This product is used to treat a certain nervous system
disorder that can lead to muscle weakness and muscle loss (spinal muscular
atrophy). Onasemnogene abeparvovec is made from a certain virus that has
been specially prepared. The virus is used to carry a certain human gene
into cells. This type of treatment is known as gene therapy. Treatment may
improve motor function.
This product is given as directed by your doctor,
usually as a single dose. Depending on your brand, this product is given by
slow injection into a vein or into the area around the spinal cord
(intrathecal) by a health care professional. The dosage may be based on
your body weight if this product is given into a vein.
Infusion reactions may happen during the infusion of
this product into a vein. Tell your doctor right away if you have any
symptoms of infusion reactions such as flushing, swelling of the
face/tongue/throat, rash, vomiting, or shortness of breath. Your doctor may
give you other medications to help with these side effects or may slow down
or stop your treatment for some time.
If this product is given into a vein, small amounts of
virus may shed from your stool for up to 1 month after the injection. Ask
your doctor how to handle and dispose of waste materials (such as diapers)
for up to 1 month after the injection.
See also Warning and How to Use sections.
Vomiting may occur when this product is given into a
vein. Headache or dizziness may occur when this product is given into the
area around the spinal cord. If any of these effects last or get worse,
tell your doctor or pharmacist promptly.
Remember that this product has been prescribed because
your doctor has judged that the benefit to you is greater than the risk of
side effects. Many people using this product do not have serious side
effects.
When this product is given into the area around the
spinal cord, numbness/tingling/pain in the arms/legs may occur. Tell your
doctor right away if you have these serious side effects.
Tell your doctor right away if you have any serious side
effects, including:
- easy bleeding/bruising
- signs of kidney problems (such as change in the amount of
urine)
Get medical help right away if you have any very serious
side effects, including:
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.
Before this product is given, 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
the pharmacist for more details.
Before using this product, tell your doctor or
pharmacist your medical history, especially of:
- liver problems (including cirrhosis, fatty liver disease,
hepatitis B or C)
- current/recent infection
This product may make you dizzy. Alcohol or marijuana
(cannabis) can make you more dizzy. Do not drive, use machinery, or do
anything that needs alertness until you can do it safely. Limit alcoholic
beverages. Talk to your doctor if you are using marijuana
(cannabis).
Onasemnogene abeparvovec 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 the health care professional that you have received
this product before having any immunizations/vaccinations. Avoid contact
with people who have recently received live vaccines (such as flu vaccine
inhaled through the nose).
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 onasemnogene
abeparvovec. Onasemnogene abeparvovec may harm an unborn baby. Your doctor
should order a pregnancy test before you start this product. Women should
ask about the use of reliable forms of birth control for 6 months after
treatment. Men should ask about the use of reliable forms of birth control
for 3 months after treatment. If you or your partner becomes 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.
Drug interactions may change how your medications work
or increase your risk for serious side effects. This document does not
contain all possible drug interactions. Keep a list of all the products you
use (including prescription/nonprescription drugs and herbal products) and
share it with your doctor and pharmacist. Do not start, stop, or change the
dosage of any medicines without your doctor's approval.
If someone has overdosed and has serious symptoms such
as passing out or trouble breathing, call 911. Otherwise, call a poison
control center right away. US residents can call 1-800-222-1222. Canada
residents can call 1-844-764-7669.
Lab and/or medical tests (such as liver/kidney function,
complete blood count) must be done before you start receiving this product
and after you receive it. Keep all medical and lab
appointments.
After receiving this treatment, ask your doctor if you
can donate blood, organs, tissues, or cells.
Not applicable. This type of product is given in a
hospital or clinic and will not be stored at home.
Your 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).
