Description
Vadadustat is used to treat anemia caused by chronic kidney disease (CKD) in patients who have been on dialysis for at least 3 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.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of vadadustat in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vadadustat in the elderly.
Breastfeeding
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.
Drug Interactions
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 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.
- Acyclovir
- Baricitinib
- Calcium
- Calcium Acetate
- Cefaclor
- Ceftizoxime
- Ciprofloxacin
- Famotidine
- Furosemide
- Gemfibrozil
- Irinotecan
- Iron
- Lanthanum Carbonate
- Methotrexate
- Nitisinone
- Oseltamivir
- Ozanimod
- Penicillin G
- Probenecid
- Rifampin
- Rosuvastatin
- Sevelamer
- Sevelamer Carbonate
- Sevelamer Hydrochloride
- Simvastatin
- Sitagliptin
- Sofosbuvir
- Sulfasalazine
- Sunitinib
- Talazoparib
- Tenofovir Alafenamide
- Teriflunomide
- Topotecan
- Ubrogepant
- Valacyclovir
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, active or
- Patients not receiving dialysis—Use is not recommended in patients with these conditions.
- Heart disease 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.
Proper Use
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.
You may take this medicine with or without food.
Swallow the tablet whole. Do not cut, crush, or chew it.
If you are taking iron supplements or medicines that contain iron (eg, ferric citrate, sucroferric oxyhydroxide), take this medicine at least 1 hour before.
If you are taking non-iron containing phosphate binders (eg, calcium acetate, sevelamer carbonate), take this medicine at least 1 hour before or 2 hours after.
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 disease for patients on dialysis not receiving an erythropoiesis-stimulating agent (ESA) and for patients on dialysis switching from an erythropoiesis-stimulating agent (ESA):
- Adults—At first, 300 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For anemia from chronic kidney disease for patients on dialysis not receiving an erythropoiesis-stimulating agent (ESA) and for patients on dialysis switching from an erythropoiesis-stimulating agent (ESA):
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
It is very important that your doctor check your progress 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 this medicine, tell your doctor right away.
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 speaking, double vision, headache, inability to move your arms, legs, or facial muscles, inability to speak, nausea, pain in your 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.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
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 cause seizures. Check with your doctor right away if you have loss of bladder control, muscle spasm or jerking of all extremities, or sudden loss of consciousness.
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, 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
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
- Agitation
- anxiety
- back pain
- black, tarry stools
- blurred vision
- burning feeling in the chest or stomach
- burning upper abdominal or stomach pain
- chest pain, discomfort, or burning
- coma
- confusion
- constipation
- cough
- diarrhea
- difficulty in speaking
- difficulty swallowing
- dizziness or lightheadedness
- double vision
- drowsiness
- enlarged pupils
- feeling of constant movement of self or surroundings
- fever
- hallucinations
- headache
- heartburn
- inability to move the arms, legs, or facial muscles
- inability to speak
- increased sensitivity of the eyes to light
- increased sweating, possibly with fever or cold, clammy skin
- indigestion
- irritability
- loss of appetite
- mood or mental changes
- nervousness
- pain, redness, or swelling in the arm or leg
- pain or discomfort in the arms, jaw, back, or neck
- pains in chest, groin, or legs, especially calves of the legs
- pounding in the ears
- seizures
- sensation of spinning
- severe chest pain
- slow or fast heartbeat
- stiff or sore neck
- stomach cramps, burn, upset, or pain
- sudden loss of coordination
- sudden onset of slurred speech
- sudden vision changes
- sweating
- swelling of the neck
- trouble breathing
- unusual tiredness or weakness
- vomiting
- vomiting of blood or material that looks like coffee grounds
Incidence not known
- Dark urine
- loss of bladder control
- muscle spasm or jerking
- sudden loss of consciousness
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- General feeling of discomfort or illness
- lack or loss of strength
- unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
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.
CON-XXXXXXXX
