect time course of TOUJEO may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature [ see Clinical Pharmacology (12.2)]. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication [ see Drug Interactions (7)]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations (8.5, 8.6)].

Risk Mitigation Strategies for Hypoglycemia

Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. To minimize the risk of hypoglycemia do not administer TOUJEO intravenously, intramuscularly or in an insulin pump or dilute or mix TOUJEO with any other insulin products or solutions.
OVERDOSAGE

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.6)]. Mild episodes of hypoglycemia can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or physical activity level may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

11. DESCRIPTION

TOUJEO (insulin glargine injection) is a long-acting insulin supplied as a sterile solution for subcutaneous injection containing 300 Units/mL of insulin glargine.

Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Chemically, insulin glargine is 21A -Gly-31B -32B -Di-Arg -human insulin and has the empirical formula C267 H404 N72 O78 S6 and a molecular weight of 6063.
Each milliliter of TOUJEO contains 300 Units (10.91 mg) insulin glargine dissolved in a clear aqueous fluid.

The 1.5 mL SoloStar disposable prefilled pen presentation contains the following inactive ingredients per mL: 90 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection.

The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4. At pH 4, insulin glargine is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of a precipitate from which small amounts of insulin glargine are slowly released.

12. CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
HOW SUPPLIED/STORAGE AND HANDLING

16.1 How supplied
TOUJEO (insulin glargine injection) is supplied as a solution containing 300 units per mL (U-300) of insulin glargine and is available in:

Dosage Unit/Strength Package size NDC #
1.5 mL SoloStar disposable prefilled pen (300 Units/mL) Package of 3 0024-5869-03
1.5 mL SoloStar disposable prefilled pen (300 Units/mL) Package of 5 0024-5869-05
Needles are not included in the packs of TOUJEO SoloStar disposable prefilled pen.

BD Ultra-Fine� needles 1 to be used in conjunction with TOUJEO SoloStar disposable prefilled pen are sold separately and are manufactured by BD.

NDC No.00024-5869-03 0024-5869-03 0024586903 00024586903 24586903 UPC No.:3-00245-869036-3  00245-869036 300245869036  NDC No.00024-5869-03 UPC/GTIN No.3-00245-86903-6 MPN 586903No.586903 insulin pen
RX ITEM-Toujeo 300 Ml Inj 3X1.5Ml By Ave
NDC No.00024-5869-03 0024-5869-03 0024586903 00024586903 24586903 UPC No.:3-00245-869036-3 00245-869036 300245869036 NDC No.00024-5869-03 UPC/GTIN No.3-00245-86903-6 MPN 586903No.586903 insulin pen

BRAND: TOUJEO NDC: 00024-5869-03,24586903 UPC: 3-00245-86903-6,300245869036 Aventis Pharmaceuticals
Toujeo 300 Ml Inj 3X1.5Ml By Aventis Pha
BRAND: TOUJEO NDC: 00024-5869-03,24586903 UPC: 3-00245-86903-6,300245869036 Aventis Pharmaceuticals

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
INSULIN GLARGINE,HUM.REC.
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:[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.