Casimersen
Generic name: casimersen [ KAS-i-MER-sen ]
Brand name: Amondys 45
Dosage form: intravenous solution (100 mg/2 mL)
Drug class: Miscellaneous uncategorized agents
What is casimersen?
Casimersen is used to treat Duchenne muscular dystrophy in adults and children who have a certain gene mutation. Your doctor will test you for this gene mutation.
Casimersen was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to casimersen, but further studies are needed.
Casimersen may also be used for purposes not listed in this medication guide.
Casimersen side effects
Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash, blistering or peeling; fever; difficult breathing; swelling of your face, lips, tongue, or throat.
Casimersen may cause serious side effects. Call your doctor at once if you have:
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pink, brown, or red urine;
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foamy urine; or
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swelling in your face, hands, feet, or stomach.
Common side effects of casimersen may include:
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fever;
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cough; or
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cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Warnings
Before using casimersen tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breastfeeding.
Before taking this medicine
Tell your doctor if you have ever had kidney problems.
Tell your doctor if you are pregnant or breastfeeding.
How should I take casimersen?
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using casimersen.
Casimersen is given as an infusion into a vein, usually once per week. A healthcare provider will give you this injection.
casimersen must be given slowly, and the infusion can take 35 to 60 minutes to complete.
Your kidney function may need to be checked while you are using this medicine.
Casimersen doses are based on weight. Your dose needs may change if you gain or lose weight.
Casimersen dosing information
Usual Adult Dose for Muscular Dystrophy:
30 mg/kg via IV infusion once a week
Comments:
-This drug has been approved under an accelerated approval based on an increase in dystrophin production in skeletal muscle; continued approval may be contingent upon verification of a clinical benefit in confirmatory trials.
Use: For the treatment of DMD in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.
Usual Pediatric Dose for Muscular Dystrophy:
30 mg/kg via IV infusion once a week
Comments:
-This drug has been approved under an accelerated approval based on an increase in dystrophin production in skeletal muscle; continued approval may be contingent upon verification of a clinical benefit in confirmatory trials.
Use: For the treatment of DMD in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.
Related/similar drugs
Elevidys, deflazacort, Agamree, Duvyzat, Emflaza, eteplirsen
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your casimersen injection.
What happens if I overdose?
Since casimersen is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while taking casimersen?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect casimersen?
Other drugs may affect casimersen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
More about casimersen
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- Drug class: miscellaneous uncategorized agents
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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