NDC 52268-600 Pizensy

Lactitol

NDC Product Code 52268-600

NDC 52268-600-01

Package Description: 280 g in 1 BOTTLE

NDC 52268-600-02

Package Description: 560 g in 1 BOTTLE

NDC 52268-600-04

Package Description: 28 PACKET in 1 CARTON > 10 g in 1 PACKET (52268-600-03)

NDC Product Information

Pizensy with NDC 52268-600 is a a human prescription drug product labeled by Braintree Laboratories, Inc.. The generic name of Pizensy is lactitol. The product's dosage form is powder, for solution and is administered via oral form.

Labeler Name: Braintree Laboratories, Inc.

Dosage Form: Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pizensy Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LACTITOL 1 g/g

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Braintree Laboratories, Inc.
Labeler Code: 52268
FDA Application Number: NDA211281 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-12-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Pizensy Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

PIZENSY is indicated for chronic idiopathic constipation (CIC) in adults.

  • The recommended adult dosage of PIZENSY is 20 grams orally once daily, preferably with meals
  • [see Clinical Pharmacology
  • (12.3)].
  • Reduce the dosage to 10 grams once daily for persistent loose stools.Administer oral medications at least 2 hours before or 2 hours after PIZENSY
  • [see Drug Interactions
  • (7.1)]
  • .

3. Dosage Forms And Strengths

  • PIZENSY is a white to off-white crystalline powder for oral solution supplied as:280 grams of lactitol in multi-dose bottles560 grams of lactitol in multi-dose bottles10 grams of lactitol in unit-dose packets

4. Contraindications

  • PIZENSY is contraindicated in patients with:known or suspected mechanical gastrointestinal obstructiongalactosemia

6.1 Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The data described below reflect exposure to PIZENSY in 807 patients with CIC in a six-month placebo-controlled trial (Study 1), a three-month active-controlled trial (Study 2)
[see Clinical Studies
(14)]
, and a one-year uncontrolled safety study (NCT02819310). Of the 298 patients in the one-year uncontrolled study, 55 patients were enrolled from Study 1 or Study 2.

6.2 Postmarketing Experience

  • The following adverse reactions have been identified during post-approval use of lactitol outside of the United States. 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.hypersensitivity reactions, including rash and pruritus

7.1 Reduced Absorption Of Other Oral Medications

PIZENSY may reduce the absorption of concomitantly administered oral medications. Administer oral medications at least 2 hours before or 2 hours after PIZENSY
[see Dosage and Administration
(2.1)]
.

8.1 Pregnancy

Risk SummaryLactitol is minimally absorbed systemically following oral administration
[see Clinical Pharmacology
(12.3)]
, and it is unknown whether maternal use will result in fetal exposure to the drug. Available data from case reports on lactitol use in pregnant women are insufficient to evaluate for any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal developmental studies, no effects on embryo-fetal development were observed with oral administration of lactitol to rats and rabbits during organogenesis at doses much higher than the maximum recommended human dosage.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States 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.DataAnimal DataReproduction studies have been performed in pregnant rats at oral doses of lactitol up to 2 g/kg/day (about 0.93 times the recommended daily human dose based on body surface area) and in pregnant rabbits at oral doses up to 1 g/kg/day (about 0.93 times the recommended daily human dose based on body surface area) administered during the period of organogenesis. These studies did not reveal any evidence of harm to the fetus due to lactitol.In a pre-and postnatal development study in rats, lactitol, administered from gestation day 6 to lactation day 20, did not cause any adverse effect on pre and postnatal development up to 2 g/kg/day (about 0.93 times the recommended daily human dose based on body surface area).

8.2 Lactation

Risk SummaryThere are no data on the presence of lactitol in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Lactitol is minimally absorbed systemically following oral administration
[see Clinical Pharmacology
(12.3)]
. It is unknown whether the minimal systemic absorption of lactitol by adults will result in a clinically relevant exposure to breastfed infants. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PIZENSY and any potential adverse effects on the breastfed infant from PIZENSY or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of PIZENSY have not been established in pediatric patients.

8.5 Geriatric Use

Of the 807 patients who received PIZENSY in clinical trials, 202 (25%) were 65 years of age or older, and 59 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of PIZENSY were observed between geriatric patients and younger patients.

11 Description

Lactitol is an osmotic laxative for oral use. Lactitol is a simple monosaccharide sugar alcohol. It is a dry, free flowing, white to off-white powder, readily soluble in aqueous solutions. As shown by the structure diagrams, it is an analog of the disaccharide lactulose. Its chemical name is 4-O-β-dGalactopyranosyl-d-glucitol lactitol.LactitolMolecular Formula C


12H


24O


11        Molecular Weight 344.31


PIZENSY (lactitol) for oral solution is available in unit-dose packets and multi-dose bottles. There are no inactive ingredients.

12.1 Mechanism Of Action

Lactitol exerts an osmotic effect, causing the influx of water into the small intestine leading to a laxative effect in the colon.

12.2 Pharmacodynamics

No formal pharmacodynamic studies have been conducted with PIZENSY.

12.3 Pharmacokinetics

Following a single oral dose of 20-gram PIZENSY in healthy adult subjects under fed conditions, the mean ± SD peak serum concentration (C


max) is 776 ± 253 ng/mL, and the mean ± SD area under the curve (AUC) is 6,019 ± 1,771 ng*hr/mL.


AbsorptionLactitol is minimally absorbed systemically following oral administration. The mean ± SD time to reach peak serum concentration (T


max) is 3.6 ± 1.2 hours following a single oral dose of 20-gram PIZENSY in healthy adult subjects under fed conditions.


Effect of FoodC


max and AUC values increase greater than 2-fold under fasted conditions compared to fed conditions.


EliminationThe mean half-life of lactitol is 2.4 hours.ExcretionLactitol is minimally absorbed in the small intestine. Unabsorbed lactitol is expected to be degraded into organic acids in the colon and is minimally excreted in the feces.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

In a 26-week carcinogenicity study in Tg.rasH2 mice at daily oral doses of lactitol up to 2 g/kg/day (about 0.93 times the recommended daily human dose based on body surface area), there were no drug-related neoplasms.Published studies indicated that lactitol was negative in the Ames test, chromosome aberration test with cultured mammalian cells, and in vivo mouse micronucleus test.Published studies indicated that lactitol did not cause any adverse effect on fertility and early embryonic development in rats at doses up to 10 g/kg/day (about 4.6 times the recommended daily human dose based on body surface area).

16 How Supplied/Storage And Handling

  • PIZENSY is supplied in a white to off-white crystalline powder form, for oral administration following reconstitution. PIZENSY is available in three sizes:280 grams of lactitol in multi-dose bottles (NDC 52268-600-01)560 grams of lactitol in multi-dose bottles (NDC 52268-600-02)carton of 28 unit-dose packets each containing 10 grams of lactitol (NDC 52268-600-03)The measuring cap on each multi-dose bottle is marked to contain 10 grams of powder when filled to the top of white section in cap and may be used to measure the appropriate PIZENSY dose.Each bottle contains a white desiccant packet printed “Do Not Eat.”StorageStore at 20°C to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). See
  • USP controlled room temperature.

17 Patient Counseling Information

Persistent Loose StoolsAdvise patients to stop PIZENSY and contact their healthcare provider if they experience persistent loose stools.

* Please review the disclaimer below.