Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 20mg/5mL, single-dose vial (4mg/mL)
Mycosis Fungoides or Sézary Syndrome
CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody indicated for adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least 1 prior systemic therapy
First cycle
Subsequent cycles
- Days 1 and 15: 1 mg/kg IV over at least 60 min
- Continue until disease progression or unacceptable toxicity
Dosage Modifications
Dermatologic toxicity
- Grade 1: Consider topical steroids
- Grade 2 or 3: Interrupt treatment and administer at least 2 weeks of topical corticosteroids; if rash improves to Grade ≤1, resume treatment
- Life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN): Permanently discontinue treatment
- If SJS or TEN is suspected, stop treatment, and do not resume unless SJS or TEN has been excluded and cutaneous reaction has resolved to Grade ≤1
Infusion reactions
- If an infusion reaction occurs, administer premedication (eg, diphenhydramine, acetaminophen) for subsequent infusions
- Grades 1 to 3: Temporarily interrupt infusion and treat symptoms; after symptoms resolve, restart infusion at a reduced infusion rate (by at least 50%); if reaction recurs and is unmanageable, discontinue infusion
- Grade 4: Permanently discontinue
Renal impairment
- CrCl <90 mL/min: No clinically significant pharmacokinetic changes observed
Hepatic impairment
- Mild (total bilirubin ≤3x ULN and any AST): No dosage adjustment necessary
- Severe (total bilirubin >3x ULN and any AST): Pharmacokinetics of mogamulizumab is unknown
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (7)
- axicabtagene ciloleucel
mogamulizumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
mogamulizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
mogamulizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
mogamulizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
mogamulizumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- palifermin
palifermin increases toxicity of mogamulizumab by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- tisagenlecleucel
mogamulizumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (7)
- dengue vaccine
mogamulizumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of mogamulizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- ponesimod
ponesimod and mogamulizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- siponimod
siponimod and mogamulizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- trastuzumab
trastuzumab, mogamulizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, mogamulizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- ublituximab
ublituximab and mogamulizumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
Adverse Effects
All grades of severity listed unless otherwise indicated
>10%
Decreased CD4 lymphocytes (63%)
Hyperglycemia (52%)
Decreased CD4 lymphocytes, Grade 3 or more (43%)
Rash, including drug eruption (35%)
Anemia (35%)
Decreased albumin (34%)
Infusion-related reaction (33%)
Decreased white blood cells (33%)
Decreased lymphocytes (31%)
Fatigue (31%)
Decreased calcium (30%)
Thrombocytopenia (29%)
Uric acid increased (29%)
Phosphate decreased (27%)
Diarrhea (28%)
Aspartate transaminase (AST) increased (25%)
Drug eruption (24%)
Upper respiratory tract infection (22%)
Musculoskeletal pain (22%)
Skin infection (19%)
Alanine transaminase (ALT) increased (18%)
Alkaline phosphatase increased (17%)
Pyrexia (17%)
Magnesium decreased (17%)
Decreased lymphocytes, Grade 3 or more (16%)
Edema (16%)
Nausea (16%)
Thrombocytopenia (14%)
Decreased glucose (14%)
Headache (14%)
Constipation (13%)
Increased calcium (12%)
Anemia (12%)
Mucositis (12%)
Cough (11%)
1-10%
Hypertension (10%)
Neutropenia (10%)
Candidiasis (9%)
Urinary tract infection (9%)
Renal insufficiency (9%)
Hyperglycemia (9%)
Insomnia (9%)
Hyperuricemia (8%)
Increased weight (8%)
Folliculitis (8%)
Xerosis (8%)
Dizziness (8%)
Decreased appetite (8%)
Dyspnea (7%)
Chills (7%)
Vomiting (7%)
Peripheral neuropathy (7%)
Alopecia (7%)
Depression (7%)
Decreased weight (6%)
Hypomagnesemia (6%)
Pneumonia (6%)
Falls (6%)
Muscle spasms (5%)
Phosphate decreased, Grade 3 or more (5%)
Arrhythmia (5%)
Conjunctivitis (5%)
Otitis (5%)
Abdominal pain (5%)
Herpes virus infection (5%)
Grade 3 or more
- Rash, including drug eruption (5%)
- Drug eruption (5%)
- Hyperglycemia (5%)
- Skin infection (3%)
- Infusion-related reaction (2%)
- Decreased white blood cells (2%)
- Anemia (2%)
- AST increased (2%)
- Mucositis (1%)
- ALT increased (1%)
<1%
Musculoskeletal pain
Pyrexia
Tumor lysis syndrome
Myocardial ischemia or infarction
Cardiac failure
Increased calcium, Grade 3 or more
Cytomegalovirus infection
Postmarketing Reports
Infections: Hepatitis B virus reactivation
Cardiac disorders: Stress cardiomyopathy
Warnings
Contraindications
None
Cautions
