). In patients with a chronic infection or a history of recurrent infection, the potential risks and Product Monograph Spevigo® (spesolimab) Page 10 of 47 expected clinical benefits of treatment should be considered prior to prescribing Spevigo.
Treatment with Spevigo should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients should be instructed to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment with Spevigo.
Spevigo Subcutaneous Injection for GPP flare prevention If a patient is on treatment with Spevigo subcutaneous injection for GPP flare prevention, and develops a clinically important active infection, treatment with Spevigo should be stopped.
Re- initiation can be considered once the infection resolves or is adequately treated. Pre-treatment evaluation for tuberculosis Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment with Spevigo.
Spevigo should not be administered to patients with active TB infection. Anti-TB therapy should be considered prior to initiating Spevigo in patients with latent TB or a history of TB in whom an adequate course of treatment cannot be confirmed.
During and after Spevigo treatment, patients should be monitored for signs and symptoms of active TB. Hypersensitivity and infusion-related reactions Hypersensitivity and infusion-related reactions may occur with monoclonal antibodies such as Spevigo.
Hypersensitivity may include immediate reactions such as anaphylaxis and delayed reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Immediate hypersensitivity reactions, including anaphylactic reactions have been reported in patients treated with Spevigo (see 8 ADVERSE REACTIONS).
If a patient develops signs of anaphylaxis or other serious hypersensitivity, Spevigo should be discontinued immediately, and appropriate treatment should be initiated (see 2 CONTRAINDICATIONS). Spevigo Subcutaneous Injection for GPP flare prevention Prior to initiating Spevigo for GPP flare prevention, completion of all appropriate immunizations should be considered according to current immunization guidelines.
, 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 (see 4 DOSAGE AND ADMINISTRATION). Immunizations No specific studies have been conducted in patients who have recently received live viral or live bacterial vaccines.
Live vaccines should not be given concurrently with Spevigo. The interval between live vaccinations and initiation of Spevigo therapy should be at least 4 weeks. Live vaccines should not be administered during and for at least 16 weeks after treatment with Spevigo.
Driving and Operating Machinery Spevigo has no or negligible influence on the ability to drive and use machines. Neurologic Peripheral neuropathy The potential for peripheral neuropathy with Spevigo is unknown. Cases of peripheral neuropathy have been reported in clinical trials with spesolimab.
Physicians should be vigilant for symptoms potentially indicative of new-onset peripheral neuropathy.
Reproductive Health:
Female and Male Potential • Fertility There are no data available on the effect of Spevigo on human fertility. No specific non-clinical animal study on fertility has been conducted with spesolimab (see 16 NON-CLINICAL TOXICOLOGY). 1 Pregnant Women There are limited data from the use of Spevigo in pregnant women.
Non-clinical animal reproductive and developmental toxicology studies were not conducted with spesolimab due to lack of pharmacologic activity in non-human species (see 16 NON-CLINICAL TOXICOLOGY). Human IgG are known to cross the human placental barrier.
As a precautionary measure, it is recommended to avoid the use of Spevigo in pregnancy. 2 Breast-feeding It is unknown whether Spevigo is excreted in human milk. There are no data on 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. A risk to newborns/infants cannot be excluded. 3 Pediatrics (<18 years of age) The safety and efficacy of Spevigo have been established in adolescents with GPP aged 12 years and older.
3 Pharmacokinetics and 14 CLINICAL TRIALS). The safety and efficacy of Spevigo in pediatric patients younger than 12 years have not been established. No data are available in this population. 4 Geriatrics (≥65 years of age) No dose adjustment is required.
There is limited information in patients aged 65 years and older. 1 Adverse Reaction Overview Spevigo has been studied in clinical trials including 183 patients with GPP. The safety data provided in the following are based on two randomized, double-blind, placebo-controlled trials comparing treatment with Spevigo to placebo (EFFISAYIL-1 and EFFISAYIL-2), open-label extension trials and post-marketing experience.
In clinical trials, the most frequently reported adverse reactions associated with Spevigo were infections. During the […]