What is Unituxin (dinutuximab), and how does it work?
Unituxin (dinutuximab) is indicated, 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 firstline multiagent, multimodality therapy.
What are the side effects of Unituxin?
The most common adverse drug reactions (≥ 25%) in the Unituxin/RA group were pain, pyrexia, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia.
Serious Infusion Reactions
Inform patients and caregivers of the risk of serious infusion reactions and anaphylaxis and to immediately report any signs or symptoms, such as facial or lip swelling, urticaria, difficulty breathing, lightheadedness or dizziness that occur during or within 24 hours following the infusion.
Pain, Peripheral Neuropathy, Prolonged Urinary Retention, And Transverse Myelitis
Inform patients and caregivers of the risk of severe pain, sensory and motor neuropathy, prolonged urinary retention, and transverse myelitis, and to promptly report severe or worsening pain and signs and symptoms such as numbness, tingling, burning, weakness, or inability to urinate.
Neurological Disorders Of The Eye
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
Capillary Leak Syndrome
Inform patients and caregivers of the risk of capillary leak syndrome and to immediately report any signs or symptoms.
Inform patients and caregivers of the risk of hypotension during the infusion and to immediately report any signs or symptoms.
Inform patients and caregivers of the risk of infection following treatment and to immediately report any signs or symptoms.
Bone Marrow Suppression
Inform patients and caregivers of the risk of electrolyte abnormalities including hypokalemia, hyponatremia, and hypocalcemia, and to report any signs or symptoms such as seizures, heart palpitations, and muscle cramping.
Atypical Hemolytic Uremic Syndrome
What is the dosage for Unituxin?
- Verify that patients have adequate hematologic, respiratory, hepatic, and renal function prior to initiating each course of Unituxin.
- Administer required premedication and hydration prior to initiation of each Unituxin infusion.
- 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 (Tables 1 and 2 ).
- 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. Follow dose modification instructions for adverse reactions.
Table 1: Schedule of Unituxin Administration for Cycles 1, 3, and 5
|Cycle Day||1 through 3||4||5||6||7||8 through 24*|
|* Cycles 1, 3, and 5 are 24 days in duration.|
Table 2: Schedule of Unituxin Administration for Cycles 2 and 4
|Cycle Day||1 through 7||8||9||10||11||12 through 32*|
|* Cycles 2 and 4 are 32 days in duration.|
Required Pre-Treatment And Guidelines For Pain Management
- Administer 0.9% Sodium Chloride Injection, USP 10 mL/kg as an intravenous infusion over one hour just prior to initiating each Unituxin infusion.
- Administer morphine sulfate (50 mcg/kg) intravenously immediately prior to initiation of Unituxin and then continue as a morphine sulfate drip at an infusion rate of 20 to 50 mcg/kg/hour during and for two hours following completion of Unituxin.
- Administer additional 25 mcg/kg to 50 mcg/kg intravenous doses of morphine sulfate as needed for pain up to once every 2 hours followed by an increase in the morphine sulfate infusion rate in clinically stable patients.
- Consider using fentanyl or hydromorphone if morphine sulfate is not tolerated.
- If pain is inadequately managed with opioids, consider use of gabapentin or lidocaine in conjunction with intravenous morphine.
Antihistamines And Antipyretics
- Administer an antihistamine such as diphenhydramine (0.5 to 1 mg/kg; maximum dose 50 mg) intravenously over 10 to 15 minutes starting 20 minutes prior to initiation of Unituxin and as tolerated every 4 to 6 hours during the Unituxin infusion.
- Administer acetaminophen (10 to 15 mg/kg; maximum dose 650 mg) 20 minutes prior to each Unituxin infusion and every 4 to 6 hours as needed for fever or pain. Administer ibuprofen (5 to 10 mg/kg) every 6 hours as needed for control of persistent fever or pain.
Instructions For Preparation And 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-use vial if the solution is cloudy, has pronounced discoloration, or contains particulate matter.
- Aseptically withdraw the required volume of Unituxin from the single-use 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 drugs interact with Unituxin?
No drug-drug interaction studies have been conducted with dinutuximab.
Is Unituxin safe to use while pregnant or breastfeeding?
Advise women of reproductive potential of the potential risk to the fetus if administered during pregnancy and the need for use of effective contraception during and for at least two months after completing therapy.
Latest Cancer News
Daily Health News
Multimedia: Slideshows, Images & Quizzes
Understanding Cancer: Metastasis, Stages of Cancer, and More
Learn the basics about cancer including types, causes, how it spreads, symptoms and signs, stages and treatment options. Read...
Cancer: Cancer 'Remedies' That Don't Work
You may have read about an all-natural cure for cancer. While many therapies are helpful, some aren't worth your time or money....
Cancer: Does This Cause Cancer?
Everything gives you cancer, right? Not really. WebMD's slide show tells you about the research into cancer and cell phones,...
Top 10 Cancers Quiz
Take this quiz to learn the causes of cancer. Get the facts about the causes, symptoms, and treatments for the world's most...
Related Disease Conditions
Neuroblastoma is a type of cancer that usually afflicts children under 5 years of age. The cancer forms in the adrenal glands, neck, chest, or spinal cord. Symptoms include bulging eyes, bone pain, dark eye circles, a lump in the neck, chest, or abdomen, weakness, or swollen stomach. Treatment depends upon the risk group, which is determined by staging, the child's age, tumor histology, and the tumor biology.
Childhood Acute Lymphoblastic Leukemia (ALL)
Childhood acute lymphoblastic leukemia is the most common type of cancer in children. Symptoms and signs include fever, easy bruising, bone or joint pain, weakness, loss of appetite, and painless lumps in the neck, underarm, stomach, or groin. Treatment depends upon staging and may include chemotherapy, radiation, or stem cell transplant.
Treatment & Diagnosis
- Cancer: Confronting Cancer with Humor
- Cancer and Green Tea
- Cancer Survival and Attitude with Hamilton Jordan
- Cancer: Emotional Aftershocks: When Cancer Comes Back 10/30/02
- Cancer: The Importance of Joining a Cancer Support Group with Selma Schimmel
- Cancer Treatment: Writing to Heal with Margie Davis
- Cancer: Journaling to Save Your Life
- Cancer Patients Need Proper Diet and Exercise
- Cancer: Living Well Despite with Win Boerckel
- Cancers: Children's Cancers
- Cancer: Childhood Cancer Survivors
- Cancer Pain Management with Ann Reiner
- Cancer Research: Going the Distance
Medications & Supplements
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.