Veltassa

Veltassa (patiromer) belongs to a class of medications called potassium removing agents.

Veltassa is used in adults and children at least 12 years old to treat hyperkalemia (high levels of potassium in your blood). It works by removing excess potassium from the body.

Veltassa comes as a powder to mix with water and take by mouth.

Veltassa is not used for emergency treatment of life-threatening hyperkalemia because it takes some time to work.

Take Veltassa oral powder exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Veltassa oral powder is usually taken once daily with or without food.

Veltassa oral powder must be mixed with water before you take it. Stir this mixture well and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away, repeat as needed.

Do not mix the oral powder with hot liquid or hot food. Do not take the dry powder without mixing it with water.

You can mix Veltassa oral powder with other beverages or soft food like apple sauce, yogurt, or pudding instead of water.

Do not try to warm the medication by heating it in a microwave, or adding it to heated foods or liquids.

While taking this medicine, your blood will need to be tested often and your dose may be changed based on the results.

You may need to follow a special diet. Follow all instructions of your doctor or dietitian. Learn about the foods you should eat or avoid.

Store unmixed oral powder in the refrigerator. Do not open a medicine packet until you are ready to mix a dose.

If stored at room temperature away from moisture and heat, you should use this medication within 3 months.

Avoid taking other medicines by mouth within 3 hours before or 3 hours after you take Veltassa oral powder.

Tell your doctor if you have or have ever had difficulty swallowing, gastrointestinal (GI; affecting the stomach or intestines) surgery, constipation, fecal impaction (a dry hard stool stuck in the rectum), bowel obstruction (blockage in your intestine), a problem with your bowels after bowel surgery, or GI disease.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

You should not use Veltassa if you are allergic to patiromer, or if you have:

• bowel obstruction;
• bowel problems caused by recent surgery;
• trouble swallowing;
• severe constipation; or
• low levels of magnesium in your blood.

Tell your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction to Veltassa: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Patiromer may cause serious side effects. Call your doctor at once if you have:

• low magnesium - dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling.

Common Veltassa side effects may include:

• constipation, diarrhea;
• stomach discomfort, nausea; or
• gas.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Hyperkalemia:

Initial dose: 8.4 g orally once a day -Monitor serum potassium level and adjust dose in 8.4 g increments at 1-week intervals based on serum potassium level and desired target range Maintenance dose: 8.4 to 25.2 g/day Maximum dose 25.2 g/day Comments: -This drug should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. -This drug should be administered at least 3 hours before or 3 hours after other oral medications. Use: For the treatment of hyperkalemia.

Usual Pediatric Dose for Hyperkalemia: 12 to 17 years: Initial dose: 4 g orally once a day -Monitor serum potassium level and adjust dose in 4 g increments at 1-week intervals based on serum potassium level and desired target range Maximum dose: 25.2 g/day

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause low potassium (leg cramps, constipation, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling).

Avoid taking other medicines within 3 hours before or 3 hours after you take Veltassa. Patiromer can make it harder for your body to absorb other medicines you take by mouth.

Patiromer can make it harder for your body to absorb other medicines you take by mouth. If you take any of the following medications, take them 3 hours before or after you take Veltassa:

• telmisartan;
• bisoprolol, carvedilol, nebivolol;
• ciprofloxacin;
• levothyroxine;
• metformin;
• mycophenolate;
• quinidine; or
• thiamine.

This list is not complete and many other drugs may interact with patiromer. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Active ingredient: patiromer Inactive ingredients: xanthan gum

Vifor Pharma, Inc., Redwood City, CA 94063. USA.