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Emapalumab-lzsg Injection

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Why is this medication prescribed?

Emapalumab-lzsg injection is used to treat adults and children (newborn and older) who have primary hemophagocytic lymphohistiocytosis (HLH; an inherited condition in which the immune system malfunctions and causes swelling and damage to the liver, brain, and bone marrow), and whose disease has not improved, has gotten worse, has returned, or who are unable to take other medications. Monoclonal antibodies are a class of drugs that include emapalumab-lzsg injection. It functions by preventing the immune system’s production of a specific protein that triggers inflammation.

How should this medicine be used?

Emapalumab-lzsg is administered as a liquid over the course of an hour by a physician or nurse in a hospital or other healthcare setting. For as long as your doctor advises you to receive treatment, it is typically administered twice per week, every 3 or 4 days.

Your doctor might begin you on a low dose of emapalumab-lzsg injection and progressively raise it up to once every three days.

A severe reaction to emapalumab-lzsg injection may occur while or soon after the medicine is infused. As you take the drug, a doctor or nurse will keep a close eye on you. Tell your doctor right away if you suffer any of the following symptoms: Skin redness, itchiness, fever, rash, excessive perspiration, chills, nausea, vomiting, lightheadedness, dizziness, chest discomfort, or shortness of breath are all symptoms that should be reported.

When you start therapy with emapalumab-lzsg injection and each time you get the drug, your doctor or pharmacist will give you the manufacturer’s patient information leaflet (drug Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. 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).

Other uses for this medicine

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

What special precautions should I follow?

Before receiving emapalumab-lzsg injection,

  • If you have an allergy to emapalumab-lzsg, any other drugs, or any of the ingredients in emapalumab-lzsg injection, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor of any medical conditions you now have or have ever had.
  • Inform your doctor and pharmacist 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 doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you get pregnant while getting emapalumab-lzsg injection.
  • You should be aware that emapalumab-lzsg injection may reduce your capacity to fight infection from bacteria, viruses, and fungi and raise your risk of developing a serious or lethal infection. Infections of any kind are common; if you currently have one or suspect one, let your doctor know. Included in this are transient infections (like cold sores or herpes), mild infections (such open cuts or sores), and persistent illnesses that persist over time. Call your doctor right away if you have any of the following signs and symptoms throughout or soon after receiving an injection of emapalumab-lzsg: Symptoms of infection include fever, sweats, or chills; muscle aches; cough; bloody mucus; shortness of breath; sore throat; difficulty swallowing; warm, red, or painful skin or sores on your body; diarrhea; stomach pain; frequent, urgent, or painful urination; or other symptoms.
  • You should be aware that getting emapalumab-lzsg injection increases your risk of contracting tuberculosis (TB; a dangerous lung infection), particularly if you currently have TB but do not exhibit any symptoms of the illness. Inform your doctor if you have TB, have ever had TB, have lived in a country where TB is prevalent, or have come into contact with someone who has TB. Before beginning your emapalumab-lzsg injection treatment, your doctor will test you for TB. If you have a history of TB or have active TB, they may treat you for it. Call your doctor right once if you have any of the following TB symptoms or if you acquire any of these symptoms while receiving treatment for the disease: Cough, coughing up blood or mucus, weakness or exhaustion, weight loss, appetite loss, chills, fever, or night sweats are other symptoms.
  • During and for at least 4 weeks following your final dose of emapalumab-lzsg injection, avoid getting any shots without first consulting your doctor.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What side effects can this medication cause?

The injection of emapalumab-lzsg may have unwanted effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Constipation
  • A nosebleed

Some adverse effects can be very harmful. Emapalumab-lzsg injection should be stopped immediately if you have any of the following symptoms, along with those mentioned in the HOW and SPECIAL PRECAUTIONS sections, and you should seek emergency medical attention if necessary:

  • Irregular, quick, or sluggish heartbeat
  • Rapid respiration
  • Muscular pain
  • Feeling numb and tingly
  • Dark, tarry, or bloody stools
  • Vomit blood or a dark substance that looks like coffee grinds
  • Less urinations
  • Edema in the lower legs, ankles, feet, or hands

Other negative effects from emapalumab-lzsg injection are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. Before and during your emapalumab-lzsg injectable treatment, your doctor will request specific lab tests to determine how well your body is responding to the drug. Your blood pressure will also be periodically checked.

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

  • Gamifant®
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