Jesduvroq daprodustat 8 mg Tablet, Film Coated, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Daprodustat is used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time) who have been receiving hemodialysis for at least 4 months Daprodustat is in a class of medications called HIF PH inhibitors. It works by increasing the hormone, erythropoietin, needed by the body to produce more red blood cells.
Read the full MedlinePlus article ↗- Jesduvroq is designed to treat anemia — low red blood cell levels — that comes from chronic kidney disease in people on dialysis. It works by prompting your body to produce more of...
- What exactly is Jesduvroq supposed to do for me?
- Daprodustat starts boosting your body's erythropoietin within about 6 to 8 hours of your first dose. You'll start seeing new red blood cells appear in your blood within 1 to 2 week...
- The most common ones are high blood pressure, belly pain, and dizziness. But the most serious risk — one serious enough to be on a warning label — is blood clots. This includes clo...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Daprodustat — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
10 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Jesduvroq 8 mgthis 00173-0914-13 | GlaxoSmithKline | 30 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11117871 ↗ | Drug substance | U-3535 | Mar 13, 2038 |
| US 11117871 ↗ | Drug substance | U-3535 | Mar 13, 2038 |
| US 11117871 ↗ | Drug substance | U-3535 | Mar 13, 2038 |
| US 11117871 ↗ | Drug substance | U-3535 | Mar 13, 2038 |
| US 11117871 ↗ | Drug substance | U-3535 | Mar 13, 2038 |
| US 8815884 ↗ | Method of use | U-1238 | Jun 22, 2027 |
| US 8815884 ↗ | Method of use | U-1238 | Jun 22, 2027 |
| US 8815884 ↗ | Method of use | U-1238 | Jun 22, 2027 |
| US 8815884 ↗ | Method of use | U-1238 | Jun 22, 2027 |
| US 8815884 ↗ | Method of use | U-1238 | Jun 22, 2027 |
| US 8557834 ↗ | Method of use | U-1238 | Jun 22, 2027 |
| US 8557834 ↗ | Method of use | U-1238 | Jun 22, 2027 |
| US 8557834 ↗ | Method of use | U-1238 | Jun 22, 2027 |
| US 8557834 ↗ | Method of use | U-1238 | Jun 22, 2027 |
| US 8557834 ↗ | Method of use | U-1238 | Jun 22, 2027 |
| US 11649217 ↗ | Method of use | U-3535 | Mar 13, 2038 |
| US 11649217 ↗ | Method of use | U-3535 | Mar 13, 2038 |
| US 11649217 ↗ | Method of use | U-3535 | Mar 13, 2038 |
| US 11649217 ↗ | Method of use | U-3535 | Mar 13, 2038 |
| US 11649217 ↗ | Method of use | U-3535 | Mar 13, 2038 |
| US 11643397 ↗ | Drug substance | U-3535 | Jun 22, 2027 |
| US 11643397 ↗ | Drug substance | U-3535 | Jun 22, 2027 |
| US 11643397 ↗ | Drug substance | U-3535 | Jun 22, 2027 |
| US 11643397 ↗ | Drug substance | U-3535 | Jun 22, 2027 |
| US 11643397 ↗ | Drug substance | U-3535 | Jun 22, 2027 |
| US 8324208 ↗ | Drug substance | — | Dec 11, 2028 |
| US 8324208 ↗ | Drug substance | — | Dec 11, 2028 |
| US 8324208 ↗ | Drug substance | — | Dec 11, 2028 |
| US 8324208 ↗ | Drug substance | — | Dec 11, 2028 |
| US 8324208 ↗ | Drug substance | — | Dec 11, 2028 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | Feb 1, 2028 |
| NCE | New Chemical Entity (5-year) | Feb 1, 2028 |
| NCE | New Chemical Entity (5-year) | Feb 1, 2028 |
| NCE | New Chemical Entity (5-year) | Feb 1, 2028 |
| NCE | New Chemical Entity (5-year) | Feb 1, 2028 |
Is there a generic version of JESDUVROQ 8 MG TABLET?
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00173-0914-13 You're viewing this | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0914-13) | 2023-02-01 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS JESDUVROQ increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE) [see Warnings and Precautions ( 5.1 )] . Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels [see Warnings and Precautions ( 5.1 )] .
