PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lanthanum Carbonate Chewable Tablets 1000 mg - Bottle of 10 Tablets

Label artwork:
NDC 68180-821-10
Bottle of 10 tablets
Each chewable tablet contains 1000 mg of lanthanum as lanthanum carbonate dihydrate


** Carton artwork:**
****NDC 68180-821-47
Each chewable tablet contains 1000 mg of lanthanum as lanthanum carbonate dhydrate
PATIENT PACK ONE MONTH SUPPLY
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.



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INDICATIONS & USAGE SECTION

Highlight: * Lanthanum carbonate chewable tablet is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). (1)

1 INDICATIONS AND USAGE

Lanthanum carbonate chewable tablet 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.

DOSAGE & ADMINISTRATION SECTION

Highlight: * 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)
• Lanthanum carbonate chewable tablets: Chew or crush tablet completely before swallowing. (2)
• Consider powder formulation in patients with poor dentition or who have difficulty chewing tablets (2)

2 DOSAGE AND ADMINISTRATION

Divide the total daily dose of lanthanum carbonate chewable tablets and take with or immediately after meals. The recommended initial total daily dose of lanthanum carbonate chewable tablets is 1,500 mg. Titrate the dose every 2 to 3 weeks until an acceptable serum phosphate level is reached. Monitor serum phosphate levels as needed during dose titration and on a regular basis thereafter.

Lanthanum carbonate chewable tablets have the potential to bind other orally administered drugs; consider separating the administration of other oral medications [see Drug Interactions (7)].

In clinical studies patients with ESRD, lanthanum carbonate chewable tablets doses up to 4,500 mg were evaluated. Most patients required a total daily dose between 1,500 mg and 3,000 mg to reduce plasma phosphate levels to less than 6.0 mg/dL. Doses were generally titrated in increments of 750 mg/day.

Information for lanthanum carbonate chewable tablets
Chew or crush lanthanum carbonate chewable tablets completely before swallowing. Do not swallow intact lanthanum carbonate chewable tablets.

Consider using the oral powder formulation in patients with poor dentition or who have difficulty chewing tablets.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: * Lanthanum Carbonate Chewable Tablets: 500 mg, 750 mg and 1,000 mg. (3)

3 DOSAGE FORMS AND STRENGTHS

Lanthanum Carbonate Chewable Tablets: 500 mg, 750 mg, and 1,000 mg.

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CONTRAINDICATIONS SECTION

Highlight: * Bowel obstruction, ileus, and fecal impaction. (4)

4 CONTRAINDICATIONS

Contraindicated in bowel obstruction, including ileus and fecal impaction.

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USE IN SPECIFIC POPULATIONS SECTION

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

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 tablet 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)].

8.2 Lactation

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.

8.4 Pediatric Use

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.

8.5 Geriatric Use

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.

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ADVERSE REACTIONS SECTION

Highlight: * 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 injury while chewing the tablet. (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Gastrointestinal Adverse Effects [see Warnings and Precautions (5.1)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Overall, the safety profile of lanthanum carbonate chewable tablets have been studied in over 5,200 subjects in completed clinical trials. The most common adverse reactions for lanthanum carbonate chewable tablets were gastrointestinal events, such as nausea, vomiting, and abdominal pain and they generally abated over time with continued dosing.

In double-blind, placebo-controlled studies where a total of 180 and 95 patients with ESRD were randomized to lanthanum carbonate chewable tablets and placebo, respectively, for 4 to 6 weeks of treatment, the most common reactions that were more frequent (≥5% difference) in the lanthanum carbonate chewable tablets group were nausea, vomiting, and abdominal pain (Table 1).

Table 1: Adverse Reactions That Were More Common on Lanthanum Carbonate Chewable*
** Tablets in Placebo-Controlled, Double-Blind Studies with Treatment Periods of 4 to 6 Weeks**

In an open-label, long-term 2 year extension study in 93 patients who had transitioned from other studies, resulting in a total of up to 6 years treatment, mean baseline values and changes in transaminases were similar to those observed in the earlier comparative studies, with little change during treatment.

