mogamulizumab (Rx)

Brand and Other Names:Poteligeo, mogamulizumab-kpkc
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Dosing & Uses

AdultPediatric

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

1 mg/kg IV on days 1, 8, 15, and 22 of the first 28-day cycle, THEN days 1 and 15 of each subsequent cycle until disease progression or unacceptable toxicity

Infuse over at least 60 min

Also see Administration

Dosage Modifications

Dermatologic toxicity

  • Mild (Grade 1) rash occurs: Consider topical steroids
  • Moderate or severe (Grade 2 or 3) rash occurs: 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 the cutaneous reaction has resolved to ≤Grade 1

Infusion reactions

  • If an infusion reaction occurs, administer premedication (eg, diphenhydramine, acetaminophen) for subsequent infusions
  • Mild to severe (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
  • Life-threatening (Grade 4) infusion reaction: Permanently discontinue

Renal impairment

  • CrCl <90 mL/min: No clinically significant pharmacokinetic changes observed

Hepatic impairment

  • Mild (total bilirubin ≤ULN and AST<ULN, or total bilirubin <1-1.5 x ULN and any AST) or moderate (total bilirubin >1.5-3 x ULN and any AST): No clinically significant pharmacokinetic changes observed
  • Severe (total bilirubin >3 times ULN and any AST): Unknown

Safety and efficacy not established

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Interactions

Interaction Checker

and mogamulizumab

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            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

            Postmarketing Reports

            Infections: Hepatitis B virus reactivation

            Cardiac disorders: Stress cardiomyopathy

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            Warnings

            Contraindications

            None

            Cautions

            Also see Dosage Modifications

            Fatal and life-threatening skin adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (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, and a variant of Guillain Barré 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 in 1.3% of patients 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
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            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.

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            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

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            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 4 hr
            • Do not freeze; do not shake
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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