Spesolimab

Spesolimab is a prescription medication used for the treatment of generalized pustular psoriasis (GPP) flares in adults.

• Spesolimab is available under the following different brand names: Spevigo, spesolimab-sbzo.

Common side effects of Spesolimab include:

• weakness/lethargy
• fatigue
• nausea
• vomiting
• headache
• itching (may be intense in spots)
• infusion site bruising
• urinary tract infection (UTI)

Serious side effects of Spesolimab include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• dizziness
• lightheadedness
• fainting
• fever
• chills
• sweating
• cough
• muscle aches
• shortness of breath
• cough with bloody mucus
• mouth sores
• chest tightness
• skin rash that is different from the psoriasis
• itching
• swollen lymph nodes

Rare side effects of Spesolimab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 450 mg/7.5 mL single-dose vial

Psoriasis

Adult dosage

• 900 mg IV as a single dose
• If GPP flare persists, may administer an additional 900 mg dose 1 week after the initial dose.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Spesolimab has severe interactions with no other drugs.
• Spesolimab has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • tisagenlecleucel
• Spesolimab has moderate interactions with no other drugs.
• Spesolimab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to spesolimab or excipients.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Spesolimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Spesolimab?”

Cautions

• Infections
  • May increase the risk of infections
  • Consider potential risk in patients with chronic infection or a history of recurrent infection
  • Not recommended in patients with any clinically important active infection until the infection resolves or is adequately treated
  • Instruct patients to seek medical advice if signs or symptoms of infection occur after Spesolimab treatment
• Risk of tuberculosis (TB)
  • Evaluate patients for TB infection before initiating
  • Do not administer with active TB infection
  • Consider initiating anti-TB therapy before starting spesolimab in patients with latent TB or a history of TB in whom an adequate course of treatment cannot be confirmed
  • Monitor for signs and symptoms of active TB during and after treatment
• Hypersensitivity and infusion-related reactions
  • Hypersensitivity reactions may include immediate reactions (eg, anaphylaxis) and delayed reactions (eg, drug reaction with eosinophilia and systemic symptoms [DRESS])
  • DRESS reported during clinical trials
  • Discontinue immediately if anaphylaxis or other serious hypersensitivity occurs; immediately initiate appropriate treatment
  • If mode or moderate infusion-related reaction occurs, stop an infusion, and consider appropriate medical therapy (eg, systemic antihistamines and/or corticosteroids)
  • Upon resolution, may restart infusion at a slower rate and gradually increase to complete infusion.
• Drug interaction overview
• Live vaccines
  • Avoid the use of live vaccines in patients treated with spesolimab, owing to the potentially increased risk of infections
  • Studies have not been conducted in spesolimab-treated patients who have recently received live viral or live bacterial vaccines

Pregnancy and Lactation

• Data regarding the use of pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes
• Human IgG crosses the placental barrier; therefore, spesolimab may be transmitted from the mother to the developing fetus
• Lactation
  • Data are not available on the presence of human milk, its effects on breastfed infants, or milk production
  • Monoclonal antibodies are expected to be present in human milk