Danyelza price | Danyelza cost | 100% Good Quality

$197,860.00

Danyelza (naxitamab) is a prescription medicine used to treat high-risk neuroblastoma (a rare form of cancer) in adults and children at least 1 year old. Danyelza price | Danyelza cost.

Description

What is DANYELZA and how is it used? | Danyelza price Danyelza cost

DANYELZA, Danyelza price Danyelza cost is a prescription medicine used in combination with a medicine called granulocytemacrophage colony-stimulating factor (GM-CSF) to treat children 1 year of age and older and adults with high-risk neuroblastoma in the bone or bone marrow that:

  • has come back (relapsed) or that did not respond to previous treatment (refractory), and
  • has shown a partial response, minor response, or stable disease to prior therapy.

What are the possible side effects of DANYELZA? | Danyelza price Danyelza cost

DANYELZA may cause serious side effects, including:

  • See “What is the most important information I should know about DANYELZA?”
  • High blood pressure (hypertension). High blood pressure is common in people who receive DANYELZA. Your blood pressure will be monitored during your DANYELZA infusion, and at least each day on Days 1 to 8 of each DANYELZA treatment cycle. Tell your healthcare provider right away if you get any signs or symptoms of high blood pressure, including:
    • headaches
    • seizures
    • nausea or vomiting
    • chest pain
    • dizziness
    • visual changes
    • shortness of breath
    • feeling that your heart is pounding or racing (palpitations)
    • nose bleeds

The most common side effects of DANYELZA include:

  • fast heart rate
  • vomiting
  • cough
  • nausea
  • decreased white blood cell, red blood cell, and platelet counts
  • diarrhea
  • decreased appetite
  • tiredness
  • skin rashes
  • decreased level of potassium, sodium, and phosphate in the blood
  • hives
  • fever
  • headache
  • injection site reaction
  • swelling of the body or only in one part of the body
  • anxiety
  • irritability
  • increased liver function blood tests
  • decreased blood sugar level
  • decreased calcium levels in the blood
  • decreased protein levels (albumin) in the blood

These are not all of the possible side effects of DANYELZA.

Warnings

Danyelza can cause serious side effects. Call your doctor at once if you have pain or a severe headachenumbness or tingling, weakness, problems with speech or thought, vision problems, painful urination, fast or pounding heartbeats, chest pain, or a seizure. Danyelza price Danyelza cost

Tell your caregiver if you have any of these side effects during the injection: feeling dizzy or light-headed, itching, warmth or tingling, shortness of breath, noisy breathing, or swelling in your face. Danyelza price Danyelza cost

Before taking this medicine

You should not be treated with Danyelza if you are allergic to naxitamab.

To make sure Danyelza is safe for you, tell your doctor if you have ever had: high blood pressure.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Danyelza if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose. Danyelza price Danyelza cost

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

How is Danyelza given?

Danyelza is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take 30 to 60 minutes to complete.

Danyelza is usually given in a 28-day treatment cycle, repeated every 4 or 8 weeks. You may need to use the medicine only during the first week of each cycle. Your doctor will determine how long to treat you with this medicine.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

You will be watched closely for at least 2 hours after the injection to make sure you do not have an allergic reaction or certain side effects.

You may need frequent blood tests to be sure this medicine is not causing harmful effects. Your blood pressure will also need to be checked often.

PRECAUTIONS

Serious Infusion-Related Reactions

DANYELZA can cause serious infusion reactions requiring urgent intervention including fluid resuscitation, administration of bronchodilators and corticosteroids, intensive care unit admission, infusion rate reduction or interruption of this medication infusion. Infusion-related reactions included hypotension, bronchospasm, hypoxia, and stridor [see ADVERSE REACTIONS]. Danyelza price Danyelza cost

Serious infusion-related reactions occurred in 4% of patients in Study 201 and in 18% of patients in Study 12-230. Infusion-related reactions of any Grade occurred in 100% of patients in Study 201 and 94% of patients in Study 12­-230. Hypotension of any grade occurred in 100% of patients in Study 201 and 89% of patients in Study 12-230. Danyelza price Danyelza cost

In Study 201, 68% of patients experienced Grade 3 or 4 infusion reactions; and in Study 12-230, 32% of patients experienced Grade 3 or 4 infusion reactions. Anaphylaxis occurred in 12% of patients and 2 patients (8%) permanently discontinued this medication due to anaphylaxis in Study 201. One patient in Study 12-230 (1.4%) experienced a Grade 4 cardiac arrest 1.5 hours following completion of this medication infusion. Danyelza price Danyelza cost

In Study 201, infusion reactions generally occurred within 24 hours of completing a DANYELZA infusion, most often within 30 minutes of initiation. Infusion reactions were most frequent during the first infusion of this medication in each cycle. Eighty percent of patients required reduction in infusion rate and 80% of patients had an infusion interrupted for at least one infusion-related reaction. Danyelza price Danyelza cost

Premedicate with an antihistamine, acetaminophen, an H2 antagonist and corticosteroid as recommended [see DOSAGE AND ADMINISTRATION]. Monitor patients closely for signs and symptoms of infusion reactions during and for at least 2 hours following completion of each this medication infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Danyelza price Danyelza cost

Reduce the rate, interrupt infusion, or permanently discontinue this medication based on severity and institute appropriate medical management as needed [see DOSAGE AND ADMINISTRATION and CONTRAINDICATIONS]. Danyelza price Danyelza cost

Danyelza side effects

Get emergency medical help if you have signs of an allergic reaction to Danyelza: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, light-headed, itchy, warm or tingly, short of breath, or if you have a cough, noisy breathing, or swelling in your face.

Call your doctor at once if you have:

  • severe pain anywhere in your body;
  • numbness, tingling, or burning pain in your hands or feet;
  • severe headache, confusion, thinking problems, weakness, vision loss;
  • a seizure;
  • painful or difficult urination;
  • cold symptoms – such as runny or stuffy nose, sneezing, sore throat, cough, low fever, and not feeling well;
  • eye problems – blurred vision, trouble focusing, dilated pupils, unequal pupil size, being more sensitive to light;
  • high blood pressure – headache, nauseavomitingdizziness, vision changes, nosebleeds, chest pain, fast or pounding heartbeats, pounding in your neck or ears; or
  • low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Danyelza side effects may include:

  • nausea, vomiting, diarrhea, loss of appetite;
  • low blood cell counts, or other abnormal lab tests;
  • skin rash or hives;
  • swelling;
  • headache, fever, feeling tired;
  • fast heart rate;
  • feeling anxious or irritable;
  • cough; or
  • pain, bruising, swelling, or irritation where the medicine was injected.

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