Iptacopan is used to treat a certain blood disorder
(paroxysmal nocturnal hemoglobinuria - PNH). This disorder causes your
body's immune system to break down red blood cells, which results in
anemia. Iptacopan works by helping to block the body's breakdown of red
blood cells. This effect helps lessen symptoms of anemia (such as
tiredness, shortness of breath) and may reduce the need for blood
transfusions.
This medication is also used to treat certain kidney
problems (such as primary immunoglobulin A nephropathy - IgAN, complement 3
glomerulopathy - C3G). Iptacopan helps to lower levels of protein in the
urine.
Read the Medication Guide provided by your pharmacist
before you start taking iptacopan and each time you get a refill. Carry the
Patient Safety Card with you at all times during treatment and for 2 weeks
after your last dose of iptacopan. If you have any questions, ask your
doctor or pharmacist.
Take this medication by mouth with or without food as
directed by your doctor, usually twice daily. Swallow the capsule whole. Do
not open, break, or chew the capsules.
Do not increase your dose or use this drug more often or
for longer than prescribed. Your condition will not improve any faster, and
your risk of side effects will increase.
Use this medication regularly to get the most benefit
from it. To help you remember, take it at the same times each
day.
If you are changing to this medication treatment from
another drug, carefully follow your doctor's directions for when to start
or stop this and your other medication(s). Do not stop taking this
medication without consulting your doctor. If you are taking this
medication for PNH, your condition may become worse when the drug is
stopped. If you do stop taking this medication, your doctor will monitor
you for at least 2 weeks after the last dose to make sure your condition
does not get worse. Consult your doctor for more details.
Tell your doctor if your condition does not get better
or if it gets worse.
See also Warning section.
Headache, cold symptoms (stuffy/runny nose, cough),
nausea, diarrhea, abdominal pain, joint pain, or dizziness 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.
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 taking iptacopan, 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, especially of:
- current/recent infection
- liver disease
Iptacopan can make you more likely to get certain
infections (such as colds, meningitis). Talk to your doctor for more
details.
Tell your doctor your vaccine history and ask if you
need to get any vaccines before starting treatment with this medication.
Tell your health care professional that you are using iptacopan before
having any immunizations/vaccinations. Avoid contact with people who have
recently received live vaccines (such as flu vaccine inhaled through the
nose).
This drug 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).
Before having surgery, tell your doctor or dentist about
all the products you use (including prescription drugs, nonprescription
drugs, and herbal products).
During pregnancy, this medication should be used only
when clearly needed. Discuss the risks and benefits with your
doctor.
It is unknown if this medication passes into breast
milk. Breastfeeding is not recommended while using this medication and for
5 days after the last dose. 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.
Other medications can affect the removal of iptacopan
from your body, which may affect how iptacopan works. An example of an
affected drug is gemfibrozil, among others.
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 complete blood count,
blood cholesterol/triglyceride level) should be done while you are taking
this medication. Keep all medical and lab appointments. Consult your doctor
for more details.
If you miss one or more doses, take one dose as soon as
you remember. Then take your next dose at the regular time. Do not double
the dose to catch up.
Store at room temperature away from light and moisture.
Do not store in the bathroom. 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.
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).