WARNING

Danyelza (naxitamab-gqgk) is a medication used to treat neuroblastoma, a type of cancer, in pediatric patients. While it offers therapeutic benefits, it also comes with several risks and potential side effects. Here are the main risks associated with taking Danyelza:

• Infusion-related reactions: These are the most common and can include fever, chills, difficulty breathing, rash, and low blood pressure. Patients are typically monitored closely during and after the infusion to manage these reactions.
• Pain: Significant pain, particularly abdominal pain and bone pain, is commonly reported. Pain management strategies are often required.
• Hypertension: Elevated blood pressure can occur and needs to be monitored and managed during treatment.
• Bone marrow suppression: This can lead to decreased levels of blood cells, increasing the risk of infections, anemia, and bleeding.
• Neurological issues: Patients may experience peripheral neuropathy, which is characterized by numbness, tingling, or pain in the extremities.
• Infections: Due to immune system effects, patients may be at a higher risk of infections.
• Electrolyte imbalances: Abnormal levels of electrolytes like sodium, potassium, or calcium can occur and need regular monitoring.

These risks necessitate careful monitoring by healthcare providers during treatment to mitigate and manage any adverse effects.

Why is this medication prescribed?

Danyelza (naxitamab-gqgk) is prescribed for the treatment of neuroblastoma, a type of cancer that typically affects children. Specifically, it is used for:

• Relapsed or Refractory Neuroblastoma: Danyelza is indicated for pediatric patients with neuroblastoma that has returned (relapsed) or has not responded to initial treatments (refractory).
• Bone or Bone Marrow Involvement: It is particularly used when the cancer has spread to the bones or bone marrow.

Danyelza works by targeting GD2, a glycolipid found on the surface of neuroblastoma cells, helping the immune system to identify and destroy these cancerous cells.

How should this medicine be used?

Danyelza is administered under the supervision of a healthcare professional with experience in cancer chemotherapy and the management of severe infusion reactions. Here are the key points regarding its usage:

• Administration: Danyelza is given as an intravenous (IV) infusion. The dosing schedule typically involves several cycles of treatment, with each cycle consisting of multiple infusion days followed by rest periods.
• Pre-medication: Before receiving Danyelza, patients are usually given pre-medications to reduce the risk of infusion-related reactions. This may include antihistamines, corticosteroids, and analgesics.
• Monitoring: Patients need to be closely monitored during and after the infusion for any adverse reactions. Vital signs are frequently checked, and medical support is on standby to manage any serious side effects.
• Dose Adjustment: The dose of Danyelza may be adjusted based on the patient’s response to the treatment and any side effects experienced. It is crucial to follow the healthcare provider’s instructions regarding dosing and administration schedules.
• Supportive Care: Pain management, antihypertensives, and other supportive care measures may be required to manage the side effects associated with Danyelza.

Patients and caregivers should be educated about the potential side effects and the importance of adhering to the treatment regimen and follow-up appointments. This ensures that any complications can be promptly addressed.

Other uses for this medicine

While Danyelza (naxitamab-gqgk) is primarily approved for the treatment of relapsed or refractory neuroblastoma in pediatric patients, its use in other types of cancers or conditions is currently limited and under investigation in clinical trials. Research is ongoing to explore its potential efficacy in other GD2-expressing cancers, such as certain sarcomas and melanomas, but these uses are not yet established as standard treatment options.

What special precautions should I follow?

As for special precautions when using Danyelza:

• Medical Supervision: Danyelza should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer therapies.
• Allergies: Inform your healthcare provider of any allergies you may have, especially if you’ve had any allergic reactions to naxitamab-gqgk or any other medications.
• Pregnancy and Breastfeeding: Discuss with your doctor if you are pregnant, planning to become pregnant, or breastfeeding, as the effects of Danyelza in these situations are not well understood.
• Interactions: Inform your doctor about all medications, supplements, and herbal products you are taking, as Danyelza may interact with other drugs.
• Side Effects: Be aware of potential side effects of Danyelza, which may include but are not limited to fever, pain, vomiting, diarrhea, low blood pressure, and allergic reactions. Report any unusual symptoms to your healthcare provider promptly.
• Monitoring: Your healthcare provider will monitor you closely during and after treatment with Danyelza to assess its effectiveness and manage any side effects.

