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Lumvoa®

GoodRx

Veligrotug-vvze · intravenous infusion

Injections & Implants

Indication
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.
Available Forms
500 mg/10 mL (50 mg/mL) single-dose vial
Mechanism of Action
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.
Dosage
The recommended dosage of LUMVOA is 10 mg/kg administered by intravenous infusion every three weeks for a total of 5 infusions. Administer the diluted solution intravenously over 45 minutes for the first infusion. If well tolerated, subsequent infusions can be administered over a minimum of 30 minutes. If not well tolerated, the minimum time for subsequent infusions should remain at 45 minutes. The storage time of the diluted solution in the infusion bag containing 0.9% Sodium Chloride Injection is 4 hours at room temperature 20°C to 25°C (68°F to 77°F) or up to 72 hours under refrigerated conditions at 2°C to 8°C (36°F to 46°F), protected from light. Do not administer LUMVOA as an intravenous push or bolus. LUMVOA should not be infused concomitantly with other agents.
Warnings & Precautions
  • Infusion Reactions: Infusion reactions have been reported in approximately 9% of patients and may occur during or soon after an infusion. Signs and symptoms include transient increases in blood pressure, fever, chills, headache, and fatigue. Reactions are usually mild or moderate and can usually be managed with corticosteroids, antihistamines, and antipyretics. If one occurs, interrupt or slow the infusion and use appropriate medical management. Then consider standard premedication and/or a slower infusion rate.
  • 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. Monitor patients for signs and symptoms of IBD, including patients without a history of IBD. If IBD is suspected, discontinue use of LUMVOA.
  • Hyperglycemia: Hyperglycemia or increased blood glucose may occur. In clinical trials, 12% of patients, of whom one half had pre-existing diabetes or impaired glucose tolerance, experienced hyperglycemia. Use medications for glycemic control if necessary. Assess blood glucose and symptoms before infusion and monitor during treatment. Ensure appropriate glycemic control in patients with hyperglycemia or preexisting diabetes before and during treatment. Continue monitoring after treatment if hyperglycemia occurs.
  • 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 & Lactation
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. LUMVOA should not be used during pregnancy. Appropriate forms of contraception should be implemented prior to initiation, during treatment and for 6 months after the last dose of LUMVOA. Women of childbearing potential should have a pregnancy test performed by their doctor before starting treatment with LUMVOA. If the patient becomes pregnant during treatment, LUMVOA should be discontinued and the patient advised of the potential risk to the fetus.
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.
Pediatric Use
The safety and effectiveness of LUMVOA have not been established in pediatric patients.