Qarziba
Monoclonal Antibody for High-Risk Neuroblastoma Treatment
Quick Facts About Qarziba
Key Takeaways About Qarziba
- Qarziba (dinutuximab beta) is a monoclonal antibody that targets GD2 on neuroblastoma cells, activating the immune system to destroy them through ADCC and CDC mechanisms.
- It is used for high-risk neuroblastoma in children aged 12 months and older, either after stem cell transplant or for relapsed/refractory disease, and may be combined with interleukin-2 (IL-2).
- Treatment consists of 5 courses of 35 days each, with a total dose of 100 mg/m² body surface area per course, administered as either a continuous 10-day or intermittent 5-day intravenous infusion.
- Pain is the most common side effect due to GD2 expression on peripheral nerves; pre-medication with analgesics including opioids is required before each infusion.
- Qarziba must be administered in a hospital setting only, under the supervision of a physician experienced in the use of anti-cancer therapies, with full resuscitation facilities available.
What Is Qarziba and What Is It Used For?
Qarziba contains the active substance dinutuximab beta, a chimeric monoclonal antibody of the IgG1 class. It is classified as an antineoplastic agent and belongs to the group of targeted immunotherapies used in paediatric oncology. The medicine received marketing authorisation in the European Union based on clinical data demonstrating improved outcomes in high-risk neuroblastoma patients.
Neuroblastoma is a rare type of cancer that develops from immature nerve cells called neuroblasts. It most commonly occurs in children under the age of 5 and typically arises in the adrenal glands (located above the kidneys) or along the chain of nerve tissue that runs from the neck to the pelvis (the sympathetic nervous system). High-risk neuroblastoma is an aggressive form of the disease that requires intensive multimodal treatment, including chemotherapy, surgery, radiation therapy, and stem cell transplantation.
Dinutuximab beta works by binding specifically to a carbohydrate molecule called GD2 (disialoganglioside 2), which is overexpressed on the surface of neuroblastoma cells. GD2 is present in high concentrations on tumour cells but has limited expression on normal healthy tissue, making it an attractive target for immunotherapy. When dinutuximab beta attaches to GD2, it flags the cancer cell for destruction by the patient’s own immune system through two key mechanisms:
- Antibody-dependent cell-mediated cytotoxicity (ADCC): Natural killer (NK) cells and other immune cells recognise the antibody bound to the tumour cell and release cytotoxic substances that kill the cancer cell.
- Complement-dependent cytotoxicity (CDC): The antibody activates the complement system, a part of the innate immune system, which creates pores in the cancer cell membrane leading to cell lysis and death.
Qarziba is authorised for the following indications in patients from 12 months of age:
- High-risk neuroblastoma in patients who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).
- Relapsed or refractory neuroblastoma, with or without residual disease. For relapsed neuroblastoma, the patient may not have received prior anti-GD2 immunotherapy and must not show evidence of progressive disease.
In the treatment of high-risk neuroblastoma following stem cell transplant, Qarziba may be combined with subcutaneous interleukin-2 (IL-2) to enhance the immune response. The decision to use IL-2 in combination is made by the treating oncologist based on the individual patient’s clinical situation and risk-benefit assessment. Studies have shown that the addition of anti-GD2 immunotherapy to the post-transplant consolidation phase significantly improves event-free survival and overall survival in high-risk neuroblastoma patients.
What Should You Know Before Using Qarziba?
Contraindications
Qarziba must not be used in the following situations:
- Hypersensitivity: Known allergy to dinutuximab beta or to any of the excipients (histidine, sucrose, polysorbate 20, hydrochloric acid, water for injections).
- Severe graft-versus-host disease (GVHD): Patients with acute GVHD grade 3 or 4, or extensive chronic GVHD, must not receive Qarziba. The immune activation caused by dinutuximab beta could severely worsen GVHD.
Warnings and Precautions
Treatment with Qarziba requires careful monitoring. Your child’s medical team will be vigilant for the following potential complications:
- Pain: Pain is the most frequent side effect because GD2 is also found on peripheral nerve fibres. Pain can be severe and requires pre-medication with analgesics, including intravenous opioids (e.g. morphine) and non-opioid pain relievers, before and during each infusion. The infusion may need to be slowed or interrupted if pain is inadequately controlled.