No trial has identified a hemoglobin target level, dose of JESDUVROQ, or dosing strategy that does not increase these risks [see Dosage and Administration ( 2.4 )]. Use the lowest dose of JESDUVROQ sufficient to reduce the need for red blood cell transfusions [see Dosage and Administration ( 2.4 )] . WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS See full prescribing information for complete boxed warning. • JESDUVROQ increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE).
( 5.1 ) • Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. ( 5.1 ) • No trial has identified a hemoglobin target level, dose of JESDUVROQ, or dosing strategy that does not increase these risks. ( 2.4 ) • Use the lowest dose of JESDUVROQ sufficient to reduce the need for red blood cell transfusions.
( 2.4 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE JESDUVROQ is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Limitations of Use JESDUVROQ has not been shown to improve quality of life, fatigue, or patient well-being. JESDUVROQ is not indicated for use: • As a substitute for red blood cell transfusions in patients who require immediate correction of anemia. • For treatment of anemia of chronic kidney disease in patients who are not on dialysis.
JESDUVROQ is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. ( 1 ) Limitations of Use Not shown to improve quality of life, fatigue, or patient well-being. Not indicated for use: • As a substitute for transfusion in patients requiring immediate correction of anemia. • In patients not on dialysis.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Administer orally once daily, with or without food. ( 2.2 , 2.3 ) • See Full Prescribing Information for starting dosage based on hemoglobin level, liver function and concomitant medications, and for dose titration and monitoring recommendations. ( 2.3 , 2.4 , 2.5 , 2.6 )
2.1Pre-Treatment and On-Treatment Evaluations of Anemia, Iron Stores, and Liver Tests Evaluation of Anemia and Iron Stores Correct and exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding) before initiating JESDUVROQ. Evaluate the iron status in all patients before and during treatment with JESDUVROQ. Administer supplemental iron therapy when serum ferritin is less than 100 ng/ml or when serum transferrin saturation is less than 20%.
The majority of patients with CKD will require supplemental iron during the course of therapy. Liver Testing Assess serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin prior to initiation of JESDUVROQ. Repeat the liver tests if the patient develops signs or symptoms that could be consistent with liver disease during treatment with JESDUVROQ.
2.2Important Dosing Information Individualize dosing and use the lowest dose of JESDUVROQ sufficient to reduce the need for red blood cell transfusions. Do not target a hemoglobin higher than 11 g/dL. JESDUVROQ can be taken with or without food, and without regard to concomitant administration of iron or phosphate binders [see Clinical Pharmacology ( 12.3 )] .
JESDUVROQ should be swallowed whole. Tablets should not be cut, crushed, or chewed. JESDUVROQ can be administered without regard to the timing or type of dialysis [see Clinical Pharmacology ( 12.3 )] .
If a dose of JESDUVROQ is missed, it should be taken as soon as possible, unless it is the same day as the next dose. In this case, the missed dose should be skipped, and the next dose taken at the usual time. Double-doses should not be taken to make-up for a missed dose.
2.3Recommended Starting Dose of JESDUVROQ Adults with Anemia Due to Chronic Kidney Disease Receiving Dialysis for at Least 4 Months Adults Not Being Treated with an ESA: For adults not being treated with an ESA, the starting dose of JESDUVROQ is based on the hemoglobin level (see Table 1 ). Dose modifications are needed for patients receiving concomitant treatment with a moderate CYP2C8 inhibitor or moderate hepatic impairment [see Dosage and Administration ( 2.5 , 2.6 ), Drug Interactions ( 7.1 ), Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] .
Table 1: Starting Dose of JESDUVROQ for Adults on Dialysis not Receiving an Erythropoiesis-Stimulating Agent Pre-Treatment Hemoglobin Level (g/dL) Starting Dose of JESDUVROQ (Once Daily Dosing) a <9 4 mg ≥9 to ≤10 2 mg >10 1 mg a See dosing modifications in Section 2.5 if the patient has moderate hepatic impairment and Section 2.6 if the patient is on a moderate CYP2C8 inhibitor. Adults Being Switched from an ESA: For adults being switched from an ESA to JESDUVROQ, the starting dose of JESDUVROQ is based on the dose regimen of the ESA at the time of substitution (see Table 2 ).
