Is Naxitamab approved by the FDA?
Naxitamab, marketed under the brand name Danyelza, is a medication used to treat high-risk neuroblastoma, a rare form of cancer, in both adults and children who are at least one year old. It belongs to the drug class of miscellaneous antineoplastics and is administered as an intravenous solution.
Naxitamab received accelerated approval from the U.S. Food and Drug Administration (FDA) on November 25, 2020. This accelerated approval was granted based on clinical studies showing that some patients responded positively to the treatment. However, further studies are needed to confirm its clinical benefit.
Use and Administration
Naxitamab is specifically used in combination with another medicine that stimulates the production of certain blood cells, which help fight cancer and protect the body from infections. It is typically prescribed for patients whose neuroblastoma has not responded well to previous treatments or for those whose cancer has returned after initial treatment.
The medication is administered through an infusion into a vein, with each infusion taking 30 to 60 minutes to complete. The treatment is usually given in 28-day cycles, repeated every 4 to 8 weeks, depending on the patient's response and the treating physician's recommendations. Patients may need to use the medication only during the first week of each cycle.
Side Effects
Common Side Effects:
- Nausea, vomiting, diarrhea
- Loss of appetite
- Low blood cell counts
- Skin rash or hives
- Swelling
- Headache, fever, fatigue
- Fast heart rate
- Anxiety or irritability
- Cough
- Pain, bruising, swelling, or irritation at the injection site
Serious Side Effects:
- Severe pain anywhere in the body
- Numbness, tingling, or burning pain in hands or feet
- Severe headache, confusion, weakness, vision loss
- Seizures
- Painful or difficult urination
- Symptoms of cold, such as runny or stuffy nose, sneezing, sore throat, cough, low fever
- Eye problems, including blurred vision and sensitivity to light
- High blood pressure
- Low blood cell counts, leading to symptoms like fever, chills, tiredness, mouth sores, easy bruising, unusual bleeding, and pale skin
Patients are closely monitored for at least 2 hours after the infusion to watch for allergic reactions or other serious side effects.
Warnings and Precautions
- Allergic Reactions: Patients with known allergies to naxitamab should not use it.
- Pregnancy and Breastfeeding: Naxitamab can harm an unborn baby, so it is crucial to avoid pregnancy during treatment and for at least 2 months after the last dose. Breastfeeding is also not recommended during this period.
- Pre-existing Conditions: Inform your doctor if you have a history of high blood pressure or other chronic illnesses.
- Interactions: Naxitamab may interact with other medications, including prescription and over-the-counter drugs, vitamins, and herbal products. Patients should inform their healthcare provider about all medications they are taking.
Conclusion
Naxitamab, under the brand name Danyelza, is FDA approved for treating high-risk neuroblastoma in children and adults. It is an essential treatment option for patients whose previous cancer treatments have failed. As with any medication, it is crucial to understand the potential side effects and precautions to ensure safe and effective use.
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