Patiromer

Keep this medication in the container it came in, closed, and out of reach of children. Store it in either the refrigerator or at room temperature away from excess heat and moisture (not in the bathroom). If patiromer powder is stored at room temperature, dispose of it after 90 days.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Serious side effects have been reported with patiromer. See the “Patiromer Precautions” section.

Common side effects of patiromer include the following:

• constipation
• diarrhea
• nausea
• stomach discomfort
• gas
• low levels of magnesium

This is not a complete list of patiromer side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Serious side effects have been reported with Patiromer including the following:

• Low levels of magnesium in your blood (hypomagnesemia). Low levels of magnesium in the blood can occur when taking Veltassa. Your doctor will check the magnesium levels in your blood during treatment with patiromer. Your doctor may prescribe a magnesium supplement if you have low levels of magnesium in your blood. 
• Slowing of the movements of the digestive system. Veltassa may not work and may worsen stomach and intestine conditions. Tell your doctor if you have severe constipation, have bowel obstruction or impaction, and/or have problems with your bowels after bowel surgery.

Do not take patiromer if you are allergic to patiromer or to any of its ingredients.

Before taking patiromer, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to patiromer or to any of its ingredients
• have problems having a bowel movement, including if you have severe constipation, a blockage (obstruction) in your bowel, or dry hard stool that will not pass out of your rectum (impaction)
• have problems with your bowels after bowel surgery
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take patiromer exactly as prescribed. Your doctor may change your dose if needed.

This medication comes in a powder which is mixed by water and taken by mouth. It is typically taken once a day, with food. 

Prepare each dose of patiromer separately

Follow the diet that your doctor has prescribed for you.

To mix a dose of patiromer:

• Pour 30 mL (1 ounce) of water into an empty glass or cup
• Carefully pour all of the packet contents into the glass or cup with the water. You may need more than 1 packet of patiromer for your prescribed dose.
• Stir the mixture well.
• Pour 60 mL (2 ounces) of water into the glass or cup containing the mixture.
• Stir the mixture well. The powder will not completely dissolve and the mixture will look cloudy.
• Drink the mixture right away.
• If any powder is left in the glass or cup after drinking, add more water, stir the mixture, and drink the mixture right away. Repeat as needed to make sure you take your entire dose of patiromer. Do not take patiromer that has not been mixed with water.

Do not heat, microwave, or add patiromer to heated foods or liquids. 

Take your other medications, that are taken by mouth, at least 3 hours before or 3 hours after patiromer.  

If you take too much patiromer, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

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, thirst, urination, numbness or tingling, muscle weakness or limp feeling).

Avoid taking other medicines within 3 hours before or 3 hours after you take patiromer. Patiromer can make it harder for your body to absorb other medicines you take by mouth. This could make the other medicines less effective.

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

Call your doctor at once if you have:

• back-and-forth movements of the eyes;

• a seizure (convulsions);

• muscle pain or weakness;

• numbness; or

• tiredness.

Common side effects may include:

• constipation, diarrhea;

• stomach pain, 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.

It is very important that your doctor check your progress at regular visits to make sure that patiromer is working properly. Blood tests may be needed to check for unwanted effects.

patiromer may cause hypomagnesemia (low magnesium levels in the blood). Check with your doctor right away if you have drowsiness, loss of appetite, mood or mental changes, muscle spasms (tetany) or twitching, seizures, nausea or vomiting, trembling, or unusual tiredness or weakness.

• Patiromer Sorbitex Calcium

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling.

Applies to patiromer: oral powder for suspension

Along with its needed effects, patiromer 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 while taking patiromer:

• Drowsiness
• loss of appetite
• mood or mental changes
• muscle spasms (tetany) or twitching
• nausea or vomiting
• seizures
• trembling
• unusual tiredness or weakness

Some side effects of patiromer 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:

• Difficulty having a bowel movement (stool)

• Abdominal or stomach discomfort
• bloated or full feeling
• diarrhea
• excess air or gas in the stomach or intestines
• passing gas

In animal studies, this drug did not impair fertility in males or females at doses up to 10-fold the maximum recommended human dose (MRHD). US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Use is considered acceptable. US FDA pregnancy category: Not assigned Comment: -This drug is not absorbed systemically following oral administration and maternal use is not expected to result in fetal risk.