Dose modifications are needed for patients receiving concomitant treatment with a moderate CYP2C8 inhibitor or moderate hepatic impairment [see Dosage and Administration ( 2.5 , 2.6 ), Drug Interactions ( 7.1 ), Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . Table 2: Starting Dose of JESDUVROQ for Adults on Dialysis Switching from an Erythropoiesis-Stimulating Agent Current Dose of ESA Dose of JESDUVROQ a Epoetin Alfa b Intravenous (units/week) Darbepoetin Alfa Subcutaneous /Intravenous (mcg/4 weeks) Methoxy PEG-Epoetin Beta Subcutaneous /Intravenous (mcg/month) Once Daily Dosing Less than or equal to 2,000 20 to 30 30 to 40 4 mg Greater than 2,000 to less than 10,000 Greater than 30 to 150 Greater than 40 to 180 6 mg Greater than or equal to 10,000 to less…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: • 1 mg, gray, biconvex, round film-coated tablets debossed with “GS KF” on one face. • 2 mg, yellow, biconvex, round film-coated tablets debossed with “GS V7” on one face. • 4 mg, white, biconvex, round film-coated tablets debossed with “GS 13” on one face. • 6 mg, pink, biconvex, round film-coated tablets debossed with “GS IM” on one face. • 8 mg, orange, biconvex, round film-coated tablets debossed with “GS 5E” on one face. Tablets: 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS JESDUVROQ is contraindicated in patients: • Receiving a strong CYP2C8 inhibitor such as gemfibrozil [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] . • With uncontrolled hypertension [see Warnings and Precautions ( 5.3 )] . • Strong cytochrome P450 2C8 (CYP2C8) inhibitors such as gemfibrozil. ( 4 ) • Uncontrolled hypertension. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Risk of Hospitalization for Heart Failure: Increased in patients with a history of heart failure. ( 5.2 ) • Hypertension: Worsening hypertension, including hypertensive crisis may occur. Monitor blood pressure.
Adjust anti-hypertensive therapy as needed. ( 5.3 ) • Gastrointestinal Erosion: Gastric or esophageal erosions and gastrointestinal bleeding have been reported. ( 5.4 ) • Not indicated for treatment of anemia of CKD in patients who are not dialysis-dependent ( 5.5 ) • Malignancy: May have unfavorable effects on cancer growth.
Not recommended if active malignancy. ( 5.6 )
5.1Increased Risk of Death, Myocardial Infarction, Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access JESDUVROQ increases the risk of arterial and venous thrombotic events, that may be fatal, including myocardial infarction, stroke, venous thromboembolism and vascular access thrombosis [see Boxed Warning, Adverse Reactions ( 6.1 )] . Patients with cardiovascular or cerebrovascular disease are at increased risk of these events. Avoid use in patients with a history of myocardial infarction, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting JESDUVROQ.
A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. Targeting a hemoglobin level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with ESAs, which also increase erythropoietin levels. No trial has identified a hemoglobin target level, dose of JESDUVROQ, or dosing strategy that does not increase these risks.
Use the lowest dose of JESDUVROQ sufficient to reduce the need for red blood transfusions. Adherence to dosing and hemoglobin monitoring recommendations is important to avoid excessive erythropoiesis [see Dosage and Administration ( 2.4 )] . Advise patients to seek immediate medical attention if they develop signs or symptoms of myocardial infarction, stroke, venous thromboembolism, or thrombosis of vascular access.
Evaluate and manage promptly if these occur.
5.2Risk of Hospitalization for Heart Failure In the ASCEND-D trial, hospitalization for heart failure was observed in 7.5% (3.3 per 100 Person Years [PY]) of patients on dialysis receiving JESDUVROQ and 6.8% (3.0 per 100 PY) of patients receiving recombinant human erythropoietin (rhEPO). Patients with a pre-existing history of heart failure were at increased risk of hospitalization for heart failure with JESDUVROQ (14.5%; 6.8 per 100 PY) compared to rhEPO (11.3%; 5.1 per 100 PY). Consider the patient’s history of heart failure when deciding whether to prescribe JESDUVROQ.
Advise patients of the symptoms and signs of heart failure and to immediately report any worsening to their healthcare provider.
5.3Hypertension JESDUVROQ is contraindicated in patients with uncontrolled hypertension. In the ASCEND-D trial, worsening of hypertension occurred in 24% (12 per 100 PY) of patients receiving JESDUVROQ and 24% (12 per 100 PY) of patients receiving rhEPO [see Adverse Reactions ( 6.1 )] . Serious worsening of hypertension occurred in 3.1% of patients receiving JESDUVROQ and 3.1% of patients receiving rhEPO.
Cases of hypertensive crisis including hypertensive encephalopathy and seizures have also been reported in patients receiving JESDUVROQ. Periodically monitor blood pressure and adjust or initiate anti-hypertensive therapy as needed.
