Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about being given this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I being given Spevigo?
Spevigo contains the active ingredient spesolimab. Spevigo is used to treat flares
in adult patients with generalised pustular psoriasis.
2. What should I know before I am given Spevigo?
You should not be given Spevigo if you have ever had an allergic reaction to Spevigo
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Spevigo and affect how it works.
4. How do I use Spevigo?
Your doctor will administer Spevigo treatment for you using an intravenous infusion.
5. What should I know whilst being given Spevigo?
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Things you should do
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Call your doctor right away if you develop signs and symptoms of:
A serious infection, such as high fever; chills; sweating; weakness; a rapid heart rate.
Signs of problems with your nervous system, such as numbness, tingling throughout your body, arm or leg weakness, or double
or blurred vision
A serious allergic reaction, such as fever; a wide-spread skin rash; swollen glands; swollen face, lips or tongue;
yellow skin; abdominal pain; confusion or drowsiness; nausea or vomiting; difficulty
in breathing; feeling very tired or unwell.
Remind any doctor, dentist or pharmacist you visit that you are using Spevigo.
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Driving or using machines
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Spevigo is not expected to have any effect on your ability to drive or use machines
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6. Are there any side effects?
Common side effects include: urinary tract infection; upper respiratory tract infection;
itching; injection site reactions; fatigue.
Serious side effects include: serious infection; nervous system problems; allergic
reactions.
For more information, including common side effects and what to do if you have any
side effects, see Section
6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient: spesolimab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about being given Spevigo. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about being given Spevigo.
Where to find information in this leaflet:
1. Why am I being given Spevigo?
Spevigo contains the active ingredient spesolimab. Spesolimab is an interleukin inhibitor. It works by blocking a group of proteins
called interleukin 36 receptors (IL-36R) to help suppress inflammatory processes in
the body.
Spevigo is used to treat flares in adult patients with generalised pustular psoriasis.
Generalised pustular psoriasis is a rare and serious condition that causes severe
inflammation and scarring.
In generalised pustular psoriasis, the immune system does not work properly and triggers
recurrent, severe episodes of inflammation where the skin becomes red, and painful
and pus-filled blisters (pustules) appear all over the body. Inflammation of the organs
and other tissues can also occur, causing fatigue, fever, body pains, muscle weakness,
dehydration, and nausea.
By blocking IL-36R, Spevigo improves skin clearance, relieves pain and itching, and
other symptoms of a flare in patients with generalised pustular psoriasis.
2. What should I know before I am given Spevigo?
Warnings
You should not be given Spevigo if:
you are allergic to spesolimab, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
Have an infection or a history of recurrent or chronic infections
Have tuberculosis or a history of tuberculosis
Have received a live viral or bacterial vaccine within four weeks before treatment
with Spevigo
Intend to have a live viral or bacterial vaccine within 16 weeks after treatment with
Spevigo
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant, or if you
are breastfeeding or intend to breastfeed.
Your doctor will discuss with you the benefits and risks of being given Spevigo during
pregnancy and breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Live vaccines must not be given together with Spevigo.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Spevigo.
4. How do I use Spevigo?
You doctor will administer your Spevigo treatment for you. Spevigo treatment is given
using an intravenous infusion (also known as a drip). The process usually takes 90
to 180 minutes.
How much will be given
The recommended dose of Spevigo is 900 mg, given as two vials containing 450 mg/7.5mL
each.
If the flare persists, your doctor may give an additional dose of 900 mg one week
after the first treatment.
When you will be given Spevigo
Your doctor will discuss with you about when Spevigo treatment should be given to
you.
5. What should I know whilst being given Spevigo?
Things you should do
Call your doctor straight away if you develop:
Signs and symptoms of a serious infection, such as a high fever, chills, weakness, sweating, or a rapid heart rate.
Signs of problems with your nervous system, such as numbness, tingling throughout your body, arm, or leg weakness, or double
or blurred vision
Signs of a serious allergic reaction, such as fever, wide-spread skin rash with blisters and skin loss, swollen glands/face/lips/tongue,
yellowing of the skin, abdominal pain, confusion, drowsiness, nausea, vomiting, difficulty
breathing, or feeling very tired
In very rare instances, intravenous infusions can cause a very serious type of delayed
allergic reaction which can occur days or weeks after treatment.
Remind any doctor, dentist or pharmacist you visit that you are being given Spevigo.
Driving or using machines
Spevigo has little to no effect on the ability to drive and use machines.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Urinary tract infection
Burning sensation when urinating
Frequent and urgent need to urinate but only passing small amounts of urine
Cloudy, smelly, or bloody urine
Pain or pressure in the lower abdomen
Upper respiratory tract infection
Cough with or without phlegm
Congested or runny nose
Sore throat
Headache
Breathlessness, tight chest, or wheezing
Fever
Skin
Pruritis (itching)
Injection site reactions, such as pain, swelling, redness, warmth, or induration (hardening
caused by inflammation)
Brain and nervous system
Fatigue
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Serious infection
High fever
Chills
Weakness
Sweating
Rapid heart rate
Brain and nervous system
Numbness
Tingling throughout your body
Arm or leg weakness
Double or blurred vision
Allergic reactions
Fever
Wide-spread skin rash with blisters and skin loss
Swollen glands/face/lips/tongue
Yellowing of the skin
Abdominal pain
Confusion
Drowsiness
Nausea
Vomiting
Difficulty breathing
Feeling very tired
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Spevigo contains
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Active ingredient
(main ingredient)
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Spesolimab
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Other ingredients
(inactive ingredients)
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Polysorbate 20
Sodium acetate trihydrate
Sucrose
Arginine hydrochloride
Glacial acetic acid
Water for injections
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You must not be given this medicine if you are allergic to any of these ingredients.
Spevigo contains 772 mg sucrose in each 900 mg/15 mL infusion.
What Spevigo looks like
Spevigo is a colourless to slightly brown-yellow, clear to slightly opalescent solution
(AUST R 388597).
Who distributes Spevigo
Boehringer Ingelheim Pty Limited
ABN 52 000 452 308
78 Waterloo Road
North Ryde NSW 2113
This leaflet was prepared in November 2023.