Always follow your healthcare provider’s instructions and guidance regarding the use of Danyelza or any other medication.

What special dietary instructions should I follow?

• Stay Hydrated: Drink plenty of fluids to stay hydrated, especially if you experience any side effects like diarrhea.
• Balanced Diet: Eat a balanced diet rich in fruits, vegetables, lean proteins, and whole grains to support your immune system and overall health.
• Manage Side Effects: If you experience nausea or other gastrointestinal side effects, eat smaller, more frequent meals and avoid foods that can trigger symptoms.

What should I do if I forget a dose?

Danyelza is administered by healthcare professionals in a clinical setting, so you should not miss a dose on your own. If you miss a scheduled treatment appointment, contact your healthcare provider as soon as possible to reschedule. It’s important to follow the treatment schedule closely to ensure the effectiveness of the therapy.

What side effects can this medication cause?

Danyelza (naxitamab-gqgk) can cause a range of side effects, which can vary in severity from person to person. Some common side effects include:

• Fever: Fever is a common side effect of Danyelza treatment. It may occur during or shortly after infusion and can usually be managed with medications like acetaminophen.
• Pain: Patients may experience various types of pain, including abdominal pain, bone pain, headache, and muscle pain.
• Vomiting and Diarrhea: Gastrointestinal symptoms such as vomiting and diarrhea can occur as side effects of Danyelza treatment. These symptoms may require supportive care and management.
• Low Blood Pressure: Danyelza can cause a drop in blood pressure, leading to symptoms such as dizziness, lightheadedness, or fainting. Monitoring of blood pressure during treatment is essential.
• Allergic Reactions: Some individuals may experience allergic reactions to Danyelza, which can manifest as rash, itching, swelling, or difficulty breathing. Immediate medical attention is necessary if an allergic reaction occurs.
• Infections: Danyelza can increase the risk of infections, including bacterial, viral, and fungal infections. Patients should be monitored for signs of infection and treated promptly if necessary.
• Neurological Effects: Rarely, Danyelza may cause neurological side effects such as confusion, dizziness, or seizures. These symptoms should be reported to healthcare providers immediately.
• Other Side Effects: Other side effects that may occur with Danyelza treatment include fatigue, anemia, decreased appetite, and electrolyte imbalances.

It’s important for patients to report any side effects they experience to their healthcare providers promptly. Healthcare providers can offer supportive care and adjust treatment as necessary to manage side effects effectively.

What should I know about storage and disposal of this medication?

Storage and Disposal of Danyelza:

Storage:

• Temperature: Danyelza should be stored in a refrigerator at a temperature between 2°C to 8°C (36°F to 46°F).
• Light Protection: Keep the medication in its original packaging to protect it from light.
• Freezing: Do not freeze Danyelza.
• Handling: Handle with care and avoid shaking the vial.

Disposal:

• Unused Medication: Do not dispose of Danyelza in household trash. Follow local regulations for disposing of medical waste.
• Medical Waste: Use proper medical waste disposal methods as instructed by your healthcare provider or local waste disposal company.
• Return Programs: Check if your healthcare facility or pharmacy has a take-back program for unused medications.

In case of emergency/overdose

• Contact emergency medical services immediately by dialing your local emergency number (e.g., 911 in the United States).
• If possible, provide emergency responders with information about the medication taken, including the name (Danyelza/naxitamab-gqgk), dosage, and any other relevant details.
• Follow any instructions provided by emergency medical personnel.

What other information should I know?

• Regular Monitoring: Your healthcare provider will likely monitor your condition closely during and after treatment with Danyelza to assess its effectiveness and monitor for any side effects.
• Blood Tests: You may need to undergo regular blood tests to monitor your blood cell counts and other parameters during Danyelza treatment.
• Follow-up Appointments: Attend all scheduled follow-up appointments with your healthcare provider to ensure proper monitoring and management of your condition.
• Potential Interactions: Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as Danyelza may interact with other drugs.
• Patient Support: Your healthcare provider or treatment center may offer support services and resources to help you cope with the challenges of cancer treatment.

Always follow your healthcare provider’s instructions and guidance regarding the use, storage, and disposal of Danyelza or any other medication. If you have any questions or concerns, do not hesitate to discuss them with your healthcare provider or pharmacist.