FDA-filed SPL labeling · retrieved through openFDA

Lusutrombopag

Lusutrombopag is an oral thrombopoietin receptor agonist used to treat low platelet counts (thrombocytopenia) in adults with chronic liver disease who are preparing for a medical procedure.

Brand name Mulpleta
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveOct 29, 2020
Clinical labels in scope 3
AvailabilityRx
Earliest approval/marketing year 2018
FDA-listed product records 4
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Lusutrombopag at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Mulpleta (lusutrombopag) is a short-course oral tablet that boosts platelet counts in adults with chronic liver disease before a scheduled procedure, reducing bleeding risk. The main safety concern is the potential for blood clots, so your care team will monitor your platelet levels closely. Take it exactly as prescribed — for 7 days, timed to your procedure date — and report any signs of a clot to your doctor immediately.

📖 Lusutrombopag: Patient Information Guide

A plain-language walkthrough of Lusutrombopag — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Lusutrombopag is used to temporarily raise platelet counts before a scheduled medical procedure in adults with chronic liver disease.

  • Mulpleta (oral tablet) is approved to treat thrombocytopenia (low platelet counts) in adults with chronic liver disease who are scheduled to undergo a procedure — helping reduce the risk of bleeding during that procedure.
  • Mulpleta is used as a short, fixed 7-day course and is not intended for long-term platelet management or to fully normalize platelet counts.
⚙️How it works

Lusutrombopag works by mimicking thrombopoietin (TPO), a hormone your body naturally uses to signal platelet production. It binds to TPO receptors on megakaryocytes — specialized bone marrow cells — and tells them to multiply and mature into platelets. This leads to a measurable rise in platelet count, typically peaking around 12 days after starting the medication. The drug is taken by mouth and is absorbed well regardless of whether you eat beforehand.

💊How it's taken

Mulpleta is taken as an oral tablet once daily for exactly 7 days. It can be taken with or without food — a meal does not meaningfully change how much medicine is absorbed. Timing around the procedure is precise: start Mulpleta 8 to 14 days before the procedure, and have the procedure done 2 to 8 days after the last dose.

  • If you miss a dose, take it as soon as you remember on that same day — then continue your normal schedule the next day.
  • Do not use Mulpleta beyond the prescribed 7-day course or to chase a normal platelet count.
🤒Side effects — in detail

The most commonly reported side effect of Mulpleta in clinical trials was headache.

  • Headache

More seriously, Mulpleta can raise the risk of blood clots, including portal vein thrombosis (a clot in the vein near the liver). Seek immediate medical attention if you develop sudden leg pain or swelling, chest pain, difficulty breathing, or severe abdominal pain — these could be signs of a dangerous clot.

⚠️Warnings & precautions
  • Blood clots (thrombosis/thromboembolism): TPO receptor agonists like Mulpleta have been linked to blood clots in patients with chronic liver disease, including portal vein thrombosis. These clots can occur even without a large jump in platelet count. Your doctor will monitor your platelet levels closely.
  • Do not use to normalize platelets: Mulpleta is only for short-term use before a procedure — never use it just to bring platelet counts to a normal range.
  • Higher risk groups: If you have had prior clots, known genetic clotting disorders (such as Factor V Leiden or Protein C deficiency), or reduced liver blood flow, discuss the risks carefully with your doctor before starting.
  • Overdose risk: Too much of this medication could cause platelet counts to rise too high, increasing clot risk. There is no antidote — treatment focuses on monitoring and managing any clotting complications.
🔀What it interacts with

Lusutrombopag has a low potential to interfere with many common liver enzymes that process other drugs, but a few interactions have been studied:

