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CASGEVY is a cellular gene therapy whose active ingredient is autologous CD34 hematopoietic stem cells (HSCs) edited using CRISPR/Cas9 technology to increase fetal hemoglobin production. It is formulated as a frozen suspension that is thawed for administration as a hematopoietic stem cell transplant. The suspension includes 5% dimethyl sulfoxide (DMSO) and dextran 40.
How should I use this medication?
This medication is infused into a vein. It is given by your care team in a hospital or clinic setting.
This therapy uses your own stem cells. Your care team will give you other medications as part of your treatment. Before therapy, your care team will give you a medication that helps move your stem cells from your bone marrow to the blood stream, so they can collect them. This is called mobilization. These cells will be used to make your treatment. Shortly before you receive treatment, you will receive another medication that helps prepare your body for the stem cell transplant. This is called conditioning.
Talk to your care team about the use of this medication in children. While it may be given to children as young as 12 years 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.
What if I miss a dose?
This does not apply. This medication is not for regular use.
Where should I keep my medication?
This medication is given in a hospital or clinic. It 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.
What side effects may I notice from receiving this medication?
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
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.
What should I tell my care team before I take this medication?
They need to know if you have any of these conditions:
What may interact with this medication?
Certain medications should be stopped weeks to months before starting any phase of treatment. Talk to your care team about all of the medications you take before you begin treatment.
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.
What should I watch for while using this medication?
Your condition will be monitored carefully while you are receiving this medication.
You may need blood work done while you are taking this medication.
Do not donate blood, organs, tissues, or cells any time after receiving this treatment.
Talk to your care team if you may be pregnant. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for at least 6 months after your last dose. Your care team can help you find the option that works for you.
Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.
If your partner can get pregnant, use a condom during sex while taking this medication and for at least 6 months after the last dose.
The conditioning medication may cause infertility. Talk to your care team if you are concerned about your fertility.
Source: This information is sourced from Elsevier Inc.
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Prescription medications affect individuals differently, and what works for one person may not work for another. Always consult your doctor, pharmacist, or other qualified healthcare provider to ensure the information displayed applies to your personal circumstances. Only a licensed healthcare provider can advise you on what is safe and effective for you.
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