PIZENSY

PIZENSY- lactitol powder, for solution
Braintree Laboratories, Inc.

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

  • 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)] .

2.2 Preparation and Administration Instructions

PIZENSY Multi-dose bottle

NOTE: The bottle top is a measuring cap marked to contain 10 grams of powder when filled to the top of white section in the cap marked by the arrow.

  1. Using the measuring cap, measure the prescribed dose.
    20-gram dose : Fill the measuring cap twice to the top of the white section in cap marked by the arrow.
    10-gram dose: Fill the measuring cap once to the top of the white section in cap marked by the arrow.
  2. Pour the measured dose into an empty 8-ounce glass.
  3. Add 4 ounces to 8 ounces of water, juice or other common beverages (coffee, tea, soda) and stir to dissolve.
  4. Drink the entire contents of the glass.

PIZENSY Unit-dose packets

  1. Pour the contents of one or two unit-dose packets, as prescribed, into an empty 8-ounce glass.
  2. Add 4 ounces to 8 ounces of water, juice or other common beverages (coffee, tea, soda) to the glass containing the powder and stir thoroughly to dissolve.
  3. Drink the entire contents of the glass.

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 bottles
  • 560 grams of lactitol in multi-dose bottles
  • 10 grams of lactitol in unit-dose packets

4. CONTRAINDICATIONS

PIZENSY is contraindicated in patients with:

  • known or suspected mechanical gastrointestinal obstruction
  • galactosemia

6. ADVERSE REACTIONS

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.

Most Common Adverse Reactions:

Table 1 provides the incidence of adverse reactions in Study 1 reported in at least 3% of patients in the PIZENSY treatment group and at higher incidence than placebo.

Table 1: Common Adverse Reactions 1 Reported in Adult Patients with CIC in Study 1

1 reported in at least 3% of patients and greater than placebo

2 74 of 291 patients in the PIZENSY group at least temporarily reduced their dose

3 Upper respiratory tract infection includes the terms viral upper respiratory tract infection and nasopharyngitis.

4 Increased blood creatinine phosphokinase includes the term blood creatinine phosphokinase myocardial band (MB) increased.

5 Increased blood pressure includes the term Hypertension

PIZENSY 2

N=291

(%)

Placebo

N=302

(%)

Upper Respiratory Tract Infection 3 9 6
Flatulence 8 3
Diarrhea 4 3
Increased blood creatinine phosphokinase 4 4 3
Abdominal Distension 3 1
Increased blood pressure 5 3 1

In Study 2, the safety profile of PIZENSY was similar to Study 1.

In the 1-year uncontrolled safety study, adverse reactions reported in patients receiving PIZENSY (N=298) with an incidence of at least 3% that are not represented in Table 1 include urinary tract infection (5%) and abdominal pain (3%).

Adverse Reaction of Special Interest — Severe Diarrhea

In Study 1, severe diarrhea was reported in 2 (1%) PIZENSY-treated patients compared to no patients in the placebo group.

Adverse Reactions Leading to Discontinuation

In Study 1, 11/291 (4%) PIZENSY-treated patients discontinued due to adverse reactions, compared to 10/302 (3%) of patients in the placebo group. The most common adverse reactions leading to discontinuation in PIZENSY-treated patients (1% each) were elevated creatinine kinase, flatulence, diarrhea and increased blood pressure.

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
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