Data from FDA - Curated by EPG Health - Last updated 22 November 2019

Indication(s)

1 INDICATIONS AND USAGE CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. CLENPIQ™ is a combination of sodium picosulfate, a stimulant laxative, and magnesium oxide and anhydrous citric acid, which form magnesium citrate, an osmotic laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients ages 9 years and older. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS CLENPIQ is contraindicated in the following conditions: Patients with severe renal impairment (creatinine clearance less than 30 mL/minute), which may result in accumulation of magnesium [see Warnings and Precautions (5.3)] Gastrointestinal obstruction or ileus [see Warnings and Precautions (5.6)] Bowel perforation [see Warnings and Precautions (5.6)] Toxic colitis or toxic megacolon Gastric retention Hypersensitivity to any of the ingredients in CLENPIQ [see Adverse Reactions (6.2)] Patients with severe renal impairment (creatinine clearance less than 30 mL/minute) (4, 5.3, 8.6) Gastrointestinal (GI) obstruction or ileus (4) Bowel perforation (4) Toxic colitis or toxic megacolon (4) Gastric retention (4) Hypersensitivity to any of the ingredients in CLENPIQ (4)
Adverse reactions
6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions (5.1)] Seizures [see Warnings and Precautions (5.2)] Use in Patients with Renal Impairment [see Warnings and Precautions (5.3)] Cardiac Arrhythmias [see Warnings and Precautions (5.4)] Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis [see Warnings and Precautions (5.5)] Use in Patients with Significant Gastrointestinal Disease [see Warnings and Precautions (5.6)] Aspiration [see Warnings and Precautions (5.7)] Most common adverse reactions (>1%) are: Adults (>1%): nausea, headache and vomiting. (6.1) Pediatrics 9 to 16 years (>5%): nausea, vomiting, and abdominal pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The safety of CLENPIQ has been established from adequate and well-controlled trials of another orally administered product of sodium picosulfate, magnesium oxide and anhydrous citric acid [see Clinical Studies (14)]. Adverse reactions reported in these adequate and well-controlled studies are described below. In two randomized, multicenter, investigator-blinded, active-controlled clinical trials for colon cleansing, another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid was compared with a regimen of two liters (2 L) of polyethylene glycol plus electrolytes solution (PEG + E) and two 5-mg bisacodyl tablets, all administered the day before the procedure [see Clinical Studies (14)]. Patients were not blinded to study treatment. Table 1 displays the most common adverse reactions for the Split-Dose and Day-Before dosing regimens in Studies 1 and Study 2, respectively. Since abdominal bloating, distension, pain/cramping, and watery diarrhea are known to occur in response to colon cleansing preparations, these effects were documented as adverse reactions in the clinical trials only if they required medical intervention (such as a change in study drug or led to study discontinuation, therapeutic or diagnostic procedures, met the criteria for a serious adverse reaction), or showed clinically significant worsening during the study that was not in the frame of the usual clinical course, as determined by the investigator. Table 1: Common Adverse Reactionsabdominal bloating, distension, pain/cramping, and watery diarrhea not requiring an intervention were not collected observed in at Least 1% of Patients using the Split-Dose Regimen or Day-Before Regimen for Colon Cleansing Adverse Reaction Study 1: Split-Dose Regimen Study 2: Day-Before Regimen Sodium picosulfate, magnesium oxide, and anhydrous citric acid (N=305) n (% = n/N) 2 L PEG+E2 L PEG + E = two liters polyethylene glycol plus electrolytes solution. with 2 × 5-mg bisacodyl tablets (N=298) n (% = n/N) Sodium picosulfate, magnesium oxide, and anhydrous citric acid (N=296) n (% = n/N) 2 L PEG+E with 2 × 5-mg bisacodyl tablets (N=302) n (% = n/N) Nausea 8 (3) 11 (4) 9 (3) 13 (4) Headache 5 (2) 5 (2) 8 (3) 5 (2) Vomiting 3 (1) 10 (3) 4 (1) 6 (2) Electrolyte Abnormalities In general, sodium picosulfate, magnesium oxide, and anhydrous citric acid was associated with numerically higher rates of abnormal electrolyte shifts on the day of colonoscopy compared to the control regimen (Table 2). These shifts were transient in nature and numerically similar between treatment arms at the Day 30 visit. Table 2: Shifts from Normal Baseline to Outside the Normal Range at Day 7 and Day 30 Laboratory Parameter (direction of change) Visit Study 1: Split-Dose Regimen Study 2: Day-Before Regimen Sodium picosulfate, magnesium oxide, and anhydrous citric acid 2 L PEG+E with 2× 5 mg bisacodyl tablets Sodium picosulfate, magnesium oxide, and anhydrous citric acid 2 L PEG+E with 2× 5 mg bisacodyl tablets N/N (%) N/N (%) eGFR = estimated glomerular filtration rate Potassium (low) Day of Colonoscopy 19/260 (7.3) 11/268 (4.1) 13/274 (4.7) 13/271 (4.8) 24-48 hours 3/302 (1.0) 2/294 (0.7) 3/287 (1.0) 5/292 (1.7) Day 7 11/285 (3.9) 8/279 (2.9) 6/276 (2.2) 14/278 (5.0) Day 30 11/284 (3.9) 8/278 (2.9) 7/275 (2.5) 8/284 (2.8) Sodium (low) Day of Colonoscopy 11/298 (3.7) 3/295 (1.0) 3/286 (1.0) 3/295 (1.0) 24-48 hours 1/303 (0.3) 1/295 (0.3) 1/288 (0.3) 1/293 (0.3) Day 7 2/300 (0.7) 1/292 (0.3) 1/285 (0.4) 1/291 (0.3) Day 30 2/299 (0.7) 3/291 (1.0) 1/284 (0.4) 1/296 (0.3) Chloride (low) Day of Colonoscopy 11/301 (3.7) 1/298 (0.3) 3/287 (1.0) 0/297 (0.0) 24-48 hours 1/303 (0.3) 0/295 (0.0) 2/288 (0.7) 0/293 (0.0) Day 7 1/303 (0.3) 3/295 (1.0) 0/285 (0.0) 0/293 (0.0) Day 30 2/302 (0.7) 3/294 (1.0) 0/285 (0.0) 0/298 (0.0) Magnesium (high) Day of Colonoscopy 34/294 (11.6) 0/294 (0.0) 25/288 (8.7) 1/289 (0.3) 24-48 hours 0/303 (0.0) 0/295 (0.0) 0/288 (0.0) 0/293 (0.0) Day 7 0/297 (0.0) 1/291 (0.3) 1/286 (0.3) 1/285 (0.4) Day 30 1/296 (0.3) 2/290 (0.7) 0/286 (0.0) 0/290 (0.0) Calcium (low) Day of Colonoscopy 2/292 (0.7) 1/286 (0.3) 0/276 (0.0) 2/282 (0.7) 24-48 hours 0/303 (0.0) 0/295 (0.0) 0/288 (0.0) 0/293 (0.0) Day 7 0/293 (0.0) 1/283 (0.4) 0/274 (0.0) 0/278 (0.0) Day 30 0/292 (0.0) 1/282 (0.4) 0/274 (0.0) 1/283 (0.4) Creatinine (high) Day of Colonoscopy 5/260 (1.9) 13/268 (4.9) 12/266 (4.5) 16/270 (5.9) 24-48 hours 1/303 (0.3) 0/295 (0.0) 0/288 (0.0) 0/293 (0.0) Day 7 10/264 (0.4) 13/267 (4.8) 10/264 (3.8) 10/265 (3.8) Day 30 11/264 (4.2) 14/265(5.3) 18/264 (6.8) 10/272 (3.7) eGFR (low) Day of Colonoscopy 22/221 (10.0) 17/214 (7.9) 26/199 (13.1) 25/224 (11.2) 24-48 hours 76/303 (25.1) 72/295 (24.4) 82/288 (28.5) 62/293 (21.2) Day 7 22/223 (10.0) 17/213 (8.0) 11/198 (5.6) 28/219 (12.8) Day 30 24/223(10.8) 21/211 (10.0) 21/199 (10.6) 24/224 (10.7) Pediatrics In the pediatric patients aged 9 to 16 years who received another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid, the most common adverse reactions (> 5%) were nausea, vomiting, and abdominal pain [see Clinical Studies (14)]. Electrolytes abnormalities were observed in pediatric patients similar to those seen in adults. Three patients had abnormally low glucose levels (40 to 47 mg/dL). Two patients received sodium picosulfate, magnesium oxide, and anhydrous citric acid and one received the comparator (PEG). The abnormal values occurred at the colonoscopy visit for one patient (sodium picosulfate, magnesium oxide, and anhydrous citric acid) and at the 5-day follow up visit for the other two patients (sodium picosulfate, magnesium oxide, and anhydrous citric acid and PEG). All three patients were asymptomatic. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of another oral product of sodium picosulfate (10 mg), magnesium oxide (3.5 mg) and anhydrous citric acid (12 g). 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. Hypersensitivity: rash, urticaria, and purpura Gastrointestinal: abdominal pain, diarrhea, fecal incontinence, proctalgia, reversible aphthoid ileal ulcers, ischemic colitis [see Warnings and Precautions (5.5)] Neurologic: generalized tonic-clonic seizures with and without hyponatremia in epileptic patients [see Warnings and Precautions (5.2)].