5.4Gastrointestinal Erosion In the ASCEND-D trial, gastric or esophageal erosions occurred in 5.7% (2.5 per 100 PY) of patients receiving JESDUVROQ and 6.6% (2.9 per 100 PY) of rhEPO-treated patients. Serious erosions, including gastrointestinal bleeding and the need for red blood cell transfusions, were reported in 3.6% and 3.1% of those receiving JESDUVROQ and rhEPO, respectively. Consider this risk particularly in patients at increased risk for gastrointestinal erosions, such as those with a history of gastrointestinal ero…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Increased Risk of Death, Myocardial Infarction, Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access [see Boxed Warning, Warnings and Precautions ( 5.1 )] . • Risk of Hospitalization for Heart Failure [see Warnings and Precautions ( 5.2 )] . • Hypertension [see Warnings and Precautions ( 5.3 )] . • Gastrointestinal Erosion [see Warnings and Precautions ( 5.4 )] . Most common adverse reactions (incidence ≥10%) are hypertension, thrombotic vascular events, and abdominal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of JESDUVROQ was evaluated in adults with dialysis-dependent chronic kidney disease with anemia in the ASCEND-D trial based on an on-study analysis (on and off treatment) [see Clinical Studies ( 14.1 )] . Patients were randomized to JESDUVROQ or rhEPO (epoetin alfa for patients on hemodialysis; darbepoetin alfa for patients on peritoneal dialysis).
Of the 2,964 patients randomized in the trial, 1,487 were randomized to JESDUVROQ, 1,316 (88.5%) of whom were on hemodialysis and 171 (11.5%) of whom were on peritoneal dialysis. The median extent of exposure to JESDUVROQ and rhEPO was similar. In the JESDUVROQ treatment arm, 65% of the participants were exposed to at least 18 months of JESDUVROQ and 29% of participants received JESDUVROQ for at least 2.5 years.
JESDUVROQ was non-inferior to rhEPO on the time to first occurrence of major adverse cardiovascular events (MACE) in adults with anemia due to CKD who were on dialysis [see Clinical Studies ( 14.1 )] . Permanent treatment discontinuation due to an adverse reaction was reported in 19% of patients treated with JESDUVROQ and 18% of patients treated with rhEPO. No specific adverse reaction resulted in permanent treatment discontinuation in >1% of patients treated with JESDUVROQ.
The most common adverse reactions (≥10% of JESDUVROQ-treated patients) were hypertension, thrombotic vascular events, and abdominal pain. Table 4 lists the most common adverse reactions (reported in ≥5% of patients treated with JESDUVROQ). Table 4: Adverse Reactions Reported in ≥5% of Patients Treated with JESDUVROQ in the ASCEND-D Trial Adverse Reaction JESDUVROQ (n = 1,482) % rhEPO (n = 1,474) % Hypertension 24 24 Abdominal pain a 11 8 Dizziness 7 6 Hypersensitivity b 7 7 rhEPO = Recombinant human erythropoietin. a Includes unspecified abdominal pain, upper abdominal pain, abdominal discomfort. b Includes rash, urticaria and dermatitis.
Thrombotic Vascular Events Adjudicated thrombotic vascular events (fatal and non-fatal) were observed in 9.8 per 100 PY of patients receiving JESDUVROQ and in 11.7 per 100 PY of patients receiving rhEPO (see Table 5 ). Table 5: Adjudicated Thrombotic Vascular Events (Fatal and Non-Fatal) in the ASCENDD Trial a Event JESDUVROQ (n = 1,482) rhEPO (n = 1,474) Rate per 100 PY Rate per 100 PY Vascular access thrombosis 5.0
6.3Myocardial infarction 3.4
4.1Stroke 1.2
1.5Deep vein thrombosis 0.7
0.6Pulmonary embolism 0.3
0.4PY = Person Years; rhEPO = Recombinant human erythropoietin. a These data are not an adequate basis for comparison of rates between the study drug and the active control.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Moderate CYP2C8 Inhibitors: Reduce starting dose. ( 7.1 ) • CYP2C8 Inducers: Monitor hemoglobin and adjust the dose of JESDUVROQ as appropriate. ( 7.2 )
7.1CYP2C8 Inhibitors Concomitant administration of strong CYP2C8 inhibitors (e.g., gemfibrozil) with JESDUVROQ is contraindicated due to a marked increase in daprodustat exposure [see Contraindications ( 4 ), Clinical Pharmacology ( 12.3 )] . Concomitant administration of moderate CYP2C8 inhibitors (e.g., clopidogrel) increases daprodustat exposure [see Clinical Pharmacology ( 12.3 )] . Reduce the starting dose of JESDUVROQ by half when initiating treatment in patients on clopidogrel or a moderate CYP2C8 inhibitor except in patients whose starting dose is already 1 mg.
