Qarziba (Dinutuximab beta)

Qarziba (Dinutuximab beta) Uses, Dosage, Side Effects, Food Interaction and all others data.

Qarziba (Dinutuximab beta) is an IgG1 monoclonal human/mouse chimeric antibody against GD2, a disialoganglioside expressed on tumors of neuroectodermal origin, including human neuroblastoma and melanoma, with highly restricted expression on normal tissues. It is composed of the variable heavy- and light-chain regions of the murine anti-GD2 mAb 14.18 and the constant regions of human IgG1 heavy-chain and kappa light-chain. By binding to GD2, dinutiximab induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity of tumor cells thereby leading to apoptosis and inhibiting proliferation of the tumour. It 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 first-line multiagent, multimodality therapy. Despite a high clinical response seen after first-line treatment, the complete eradication of neuroblastoma is rarely achieved and the majority of patients with advanced disease suffer a relapse. Current strategies for treatment include immunotherapy with drugs such as dinutuximab to target surviving neuroblastoma cells and to prevent relapse.

In vitro dinutuximab binds to neuroblastoma tumour cells and mediates the lysis of tumour cells via cell-mediated and complement-mediated cytotoxicity.

Qarziba (Dinutuximab beta)
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Qarziba (Dinutuximab beta)
Availability	Prescription only
Generic	Dinutuximab
Dinutuximab Other Names	Dinutuximab, Dinutuximab beta, Monoclonal antibody ch14.18
Related Drugs	doxorubicin, cisplatin, vincristine, Adriamycin, Danyelza, Platinol
Type
Formula	C₆₄₂₂H₉₉₈₂N₁₇₂₂O₂₀₀₈S₄₈
Weight	145000.0 Da
Groups	Approved, Investigational
Therapeutic Class
Manufacturer	Eusa Pharma UK
Available Country	United Kingdom
Last Updated:	September 19, 2023 at 7:00 am

Uses

Qarziba (Dinutuximab beta) is an immunotherapeutic agent used in combination with other immunomodulating agents to treat high-risk neuroblastoma in pediatric patients who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

Qarziba (Dinutuximab beta) 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 first-line multiagent, multimodality therapy. Despite a high clinical response seen after first-line treatment, the complete eradication of neuroblastoma is rarely achieved and the majority of patients with advanced disease suffer a relapse. Current strategies for treatment include immunotherapy with drugs such as dinutuximab to target surviving neuroblastoma cells and to prevent relapse.

Qarziba (Dinutuximab beta) is also used to associated treatment for these conditions: High Risk Neuroblastoma

How Qarziba (Dinutuximab beta) works

Toxicity

The most common (incidence 15 %) grade 3 or 4 treatment-related adverse events in dinutuximab compared with standard therapy recipients were neuropathic pain (52 vs. 6 %), fever without neutropenia (39 vs. 6 %), any in-fection (39 vs. 22 %), hypokalaemia (35 vs. 2 %), hypersensitivity reactions (25 vs. 1 %), hyponatraemia (23 vs. 4 %), elevation of alanine transferase levels (23 vs. 3 %) and hypotension (18 vs. 0 %). Based on its mechanism of action, dinutuximab may cause fetal harm when administered to a pregnant woman however, there are no studies in pregnant women and no reproductive studies in animals to inform the drug-associated risk. Non-clinical studies suggest that dinutuximab-induced neuropathic pain is mediated by binding of the antibody to the GD2 antigen located on the surface of peripheral nerve fibers and myelin and subsequent induction of cell- and complement-mediated cytotoxicity. In clinical trials, 114 (85%) patients treated in the dinutuximab/RA group experienced pain despite pre-treatment with analgesics including morphine sulfate infusion. Severe (Grade 3) pain occurred in 68 (51%) patients in the dinutuximab/RA group compared to 5 (5%) patients in the RA group. Pain typically occurred during the dinutuximab infusion and was most commonly reported as abdominal pain, generalized pain, extremity pain, back pain, neuralgia, musculoskeletal chest pain, and arthralgia.

Food Interaction

No interactions found.

Qarziba (Dinutuximab beta) Hypertension interaction

[Major] The use of monoclonal antibodies administered via IV infusion may cause serious infusion reactions, including bronchospasm, hypoxia, dyspnea, fluctuations in blood pressure, laryngeal edema and pulmonary edema.

Caution should be taken in patients with a history of cardiopulmonary disease as they may require additional post-infusion medications to manage respiratory complications.

It is recommended to administer required intravenous hydration and premedication with antihistamines, analgesics, and antipyretics before administration.

Monitor closely for signs and symptoms of infusion reactions during and for at least 4 hours following completion of each infusion in a setting where cardiopulmonary resuscitation medication and equipment are available.

Immediately interrupt or permanently discontinue treatment and institute supportive management for severe or prolonged infusion reactions as appropriate.