This medication is used to treat a severe form of
psoriasis (generalized pustular psoriasis). Spesolimab belongs to a class
of drugs known as monoclonal antibodies. It works by blocking a certain
natural protein in your body (interleukin-36) that may cause inflammation
and swelling.
Read the Medication Guide provided by your pharmacist
before you start using spesolimab and each time you get a refill. If you
have any questions, ask your doctor or pharmacist.
Before treatment with this medication, your doctor will
test you for tuberculosis (TB). Your doctor should also monitor you for
symptoms of TB during and after treatment with this drug. If needed,
treatment for TB or other infections should be given before using this
medication.
This medication is given by injection into a vein as
directed by your doctor, usually as a single dose injected over 90 minutes.
If your symptoms continue, your doctor may prescribe a second dose, usually
1 week after the first dose. The dosage and treatment schedule are based on
your medical condition and response to treatment.
Infusion reactions may happen during the infusion of
this drug. Tell your doctor right away if you have any symptoms of infusion
reactions such as dizziness, lightheadedness, trouble breathing, fever,
chest tightness, or itching. Your doctor may give you other medications to
help with these side effects or may slow down or stop your treatment for
some time.
Tell your doctor if your condition does not get better
or if it gets worse.
Headache, nausea, vomiting, tiredness, or weakness may
occur. Pain, redness, swelling, or bruising at the injection site may also
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.
This medication may lower your ability to fight
infections. This may make you more likely to get a serious (rarely fatal)
infection or make any infection you have worse. Get medical help right away
if you have any signs of infection (such as sore throat that doesn't go
away, fever, swollen lymph nodes, chills, cough).
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 using spesolimab, 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/returning infection (such as tuberculosis,
herpes)
Spesolimab can make you more likely to get infections or
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 your health care professional that you are using
spesolimab before having any immunizations/vaccinations. Avoid getting a
live vaccine while using this medication and for 16 weeks after the last
dose. 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).
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. 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.
Keep all medical and lab appointments.
Not applicable. This medication is given in a hospital
or clinic or doctor's office and will not be stored at
home.
