Dinutuximab

Dinutuximab is a prescription medication indicated in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA) for pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-time multiagent, multimodality therapy.

• Dinutuximab is available under the following different brand names: Unituxin

Common side effects of Dinutuximab include:

• pain
• fever
• low levels of platelets (thrombocytopenia)
• low levels of lymphocytes (lymphopenia)
• infusion reactions
• low blood pressure (hypotension)
• high blood pressure (hypertension)
• low blood sodium levels (hyponatremia)
• increased alanine aminotransferase
• anemia
• vomiting
• diarrhea
• low blood potassium (hypokalemia)
• capillary leak syndrome
• low white blood cells (neutropenia)
• hives
• low blood albumin (hypoalbuminemia)
• increased aspartate aminotransferase
• low blood calcium (hypocalcemia)
• infections
• high blood sugar (hyperglycemia)
• swelling
• bleeding
• decreased appetite
• weight gain
• nausea
• fast heart rate
• numbness and tingling in the hands and feet

Serious side effects of Dinutuximab include:

• hives
• difficult breathing
• swelling of the face, lips, tongue, or throat
• sudden vision loss or vision changes
• headache, confusion, thinking problems, seizure
• severe dizziness or fainting
• vomiting, diarrhea, feeling very ill
• nerve problems -sharp or shooting pain, numbness, or tingling, burning or cold feeling, weakness, loss of movement, problems with walking or daily activities, loss of bladder or bowel control
• low blood cell counts -fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands, and feet, feeling light-headed or short of breath
• signs of an electrolyte imbalance --increased thirst or urination, constipation, muscle pain or weakness, leg cramps, numbness, or tingling, feeling jittery, irregular heartbeats, fluttering in your chest, or a choking feeling

Rare side effects of Dinutuximab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

Solution for injection

• 17.5 mg/5 mL (3.5 mg/mL)

Neuroblastoma

Adult dosage

• 17.5 mg/m2/d IV over 10-20 h for 4 consecutive days for a maximum of 5 cycles
• Cycles 1, 3, and 5 (24-d duration): Administer on days 4, 5, 6, and 7
• Cycles 2 and 4 (32-d duration): Administer on days 8, 9, 10, and 11

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Dinutuximab has no noted severe interactions with any other drugs.
• Dinutuximab has no noted serious interactions with any other drugs.
• Dinutuximab has no noted moderate interactions with any other drugs.
• Dinutuximab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dinutuximab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dinutuximab?”

Cautions

• Infusion reactions may occur; before dinutuximab infusion, administer required IV hydration and premedication with antihistamines, analgesics, and antipyretics and monitor for signs and symptoms of infusion reactions during and for at least 4 h following completion of each infusion in a setting where cardiopulmonary resuscitation medication and equipment are available
• Abdominal pain, generalized pain, extremity pain, back pain, neuralgia, musculoskeletal pain, and arthralgia reported in dinutuximab/retinoic acid treated group; premedicated with analgesics, including IV opioids, before each dose of dinutuximab and continue until 2 h following completion of dinutuximab; for severe pain, decrease dinutuximab infusion rate to 0.875 mg/m2/h; discontinue therapy if the pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures
• Permanently discontinue therapy in patients with grade 2 peripheral motor neuropathy, grade 3 sensory neuropathy that interferes with daily activities for more than 2 weeks, or grade 4 sensory neuropathy
• Immediately interrupt or discontinue therapy and institute supportive management in patients with symptomatic or severe capillary leak syndrome
• Closely monitor blood pressure during treatment; immediately interrupt or discontinue therapy and institute supportive management in patients with symptomatic hypotension, systolic blood pressure less than the lower limit of normal for age, or systemic blood pressure that is decreased by more than 15% compared with baseline
• Monitor patients for signs and symptoms of systemic infection and temporarily discontinue therapy in patients who develop systemic infection until resolution of infection
• Interrupt therapy in patients experiencing dilated pupil with sluggish light reflex or other visual disturbances that do not cause visual loss; upon resolution and if continued treatment with therapy is necessary, decrease dinutuximab dose by 50%; permanently discontinue therapy in patients with recurrent signs of eye disorder following dose reduction and patients who experience vision loss
• Bone marrow suppression reported; monitor peripheral blood cell counts closely during therapy
• Electrolyte abnormalities reported; monitor serum electrolytes daily during therapy
• Atypical hemolytic uremic syndrome reported; permanently discontinue therapy and institute supportive management for signs of the syndrome
• Advise pregnant women of the potential risk to a fetus; advise women of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of dinutuximab
• Urinary retention that persists for weeks to months following discontinuation of opioids reported; permanently discontinue therapy in patients with urinary retention that does not resolve following discontinuation of opioids
• Transverse myelitis reported; promptly evaluate any patient with signs or symptoms of transverse myelitis such as weakness, paresthesia, sensory loss, or incontinence; permanently discontinue therapy in patients who develop transverse myelitis
• Reversible posterior leukoencephalopathy syndrome (RPLS) reported; institute appropriate medical treatment and permanently discontinue therapy in patients with signs and symptoms of RPLS (eg, severe headache, hypertension, visual changes, lethargy, or seizures)

Pregnancy and Lactation

• Based on the mechanism of action, fetal harm may occur when administered to pregnant women
• There are no studies in pregnant women and no reproductive studies in animals to inform the drug-associated risk
• Contraception
  • Women of reproductive potential: Use effective contraception during treatment and for 2 months after the final dose
• Lactation
  • No information available on drug presence in human milk, its effects on the breastfed infant, or milk production
  • However, human IgG is present in human milk
  • Discontinue breastfeeding during treatment