openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
5 WARNINGS AND PRECAUTIONS Infusion Reactions : If an infusion reaction occurs, interrupt or slow the rate of infusion and use appropriate medical management ( 5.1 ) Inflammatory Bowel Disease (IBD) : Monitor patients for signs and symptoms of disease, including patients without a history of IBD; discontinue LUMVOA if IBD is suspected ( 5.2 ) Hyperglycemia : Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with LUMVOA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving LUMVOA. Continue monitoring after treatment for patients who experience hyperglycemia while on LUMVOA ( 5.3 ) Hearing Impairment including Hearing Loss : LUMVOA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patient's hearing before, during, and after treatment with LUMVOA and consider the benefit-risk of treatment with patients ( 5.4 ) 5.1 Infusion Reactions LUMVOA may cause infusion reactions. Infusion reactions have been reported in approximately 9% of patients treated with LUMVOA. Signs and symptoms of infusion-related reactions include transient increases in blood pressure, fever, chills, headache, and fatigue. Infusion reactions may occur during or soon after an infusion. Reported infusion reactions are usually mild or moderate in severity and can usually be successfully managed with corticosteroids, antihistamines, and antipyretics. In patients who experience an infusion reaction, consideration should be given to standard premedication and/or administering infusions at a slower infusion rate. 5.2 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. 5.3 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. Hyperglycemic events should be controlled with medications for glycemic control, if necessary. Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with LUMVOA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving LUMVOA. Continue monitoring after treatment for patients who experience hyperglycemia while on LUMVOA. 5.4 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.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [ see Warnings and Precautions ( 5.1 ) ] Inflammatory Bowel Disease [ see Warnings and Precautions ( 5.2 ) ] Hyperglycemia [ see Warnings and Precautions ( 5.3 ) ] Hearing Impairment [ see Warnings and Precautions ( 5.4 ) ] 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 ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viridian Therapeutics, Inc. at 1-866-321-VRDN (1-866-321-8736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of LUMVOA was evaluated in two randomized, double-masked, placebo-controlled clinical studies (Study 1 [NCT05176639] and Study 2 [NCT06021054]) consisting of 113 patients with active thyroid eye disease (75 received LUMVOA and 38 received placebo) and 188 patients with chronic thyroid eye disease (125 received LUMVOA and 63 received placebo). Patients were treated with LUMVOA 10 mg/kg or placebo given as an intravenous infusion every 3 weeks for a total of 5 infusions. The majority of patients completed 5 infusions (94% of LUMVOA patients and 99% of placebo patients). The most common adverse reactions (≥5%) that occurred at greater incidence in the LUMVOA group than in the control group during the treatment period of Studies 1 and 2 are summarized in Table 1 . In addition, menstrual disorders (amenorrhea, menstruation irregular, dysmenorrhea, menstruation delayed, intermenstrual bleeding, and menstrual disorder) were reported in approximately 29% (24/82) of menstruating women treated with LUMVOA compared to 6% (2/33) of patients treated with placebo in the clinical trials. Table 1: Adverse Reactions Occurring in 5% or More of Patients Treated with LUMVOA and Greater Incidence than Placebo in Study 1 and Study 2 Adverse Reactions LUMVOA N=200 N (%) Placebo N=101 N (%) 1 Hearing impairment includes tinnitus, hypoacusis, deafness, and autophony. 2 Hyperglycemia includes blood glucose increased, glucose tolerance impaired, glycosylated hemoglobin increased, diabetes mellitus, glucose urine present, and impaired fasting glucose. 3 Fatigue includes asthenia. 4 Ear discomfort includes ear feels clogged or blocked, ear plugging, sensation of ear pressure, and ear popping. Muscle spasms 79 (40%) 7 (7%) Headache 34 (17%) 14 (14%) Hearing impairment 1 29 (15%) 6 (6%) Hyperglycemia 2 25 (13%) 5 (5%) Fatigue 3 25 (13%) 11 (11%) Diarrhea 22 (11%) 7 (7%) Ear discomfort 4 19 (10%) 3 (3%) Infusion-related reaction 18 (9%) 2 (2%) Nausea 15 (8%) 6 (6%) Nasopharyngitis 14 (7%) 1 (1%) Blood creatine phosphokinase increased 12 (6%) 1 (1%) Dry skin 12 (6%) 2 (2%) Hypertension 11 (6%) 5 (5%) During the follow-up period, the most common adverse reactions in patients treated with LUMVOA were alopecia and onychoclasis (5%). Immune thrombocytopenia was also reported in one patient.