Monitor hemoglobin and adjust the dose of JESDUVROQ when initiating or stopping therapy with clopidogrel or a moderate CYP2C8 inhibitor during treatment with JESDUVROQ [see Dosage and Administration ( 2.6 )] .
7.2CYP2C8 Inducers CYP2C8 inducers (e.g., rifampin) may decrease daprodustat exposure, which may result in loss of efficacy. Monitor hemoglobin and adjust the dose of JESDUVROQ when initiating or stopping therapy with CYP2C8 inducers during treatment with JESDUVROQ [see Clinical Pharmacology ( 12.3 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Pregnancy: May cause fetal harm. ( 8.1 ) • Lactation: Breastfeeding not recommended until one week after the final dose. ( 8.2 ) • Hepatic Impairment: Reduce the starting dose in patients with moderate hepatic impairment (Child-Pugh Class B). JESDUVROQ not recommended in severe hepatic impairment (Child-Pugh Class C). ( 8.6 )
8.1Pregnancy Risk Summary Available data with JESDUVROQ use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with CKD ( see Clinical Considerations ) . Daprodustat administered orally to pregnant rats and rabbits during the period of organogenesis was associated with adverse fetal outcomes, including embryonic and fetal loss and reduced fetal weight, at doses that caused maternal toxicity and polycythemia ( see Data ).
Advise pregnant women of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: CKD in pregnancy increases the risk for maternal hypertension, preeclampsia, miscarriage, stillbirth, preterm delivery, low birth weight infants, and polyhydramnios. Data Animal Data : Daprodustat was orally administered to pregnant rats at 0.5, 7, or 60 mg/kg/day from gestation day 6 to gestation day 17 during the period of organogenesis.
No adverse effects were observed at doses less than or equal to 7 mg/kg/day (3 times the maximum recommended human dose [MRHD] based on body surface area). Daprodustat administration resulted in post-implantation loss, increased embryofetal death, and reduction in skeletal ossification in rats at a dose of 60 mg/kg/day (24 times the MRHD based on body surface area), which was associated with maternal toxicity (reduced body weight gain or weight loss). Maternal toxicity occurred at doses associated with polycythemia.
Daprodustat was orally administered to pregnant rabbits at doses of 4, 30, or 60 mg/kg/day from gestation day 7 until gestation day 19 during the period of organogenesis. No adverse effects were observed at doses less than or equal to 30 mg/kg/day (24 times the MRHD based on body surface area). Daprodustat administration was associated with a low incidence of abortions and fetal skeletal malformations (irregularly shaped anterior fontanelle, manubrium, fused sternal centra, and microphthalmia) at a dose of 60 mg/kg/day (49 times the MRHD based on body surface area) in the presence of maternal toxicity (reduced body weight gain or weight loss) and polycythemia.
In a pre- and postnatal development study, pregnant rats were dosed orally with daprodustat from implantation until weaning (gestation day 6 to lactation day 21) at 0.8, 7, or 40 mg/kg/day concomitantly with 3 major human metabolites of daprodustat. No adverse effects were observed at doses less than or equal to 7 mg/kg/day (3 times the MRHD based on body surface area). Maternal toxicity (in the presence of polycythemia) was noted at 40 mg/kg/day (16 times the MRHD based on body surface area), which was associated with increased pup deaths and decreased pup weights.
8.2Lactation Risk Summary There are no data on the presence of daprodustat in human milk, the effects on the breastfed child, or the effects on milk production. Daprodustat is present in the milk of lactating rats (see Data) . When a drug is present in animal milk, it is likely that the drug will be present in human milk. Given the serious adverse reactions seen in adults treated with JESDUVROQ, such as thrombotic vascular events, advise patients…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data with JESDUVROQ use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with CKD ( see Clinical Considerations ) . Daprodustat administered orally to pregnant rats and rabbits during the period of organogenesis was associated with adverse fetal outcomes, including embryonic and fetal loss and reduced fetal weight, at doses that caused maternal toxicity and polycythemia ( see Data ).
