Version May 2024
Dosage guidance:
Safety: Administer premedication (diphenhydramine and acetaminophen) prior to the first mogamulizumab infusion; may continue premedication with subsequent doses in patients who experienced an infusion reaction in previous cycles.
Adult T-cell leukemia/lymphoma, relapsed or refractory (off-label use): Note: In transplant-eligible patients, mogamulizumab should not be used within 50 days of transplant due to a possible increased risk for graft-versus-host disease (Ref).
Cycle 1: IV: 1 mg/kg on days 1, 8, 15, and 22 of the 28-day cycle (Ref).
Cycle 2 and beyond: IV: 1 mg/kg on days 1 and 15 of each 28-day cycle; continue until disease progression or unacceptable toxicity (Ref).
Missed doses: Administer mogamulizumab within 2 days of the scheduled dose; if a dose is missed, administer the next dose as soon as possible and resume dosing schedule.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Note: Kidney function estimated using Cockcroft-Gault equation.
CrCl <90 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant pharmacokinetic changes were observed based on kidney impairment.
Mild (total bilirubin ≤ ULN and AST < ULN, or total bilirubin <1 to 1.5 times ULN and any AST) or moderate (total bilirubin >1.5 to 3 times ULN and any AST) impairment: There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant pharmacokinetic changes were observed based on mild or moderate hepatic impairment.
Severe impairment (total bilirubin >3 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2 : The dosing in the FDA-approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m2 experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status (Ref).
Autoimmune toxicity: Consider therapy interruption or permanent discontinuation; evaluate the risk/benefit of mogamulizumab therapy in patients with a history of autoimmune disease.
Dermatologic toxicity:
Grade 1 rash (mild): Consider topical corticosteroids.
Grade 2 or 3 rash (moderate or severe): Interrupt mogamulizumab therapy and administer at least 2 weeks of topical corticosteroids. If rash improves to ≤ grade 1, may resume therapy.
Grade 4 rash (life-threatening), Stevens-Johnson syndrome (SJS), or toxic epidermal necrolysis (TEN): Permanently discontinue mogamulizumab for grade 4 rash, confirmed SJS, or TEN. If SJS/TEN is suspected, interrupt mogamulizumab therapy and do not resume unless SJS/TEN has been ruled out and the cutaneous reaction has improved to ≤ grade 1.
Infection: Manage promptly.
Infusion reactions:
Grade 1, 2, or 3 (mild, moderate, or severe): Temporarily interrupt infusion and manage symptoms as clinically necessary. After symptoms resolve, resume the infusion with the rate reduced by at least 50% (administer premedication with diphenhydramine and acetaminophen prior to subsequent infusions). If the reaction recurs and is unmanageable, discontinue mogamulizumab.
Grade 4 (life-threatening): Permanently discontinue mogamulizumab.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Cardiovascular: Edema (16%)
Dermatologic: Skin infection (19%; serious: 3%), skin rash (25% to 35%; including dermatitis [granulomatous, psoriasiform, spongiotic] lichenoid eruption, maculopapular rash, morbilliform rash, papular rash, pustular rash, and scaly plaques)
Endocrine & metabolic: Decreased serum albumin (34%), decreased serum calcium (30%), decreased serum glucose (14%), decreased serum magnesium (17%), hyperglycemia (9% to 52%), increased serum calcium (12%), increased uric acid (29%)
Gastrointestinal: Constipation (13%), diarrhea (28%), nausea (16%), stomatitis (12%; grades ≥3: 1%)
Hematologic & oncologic: Anemia (12% to 35%; grades 3/4: 2%), decreased T cell lymphocytes (CD4: 63%; ≥grade 3: 43%), decreased white blood cell count (33%; ≥grade 3: 2%), lymphocytopenia (5% to 31%; ≥grade 3: 16%), thrombocytopenia (14% to 29%)
Hepatic: Increased serum alanine aminotransferase (18%), increased serum alkaline phosphatase (17%), increased serum aspartate aminotransferase (25%)
Hypersensitivity: Fixed drug eruption (24%), infusion-related reaction (33% to 35%)
Immunologic: Antibody development (14%)
Infection: Infection (including serious infection; grades ≥3: 18%)
Nervous system: Fatigue (31%), headache (14%)
Neuromuscular & skeletal: Musculoskeletal pain (22%)
Respiratory: Cough (11%), upper respiratory tract infection (22%)
Miscellaneous: Fever (17%)
1% to 10%:
Cardiovascular: Cardiac arrhythmia (5%), hypertension (10%)
Dermatologic: Alopecia (7%), folliculitis (8%), xeroderma (8%)
Endocrine & metabolic: Hyperuricemia (8%), hypomagnesemia (6%), hypophosphatemia (1%), hypothyroidism (1%; new-onset), weight gain (8%), weight loss (6%)
Gastrointestinal: Abdominal pain (5%), decreased appetite (8%), vomiting (7%)
Genitourinary: Urinary tract infection (9%)
Hematologic & oncologic: Leukopenia (1%), neutropenia (10%; grades 3/4: 2%)
Hepatic: Hepatitis (2%)
Infection: Candidiasis (9%), herpes virus infection (5%), sepsis (4%)
Nervous system: Chills (7%), depression (7%), dizziness (8%), falling (6%), insomnia (9%), peripheral neuropathy (7%)
Neuromuscular & skeletal: Muscle spasm (5%)
Ophthalmic: Conjunctivitis (5%)
Otic: Otitis (5%)
Renal: Renal insufficiency (9%)
Respiratory: Dyspnea (7%), pneumonia (6%), pneumonitis (2%)
<1%:
Cardiovascular: Acute myocardial infarction, heart failure, ischemic heart disease
Hematologic & oncologic: Tumor lysis syndrome
Infection: Cytomegalovirus disease
Frequency not defined:
Dermatologic: Stevens-Johnson syndrome, toxic epidermal necrolysis
Hypersensitivity: Type III hypersensitivity reaction (including glomerulonephritis, myocarditis, myositis, polymyositis, and a variant of Guillain-Barre syndrome)
Respiratory: Lower respiratory tract infection
Postmarketing:
Cardiovascular: Cardiomyopathy (stress)
Infection: Reactivation of HBV
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Autoimmune toxicity: Life-threatening and fatal immune-mediated complications have occurred in patients receiving mogamulizumab. Grade 3 or higher immune-mediated (or possibly immune-mediated) reactions included myositis, myocarditis, polymyositis, hepatitis, pneumonitis, and a variant of Guillain-Barré syndrome; some patients received systemic immunosuppressants for the management of immune-mediated reactions. New-onset grade 1 or 2 hypothyroidism also occurred in a small number of patients, and was managed with observation or thyroid medication. Consider the risk/benefit of mogamulizumab therapy in patients with a history of autoimmune disease.
