LANTHANUM CARBONATE tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lanthanum carbonate chewable tablets are 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 lanthanum carbonate chewable tablets 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 lanthanum carbonate chewable tablets 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 lanthanum carbonate chewable tablets 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 lanthanum carbonate chewable tablets 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 lanthanum carbonate chewable tablets in this population is not recommended. Of the total number of patients in clinical studies of lanthanum carbonate chewable tablets, 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:

Lanthanum carbonate chewable tablets are available as: 500 mg: White to off-white, round, flat-faced, beveled-edge tablet, debossed with stylized b  over 1137  on one side and plain on the other side. Available in a Patient Pack: 2 Bottles of 45 Tablets (NDC 0093-5938-98). 750 mg: White to off-white, round, flat-faced, beveled-edge tablet, debossed with stylized b  over 750  on one side and plain on the other side. Available in a Patient Pack: 6 Bottles of 15 Tablets (NDC 0093-5939-98). 1,000 mg: White to off-white, round, flat-faced, beveled-edge tablet, debossed with stylized b  over 1139  on one side and plain on the other side. Available in a Patient Pack: 9 Bottles of 10 Tablets (NDC 0093-5940-98). Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LANTHANUM CARBONATE- LANTHANUM CARBONATE TABLET, CHEWABLE
Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Lanthanum Carbonate (lan' tha num kar' bo nate) Chewable Tablets
Read this Medication Guide before you start taking lanthanum carbonate
chewable tablets 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 lanthanum
carbonate chewable tablets?
Lanthanum carbonate chewable tablets 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 lanthanum carbonate chewable tablets 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 lanthanum carbonate 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 are lanthanum carbonate chewable tablets?
Lanthanum carbonate chewable tablets are 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 lanthanum carbonate chewable tablets?
Do not take lanthanum carbonate chewable tablets if you:
•
have blocked bowels
•
have severe constipation
Lanthanum carbonate chewable tablets have not been studied in children
and adolescents under 18 years
of age.
What should I tell my healthcare provider before taking lanthanum
carbonate chewable tab

Summary of Product characteristics

LANTHANUM CARBONATE- LANTHANUM CARBONATE TABLET, CHEWABLE
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANTHANUM CARBONATE
CHEWABLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LANTHANUM
CARBONATE CHEWABLE TABLETS.
LANTHANUM CARBONATE CHEWABLE TABLETS, 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
Lanthanum carbonate chewable tablets are 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 lanthanum carbonate
chewable tablets is 1,500 mg in
divided doses. Titrate every 2 to 3 weeks based on serum phosphate
level. (2)
Take lanthanum carbonate chewable tablets with or immediately after
meals. (2)
Chew or crush tablet completely before swallowing. (2)
DOSAGE FORMS AND STRENGTHS
Chewable Tablets: 500 mg, 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)
Lanthanum carbonate chewable tablets have 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 lanthanum carbonate chewable tablets were nausea,
vomiting, and abdominal pain. (6.1)
The following adverse reactions have been identified during
post-approval use of lanthanum carbonate
chewable tablets: constipation, dyspepsia, allergic skin reactions,
and tooth in