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Rx Item-Padcev 20mg sdv (enfortumab vedotin-ejfv) by Seattle Genetics

NDC No.  UPC/GTIN No. MPN No.  Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Physical Therapist, Podiatrist,Rx Item-Padcev (enfortumab vedotin-ejfv)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

Rx Item-Padcev 20mg sdv (enfortumab vedotin-ejfv) by Seattle Genetics

$0.00

Item No. RX10232439/56609 NDC No. 51144-0020-01 51144-020-01 5114402001 51144002001 UPC/GTIN No.3-04698-23412-1 304698234121 304698-234121 MPN No. 2001 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 their Practice Can Order Rx Item. Rx Item No.RX Other Name: enfortumab vedotin-ejfv for: Urothelial Carcinoma
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For: Urothelial Carcinoma

Padcev (enfortumab vedotin-ejfv) is a Nectin-4 targeted antibody-drug conjugate (ADC) for the treatment of patients with locally advanced or metastatic urothelial cancer.

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PADCEV safely and effectively. See full prescribing information for
PADCEV.
PADCEVTM (enfortumab vedotin-ejfv) for injection, for intravenous use
Initial U.S. Approval: 2019
--------------------------- INDICATIONS AND USAGE --------------------------
PADCEV is a Nectin-4-directed antibody and microtubule inhibitor conjugate
indicated for the treatment of adult patients with locally advanced or
metastatic urothelial cancer who have previously received a programmed
death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and
a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally
advanced or metastatic setting. (1)
This indication is approved under accelerated approval based on tumor
response rate. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory trials. (14.1)
---------------------- DOSAGE AND ADMINISTRATION ----------------------
 For intravenous infusion only. Do not administer PADCEV as an
intravenous push or bolus. Do not mix with, or administer as an infusion
with, other medicinal products. (2.3)
 The recommended dose of PADCEV is 1.25 mg/kg (up to a maximum dose
of 125 mg) given as an intravenous infusion over 30 minutes on Days 1, 8
and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
(2.1)
 Avoid use in patients with moderate or severe hepatic impairment (8.6)
--------------------- DOSAGE FORMS AND STRENGTHS --------------------
For Injection: 20 mg and 30 mg of enfortumab vedotin-ejfv as a lyophilized
powder in a single-dose vial for reconstitution. (3)
------------------------------ CONTRAINDICATIONS -----------------------------
None. (4)
----------------------- WARNINGS AND PRECAUTIONS ----------------------
 Hyperglycemia: Diabetic ketoacidosis may occur in patients with and
without preexisting diabetes mellitus, which may be fatal. Closely monitor
blood glucose levels in patients with, or at risk for, diabetes mellitus or
hyperglycemia. Withhold PADCEV if blood glucose >250 mg/dL. (2.2,
5.1)
 Peripheral neuropathy: Monitor patients for new or worsening peripheral
neuropathy and consider dose interruption, dose reduction or
discontinuation of PADCEV. (2.2, 5.2)
 Ocular disorders: Ocular disorders, including vision changes, may occur.
Monitor patients for signs or symptoms of ocular disorders. Consider
prophylactic artificial tears for dry eyes and treatment with ophthalmic
topical steroids after an ophthalmic exam. Consider dose interruption or
dose reduction of PADCEV when symptomatic ocular disorders occur.
(5.3)
 Skin reactions: If severe, withhold PADCEV until improvement or
resolution. (2.2, 5.4)
 Infusion Site Extravasation: Ensure adequate venous access prior to
administration. Monitor the infusion site during PADCEV administration
and stop the infusion immediately for suspected extravasation. (5.5)
 Embryo-fetal toxicity: PADCEV can cause fetal harm. Advise of the
potential risk to a fetus and to use effective contraception. (5.6, 8.1, 8.3)
------------------------------ ADVERSE REACTIONS -----------------------------
The most common adverse reactions (≥20%) included fatigue, peripheral
neuropathy, decreased appetite, rash, alopecia, nausea, dysgeusia, diarrhea,
dry eye, pruritus and dry skin. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Astellas
Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
------------------------------ DRUG INTERACTIONS -----------------------------
Concomitant use of strong inhibitors of CYP3A4 with PADCEV may increase
the exposure to monomethyl auristatin E (MMAE). (7.1)
----------------------- USE IN SPECIFIC POPULATIONS ----------------------
 Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDAapproved patient labeling.
Revised: 12/2019

NDC No.  UPC/GTIN No. MPN No.  Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Physical Therapist, Podiatrist,
Rx Item-Padcev (enfortumab vedotin-ejfv)
NDC No. UPC/GTIN No. MPN No. Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Physical Therapist, Podiatrist,

Rx Item-Padcev (enfortumab vedotin-ejfv)
AmericanPharmaWholesale.com
Rx Item-Padcev (enfortumab vedotin-ejfv)

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
NDC No. UPC/GTIN No. MPN No. Only Lic.
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