Spevigo

About Spesolimab-sbzo

• Spevigo received Food and Drug Administration (FDA) approval on September 1, 2022. Spevigo is an interleukin-36 receptor antagonist that belongs to the family called interleukin inhibitors.
• Spevigo, is specifically indicated for the treatment of generalized pustular psoriasis flares in adults. This medication is designed to address the symptomatic episodes associated with this skin condition, providing targeted relief for individuals experiencing flares of generalized pustular psoriasis.
• Spesolimab-sbzo, is a humanized monoclonal IgG1 antibody against human IL-36R, manufactured in Chinese hamster ovary (CHO) cells through recombinant DNA technology. 
• Spevigo (spesolimab-sbzo) injection, with a molecular weight of about 146 kDa, is a sterile, preservative-free solution in a single-dose vial for intravenous infusion.
• Spesolimab-sbzo, a humanized monoclonal antibody, inhibits interleukin-36 (IL-36) signaling by binding specifically to the IL36R. This prevents the activation of IL36R by its ligands (IL-36 α, β, and γ), leading to the interruption of pro-inflammatory and pro-fibrotic pathways. 
• While the precise connection between reduced IL36R activity and the treatment of generalized pustular psoriasis flares is not fully elucidated, Spesolimab-sbzo’s interference with IL-36 signaling is central to its mechanism of action.
• Pustular psoriasis flares are sudden and severe outbreaks of pustular psoriasis, a rare variation of psoriasis characterized by noninfectious, neutrophil-containing pustules on an erythematous background. 
• Pustular psoriasis flares often occur with systemic symptoms, such as fever, chills, malaise, anorexia, nausea, severe pain, and itchiness. 
• Generalized pustular psoriasis (GPP) is a severe form of pustular psoriasis that can cover large areas of the body and typically presents with fever, shivers, intense itching, a rapid pulse, fatigue, headache, nausea, muscle weakness, and joint pain. 
• Obtaining advice from a healthcare professional is vital for precise diagnosis and proper management.

Strength: 

Spevigo is available as an injection of 450 mg/7.5 mL (60 mg/mL) solution in a single-dose vial. 

Recommended Dosage:

Spevigo requires dilution before administration. Visual inspection of the parenteral drug product is essential for particulate matter and discoloration assessment, and the solution should be discarded if cloudy, discolored, or contains large or colored particulates. 

For preparation, adhere to aseptic techniques, withdraw and discard 15 mL from a 100 mL container of sterile 0.9% Sodium Chloride Injection, slowly replace it with 15 mL of Spevigo (contents from two vials of 450 mg/7.5 mL), and mix gently before use. 

• Administer the diluted Spevigo solution as a single 900 mg dose through intravenous infusion over 90 minutes. 
• In case of persistent flare symptoms, an additional 900 mg dose may be administered one week after the initial dose. 

Important:

Do not combine Spevigo with other medicinal products. If the infusion is slowed or temporarily halted, ensure that the total infusion time, including any pause, does not exceed 180 minutes. For administration, a pre-existing intravenous line can be used, and it must be flushed with a sterile 0.9% Sodium Chloride Injection before and after the infusion. There should be no simultaneous administration of any other infusions through the same intravenous access. 

Before initiating Spevigo injection, engage in a thorough discussion with your healthcare professional regarding your medical history and existing medications. Cease smoking, avoid alcohol consumption, and promptly communicate any new symptoms encountered while on Spevigo. Furnish your healthcare provider with a comprehensive list of all medications you are currently taking, encompassing prescriptions, over-the-counter drugs, vitamins, and herbal supplements. Maintain a record for reference and share it with your healthcare provider and pharmacist when introducing a new medication.

Warnings & Precautions

• Spevigo is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or any excipients in Spevigo, with reported reactions including drug reaction with eosinophilia and systemic symptoms (DRESS). 
• The use of Spevigo may increase the risk of infections, as demonstrated in the Effisayil-1 trial, where 14% of treated subjects reported infections compared to 6% in the placebo group. 
• In patients with chronic or recurrent infections, careful consideration of the risks and expected benefits is necessary before prescribing Spevigo. 
• It is not recommended for patients with clinically important active infections. Tuberculosis (TB) evaluation is crucial before initiating Spevigo, and anti-TB therapy should be considered for those with latent TB or a history of TB. 
• Hypersensitivity reactions, including anaphylaxis and DRESS, may occur, requiring immediate discontinuation of Spevigo and appropriate treatment. 
• Infusion-related reactions should be addressed with medical therapy, and vaccinations with live vaccines are to be avoided in Spevigo-treated patients, with no specific studies conducted in this population for recently received live viral or bacterial vaccines.

Common Spevigo Side Effects:

• Feeling tired or weak
• Fatigue
• Nausea and vomiting
• Headache
• Itching or itchy bumps
• A collection of blood under the skin (bruising)
• Urinary tract infection
• Diarrhea
• Earache
• Ear drainage
• Itching ears
• Lack or loss of strength
• Change in hearing

Use in Specific Population

• Before commencing Spevigo treatment, it is essential to communicate any pregnancy plans or current pregnancy status to your doctor due to limited and insufficient data on Spevigo use in pregnant women, making it challenging to determine associated risks of adverse pregnancy outcomes. 
• If breastfeeding or planning to breastfeed, notify your doctor, as the passage of Spevigo into breast milk is uncertain, with no available data. Discuss the most suitable feeding approach for your baby while on Spevigo. 
• The safety and effectiveness of Spevigo in pediatric patients remain unestablished, and clinical studies lacked sufficient subjects aged 65 and over to ascertain potential differences in response compared to younger adults. 
• Always consult your doctor, openly addressing any concerns, to ensure a safe and well-informed treatment plan.

Storage and Handling

• It is imperative to refrigerate Spevigo and store it at temperatures between 2°C to 8°C (36°F to 46°F) within the original carton to shield it from light. 
• Avoid freezing. Unopened Spevigo vials can be stored at room temperature (20°C to 25°C or 68°F to 77°F) for up to 24 hours before use, provided they remain in the original carton to protect them from light.
• Keep the medicine away from pets and children.