Advise pregnant women of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: CKD in pregnancy increases the risk for maternal hypertension, preeclampsia, miscarriage, stillbirth, preterm delivery, low birth weight infants, and polyhydramnios. Data Animal Data : Daprodustat was orally administered to pregnant rats at 0.5, 7, or 60 mg/kg/day from gestation day 6 to gestation day 17 during the period of organogenesis.
No adverse effects were observed at doses less than or equal to 7 mg/kg/day (3 times the maximum recommended human dose [MRHD] based on body surface area). Daprodustat administration resulted in post-implantation loss, increased embryofetal death, and reduction in skeletal ossification in rats at a dose of 60 mg/kg/day (24 times the MRHD based on body surface area), which was associated with maternal toxicity (reduced body weight gain or weight loss). Maternal toxicity occurred at doses associated with polycythemia.
Daprodustat was orally administered to pregnant rabbits at doses of 4, 30, or 60 mg/kg/day from gestation day 7 until gestation day 19 during the period of organogenesis. No adverse effects were observed at doses less than or equal to 30 mg/kg/day (24 times the MRHD based on body surface area). Daprodustat administration was associated with a low incidence of abortions and fetal skeletal malformations (irregularly shaped anterior fontanelle, manubrium, fused sternal centra, and microphthalmia) at a dose of 60 mg/kg/day (49 times the MRHD based on body surface area) in the presence of maternal toxicity (reduced body weight gain or weight loss) and polycythemia.
In a pre- and postnatal development study, pregnant rats were dosed orally with daprodustat from implantation until weaning (gestation day 6 to lactation day 21) at 0.8, 7, or 40 mg/kg/day concomitantly with 3 major human metabolites of daprodustat. No adverse effects were observed at doses less than or equal to 7 mg/kg/day (3 times the MRHD based on body surface area). Maternal toxicity (in the presence of polycythemia) was noted at 40 mg/kg/day (16 times the MRHD based on body surface area), which was associated with increased pup deaths and decreased pup weights.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of JESDUVROQ in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of subjects treated with JESDUVROQ in the ASCEND-D study (n = 2,964), 480 (32%) subjects were aged 65 years and older, and 159 (11%) were aged 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. No other reported clinical experience has identified differences in responses between the elderly and younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE Headache and gastrointestinal adverse reactions (e.g., nausea) may be seen with acute overdose with JESDUVROQ. There is no specific antidote. Hemodialysis will not substantially remove daprodustat because it is highly protein bound.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Daprodustat is a reversible inhibitor of HIF-PH1, PH2 and PH3 (IC 50 in the low nM range). This activity results in the stabilization and nuclear accumulation of HIF-1α and HIF-2α transcription factors, leading to increased transcription of the HIF-responsive genes, including erythropoietin.
12.2Pharmacodynamics Effects on Erythropoiesis Daprodustat increases endogenous erythropoietin in a dose-dependent manner within 6 to 8 hours after administration. With repeat doses, peak increases in reticulocyte counts occur between 7 and 15 days, with subsequent increases in red blood cell production. New hemoglobin steady-state levels are reached several weeks (approximately 4 weeks in ESA-users and approximately 16-20 weeks in ESA-non-users) after initial administration.
Effects on Iron Metabolism and Utilization Daprodustat increased serum transferrin and total iron binding capacity (TIBC) and decreased serum ferritin, transferrin saturation, and hepcidin when administered for 52 weeks in adults on dialysis with anemia due to CKD. Cardiac Electrophysiology At a dose 10 times the maximum recommended dose, daprodustat does not prolong the QTc interval to any clinically relevant extent.
12.3Pharmacokinetics Daprodustat exposure generally increases in a dose-proportional manner over the range of approved doses. Steady-state concentrations are achieved within 24-hours of dosing. Absorption Following oral administration, daprodustat is readily absorbed with median time to peak concentration (T max ) in healthy subjects ranging from 1 hour to 4 hours.
The absolute bioavailability of daprodustat is 65%. Administration of JESDUVROQ with a high fat/high calorie meal did not significantly alter daprodustat exposure compared to administration in the fasted state. Distribution Daprodustat has an approximately equal distribution between plasma and blood cells (blood:plasma ratio of 1.23).
Following intravenous dosing, the volume of distribution at steady-state in healthy subjects is
14.3L. In vitro, plasma protein binding of daprodustat is >99%. Elimination The terminal elimination half-life of daprodustat is approximately 1 hour to 4 hours.
