Resiliva 80 — Resmetirom 80 mg, 30 Tablets

Resiliva is formulated as film-coated tablets for oral administration. Each tablet contains:

• Active Ingredient: Resmetirom — 80 mg.
• Inactive Core Excipients: Microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, and mannitol (optimized for uniform absorption).
• Film Coating: Opadry Purple/Pink (polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide black).

Pharmacodynamics: Resmetirom is an oral, thyroid hormone receptor-beta (THR-β) selective agonist. Within the liver, THR-β is the key receptor regulating lipid pathways. By mimicking natural thyroid hormone activity selectively at THR-β, resmetirom restores mitochondrial activity, promotes hepatic beta-oxidation of fatty acids, and reduces intrahepatic triglyceride accumulation, thereby decreasing steatosis, localized inflammation, and preventing further fibrotic tissue deposition.

Pharmacokinetics: Following oral administration, resmetirom is rapidly absorbed, reaching peak plasma concentration (Cmax) in approximately 4 hours. Systemic exposure increases in a dose-proportional manner. Plasma protein binding is exceptionally high (exceeding 99%). Resmetirom is metabolized primarily by CYP2C8 and to a lesser extent by CYP3A4. The terminal half-life (T1/2) is approximately 4.5 hours. It is eliminated mainly as metabolites via feces and urine.

Resiliva 80 mg is clinically indicated for adult patients under the following therapeutic parameters:

• 🔹 Treatment of Non-Alcoholic Steatohepatitis (NASH) / MASH: In adult patients with non-cirrhotic NASH who have moderate to advanced liver fibrosis (corresponding to stages F2 to F3 on the METAVIR scale), utilized in conjunction with a reduced-calorie diet and increased physical activity.

Resiliva therapy must be initiated, monitored, and adjusted under the care of a qualified physician (gastroenterologist, hepatologist, or internist):

• Standard Regimen: The recommended therapeutic dosage is 80 mg (1 tablet) taken orally once daily. For patients with a total body weight exceeding 100 kg, the supervising physician may adjust the daily dosage to 100 mg once daily.
• Administration Rules: Tablets should be taken at approximately the same time every day, with or without food. Swallow the tablet whole; do not crush or chew.
• Duration and Assessment: This represents a long-term therapeutic regimen. Periodic medical assessments (such as liver enzyme panels, non-invasive fibrosis testing, and lipid profiles) are conducted by the physician to monitor progress.

The administration of Resiliva is contraindicated or must be strictly monitored under the following patient profiles:

• ⛔ Hypersensitivity: Known history of hypersensitivity or severe allergic reaction to resmetirom or any inactive tablet ingredients.
• ⛔ Severe Hepatic Impairment: Moderate to severe hepatic impairment (Child-Pugh Class B or C; decompensated liver cirrhosis).
• ⛔ Pregnancy and Lactation: Safety profile in pregnant women is not established. Breastfeeding is not recommended during the treatment course.
• ⛔ Pediatric Use: Safety and efficacy have not been studied in patients under 18 years of age.

Resmetirom exhibits specific drug interaction patterns that require medical oversight:

• ⚠️ HMG-CoA Reductase Inhibitors (Statins): Resmetirom can increase the plasma concentration of statins (especially atorvastatin, rosuvastatin, and pravastatin), elevating the risk of statin-induced myopathy. A statin dose reduction may be required.
• ⚠️ CYP2C8 Inhibitors: Concomitant use with strong CYP2C8 inhibitors (such as gemfibrozil) can significantly increase systemic exposure to resmetirom.
• ⚠️ Bile Acid Sequestering Agents: Medications like cholestyramine or colestipol may decrease the absorption of resmetirom. Resiliva should be administered at least 4 hours before or 4 hours after these agents.

Reproductive and pregnancy safety measures during Resiliva therapy:

• Contraception: Female patients of reproductive potential should utilize reliable, effective contraceptive methods during therapy with Resiliva.
• Pregnancy: Avoid using Resiliva during pregnancy unless the potential clinical benefits to the mother outweigh any potential risks to the developing fetus.
• Breastfeeding: Due to a lack of clinical data regarding the excretion of resmetirom into human milk, breastfeeding should be discontinued during therapy.

Adverse reactions associated with Resiliva 80 mg therapy are categorized by frequency and severity:

• 🟢 Gastrointestinal (Very Common): Mild-to-moderate diarrhea (most prominent during the initiation of therapy and typically self-resolving), nausea, abdominal pain, and vomiting.
• 🟡 Musculoskeletal: Transient muscle pruritus, arthralgia (joint pain), and localized extremity spasms.
• 🟠 Cardiovascular: Minor fluctuations in blood pressure and transient heart palpitations (uncommon).
• 🔵 Laboratory Findings: Reversible, minor fluctuations in hepatic transaminase levels during the early phases of treatment.

Acute overdose clinical details for Resiliva are highly limited:

• Symptoms: An accidental or deliberate overdose may lead to a severe worsening of dose-dependent adverse effects, such as intense diarrhea, nausea, systemic dehydration, and tachycardia.
• Management: There is no specific antidote. Treatment should involve gastric lavage, administration of activated charcoal, continuous monitoring of liver enzymes and cardiac parameters, and supportive intravenous hydration.

Storage instructions to maintain the clinical efficacy of Resiliva:

• 🌡️ Temperature: Keep stored in its original packaging in a dry environment protected from direct sunlight at a room temperature not exceeding 30 °C.
• 👶 Safety: Store the bottle tightly sealed, entirely out of reach of children and household pets.
• ⏳ Shelf Life: 3 years. Do not administer the tablets after the expiration date printed on the carton and bottle label.

Genuine Resiliva 80 mg by Everest Pharmaceuticals features a comprehensive multi-layered physical and digital security system to protect patients against counterfeit medications:

• 🛡️ Official Holographic Seal: The top opening flap of the cardboard carton is secured with a genuine, metallized holographic sticker featuring the Everest logo. Under changing light angles, this seal displays rainbow color shifts and complex security patterns. The carton cannot be opened without visibly tearing or destroying this seal.
• 🔑 Scratch-and-Verify Security Code: A dedicated security label containing a silver scratch-off panel is located on the side of the box. Scratching this panel with a coin reveals a unique, confidential alphanumeric verification code. Enter this code on the manufacturer's official verification portal at www.everestpharmaceuticals.com to receive instant confirmation that the pack is genuine and that the code has not been previously checked.
• 🔗 Integrated QR Code: Next to the scratch-off panel, a QR code is printed. Scanning this QR code with a mobile camera automatically redirects you to Everest’s verification portal with your individual security code already filled in for instant verification.
• 🔒 Bottle Induction Seal & Shrink Sleeve: The white plastic bottle inside features a child-resistant safety cap (push down and turn). Underneath the cap, the bottle neck is hermetically sealed with a thick tamper-evident induction foil membrane (typically printed with "Sealed for your protection" or the brand logo). Furthermore, the outer cap of the bottle is encased in a transparent protective plastic shrink sleeve.
• 🔍 Tactile Packaging & Laser Coding: The brand name "Resiliva" and the "Everest" logo on the carton are printed with raised embossed ink, making them tactile to the touch. The batch number (B.No.), manufacturing date (Mfd.Date), and expiration date (Exp.Date) are permanently laser-etched on the bottom of the carton and printed on the bottle label. These details must match perfectly on both components.