Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

VELTASSA (NDA-205739)

(PATIROMER SORBITEX CALCIUM)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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10/02/2023 (SUPPL-38)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Hypomagnesemia

(Additions and/or revisions underlined)

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 adult patients treated with Veltassa [see Adverse Reactions (6.1)]. Monitor serum magnesium. Consider magnesium supplementation in patients who develop low serum magnesium levels on Veltassa.

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions underlined)

Adult Patients

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 adult patients treated with Veltassa in these clinical trials. Most adverse reactions were mild to moderate. Constipation generally resolved during the course of treatment.

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 adult patients treated with Veltassa in clinical trials. Reactions have included edema of the lips.

Laboratory Abnormalities

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

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

Pediatric Patients

In a single-arm, open-label pediatric study, 14 patients 12 to 17 years of age received at least one dose of Veltassa, including 12 patients exposed for at least 25 weeks. The safety profile was generally similar to that observed in adult patients.

7 Drug Interactions

7.1 Clinically Important Interaction of Veltassa with Other Drugs

(Additions and/or revisions underlined)

The in-vitro binding of the following drugs to patiromer was evaluated and potentially clinically significant binding was observed. Some drugs were subsequently tested in-vivo and significant reduction in systemic exposure was observed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)].

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.

7.2 No Observed Clinically Important Interaction of Veltassa with Other Drugs

(Additions and/or revisions underlined)

The binding of the following drugs to patiromer was evaluated [see Clinical Pharmacology (12.3)] and no clinically significant binding was observed. No separation of dosing is required for these drugs.

8 Use in Specific Populations

8.4 Pediatric Use

(Additions and/or revisions underlined)

The safety and effectiveness of Veltassa for lowering serum potassium levels have been established in pediatric patients ages 12 years and older. Use of Veltassa for this indication is supported by evidence from an adequate and well-controlled study in adults, with additional pharmacodynamic and safety data in pediatric patients aged 12 years and older [see Dosage and Administration (2.2), Adverse Reactions (6.1), and Clinical Studies (14.3)].

Safety and efficacy have not been established in pediatric patients below the age of 12 years. Although the pediatric study included 9 patients 6 to less than 12 years of age, the dosing regimen that was evaluated in these patients did not appear to be effective in reducing serum potassium levels in this age group after 2 weeks. The starting dose of Veltassa in this age group was 2 g/day and the median dose at Day 14 was 6 g/day. In this age group the mean change in serum potassium from Baseline to Day 14 was -0.1 mEq/L (95% CI -0.7, 0.4). Because the available data are not sufficient to determine a safe and effective dosing regimen in patients 6 to less than 12 years of age, labeling recommendations cannot be provided for this age group.

8.5 Geriatric Use

(Additions and/or revisions underlined)

Of the 666 patients treated with Veltassa in clinical studies, 60% were age 65 and over, and 20% were age 75 and over. No overall differences in effectiveness were observed between these patients and younger patients. Patients age 65 and older reported more gastrointestinal adverse reactions than younger patients.

8.6 Renal Impairment

(Additions and/or revisions underlined)

Of the 666 adult patients treated with Veltassa in clinical studies, 93% had chronic kidney disease (CKD). All 14 pediatric patients ages 12 years and older treated with Veltassa in the clinical study had chronic kidney disease. No special dosing adjustments are needed for patients with renal impairment.

03/27/2023 (SUPPL-37)

Approved Drug Label (PDF)

7 Drug Interactions

(Additions and/or revisions underlined)

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 [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)].

7.1 Clinically Important Interaction of Veltassa With Other Drugs

(Newly added subsection)

Table 2. Clinically important drug interactions of Veltassa

7.2 No Observed Clinically Important Interaction of Veltassa with Other Drugs

(Newly added subsection)

The binding of the following drugs to patiromer was evaluated [see Section Pharmacokinetics (12.3)] and no clinically significant binding was observed. No separation of dosing is required for these drugs.

Table 3 No observed clinically important drug interactions of Veltassa

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Drug Interactions

Advise patients who are taking other oral medication that separation of dosing of Veltassa by at least 3 hours (before or after) may be needed except those shown to not have a clinically important interaction in table 3 above. [see Drug Interactions (7)].

11/25/2016 (SUPPL-9)

Approved Drug Label (PDF)

7 Drug Interactions

(addition underlined)

In clinical studies, Veltassa decreased systemic exposure of some coadministered oral medications . 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.