COLESEVELAM HCL tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

COLESEVELAM HYDROCHLORIDE (UNII: P4SG24WI5Q) (COLESEVELAM - UNII:1XU104G55N)

Disponibbli minn:

Ascend Laboratories, LLC

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Colesevelam hydrochloride tablets are indicated to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification. Colesevelam hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. - Colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. - Colesevelam hydrochloride has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. Colesevelam hydrochloride is contraindicated in patients with: - Serum TG concentrations greater than 500 mg/dL [see Warnings and Precautions (5.1)] - History of hypertriglyceridemia-induced pancreatitis [see Warnings and Precautions (5.1)] - A history of bowel obstruction [see Warnings and Precautions (5.2)] Risk Summary Colesevelam hydrochloride is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Limited available data on the use of colesevelam hydrochloride are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies, no evidence of either maternal or fetal toxicity was found in rats or rabbits exposed to colesevelam hydrochloride during the period of fetal organogenesis at 8 and 5 times, respectively, the maximum recommended human dose (MRHD) of 3.75 g/day, based on body surface area (mg/m2 ). No adverse effects on offspring survival and development were observed in rats administered 5 times the MRHD (see Data).Colesevelam hydrochloride may decrease the absorption of fat-soluble vitamins [see Warnings and Precautions (5.3)]. There are no data available on the effect of colesevelam hydrochloride on the absorption of fat-soluble vitamins in pregnant women. If the patient becomes pregnant while taking colesevelam hydrochloride, the patient should be advised of the lack of known clinical benefit with continued use during pregnancy. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data  There are no adequate and well-controlled studies of colesevelam hydrochloride use in pregnant women. In the postmarketing setting there have been infrequent reports of pregnancy with use of colesevelam hydrochloride and a causal association with congenital anomalies has not been established. Animal Data In pregnant rats given dietary doses of 0.3, 1.0, 3.0 g/kg/day colesevelam hydrochloride from gestation days 7 through 17, no teratogenic effects were observed. Exposures at 3.0 g/kg/day were 8 times the human exposure at 3.75 g/day MRHD, based on body surface area (mg/m2 ). In pregnant rabbits given oral gavage doses of 0.1, 0.5, 1.0 g/kg/day colesevelam hydrochloride from gestation days 6 through 18, no teratogenic effects were observed. Exposures at 1.0 g/kg/day were 5 times the human exposure at 3.75 g/day MRHD, based on body surface area (mg/m2 ). In pregnant rats given oral gavage doses of 0.1, 0.3, 1.0 g/kg/day colesevelam hydrochloride from gestation day 6 through lactation day 21 (weaning), no adverse effects on survival and development were observed. Exposures at 1.0 g/kg/day were 5 times the human exposure at 3.75 g/day MRHD, based on body surface area (mg/m2 ). Risk Summary Colesevelam hydrochloride is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to colesevelam hydrochloride. Contraception Use of colesevelam hydrochloride may reduce the efficacy of oral contraceptives. Advise patients to take oral contraceptives at least 4 hours prior to taking colesevelam hydrochloride [see Drug Interactions (7)]. Primary Hyperlipidemia The safety and effectiveness of colesevelam hydrochloride to reduce LDL-C levels in boys and postmenarchal girls 10 to 17 years of age with HeFH who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification have been established. Use of colesevelam hydrochloride for this indication is supported by a study in 129 colesevelam hydrochloride-treated pediatric patients aged 10 to 17 years with HeFH [see Clinical Studies (14.1)]. Adverse reactions commonly observed in pediatric patients compared to placebo, but not in adults, included headache (3.9%), creatine phosphokinase increase (2.3%), and vomiting (2.3%) [see Adverse Reactions (6.1)]. There were no significant effects on fat-soluble vitamin levels or clotting factors in the adolescent boys or girls relative to placebo. Due to colesevelam hydrochloride tablet size, colesevelam hydrochloride for oral suspension is recommended for use in the pediatric population [see Dosage and Administration (2.2, 2.4)]. The safety and effectiveness of colesevelam hydrochloride in pediatric patients with HeFH less than 10 years of age or in premenarchal females have not been established. Type 2 Diabetes Mellitus The safety and effectiveness of colesevelam hydrochloride to improve glycemic control in pediatric patients with type 2 diabetes mellitus have not been established. Effectiveness was not demonstrated in a 6-month, adequate and well-controlled study conducted in 141 colesevelam hydrochloride -treated pediatric patients aged 10 to 17 years with type 2 diabetes mellitus. Primary Hyperlipidemia Of the 1350 patients enrolled in the hyperlipidemia clinical studies, 349 (26%) were ≥65 years old, and 58 (4%) were ≥75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Type 2 Diabetes Mellitus Of the 2048 patients enrolled in the six diabetes studies, 397 (19%) were ≥65 years old, and 36 (2%) were ≥75 years old. In these trials, colesevelam hydrochloride 3.8 g/day or placebo was added onto background anti-diabetic therapy. No overall differences in safety or effectiveness were observed between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Type 2 Diabetes Mellitus Of the 2048 patients enrolled in the six diabetes studies, 807 (39%) had mild renal insufficiency (creatinine clearance [CrCl] 50-<80 mL/min), 61 (3%) had moderate renal insufficiency (CrCl 30-<50 mL/min), and none had severe renal insufficiency (CrCl <30 mL/min), as estimated from baseline serum creatinine using the Modification of Diet in Renal Disease (MDRD) equation. No overall differences in safety or effectiveness were observed between patients with CrCl <50 mL/min (n=53) and those with a CrCl ≥50 mL/min (n=1,075) in the add-on to metformin, sulfonylureas, and insulin diabetes studies. In the monotherapy study and add-on to pioglitazone study, only 3 and 5 patients, respectively, had moderate renal insufficiency.