The safety of lanthanum carbonate chewable tablets was studied in two long- term, open-label clinical trials, which included 1,215 patients treated with lanthanum carbonate chewable tablets and 944 with alternative therapy. Fourteen percent (14%) of patients treated with lanthanum carbonate chewable tablets discontinued treatment due to adverse events. Gastrointestinal adverse reactions, such as nausea, diarrhea, and vomiting were the most common types of event leading to discontinuation.

In pooled active comparator controlled clinical trials, hypocalcemia was noted with an incidence of approximately 5% in both lanthanum and active comparator groups. A nonclinical study and a phase 1 study have shown reduced absorption of calcium in the intestine with lanthanum carbonate treatment.

In a crossover study in 72 healthy individuals comparing lanthanum chewable tablets to lanthanum oral powder, gastrointestinal adverse reactions such as nausea, diarrhea, and vomiting were more common for the oral powder formulation (18%) than for the chewable tablets (7%).

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of lanthanum carbonate chewable tablets. 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.

Cases of constipation, intestinal perforation, intestinal obstruction, ileus, subileus, dyspepsia, allergic skin reactions, hypophosphatemia, and tooth injury while chewing the tablet have been reported.

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OVERDOSAGE SECTION

10 OVERDOSAGE

The symptoms associated with overdose are adverse reactions such as headache, nausea and vomiting. In clinical trials in healthy adults, gastrointestinal (GI) symptoms were reported with daily doses up to 6,000 mg/day of lanthanum carbonate administered with food. Given the topical activity of lanthanum in the gut, and the excretion of the majority of the dose in feces, supportive therapy is recommended for overdosage. Lanthanum carbonate was not acutely toxic in animals by the oral route. No deaths and no adverse effects occurred in mice, rats, or dogs after single oral doses of 2,000 mg/kg (1.7, 3.4, and 11.3 times the MRHD, respectively, on a mg/m2 basis).

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INFORMATION FOR PATIENTS SECTION

17 PATIENT COUNSELING INFORMATION

• Advise the patient to read the FDA-approved patient labeling (Medication Guide).
• Advise patients to take lanthanum carbonate chewable tablets with or immediately after meals [see Dosage and Administration (2)].
• Instruct patients on concomitant medications that should be dosed apart from lanthanum carbonate chewable tablets [see Drug Interactions (7)].
• Instruct patients who are prescribed lanthanum carbonate chewable tablets to chew or crush tablets completely before swallowing**.** Emphasize that lanthanum carbonate chewable tablets should not be swallowed intact. Consider crushing lanthanum carbonate chewable tablets completely or prescribing the oral powder formulation for patients with poor dentition or who have difficulty chewing tablets [see Dosage and Administration (2)].
• Advise patients who are taking an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy to separate the dosing of lanthanum carbonate chewable tablets from the dosing of the affected drug by several hours [see Drug Interactions (7)].
• Advise patients to notify their physician that they are taking lanthanum carbonate chewable tablets prior to an abdominal X-ray or if they have a history of gastrointestinal disease [see Warnings and Precautions (5.1, 5.2)].

Manufactured by:

NATCO PHARMA LIMITED

India.

Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

** Rev: Dec 2023**

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?

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****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 health care provider.

What is lanthanum carbonate chewable tablet?

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Lanthanum carbonate chewable tablet 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 lanthanum carbonate chewable tablets?

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****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.

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** What should I tell my healthcare provider before taking lanthanum carbonate chewable tablets?**

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Lanthanum carbonate chewable tablets may not be right for you. Before starting lanthanum carbonate chewable tablets, 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 of food through your stomach and bowel especially if you also have diabetes

• have ulcerative colitis, Crohn’s disease or an infection or inflammation of the stomach/bowel (peritonitis)

• plan to have an X-ray of your stomach (abdomen)

• have any other medical conditions

• are pregnant, plan to become pregnant, or plan to breastfeed.Tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

• Especially tell your healthcare provider if you take:

• antacids

• antibiotics

• thyroid medicine

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take lanthanum carbonate chewable tablets?

