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Rx Item-POTELIGEO- mogamulizumab-kpkc injection 20MG/5ML SDV INJ BY Kyowa Kirin,

RX42747-761-01 Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.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-POTELIGEO- mogamulizumab-kpkc injection 20MG/5ML SDV INJ BY Kyowa Kirin,

$0.00

NDC No. 42747-761-01 42747-0761-01 42747076101 4274776101 UPC/GTIN No.3-42747-76101-2 342747-761012 342747761012 MPN No.776104 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.

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For: Mycosis Fungoides; SÚzary Syndrome

Poteligeo (mogamulizumab-kpkc) is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) for the treatment of Mycosis Fungoides (MF) and SÚzary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma (CTCL). POTELIGEO (mogamulizumab-kpkc) injection is a sterile, preservative-free, clear to slightly opalescent colorless solution supplied in a carton containing one 20 mg/5 mL (4 mg/mL), single-dose glass vial (NDC 42747-761-01).

Store vials under refrigeration at 2░C to 8░C (36░F to 46░F) in original package to protect from light until time of use. Do not freeze. Do not shake.
These highlights do not include all the information needed to use POTELIGEO safely and effectively. See full prescribing information for POTELIGEO.

POTELIGEO« (mogamulizumab-kpkc) injection, for intravenous use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE

POTELIGEO is a CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or SÚzary syndrome after at least one prior systemic therapy [1].
DOSAGE AND ADMINISTRATION

1 mg/kg as an intravenous infusion over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle [2].
DOSAGE FORMS AND STRENGTHS

Injection: 20 mg/5 mL (4 mg/mL) solution in a single-dose vial [3].
CONTRAINDICATIONS

None [4].
WARNINGS AND PRECAUTIONS

Dermatologic Toxicity: Temporarily interrupt POTELIGEO for moderate or severe skin rashes. Permanently discontinue POTELIGEO for life-threatening rash [5.1].
Infusion Reactions: Temporarily interrupt POTELIGEO for any infusion reaction. Permanently discontinue POTELIGEO for any life-threatening infusion reaction [5.2].
Infections: Monitor and treat promptly [5.3].
Autoimmune Complications: Interrupt or permanently discontinue POTELIGEO as appropriate [5.4].
Complications of Allogeneic HSCT after POTELIGEO: Monitor for severe acute graft-versus-host disease (GVHD) and steroid-refractory GVHD. Transplant-related mortality has occurred. [5.5].

ADVERSE REACTIONS

The most common adverse reactions (reported in ?20% of patients) were rash, infusion related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection [6.1].

To report SUSPECTED ADVERSE REACTIONS, contact Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 8/2018

RX42747-761-01
Rx Item-POTELIGEO- mogamulizumab-kpkc in
RX42747-761-01

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-POTELIGEO- mogamulizumab-kpkc in
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

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
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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