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Afamitresgene AutoleucelMedical AlertYour condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada). WarningThis product may cause a serious (even fatal) reaction called cytokine release syndrome-CRS. Careful monitoring and prompt treatment may decrease your risk. Before treatment with this product, tell your doctor your medical history, especially of any current/recent infection. Tell your doctor right away if you have any symptoms of CRS such as fever, chills/shaking chills, fast/irregular heartbeat, shortness of breath, severe nausea/vomiting/diarrhea, severe headache, low blood pressure, or dizziness/lightheadedness. PrecautionsBefore receiving afamitresgene autoleucel, tell your doctor or pharmacist if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this product, tell your doctor or pharmacist your medical history, especially of: heart problems, kidney problems, liver problems, lung/breathing problems, nerve problems (such as memory loss, seizures), past/current/recent infection. This product can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details. Tell your health care professional that you are using afamitresgene autoleucel before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. This drug may make you drowsy or dizzy, affect your coordination, or make it harder for you to think clearly. Alcohol or marijuana (cannabis) can worsen these effects. Do not drive, use machinery, or do anything that needs alertness until you can do it safely (at least 4 weeks after receiving treatment is recommended by the manufacturer). Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using this product. Afamitresgene autoleucel may harm an unborn baby. Your doctor should order a pregnancy test before you start this product. If you become pregnant, talk to your doctor right away about the risks and benefits of this product. It is unknown if this product passes into breast milk. Consult your doctor before breastfeeding. Side EffectsSee also Warning section. Nausea, vomiting, constipation, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk. Serious nerve problems can occur after treatment with afamitresgene autoleucel. Tell your doctor right away if you have drowsiness, seizures, mental/mood changes (such as confusion, anxiety, memory loss), or trouble with reading, writing, speaking, or understanding. Although afamitresgene autoleucel is used to treat cancer, it may rarely increase your risk of developing other cancers. Also, this product may cause a severe decrease in your blood cells, which lowers your ability to fight infections and increases the risk of anemia/bleeding problems. You may be more likely to get a serious (rarely fatal) infection and any infection you have may get worse. Tell your doctor right away if you develop unusual growths or lumps, swollen glands, signs of infection (such as a sore throat that doesn't go away, fever, chills), easy or unusual bruising/bleeding, or unusual tiredness. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. |