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RX ITEM-Aranesp 150Mcg .75 Vial 4X0.75ml by Amgen

NDC No.55513-0053-04 UPC/GTIN No.3-55513-05304-4 MPN 5304 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical TherapistAmgen IncOnly 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-Aranesp 150Mcg .75 Vial 4X0.75ml by Amgen

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NDC No.55513-0053-04 UPC/GTIN No.3-55513-05304-4 MPN 5304 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.Rx809552 Aranesp 150Mcg/.75 Vial 4X0.75ml by Amgen Item No.3809552 NDC No.55513005304 UPC No.355513053044 Other Name Darbepoetin Alfa Therapeutic Code 201600 Therapeutic Class Hematopoietic

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ARANESP- darbepoetin alfa injection, solution
ARANESP- darbepoetin alfa solution
Amgen Inc

WARNING: ESAS INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis -stimulating agents (ESAs) to target hemoglobin level of greater than 11 g/dL.

No trial has identified hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks.

Use the lowest Aranesp dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions 5.1 )] .
Cancer:
ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non -small cell lung, head and neck, lymphoid, and cervical cancers [see Table 3, Warnings and Precautions 5.3 )] .

Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Aranesp to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance [see Warnings and Precautions 5.2 )] .

To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see Dosage and Administration 2.3 )] .

Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and USAge 1.2 )].

ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and USAge 1.3 )] .


Discontinue following the completion of chemotherapy course


INDICATIONS AND USAGE
1. Anemia Due to Chronic Kidney Disease
Aranesp is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
1.2 Anemia Due to Chemotherapy in Patients ith Cancer
Aranesp is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is minimum of two additional months of planned chemotherapy.
1.3 Limitations of Use
Aranesp has not been shown to improve quality of life, fatigue, or patient well-being.
Aranesp is not indicated for use:
In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.

In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.

As substitute for RBC transfusions in patients who require immediate correction of anemia see Clinical Pharmacology 12.2) .
2 DOSAGE AND ADMINISTRATION
2.1 Evaluation of Iron Stores and Nutritional Factors
Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Aranesp see Warnings and Precautions 5.10) ].
2.2 Patients with Chronic Kidney Disease
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis -stimulating agents (ESAs) to target hemoglobin level of greater than 11 g/dL No trial has identified hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. ndividualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions ]. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events
DOSAGE FORMS AND STRENGTHS
Aranesp is available as polysorbate-containing solution.
Single-dose vials
Injection: 25 mcg, 40 mcg, 60 mcg, 100 mcg, 200 mcg, 300 mcg, and 500 mcg/1 mL, and 150 mcg/0.75 mL
Single-dose prefilled syringes
Injection: 10 mcg/0.4 mL, 25 mcg/0.42 mL, 40 mcg/0.4 mL, 60 mcg/0.3 mL, 100 mcg/0.5 mL, 150 mcg/0.3 mL, 200 mcg/0.4 mL, 300 mcg/0.6 mL, and 500 mcg/1 mL
CONTRAINDICATIONS
Aranesp is contraindicated in patients with:
Uncontrolled hypertension [see Warnings and Precautions 5.4)].