Metabolism: In vitro, daprodustat is primarily metabolized by CYP2C8 (95% contribution), with a minor contribution by CYP3A4 (5%). Following oral or intravenous administration of radiolabeled daprodustat to healthy adults, approximately 40% of the total circulating radioactivity in plasma was daprodustat, and the remaining 60% was metabolites. In patients treated with JESDUVROQ, the parent drug is the principal circulating component in plasma.
Three metabolites, each accounting for more than 10% of circulating drug-related material, have been identified; in vitro and non-clinical data suggest that each may contribute to the pharmacologic response in vivo; however, the extent of this contribution is unknown. Excretion: Mean clearance from plasma was
18.9L/h, which correlates to blood clearance of 15 L/h and equates to a hepatic extraction of approximately 18%. Within seven days of an oral dose of radiolabeled daprodustat, 74% of the radioactivity was recovered in the feces, and 21% in the urine. Approximately 99.5% of the dose was excreted as oxidative metabolites, with the rest accounted for by daprodustat.
Specific Populations Elderly: Population pharmacokinetic analyses in adults with CKD (22 years to 93 years) showed that age did not influence the pharmacokinetics of daprodustat. Renal Impairment: The steady-state exposure of daprodustat is similar in patients with normal renal function and those with varying degrees of renal impairment; daprodustat exposure is not significantly impacted by hemodialysis or peritoneal dialysis. The systemic exposure of daprodustat metabolites was higher in patients with Stage 3 to 5 CKD compared to those with normal renal function.
Exposures of metabolites were higher on non-dialysis days compared to dialysis days. Hepati…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Daprodustat is a reversible inhibitor of HIF-PH1, PH2 and PH3 (IC 50 in the low nM range). This activity results in the stabilization and nuclear accumulation of HIF-1α and HIF-2α transcription factors, leading to increased transcription of the HIF-responsive genes, including erythropoietin.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied JESDUVROQ tablets contain 1 mg, 2 mg, 4 mg, 6 mg or 8 mg of daprodustat. Tablet Strength Package Configuration and NDC Number Tablet Description and Markings 1 mg 30 count bottle (NDC 0173-0897-13) Round, gray, biconvex, film-coated tablets debossed with “GS KF” on one side 100 count blister pack (NDC 0173-0897-56) 2 mg 30 count bottle (NDC 0173-0903-13) Round, yellow, biconvex, film-coated tablets debossed with “GS V7” on one side 100 count blister pack (NDC 0173-0903-56) 4 mg 30 count bottle (NDC 0173-0906-13) Round, white, biconvex, film-coated tablets debossed with “GS 13” on one side 100 count blister pack (NDC 0173-0906-56) 6 mg 30 count bottle (NDC 0173-0911-13) Round, pink, biconvex, film-coated tablets debossed with “GS IM” on one side 100 count blister pack (NDC 0173-0911-56) 8 mg 30 count bottle (NDC 0173-0914-13) Round, orange, biconvex, film-coated tablets debossed with “GS 5E” on one side 100 count blister pack (NDC 0173-0914-56) Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F). [See USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION JESDUVROQ contains daprodustat, an inhibitor of hypoxia inducible factor (HIF), prolyl 4-hydroxylases (PH)1, PH2 and PH3. The chemical name of daprodustat is N‑[(1,3‑dicyclohexylhexahydro-2,4,6-trioxopyrimidin-5-yl) carbonyl]glycine. The molecular formula of daprodustat is C 19 H 27 N 3 O 6 , and its molecular mass is 393.43.
The structural formula is shown below. Daprodustat is a white to off-white powder that is poorly soluble in water. Each JESDUVROQ oral tablet contains 1 mg, 2 mg, 4 mg, 6 mg, or 8 mg of daprodustat.
Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, mannitol and microcrystalline cellulose. The tablet film-coating inactive ingredients include hypromellose, iron oxide black (1 mg, 2 mg, and 6 mg tablets), iron oxide red and iron oxide yellow (1 mg, 2 mg, 6 mg, and 8 mg tablets), polyethylene glycol, and titanium dioxide. N [(1,3 dicyclohexylhexahydro-2,4,6-trioxopyrimidin-5-yl) carbonyl]glycine chemical structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients: • Of the increased risks of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access [see Warnings and Precautions ( 5.1 )] . • Of the risk of hospitalization due to heart failure, the symptoms and signs of heart failure and to promptly report these symptoms to their healthcare provider [see Warnings and Precautions ( 5.2 )] . • Of the risk of hypertension, to undergo regular blood pressure monitoring and to adhere to the prescribed anti-hypertensive regimen [see Warnings and Precautions ( 5.3 )] . • Of the risk of gastric erosions and gastrointestinal bleeding, the associated symptoms and signs and to report these symptoms to their healthcare provider [see Warnings and Precautions ( 5.4 )] . • Of the need to have regular laboratory tests for hemoglobin [see Dosage and Administration ( 2.1 , 2.4 )] . • Of the need to inform their healthcare provider if they are taking strong CYP2C8 inhibitors, including gemfibrozil or moderate CYP2C8 inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] . • Pregnancy JESDUVROQ may cause fetal harm.
Advise females to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations ( 8.1 )]. • Lactation Advise females not to breastfeed during treatment with JESDUVROQ and for one week after the final dose [see Use in Specific Populations ( 8.2 )]. Trademarks are owned by or licensed to the GSK group of companies. Manufactured by GlaxoSmithKline Durham, NC 27701 ©2023 GSK group of companies or its licensor.
JDV:3PI
💬 Medication Guide ▾
PHARMACIST - DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - MEDICATION GUIDE JESDUVROQ (jez–DOOV–rok) (daprodustat) tablets What is the most important information I should know about JESDUVROQ? JESDUVROQ may cause serious side effects, including: • Increased risk of death, heart attack, stroke, and blood clots. These risks may happen if you are treated with JESDUVROQ to increase red blood cells (RBCs) to near the same level found in healthy people.
These risks may be increased if you have heart or blood vessel problems, or problems with blood flow to your brain (cerebrovascular disease). Blood clots can form in the blood vessels (veins), including in your legs (deep vein thrombosis or DVT), lungs (pulmonary embolism or PE), and in your dialysis access (vascular access thrombosis or VAT). Get medical help right away if you get any of the following symptoms: ○chest pain ○sudden trouble seeing ○trouble breathing or shortness of breath ○sudden trouble walking, dizziness, loss of balance or coordination ○pain in your leg or arm, with or without swelling ○lightheadedness or fainting ○unusual coolness or warmth in arm or leg ○dialysis access stops working ○sudden confusion, trouble speaking, or trouble understanding others’ speech ○do not feel a vibration (“thrill”) over the dialysis access area ○sudden numbness or weakness in your face, arm, or leg, especially on one side of your body See “What are the possible side effects of JESDUVROQ?” for more information about side effects.
If you decide to take JESDUVROQ, your healthcare provider should prescribe the lowest dose of JESDUVROQ that is necessary to reduce your chance of needing red blood cell transfusions. What is JESDUVROQ? JESDUVROQ is a prescription medicine used to treat anemia that is caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least 4 months.
People with anemia have a lower-than-normal number of RBCs. JESDUVROQ works by increasing a protein called erythropoietin to help your body make more RBCs. JESDUVROQ is used to reduce or avoid the need for RBC transfusions.
If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take JESDUVROQ, even if you do not have an increase in your hemoglobin levels. JESDUVROQ has not been proven to improve quality of life, tiredness (fatigue), or well-being.
JESDUVROQ should not be used : • in place of emergency treatment for anemia (red blood cell transfusions). • for the treatment of anemia that is caused by CKD in people who are not on dialysis. It is not known if JESDUVROQ is safe and effective in children. Do not take JESDUVROQ if you: • take certain medicines called strong CYP2C8 inhibitors such as gemfibrozil.
Ask your healthcare provider if you are not sure. • have high blood pressure that is not controlled (uncontrolled hypertension) Before taking JESDUVROQ, tell your healthcare provider about all of your medical conditions, including if you: • have heart disease • have had a stroke • have a history of heart failure • have high blood pressure • have a history of damage to the lining of the stomach, the tube that connects the mouth and stomach (esophagus), or intestines • have a history of stomach ulcers (peptic ulcer disease) • smoke tobacco or drink alcohol • have cancer • have liver problems • are pregnant or plan to become pregnant.
JESDUVROQ may cause harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with JESDUVROQ. • are breastfeeding or plan to breastfeed. It is not known if JESDUVROQ passes into your breast milk.
Do not breastfeed during treatment with JESDUVROQ and for 1 week after your final dose. Tell your healthcare provider about a…