- Allergic reactions and anaphylaxis: Severe allergic reactions, including anaphylaxis, can occur. Pre-medication with antihistamines (H1 and H2 blockers) is required. Resuscitation equipment must be immediately available during infusion.
- Capillary leak syndrome (CLS): This serious condition involves leakage of fluid from blood vessels into surrounding tissues, causing low blood pressure, swelling, and in severe cases organ failure. Patients must be closely monitored for signs of CLS, particularly during the first two treatment courses.
- Eye problems: Dinutuximab beta can cause eye disorders including pupil dilation and unequal pupils (anisocoria), blurred vision, photosensitivity, and swelling of the optic nerve or retina. Patients should have regular ophthalmological examinations during treatment.
- Peripheral neuropathy: Numbness, tingling, weakness, or pain in the hands and feet may occur. Treatment should be interrupted or discontinued if significant neuropathy develops.
- Central nervous system problems: Rarely, posterior reversible encephalopathy syndrome (PRES) may occur, presenting with headache, seizures, visual disturbances, and altered consciousness. Treatment must be immediately stopped if PRES is suspected.
- Kidney problems: Renal impairment, including haemolytic uraemic syndrome, has been reported. Kidney function should be monitored throughout treatment.
Use in Children
Qarziba is approved for use in patients from 12 months of age. The safety and efficacy have not been established in infants younger than 12 months. There is very limited experience in adolescents over 17 years of age, and no data in adults. The dosing is based on body surface area (m²), allowing individualised dosing for children of different sizes.
Drug Interactions
Before starting Qarziba treatment, the treating physician should be informed of all medications the patient is receiving. Key interaction considerations include:
- Immunosuppressive medicines: Systemic immunosuppressive agents should be avoided for at least 2 weeks before the first dose of Qarziba, as they may reduce the immune-mediated anti-tumour effect (ADCC and CDC).
- Corticosteroids: Systemic corticosteroids should be avoided during Qarziba treatment as they may impair the immune response necessary for the drug’s mechanism of action. However, corticosteroids may be used for life-threatening conditions.
- Vaccines: Live vaccines should not be administered during Qarziba treatment and for at least 10 weeks after the last treatment course, due to the risk of infection from the live vaccine in an immunocompromised patient. Inactivated vaccines may also have reduced effectiveness.
- Interleukin-2 (IL-2): When IL-2 is used in combination with Qarziba, the two medicines interact synergistically. IL-2 enhances NK cell activity, potentially increasing both the anti-tumour effect and side effects. Additional monitoring is required during combination therapy.
Pregnancy and Breastfeeding
There are no clinical data on the use of Qarziba during pregnancy. Given the mechanism of action (immune activation) and the fact that IgG1 antibodies can cross the placenta, Qarziba has the potential to cause harm to the developing foetus. Women of childbearing potential should use effective contraception during treatment and for at least 6 months after the last dose. It is not known whether dinutuximab beta is excreted in human milk. Breastfeeding should be discontinued during treatment with Qarziba.
Driving and Operating Machinery
Qarziba is administered in a hospital setting to paediatric patients. Due to the potential for side effects such as dizziness, visual disturbances, and somnolence, patients (or their caregivers) should be advised that the medicine may affect the ability to perform activities requiring alertness. However, as the typical patient population consists of young children, this is rarely a practical consideration.
How Does Qarziba Interact with Other Drugs?
As Qarziba is administered exclusively in a hospital setting under specialist supervision, all potential drug interactions are managed by the treating medical team. The following table summarises the key interactions:
| Drug / Drug Class | Interaction | Recommendation |
|---|---|---|
| Immunosuppressants (e.g. ciclosporin, tacrolimus, mycophenolate) | May reduce ADCC and CDC, decreasing the anti-tumour effect of Qarziba | Avoid for at least 2 weeks before first Qarziba dose |
| Corticosteroids (systemic) | Suppress immune function, potentially reducing the efficacy of Qarziba | Avoid during treatment; use only for life-threatening conditions |
| Live vaccines (e.g. MMR, varicella, rotavirus) | Risk of infection from live vaccine in immunocompromised patient | Do not administer during treatment or for 10 weeks after last course |
| Inactivated vaccines | Immune response to vaccine may be reduced | Effectiveness may be diminished; discuss timing with oncologist |
| Interleukin-2 (IL-2) | Synergistic: enhances NK cell activity, increasing both ADCC efficacy and side effects | Used in combination per protocol; additional monitoring required |
| IV immunoglobulins (IVIG) | May interfere with Qarziba binding to GD2 by competing for Fc receptors | Avoid concomitant use; discuss timing with treating physician |
Since Qarziba is administered exclusively in a hospital setting under specialist oncology supervision, the medical team manages all potential drug interactions as part of the treatment protocol. Formal pharmacokinetic interaction studies have not been performed, as the clinical use is highly controlled. Always inform the treating team of all medications the patient is receiving, including over-the-counter medicines and herbal supplements.