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Administration: CLENPIQ is ready to drink. It does not need to be diluted prior to administration. One bottle of CLENPIQ is equivalent to one dose. (2.1) Two doses of CLENPIQ are required for a complete preparation for colonoscopy. The preferred method is the "Split-Dose" method. The alternative is the "Day Before" method. (2.1) Additional fluids must be consumed after every dose of CLENPIQ in both dosing regimens. (2.1, 5.1) Do not take oral medications within 1 hour of start of each dose. (2.1, 7.2) If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of CLENPIQ. (2.1, 7.3) For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing information. (2.1, 2.2, 2.3) Split-Dose Dosage Regimen (Preferred Method) (2.2) First dose: administer during evening before the colonoscopy Second dose: administer the next day, during the morning prior to the colonoscopy. Day-Before Dosage Regimen (Alternative Method), if Split-Dosing is inappropriate (2.3) First dose: administer during afternoon or early evening before the colonoscopy. Second dose: administer 6 hours later during evening before colonoscopy. 2.1 Important Administration Instructions Correct fluid and electrolyte abnormalities before administration of CLENPIQ. CLENPIQ is ready to drink. It is a clear solution with possible presence of visible particles and it does not need to be diluted prior to administration. One bottle of CLENPIQ is equivalent to one dose. Two doses of CLENPIQ are required for a complete preparation for colonoscopy either as a Split-Dose (preferred) or Day-Before dosing regimen. The preferred method is the "Split-Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy [see Dosage and Administration (2.2)]. The alternative method is the "Day-Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy [see Dosage and Administration (2.3)]. Additional fluids must be consumed after every dose of CLENPIQ in both dosing regimens [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)]. Consume only clear fluids (no solid food) from the start of CLENPIQ treatment until after the colonoscopy. Do not eat solid food or dairy and do not drink anything colored red or purple. Do not drink alcohol. Do not take other laxatives while taking CLENPIQ Do not take oral medications within one hour of starting CLENPIQ. If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of CLENPIQ. Stop consumption of all fluids at least 2 hours before the colonoscopy. 2.2 Split-Dose Dosage Regimen (Preferred Method) The Split-Dose regimen is the preferred dosing method. The recommended dosage in adults and pediatric patients 9 years of age and older is shown below. Instruct patients to take two separate doses in conjunction with fluids, as follows: Dose 1 – On the day before colonoscopy: Instruct patients to consume only clear liquids (no solid food or dairy) on the day before the colonoscopy up until 2 hours before the time of the colonoscopy. Take the first dose (1 bottle) of CLENPIQ during the evening before the colonoscopy (e.g., 5:00 to 9:00 PM). Follow CLENPIQ by drinking five 8-ounce cups (cup provided) of clear liquids (40 ounces total) within 5 hours and before bed. If severe bloating, distention, or abdominal pain occurs, following the first dose, delay the second dose until the symptoms resolve. Dose 2 – Next morning on the day of colonoscopy (start approximately 5 hours prior to colonoscopy): Continue to consume only clear liquids (no solid food or dairy). Take the second dose (the second bottle) of CLENPIQ. Following the CLENPIQ dose, drink at least three 8-ounce cups (cup provided) of clear liquids (24 ounces) at least 2 hours before the colonoscopy. 2.3 Day-Before Dosage Regimen (Alternative Method) The Day-Before regimen is the alternative dosing method for patients for whom the Split-Dosing is inappropriate. The recommended dosage in adults and pediatric patients 9 years of age and older is shown below. Instruct patients to take two separate doses in conjunction with fluids, as follows: Dose 1 – On the day before colonoscopy: Instruct patients to consume only clear liquids (no solid food or dairy) on the day before the colonoscopy up until 2 hours before the time of the colonoscopy. Take the first dose (1 bottle) of CLENPIQ in the afternoon or early evening before the colonoscopy (e.g., 4:00 to 6:00 PM). Following the CLENPIQ dose, drink five 8-ounce cups (cup provided) of clear liquids (40 ounces total) within 5 hours and before the next dose. If severe bloating, distention, or abdominal pain occurs, following the first dose, delay the second dose until the symptoms resolve. Dose 2 – Approximately 6 hours later in the evening the night before the colonoscopy (e.g., 10:00 PM to 12:00 AM): Take the second dose (the second bottle) of CLENPIQ. Following the CLENPIQ dose, drink three 8-ounce cups (cup provided) (24 ounces) of clear liquids within 5 hours and before bed.
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no data with CLENPIQ use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1.2 times the recommended human dose based on body surface area during organogenesis. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Reproduction studies with sodium picosulfate, magnesium oxide, and anhydrous citric acid have been performed in pregnant rats following oral administration of up to 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area) during the period of organogenesis. There was no evidence of harm to the fetus due to sodium picosulfate, magnesium oxide, and anhydrous citric acid. The reproduction study in rabbits was not adequate, as treatment-related mortalities were observed at all doses. A pre and postnatal development study with sodium picosulfate, magnesium oxide, and anhydrous citric acid in rats showed no evidence of any adverse effect on pre and postnatal development at oral doses up to 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area). Published reproduction studies with sodium picosulfate in pregnant rats and rabbits during the period of organogenesis did not show evidence of harm to the fetus at doses up to 100 mg/kg (approximately 49 and 98 times, respectively, the recommended human dose of 10 mg sodium picosulfate based on body surface area). 8.2 Lactation Risk Summary There are no data on the presence of magnesium oxide or anhydrous citric acid in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Published data on lactating women indicate that the active metabolite of sodium picosulfate, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM) remained below the limit of detection (1 ng/mL) in breast milk after both single and multiple doses of 10 mg/day. There are no data on the effects of sodium picosulfate on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CLENPIQ and any potential adverse effects on the breastfed infant from CLENPIQ or the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of CLENPIQ have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 9 years of age and older. Use of CLENPIQ in this age group is supported by evidence from adequate and well-controlled trials in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age all of which evaluated another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid [see Clinical Studies (14)]. The safety profile in this pediatric population was similar to that seen in adults [see Adverse Reactions (6.1)]. Monitor for possible hypoglycemia in pediatric patients, as CLENPIQ has no caloric substrate. The safety and effectiveness of CLENPIQ in pediatric patients less than 9 years of age have not been established. 8.5 Geriatric Use Of the 1201 patients in clinical trials who received another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid, 215 (18%) patients were 65 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients. 8.6 Renal Impairment CLENPIQ is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min), as accumulation of magnesium in plasma may occur [see Contraindications (4)]. Patients with less severe renal impairment or patients taking concomitant medications that may affect renal function may be at increased risk for renal injury [see Warnings and Precautions (5.3)]. Advise these patients of the importance of adequate hydration before, during, and after the use of CLENPIQ [see Dosage and Administration (2.1)]. Consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients

