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QUICK LINKS: Submit Rx • What your patient can expect

You've prescribed Rezdiffra® (resmetirom). Now let us help support the next steps.

Submit prescription and Patient Authorization Form together

Rezdiffra is available at specialty pharmacies within our limited distribution network (LDN).

When you submit the prescription, give your patient the option to enroll in Madrigal Patient Support®. If they choose to enroll, ask them to complete the Patient Authorization Form at the same time. With their authorization, they can access financial assistance options to help with their Rezdiffra prescription.

Complete prior authorization (PA) or renewal (if required)

Use your preferred electronic prior authorization platform to help expedite processing and reduce turnaround time.

PA is approved

  • The specialty pharmacy contacts your patient to coordinate delivery.

PA is denied

  • Submit an appeal to the payer.
  • Send the prescription to CoAssist Pharmacy for possible Bridge/Patient Assistance Program support.

If you would like proactive education on the Rezdiffra fulfillment process, financial assistance options, local payer policies, and Madrigal Patient Support, you can request a follow-up from your dedicated Access Reimbursement Manager.

What happens next for your enrolled patients

Patient Access Manager welcome

If your patient has enrolled, their dedicated Patient Access Manager will provide helpful support. They will coordinate with your office, your patient, and the specialty pharmacy to help provide a smooth process.

Prescription delivery

The specialty pharmacy or Madrigal Patient Support will contact your patient to confirm delivery details. Please remind your patient to answer the call from the pharmacy. Depending on their insurance coverage, your patient will typically receive their initial prescription at their home address within 30–45 days.

Refill coordination

The specialty pharmacy or Madrigal Patient Support will contact your patient monthly to assist with prescription refills. Please remind your patient to expect and answer these calls.

Questions?

CALL 1-877-219-7770

Monday – Friday, 8 AM – 8 PM ET

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Indication and Important Safety Information

Indication

Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

This indication is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Limitation of Use: Avoid use in patients with decompensated cirrhosis.

WARNINGS AND PRECAUTIONS

Hepatotoxicity

Hepatotoxicity has been observed with the use of Rezdiffra. One patient developed substantial elevations of liver biochemistries that resolved when treatment was interrupted. Please see full Prescribing Information for more details on this specific case of Hepatotoxicity [see Warnings and Precautions (5.1)].

Monitor for elevations in liver tests, liver-related adverse reactions, and symptoms/signs of hepatotoxicity (eg, fatigue, nausea, vomiting, right upper quadrant pain or tenderness, jaundice, fever, rash, and/or eosinophilia [>5%]). If hepatotoxicity is suspected, discontinue Rezdiffra and monitor. If laboratory values return to baseline, weigh the potential risks against the benefits of restarting Rezdiffra. If laboratory values do not return to baseline, consider drug-induced autoimmune-like hepatitis (DI-ALH) or autoimmune liver disease in the evaluation of elevations in liver tests.

Gallbladder-Related Adverse Reactions

Cholelithiasis, acute cholecystitis, and obstructive pancreatitis (gallstone) were observed more often in Rezdiffra-treated patients than in placebo-treated patients. The exposure-adjusted incidence rates (EAIRs) for these events were less than 1 per 100 person-years (PY) for all treatment arms. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated. If an acute gallbladder event is suspected, interrupt treatment until the event is resolved.

Drug Interaction with Certain Statins

An increase in exposure of atorvastatin, pravastatin, rosuvastatin, and simvastatin was observed when concomitantly administered with Rezdiffra, which may increase the risk of adverse reactions related to these drugs.

Dosage adjustment for certain statins is recommended. Monitor for statin-related adverse reactions including, but not limited to, elevation of liver tests, myopathy, and rhabdomyolysis.

ADVERSE REACTIONS

The most common adverse reactions with Rezdiffra (reported in ≥5% of patients and higher compared to placebo) are diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness. Diarrhea and nausea were the most common causes of treatment discontinuation.

DRUG INTERACTIONS

Clinically Significant Interaction Effects of Strong or Moderate CYP2C8 Inhibitors on Rezdiffra

  • Concomitant use with strong CYP2C8 inhibitors (eg, gemfibrozil) is not recommended. Reduce Rezdiffra dosage if used concomitantly with a moderate CYP2C8 inhibitor (eg, clopidogrel).

Clinically Significant Interactions Affecting Other Drugs

  • Statins: Limit daily rosuvastatin and simvastatin dosage to 20 mg. Limit pravastatin and atorvastatin dosage to 40 mg.
  • CYP2C8 Substrates: Monitor patients more frequently for substrate-related adverse reactions if Rezdiffra is co-administered with CYP2C8 substrates where minimal concentration changes may lead to serious adverse reactions.

USE IN SPECIFIC POPULATIONS

Pregnancy

There are no available data on Rezdiffra use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Madrigal Pharmaceuticals, Inc. Adverse Event Reporting line at 1-800-905-0324 and visit https://pregnancyregistry.madrigalpharma.com for information about a pregnancy safety study.

