Spesolimab-sbzo (Intravenous)

Spesolimab-sbzo injection is used to treat flares of generalized pustular psoriasis (GPP). GPP is a long-term skin condition that causes sudden outbreaks of painful, pus-filled blisters over large areas of the body.

This medicine must be given only by your doctor or under their direct supervision.

It is very important for your doctor to check your or your child's progress at regular visits to ensure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Contact your doctor immediately if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness. These may indicate that you have an infection.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Contact your doctor right away if you experience chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Inform your doctor right away if you begin to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), can occur with this medicine. Contact your doctor immediately if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

While you are being treated with spesolimab-sbzo, do not receive any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with spesolimab-sbzo.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits of the medicine. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have been no appropriate studies to determine how age affects the effects of spesolimab-sbzo injection in children. We do not know if it is safe or effective for this age group.

Geriatric

There have been no appropriate studies on how age affects the effects of spesolimab-sbzo injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of an interaction. In these cases, your doctor may adjust the dose or take other precautions. When you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant and may not include all possibilities.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Adenovirus Vaccine, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or specific types of food because interactions may occur. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Infection, active (e.g., tuberculosis)—Use is not recommended for patients with this condition.

• Infection, chronic or recurrent, history of—Use with caution. It may worsen this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bladder pain
• Bloody or cloudy urine
• Painful, burning, or difficult urination
• Frequent urge to urinate
• Large, flat, blue, or purplish patches on the skin
• Lower back or side pain

Less common

• Blistering, crusting, irritation, itching, or reddening of the skin
• Bruising at the injection site
• Body aches or pain
• Chest pain
• Chills
• Cough
• Coughing or spitting up blood
• Ear congestion
• Fever
• Headache
• Itching of the vagina or genitals
• Loss of voice
• Muscle aches
• Night sweats
• Sneezing
• Sore throat
• Stuffy or runny nose
• Sudden high fever or low-grade fever lasting for months
• Swelling
• Thick, white vaginal discharge with mild or no odor
• Trouble breathing
• Unusual tiredness or weakness

Incidence not known

• Black, tarry stools
• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Inability to move the arms and legs
• Painful or difficult urination
• Sores, ulcers, or white spots on the lips or in the mouth
• Sudden numbness and weakness in the arms and legs
• Swollen glands
• Unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also be able to suggest ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue, become bothersome, or if you have any questions about them:

More common

• Change in hearing
• Diarrhea
• Earache
• Ear drainage
• Itching ears
• Lack or loss of strength
• Nausea
• Vomiting

Less common

• Hives, itching, or skin rash
• Swelling of the eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Spevigo

Available Dosage Forms:

• Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Spesolimab

Find detailed information on biosimilars for this medication.

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle that is placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 90 minutes.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have questions.