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Danyelza (Generic Naxitamab-gqgk Injection)

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WARNING

Injection of naxitamab-gqgk may result in adverse effects that are serious or fatal. When getting the infusion and for at least two hours later, a doctor or nurse will keep a close eye on you or your kid to administer treatment in case of a severe reaction to the medication. To avoid or treat infusion responses, different drugs may be administered both before and during naxitamab-gqgk. If you have any of the following symptoms during or after your infusion, call your doctor right away: Hives, rash, itching, reddening of the skin, fever, chills, wheezing or trouble breathing or swallowing, swelling of the face, throat, tongue, or lips, feeling faint or dizzy, or a rapid heartbeat.

Nerve injury brought on by naxitamab-gqgk injection may result in pain or other symptoms. Painkillers may be administered to you or your kid prior to, during, and following the naxitamab-gqgk infusion. If you or your kid experiences any of the following symptoms both during and after the infusion, contact your doctor or other healthcare provider(s) right away. Seizures, confusion, or decreased alertness may accompany severe or worsening pain, particularly in the stomach, back, chest, muscles, or joints; numbness, tingling, burning, or weakness in the feet or hands; difficulty urinating or emptying your bladder; headache; blurred vision, vision changes, a larger pupil size, difficulty focusing, or sensitivity to light.

The manufacturer’s patient information sheet (Medication Guide) will be sent to you by your doctor or chemist when you start taking naxitamab-gqgk and each time you get a prescription refill. If you have any questions, carefully read the information and ask your doctor or chemist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Discuss the potential risks of receiving naxitamab-gqgk with your doctor.

Why is this medication prescribed?

For the treatment of neuroblastoma (a cancer that starts in nerve cells) in the bone or bone marrow that has returned or that has not responded to a previous treatment but has responded to other treatments, naxitamab-gqgk injection is used in conjunction with another drug in adults and children aged one year and older. A group of drugs known as monoclonal antibodies includes naxitamab-gqgk injection. It kills cancer cells to do its job.

How should this medicine be used?

Naxitamab-gqgk is administered intravenously (into a vein) over the course of 30 to 60 minutes by a doctor or nurse at a hospital or infusion centre. It is typically administered on days 1, 3, and 5 of a 28-day treatment cycle, and depending on your reaction, it might be given again. Your doctor can advise additional treatment cycles every eight weeks after the initial treatment.

To assist you avoid specific side effects, your doctor may likely administer additional medications both before and during each dose. Your therapy may need to be stopped temporarily or permanently by your doctor, or your dosage of naxitamab-gqgk may need to be reduced. The effectiveness of the drug and any negative side effects you encounter will determine this. During the course of your naxitamab-gqgk medication, be sure to let your doctor know how you are feeling.

Other uses for this medicine

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving naxitamab-gqgk,

  • If you have an allergy to naxitamab-gqgk, any other drugs, or any of the chemicals in naxitamab-gqgk injection, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your chemist.
  • Inform your doctor and chemist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your physician if you have ever experienced urine retention or high blood pressure (sudden inability to urinate).
  • If you are pregnant or plan to become pregnant, let your doctor know. Before beginning treatment, you must perform a pregnancy test. Throughout your therapy and for two months following your last dose, you should take an effective form of birth control. Call your doctor if you get pregnant while taking naxitamab-gqgk. The foetus can suffer from naxitamab-gqgk.
  • Describe to your doctor if you are nursing a baby. For two months following your final dosage of naxitamab-gqgk and while you are receiving therapy, you shouldn’t breastfeed.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Call your doctor as soon as you can if you are unable to keep a scheduled appointment to receive naxitamab-gqgk.

What side effects can this medication cause?

There could be adverse consequences from naxitamab-gqgk. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Vomiting
  • Nausea
  • Diarrhea
  • Reduced appetite
  • Anxiety
  • Tiredness
  • Cough, runny nose, fever, or other infection-related symptoms

Certain adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT CAUTION section:

  • Dizziness, shortness of breath, fast or irregular pulse, severe headache, nasal bleeds, or exhaustion

Further negative effects of naxitamab-gqgk are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What other information should I know?

Keep all of your appointments with your physician and the lab. In order to monitor your body’s reaction to naxitamab-gqgk, your doctor will conduct specific tests and check your blood pressure at specific points during your treatment cycle.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Danyelza®
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