Rezdiffra dosage, forms, and strengths

Rezdiffra is a brand-name prescription drug that treats nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring that has not yet progressed to liver cirrhosis. NASH is a condition where fat builds up in the liver and causes swelling, liver damage, and scarring (fibrosis). The standard treatment involves dietary changes, exercise, and weight loss to reduce fat levels in the liver. Rezdiffra is the first medical treatment approved by the U.S. Food and Drug Administration for fatty liver. Rezdiffra pills are taken once daily.

Rezdiffra forms and strengths

Rezdiffra comes in only one dosage form:

• Tablets: 60 mg, 80 mg, 100 mg

Rezdiffra dosage for adults

Healthcare professionals prescribe Rezdiffra to reduce fat levels in the liver in people diagnosed with NASH that hasn’t progressed to cirrhosis (irreversible scarring of the liver). Dosages are based on body weight, but only two possible dosages exist. People weighing less than 100 kg (220 pounds) take a lower dose than people who exceed that weight. Tablets are taken once per day.

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Rezdiffra dosage for nonalcoholic steatohepatitis (NASH)

The FDA recently approved Rezdiffra to treat nonalcoholic steatohepatitis, which involves liver scarring that has not advanced to liver cirrhosis. Currently, it is the only drug FDA approved to treat fatty liver. The FDA granted the drug accelerated approval because of its performance in clinical studies. However, the approval may be revoked as further clinical studies are completed. 

NASH is a type of fatty liver disease that causes inflammation and liver damage. Unlike nonalcoholic fatty liver (NAFL), which only causes hepatic impairment, NASH can have symptoms and damage the liver enough to cause scarring (fibrosis). 

Both nonalcoholic fatty liver and nonalcoholic steatohepatitis are considered “fatty liver disease” (NAFLD, also known as metabolic dysfunction-associated steatotic liver disease (MASLD) ), a potentially progressive disease that may worsen over time. About 20% of people with fatty liver develop NASH. About 20% of people with NASH eventually progress to NASH cirrhosis. About 5–13% of those develop liver cancer.

Doctors call liver scarring “fibrosis” and grade its severity from 0 to 4. Liver cirrhosis is the highest stage of liver scarring (F4 fibrosis) and is irreversible. Rezdiffra is only used when people have progressed to moderate to severe liver scarring (F2 and F3 fibrosis). 

Rezdiffra reverses fatty liver by reducing fat content in the liver cells. This can help the liver recover from fibrosis or, at the very least, halt the worsening of fibrosis. The active ingredient in Rezdiffra is resmetirom, a thyroid hormone receptor-beta agonist (THR-β partial agonist). It acts like a thyroid hormone in the liver but not elsewhere. Thyroid hormones stimulate the liver to break down fat and cholesterol, so the liver breaks down more of the fat collecting in the liver.

Rezdiffra is intended as an add-on treatment for traditional therapies for fatty liver. People taking Rezdiffra will still need to modify their diets by reducing their fat, cholesterol, and carbohydrate intake. They will also need to exercise, lose weight, and take drugs to control diabetes, high cholesterol, and underactive thyroid (hypothyroidism) if deemed necessary by their physician. 

• Standard Rezdiffra dosage for adults: 80 mg tablet once daily (<100 kg body weight) or 100 mg tablet once daily (≥100 kg body weight)

Rezdiffra dosage for children

Rezdiffra is not approved by the FDA for use in children as safety and effectiveness has not been established.

Rezdiffra dosage restrictions

No dosage restrictions are required for people with mild kidney disease or mild liver impairment. Rezdiffra has not been studied in patients with severe renal impairment. People with more severe liver impairment or cirrhosis cannot take Rezdiffra. Rezdiffra doses will be reduced in people taking drugs that interfere with the body’s ability to break down Rezdiffra.

How to take Rezdiffra

Rezdiffra is taken once per day by mouth.

• Follow your healthcare provider’s instructions on taking doses and regarding diet and exercise.

• Take Rezdiffra by mouth once daily, with or without food. 

• Keep all appointments with your healthcare provider.

• Store Rezdiffra at room temperature.

Rezdiffra dosage FAQs

How long does it take Rezdiffra to work?