• Dermatologic toxicity: Dermatologic toxicity, including fatal and life-threatening reactions (eg, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN]), has occurred. Rash (drug eruption) is one of the most frequently reported toxicities of mogamulizumab therapy; in a clinical trial, the majority of rashes were grade 1 or 2, although grade 3 or 4 toxicity has also been reported. The onset of drug eruption and affected areas/appearance may vary; however, in the clinical trial, the median time to onset of drug eruption was 15 weeks (with one-quarter of cases occurring after 31 weeks). Papular or maculopapular rash, lichenoid, spongiotic or granulomatous dermatitis, and morbilliform rash were the most common presentations of drug eruption; other clinical presentations included scaly plaques, pustular eruption, folliculitis, non-specific dermatitis, and psoriasiform dermatitis.
• Infections: Life-threatening and fatal infections have been reported, including sepsis, pneumonia, and skin infection. Close to 20% of patients experienced grade 3 or higher infection or an infection-related serious adverse reaction. Postmarketing identification of hepatitis B reactivation has been observed.
• Infusion reactions: Infusion reactions have been reported with mogamulizumab, including life-threatening and fatal events. The majority of reactions occur during or shortly after the first infusion, but may also occur with subsequent infusions. Commonly reported signs/symptoms include chills, nausea, fever, tachycardia, rigors, headache, and vomiting.
Disease-related concerns:
• Hematopoietic cell transplant: Increased transplant complications have been reported in patients who receive allogeneic hematopoietic cell transplantation (HCT) after mogamulizumab therapy, including grade 3 or 4 acute graft-versus-host disease (GVHD), steroid-refractory GVHD, and transplant-related death. A higher risk of transplant complications has been reported when mogamulizumab is administered within a shorter time frame (~50 days) before HCT.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Poteligeo: Mogamulizumab-kpkc 20 mg/5 mL (5 mL) [contains polysorbate 80]
No
Solution (Poteligeo Intravenous)
20 mg/5 mL (per mL): $1,081.57
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IV: Administer IV over at least 60 minutes through an IV line containing a sterile, low protein binding, 0.22 micron (or equivalent) in-line filter. Do not administer subcutaneously or by rapid IV administration. Do not mix mogamulizumab with any other medications or infuse other medications through the same line.
Premedicate prior to the first infusion with diphenhydramine and acetaminophen. If a mild, moderate, or severe infusion reaction occurs (grade 1 to 3), temporarily interrupt infusion until symptoms resolve and resume infusion with the rate reduced by at least 50% (premedicate prior to subsequent infusions). Permanently discontinue for life-threatening (grade 4) infusion reactions.
Mycosis fungoides, relapsed or refractory: Treatment of adult patients with relapsed or refractory mycosis fungoides (MF) after at least one prior systemic therapy.
Sézary syndrome, relapsed or refractory: Treatment of adult patients with relapsed or refractory Sézary syndrome (SS) after at least one prior systemic therapy.
Adult T-cell leukemia/lymphoma, relapsed or refractory
Mogamulizumab may be confused with ibalizumab, margetuximab, mepolizumab, mirvetuximab soravtansine, mosunetuzumab, moxetumomab pasudotox, tildrakizumab.
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Evaluate pregnancy status prior to use. Patients who could become pregnant should use effective contraception during treatment and for 3 months after mogamulizumab therapy is complete.
Adverse events were not observed in animal reproduction studies.
IgG molecules are known to cross the placenta.
It is not known if mogamulizumab is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Verify pregnancy status prior to therapy initiation in patients who could become pregnant. Monitor for dermatologic toxicity/rash (skin biopsy may be considered to distinguish dermatologic toxicity/drug eruption from disease progression). Monitor for signs/symptoms of infusion reactions, infections, and autoimmune-mediated reactions. Monitor closely for early evidence of transplant-related complications (in patients who receive hematopoietic cell transplant).
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Mogamulizumab is a first-in-class defucosylated, humanized IgG1 kappa monoclonal antibody which selectively binds to C-C chemokine receptor 4 (CCR4). CCR4 mediates cell trafficking of lymphocytes to skin and various organs and is consistently expressed on the surface of T-cell malignancies (eg, mycosis fungoides, Sézary syndrome, adult T-cell leukemia/lymphoma, peripheral T-cell lymphoma) (Kim 2018). Mogamulizumab binding to CCR4 targets a cell for antibody-dependent cellular cytotoxicity (ADCC), resulting in target cell depletion.
Distribution: Vd: 3.6 L.
Half-life elimination: 17 days.
Excretion: Clearance: 12 mL/hour.
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