GAVILYTE-N

6 ADVERSE REACTIONS Most common adverse reactions (≥3%) are: nausea, abdominal fullness and bloating. Abdominal cramps, vomiting and anal irritation occur less frequently ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions ( 5.1 )] . Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] . Seizures [see Warnings and Precautions ( 5.3 )] . Renal Impairment [see Warnings and Precautions ( 5.4 )] . Colonic Mucosal Ulcerations, Ischemic Colitis and Ulcerative 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 )] . Direct Ingestion [see Warnings and Precautions ( 5.8 )] . The following adverse reactions have been identified during post-approval use of GaviLyte-N. 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. Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of GaviLyte-N. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions. Published literature contains isolated reports of serious adverse reactions following the administration of PEG-electrolyte solution products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and "butterfly-like" infiltrates on chest X-ray after vomiting and aspirating PEG.

4 CONTRAINDICATIONS Gastrointestinal (GI) obstruction, ileus, or gastric retention ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Known allergy or hypersensitivity to components of GaviLyte-N ( 4 , 11 ) GaviLyte-N is contraindicated in the following conditions: Gastrointestinal (GI) obstruction, ileus, or gastric retention Bowel perforation Toxic colitis or toxic megacolon Known allergy or hypersensitivity to any component of GaviLyte-N for oral solution [see How Supplied/Storage and Handling (16) ]

11 DESCRIPTION For oral solution: Each 4 liter (4L) GaviLyte-N jug contains a white powder for reconstitution. GaviLyte-N is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Each 4 liter jug contains: polyethylene glycol 3350 420g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.4 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, NF 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 PEG structure Sod-Bicarbonate

2 DOSAGE AND ADMINISTRATION GaviLyte-N, supplied as a powder, must be reconstituted with water before its use ( 2.1 , 5.8 ) On day prior to colonoscopy, instruct patients to: Eat a light breakfast or have clear liquids (avoid red and purple liquids) ( 2.2 ). If adding a GaviLyte-N flavor pack, pour the contents of flavor powder (i.e., cherry, lemon or orange) into container prior to reconstitution ( 2.2 ). Early in the evening prior to colonoscopy, fill container containing GaviLyte-N powder with lukewarm water to 4 liter fill line ( 2.2 ). After capping container, shake vigorously several times ( 2.2 ). Instruct patients to consume water or clear liquids during and after bowel preparation up until 2 hours before time of colonoscopy ( 2.3 ). Adults: Drink at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or rectal effluent is clear. For nasogastric tube (NGT), rate is 1.2 to 1.8 liters per hour ( 2.3 ) Pediatric patients (aged 6 months or greater ): Drink 25 mL/kg/hour orally or administer by NGT. Continue drinking until watery stool is clear and free of solid matter ( 2.3 ). 2.1 Dosage Overview GaviLyte-N, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration (2.2) , Warnings and Precautions (5.8) ]. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7) ]. The 4-liter reconstituted GaviLyte-N solution contains: 420 grams of polyethylene glycol (PEG) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, and 1.4 grams of potassium chloride. GaviLyte-N may be used with or without one of the supplied flavor packs. 2.2 Administration Instructions Prior to Dosage On the day prior to the colonoscopy, instruct patients to: Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast. If adding a GaviLyte-N flavor pack, pour the contents of the 2 gram flavor powder (i.e., cherry, lemon, or orange) into the container prior to reconstitution. No additional flavorings should be added. Discard unused flavor packs. The GaviLyte-N flavor packs are for use only in combination with the contents of the accompanying 4 liter container . Early in the evening prior to colonoscopy , fill the supplied container containing the GaviLyte-N powder (and if applicable, a flavor powder) with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours. 2.3 Dosage The following is the recommended dose of reconstituted GaviLyte-N solution for adults and pediatric patients ≥ 6 months. Instruct patients they may consume water or 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. Adults: Instruct patients to drink a total of up to 4 liters at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. For NGT, rate is 20 -30 mL per minute (1.2 – 1.8 liters per hour). Pediatric Patients ≥ 6 Months: Pediatric patients should drink 25 mL/kg/hour until the stool is watery, clear, and free of solid matter. If pediatric patients are unable to drink the reconstituted GaviLyte-N solution, the solution may be given by nasogastric (NGT). NGT administration is at the rate of 25 mL/kg/hour. The first bowel movements should occur approximately one hour after the start of GaviLyte-N administration. Continue drinking until the watery stool is clear and free of solid matter.

1 INDICATIONS AND USAGE GaviLyte-N is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater ( 1 ) GaviLyte-N is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.

