Brand Name
Jesduvroq
Generic Name
Daprodustat
View Brand Information FDA approval date: February 01, 2023
Classification: Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor
Form: Tablet
What is Jesduvroq (Daprodustat)?
JESDUVROQ is indicated for the treatment of anemia due to chronic kidney disease 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 inhibitor indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. 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.
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Brand Information
Jesduvroq (daprodustat)
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)
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
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 cell transfusions
1INDICATIONS 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.
2DOSAGE 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.
3CONTRAINDICATIONS
JESDUVROQ is contraindicated in patients:
- Receiving a strong CYP2C8 inhibitor such as gemfibrozil
- With uncontrolled hypertension
4ADVERSE 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
- Risk of Hospitalization for Heart Failure
- Hypertension
- Gastrointestinal Erosion
4.1Clinical 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)
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
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).
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
PY = 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.
5OVERDOSAGE
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.
6DESCRIPTION
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
![N [(1,3 dicyclohexylhexahydro-2,4,6-trioxopyrimidin-5-yl) carbonyl]glycine chemical structure](https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=jesduvroq-spl-graphic-01.jpg&setid=d82aa06e-5a33-4844-99b7-4701313455a4)
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.
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
JESDUVROQ tablets contain 1 mg, 2 mg, 4 mg, 6 mg or 8 mg of daprodustat.
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].
8PATIENT 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
- 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
- Of the risk of hypertension, to undergo regular blood pressure monitoring and to adhere to the prescribed anti-hypertensive regimen
- Of the risk of gastric erosions and gastrointestinal bleeding, the associated symptoms and signs and to report these symptoms to their healthcare provider
- Of the need to have regular laboratory tests for hemoglobin
- Of the need to inform their healthcare provider if they are taking strong CYP2C8 inhibitors, including gemfibrozil or moderate CYP2C8 inhibitors
- Pregnancy
- JESDUVROQ may cause fetal harm. Advise females to inform their healthcare provider of a known or suspected pregnancy
- Lactation
- Advise females not to breastfeed during treatment with JESDUVROQ and for one week after the final dose
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