Important Preparation and Administration Instructions

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Correct fluid and electrolyte abnormalities before treatment with PLENVU [see Warnings and Precautions (5.1)].

Two doses of PLENVU are required for a complete preparation for colonoscopy. The time interval between the two doses depends on the regimen prescribed and the planned timing of the colonoscopy procedure [see Dosage and Administration (2.2, 2.3)].

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The “Two-Day Split-Dosing” method consists of two separate doses: the first dose is taken the evening before the colonoscopy and the second dose is taken the next day, the morning of the day of the colonoscopy [see Dosage and Administration (2.2)].

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The “One-Day Morning Dosing” method consists of two separate doses: both doses are taken in the morning of the day of the colonoscopy, with a minimum of 2 hours between the start of the first dose and the start of the second dose [see Dosage and Administration (2.3)].

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PLENVU must be reconstituted in the mixing container with water prior to ingestion. It may take 2 to 3 minutes for complete dissolution. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)].

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Additional clear liquids (including water) must be consumed in both dosing regimens [see Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.1)].

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Consume only clear liquids (no solid food) from the start of PLENVU treatment until after the colonoscopy.

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Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.

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Do not take other laxatives while taking PLENVU.

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Do not take oral medications within 1 hour before or after starting each dose of PLENVU [see Drug Interactions (7.2)].

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Ensure completion of Dose 2, including all additional liquids, at least 2 hours before the colonoscopy.

Two-Day Split-Dosing Regimen

The Two-Day Split-Dosing Regimen commences in the evening of the day before the colonoscopy.

Instruct adult patients that on the day before the clinical procedure, they can consume a light breakfast followed by a light lunch, which must be completed at least 3 hours prior to the start of the first PLENVU dose.

Instruct patients to take two separate doses in conjunction with clear liquids as follows:

Dose 1 – In the evening before the colonoscopy, between approximately 4 pm and 8 pm:

1.

Empty the contents of Dose 1 into the mixing container that comes with PLENVU.

2.

Add water to the fill line on the mixing container (at least 16 fluid ounces). Do not add other ingredients to the PLENVU solution.

3.

Thoroughly mix with a spoon or shake with lid on securely until completely dissolved (which may take 2 to 3 minutes).

4.

Drink over the next 30 minutes. Be sure to drink all of the solution.

5.

Refill the mixing container to the fill line (at least 16 fluid ounces) with clear liquids and drink over the next 30 minutes.

6.

Consume additional clear liquids during the evening.

7.

If severe bloating, abdominal distention, or abdominal pain occurs following the first dose, delay the second dose until the symptoms resolve.

Dose 2 – The next morning, on the day of the colonoscopy, approximately 12 hours after the start of Dose 1 (between approximately 4 am and 8 am):

1.

Empty the contents of Dose 2 Pouch A and Dose 2 Pouch B into the mixing container that comes with PLENVU.

2.

Add water to the fill line on the mixing container (at least 16 fluid ounces). Do not add other ingredients to the PLENVU solution.

3.

Thoroughly mix with a spoon or shake with lid on securely until completely dissolved (which may take 2 to 3 minutes). Drink over the next 30 minutes. Be sure to drink all of the solution.

4.

Refill the mixing container to the fill line (at least 16 fluid ounces) with clear liquids and drink over the next 30 minutes.

5.

Consume additional water or clear liquids up to 2 hours before the colonoscopy or as prescribed by your doctor. Then stop drinking liquids until after the colonoscopy.

Stop drinking PLENVU temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort or distention occurs, until these symptoms resolve.

One-Day Morning Dosing Regimen

The One-Day Morning Dosing Regimen commences in the morning of the day of the colonoscopy.

Instruct adult patients that on the day before the clinical procedure, they can consume a light breakfast followed by a light lunch, and clear broth soup and/or plain yogurt for dinner, which should be completed by approximately 8 pm.

Instruct patients to take two separate doses in conjunction with clear liquids as follows:

Dose 1 – On the day of the colonoscopy, between approximately 3 am and 7 am:

1.

Empty the contents of Dose 1 into the mixing container that comes with PLENVU.

2.

Add water to the fill line on the mixing container (at least 16 fluid ounces). Do not add other ingredients to the PLENVU solution.

3.

Thoroughly mix with a spoon or shake with lid on securely until completely dissolved (which may take 2 to 3 minutes).

4.

Drink over the next 30 minutes. Be sure to drink all of the solution.

5.

Refill the mixing container to the fill line (at least 16 fluid ounces) with clear liquids and drink over the next 30 minutes.

6.

If severe bloating, abdominal distention, or abdominal pain occurs following the first dose, delay the second dose until the symptoms resolve.

Dose 2 – On the day of the colonoscopy, a minimum of 2 hours after the start of Dose 1:

1.

Empty the contents of Dose 2 Pouch A and Dose 2 Pouch B into the mixing container that comes with PLENVU.

2.

Add water to the fill line on the mixing container (at least 16 fluid ounces). Do not add other ingredients to the PLENVU solution.

3.

Thoroughly mix with a spoon or shake with lid on securely until completely dissolved (which may take 2 to 3 minutes). Drink over the next 30 minutes. Be sure to drink all of the solution.

4.

Refill the mixing container to the fill line (at least 16 fluid ounces) with clear liquids and drink over the next 30 minutes.

5.

Consume additional water or clear liquids up to 2 hours before the colonoscopy or as prescribed by your doctor. Then stop drinking liquids until after the colonoscopy.

Stop drinking PLENVU temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort or distention occurs, until these symptoms resolve.

Storage:
After reconstitution, keep PLENVU solution at room temperature, between 68°F to 77°F (20°C to 25°C) [see USP Controlled Room Temperature]. The solution may also be stored in a refrigerator. Use within 24 hours after it is mixed in water.