Sommarju tal-prodott:

Colesevelam Hydrochloride Tablets are Off-white to light yellow colored, oval, film coated tablets imprinted "C625" on one side. They are supplied as follows: Bottle of 30: NDC 67877-506-30 Bottle of 90: NDC 67877-506-90 Bottle of 180: NDC 67877-506-51 Bottle of 500: NDC 67877-506-05 Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Brief exposure to 40°C (104°F) does not adversely affect colesevelam hydrochloride tablets.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

COLESEVELAM HCL - COLESEVELAM HCL TABLET, FILM COATED
ASCEND LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COLESEVELAM
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
COLESEVELAM HYDROCHLORIDE TABLETS.
COLESEVELAM HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Colesevelam hydrochloride is a bile acid sequestrant indicated as an
adjunct to diet and exercise to:
• reduce elevated low-density lipoprotein cholesterol (LDL-C) in
adults with primary hyperlipidemia
(1.1).
• reduce LDL-C levels in boys and postmenarchal girls, 10 to 17
years of age, with heterozygous
familial hypercholesterolemia
(HeFH), unable to reach LDL-C target levels despite an adequate trial
of diet and lifestyle modification
(1.1).
• improve glycemic control in adults with type 2 diabetes mellitus
(1.2).
Limitations of Use (1.3):
• Do not use for treatment of type 1 diabetes or for diabetic
ketoacidosis.
• Not studied in Fredrickson Type I, III, IV, and V dyslipidemias
DOSAGE AND ADMINISTRATION
• Obtain lipid parameters, including serum triglyceride (TG) levels,
before starting colesevelam
hydrochloride tablets (2.1).
• The recommended dosage for adults and for boys and postmenarchal
girls aged 10 to 17 years with
primary hyperlipidemia is
3.75 grams daily. The recommended dosage for adults with type 2
diabetes mellitus is 3.75 grams
daily. Colesevelam hydrochloride tablets should be taken as follows
(2.2, 2.4):
Tablets
Take 6 tablets once daily or 3 tablets twice daily with a meal and
liquid.
DOSAGE FORMS AND STRENGTHS
Tablets: 625 mg (3)
CONTRAINDICATIONS
Patients with serum triglyceride levels greater than 500 mg/dL (4)
Patients with a history of hypertriglyceridemia-induced pancreatitis
(4)
Patients with a history of bowel obstruction (4)
WARNINGS AND PRECAUTIONS
_Hypertriglyceridemia and Pancreatitis: _Colesevelam hydrochoride can
increase TG.
Hypertriglyceridemia can c