Veligrotug-vvze · intravenous infusion
Injections & Implants
LUMVOA is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration.
Contraindications
None.
500 mg/10 mL single-dose vial, 50 mg/mL single-dose vial
Veligrotug-vvze's mechanism of action in patients with thyroid eye disease has not been fully characterized. Veligrotug-vvze is a humanized IgG1 monoclonal antibody that binds to IGF-1R and inhibits IGF-1R signaling by blocking ligand-induced receptor autophosphorylation.
10 mg/kg every three weeks for a total of 5 infusions Administer LUMVOA by intravenous infusion over 30 to 45 minutes See full prescribing information for dose preparation and administration instructions.
Warnings & Precautions
- Infusion Reactions: LUMVOA may cause infusion reactions. Infusion reactions have been reported in approximately 9% of patients treated with LUMVOA.
- Inflammatory Bowel Disease: LUMVOA may cause an exacerbation of inflammatory bowel disease (IBD). IBD has been reported in some patients receiving insulin-like growth factor-1 receptor inhibitors without a prior diagnosis of IBD.
- Hyperglycemia: Hyperglycemia or increased blood glucose may occur in patients treated with LUMVOA. In clinical trials, 12% of patients, of whom one half had pre-existing diabetes or impaired glucose tolerance, experienced hyperglycemia.
- Hearing Impairment Including Hearing Loss: LUMVOA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients' hearing before, during, and after treatment with LUMVOA and consider the benefit-risk of treatment with patients.
Common Side Effects
Most common adverse reactions (incidence of 5% or more) are muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, blood creatine phosphokinase increased, dry skin, and hypertension.
Pregnancy: Because inhibiting insulin-like growth factor-1 receptor (IGF-1R) signaling impacts embryonic development and placental development and function, LUMVOA may cause fetal harm when administered to a pregnant woman .
Lactation: There is no information regarding the presence of LUMVOA in human milk, the effects on the breast-fed infant or the effects on milk production.
The safety and effectiveness of LUMVOA have not been established in pediatric patients.