Mogamulizumab-kpkc
Generic Name: mogamulizumab-kpkc
Brand Names:
Poteligeo
11 DESCRIPTION Mogamulizumab-kpkc is a recombinant humanized monoclonal antibody that targets CC chemokine receptor 4 (CCR4)-expressing cells. Mogamulizumab-kpkc is an IgG1 kappa immunoglobulin that has a calculated molecular mass of approximately 149 kDa. Mogamulizumab-kpkc is produced by recombinant DNA technology in Chinese hamster ovary cells.
Overview
11 DESCRIPTION Mogamulizumab-kpkc is a recombinant humanized monoclonal antibody that targets CC chemokine receptor 4 (CCR4)-expressing cells. Mogamulizumab-kpkc is an IgG1 kappa immunoglobulin that has a calculated molecular mass of approximately 149 kDa. Mogamulizumab-kpkc is produced by recombinant DNA technology in Chinese hamster ovary cells.
Uses
1 INDICATIONS AND USAGE POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. 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 Sézary syndrome after at least one prior systemic therapy ( 1 ).
Dosage
2 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 ). 2.1 Recommended Dosage The recommended dose of POTELIGEO is 1 mg/kg administered as an intravenous infusion over at least 60 minutes. Administer on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity. Administer POTELIGEO within 2 days of the scheduled dose. If a dose is missed, administer the next dose as soon as possible and resume dosing schedule. Do not administer POTELIGEO subcutaneously or by rapid intravenous administration.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Dermatologic Toxicity [ see Warnings and Precautions (5.1) ]. Infusion Reactions [ see Warnings and Precautions (5.2) ]. Infections [ see Warnings and Precautions (5.3) ]. Autoimmune Complications [ see Warnings and Precautions (5.4) ]. Complications of Allogeneic HSCT after POTELIGEO [ see Warnings and Precautions (5.5) ]. The most common adverse reactions (reported in ≥20% of patients) are 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 .
Warnings
5 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 ). 4 CONTRAINDICATIONS None. None ( 4 ).
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on POTELIGEO use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In an animal reproduction study, administration of mogamulizumab-kpkc to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show a potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose, based on AUC ( see Data ).
Storage
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.
Frequently Asked Questions
What is Mogamulizumab-kpkc used for?▼
1 INDICATIONS AND USAGE POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. 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 Sézary syndrome after at least one prior systemic therapy ( 1 ).
What are the side effects of Mogamulizumab-kpkc?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Dermatologic Toxicity [ see Warnings and Precautions (5.1) ]. Infusion Reactions [ see Warnings and Precautions (5.2) ]. Infections [ see Warnings and Precautions (5.3) ]. Autoimmune Complications [ see Warnings and Precautions (5.4) ]. Complications of Allogeneic HSCT after POTELIGEO [ see Warnings and Precautions (5.5) ]. The most common adverse reactions (reported in ≥20% of patients) are 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 .
Can I take Mogamulizumab-kpkc during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on POTELIGEO use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In an animal reproduction study, administration of mogamulizumab-kpkc to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show a potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose, based on AUC ( see Data ).
What are the important warnings for Mogamulizumab-kpkc?▼
5 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 ). 4 CONTRAINDICATIONS None. None ( 4 ).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.