What is Danyelza?
Danyelza, a prescription medication, is used to treat high-risk neuroblastoma in adults and children older than 1 year. Danyelza is used in combination with another medicine called granulocyte-macrophage colony-stimulating factor (GM-CSF), which causes your body to produce certain blood cells that help fight cancer and protect you from infection. Danyelza can be given when other cancer treatments have failed or stopped working. Danyelza has been approved by the US Food and Drug Administration on an "accelerated basis". Some people have responded to the medicine in clinical studies. However, further research is needed.
Warnings
Danyelza may cause serious side effects. Contact your doctor immediately if you experience pain or a severe migraine. If you experience any of the following side effects after receiving an injection, tell your healthcare provider: dizziness or lightheadedness, itching, warmth, tingling or shortness of breath, noisy breathing, or swelling of your face
Before you take this drug
If you have an allergy to naxitamab, Danyelza should not be used. Tell your doctor about any of the following: high pressure. Before starting the treatment, you may need to take a pregnancy test. Danyelza should not be used if you're pregnant. Danyelza could harm an unborn child. Use birth control to avoid pregnancy during the time you use this medication and for 2 months following your last dose. Do not breastfeed for 2 months after the last dose of this medication.
Similar/related drugs
Cisplatin, doxorubicin, Adriamycin, Vincristine, Unituxin, and Dinutuximab
How to take Danyelza?
Danyelza can be infused into a vein. This injection will be given by a healthcare provider. The infusion may take between 30 and 60 minutes. Danyelza is usually given as a 28-day cycle of treatment, which is repeated every four or eight weeks. The medicine may only be needed during the first few days of each cycle. Your doctor will decide how long you should take this medication. Other medications may be prescribed to prevent allergic reactions or serious side effects. Continue to use these medications as prescribed by your doctor. After the injection, you will be closely monitored for at least two hours to ensure that there are no side effects or allergic reactions. It is possible that you will need to have frequent blood tests done in order to ensure this medication does not cause harmful side effects. As part of maintaining good health, regularly monitoring your blood pressure is required.
What happens if I miss the dose?
If you are unable to attend your appointment for the Danyelza shot, call your doctor.
What happens if I overdose?
Overdoses are unlikely because this medicine is administered by a health professional in a medical environment.
What should be avoided?
If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.
Side effects of Danyelza
If you experience any of the following: hives, difficulty breathing, swelling of your lips, face, tongue, or throat, contact an emergency medical professional immediately. Some side effects can occur during injection. You should tell your caregiver if your symptoms include feeling dizzy, lightheaded, itchy or warm, short of breath, or having a cough or noisy breathing.
If you experience:
- You may experience severe pain in any part of your body.
- You may experience tingling or burning in your feet or hands.
- Severe headaches, confusion, thinking difficulties, weakness, and vision loss.
- A seizure;
- Urination that is painful or difficult
- Cold symptoms include a runny nose or stuffy nose; sneezing; a sore neck; and a cough.
- Eye problems: blurred vision; difficulty focusing; dilated pupils; unequal size of pupils; increased sensitivity to light.
- High blood pressure—headache, nausea, vomiting, and dizziness. Vision changes, nosebleeds, and chest pain
- Low blood cell counts: fever, chills, and tiredness; mouth sores or skin sores; easy bruising; unusual bleeding. Pale skin, cold feet, and cold hands
Should any adverse side effects arise during treatment for cancer, your treatment could either be postponed or stopped altogether.
Danyelza may cause side effects such as:
- Loss of appetite, nausea, vomiting, diarrhea;
- Low or abnormally-low blood cell counts or laboratory test results
- Skin rash, or hives
- Swelling;
- Feeling tired, headache, and fever
- Rapid heart rate
- Feeling anxious or irritable
- Cough;
- Pain, redness or inflammation at the injection site
There may be other side effects. To seek medical advice regarding side effects, speak to your healthcare provider; alternatively you can reach out to FDA at 1-800-FDA-1088 in order to report them.
Interaction with other drug
Other drugs, such as vitamins and herbal products, may interact with naxitamab.Informing your physician of all medications you are currently taking as well as those you stop or start using is imperative for optimal health and well-being.
