Veltassa

What Is Veltassa?

Veltassa (patiromer) for oral suspension is a potassium binder indicated for the treatment of high potassium levels in the blood (hyperkalemia).

What Are Side Effects of Veltassa?

Common side effects of Veltassa include:

• constipation,
• blood magnesium deficiency,
• diarrhea,
• nausea,
• abdominal discomfort, and
• gas

Dosage for Veltassa

The recommended starting dose of Veltassa is 8.4 grams administered orally once daily with food.

What Drugs, Substances, or Supplements Interact with Veltassa?

Veltassa may interact with other drugs taken orally. Administer other oral medications at least 6 hours before or 6 hours after Veltassa. Tell your doctor all medications and supplements you use.

Veltassa During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before taking Veltassa. Veltassa is not expected to pose fetal risk. Veltassa is not absorbed systemically by the mother so is not expected to pass into breast milk or harm a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Veltassa (patiromer) for oral suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Veltassa Consumer Information

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.

Read the entire detailed patient monograph for Veltassa (Patiromer Powder for Suspension in Water for Oral Administration)

 

Veltassa Professional Information

SIDE EFFECTS

The following adverse reaction is discussed in greater detail elsewhere in the label:

• Hypomagnesemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Veltassa cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice.

In the safety and efficacy clinical trials, 666 adult patients received at least one dose of Veltassa, including 219 exposed for at least 6 months and 149 exposed for at least one year.

Table 1 provides a summary of the most common adverse reactions (occurring in ≥ 2% of patients) in patients treated with Veltassa in these clinical trials. Most adverse reactions were mild to moderate. Constipation generally resolved during the course of treatment.

Table 1: Adverse Reactions Reported in ≥ 2% of Patients

Adverse Reactions	Patients treated with Veltassa (N=666)
Constipation	7.2%
Hypomagnesemia	5.3%
Diarrhea	4.8%
Nausea	2.3%
Abdominal discomfort	2.0%
Flatulence	2.0%

During the clinical studies, the most commonly reported adverse reactions leading to discontinuation of Veltassa were gastrointestinal adverse reactions (2.7%), including vomiting (0.8%), diarrhea (0.6%), constipation (0.5%) and flatulence (0.5%).

Mild to moderate hypersensitivity reactions were reported in 0.3% of patients treated with Veltassa in clinical trials. Reactions have included edema of the lips.

Laboratory Abnormalities

Approximately 4.7% of patients in clinical trials developed hypokalemia with a serum potassium value < 3.5 mEq/L.

Approximately 9% of patients in clinical trials developed hypomagnesemia with a serum magnesium value < 1.4 mg/dL.

DRUG INTERACTIONS

In clinical studies, Veltassa decreased systemic exposure of some coadministered oral medications [see CLINICAL PHARMACOLOGY]. Binding of Veltassa to other oral medications could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time Veltassa is administered. Administer other oral medications at least 3 hours before or 3 hours after Veltassa [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Veltassa (Patiromer Powder for Suspension in Water for Oral Administration)