Pure red cell aplasia (PRCA) that begins after treatment with Aranesp or other erythropoietin protein drugs [see Warnings and Precautions 5.7)].
Serious allergic reactions to Aranesp [see Warnings and Precautions
DESCRIPTION
Aranesp (darbepoetin alfa) is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Aranesp is 165-amino acid protein that differs from recombinant human erythropoietin in containing N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains chains. The additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons.
Aranesp is formulated as sterile, colorless, preservative-free solution containing polysorbate for intravenous or subcutaneous administration. Each mL contains polysorbate 80 (0.05 mg), sodium chloride (8.18 mg), sodium phosphate dibasic anhydrous (0.66 mg), and sodium phosphate monobasic monohydrate (2.12 mg) in Water for Injection, USP (pH 6.2 0.2).
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Aranesp stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.
12.2 Pharmacodynamics
Increased hemoglobin levels are not generally observed until to weeks after initiating treatment with Aranesp.
HOW SUPPLIED/STORAGE AND HANDLING
Store at 36?F to 46?F (2?C to 8?C). Do not freeze.
Do not shake. Protect from light; store Aranesp in the carton until use.
Do not use Aranesp that has been shaken or frozen.
Aranesp is available in the following packages:
Single-dose Vial
1 Vial/Pack, Packs/Case
4 Vials/Pack, 10 Packs/Case
200 mcg/1 mL(NDC 55513-006-01)300 mcg/1 mL(NDC 55513-110-01)
25 mcg/1 mL(NDC 55513-002-04)40 mcg/1 mL(NDC 55513-003-04)60 mcg/1 mL(NDC 55513-004-04)100 mcg/1 mL(NDC 55513-005-04)150 mcg/0.75 mL(NDC 55513-053-04)
Single-dose Prefilled Syringe (SingleJect? with 27-gauge, ?-inch needle with an UltraSafe? Needle Guard that is manually activated to cover the needle during disposal
1 Syringe/Pack, Packs/Case
4 Syringes/Pack, 10 Packs/Case
200 mcg/0.4 mL(NDC 55513-028-01)300 mcg/0.6 mL(NDC 55513-111-01)500 mcg/1 mL(NDC 55513-032-01)
10 mcg/0.4 mL(NDC 55513-098-04)25 mcg/0.42 mL(NDC 55513-057-04)40 mcg/0.4 mL(NDC 55513-021-04)60 mcg/0.3 mL(NDC 55513-023-04)100 mcg/0.5 mL(NDC 55513-025-04)150 mcg/0.3 mL(NDC 55513-027-04)
17 PATIENT COUNSELING info.
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Prior to treatment, inform patients of the risks and benefits of Aranesp. Inform patients with cancer that they must sign the patient-healthcare provider acknowledgment form before the start of each treatment course with Aranesp and that healthcare providers must enroll and comply with the ESA APPRISE Oncology Program in order to prescribe Aranesp.
Review the steps for direct patient administration with patients and caregivers. Training should aim to ensure that patients and caregivers can successfully perform all of the steps in the Instructions for Use of Aranesp prefilled syringe, including showing the patient or caregiver how to measure the required dose, particularly if patient is on dose other than the entire prefilled syringe. If patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of Aranesp or whether the patient would benefit from different Aranesp presentation.
Inform patients:
To read the Medication Guide.
Of the increased risks of mortality, serious cardiovascular reactions, thromboembolic reactions, stroke, and tumor progression see Warnings and Precautions 5.1, 5.3)].
To undergo regular blood pressure monitoring, adhere to prescribed anti-hypertensive regimen and follow recommended dietary restrictions.
To contact their healthcare provider for new-onset neurologic symptoms or change in seizure frequency.
Of the need to have regular laboratory tests for hemoglobin.
Instruct patients who self-administer Aranesp of the:
Importance of following the Instructions for Use.
Dangers of reusing needles, syringes, or unused portions of single-dose vials.
Proper disposal of used syringes, needles, and unused vials, and of the full container.
Importance of informing healthcare provider if difficulty occurs when measuring or administering partial doses from the Aranesp prefilled syringe. If difficulty occurs, use of other syringes or Aranesp vial may be considered.
Aranesp? (darbepoetin alfa)

NDC No.55513-0053-04 UPC/GTIN No.3-55513-05304-4 MPN 5304 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist
Aranesp 150Mcg .75 Vial 4X0.75ml by Amge
NDC No.55513-0053-04 UPC/GTIN No.3-55513-05304-4 MPN 5304 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist

Amgen Inc
AmericanPharmaWholesale.com
Amgen Inc

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
DARBEPOETIN ALFA IN POLYS
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.