Spevigo IV

/ Boehringer Ingelheim

The recommended dosage for treatment of GPP flare in adults is a a single 900 mg dose administered by intravenous infusion over 90 minutes.
If GPP flare symptoms persist, an additional intravenous 900 mg dose (over 90 minutes) may be administered one week after the initial dose.
See prescribing information for full details.

Treatment of generalized pustular psoriasis (GPP) flares in adults

Hypersensitivity to spesolimab or to any of the excipients

Infections
In patients with a chronic infection or a history of recurrent infection, consider the potential risks and expected clinical benefits of treatment prior to prescribing. Treatment is 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 clinically important infection occur during or after treatment. If a patient develops a clinically important active infection, discontinue therapy until the infection resolves or is adequately treated.
Risk of Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment. Avoid use in patients with active TB infection.
Consider initiating anti-TB therapy prior to initiating spesolimab in patients with latent TB or a history of TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after treatment.
Hypersensitivity and Infusion-Related Reactions
Hypersensitivity reactions may include immediate reactions such as anaphylaxis and delayed reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). If a patient develops mild or moderate hypersensitivity during an intravenous infusion or other infusion-related reactions, stop infusion and consider appropriate medical therapy (e.g., systemic antihistamines and/or corticosteroids). Upon resolution of the reaction, the infusion may be restarted at a slower infusion rate with gradual increase to complete the infusion.
Vaccinations
Avoid use of live vaccines in patients during and for at least 16 weeks after treatment.
No specific studies have been conducted in spesolimab treated patients who have recently received live viral or live bacterial vaccines.

Adverse Reactions Occurring in ≥1% of the Intravenous spesolimab Group and
More Frequently than in the Placebo Group through: Asthenia and Fatigue, Headache, Nausea, Pruritus and prurigo, Infusion site hematoma and bruising, Urinary tract infection, Bacteremia, Bacteriuria, Cellulitis, Herpes dermatitis and oral herpes, Upper respiratory tract infection, Dyspnea, Eye edema, Urticaria.

No formal drug interactions studies have been conducted with spesolimab. In patients with GPP, spesolimab is not expected to cause cytokine-mediated CYP interactions as a perpetrator.

Pregnancy: The limited data on the use of spesolimab in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes.
Lactation: There are no data on the presence of spesolimab in human milk, the effects on the breastfed infant, or the effects on milk production. Spesolimab is a monoclonal antibody and is expected to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need
and any potential adverse effects on the breastfed infant from spesolimab or from the underlying maternal condition.
See prescribing information for full details.