What Is the Correct Dosage of Qarziba?
Standard Dosing
Standard Treatment Protocol
- Total dose per course: 100 mg/m² body surface area
- Number of courses: 5 courses of 35 days each
- Total treatment duration: approximately 175 days (5 × 35 days)
- Route: Intravenous infusion only
- Setting: Hospital use only, under specialist supervision
Continuous Infusion Schedule
Continuous 10-Day Infusion
- Daily dose: 10 mg/m²/day
- Duration: Continuous infusion over 10 days (days 1–10 of each 35-day course)
- Total dose per course: 100 mg/m² (10 mg/m² × 10 days)
- Infusion rate: Administered as a continuous intravenous infusion over 24 hours per day for 10 consecutive days
This schedule may be associated with a more gradual onset of side effects due to the lower daily dose, although pain and other infusion-related reactions can still occur.
Intermittent Infusion Schedule
5-Day Intermittent Infusion (8 Hours Each)
- Daily dose: 20 mg/m²/day
- Duration: 5 daily infusions, each over approximately 8 hours
- Total dose per course: 100 mg/m² (20 mg/m² × 5 days)
- Administration days: Days 1–5 of each 35-day course
The intermittent schedule delivers a higher daily dose but over fewer days, which may be logistically preferred in some clinical settings. The choice of infusion schedule is made by the treating physician based on clinical judgement and institutional protocols.
IL-2 Combination Schedule
Interleukin-2 (IL-2) Combination Regimen
- IL-2 dose: 6 × 10⁶ IU/m²/day administered subcutaneously
- IL-2 duration: 5 consecutive days, given in two 5-day blocks per course
- Timing: IL-2 is administered during specific courses as determined by the treatment protocol
- Purpose: IL-2 activates natural killer (NK) cells, enhancing the antibody-dependent cell-mediated cytotoxicity (ADCC) of dinutuximab beta
The combination of Qarziba with IL-2 may increase both efficacy and the incidence and severity of side effects, particularly capillary leak syndrome, fever, and pain. The treating oncologist will determine whether IL-2 combination is appropriate based on the patient’s clinical status and treatment response.
Dose Modifications for Adverse Reactions
The infusion rate may be reduced or the infusion temporarily interrupted in response to adverse reactions. Specific guidelines for dose modification include:
- Pain: If pain is not adequately controlled despite pre-medication, the infusion rate should be reduced by 50%. If pain remains uncontrolled, the infusion should be interrupted until pain is manageable.
- Allergic reactions: For grade 1–2 reactions, the infusion should be interrupted, appropriate treatment given, and the infusion may be resumed at 50% of the previous rate once resolved. For grade 3–4 anaphylaxis, the infusion must be permanently discontinued.
- Capillary leak syndrome: For grade 3 or higher CLS, the infusion should be interrupted immediately. Treatment may be resumed in the next course only after complete resolution.
- Neuropathy: For grade 2 or higher peripheral motor neuropathy, or grade 3 or higher sensory neuropathy, treatment should be permanently discontinued.
- Eye disorders: For grade 3 or higher eye toxicity, treatment should be permanently discontinued.
Qarziba must never be administered as a bolus injection. It must always be diluted before use and given as a controlled intravenous infusion. The dose must not exceed 100 mg/m² per 35-day course. Pre-medication with analgesics (including opioids), antipyretics, and antihistamines is mandatory before each infusion.
What Are the Side Effects of Qarziba?
