Patiromer for oral suspension

What is Patiromer?

• Patiromer sorbitex calcium which consists of the active moiety, patiromer, a non-absorbed potassium-binding polymer, and a calcium-sorbitol counterion. Each gram of patiromer is equivalent to a nominal amount of 2 grams of patiromer sorbitex calcium.
• Chemical name for patiromer sorbitex calcium: It is a cross-linked polymer of calcium 2-fluoroprop-2-enoate with diethenylbenzene and octa-1,7-diene, combination with D-glucitol.
• Patiromer sorbitex calcium is an amorphous, free-flowing powder that is composed of individual spherical beads. Patiromer sorbitex calcium is insoluble in solvents such as water, 0.1 M HCl, n-heptane and methanol.

Patiromer

What are the uses of this medicine?

It is indicated for the treatment of hyperkalemia.

How does this medicine work?

• Patiromer is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol counterion.
• Patiromer increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels.

Who Should Not Use this medicine?

• Patiromer is contraindicated in patients with a history of a hypersensitivity reaction to it.
• It should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

What are the brand names and dosage forms of this medicine?

• Brand name: Veltassa; NDC codes: 53436-084-01, 53436-084-04, 53436-084-30, 53436-084-91, 53436-084-92, 53436-168-01, 53436-168-30, 53436-252-01, 53436-252-30.
• Veltassa is an off-white to light-brown powder for oral suspension packaged in single-use packets containing 8.4 grams, 16.8 grams or 25.2 grams patiromer.

Is this medicine FDA approved?

It is approved by US FDA on Oct 21, 2015.

What are the active and inactive ingredients in Patiromer for oral suspension?

• Active ingredient: Patiromer
• Inactive ingredient: xanthan gum

How should this medicine be used?

• It’s important to take VELTASSA every day with or without food, as prescribed by your doctor. If you stop taking VELTASSA, even for a few days, your potassium levels can increase.
• Measure 1/3 cup of water in a measuring cup. Pour half of the water into an empty drinking glass. Pour all of the VELTASSA packet contents into the drinking glass with water. Stir the mixture well.
• Pour the rest of the water from the measuring cup into the drinking glass containing the mixture. Stir the mixture well. The powder will not dissolve and the mixture will look cloudy. If the mixture is too thick, you can add more water.
• Drink the mixture right away. If any powder is left in the glass after drinking, add more water, stir the mixture, and drink the remaining mixture right away. Repeat as needed to make sure you take your entire dose of VELTASSA.

What special precautions should I follow?

• Avoid use of Veltassa in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions.
• Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3% of patients treated with Veltassa. Monitor serum magnesium. Consider magnesium supplementation in patients who develop low serum magnesium levels on Veltassa.

What side effects can this medication cause?

• Constipation
• Hypomagnesemia
• Diarrhea
• Nausea
• Abdominal discomfort
• Flatulence

What to do in case of emergency/overdose?

• Doses of Veltassa in excess of 50.4 grams per day have not been tested. Excessive doses of Veltassa may result in hypokalemia. Restore serum potassium if hypokalemia occurs.
• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

Veltassa is not absorbed systemically following oral administration and maternal use is not expected to result in fetal risk.

Can this medicine be used in children?

Safety and efficacy in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Veltassa should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F).
• If stored at room temperature (25°C ± 2°C [77°F ± 4°F]), Veltassa must be used within 3 months of being taken out of the refrigerator. For either storage condition, do not use Veltassa after the expiration date printed on the packet.
• Avoid exposure to excessive heat above 40°C (104°F).

• Dailymed label info on Patiromer for oral suspension
• FDA Patiromer for oral suspension

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