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Unituxin is a brand name for Dinutuximab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). It is administered in combination…
Verbatim from this product's EMA label. Tap a section to expand.
Unituxin is restricted to hospital-use only and must be administered under the supervision of a physician experienced in the use of oncological therapies. It must be administered by a healthcare professional prepared to manage severe allergic reactions including anaphylaxis in an environment where full resuscitation services are immediately available.
5 mg/m2. It is administered on Days 4–7 during Courses 1, 3, and 5 (each course lasting approximately 24 days) and on Days 8–11 during Courses 2 and 4 (each course lasting approximately 28 days). The treatment regimen consists of dinutuximab, GM-CSF, IL-2, and isotretinoin, administered over six consecutive courses.
Medicinal product no longer authorised 3 Table 1:
Courses 1, 3, and 5 dosing schedule for Unituxin, GM-CSF and isotretinoin Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15-24 GM-CSF1 X X X X X X X X X X X X X X Dinutuximab2 X X X X Isotretinoin3 X X X X X 1. Granulocyte macrophage colony-stimulating factor (GM-CSF): 250 μg/m2/day, administered by either subcutaneous injection (strongly recommended) or intravenous infusion over 2 hours.
2. 5 mg/m2/day, administered by intravenous infusion over 10–20 hours. 3. 33 mg/kg/day (round dose up to nearest 10 mg).
Table 2:
Courses 2 and 4 dosing schedule for Unituxin and IL-2; Courses 2, 4, and 6 dosing schedule for isotretinoin Day 1 2 3 4 5 6 7 8 9 10 11 12-14 15-28 IL-21 X X X X X X X X Dinutuximab2 X X X X Isotretinoin3 X 1. 5 MIU/m2/day on Days 8-11.
2. 5 mg/m2/day, administered by intravenous infusion over 10-20 hours. 3. 33 mg/kg/day (round dose up to nearest 10 mg). Prior to starting each treatment course, refer to Table 3 for a list of criteria that must be evaluated.
Table 3:
Clinical criteria that must be evaluated prior to the start of each treatment course of Unituxin Central nervous system (CNS) toxicity • Delay course initiation until CNS toxicity is Grade 1 or resolved and/or seizure disorder is well controlled Hepatic dysfunction • Delay initiation of first course until alanine aminotransferase (ALT) is less than 5 times upper limit of normal (ULN).
Delay initiation of courses 2-6 until ALT is less than 10 times ULN. Thrombocytopenia • Delay course initiation until platelet count is at least 20,000/μL. • If patient has CNS metastases, delay course initiation and give platelet transfusion to maintain platelet count at least 50,000/μL.
Medicinal product no longer authorised 9 Summary of the safety profile Adverse reactions reported in four clinical studies (ANBL0032, ANBL0931, CCG-0935A, and DIV-NB- 201) of dinutuximab in patients (N=984) with high-risk neuroblastoma are summarized in Table
g. hydroxyzine or diphenhydramine) should be administered by intravenous injection approximately 20 minutes before starting each dinutuximab infusion. It is recommended that antihistamine medicinal product be repeated every 4–6 hours as required during infusion of Unituxin.
Patients should be monitored for signs and symptoms of infusion reactions for 4 hours after the completion of the Unituxin infusion. Epinephrine (adrenaline) and hydrocortisone for intravenous administration should be immediately available at the bedside during administration of dinutuximab to manage life-threatening allergic reactions.
It is recommended that treatment for such reactions include hydrocortisone administered by intravenous bolus, and epinephrine administered by intravenous bolus once every 3–5 minutes as necessary according to clinical response. 8). Capillary leak syndrome Capillary leak syndrome is more likely when dinutuximab is co-administered with IL-2.
It is recommended to administer oral metolazone or intravenous furosemide every 6–12 hours as required. Medicinal product no longer authorised 7 Characteristic symptoms and signs include hypotension, generalized oedema, ascites, dyspnoea, pulmonary oedema and acute renal failure associated with hypoalbuminaemia and haemoconcentration.
Pain Severe pain (Grade 3 or 4) occurs most frequently during the first 4-day course of dinutuximab, often subsiding over time with subsequent courses. 875 mg/m2/hour. 8). Paracetamol should be administered orally 20 minutes prior to starting each dinutuximab infusion, and repeated every 4-6 hours as needed.
