Emcitate (tiratricol)

“WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS” (opens the prescribing information at this quote)CopyFlag

“Thyroid hormones, including EMCITATE, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss” (opens the prescribing information at this quote)CopyFlag

“EMCITATE should not be taken for weight reduction as it may cause symptoms of thyrotoxicosis that could be serious or life-threatening.” (opens the prescribing information at this quote)CopyFlag

“EMCITATE is contraindicated in patients with primary hyperthyroidism” (opens the prescribing information at this quote)CopyFlag

“Signs and symptoms of thyrotoxicosis, such as increased heart rate, elevated blood pressure, diarrhea, hyperhidrosis, irritability, insomnia, and nightmares, have occurred in patients receiving EMCITATE” (opens the prescribing information at this quote)CopyFlag

“These symptoms may occur if the EMCITATE dose is further increased despite T3 normalization, due to a drug-induced thyromimetic effect” (opens the prescribing information at this quote)CopyFlag

“Signs and symptoms of thyrotoxicosis may also occur during the dose titration period due to a combined thyromimetic effect from endogenous T3 levels that have not yet declined and EMCITATE.” (opens the prescribing information at this quote)CopyFlag

“If signs and symptoms of thyrotoxicosis occur despite T3 level normalization, decrease the EMCITATE dose according to the dose titration schedule” (opens the prescribing information at this quote)CopyFlag

“Tiratricol can cross-react with T3 immunoassays leading to unreliable T3 results. When present, such cross-reactivity causes an overestimation of T3. Cross-reactivity of tiratricol is not expected to impact measurement of T3 by LC-MS/MS. An FDA-authorized LC-MS/MS test for the measurement of total T3 is not currently available.” (opens the prescribing information at this quote)CopyFlag

“Varying concentrations (50-1,000 ng/dL) of TRIAC (Sigma Aldrich) were added to pooled serum and assayed for total T3 (TT3) and free T3 (FT3) on the following platforms: e602 (Roche Diagnostics), Architect (Abbott Diagnostics), Centaur (Siemens Healthcare Diagnostics), IMMULITE (Siemens Healthcare Diagnostics), DxI (Beckman Coulter), and Vitros (Ortho Clinical Diagnostics).” (opens the source at this quote in a new tab)CopyFlag

“Significant overestimation of TT3 and FT3 assays were observed across all platforms corresponding to increasing concentrations of TRIAC. The TRIAC effect at 250 ng/dL showed a constant interference of approximately 190 ng/dL TT3.” (opens the source at this quote in a new tab)CopyFlag

“All commercial TT3 and FT3 assays tested in this work cross-react significantly with TRIAC. Therefore, patients undergoing TRIAC therapy should have T3 hormone response monitored using alternative nonimmunoassay-based methods to avoid misinterpretation of thyroid function profiles.” (opens the source at this quote in a new tab)CopyFlag

“However, in many commercial total and FT3 assays, TRIAC has been shown to cross-react with T3 in a dose-dependent manner, likely due to a shared antibody-binding epitope.” (opens the source at this quote in a new tab)CopyFlag

“This cross-reactivity can lead to overestimation of T3 levels in patients receiving TRIAC treatment” (opens the source at this quote in a new tab)CopyFlag

“In patients receiving TH analogues, particularly TRIAC, T3 levels should be measured using LC-MS whenever available.” (opens the source at this quote in a new tab)CopyFlag

“If LC-MS assays are unavailable, some specific immunoassays may show lower cross-reactivity between T3 and TRIAC.” (opens the source at this quote in a new tab)CopyFlag

“Study 1 enrolled 20 male patients with MCT8 deficiency.” (opens the prescribing information at this quote)CopyFlag

“Adverse reactions reported in > 5% of patients treated with EMCITATE are summarized in Table 1.” (opens the prescribing information at this quote)CopyFlag

“The most common side effects with Emcitate (which may affect up to 1 in 10 people) include hyperhidrosis (excessive sweating), diarrhoea, irritability, anxiety and nightmares.” (opens the source at this quote in a new tab)CopyFlag

“These side effects usually happen at the start of treatment, or when the dose is increased, and tend to get better within a few days.” (opens the source at this quote in a new tab)CopyFlag

“The most commonly reported adverse reactions associated with the use of tiratricol treatment were hyperhidrosis (7%), diarrhoea (6%), irritability (2%), anxiety (2%), and nightmares (2%). These reactions usually occurred at the start of treatment and/or when the dose was increased, and generally resolved within a few days.” (opens the source at this quote in a new tab)CopyFlag

“In clinical trials in patients with MCT8 deficiency, the onset of the observed adverse reactions hyperhidrosis, irritability, anxiety, and nightmares coincided with treatment initiation or dose modification. In all cases, these reactions were mild and resolved spontaneously.” (opens the source at this quote in a new tab)CopyFlag

“Signs and symptoms of a hypermetabolic state may appear in cases of overdose. Decreasing the dose of Emcitate or temporarily discontinuing treatment alleviates these symptoms.” (opens the source at this quote in a new tab)CopyFlag

“Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.” (opens the source at this quote in a new tab)CopyFlag

“Hyperthyroidism for other reasons than MCT8 deficiency (e.g. Grave’s Disease).” (opens the source at this quote in a new tab)CopyFlag

“Caution should be used during dose titration in patients with cardiac disease, as they may be at increased risk of adverse reactions associated with a hypermetabolic state (see section 4.8).” (opens the source at this quote in a new tab)CopyFlag

“Tiratricol should not be taken for weight reduction. It may cause serious or life-threatening undesirable effects, particularly in combination with orlistat (see section 4.5 under “Orlistat”).” (opens the source at this quote in a new tab)CopyFlag

“Emcitate tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.” (opens the source at this quote in a new tab)CopyFlag

“Beagle dogs treated orally for 13 weeks with 0, 0.15, 0.5, or 5 mg/kg/day tiratricol had lens opacities and lens fiber degeneration in all animals treated at the highest dose (approximately 24-fold clinical exposures based on AUC estimates).” (opens the prescribing information at this quote)CopyFlag

“The risk of ocular toxicity from tiratricol use in humans is unknown, but is considered low based on the absence of findings in dogs at clinically relevant exposures.” (opens the prescribing information at this quote)CopyFlag

“Tiratricol was not carcinogenic in Tg-RasH2 mouse carcinogenicity studies up to the highest tolerable dose tested of 15 mg/kg/day.” (opens the prescribing information at this quote)CopyFlag

“Tiratricol was not genotoxic in a bacterial reverse mutation assay, an in vitro micronucleus assay in human lymphoblastoid cells, and in an in vivo rat bone marrow micronucleus assay.” (opens the prescribing information at this quote)CopyFlag

“Dedicated fertility studies have not been conducted with tiratricol.” (opens the prescribing information at this quote)CopyFlag

“Embryofetal development studies showed embryolethality in rabbits and embryolethality and structural myocardial damage in rats.” (opens the source at this quote in a new tab)CopyFlag

“No effects on mating ability or fertility were observed in a study in male and female rats administered high and otherwise toxic doses of tiratricol.” (opens the source at this quote in a new tab)CopyFlag