Dinutuximab

What is Dinutuximab?

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

What are the uses of this medicine?

• 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.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a history of anaphylaxis to dinutuximab

What drug interactions can this medicine cause?

• No drug-drug interaction studies have been conducted with dinutuximab.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

• 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.

What are the dosage forms and brand names of this medicine?

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

• Unituxin

What side effects can this medication cause?

The most common side effects of this medicine include:

• pain
• pyrexia
• thrombocytopenia
• lymphopenia
• infusion reactions
• hypotension
• hyponatremia
• increased alanine aminotransferase
• anemia
• vomiting
• diarrhea
• hypokalemia
• capillary leak syndrome
• neutropenia
• urticaria
• hypoalbuminemia
• increased aspartate aminotransferase
• hypocalcemia

Unituxin may cause serious side effects, including:

• infections
• infusion reactions
• hypokalemia
• hypotension
• pain
• fever
• capillary leak syndrome

What special precautions should I follow?

• 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.

What to do in case of emergency/overdose?

• 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.

Can this medicine be used in pregnancy?

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

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active ingredient:

• DINUTUXIMAB

Inactive ingredients:

• histidine
• polysorbate 20
• sodium chloride
• water
• hydrochloric acid

Who manufactures and distributes this medicine?

• Packager: United Therapeutics Corporation

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Dinutuximab
• FDA Dinutuximab

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