7 DRUG INTERACTIONS Some drugs increase risks due to fluid and electrolyte changes ( 7.1 ) Oral medication taken within 1 hour of start of each dose may not be absorbed properly ( 7.2 ) 7.1 Drugs that May Lead to Fluid and Electrolyte Abnormalities Use caution when prescribing GaviLyte-N for patients 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 prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , and 5.4 )] in patients taking these concomitant medications. 7.2 Potential for Altered Drug Absorption Oral medication administered within one hour of the start of administration of GaviLyte-N may be flushed from the gastrointestinal tract and the medication may not be absorbed properly. 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and GaviLyte-N may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking GaviLyte-N.

12 CLINICAL PHARMACOLOGY 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. 12.2 Pharmacodynamics GaviLyte-N induces as diarrhea which rapidly cleanses the bowel, usually within four hours. 12.3 Pharmacokinetics The pharmacokinetics of PEG3350 following administration of GaviLyte-N were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

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.

12.2 Pharmacodynamics GaviLyte-N induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

12.3 Pharmacokinetics The pharmacokinetics of PEG3350 following administration of GaviLyte-N were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

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3 DOSAGE FORMS AND STRENGTHS For oral solution: polyethylene glycol 3350 420 grams, sodium bicarbonate 5.72 grams, sodium chloride 11.2 grams, potassium chloride 1.48 grams, and flavoring ingredients 2 grams; supplied in one 4 liter disposable jug( 3 ) For oral solution: One 4 liter jug with powder for reconstitution with water. Each 4 liter jug contains: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

GAVILYTE-N polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 SODIUM CHLORIDE CHLORIDE ION SODIUM BICARBONATE SODIUM CATION POTASSIUM CHLORIDE POTASSIUM CATION SACCHARIN SODIUM MALTODEXTRIN

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies in animals have not been performed to evaluate carcinogenic potential of GaviLyte-N. Studies to evaluate the possible impairment of fertility or mutagenic potential of GaviLyte-N have not been performed.

ANDA090019

GAVILYTE-N

polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate

43386-050

HUMAN PRESCRIPTION DRUG

ORAL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL GaviLyte-N Container Label Flavor Packs (Cherry Flavor, Lemon Flavor and Orange Flavor) label Flavor Packs

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

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (Medication Guide). Instruct patients: To let you know if they have trouble swallowing or are prone to regurgitation or aspiration. Not to take other laxatives while they are taking GaviLyte-N. To consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. That if they experience severe bloating, distention or abdominal pain, the administration of the solution should be slowed or temporarily discontinued until the symptoms abate. Advise patients to report these events to their health care provider. That if they have hives, rashes, or any allergic reaction, they should discontinue the medication and contact their health care provider. Medication should be discontinued until they speak to their physician. To contact their healthcare provider if they develop signs and symptoms of dehydration [see Warnings and Precautions (5.1) ]. That oral medication administered within one hour of the start of administration of GaviLyte-N solution may be flushed from the GI tract and the medication may not be absorbed completely. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 SAP Code: 270544 Rev. 05/2022

