Brand Name
Veltassa
Generic Name
Patiromer
View Brand Information FDA approval date: October 23, 2015
Classification: Potassium Binder
Form: Powder
What is Veltassa (Patiromer)?
Veltassa is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older. Limitation of Use: Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (1.
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Brand Information
VELTASSA (patiromer)
1INDICATIONS AND USAGE
Veltassa is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older.
Limitation of Use: Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action
2DOSAGE FORMS AND STRENGTHS
Veltassa is an off-white to light-brown powder for oral suspension packaged in single-use packets containing 1 gram, 8.4 grams, 16.8 grams or 25.2 grams patiromer.
3CONTRAINDICATIONS
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components
4ADVERSE REACTIONS
The following adverse reaction is discussed in greater detail elsewhere in the label:
- Hypomagnesemia
5DRUG INTERACTIONS
Veltassa has the potential to bind some oral co-administered medications, which could decrease their gastrointestinal absorption. Binding of Veltassa to other oral medications not listed in Table 3 below 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
5.1Clinically Important Interaction of Veltassa with Other Drugs
The
Binding by Veltassa may reduce the systemic exposure and decrease the clinical efficacy of the co-administered drugs shown in Table 2. The administration of these drugs (and any drugs not listed in Table 3) should be separated by at least 3 hours from Veltassa.
5.2No Observed Clinically Important Interaction of Veltassa with Other Drugs
The binding of the following drugs to patiromer was evaluated
6OVERDOSAGE
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.
7DESCRIPTION
Veltassa is a powder for suspension in water for oral administration. The active ingredient is 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.
The chemical name for patiromer sorbitex calcium is 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. The chemical structure of patiromer sorbitex calcium is presented in Figure 1.
Figure 1: Chemical Structure of Patiromer Sorbitex Calcium
Each packet of Veltassa contains 1 gram, 8.4 grams, 16.8 grams or 25.2 grams of patiromer, the active moiety. The inactive ingredient is xanthan gum.
8PRINCIPAL DISPLAY PANEL - 8.4 g Packet Carton
30 packets
Veltassa
For Oral Suspension
www.veltassa.com
Each packet contains 8.4 grams of patiromer.
Rx only
8.4 g
9PRINCIPAL DISPLAY PANEL - 16.8 g Packet Carton
30 packets
Veltassa
For Oral Suspension
www.veltassa.com
Each packet contains 16.8 grams of patiromer.
Rx only
16.8 g
10PRINCIPAL DISPLAY PANEL - 25.2 g Packet Carton
30 packets
NDC 53436-252-30
NDC 53436-252-30
Veltassa®
(patiromer)
(patiromer)
For Oral Suspension
www.veltassa.com
Each packet contains 25.2 grams of patiromer.
Rx only
25.2 g
11PRINCIPAL DISPLAY PANEL - 1 g Packet Carton
60 packets
Veltassa
For Oral Suspension
www.veltassa.com
Each packet contains 1 gram of patiromer.
Rx only
1 g
