Pronunciation:

dap-roe-DOO-stat

Brand Names:

• Jesduvroq

Dosage Forms:

• Tablet

Warnings:

Increased Risk of Death, Myocardial Infarction, Stroke, Venous Thromboembolism, and Thrombosis of Vascular AccessDaprodustat 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 daprodustat, or dosing strategy that does not increase these risks.Use the lowest dose of daprodustat sufficient to reduce the need for red blood cell transfusions .

Classifications:

Therapeutic—

Blood Modifier Agent

Uses of This Medicine:

Daprodustat is used to treat anemia caused by chronic kidney disease (CKD) in patients who have been on dialysis for at least 4 months. This medicine works by increasing erythropoietin (protein) to help the body make more red blood cells. It is also used to lessen or avoid the need for blood transfusion.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of daprodustat in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of daprodustat in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Abiraterone Acetate
• Gemfibrozil

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Clopidogrel
• Dabrafenib
• Deferasirox
• Rifampin
• Teriflunomide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer or
• Liver disease, severe or
• Patients not receiving dialysis—Use is not recommended in patients with these conditions.

• Heart disease or
• Heart failure, history of or
• Stomach or bowel problems (eg, gastrointestinal erosion, peptic ulcer), history of or
• Stroke, history of—Use with caution. May make these conditions worse.

• Hypertension (high blood pressure), uncontrolled—Should not be used in patients with this condition.

• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of this medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects. Do not use this medicine as a substitute for emergency treatment of anemia (eg, blood transfusion).

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not cut, crush, or chew it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For anemia from chronic kidney failure for patients on dialysis not receiving an erythropoiesis-stimulating agent (ESA):
    • Adults—Starting dose is based on your hemoglobin level. The dose is usually one tablet once a day. Each tablet may contain 1 milligram (mg), 2 mg, 4 mg, 6 mg, or 8 mg. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For anemia from chronic kidney failure for patients on dialysis switching from an erythropoiesis-stimulating agent (ESA):
    • Adults—Starting dose is based on the dose of ESA you are currently receiving. The dose is usually one tablet once a day. Each tablet may contain 1 milligram (mg), 2 mg, 4 mg, 6 mg, or 8 mg. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your blood on a regular basis while you are using this medicine. You may also need to monitor your blood pressure at home. If you notice any changes to your recommended blood pressure, call your doctor right away.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not use this medicine together with gemfibrozil (Lopid®).

This medicine may increase your risk of having heart attack, stroke, or blood clots. Check with your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move the arms, legs, or facial muscles, inability to speak, nausea, pain in chest, groin, or legs, especially the calves, pain or discomfort in the arms, jaw, back, or neck, slow speech, sudden, severe weakness or numbness in the arm or leg, sudden loss of coordination, sweating, trouble breathing, or vomiting.

This medicine may increase your risk of hospitalization for heart failure. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain.

Call your doctor right away if you have blurred vision, dizziness, nervousness, headache, pounding in the ears, or slow or fast heartbeat. These may be symptoms of high blood pressure.

This medicine may increase your risk of serious stomach or bowel problems (eg, damage to the stomach lining, esophagus, and intestines). This risk may increase if you have a history of stomach or bowel problems (eg, gastrointestinal erosion), use certain medicines, or currently smoke tobacco or drink alcohol. Check with your doctor right away if you have bloody or black, tarry stools, chest pain, constipation, severe stomach pain, throat pain, trouble swallowing, or vomiting of blood or material that looks like coffee grounds.

This medicine may cause cancer. If you are concerned about this, talk with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

chest tightness

dizziness

fever

headache

hoarseness

irritation

joint pain, stiffness, swelling

nervousness

pounding in the ears

redness of the skin

slow or fast heartbeat

swelling of the eyelids, face, lips, hands, or feet

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

trouble breathing

trouble swallowing

Less common

Blood or black, tarry stools

chest pain or discomfort

confusion

constipation

difficulty in speaking

double vision

inability to move the arms, legs, or facial muscles

inability to speak

nausea

pain or discomfort in the arms, jaws, back, or neck

sever stomach pain

slow speech

sweating

vomiting

vomiting of blood material that looks like coffee grounds

Rare

Anxiety

cough

dizziness or lightheadedness

fainting

pain, redness, or swelling in the arm or leg

Incidence not known

Agitation

back pain

coma

drowsiness

hallucination

mood or mental changes

seizures

stiff neck

unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.