Contact the treating medical team immediately or seek emergency care if the patient experiences any of the following during or after Qarziba infusion:
- Severe allergic reaction (difficulty breathing, swelling of face/throat, hives, rapid heartbeat)
- Signs of capillary leak syndrome (sudden weight gain, swelling, dizziness, difficulty breathing)
- Seizures or altered consciousness
- Sudden vision changes or loss of vision
- Signs of severe infection (high fever, chills, confusion)
- Decreased or no urine output
- Severe, uncontrolled pain
Very Common (may affect more than 1 in 10 patients)
- Capillary leak syndrome
- Pain (abdominal, musculoskeletal, back, limb, chest, generalised)
- Hypersensitivity reactions / allergic reactions
- Cytokine release syndrome
- Fever (pyrexia)
- Chills / rigors
- Vomiting
- Diarrhoea
- Constipation
- Stomatitis (mouth inflammation)
- Cough
- Itching (pruritus)
- Rash
- Low blood pressure (hypotension)
- Rapid heart rate (tachycardia)
- Low oxygen levels (hypoxia)
- Oedema (swelling)
- Weight gain
- Infections (including catheter-related)
- Headache
- Pupil dilation / unequal pupils
- Abnormal blood counts (anaemia, thrombocytopenia, neutropenia, lymphopenia)
- Abnormal liver function tests (elevated ALT, AST, GGT)
- Low albumin levels (hypoalbuminaemia)
- Electrolyte disturbances (hyponatraemia, hypokalaemia, hypocalcaemia)
- Elevated creatinine / abnormal urinalysis
Common (may affect up to 1 in 10 patients)
- Sepsis (bloodstream infection)
- Seizures / convulsions
- Agitation
- Anxiety
- Peripheral neuropathy
- Dizziness
- Tremor
- Muscle cramps / spasms
- Eye muscle paralysis (oculomotor nerve disorder)
- Blurred vision
- Photosensitivity (light sensitivity)
- Retinal swelling (macular oedema)
- High blood pressure (hypertension)
- Heart failure
- Pericardial effusion (fluid around the heart)
- Respiratory failure
- Pleural effusion (fluid around the lungs)
- Bronchospasm
- Decreased appetite
- Nausea
- Abdominal distension
- Ascites (fluid in the abdomen)
- Injection site reactions
- Skin problems (erythema, dermatitis)
- Urinary retention
- Weight loss
- Dehydration
Uncommon (may affect up to 1 in 100 patients)
- Hypovolaemic shock
- Disseminated intravascular coagulation (DIC)
- Serum sickness
- Posterior reversible encephalopathy syndrome (PRES)
- Bowel inflammation (enterocolitis)
- Liver damage (hepatotoxicity)
- Renal failure
- Veno-occlusive disease (hepatic sinusoidal obstruction syndrome)
Not Known (frequency cannot be estimated from available data)
- Atypical haemolytic uraemic syndrome (aHUS)
If you notice any side effects not listed here, or if any side effect becomes serious, please inform the treating medical team. You can also report side effects directly to your national medicines regulatory authority. By reporting side effects, you can help provide more information on the safety of this medicine.
How Should You Store Qarziba?
- Storage temperature: Store in a refrigerator at 2–8°C. Do not freeze.
- Light protection: Keep the vial in the outer carton to protect from light.
- After opening: The product should be used immediately after opening the vial. Any unused product must be discarded.
- Diluted solution: After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection containing 1% human albumin, chemical and physical in-use stability has been demonstrated for 48 hours at 25°C (including infusion time) and for up to 7 days at 2–8°C followed by 48 hours at 25°C (including infusion time). From a microbiological point of view, the product should be used immediately.
- Shelf life: 3 years when stored unopened under the recommended conditions.
- Keep out of reach: As with all medicines, keep Qarziba out of the sight and reach of children.
- Do not use after the expiry date stated on the carton and vial label after “EXP”.
What Does Qarziba Contain?
- Active substance: Dinutuximab beta, 4.5 mg/ml. Each vial contains 20 mg of dinutuximab beta in 4.5 ml of concentrate.
- Excipients:
- Histidine
- Sucrose
- Polysorbate 20
- Water for injections
- Hydrochloric acid (for pH adjustment)
- Appearance: Colourless to slightly yellowish liquid, clear to slightly opalescent.
- Container: Type I glass vial with a bromobutyl rubber stopper and aluminium seal.
- Pack size: 1 vial per carton.
- Manufacturer: Patheon Italia S.P.A.
- Marketing authorisation holder: Recordati Netherlands B.V.
