Fosrenol 750 mg/1

lanthanum carbonate · POWDER · Takeda Pharmaceuticals America, Inc.

No Recall History

Plain English

Fosrenol is a powder containing lanthanum carbonate at 750 mg/1, taken oral. Manufactured by Takeda Pharmaceuticals America, Inc..

Key Facts

Brand Name: Fosrenol
Generic Name: lanthanum carbonate
NDC Code (Product): 54092-256
Manufacturer: Takeda Pharmaceuticals America, Inc.
Strength: 750 mg/1
Dosage Form: POWDER
Route: ORAL
Marketing Status
Application #: NDA204734
Marketing Start: 09/24/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death671 reports

nausea474 reports

vomiting461 reports

constipation355 reports

sepsis349 reports

abdominal pain347 reports

general physical health deterioration314 reports

off label use312 reports

abdominal distension290 reports

hyponatraemia275 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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. FOSRENOL is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Divide the total daily dose of FOSRENOL and take with or immediately after meals. The recommended initial total daily dose of FOSRENOL 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. FOSRENOL has the potential to bind other orally administered drugs; consider separating the administration of other oral medications [see Drug Interactions (7) ] . In clinical studies of patients with ESRD, FOSRENOL 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. 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 imm…

Contraindications

4 CONTRAINDICATIONS Contraindicated in patients with: - hypersensitivity to FOSRENOL or to any ingredient in the formulation. - bowel obstruction, including ileus and fecal impaction. Hypersensitivity to FOSRENOL or to any ingredient in the formulation. ( 4 ) Bowel obstruction, ileus, and fecal impaction. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS There is a potential for FOSRENOL to interact with compounds that bind to cationic antacids (i.e., aluminum-, magnesium-, or calcium-based); therefore, do not take such compounds within 2 hours of dosing with FOSRENOL. ( 7.1 ) Oral quinolone antibiotics must be taken at least 1 hour before or 4 hours after FOSRENOL. ( 7.2 ) Do not take thyroid hormone replacement therapy within 2 hours of dosing with FOSRENOL. Monitoring of TSH levels is recommended in patients receiving both medicinal agents. ( 7.3 ) For oral medications where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, consider separation of the timing of the administration of the two drugs. ( 7.4 ) 7.1 Drugs Binding to Antacids There is a potential for FOSRENOL to interact with compounds which bind to cationic antacids (i.e., aluminum-, magnesium-, or calcium-based); therefore, do not administer such compounds within 2 hours of dosing with FOSRENOL. Examples of relevant classes of compounds where antacids have been demonstrated to reduce bioavailability include antibiotics (such as quinolones, ampicillin, and tetracyclines), thyro…

Adverse Reactions

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) ] In controlled trials, the most common adverse reactions that were more frequent (≥5% difference vs. placebo) in FOSRENOL were nausea, vomiting, and abdominal pain. ( 6.1 ) The following adverse reactions have been identified during post-approval use of FOSRENOL: constipation, dyspepsia, allergic skin reactions, and tooth injury while chewing the tablet. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) 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 the clinical trials of another drug and may not reflect the rates observed in practice. Overall, the safety profile of FOSRENOL has been studied in over 5,200 subjects in completed clinical trials. The most common adverse reactions for FOSRENOL were gastrointestinal even…

Frequently Asked Questions

What is Fosrenol used for?

Fosrenol contains lanthanum carbonate. It is a powder taken oral. Consult your doctor for specific uses.

Is Fosrenol a controlled substance?

Fosrenol is not classified as a controlled substance by the DEA.

What is the generic name for Fosrenol?

The generic name for Fosrenol is lanthanum carbonate. There are 11 other brand versions of lanthanum carbonate.

What is the NDC code for Fosrenol 750 mg/1?

The NDC (National Drug Code) for Fosrenol 750 mg/1 is 54092-256, listed by Takeda Pharmaceuticals America, Inc..

Product NDC

54092-256

Package NDC

54092-256-02

Other Lanthanum Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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