Lactation

There is no information regarding the presence of Rezdiffra in human or animal milk, the effects on the breast-fed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Rezdiffra and any potential adverse effects on the breastfed infant from Rezdiffra or from the underlying maternal condition.

Geriatric Use

Numerically higher incidence of adverse reactions have been observed in patients ≥65 years of age compared to younger adult patients.

Renal Impairment

The recommended dosage of Rezdiffra in patients with mild, moderate, or severe renal impairment is the same as in patients with normal kidney function.

Hepatic Impairment

Avoid use in patients with decompensated cirrhosis (consistent with moderate to severe hepatic impairment). Moderate or severe hepatic impairment (Child-Pugh Class B or C) may increase the risk of adverse reactions.

The safety and effectiveness of Rezdiffra have not been established in patients with cirrhosis.

Please see full Prescribing Information for Rezdiffra.

Indication and Important Safety Information

Indication

Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

This indication is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Limitation of Use: Avoid use in patients with decompensated cirrhosis.

WARNINGS AND PRECAUTIONS

Hepatotoxicity

Hepatotoxicity has been observed with the use of Rezdiffra. One patient developed substantial elevations of liver biochemistries that resolved when treatment was interrupted. Please see full Prescribing Information for more details on this specific case of Hepatotoxicity [see Warnings and Precautions (5.1)].

Monitor for elevations in liver tests, liver-related adverse reactions, and symptoms/signs of hepatotoxicity (eg, fatigue, nausea, vomiting, right upper quadrant pain or tenderness, jaundice, fever, rash, and/or eosinophilia [>5%]). If hepatotoxicity is suspected, discontinue Rezdiffra and monitor. If laboratory values return to baseline, weigh the potential risks against the benefits of restarting Rezdiffra. If laboratory values do not return to baseline, consider drug-induced autoimmune-like hepatitis (DI-ALH) or autoimmune liver disease in the evaluation of elevations in liver tests.

Gallbladder-Related Adverse Reactions

Cholelithiasis, acute cholecystitis, and obstructive pancreatitis (gallstone) were observed more often in Rezdiffra-treated patients than in placebo-treated patients. The exposure-adjusted incidence rates (EAIRs) for these events were less than 1 per 100 person-years (PY) for all treatment arms. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated. If an acute gallbladder event is suspected, interrupt treatment until the event is resolved.

Drug Interaction with Certain Statins

An increase in exposure of atorvastatin, pravastatin, rosuvastatin, and simvastatin was observed when concomitantly administered with Rezdiffra, which may increase the risk of adverse reactions related to these drugs.

Dosage adjustment for certain statins is recommended. Monitor for statin-related adverse reactions including, but not limited to, elevation of liver tests, myopathy, and rhabdomyolysis.

ADVERSE REACTIONS

The most common adverse reactions with Rezdiffra (reported in ≥5% of patients and higher compared to placebo) are diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness. Diarrhea and nausea were the most common causes of treatment discontinuation.

DRUG INTERACTIONS

Clinically Significant Interaction Effects of Strong or Moderate CYP2C8 Inhibitors on Rezdiffra

  • Concomitant use with strong CYP2C8 inhibitors (eg, gemfibrozil) is not recommended. Reduce Rezdiffra dosage if used concomitantly with a moderate CYP2C8 inhibitor (eg, clopidogrel).

Clinically Significant Interactions Affecting Other Drugs

  • Statins: Limit daily rosuvastatin and simvastatin dosage to 20 mg. Limit pravastatin and atorvastatin dosage to 40 mg.
  • CYP2C8 Substrates: Monitor patients more frequently for substrate-related adverse reactions if Rezdiffra is co-administered with CYP2C8 substrates where minimal concentration changes may lead to serious adverse reactions.

USE IN SPECIFIC POPULATIONS

Pregnancy

There are no available data on Rezdiffra use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Madrigal Pharmaceuticals, Inc. Adverse Event Reporting line at 1-800-905-0324 and visit https://pregnancyregistry.madrigalpharma.com for information about a pregnancy safety study.

Lactation

There is no information regarding the presence of Rezdiffra in human or animal milk, the effects on the breast-fed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Rezdiffra and any potential adverse effects on the breastfed infant from Rezdiffra or from the underlying maternal condition.

Geriatric Use

Numerically higher incidence of adverse reactions have been observed in patients ≥65 years of age compared to younger adult patients.

Renal Impairment

The recommended dosage of Rezdiffra in patients with mild, moderate, or severe renal impairment is the same as in patients with normal kidney function.

Hepatic Impairment

Avoid use in patients with decompensated cirrhosis (consistent with moderate to severe hepatic impairment). Moderate or severe hepatic impairment (Child-Pugh Class B or C) may increase the risk of adverse reactions.

The safety and effectiveness of Rezdiffra have not been established in patients with cirrhosis.

Please see full Prescribing Information for Rezdiffra.