dinutuximab (di-noo-tux-i-mab) Unituxin

 Indications

Treatment (with granulocyte-macrophage colony-stimulating

factor [GM-CSF], interleukin-2 [IL-2], and 13-

cis-retinoic acid [RA]) of pediatric patients with highrisk

neuroblastoma who have had at least a partial

response to previous first-line multiagent, multimodality

therapy.

Action

Acts as a glycolipid disialoganglioside (GD2)-binding

monoclonal antibody that binds to specific cells in the

CNS and peripheral nerves, inducing cell lysis through

antibody-dependent cell-mediated cytotoxicity (ADCC)

and complement-dependent cytotoxicity (CDC). Therapeutic

Effects: Decreased progression of neuroblastoma.

Pharmacokinetics

Absorption: IV administration results in complete

bioavailability.

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: 10 days.

TIME/ACTION PROFILE (event-free survival

probability)

ROUTE ONSET PEAK DURATION

IV 6 mo 2 yr unknown

Contraindications/Precautions

Contraindicated in: Previous anaphylactic reaction

to dinutuximab; OB: May cause fetal harm; Lactation:

Discontinue breast feeding.

Use Cautiously in: Female patients with reproductive

potential (effective contraception is required);

Geri: Safe and effective use in geriatric patients has not

been established; Safe and effective use in renal or hepatic

impairment has not been established; Pedi: Has

been used in children.

Adverse Reactions/Side Effects

CNS: REVERSE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME

(RPLS). EENT: neurologic disorders of the eye.

Resp: hypoxia. CV: HYPOTENSION, tachycardia. GI:p

appetite, diarrhea,qliver enzymes, vomiting. GU: proteinuria,

urinary retention. Derm: urticaria. F and E:

HYPOKALEMIA, hypocalcemia, hyponatremia. Hemat:

anemia, lymphopenia, neutropenia, thrombocytopenia.

Metab: hyperglycemia, hypertriglyceridemia, hypoalbuminemia,

qweight. Neuro: neuropathic pain, peripheral

neuropathy, transverse myelitis. Misc: CAPILLARY

LEAK SYNDROME, FEBRILE NEUTROPENIA,

INFUSION-RELATED REACTIONS, pain, ATYPICAL HEMOLYTIC

UREMIC SYNDROME.

Interactions

Drug-Drug:qrisk of myelosuppression with other

myelosuppressants, antineoplastics and radiation

therapy.

Route/Dosage

Pretreatment with opioid analgesics, antihistamines and

antipyretics is required.

IV (Adults): 17.5 mg/m2/day for 4 consecutive days

for up to 5 cycles. Infusion-related reactions may require

slowed infusion rate, dose reduction or discontinuation.

Availability

Solution for IV administration (requires further

dilution): 3.5 mg/mL.