GoLYTELY

Warnings and Precautions, Aspiration: ( 5.7 ) 05/2021

1 INDICATIONS AND USAGE GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults. GoLYTELY is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. ( 1 )

2 DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.1 ): Correct fluid and electrolyte abnormalities before treatment with GoLYTELY. Reconstitute GoLYTELY with water prior to ingestion. Do not take oral medications within 1 hour before the start or during administration of GoLYTELY. ( 2.1 ) Do not take other laxatives while taking GoLYTELY. Consume only clear liquids; avoid red and purple liquids. Consume water or other clear liquids up until 2 hours before the time of the colonoscopy. Do not consume solid food within 2 hours before starting GoLYTELY. Adult Dosing Regimen ( 2.2 ): On day prior to colonoscopy, instruct patients to consume a light breakfast at least 2 hours before starting GoLYTELY. Begin the recommended dosage regimen for GoLYTELY early in the evening on the day before colonoscopy. Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear. For complete information on dosing, preparation and administration, see the full prescribing information. ( 2.1 , 2.2 ) 2.1 Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with GoLYTELY [see Warnings and Precautions ( 5.1 )] . Reconstitute GoLYTELY with water prior to ingestion, do not take undissolved GoLYTELY [see Dosage and Administration ( 2.2 )] . Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions ( 5.7 )] . Do not take oral medications within 1 hour before the start of or during administration of GoLYTELY [see Drug Interactions ( 7.2 )] . Do not take other laxatives while taking GoLYTELY [see Drug Interactions ( 7.3 )] . Consume only clear liquids, avoid red and purple liquids. Patients may consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration. Do not consume solid food within 2 hours before starting GoLYTELY. For the best results, do not consume solid food for 3 to 4 hours before drinking the solution. If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue GoLYTELY until the symptoms abate. 2.2 Dosage Regimen Instruct adult patients that on the day before the colonoscopy procedure, they may consume a light breakfast at least 2 hours before starting GoLYTELY. Begin the recommended dosage regiment for GoLYTELY early in the evening on the day before colonoscopy. Instruct patients to take GoLYTELY in conjunction with clear liquids as follows: 4 Liter Jug Fill the supplied container containing the GoLYTELY powder with lukewarm drinking water to the 4-liter fill line Do not add any other ingredients, flavors, etc. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. Drink at a rate of 8 ounces every 10 minutes until the entire contents are consumed or the rectal effluent is clear. A loose watery bowel movement should result in approximately one hour. After reconstitution, keep solution refrigerated 2° to 8°C (36° to 46°F). Do not freeze. Use within 48 hours, discard unused portion. Administration via a Nasogastric Tube For patients with a nasogastric tube, administer the reconstituted GoLYTELY solution at a rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour).

3 DOSAGE FORMS AND STRENGTHS For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder. When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride. For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride per 4 liters.

4 CONTRAINDICATIONS GoLYTELY is contraindicated in the following conditions: Gastrointestinal (GI) obstruction [see Warnings and Precautions ( 5.6 )] Bowel perforation [see Warnings and Precautions ( 5.6 )] Toxic colitis or toxic megacolon Gastric retention Ileus Hypersensitivity to any component of GoLYTELY [see Warnings and Precautions ( 5.8 )] Gastrointestinal (GI) obstruction ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Ileus ( 4 ) Hypersensitivity to components of GoLYTELY ( 4 , 5.8 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Renal impairment [see Warnings and Precautions ( 5.4 )] Colonic mucosal ulcerations and ischemic colitis [see Warnings and Precautions ( 5.5 )] Patients with significant gastrointestinal disease [see Warnings and Precautions ( 5.6 )] Aspiration [see Warnings and Precautions ( 5.7 )] The following adverse reactions associated with the use of GoLYTELY were identified in clinical trials or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a causal relationship to drug exposure. Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration [see Warnings and Precautions ( 5.2 )] . Nervous system: tremor, seizure [see Warnings and Precautions ( 5.3 )] Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Contraindications ( 4 ), Warnings and Precautions ( 5.8 )] Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients). Other less common adverse reactions include: abdominal cramps, vomiting, “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)]. Most common adverse reactions are: nausea, abdominal fullness, bloating, abdominal cramps, vomiting and anal irritation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

7 DRUG INTERACTIONS Some drugs increase risks due to fluid and electrolyte changes ( 7.1 ) 7.1 Drugs that May Increase Risks Due to Fluid and Electrolyte Abnormalities Use caution when prescribing GoLYTELY for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [ see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 ) ]. Consider additional patient evaluations as appropriate. 7.2 Potential for Reduced Drug Absorption GoLYTELY can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of GoLYTELY [see Dosage and Administration ( 2.1 )] . 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and GoLYTELY may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking GoLYTELY [see Warnings and Precautions ( 5.5 )] .

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Animal reproduction studies have not been conducted with GoLYTELY. It is also not known whether GoLYTELY can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GoLYTELY should be given to a pregnant woman only if clearly needed. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GoLYTELY is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of GoLYTELY in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of GoLYTELY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 8.6 Renal Impairment Use GoLYTELY with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see Drug Interactions ( 7.1 )] . These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of GoLYTELY and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions ( 5.4 )] .

12.1 Mechanism of Action The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool.

11 DESCRIPTION GoLYTELY is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP Sodium Sulfate, USP The chemical name is Na 2 SO 4 . The average Molecular Weight is 142.04. The structural formula is: Sodium Bicarbonate, USP The chemical name is NaHCO 3 . The average Molecular Weight is 84.01. The structural formula is: Sodium Chloride, USP The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is: Na + Cl - Potassium Chloride, USP The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is: K-Cl Polyethylene Glycol 3350 Structural Formula Sodium Sulfate Structural Formula Sodium Bicarbonate Structural Formula

16 HOW SUPPLIED/STORAGE AND HANDLING GoLYTELY (polyethylene glycol 3350 and electrolytes for oral solution) is supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder. When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride. GoLYTELY 4 Liter Disposable Jug NDC 52268-100-01 Storage Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of GoLYTELY at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration ( 2.1 )] .