Rezdiffra is a long-term treatment that lowers fat levels and reduces fibrosis or prevents further liver scarring (fibrosis). In clinical studies, researchers detected reductions in liver fat in 16 weeks. It took 52 weeks for Rezdiffra to produce significant improvements in liver fat levels, fibrosis reversal, or NASH resolution compared to a placebo.

How long does Rezdiffra stay in your system?

It takes the body about four and a half hours to clear half a dose of Rezdiffra from the body. However, after taking Rezdiffra for a long time, it will take the body over 17 hours to clear half of all the Rezdiffra in the system. 

What happens if I miss a dose of Rezdiffra?

Ask the doctor what to do if you miss or forget a dose of Rezdiffra.

How long can you take Rezdiffra?

Rezdiffra is intended as a long-term treatment. Clinical studies lasted 52 weeks, during which time Rezdiffra did not cause adverse effects due to long-term use.

How do I stop taking Rezdiffra?

Rezdiffra can be stopped at any time without causing withdrawal symptoms. Do not stop taking Rezdiffra until talking to the prescribing doctor. 

You may need to stop using Rezdiffra if the doctor discovers that the medicine is damaging the liver or causing gallbladder problems. Unfortunately, there are no alternatives. Rezdiffra is the first and only drug treatment for fatty liver. 

What is the maximum dosage for Rezdiffra?

The manufacturer and the FDA have not specified a maximum Rezdiffra dosage. Consider the recommended dosage to be the maximum dosage: 100 mg daily for people weighing more than 220 pounds and 80 mg daily for people weighing less than that.

Can you overdose on Rezdiffra?

There is no information on Rezdiffra overdoses. The medicine has been recently granted accelerated approval. If you take too much Rezdiffra, call the doctor or visit an emergency room for advice.

What interacts with Rezdiffra?

To avoid potentially hazardous drug interactions, tell the doctor about all the prescription medications, over-the-counter drugs, vitamins, and supplements you take. 

Some drugs slow down the body’s metabolism of resmetirom, such as the cholesterol drug gemfibrozil, the immune suppressant cyclosporine, or the blood thinner clopidogrel. Some of these strongly inhibit the body's mechanisms to break down Rezdiffra. Healthcare providers may avoid these drugs because of the hazards. Others might require that the doctor use a lower dose of Rezdiffra.

Rezdiffra can also increase the risk of adverse reactions to statins, particularly atorvastatin, rosuvastatin, pravastatin, and simvastatin. The statin doses may need to be limited. 

Some other drugs also are more likely to cause side effects when used with Rezdiffra. The concomitant use of these drugs may require dosage adjustments.

What happens when you mix Rezdiffra and alcohol?

Drinking does not affect Rezdiffra. However, people with fatty liver and liver fibrosis should not drink alcohol because it can worsen liver health. 

Is it safe to take Rezdiffra during pregnancy?

There is no available data on Rezdiffra and its potential effects on pregnancy or an unborn baby. If you are pregnant or planning to get pregnant, get medical advice from the prescriber before starting Rezdiffra.

Is it safe to take Rezdiffra while breastfeeding?

Researchers have not studied Rezdiffra in women who are breastfeeding. It’s unknown if resmetirom affects lactation, passes into breast milk, or affects a nursing infant. Again, talk with the prescriber about the benefits and possible risks of taking Rezdiffra while breastfeeding.

What are the possible side effects of Rezdiffra?

The most common side effect of Rezdiffra is diarrhea. About 1 in 3 people in clinical trials taking the highest dose complained of diarrhea. Other common side effects include nausea, itchy skin, vomiting, constipation, and abdominal pain.

What are the serious side effects of Rezdiffra?

The most serious adverse effects of Rezdiffra are liver and gallbladder problems, including elevated liver enzymes, liver poisoning (hepatotoxicity), gallstones (cholelithiasis), and an inflamed gallbladder (cholecystitis). Because of these possible problems, the doctor will take some baseline liver function tests before prescribing Rezdiffra and continue monitoring liver function during treatment.

Sources

• Resmetirom: An orally administered, small molecule, liver-directed, β-selective THR agonist for the treatment of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis, touchREVIEWS in Endocrinology

• Rezdiffra HCP, Madrigal Pharmaceuticals, Inc.

• Rezdiffra resmetirom tablet prescribing information, DailyMed (NIH National Library of Medicine)