MEDICATION GUIDE GaviLyte™- N (GAV-ee-LITE-N) (polyethylene glycol 3350 (420 g), sodium chloride, sodium bicarbonate and potassium chloride oral solution) Read this Medication Guide before you start taking GaviLyte-N. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about GaviLyte-N? GaviLyte-N and other osmotic bowel preparations can cause serious side effects, including: Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause: abnormal heartbeats that can cause death seizures . This can happen even if you have never had a seizure. kidney problems Your chance of having fluid loss and changes in body salts with GaviLyte-N is higher if you: have heart problems have kidney problems take water pills or non-steroidal anti-inflammatory drugs (NSAIDS) Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking GaviLyte-N: vomiting that prevents you from keeping down the solution dizziness urinating less often than normal headache See Section "What are the possible side effects of GaviLyte-N" for more information about side effects. What is GaviLyte-N? GaviLyte-N is a prescription medicine used by adults to clean the colon before a colonoscopy. GaviLyte-N cleans your colon by causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. GaviLyte-N is safe and effective for use in pediatric patients aged 6 months and older. Who should not take GaviLyte-N? Do not take GaviLyte-N if your healthcare provider has told you that you have: a blockage in your bowel (obstruction) an opening in the wall of your stomach or intestine (bowel perforation) problems with food and fluid emptying from your stomach (gastric retention) a very dilated intestine (bowel) an allergy to any of the ingredients in GaviLyte-N. See the end of this leaflet for a complete list of ingredients in GaviLyte-N. What should I tell my healthcare provider before taking GaviLyte-N? Before you take GaviLyte-N, tell your healthcare provider if you: have heart problems have stomach or bowel problems have ulcerative colitis have problems with swallowing or gastric reflux have a history of seizures are withdrawing from drinking alcohol have a low blood salt (sodium) level have kidney problems any other medical conditions are pregnant. It is not known if GaviLyte-N will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed. It is not known if GaviLyte-N passes into your breast milk. You and your healthcare provider should decide if you will take GaviLyte-N while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. GaviLyte-N may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of GaviLyte-N. Especially tell your healthcare provider if you take: medicines for blood pressure or heart problems medicines for kidney problems medicines for seizures water pills (diuretics) non-steroidal anti-inflammatory medicines (NSAID) pain medicines laxatives starch-based thickeners. For patients who have trouble swallowing, do not mix GaviLyte-N with starch-based thickeners. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take GaviLyte-N? You must read, understand, and follow these instructions to take GaviLyte-N the right way. Take GaviLyte-N exactly as your healthcare provider tells you to take it. Drink 240 mL (8 oz.) every 10 minutes. Rapid drinking of each portion is better than drinking small amounts. The first bowel movement should occur approximately one hour after you start drinking the solution. You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occur, stop drinking temporarily or drink each portion at longer intervals until the discomfort goes away. Continue drinking until the watery stool is clear and free of solid matter. This usually requires 3 liters and it is best to drink all of the solution. Do not take undissolved GaviLyte-N powder that has not been mixed with water (diluted), it may increase your risk of nausea, vomiting and fluid loss (dehydration). Each jug of GaviLyte-N must be reconstituted with water (diluted) to 4 liters total volume before drinking. Do not take other laxatives while taking GaviLyte-N. Do not eat solid foods on the day before your colonoscopy and until after your colonoscopy . Drink only clear liquids: the day before your colonoscopy while taking GaviLyte-N after taking GaviLyte-N until 2 hours before your colonoscopy What are the possible side effects of GaviLyte-N? GaviLyte-N can cause serious side effects, including: See Section "What is the most important information I should know about GaviLyte-N?" changes in certain blood tests . Your healthcare provider may do blood tests after you take GaviLyte-N to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including: vomiting nausea bloating dizziness stomach (abdominal) cramping headache urinate less than usual trouble drinking clear liquid heart problems. GaviLyte-N may cause irregular heartbeats. seizures ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding. The most common side effects of GaviLyte-N include: nausea stomach (abdominal) fullness bloating stomach (abdominal) cramps vomiting anal irritation Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of GaviLyte-N. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store GaviLyte-N? Store GaviLyte-N at room temperature, between 59ºF to 86°F (15ºC to 30°C). Keep GaviLyte-N and all medicines out of the reach of children. General information about the safe and effective use of GaviLyte-N. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GaviLyte-N for a condition for which it was not prescribed. Do not give GaviLyte-N to other people, even if they are going to have the same procedure you are. It may harm them. This Medication Guide summarizes important information about GaviLyte-N. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals. For more information, call 1-866-403-7592. What are the ingredients in GaviLyte-N? Active ingredients : polyethylene glycol 3350, sodium bicarbonate, sodium chloride, and potassium chloride. Inactive ingredients : cherry flavoring, lemon flavoring, orange flavoring (flavor packs only) Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 This Medication Guide has been approved by the U.S. Food and Drug Administration. SAP Code: 270544 Rev. 05/2022

8.5 Geriatric Use Clinical studies of GaviLyte-N 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.

8.3 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 GaviLyte-N is administered to a nursing woman.

8.4 Pediatric Use Safety and effectiveness of GaviLyte-N in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of GaviLyte-N in adults with additional safety and efficacy data from published studies of similar formulations. Use of GaviLyte-N in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in one child and hypokalemia has been reported in 3 children.

8.1 Pregnancy Animal reproduction studies have not been conducted with GaviLyte-N. It is also not known whether GaviLyte-N can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GaviLyte-N should be given to a pregnant woman only if clearly needed.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Animal reproduction studies have not been conducted with GaviLyte-N. It is also not known whether GaviLyte-N can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GaviLyte-N 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 GaviLyte-N is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of GaviLyte-N in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of GaviLyte-N in adults with additional safety and efficacy data from published studies of similar formulations. Use of GaviLyte-N in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in one child and hypokalemia has been reported in 3 children. 8.5 Geriatric Use Clinical studies of GaviLyte-N 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.

16 HOW SUPPLIED/STORAGE AND HANDLING In powdered form, for oral administration as a solution following reconstitution. GaviLyte-N is available in a disposable jug in powdered form containing: GaviLyte-N with Flavor Packs : polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g (optional). When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. Each jug has an attached package containing 3 flavor packs (optional); one each 2.0 g: Cherry, Lemon, and Orange flavoring, in powdered form, for the addition of ONE pack by the pharmacist prior to dispensing. Lemon Flavor GaviLyte-N : polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion. Keep out of reach of children. GaviLyte-N with Flavor Packs NDC 43386-050-19