  • Cyclosporine (immunosuppressant): No clinically meaningful change in lusutrombopag levels was seen when taken together in clinical studies.
  • Calcium carbonate antacids: No clinically meaningful change in lusutrombopag levels was observed with co-administration.
  • General advice: Always tell your doctor and pharmacist about every medication, supplement, and herbal product you take before starting Mulpleta.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Blood clot history: Tell your doctor if you have ever had a blood clot, including portal vein thrombosis.
  • Genetic clotting disorders: Conditions like Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency, or Protein C or S deficiency increase clot risk — tell your doctor before starting.
  • Reduced liver blood flow: If blood flow toward your liver is absent or impaired, Mulpleta should only be used if the benefit clearly outweighs the risk.
  • Pregnancy: There are no human safety data. Animal studies showed harm at high doses. Tell your doctor if you are pregnant or planning to become pregnant.
  • Breastfeeding: Breastfeeding is not recommended during treatment or for at least 28 days after the last dose. Pump and discard breast milk during that time to protect your baby.
  • Children: Safety and effectiveness have not been established in pediatric patients.
  • Older adults (65+): Not enough older adults were studied to know if they respond differently; discuss your individual situation with your doctor.
  • Severe kidney disease: Limited data are available for patients with severe renal impairment — let your doctor know about any kidney problems.
🚑If you take too much

There is no antidote for a Mulpleta overdose. Taking too much could cause platelet counts to rise too high, which may lead to serious blood clots. If an overdose is suspected, seek medical care right away — doctors will monitor the platelet count closely and treat any clotting complications using standard care. Because lusutrombopag is very tightly bound to proteins in the blood, hemodialysis (a kidney-filtering treatment) is not expected to remove it effectively.

📡Pharmacodynamics — effects in the body

Lusutrombopag stimulates TPO receptors to increase platelet production. In patients with chronic liver disease and low platelet counts, the rise in platelet count is proportional to how much drug is in the body over time. In clinical studies at the recommended dose, platelet counts peaked at a median of 12 days after starting treatment. Mulpleta does not meaningfully affect the heart's electrical rhythm (QT interval) even at doses far above the recommended amount.

🔬Pharmacokinetics — how your body processes it

After an oral dose, peak blood levels are reached about 6 to 8 hours later, and steady levels in the body are achieved by day 5 of once-daily dosing. The drug stays in the body for a meaningful period — it has a half-life of roughly 27 hours, meaning it takes about a day for the body to clear half of it. Lusutrombopag is broken down mainly by liver enzymes (CYP4 family) and eliminated mostly through the stool (about 83%), with very little leaving via urine. Food does not significantly affect how much of the drug is absorbed, so it can be taken with or without a meal.

📦How to store it

Store MULPLETA in the original package at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

📄 Written from Lusutrombopag’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

54

Supplements & herbs that interact with Lusutrombopag

54 supplements and herbal products have documented interactions with Lusutrombopag in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 35
  • Minor · 17
Every supplement checked against Lusutrombopag — ranked by severity The full interaction hub: 2 major · 35 moderate · 17 minor · every one linked to its full report. Check Lusutrombopag against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Lusutrombopag — the kind of thing our pharmacy team would talk through with you at the counter.

