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.

PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER (NDA-021703)

(CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE)

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

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06/30/2017 (SUPPL-18)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Blood Glucose Abnormalities

(subsection revised, additions underlined)

The use of PRISMASOL and PHOXILLUM replacement solutions can affect blood glucose levels resulting in hypo- or hyper-glycemia depending upon the dextrose content of the replacement solution. Monitor blood glucose levels regularly. Patients may require initiation of or modification of antidiabetic therapy or other corrective measures during treatment.

6 Adverse Reactions

(additions underlined)

The following adverse reactions have been identified during postapproval use with these or other similar products and therefore may occur with use of PHOXILLUM or PRISMASOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Metabolic acidosis
Hypotension
Acid-base disorders
Electrolyte imbalanceHyperphosphatemia including calcium ionized increased (reported in PRISMASOL solutions containing calcium), hyperphosphatemia, and hypophosphatemia
Fluid imbalance

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion, additions underlined)

Risk Summary

PRISMASOL and PHOXILLUM are pharmacologically inactive solutions. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm. Animal reproduction studies have not been conducted with PRISMASOL and PHOXILLUM solutions.

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the

U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Maintenance of normal acid-base balance is important for fetal well-being.

8.2 Lactation

(PLLR conversion)

Risk Summary

The components of PRISMASOL and PHOXILLUM solutions are excreted in human milk. Appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid- base and glucose balance, is not expected to harm a nursing infant.

07/20/2016 (SUPPL-17)

Approved Drug Label (PDF)

4 Contraindications

PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products.

5 Warnings and Precautions

Electrolyte and Volume Abnormalities (revised)

PHOXILLUM and PRISMASOL solutions can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorous, other electrolytes and acid-base balance throughout the procedure. Abnormalities may be corrected by changing the formulation of replacement solution and/or dialysate, supplementation, or adjusting flow rates appropriately.
PHOXILLUM replacement solutions contain hydrogen phosphate, a weak acid that may increase the risk of metabolic acidosis.

6 Adverse Reactions

The following adverse reactions have been identified with other similar products and therefore, may occur with use of these products:

Metabolic acidosis
Hypotension
Acid-base disorders
Electrolyte imbalance
Hyperphosphatemia (for phosphate containing solutions)
Fluid imbalance

7 Drug Interactions

As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter.