Dinutuximab

What is Dinutuximab?[edit | edit source]

Dinutuximab (Unituxin) is a GD2-binding monoclonal antibody used as an anticancer agent in combination with other antineoplastic agents in the treatment of neuroblastoma.

This medicine is used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

Dinutuximab (din" ue tux' i mab) is a mouse-human chimeric monoclonal IgG1 antibody to disialoganglioside (GD2), a cell surface glycolipid that is present in low concentrations on skin, neural or peripheral nerve cells and is overexpressed on neuroblastoma cells.
Engagement of dinutuximab with GD2 triggers antibody dependent cell cytotoxicity.
Cytotoxicity of dinutuximab is increased by coadministration of granulocyte-macrophage colony stimulating factor (GM-CSF) and interleukin 2 (IL2) because of their effects on neutrophils, macrophages and immune effector cells, for which reason dinutuximab is usually combined with these cytokines.

This medicine cannot be used in patients with:

Verify that patients have adequate hematologic, respiratory, hepatic, and renal function prior to initiating each course of Unituxin.
Administer required premedication (Analgesics, Antihistamines and Antipyretics) and hydration prior to initiation of each Unituxin infusion .

Recommended Dosage:

The recommended dose of Unituxin is 17.5 mg/m2/day administered as an intravenous infusion over 10 to 20 hours for 4 consecutive days for a maximum of 5 cycles.
Initiate at an infusion rate of 0.875 mg/m2/hour for 30 minutes. The infusion rate can be gradually increased as tolerated to a maximum rate of 1.75 mg/m2/hour.

Administration

Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light by storing in the outer carton. DO NOT FREEZE OR SHAKE vials.
Inspect visually for particulate matter and discoloration prior to administration. Do not administer Unituxin and discard the single-dose vial if the solution is cloudy, has pronounced discoloration, or contains particulate matter.
Aseptically withdraw the required volume of Unituxin from the single-dose vial and inject into a 100-mL bag of 0.9% Sodium Chloride Injection, USP. Mix by gentle inversion. Do not shake. Discard unused contents of the vial.
Store the diluted Unituxin solution under refrigeration (2°C to 8°C). Initiate infusion within 4 hours of preparation.
Discard diluted Unituxin solution 24 hours after preparation.
Administer Unituxin as a diluted intravenous infusion only.
Do not administer Unituxin as an intravenous push or bolus.

This medicine is available in fallowing doasage form:

As Injection: 17.5 mg/5 mL (3.5 mg/mL) as a clear and colorless to slightly opalescent solution in a single-dose vial.

This medicine is available in fallowing brand namesː

The most common side effects of this medicine include:

Unituxin may cause serious side effects, including:

Neurological disorders of the eye may occur. Interrupt Unituxin for dilated pupil with sluggish light reflex or other visual disturbances and permanently discontinue Unituxin for recurrent eye disorders or loss of vision.
Prolonged urinary retention and transverse myelitis may occur. Permanently discontinue Unituxin and institute supportive care.
Reversible posterior leukoencephalopathy syndrome (RPLS) may occur. Permanently discontinue Unituxin and institute supportive care for signs and symptoms of RPLS.
Capillary leak syndrome and hypotension may occur. Administer required prehydration and monitor patients closely during treatment. Depending upon severity, manage by interruption, infusion rate reduction, or permanent discontinuation.
Infection may occur. Interrupt until resolution of systemic infection.
Bone marrow suppression may occur. Monitor peripheral blood counts during Unituxin therapy.
Unituxin may cause electrolyte abnormalities. Monitor serum electrolytes closely.
Atypical hemolytic uremic syndrome may occur. Permanently discontinue Unituxin and institute supportive management.
Unituxin May cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.

In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

Overdose related information is also available online at poisonhelp.org/help.
In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Based on its mechanism of action, Unituxin may cause fetal harm when administered to a pregnant woman.

The safety and effectiveness of Unituxin as part of multi-agent, multimodality therapy have been established in pediatric patients with high-risk neuroblastoma.

Active ingredient:

Inactive ingredients:

Store Unituxin vials under refrigeration at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light until time of use.
Do not freeze or shake the vial.

Dinutuximab Resources
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