This medication is used to treat symptoms due to a
certain inherited disorder (acid sphingomyelinase deficiency-ASMD). This
condition causes buildup of a fatty substance called sphingomyelin in
various parts of the body. Olipudase alfa is an enzyme that helps break
down sphingomyelin. It is not a cure for ASMD, but it can help decrease
some symptoms caused by this disorder such as enlarged spleen and
liver.
Read the Patient Information Leaflet if available from
your pharmacist before you start using olipudase alfa and each time you get
a refill. If you have any questions, ask your doctor or
pharmacist.
This medication is given by slow injection into a vein
as directed by your doctor. The first 2 doses are usually given 1 week
apart, followed by injections every 2 weeks. To reduce your risk of side
effects, your doctor may direct you to start this medication at a low dose
and gradually increase your dose.
If you are using this medication at home, learn all
preparation and usage instructions from your health care professional.
Before using, check this product for particles or discoloration. If either
is present, do not use the liquid. Learn how to store and discard medical
supplies safely.
The dosage is based on your medical condition, weight,
and response to treatment.
To get the most benefit, do not miss any doses. To help
you remember, mark your calendar with a reminder.
Tell your doctor if your condition does not get better
or if it gets worse.
See also Warning section.
Pain/redness/swelling at the infusion site, headache,
muscle/joint pain, tiredness, watering eyes, itching, nausea, vomiting, or
diarrhea may occur. If any of these effects last or get worse, tell your
doctor or pharmacist promptly.
Remember that this medication 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 medication do not have serious
side effects.
Tell your doctor right away if you have any serious side
effects, including:
- signs of liver problems (nausea/vomiting that doesn't stop,
loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark
urine)
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 using olipudase alfa, tell your doctor or
pharmacist if you are allergic to it; or if you have any other 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 medication, tell your doctor or
pharmacist your medical history.
Before having surgery, tell your doctor or dentist about
all the products you use (including prescription drugs, nonprescription
drugs, and herbal products).
Children may be more sensitive to the side effects of
this drug, especially allergic and infusion reactions.
Tell your doctor if you are pregnant or plan to become
pregnant. You should not become pregnant while using olipudase alfa.
Olipudase alfa may harm an unborn baby. Your doctor should order a
pregnancy test before you start this medication. Ask about reliable forms
of birth control while using this medication and for 14 days after the last
dose. If you become pregnant, talk to your doctor right away about the
risks and benefits of this medication.
It is unknown if this medication 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.
Do not share this medication with others.
Lab and/or medical tests (such as liver and spleen
measurements, complete blood counts) should be done while you are using
this medication. Keep all medical and lab appointments.
It is important to get each dose of this medication as
scheduled. If you miss a dose, ask your doctor or pharmacist right away for
a new dosing schedule.
Store in the refrigerator. Do not freeze. Keep all
medications away from children and pets.
Do not flush medications down the toilet or pour them
into a drain unless instructed to do so. Properly discard this product when
it is expired or no longer needed. Consult your pharmacist or local waste
disposal company.