• Take lanthanum carbonate chewable tablets exactly as prescribed by your healthcare provider

• Your healthcare provider will tell you how much lanthanum carbonate chewable tablets to take

• Your healthcare provider may change your dose if needed

*Chewable tablets - Do not swallow tablets whole. Chew tablets completely before swallowing. If you cannot chew tablets completely, or if you have tooth disease, you may crush the tablets thoroughly before swallowing or discuss the oral powder formulation with your healthcare provider.

• Take lanthanum carbonate chewable tablets with or right after meals

• If you take an antacid medicine, take the antacid 2 hours before or 2 hours after you take lanthanum carbonate chewable tablets

• If you take medicine for your thyroid (levothyroxine), take the thyroid medicine 2 hours before or 2 hours after you take lanthanum carbonate chewable tablets

• If you take an antibiotic medicine, take the antibiotic 1 hour before or 4 hours after you take lanthanum carbonate chewable tablets

What are possible or reasonably likely side effects of lanthanum carbonate chewable tablets?

See** “What is the most important information I should know about lanthanum carbonate chewable tablets?”**

The most common side effects of lanthanum carbonate chewable tablets include:

• nausea

• vomiting

• diarrhea

• stomach pain

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects of lanthanum carbonate chewable tablets. 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 lanthanum carbonate chewable tablets?

• Store lanthanum carbonate chewable tablets between 59°F to 86°F (15°C to 30°C).

Keep lanthanum carbonate chewable tablets and all medicines out of the reach of children.

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** General information about lanthanum carbonate chewable tablets**

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****Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lanthanum carbonate chewable tablets for a condition for which it was not prescribed. Do not give lanthanum carbonate chewable tablets to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about lanthanum carbonate chewable tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about lanthanum carbonate chewable tablets that is written for healthcare professionals.
For more information go to www.lupinpharmaceuticals.com or call 1-800-399-2561.

What are the ingredients in lanthanum carbonate chewable tablets?

Active ingredient: lanthanum carbonate

Inactive ingredients: colloidal silicon dioxide, dextrates, hydroxy propyl cellulose, magnesium stearate and talc.

This Medication Guide has been approved by the US Food and Drug Administration.

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Manufactured by:
NATCO PHARMA LIMITED
****India.

Distributed by:
Lupin Pharmaceuticals, Inc.
****Baltimore, Maryland 21202
United States

Rev: Jan 2024

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HOW SUPPLIED SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 Lanthanum carbonate chewable tablets

Lanthanum carbonate chewable tablets are supplied in three dosage strengths as lanthanum for oral administration: 500 mg tablets, 750 mg tablets, and 1000 mg tablets.

Lanthanum carbonate chewable tablets, 500 mg (as lanthanum) are white to off white round shaped tablets debossed ‘NAT’ on one side and ‘500’ on other side, supplied in patient pack (2 bottles of 45 chewable tablets each NDC 68180-819-52) NDC 68180-819-42.

Lanthanum carbonate chewable tablets, 750 mg (as lanthanum) are white to off white round shaped tablets debossed ‘NAT’ on one side and ‘750’ on other side, supplied in patient pack (6 bottles of 15 chewable tablets each NDC 68180-820-53) NDC 68180-820-46.

Lanthanum carbonate chewable tablets, 1000 mg (as lanthanum) are white to off white round shaped tablets debossed ‘NAT’ on one side and ‘1000’ on other side, supplied in patient pack (9 bottles of 10 chewable tablets each NDC 68180-821-10) NDC 68180-821-47.

Storage and Handling
Store lanthanum carbonate chewable tablets at 25ºC (77ºF): excursions permitted to 15º to 30˚C (59º to 86ºF).
[See USP controlled room temperature].

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