Danyelza (Naxitamab-gqgk)
- Name: Danyelza
- Generic Name: Naxitamab
- Dosage Form & Strength: Injection: 40 mg/10 mL (4 mg/mL) in a single-dose vial
- Manufactured By: Y-mAbs Therapeutics, Inc.
Medical Uses
Danyelza is used, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), to treat pediatric patients aged 1 year and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have a partial response, minor response, or stable disease to prior therapy.
Recommended Dosage: The recommended dosage of Danyelza injection is 3 mg/kg/day (up to 150 mg/day), administered as an intravenous infusion after dilution on Days 1, 3, & 5 of each treatment cycle. Repeat the treatment cycles every four weeks until the complete response or partial response, followed by the five additional cycles every four weeks. Subsequent treatment cycles may be repeated every eight weeks. Discontinue Danyelza dosage and GM-CSF for disease progression or unacceptable toxicity. Administer GM-CSF subcutaneously before and during each treatment cycle as recommended.
Warning & Precautions
- Use of danyelza 40 mg injection is restricted in patients with a history of severe hypersensitivity reaction to naxitamab.
- Naxitamab may cause severe neurotoxicity, including transverse myelitis, severe neuropathic pain, and reversible posterior leukoencephalopathy syndrome.
- Transverse myelitis has appeared with 40 mg Danyelza Injection. Permanently discontinue this medicine in patients who develop transverse myelitis.
- Avoid initiating Naxitamab in patients with uncontrolled hypertension. Monitor blood pressure while on infusion, and at least daily on Days 1-8 of each cycle and assess for complications of hypertension including RPLS.
- The danyelza neuroblastoma medicine may cause fetal harm if used in a pregnant woman. Advise women of reproductive age, including pregnant women, of the potential risk to a fetus.
Documentation & Availability
What documents are required to import DANYELZA to India?
DANYELZA (naxitamab-gqgk) can be imported by patients or government hospitals on the name of the patients only.
The following documentation are needed to import the product:
- A valid prescription from a qualified doctor.
- Patient’s diagnostic reports.
- Patient’s ID proof (issued by the Government of the respective country).
How is the order confirmed?
The order will be confirmed only after the receipt of:
- A valid prescription from a doctor.
- Import permit if applicable.
Is DANYELZA available in India?
DANYELZA (naxitamab-gqgk) is a (prescription drug, prescription medication or prescription medicine) pharmaceutical drug that legally requires a medical prescription to be dispensed.
S S Healthcare (S S Healthcare) helps import cancer medicines on the named patient supply (NPS). S S Healthcare is facilitator providing input
- On availability in India (Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore and Pune etc.)
- Medicine Price.
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- Ensuring 100% transparency.
DANYELZA can be made available to patients, doctors and hospitals at Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Srinagar, Jammu, Jaipur, Chandigarh, Ludhiana, Noida, Gurgaon, Lucknow and Pune and other cities in India. The order will be confirmed only after the receipt of a valid prescription from the doctor and import permit.
S S Healthcare (S S Healthcare) can facilitate the supply of DANYELZA (prescription medicines) to all locations in the world and in India after fulfilling the legal requirement (if applicable)
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Sourcing & Delivery
S S Healthcare is able to source the DANYELZA (Cancer Treatment Medicines) from across the globe, and has the ability to supply. S S Healthcare offers its customers worldwide access to the best available treatment.
S S Healthcare is able to dispense any valid prescription in the shortest possible time. All prescriptions are dispensed and checked by registered pharmacists and dispatched to the Patient’s address only from New Delhi, India.
FAQ
What is the Generic Name for the trade name drug Danyelza® ?
Naxitamab-gqgk is Generic Name for the trade name drug Danyelza®.
What is the Manufacturer Name of Danyelza®?
Danyelza® is manufactured by Y-mAbs Therapeutics, Inc.
Is Danyelza® approved by the FDA?
Yes, Danyelza® is approved by the FDA. Date of approval: November 25, 2020.
What is the dosage and form of Danyelza® available?
Danyelza® is available as Injection: 40 mg/10 mL (4 mg/mL) in a single-dose vial for intravenous infusion.
Is it safe to buy Danyelza® injections online?
Yes, In order to buy Danyelza (naxitamab-gqgk) online, always look for an authentic and WHO-GDP & ISO certified pharmaceutical wholesaler/distributor/supplier.
What are the most common side effects due to Danyelza®?
Most common side effects due to Danyelza® include: pain, infusion-related reactions, fast heart beats, cough, vomiting, nausea, decreased appetite, hypertension, diarrhea, fatigue, urticaria, pyrexia, injection site reaction, headache, localized edema, edema, anxiety, and irritability.
What are the storage conditions of Danyelza®?
Store the vials of Danyelza at 2°C to 8°C (36°F to 46°F) in the outer carton in order to protect from light until time of use.
How much does Danyelza® cost in India?
You can call or WhatsApp +91-7575883015 or send mail to sshealthcare1012@gmail.com to know the danyelza cost in India.
What are the Highlights of prescribing information for Danyelza®?
Click Here to download full Danyelza prescribing information.
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