FOSRENOL- lanthanum carbonate tablet, chewable FOSRENOL- lanthanum carbonate powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LANTHANUM CARBONATE (UNII: 490D9F069T) (LANTHANUM CATION (3+) - UNII:O7FU5X12W5)

Available from:

Takeda Pharmaceuticals America, Inc.

INN (International Name):

LANTHANUM CARBONATE - UNII:O7FU5X12W5)

Composition:

LANTHANUM CATION (3+) 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FOSRENOL is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders. Contraindicated in bowel obstruction, including ileus and fecal impaction. Risk Summary Available data from case reports with use of FOSRENOL in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of lanthanum carbonate to pregnant rats and rabbits during organogenesis at doses 3 and 2.5 times, respectively, the maximum recommended human dose (MRHD), resulted in no adverse developmental effects. In rabbits, lanthanum carbonate doses 5 times the MRHD was associated with maternal toxicity and resulted in increased post-implantation loss, reduced fetal weights, and delayed fetal ossification (see Data) . Deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see Use in Specific Populations (8.4)] . Use a non-lanthanum containing phosphate binder in a pregnant woman. 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 defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In pregnant rats, oral administration of lanthanum carbonate at doses as high as 2,000 mg/kg/day during organogenesis resulted in no evidence of harm to the fetus. The MRHD for FOSRENOL is 5,725 mg, representing a dose of 95.4 mg/kg, or 3,530 mg/m2 for a 60-kg patient. The 2,000-mg/kg/day dose in the rat is equivalent to 12,000 mg/m2 , 3 times the MRHD. In pregnant rabbits, oral administration of lanthanum carbonate at 1,500 mg/kg/day (18,000 mg/m2 ; 5 times the daily MRHD) during organogenesis was associated with increased postimplantation loss, reduced fetal weights, and delayed fetal ossification. No effects on the pregnant rabbits or fetuses were observed at 750 mg/kg/day (9,000 mg/m2 ; 2.5 times the MRHD). In a pre- and postnatal development study in the rat, pregnant rats were dosed at up to 2,000 mg/kg/day (12,000 mg/m2 /day; equivalent to 3 times the MRHD) from day 6 of pregnancy through 20 days postpartum (including lactation). At 2,000 mg/kg/day, no maternal toxicity was observed, nor were any changes seen with respect to gestational length or delivery; however, piloerection/pallor, delayed eye opening, decreased body weight, and delayed sexual development were observed in the offspring at 2,000 mg/kg/day. At 200 and 600 mg/kg/day (equivalent to 0.3 and 1 time the MRHD, respectively), slight delays in sexual development (delayed vaginal opening) were observed in the female offspring [see Nonclinical Toxicology (13.2)] . Risk Summary There are no data on the presence of lanthanum carbonate from FOSRENOL in human milk, the effects on the breastfed infant, or the effects on milk production. Deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see Use in Specific Populations (8.4)] . Use a non-lanthanum containing phosphate binder in a lactating woman. The safety and efficacy of FOSRENOL in pediatric patients have not been established. While growth abnormalities were not identified in long-term animal studies, lanthanum was deposited into developing bone, including growth plate. The consequences of such deposition in developing bone in pediatric patients are unknown; therefore, the use of FOSRENOL in this population is not recommended. Of the total number of patients in clinical studies of FOSRENOL, 32% (538) were ≥65 years of age, while 9.3% (159) were ≥75 years of age. No overall differences in safety or effectiveness were observed between patients ≥65 years of age and younger patients.

Product summary:

FOSRENOL is supplied as a chewable tablet in three dosage strengths for oral administration: 500-mg tablets, 750-mg tablets, and 1,000-mg tablets. Each chewable tablet is white to off-white round, flat with a beveled edge, and debossed on one side with 'S405' above the dosage strength corresponding to the content of elemental lanthanum. 500-mg Patient Pack (2 bottles of 45 tablets, NDC 54092-252-45, per each patient pack) NDC 54092-252-90. 750-mg Patient Pack (6 bottles of 15 tablets, NDC 54092-253-15, per each patient pack) NDC 54092-253-90. 1,000-mg Patient Pack (9 bottles of 10 tablets, NDC 54092-254-10, per each patient pack) NDC 54092-254-90. FOSRENOL Oral Powder is supplied in two dosage strengths for oral administration: 750 mg and 1,000 mg. Each 750-mg and 1,000-mg stick pack contains 2.1 g and 2.8 g oral powder, respectively, packed in a polyethylene terephthalate/aluminum/polyethylene laminate. Storage and Handling Store FOSRENOL Chewable Tablets and FOSRENOL Oral Powder at 25°C (77°F): excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature.]

