GoLYTELY - Azurity Pharmaceuticals, Inc.

• 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.

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).

Advise patients to hydrate adequately before, during, and after the use of GoLYTELY. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking GoLYTELY, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Correct fluid and electrolyte abnormalities before treatment with GoLYTELY.

In addition, use caution when prescribing GoLYTELY for patients who have conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment [see Drug Interactions (7.1)].

There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing GoLYTELY for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution when prescribing GoLYTELY for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions (7.1)].

Use caution when prescribing GoLYTELY for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) [see Drug Interactions (7.1)]. Advise these patients of the importance of adequate hydration and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Use in Specific Populations (8.6)].

Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and GoLYTELY may increase this risk [see Drug Interactions (7.3)]. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering GoLYTELY [see Contraindications (4)]. Use with caution in patients with severe active ulcerative colitis.

Use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. Observe these patients during administration of GoLYTELY, especially if it is administered via nasogastric tube.

Do not combine GoLYTELY with starch-based thickeners [see Dosage and Administration (2.1)]. Polyethylene glycol (PEG), a component of GoLYTELY, when mixed with starch-thickened liquids reduces the viscosity of the starch-thickened liquid. When a PEG-based product used for another indication was mixed in starch-based pre-thickened liquids used in patients with dysphagia, thinning of the liquid occurred and cases of choking and potential aspiration were reported.

GoLYTELY contains PEG and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus [see Adverse Reactions (6)]. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

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.

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)].

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)].

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.

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.

Safety and effectiveness of GoLYTELY in pediatric patients have not been established.

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.

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)].

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.

GoLYTELY induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

The pharmacokinetics of PEG 3350 following administration of GoLYTELY were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

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)].