Pronunciation:

spe-SOE-li-mab - sbzo

Brand Names:

• Spevigo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Spesolimab

Uses of This Medicine:

Spesolimab-sbzo injection is used to treat generalized pustular psoriasis (GPP). GPP is a long-term skin disease that has flares (painful, pus-filled blisters over large areas of the body) which appear suddenly.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of spesolimab-sbzo injection in children younger than 12 years of age or weighing less than 40 kilograms (kg). Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of spesolimab-sbzo injection have not been performed in the geriatric population.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection, active (eg, tuberculosis)—Use is not recommended in patients with this condition.

• Infection, chronic or recurrent, history of—Use with caution. May make this condition worse.

Proper Use of This Medicine:

This medicine is available in 2 forms. A vial and a prefilled syringe.

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

Prefilled syringe: You may also be taught how to give your medicine at home. It is usually given as a shot under the skin of your stomach or thigh. Make sure you understand all instructions before you give yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

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

Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, tender, damaged, hard, or areas with scars. Do not inject an area near your waistline or belly button.

Allow the prefilled syringe to warm to room temperature for 15 to 30 minutes before using it. Do not warm it in any other way (eg, microwave, hot water, or direct sunlight).

To use the prefilled syringe:

• Wash your hands with soap and water before and after using this medicine.
• Do not remove the needle cap.
• Check the liquid in the syringe. It should be clear and colorless to slightly brownish-yellow. Do not use it if it is cloudy, discolored, or has flakes or large or colored particles in it. Do not use the syringe if it is damaged, dropped, broken, leaking, or has cracks.
• Hold the syringe by the finger grip with one hand. Using your other hand, pull the cap straight off. Do not pull on or hold the plunger rod. Do not twist the cap. Do not put the cap back on.
• Gently pinch the skin. Hold the syringe by the blue finger grip. Using a quick, "dart-like" motion, insert the needle into the pinched skin at a 45 degree angle. Do not move the needle.
• Use your thumb to slowly press down on the blue thumb pad to push the plunger rod inside the syringe body. Continue pressing the blue thumb pad until the plunger rod has moved all the way down.
• Make sure the blue thumb pad cannot be pressed any further so that the built-in safety cover can be activated. Check that the thumb pad springs back and that the needle is inside the safety cover to make sure you have received the full dose.
• Use a new needle and prefilled syringe each time you inject your medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled syringe):
  • For generalized pustular psoriasis (GPP) with flares:
    • Adults and children 12 years of age and older and weighing at least 40 kilograms (kg)—The first dose is given by a doctor through an IV catheter placed in one of your veins. After 4 weeks, 300 milligrams (mg) (two 150 mg) injected under your skin every 4 weeks.
    • Children younger than 12 years of age weighing less than 40 kg—Use and dose must be determined by your doctor.
  • For generalized pustular psoriasis (GPP) without flares:
    • Adults and children 12 years of age and older and weighing at least 40 kilograms (kg)—600 milligrams (mg) (four 150 mg) injected under your skin followed by 300 mg (two 150 mg) after 4 weeks and every 4 weeks thereafter.
    • Children younger than 12 years of age weighing less than 40 kg—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Do not use the prefilled syringe if frozen, even if it has been thawed.

Precautions While Using This Medicine:

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

Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness. These may be signs that you have an infection.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, or 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. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, or lightheadedness or fainting after receiving this medicine.

Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away 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 have any immunizations (vaccines) without your doctor's approval. Your vaccinations need to be current before you receive this medicine. Live virus vaccines should not be given during and for at least 16 weeks after treatment with this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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

difficult, burning, or painful urination

frequent urge to urinate

large, flat, blue, or purplish patches in 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 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are 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.