Generic (Selumetinib) SEMEDX 25

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  • Model Number:
    RL2520240415
  • Brand Name:
    SEMEDX 25
  • Origin:
    Generic drug,Laos
  • Small Orders:
    Small batches also available
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Poster
  • Details
  • Description
  • Packaging Size
    25mg*60c
  • Strength
    25mg
  • Compositon
    Selumetinib
  • Treatment
    Neurofibromatosis type 1
  • Form
    Capsule
  • Brand
    SEMEDX 25
  • Quantity Unit
    60c/Bottle/box
  • Manufacturer
    BIGBEAR Pharma,LAOs PDR

Selumetinib is a prescription medicine that is used to treat children 2 years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cannot be completely removed by surgery. It is not known if Selumetinib is safe and effective in children under 2 years of age.

PEDIATRIC

Type 1 Neurofibromatosis

Indicated for neurofibromatosis type 1 (NF1) in patients aged ≥2 years who have symptomatic, inoperable plexiform neurofibromas (PN)

<2 years or body surface area (BSA) <0.55 m2: Safety and efficacy not established

≥2 years
  • BSA ≥0.55 m2: 25 mg/m2 PO BID (~q12hr)
  • Recommended dosage based on BSA
    • 0.55-0.69 m2: 20 mg PO qAM and 10 mg PO qPM
    • 0.7-0.89 m2: 20 mg PO BID
    • 0.9-1.09 m2: 25 mg PO BID
    • 1.1-1.29 m2: 30 mg PO BID
    • 1.3-1.49 m2: 35 mg PO BID
    • 1.5-1.69 m2: 40 mg PO BID
    • 1.7-1.89 m2: 45 mg PO BID
    • ≥1.9 m2: 50 mg PO BID

Dosage Modifications

Dose reductions for adverse reactions based on BSA

  • First dose reduction
    • 0.55-0.69 m2: 10 mg BID
    • 0.7-0.89 m2: 20 mg qAM and 10 mg qPM
    • 0.9-1.09 m2: 25 mg qAM and 10 mg qPM
    • 1.1-1.29 m2: 25 mg qAM and 20 mg qPM
    • 1.3-1.49 m2: 25 mg BID
    • 1.5-1.69 m2: 30 mg BID
    • 1.7-1.89 m2: 35 mg qAM and 30 mg qPM
    • ≥1.9 m2: 35 mg BID
  • Second dose reduction
    • 0.55-0.69 m2: 10 mg qDay
    • 0.7-1.09 m2: 10 mg BID
    • 1.1-1.29 m2: 20 mg qAM and 10 mg qPM
    • 1.3-1.49 m2: 25 mg qAM and 10 mg qPM
    • 1.5-1.89 m2: 25 mg qAM and 20 mg qPM
    • ≥1.9 m2: 25 mg BID
  • Subsequent dose reductions
    • Permanently discontinue in patients unable to tolerate selumetinib after 2 dose reductions

Cardiomyopathy

  • Asymptomatic decrease in left ventricular ejection fraction (LVEF) ≥10% from baseline and lower level of normal (LLN): Withhold until resolution; resume at reduced dose
  • Symptomatic decreased LVEF OR Grade 3 or 4 decreased LVEF: Permanently discontinue

Ocular toxicity

  • Retinal pigment epithelial detachment (RPED): Withhold until resolution; resume at reduced dose
  • Retinal vein occlusion (RVO): Permanently discontinue

Gastrointestinal toxicity

  • Grade 3 diarrhea: Withhold until improved to Grade <1; resume at same dose; permanently discontinue if no improvement within 3 days
  • Grade 4 diarrhea OR Grade 3 or 4 colitis: Permanently discontinue

Skin toxicity

  • Grade 3 or 4: Withhold until improvement; resume at reduced dose

Increased creatine phosphokinase (CPK)

  • Grade 4 increased CPK OR any increased CPK and myalgia: Withhold until improved to Grade <1; resume at reduced dose; permanently discontinue if no improvement within 3 weeks

Other adverse reactions

  • Intolerable Grade 2 OR Grade 3: Withhold until improved to Grade <1; resume at reduced dose
  • Grade 4: Withhold until improved to Grade <1; resume at reduced dose; consider discontinuation

Dosage modifications for drug interactions

Strong or moderate CYP3A4 inhibitors or fluconazole
  • Avoid coadministration
  • If coadministration cannot be avoided, reduce selumetinib dosage based on the recommendations below
  • Resume selumetinib after discontinuation of the strong or moderate CYP3A4 inhibitor or fluconazole for 3 elimination half-lives
  • Reduce current dose by 5 mg/m2 (eg, 25 mg/m2 to 20 mg/m2 OR 20 mg/m2 to 15 mg/m2)
  • Dosage reduction to 20 mg/m2 based on BSA
    • 0.55-0.69 m2: 10 mg BID
    • 0.7-0.89 m2: 20 mg qAM and 10 mg qPM
    • 0.9-1.09 m2: 20 mg BID
    • 1.1-1.29 m2: 25 mg BID
    • 1.3-1.49 m2: 30 mg qAM and 25 mg qPM
    • 1.5-1.69 m2: 35 mg qAM and 30 mg qPM
    • 1.7-1.89 m2: 35 mg BID
    • ≥1.9 m2: 40 mg BID
  • Dosage reduction to 15 mg/m2 based on BSA
    • 0.55-0.69 m2: 10 mg qDay
    • 0.7-0.89 m2: 10 mg BID
    • 0.9-1.09 m2: 20 mg qAM and 10 mg qPM
    • 1.1-1.29 m2: 25 mg qAM and 10 mg qPM
    • 1.3-1.49 m2: 25 mg qAM and 20 mg qPM
    • 1.5-1.69 m2: 25 mg BID
    • 1.7-1.89 m2: 30 mg qAM and 25 mg qPM
    • ≥1.9 m2: 30 mg BID

Renal impairment

  • No dosage adjustment necessary

Hepatic impairment

  • Mild (Child-Pugh A): No dosage adjustment necessary
  • Moderate (Child-Pugh B): Reduce recommended dose to 20 mg/m2 BID

    • 0.55-0.69 m2: 10 mg BID
    • 0.7-0.89 m2: 20 mg qAM and 10 mg qPM
    • 0.9-1.09 m2: 20 mg BID
    • 1.1-1.29 m2: 25 mg BID
    • 1.3-1.49 m2: 30 mg qAM and 25 mg qPM
    • 1.5-1.69 m2: 35 mg qAM and 30 mg qPM
    • 1.7-1.89 m2: 35 mg BID
    • ≥1.9 m2: 40 mg BID
  • Severe (Child-Pugh C): Selumetinib unbound AUC increased 3.2-fold in subjects with severe hepatic impairment compared with normal hepatic function; no dosage recommended

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