Interactions

7 DRUG INTERACTIONS Drugs that increase risks due to fluid and electrolyte changes. (7.1) 7.1 Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing CLENPIQ for patients with conditions or who are taking other drugs that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, arrhythmias or QT prolongation in the setting of fluid and electrolyte abnormalities, [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)]. 7.2 Potential for Reduced Drug Absorption CLENPIQ can reduce the absorption of other co-administered drugs [see Dosage and Administration (2.1)]: Administer oral medications at least one hour before of the start of administration of CLENPIQ. Administer tetracycline and fluoroquinolone antibiotics [see Drug Interactions (7.3)], iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of CLENPIQ to avoid chelation with magnesium. 7.3 Antibiotics Prior or concomitant use of antibiotics with CLENPIQ may reduce efficacy of CLENPIQ as conversion of sodium picosulfate to its active metabolite BHPM is mediated by colonic bacteria.

More information

Category Value
Authorisation number NDA209589
Agency product number XF417D3PSL
Orphan designation No
Product NDC 55566-6700
Date Last Revised 10-09-2019
Type HUMAN PRESCRIPTION DRUG
RXCUI 1994540
Storage and handling Storage Store CLENPIQ at 25°C (77°F). Excursions permitted at 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Do not refrigerate or freeze.
Marketing authorisation holder Ferring Pharmaceuticals Inc.