Why do I only take this for 7 days? Will I need it again?
Mulpleta is designed as a short, timed course — just 7 days — to raise your platelet count enough to safely get through your upcoming procedure. Once the procedure is done, the goal is met. If you need another procedure in the future, your doctor would reassess at that time. It's not meant for ongoing, long-term use.
Can I eat normally while taking Mulpleta?
Yes, you can take Mulpleta with or without food — a meal doesn't change how well the drug works. There are no specific food restrictions associated with Mulpleta, so just take it at whatever time fits your daily routine, as long as you stay consistent.
What are the signs of a blood clot I should watch for?
The most important thing to watch for is any sign of a blood clot. That includes sudden pain, swelling, or redness in your leg; chest pain or trouble breathing; sudden severe abdominal pain (especially upper right side); or symptoms that could suggest a stroke, like face drooping, arm weakness, or trouble speaking. If any of these happen, get medical help right away — don't wait.
What if I forget to take a dose?
Take the missed dose as soon as you remember — but only on that same day. Then go back to your regular schedule the next day. Don't take two doses in one day to make up for a missed one. Since the timing around your procedure matters, it's worth letting your care team know if you missed a dose.
Is it safe to take Mulpleta if I'm pregnant or breastfeeding?
There are no human studies in pregnancy, and animal studies at high doses showed some potential risks to developing offspring. If you're pregnant or might become pregnant, talk to your doctor right away so you can weigh the risks together. If you're breastfeeding, you'll need to stop nursing while you take Mulpleta and for 28 days after your last dose — during that time, pump and discard your breast milk to protect your baby.
I have a history of blood clots. Can I still take this medication?
This is a really important conversation to have with your doctor before starting. Because Mulpleta raises platelet counts, it could theoretically increase clot risk — especially if you've had clots before or have a clotting disorder like Factor V Leiden. Your doctor will weigh whether the benefit of going through your procedure safely outweighs the risk for you personally. In some situations, Mulpleta can still be used carefully with close monitoring.
Is Lusutrombopag available over the counter?
Lusutrombopag is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Lusutrombopag first available?
Lusutrombopag has been available in the United States since at least 2018, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Lusutrombopag?
Lusutrombopag is supplied by 4 manufacturers listed in the FDA NDC Directory, including Eddingpharm (U. S. ) Inc., Shionogi Inc., Shionogi Pharma Co., Ltd..

💬 Answers drafted from Lusutrombopag’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Lusutrombopag comes

Lusutrombopag is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Mulpleta
How this form is used
What it may be used for
  • Mulpleta tablets are used to treat low platelet counts (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a procedure.
Important instructions
  • Mulpleta tablets are taken by mouth once daily for 7 days, with or without food.
  • Mulpleta dosing should begin 8 to 14 days before your scheduled procedure; the procedure should take place 2 to 8 days after the last dose.
  • If you miss a dose of Mulpleta, take it as soon as possible on the same day, then resume your regular schedule the next day — do not double up.
  • Mulpleta should not be used to try to bring platelet counts fully to normal; it is for short-term use only before a procedure.
Available strengths 1 strength
3 FDA-listed product records

📊 Lusutrombopag across the U.S. market

How Lusutrombopag appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
4
Manufacturers
1
Brand names
4
FDA-listed product records
2018
First marketed

Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Eddingpharm (U. S. ) Inc.25%
Shionogi Inc.25%
Shionogi Pharma Co., Ltd.25%
Vancocin Italia Srl25%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

🔍 Compare Lusutrombopag products

A representative set of FDA-listed product records for Lusutrombopag — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Tablet
3 mg Oral Eddingpharm (U. S. ) Inc. NDA View NDC →
3 mg Oral Shionogi Inc. NDA View NDC →
3 mg Oral Vancocin Italia Srl NDA View NDC →
💊Bulk drug substance
1 kg/kg Shionogi Pharma Co., Ltd. BULK INGREDIENT View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Lusutrombopag NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Lusutrombopag RxCUI 2054984 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Tablet RxCUI 2054988 In current FDA listings
    Clinical drug / strength (SCD) 3 MG RxCUI 2054989

Look up RxCUI 2054984 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Mulpleta

🏭 Manufacturers & labelers

Eddingpharm (U. S. ) Inc. 1 Shionogi Inc. 1 Shionogi Pharma Co., Ltd. 1 Vancocin Italia Srl 1

RxNorm drug class

Lusutrombopag belongs to the Other systemic hemostatics class.

Drug family (ATC) Other systemic hemostatics

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 29, 2020
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Lusutrombopag.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Lusutrombopag after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
3
NDC products indexed
4
Distinct labelers/manufacturers represented
4
Linked representative label
Shionogi Inc.
Linked label effective
Oct 29, 2020
Composite sections available
21
Linked SPL Set ID
f9fd0cfd-717d-4a87-99bc-de7b38807e55
Linked SPL Document ID
b520c88c-9064-4ffe-b33c-81fdfe795cad
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 3 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Shionogi Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.