#高警訊藥品

急性白血病
Acute lymphoblastic leukemia (ALL): Treatment of relapsed Philadelphia chromosome-negative (Ph-) ALL in adults in second or greater relapse or whose disease has progressed after 2 or more antileukemic therapies

Antineoplastic Agent, Antibiotic:
VinCRIStine sulfate, an oncolytic vinca alkaloid, has an unknown mechanism of action, although it is thought to be related to the arrest of replicating cells at the metaphase stage through prevention of microtubule formation in the mitotic spindle.

Distribution:
Vd (children with ALL, non-Hodgkin lymphoma, or Wilms' tumor): 325 L/m(2)
Metabolism:
Liver: extensive via CYP3A subfamily
Excretion:
1. Renal: 10% to 20%
2. Dialyzable: very small amounts (hemodialysis)
3. Elimination Half Life: 85 hours

1. Hypersensitivity to vincristine, liposomal vincristine, or any component of the formulation
2. Patients with Charcot-Marie-Tooth syndrome or other demyelinating conditions
3. Administration via the intrathecal route

D (FDA) (AUS)

Avoid breastfeeding (WHO); Infant risk cannot be ruled out (MDX)

Common:
1. Dermatologic: Alopecia
2. Gastrointestinal: Constipation, Nausea and vomiting
Serious:
1. Endocrine metabolic: Syndrome of inappropriate antidiuretic hormone secretion
2. Nervous system: Abnormal gait, abnormal sensory symptoms (loss of), cranial nerve disorder (including impairment of extraocular movement, laryngeal muscle impairment, paresis, vocal cord paralysis), decreased deep tendon reflex, headache, neuritic pain, paresthesia, sensorimotor neuropathy (dysfunction), seizure<20230413>
3. Ophthalmic: Functional visual loss
4. Otic: Ototoxicity
5. Neuromuscular & skeletal: Amyotrophy, foot-drop (including slap gait)<20230413>
6. Other: Death, Intrathecal administration

CALGB 10403 regimen (Patients <40 years of age): IV
1. Induction phase: 1.5 mg/m2 (maximum: 2 mg) on days 1, 8, 15, and 22
2. Remission consolidation phase: 1.5 mg/m2 (maximum: 2 mg) on days 15, 22, 43, and 50
3. Delayed intensification phase: 1.5 mg/m2 (maximum: 2 mg) on days 1, 8, 43, and 50
4. Maintenance phase: 1.5 mg/m2 (maximum: 2 mg) on days 1, 29, and 57 of a 12-week cycle; continue maintenance phase until 2 years (females) or 3 years (males) from start of interim maintenance; phases are part of combination chemotherapy.
DFCI Consortium regimen (Patients ≤50 years of age): IV
1. Induction phase: 2 mg on days 1, 8, 15, and 22 (4-week treatment cycle)
2. CNS therapy phase: 2 mg for one dose (3-week treatment cycle)
3. Intensification phase: 2 mg on day 1 (3-week cycle; continue for 30 weeks)
4. Continuation phase: 2 mg on day 1 (3-week cycle; continue for 74 weeks); phases are part of combination chemotherapy.
Hyper-CVAD regimen: IV
2 mg on days 4 and 11 during odd-numbered cycles (cycles 1, 3, 5, 7 [in combination with cyclophosphamide, mesna, doxorubicin, and dexamethasone]) of an 8-cycle phase, followed by maintenance treatment (if needed) of 2 mg once monthly for 2 years, plus a tyrosine kinase inhibitor
CALBG 8811 regimen: IV
1. Induction phase: 2 mg on days 1, 8, 15, and 22 (4-week treatment cycle); Early intensification phase: 2 mg on days 15 and 22 (4-week treatment cycle, repeat once)
2. Late intensification phase: 2 mg on days 1, 8, and 15 (8-week treatment cycle)
3. Maintenance phase: 2 mg on day 1 every 4 weeks until 24 months from diagnosis; phases are part of combination chemotherapy
GRAALL 2003 regimen (Patients <60 years of age): IV
1. Induction phase: 2 mg on days 1, 8, 15, and 22
2. Consolidation phase: 2 mg on day 15 of consolidation blocks 2, 5, and 8
3. Late intensification phase: 2 mg on days 1, 8, and 15
4. Maintenance phase: 2 mg on day 1 every month for 12 months; phases are part of combination chemotherapy
GRAALL 2005 regimen (Patients <60 years of age): IV
1. Induction phase: 2 mg on days 1, 8, 15, and 22
2. Interphase-1: 2 mg on day 1
3. First, second, and third consolidation phases (block 2, block 5, and block 8, respectively): 2 mg on day 15
4. Late intensification phase (if complete response after first course): 2 mg on days 1, 8, 15, and 22
5. Maintenance phase: 2 mg on day 1 monthly for 12 months; phases are part of combination chemotherapy
MRC UKALL XII/ECOG E2993 (Patients <60 years of age): IV
1. Induction: 1.4 mg/m2 on days 1, 8, 15, and 22
2. Consolidation phase (cycle 1): 1.4 mg/m2 on days 1, 8, 15, and 22
3. Maintenance phase: 1.4 mg/m2 once every 3 months; continue maintenance for 2.5 years from the start of intensification; phases are part of combination chemotherapy.

1. Children ≤10 kg: 0.05 mg/kg/dose once weekly
2. Children >10 kg: 1.5 to 2 mg/m2/dose; frequency may vary based on protocol

No dosage adjustment necessary.

Serum bilirubin >3 mg/dL: Administer 50% of normal dose.