A Closer Look at POTELIGEO® (mogamulizumab-kpkc) Injection

Gafacom April 05, 2023

POTELIGEO® (mogamulizumab-kpkc) injection

POTELIGEO® (mogamulizumab-kpkc) injection is a prescription medicine used to treat certain types of skin cancer known as mycosis fungoides (MF) or Sézary syndrome (SS) in adult patients who have received at least one prior systemic therapy. It is a monoclonal antibody that works by targeting a protein called CC chemokine receptor 4 (CCR4) found on the surface of certain cancer cells, which may help to slow down or stop the growth of cancer cells.

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.

POTELIGEO® (mogamulizumab-kpkc) injection


POTELIGEO (mogamulizumab-kpkc) injection is a sterile, ready-to-use, preservative-free, clear to slightly opalescent colorless solution in a single-dose vial for dilution prior to intravenous infusion. Each vial contains 20 mg of mogamulizumab-kpkc in 5 mL of solution. Each mL of solution contains 4 mg of mogamulizumab-kpkc and is formulated in: citric acid monohydrate (0.44 mg), glycine (22.5 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. May contain hydrochloric acid/sodium hydroxide to adjust pH to 5.5.

Mechanism of Action

Mogamulizumab-kpkc is a defucosylated, humanized IgG1 kappa monoclonal antibody that binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs. Non-clinical in vitro studies demonstrate mogamulizumab-kpkc binding targets a cell for antibody-dependent cellular cytotoxicity (ADCC) resulting in depletion of the target cells. CCR4 is expressed on the surface of some Tcell malignancies and is expressed on regulatory T-cells (Treg) and a subset of Th2 T-cells.

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.

DOSAGE AND ADMINISTRATION

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.

Recommended Premedications: Administer premedication with diphenhydramine and acetaminophen for the first POTELIGEOinfusion.

Preparation and Administration

  • Visually inspect drug product solution for particulate matter and discoloration prior to administration. POTELIGEO is a clear to slightly opalescent colorless solution. Discard the vial if cloudiness, discoloration, or particulates are observed.
  • Calculate the dose (mg/kg) and number of vials of POTELIGEO needed to prepare the infusion solution based on patient weight.
  • Aseptically withdraw the required volume of POTELIGEO into the syringe and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP. The final concentration of the diluted solution should be between 0.1 mg/mL to 3.0 mg/mL.
  • Mix diluted solution by gentle inversion. Do not shake.
  • Discard any unused portion left in the vial.

The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags.

Administration

  • Administer infusion solution over at least 60 minutes through an intravenous line containing a sterile, low protein binding, 0.22 micron (or equivalent) in-line filter.
  • Do not mix POTELIGEO with other drugs.
  • Do not co-administer other drugs through the same intravenous line.

Storage of Diluted Solution

After preparation, infuse the POTELIGEO solution immediately, or store under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of infusion preparation.

Do not freeze. Do not shake.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Dermatologic Toxicity: Fatal and life-threatening skin adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have occurred in recipients of POTELIGEO. Rash (drug eruption) is one of the most common adverse reactions associated with POTELIGEO.

Monitor patients for rash throughout the treatment course. Management of dermatologic toxicity includes topical corticosteroids and interruption or permanent cessation of POTELIGEO. Consider skin biopsy to help distinguish drug eruption from disease progression.

Discontinue POTELIGEO permanently for SJS or TEN or for any life-threatening (Grade 4) reaction. For possible SJS or TEN, interrupt POTELIGEO and do not restart unless SJS or TEN is ruled out and the cutaneous reaction has resolved to Grade 1 or less.

Infusion Reactions: Fatal and life-threatening infusion reactions have been reported in patients treated with POTELIGEO.

Consider premedication (such as diphenhydramine and acetaminophen) for the first infusion of POTELIGEO in all patients. Whether premedication reduces the risk or severity of these reactions is not established.

Infections: Fatal and life-threatening infections have occurred in patients treated with POTELIGEO, including sepsis, pneumonia, and skin infection.

Autoimmune Complications: Fatal and life-threatening immune-mediated complications have been reported in recipients of POTELIGEO. Grade 3 or higher immune-mediated or possibly immune-mediated reactions have included myositis, myocarditis, polymyositis, hepatitis, pneumonitis, glomerulonephritis and a variant of Guillain-Barré syndrome. Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions.

Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) after POTELIGEO: Increased risks of transplant complications have been reported in patients who receive allogeneic HSCT after POTELIGEO including severe (Grade 3 or 4) acute graft-versus-host disease (GVHD), steroid-refractory GVHD, and transplant-related death. Among recipients of pre-transplantation POTELIGEO, a higher risk of transplant complications has been reported if POTELIGEO is given within a shorter time frame (approximately 50 days) before HSCT. Follow patients closely for early evidence of transplant-related complications.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no available data on POTELIGEO use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.

Lactation: There is no information regarding the presence of POTELIGEO in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for POTELIGEO and any potential adverse effects on the breastfed child from POTELIGEO or from the underlying maternal condition.

Females and Males of Reproductive Potential: POTELIGEO is not recommended during pregnancy or in women of childbearing potential not using contraception.

Advise females of reproductive potential to use effective contraception during treatment with POTELIGEO and for 3 months following the last dose of POTELIGEO.

Pediatric use: The safety and effectiveness of POTELIGEO in pediatric patients have not been established.

KEYWORDS

  • mogamulizumab uses
  • mogamulizumab mechanism of action
  • mogamulizumab adverse reactions
  • poteligeo indications
  • poteligeo side effects
  • mogamulizumab side effects
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