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ONASEMNOGENE ABEPARVOVEC (ON a SEM noe jeen A be PAR voe vek) is used to treat patients with spinal muscular atrophy (SMA). It is not a cure.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
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This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as newborns for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
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Interactions are not expected.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
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Your condition will be monitored carefully while you are receiving this medicine. You will need blood work done while you are taking this medicine.
This medicine may be present in urine and stool. Special care for handling body waste, trash, laundry, spills, and family interactions may be needed. Talk to your healthcare professional about how to protect yourself and family.
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This does not apply. This medicine is not for regular use.
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Side effects that you should report to your doctor or health care professional as soon as possible:
-allergic reactions like skin rash, itching or hives; swelling of the face, lips, or tongue
-signs and symptoms of infection like fever; chills; cough; sore throat
-signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
-unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):
-vomiting
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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This medicine is given in a hospital or clinic and will not be stored at home.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.