GET STARTED
Once you and your dermatologist decide that SPEVIGO® (spesolimab-sbzo) injection might be an option for you, it’s time to talk details. Learn more about how SPEVIGO is given and steps you can take to prepare for your treatment.
SPEVIGO is a prescription medicine used to treat generalized pustular psoriasis (GPP) in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg). It is not known if SPEVIGO is safe and effective in children under 12 years of age or who weigh less than 88 pounds (40 kg).
HOW SPEVIGO IS GIVEN
To treat a GPP flare, SPEVIGO is prescribed as an intravenous (IV) infusion that is given by a healthcare professional when a flare occurs. To help treat GPP when not experiencing a flare, SPEVIGO is prescribed as subcutaneous (SC) injections every 4 weeks. Depending on your situation, you and your dermatologist may decide to first treat your GPP flare with SPEVIGO IV and then treat your GPP when not flaring with SPEVIGO SC.
IV INFUSION
If you are experiencing a GPP flare, your dermatologist may prescribe a SPEVIGO IV infusion. Infusion therapy refers to medications that are administered directly into your veins through an IV or intravenous infusion.
- Infusion therapy delivers medicine directly into the bloodstream. As a result, your body may be able to absorb the medication more quickly and you may be able to obtain relief faster.
- Most infusion medications are administered by a healthcare professional in a medical setting such as your doctor’s office, a hospital, or an infusion center. Your dermatologist will determine what makes the most sense for you.
Do not receive SPEVIGO if you or your child have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the ingredients in SPEVIGO.
- Your healthcare provider will give you SPEVIGO through a needle placed in your vein (intravenous infusion). The infusion will last about 90 minutes.
- SPEVIGO is usually given one time. If GPP flare symptoms continue, your healthcare provider will decide if you should receive an additional treatment with SPEVIGO IV after 1 week.
Serious allergic reactions may happen during or after your or your child’s SPEVIGO injection. Please review the important information below about safety and side effects.
WHAT DOES THE SPEVIGO INFUSION EXPERIENCE LOOK LIKE?
If you and your dermatologist decide to treat your GPP flare with SPEVIGO, you may be curious about what treatment is like.
Watch this short video to learn more about the SPEVIGO infusion experience and access helpful resources designed to help you feel more prepared and comfortable on treatment day.
This video is provided for educational purposes only and is not intended to replace discussions with a healthcare provider.
Get ready for your first infusion.
Strike a chord.
SC INJECTION
If your dermatologist prescribes SPEVIGO to help treat GPP when not experiencing a flare, SPEVIGO is given as subcutaneous (SC) injections every 4 weeks. The medicine is injected under your skin.
- If required, the 600 mg subcutaneous loading dose of SPEVIGO will be administered by a healthcare professional. Thereafter, they will help you determine who is best suited to administer the following injections.
- Your healthcare provider should show you or your child the right way to inject SPEVIGO before you try to inject yourself or your child for the first time. Do not try to inject SPEVIGO until you have been shown the right way to give the injections.
- Read the Instructions for Use that come with SPEVIGO for information on how to prepare and inject a dose of SPEVIGO and how to properly throw away (dispose of) used SPEVIGO prefilled syringes.
- Your healthcare provider will tell you how you should use SPEVIGO. Use SPEVIGO exactly as your healthcare provider tells you to use it.
- SPEVIGO prefilled syringes must be refrigerated. Do not freeze. Do not use if previously frozen, even if it has been thawed.
- If you miss a dose of SPEVIGO, inject your dose as soon as you remember. Then, take your next dose at your regular scheduled time. In case you are not sure when to inject SPEVIGO, call your healthcare provider.
A STEP-BY-STEP GUIDE TO SPEVIGO SC INJECTIONS
Before starting SPEVIGO SC injections at home, you should first receive training from a healthcare professional on how to inject. Watch this short video as a reminder to the steps for injecting SPEVIGO prefilled syringes.
This video is provided for educational purposes only and is not intended to replace discussions with a healthcare provider.
How to inject SPEVIGO.
Prepare for your injections.
FOR ALL PATIENTS PRESCRIBED SPEVIGO
The following resources are designed to help make your journey with SPEVIGO as stress-free as possible.
Connect with BI Solutions PlusTM.
Educate others about your diagnosis.
SAFETY & SIDE EFFECTS
Before starting any treatment, it’s important to understand its potential benefits, as well as the possible risks. Take a closer look at some of the side effects SPEVIGO may cause.
Of course, if you experience any side effects, speak to your doctor right away. Your doctor will want to know how you’re feeling—as well as how you are tolerating your medication—and can make adjustments as needed.
Do not receive SPEVIGO if you or your child have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the ingredients in SPEVIGO.
What is the most important information I should know about SPEVIGO?
SPEVIGO may cause serious side effects, including:
- Infections. SPEVIGO may lower the ability of your or your child’s immune system to fight infections and may increase your or your child’s risk of infections. Your healthcare provider should check you or your child for infections and tuberculosis (TB) before starting treatment with SPEVIGO and may treat you or your child for TB before you begin treatment with SPEVIGO if you have a history of TB or have active TB. Your healthcare provider should watch you or your child closely for signs and symptoms of TB during or after treatment with SPEVIGO. Tell your healthcare provider right away if you or your child have an infection or have symptoms of an infection during or after treatment with SPEVIGO, including:
- fevers, chills, or sweats
- muscle aches
- cough
- shortness of breath
- blood in your phlegm (mucus)
- burning when you urinate
- urinating more often than normal
- Allergic reactions and infusion-related reactions. Serious allergic reactions may happen during or after your or your child’s SPEVIGO injection. If you or your child have a serious allergic reaction, your healthcare provider will stop treatment with SPEVIGO. If you or your child are given SPEVIGO in a vein (intravenously) and have an infusion-related reaction, your healthcare provider will stop your or your child’s SPEVIGO infusion and treat your or your child’s symptoms and may restart SPEVIGO at a slower infusion rate. Tell your healthcare provider or get emergency medical help right away if you or your child get any of the following symptoms during or after your or your child’s SPEVIGO injection:
- feeling faint, dizzy, or lightheaded
- swelling of your face, eyelids, lips, mouth, tongue, or throat
- trouble breathing or throat tightness
- fever
- mouth sores
- chest tightness
- hives or skin rash that is different than the rash from generalized pustular psoriasis (GPP)
- itching
- swollen lymph nodes
Before you or your child receive SPEVIGO, tell your healthcare provider about all of your medical conditions, including if you or your child:
- have an infection that does not go away or that keeps coming back.
- have TB or have been in close contact with someone with TB.
- have recently received or are scheduled to receive an immunization (vaccine). You or your child should not receive live vaccines during and for at least 16 weeks after treatment with SPEVIGO. You or your child should be brought up to date with all vaccines before starting SPEVIGO.
- are pregnant or plan to become pregnant. It is not known if SPEVIGO can harm your or your child’s unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if SPEVIGO passes into your breast milk. Talk to your healthcare provider about the best way to feed your or your child’s baby during treatment with SPEVIGO.
Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of SPEVIGO?
The most common side effects of SPEVIGO given in a vein (intravenously) for GPP flare treatment include:
- feeling tired or weak
- nausea and vomiting
- headache
- itching or itchy bumps
- a collection of blood under the skin at the infusion site or bruising
- urinary tract infection
The most common side effects of SPEVIGO when given under the skin (subcutaneously) for treatment of GPP when not experiencing a flare include:
- redness, pain, swelling, hardening, hives, or warmth at the injection site
- joint pain
- urinary tract infection
- itching
These are not all of the possible side effects of SPEVIGO. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.