Fatal and life-threatening skin adverse reactions, including SJS and TEN, have occurred; onset of drug eruption, affected areas, and appearance varies; more common presentations reported included papular or maculopapular rash, lichenoid, spongiotic, or granulomatous dermatitis, and morbilliform rash; monitor for rash throughout treatment course
Fatal and life-threatening infusion reactions reported; most reactions (~90%) occur during or shortly after the first infusion; infusion reactions can also occur with subsequent infusions; most common reported signs include chills, nausea, fever, tachycardia, rigors, headache, and vomiting
Fatal and life-threatening infections, including sepsis, pneumonia, and skin infection occurred; monitor for signs and symptoms of infection and treat promptly
Increased risks of transplant complications reported in patients who receive allogeneic HSCT after mogamulizumab ,including severe (Grade 3 or 4) acute graft-versus-host disease (GVHD), steroid-refractory GVHD, and transplant-related death; a higher risk of transplant complications reported if mogamulizumab is given within a shorter time frame (~50 days) before HSCT; closely monitor for early evidence of transplant-related complications
Autoimmune complications
- Fatal and life-threatening immune-mediated complications reported; Grade 3 or higher immune-mediated or possibly immune-mediated reactions have included myositis, myocarditis, polymyositis, hepatitis, pneumonitis, glomerulonephritis, and a variant of Guillain Barre syndrome
- Use of systemic immunosuppressants for immune-mediated reactions reported in 1.9% of recipients of mogamulizumab in Trial 1, including for a case of Grade 2 polymyalgia rheumatica
- New-onset hypothyroidism (Grade 1 or 2) reported and managed with observation or levothyroxine
- Interrupt or permanently discontinue treatment as appropriate for suspected immune-mediated adverse reactions
- Consider if benefits outweigh the risks in patients with a history of autoimmune disease
Pregnancy
Pregnancy
There are no available data on use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage
In general, IgG molecules are known to cross the placental barrier and in the monkey reproduction study mogamulizumab-kpkc was detected in fetal plasma
Therefore, drug may potentially be transmitted from the mother to the developing fetus
Not recommended during pregnancy or in women of childbearing potential not using contraception
For females of reproductive potential, verify pregnancy status prior to initiation
Animal data
- In an animal reproduction study, administration 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
Contraception
- Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months following the last dose
Lactation
There is no information regarding the presence of mogamulizumab-kpkc in human milk, the effects on the breastfed child, or the effects on milk production
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Recombinant humanized monoclonal antibody that targets CCR4-expressing cell, inhibiting CCR4-mediated signaling may mitigate chemokine-mediated cellular migration, T cell proliferation, and chemokine-mediated angiogenesis
CCR4 (also known as CD194) may be overexpressed on adult T-cell lymphoma and peripheral T-cell lymphoma
Absorption
Peak plasma concentration: 32 mcg/mL
Minimum plasma concentration: 11 mcg/mL
AUC (steady-state): 5577 mcg·hr/mL
Distribution
Vd: 3.6 L
Elimination
Half-life: 17 days
Clearance: 12 mL/hr
Administration
IV Compatibilities
0.9% NaCl
Diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bag
IV Preparation
Visually inspect solution for particulate matter and discoloration prior to administration
Solution should appear clear to slightly opalescent colorless; discard vial if cloudiness, discoloration, or particulates are observed
Calculate dose (mg/kg) and number of vials needed to prepare the infusion solution based on patient weight
Aseptically withdraw required volume and transfer into an IV bag containing 0.9% NaCl
Final concentration of the diluted solution should be between 0.1-3 mg/mL
Mix diluted solution by gentle inversion; do not shake
Discard any unused portion left in the vial
IV Administration
Infuse 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 mix with other drugs
Do not coadminister other drugs through the same IV line
Administer within 2 days of scheduled dose
Missed dose: If a dose is missed, administer the next dose as soon as possible and resume dosing schedule
Premedications
- Administer diphenhydramine and acetaminophen prior to the first infusion
Storage
Unused vials
- Refrigerate at 2-8°C (36-46°F) in original package to protect from light until time of use
- Do not freeze; do not shake
Diluted solutions
- After preparation, infuse immediately or refrigerate at 2-8°C (36-46°F) for up to 24 hr
- Do not freeze; do not shake
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Poteligeo intravenous - | 4 mg/mL vial |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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