VELTASSA® (patiromer) for oral suspension

Indication and Usage

VELTASSA is indicated for the treatment of hyperkalemia.
Limitation of Use: VELTASSA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

Important Safety Information

Contraindications: VELTASSA is contraindicated in patients with a history of a hypersensitivity reaction to VELTASSA or any of its components. Please see additional Important Safety Information Important Safety Information below and full Prescribing Information.

 

ONCE-DAILY VELTASSA:

An unflavored, drinkable suspension for your patients

Recommended Starting Dose

8.4 g/day

Titration

At weekly intervals:
can be increased or decreased by 8.4 g/day up to a maximum of
25.2 g/day*

Dosing Strengths

8.4 g/day
16.8 g/day
25.2 g/day
  1/3 cup of water

*Adjust the dose based on the serum K+ and the desired target range.

Preparation instructions for patients

Begin by filling a measuring cup with 1/3 cup of water.

MIX

MIX half of the water with entire packet contents, then stir.

ADD

ADD the other half of the water and stir.

DRINK

DRINK immediately. Add additional water and drink as needed to ensure entire dose is administered.



Notes for patients:

Take with or without food.

  • DO adhere to prescribed diet
  • DO mix VELTASSA with water only
  • DO mix with water in separate steps to avoid clumping
  • DO NOT take other oral drugs less than 3 hours before or after taking VELTASSA to avoid possible interaction
  • DO NOT heat VELTASSA or add to heated foods or liquids
  • DO NOT mix VELTASSA in a blender
  • DO NOT take in dry form


Items needed to take VELTASSA:

Veltassa Packet

Scissors

Glass

1/3 cup of water

Spoon

How to administer VELTASSA

DOWNLOAD

No interactions when VELTASSA and other oral medications are taken 3 hours apart

Drug Interactions

DRUGS IN VITRO IN VIVO*
ciprofloxacin

Absorption of ciprofloxacin is significantly reduced by concomitant administration of multivalent cation-containing products, such as calcium.1

levothyroxine

Calcium carbonate may form an insoluble chelate with levothyroxine.2

*Drugs tested in in vitro binding studies. Drugs that showed an in vitro interaction were subsequently tested in vivo to determine dose separation. There was no interaction when VELTASSA and these drugs were taken 3 hours apart.

Important Safety Information, including Boxed WARNING

Indication and Usage

VELTASSA is indicated for the treatment of hyperkalemia.

Limitation of Use: VELTASSA should not be used as an emergency treatment for life‑threatening hyperkalemia because of its delayed onset of action.


Important Safety Information

Contraindications: VELTASSA is contraindicated in patients with a history of a hypersensitivity reaction to VELTASSA or any of its components.

Worsening of Gastrointestinal Motility: 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. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.

Hypomagnesemia: 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. Approximately 9% of patients in clinical trials developed hypomagnesemia with a serum magnesium value <1.4 mg/dL. Monitor serum magnesium. Consider magnesium supplementation in patients who develop low serum magnesium levels.

Adverse Reactions: The most common adverse reactions (incidence ≥2%) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3% of patients treated with VELTASSA and included edema of the lips.

Please see full Prescribing Information Prescribing Information The VELTASSA Prescribing Information has been updated to remove the Boxed WARNING for binding to other oral medications. Administer VELTASSA at least 3 hours before or 3 hours after other oral medications. Please see Section 12.3 for detailed drug interactions.
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References: 1. Cipro® (ciprofloxacin hydrochloride) Tablets [package insert], Bayer Healthcare Pharmaceuticals, Inc. rev 09/08. 2. Levoxyl (levothyroxine sodium) Tablet [package insert], King Pharmaceuticals, Inc. rev 11/07.