Regular dosing every 4–6 hours is recommended when IL-2 is coadministered. If required for persistent pain, ibuprofen should be administered orally every 6 hours between doses of paracetamol. Ibuprofen should not be administered if there is evidence of thrombocytopenia, bleeding, or renal dysfunction.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Respiratory dysfunction • Delay course initiation until dyspnoea at rest has been resolved and/or peripheral oxygen saturation is at least 94 % on room air. 73 m2 Systemic infection or sepsis • Delay course initiation until systemic infection or sepsis has resolved.
Leukopaenia • Delay initiation of first course until absolute phagocyte count (APC) is at least 1,000/μL. Medicinal product no longer authorised 4 Dose modification Table 4 provides dose modification guidance for dinutuximab, GM-CSF and IL-2.
If patients meet criteria for discontinuation of these medications, treatment may continue with isotretinoin as clinically indicated.
Table 4:
Dose modification guidance for the management of treatment-emergent adverse reactions during administration of dinutuximab in combination with GM-CSF, IL-2 and isotretinoin. 875 mg/m2/h. 4). After resolution • Resume infusion at the original rate.
875 mg/m2/h. Grade 3 or 4 Onset of symptoms • Immediately discontinue dinutuximab and intravenous GM-CSF or IL-2. 4). 875 mg/m2/h. • Do not resume GM-CSF or IL-2 until the following day. • For GM-CSF courses, administer GM-CSF at 50 % of the dose starting the next day, and if tolerated, GM-CSF may be given at full dose after completing dinutuximab dosing for that course.
• For IL-2 courses, administer IL-2 at 50 % of the dose starting the next day and continue for the remainder of the course. • If symptoms recur with the addition of GM-CSF or IL-2 discontinue GM- CSF or IL-2 and dinutuximab. • If symptoms resolve the following day, resume dinutuximab at tolerated rate without GM-CSF or IL-2.
Recurrence • Discontinue dinutuximab and GM-CSF or IL-2 for that day. 4). Subsequent courses • Maintain tolerated dinutuximab infusion rate for all subsequent courses with GM-CSF or IL-2. Anaphylaxis Grade 3 or 4 • Permanently discontinue dinutuximab and GM-CSF or IL-2.
Capillary leak syndrome Grade 3 (severe) Onset of symptoms • Discontinue dinutuximab and intravenous GM-CSF or IL-2. 4). 875 mg/m2/h. • Resume GM-CSF or […]
An opioid, such as morphine sulphate, is recommended to be administered by intravenous infusion prior to each dinutuximab infusion and continued as an intravenous infusion during and until 2 hours after completion of the treatment.
It is recommended that additional intravenous bolus doses of an opioid are administered as needed for treatment of pain up to once every 2 hours during the dinutuximab infusion. If morphine is not tolerated, then fentanyl or hydromorphone may be utilised.
9 % sodium chloride) over 30 minutes prior to the start of each dinutuximab infusion and continued via intravenous infusion at 1 mg/kg/h up to 2 hours after completion of the treatment. Lidocaine infusion should be discontinued if the patient develops dizziness, perioral numbness, or tinnitus.
Gabapentin may be administered at the time of starting morphine premedication, at an oral dose of 10 mg/kg/day. The dose may be subsequently increased (up to a maximum of 60 mg/kg/day or 3600 mg/day) as needed for pain management. 9%) solution for injection (10 mL/kg) should be administered over one hour just prior to the dinutuximab infusion.
If hypotension occurs, this can be repeated, or intravenous albumin or packed red blood cells can be administered as clinically indicated. It is recommended that vasopressor therapy is also administered if necessary to restore an adequate perfusion pressure.
8). These changes usually resolve over time. Patients should have an ophthalmic examination before initiating therapy and be monitored for visual changes. Hepatic dysfunction Regular monitoring of liver function is recommended during dinutuximab immunotherapy.
Systemic infections Patients typically have a central venous catheter in situ and as a consequence of prior ASCT are likely to be immunocompromised during therapy, and therefore, at risk of developing systemic infection. Patients should have no evidence of systemic infection and any identified infection should be under control before beginning therapy.
8). Medicinal product no longer authorised 8 Atypical Haemolytic Uraemic Syndrome Haemolytic uraemic syndrome in the absence of documented infection and resulting in renal insufficiency, electrolyte abnormalities, anaemia, and hypertension has been reported.
Supportive measures should be instituted including control of hydration status, electrolyte abnormalities, hypertension, and anaemia. Sodium intake This medicine contains less than 1 mmol sodium (23 mg) per dose. This means it is essentially ‘sodium free’.