Vadadustat Tablets

What is this medication?

VADADUSTAT (VAD a DOO stat) treats low levels of red blood cells (anemia) in people with kidney disease. It works by helping your body make more red blood cells, which reduces the need for blood transfusions.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): VAFSEO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cancer
• Frequently drink alcohol
• Have had a heart attack
• Have had a stroke or transient ischemic attack
• Heart disease
• High blood pressure
• Liver disease
• Seizures
• Stomach ulcers, other stomach or intestine problems
• Tobacco use
• An unusual or allergic reaction to vadadustat, other medications, foods, dyes or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Take products with iron in them, including phosphate binder with iron, at a different time of day than this medication. Take this medication 1 hour BEFORE these products.

Take this medication at least 1 hour BEFORE or 2 hours AFTER taking phosphate binders that do not contain iron.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Do not take more than 1 dose a day.

What may interact with this medication?

• Certain antibiotics such as cefaclor, ceftizoxime, penicillin G, rifampin
• Certain medications for cholesterol, such as gemfibrozil, rosuvastatin, simvastatin
• Famotidine
• Furosemide
• Iron supplements
• Oseltamivir
• Phosphate binders, such as sevelamer, calcium acetate, ferric citrate, sucroferric oxyhydroxide
• Probenecid
• Sitagliptin
• Sulfasalazine
• Teriflunomide

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication. Check your blood pressure as directed. Know what your blood pressure should be and when to contact your care team.

You may need blood work done while you are taking this medication.

This medication can cause serious ulcers and bleeding in the stomach. It can happen with no warning. Tobacco, alcohol, older age, and poor health can also increase risks. Call your care team right away if you have stomach pain or blood in your vomit or stool.

Talk to your care team about your risk of cancer. You may be at more risk for certain types of cancer if you take this medication.

Do not breastfeed while taking this medication and for 2 days after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• New or worsening seizures
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Fatigue
• Headache
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.