Authorization status:

New Drug Application

Patient Information leaflet

FOSRENOL- LANTHANUM CARBONATE TABLET, CHEWABLE
FOSRENOL- LANTHANUM CARBONATE POWDER
Takeda Pharmaceuticals America, Inc.
----------
MEDICATION GUIDE
FOSRENOL® (FOSS-WREN-ALL)
(LANTHANUM CARBONATE)
Read this Medication Guide before you start taking FOSRENOL and each
time you get a refill. There
may be new information. This information does not take the place of
talking to your healthcare provider
about your medical condition or treatment.
What is the most important information I should know about FOSRENOL?
FOSRENOL may cause a bowel blockage, a hole in the bowel, or severe
constipation, which can be
serious, and sometimes lead to surgery or treatment in a hospital.
•
You may have a higher risk of bowel blockage, a hole in the bowel, or
severe constipation if you
take FOSRENOL and have:
•
a history of surgery, ulcers or cancer in the stomach or bowel
•
a history of bowel blockage, or problems resulting in a decreased
movement of food
through your stomach and bowel (e.g., feeling full quickly after
eating or constipation)
•
an infection or inflammation of the stomach/bowel (peritonitis)
Do not swallow FOSRENOL Chewable Tablets whole. Chew tablets
completely before swallowing. If
you cannot chew tablets completely, you may crush the tablets
thoroughly before swallowing or discuss
the oral powder formulation with your healthcare provider.
What is FOSRENOL?
FOSRENOL is a prescription medicine used in people with end-stage
renal disease (ESRD) to lower the
amount of phosphate in the blood.
Who should not take FOSRENOL?
Do not take FOSRENOL if you:
•
have blocked bowels
•
have severe constipation
FOSRENOL has not been studied in children and adolescents under 18
years of age.
What should I tell my healthcare provider before taking FOSRENOL?
FOSRENOL may not be right for you. Before starting FOSRENOL, tell your
healthcare provider if you:
•
have a history of surgery, ulcers or cancer in the stomach or bowel
•
have a history of a bowel blockage, constipation, or problems
resulting in a decreased movement
o

Summary of Product characteristics

FOSRENOL- LANTHANUM CARBONATE TABLET, CHEWABLE
FOSRENOL- LANTHANUM CARBONATE POWDER
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FOSRENOL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FOSRENOL.
FOSRENOL (LANTHANUM CARBONATE) CHEWABLE TABLETS, FOR ORAL USE
FOSRENOL (LANTHANUM CARBONATE) ORAL POWDER, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Warnings and Precautions (5.1)
05/2023
Warnings and Precautions (5.2)
12/2023
INDICATIONS AND USAGE
FOSRENOL is a phosphate binder indicated to reduce serum phosphate in
patients with end-stage renal
disease (ESRD). (1)
DOSAGE AND ADMINISTRATION
The recommended initial total daily dose of FOSRENOL is 1,500 mg in
divided doses. Titrate every 2 to 3
weeks based on serum phosphate level. (2)
Take FOSRENOL with or immediately after meals. (2)
FOSRENOL Chewable Tablets: Chew or crush tablet completely before
swallowing. (2)
FOSRENOL Oral Powder: Sprinkle powder on a small quantity of
applesauce or other similar food and
consume immediately. Consider powder formulation in patients with poor
dentition or who have
difficulty chewing tablets. (2)
DOSAGE FORMS AND STRENGTHS
FOSRENOL Chewable Tablets: 500 mg, 750 mg, and 1,000 mg. (3)
FOSRENOL Oral Powder: 750 mg and 1,000 mg. (3)
CONTRAINDICATIONS
Bowel obstruction, ileus, and fecal impaction. (4)
WARNINGS AND PRECAUTIONS
Serious cases of gastrointestinal obstruction, ileus, subileus,
gastrointestinal perforation, and fecal
impaction. Risks include altered gastrointestinal anatomy,
hypomotility disorders, and concomitant
medications. Advise patients to chew or crush the tablet completely.
(5.1)
FOSRENOL has radio-opaque properties and, therefore, may give the
appearance typical of an imaging
agent during abdominal X-ray procedures. (5.2)
ADVERSE REACTIONS
In controlled trials, the most common adverse reactions that were more
frequent (≥5% difference vs.
placebo) in FOSRENOL were nausea, vomiting,