Frequently Asked Questions About Qarziba
Neuroblastoma is a rare cancer that develops from immature nerve cells (neuroblasts), most commonly in children under 5 years of age. It usually starts in the adrenal glands or along the sympathetic nervous system. Qarziba (dinutuximab beta) treats neuroblastoma by binding to a molecule called GD2 on the surface of neuroblastoma cells, flagging them for destruction by the patient’s own immune system through two mechanisms: antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Qarziba is given as an intravenous (IV) infusion in a hospital setting only, under the supervision of a physician experienced in oncology. It is administered in 5 treatment courses, each lasting 35 days. The total dose per course is 100 mg per square metre of body surface area. There are two infusion schedules available: a continuous 10-day infusion (10 mg/m²/day) or 5 daily 8-hour infusions (20 mg/m²/day). Pre-medication for pain and allergic reactions is always given before each infusion.
Pain is the most common side effect of Qarziba, occurring in the majority of patients. This happens because GD2, the molecule targeted by dinutuximab beta, is also found on some normal nerve cells (peripheral nerve fibres). The pain can be severe and typically requires pre-medication with analgesics including intravenous opioids (such as morphine). Other very common side effects include fever, capillary leak syndrome, allergic reactions, vomiting, diarrhoea, and changes in blood counts.
Qarziba is approved for use in patients from 12 months of age onwards. It is not recommended for infants under 12 months as the safety and efficacy have not been established in this age group. The treating physician will carefully assess each child’s individual risk-benefit ratio before starting treatment, taking into account the severity of the disease, the child’s overall health status, and available alternative treatments.
Interleukin-2 (IL-2) is a cytokine that stimulates the growth and activity of immune cells, particularly natural killer (NK) cells. When used in combination with Qarziba, IL-2 enhances the antibody-dependent cell-mediated cytotoxicity (ADCC) by activating NK cells, potentially increasing the anti-tumour effect. IL-2 is given as subcutaneous injections (6 × 10⁶ IU/m²/day for 5 days) during specific courses of Qarziba treatment. The decision to combine IL-2 with Qarziba is made by the treating oncologist based on the individual treatment protocol.
For more detailed information about Qarziba, you can consult the European Medicines Agency (EMA) product information page at www.ema.europa.eu, which provides the full European Public Assessment Report (EPAR) with comprehensive data on the medicine’s approval and safety profile. You can also speak with your child’s treating oncologist, or contact the marketing authorisation holder Recordati Netherlands B.V. A patient-friendly package leaflet is included with the medicine.
References
This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.
- European Medicines Agency (EMA). Qarziba (dinutuximab beta) – Summary of Product Characteristics. EMA product information database. Last updated 2025. Accessed January 2026.
- European Medicines Agency (EMA). Qarziba – European Public Assessment Report (EPAR). EMA/471921/2017. Available at: www.ema.europa.eu.
- Yu AL, Gilman AL, Kummar S, et al. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. New England Journal of Medicine. 2010;363(14):1324–1334. doi:10.1056/NEJMoa0911123
- Ladenstein R, Pötschger U, Valteau-Couanet D, et al. Interleukin 2 with anti-GD2 antibody ch14.18/CHO (dinutuximab beta) in patients with high-risk neuroblastoma (HR-NBL1/SIOPEN): a multicentre, randomised, phase 3 trial. The Lancet Oncology. 2018;19(12):1617–1629. doi:10.1016/S1470-2045(18)30578-3
- Cohn SL, Pearson ADJ, London WB, et al. The International Neuroblastoma Risk Group (INRG) classification system: an INRG Task Force report. Journal of Clinical Oncology. 2009;27(2):289–297. doi:10.1200/JCO.2008.16.6785
- Park JR, Kreissman SG, London WB, et al. Effect of tandem autologous stem cell transplant vs single transplant on event-free survival in patients with high-risk neuroblastoma: a randomized clinical trial. JAMA. 2019;322(8):746–755. doi:10.1001/jama.2019.11642
- World Health Organization (WHO). WHO Model List of Essential Medicines for Children – 9th list. Geneva: WHO; 2023.
- Maris JM. Recent advances in neuroblastoma. New England Journal of Medicine. 2010;362(23):2202–2211. doi:10.1056/NEJMra0804577
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in paediatric oncology, clinical pharmacology, and internal medicine.
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