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MoviPrep

Side Effects & Drug Interactions
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SIDE EFFECTS

In the MoviPrep® trials, abdominal distension, anal discomfort, thirst, nausea, and abdominal pain were some of the most common adverse reactions to MoviPrep® administration. Since diarrhea was considered as a part of the efficacy of MoviPrep®, diarrhea was not defined as an adverse reaction in the clinical studies. Tables 3 and 4 display the most common drug-related adverse reactions of MoviPrep® and its comparator in the controlled MoviPrep® trials.

Table 3: The Most Common Drug-Related Adverse Reactions1 ( ≥ 2%) in the Study of MoviPrep® vs. 4 liter Polyethylene Glycol plus Electrolytes Solution

  MoviPrep®
(split dose) N=180		 4L PEG + E2
N=179
n % ( =n/N) n % ( =n/N)
Malaise 35 (19.4) 32 (17.9)
Nausea 26 (14.4) 36 (20.1)
Abdominal pain 24 (13.3) 27 (15.1)
Vomiting 14 (7.8) 23 (12.8)
Upper abdominal pain 10 (5.6) 11 (6.1)
Dyspepsia 5 (2.8) 2 (1.1)
1 Drug-related adverse reactions were adverse events that were possibly, probably, or definitely related to the study drug.
2 4L PEG + E is 4 liter Polyethylene Glycol plus Electrolytes Solution

Table 4: The Most Common Drug-Related Adverse Reactions1 ( ≥ 5%) in the Study of MoviPrep® vs. 90 mL Oral Sodium Phosphate Solution

  MoviPrep®
(evening-only)
(full dose)
N=169		 90 mL OSPS2
N=171
n (%=n/N) n % ( =n/N)
Abdominal distension 101 (59.8) 70 (40.9)
Anal discomfort 87 (51.5) 89 (52.0)
Thirst 80 (47.3) 112 (65.5)
Nausea 80 (47.3) 80 (46.8)
Abdominal pain 66 (39.1) 55 (32.2)
Sleep disorder 59 (34.9) 49 (28.7)
Rigors 57 (33.7) 51 (29.8)
Hunger 51 (30.2) 121 (70.8)
Malaise 45 (26.6) 90 (52.6)
Vomiting 12 (7.1) 14 (8.2)
Dizziness 11 (6.5) 31 (18.1)
Headache 3 (1.8) 9 (5.3)
Hypokalemia 0 (0 ) 10 (5.8)
Hyperphosphatemia 0 (0) 10 (5.8)
1 Drug-related adverse reactions were adverse events that were possibly, probably, or definitely related to the study drug. In addition to the recording of spontaneous adverse events, patients were also specifically asked about the occurrence of the following symptoms: shivering, anal irritations, abdominal bloating or fullness, sleep loss, nausea, vomiting, weakness, hunger sensation, abdominal cramps or pain, thirst sensation, and dizziness.
2 OSPS is Oral Sodium Phosphate Solution

Isolated cases of urticaria, rhinorrhea, dermatitis, and anaphylactic reaction have been reported with PEG-based products and may represent allergic reactions. Published literature contains isolated reports of serious adverse events following the administration of PEG-based products in patients over 60 years of age. These adverse events included upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation, asystole, and acute pulmonary edema after aspirating the PEG-based preparation.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following adverse events have been identified during post-approval use of MoviPrep®. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to MoviPrep®, or a combination of these factors.

General: Hypersensitivity reactions including anaphylaxis, rash, urticaria, lip and facial swelling, dyspnea, chest tightness and throat tightness.

DRUG INTERACTIONS

Oral medication administered within 1 hour of the start of administration of MoviPrep® may be flushed from the gastrointestinal tract and the medication may not be absorbed.

Brand Name: MoviPrep
Generic Name: PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, Ascorbic Acid
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