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Lanthanum: Drug information

Lanthanum: Drug information
(For additional information see "Lanthanum: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Fosrenol
Brand Names: Canada
  • Fosrenol;
  • NAT-Lanthanum
Pharmacologic Category
  • Phosphate Binder
Dosing: Adult

Note: Use in combination with dietary phosphate restriction (Ref).

Hyperphosphatemia in chronic kidney disease, treatment

Hyperphosphatemia in chronic kidney disease, treatment:

Oral: Initial: 1,500 mg/day in divided doses taken with or immediately after meals.

Dosage adjustment: Increase or decrease dose by 250 or 500 mg per meal at 2- to 3-week intervals as needed to obtain targeted serum phosphorus concentrations; usual dosage range: 1,500 to 3,000 mg/day in divided doses (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Diarrhea (oral powder: ≤18%; chewable tablets: ≤7%), nausea (oral powder: ≤18%; chewable tablet: ≤11%), vomiting (oral powder: ≤18%; chewable tablets: ≤9%)

1% to 10%:

Endocrine & metabolic: Hypocalcemia (5%)

Gastrointestinal: Abdominal pain (chewable tablet: 5%)

<1%, postmarketing, and/or case reports: Accidental injury (tooth injury with chewable tablets), allergic skin reaction, constipation, dyspepsia, fecal impaction, gastrointestinal perforation, hypophosphatemia, intestinal obstruction (including ileus and subileus), intestinal perforation

Contraindications

Bowel obstruction, fecal impaction, ileus

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to lanthanum carbonate or any component of the formulation; hypophosphatemia

Warnings/Precautions

Concerns related to adverse effects:

• GI obstruction: Serious GI obstruction, ileus, subileus, GI perforation, and fecal impaction have been reported, some requiring surgery or hospitalization. Risk factors include patients with altered GI anatomy (eg, diverticular disease, peritonitis, history of GI surgery, GI cancer, GI ulceration), hypomotility disorders (eg, constipation, ileus, subileus, diabetic gastroparesis), or medications known to potentiate effects; may also occur in patients without history of GI disease. Monitor patients closely for GI symptoms (eg, constipation, abdominal pain, abdominal distention); consider discontinuation in patients with unexplained severe GI symptoms.

Disease-related concerns:

• Biliary obstruction: Use with caution in patients with biliary obstruction (elimination of lanthanum may be reduced in these patients).

• Gastrointestinal disease: Use with caution in patients with active peptic ulcer, ulcerative colitis, or Crohn disease.

• Hepatic impairment: Use with caution in patients with hepatic impairment (elimination of lanthanum may be reduced in these patients).

Dosage form specific issues:

• Tablet: Chew thoroughly to decrease risk of serious adverse GI effects; do not swallow whole.

Other warnings/precautions:

• Abdominal x-rays: Lanthanum has radio-opaque properties; may appear as an imaging agent on abdominal x-ray. Product residue has been reported during endoscopic imaging.

• Bone deposition: Rising lanthanum levels were observed in bone biopsies of patients treated for up to 4.5 years. Lanthanum deposits into developing bone, including growth plates; consequences on developing bone are not known. Use in children is not recommended.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Packet, Oral:

Fosrenol: 750 mg (10 ea, 90 ea); 1000 mg (10 ea, 90 ea)

Tablet Chewable, Oral:

Fosrenol: 500 mg, 750 mg, 1000 mg

Generic: 500 mg, 750 mg, 1000 mg

Generic Equivalent Available: US

May be product dependent

Pricing: US

Chewable (Fosrenol Oral)

500 mg (per each): $14.41

750 mg (per each): $14.41

1000 mg (per each): $14.41

Chewable (Lanthanum Carbonate Oral)

500 mg (per each): $3.96 - $13.69

750 mg (per each): $4.50 - $13.69

1000 mg (per each): $4.06 - $13.69

Pack (Fosrenol Oral)

750 mg (per each): $14.41

1000 mg (per each): $14.41

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet Chewable, Oral:

Fosrenol: 250 mg [DSC], 500 mg, 750 mg, 1000 mg

Generic: 250 mg, 500 mg, 750 mg, 1000 mg

Administration: Adult

Administer with or immediately after meals. Consider separating administration of oral medications from lanthanum when reduced bioavailability would significantly affect the concomitant medication's safety or efficacy; duration of separation varies based on absorption characteristics and whether it is an IR or ER product; monitor clinical response and/or blood concentrations of concomitant medications with a narrow therapeutic range.

Chewable tablet: Tablet should be chewed completely prior to swallowing; do not swallow whole. Tablet may be crushed to aid in chewing. Unchewed or incompletely chewed tablets may cause serious GI complications.

Oral powder: Sprinkle powder on a small quantity of applesauce or other similar food (not liquid) and administer immediately. Do not store for future use.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Fosrenol: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021468s024,204734s006lbl.pdf#page=12

Use: Labeled Indications

Hyperphosphatemia in chronic kidney disease, treatment: Reduction of serum phosphate in patients with end-stage kidney disease.

Medication Safety Issues
Sound-alike/look-alike issues:

Lanthanum may be confused with lithium.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Ampicillin: Lanthanum may decrease the serum concentration of Ampicillin. Management: Administer oral ampicillin at least two hours before or after lanthanum. Risk D: Consider therapy modification

Angiotensin-Converting Enzyme Inhibitors: Lanthanum may decrease the serum concentration of Angiotensin-Converting Enzyme Inhibitors. Management: Administer angiotensin-converting enzyme (ACE) inhibitors at least two hours before or after lanthanum. Risk D: Consider therapy modification

Antacids: May diminish the therapeutic effect of Lanthanum. Management: Administer antacid products at least 2 hours before or after lanthanum. Risk D: Consider therapy modification

Bacampicillin: Lanthanum may decrease the serum concentration of Bacampicillin. Management: Administer bacampicillin at least 2 hours before or after lanthanum. Risk D: Consider therapy modification

Chloroquine: Lanthanum may decrease the serum concentration of Chloroquine. Management: Administer chloroquine at least two hours before or after lanthanum. Risk D: Consider therapy modification

Halofantrine: Lanthanum may decrease the serum concentration of Halofantrine. Management: Administer halofantrine at least two hours before or after lanthanum. Risk D: Consider therapy modification

HMG-CoA Reductase Inhibitors (Statins): Lanthanum may decrease the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Administer HMG-CoA reductase inhibitors (eg, statins) at least two hours before or after lanthanum. Risk D: Consider therapy modification

Quinolones: Lanthanum may decrease the serum concentration of Quinolones. Management: Administer oral quinolone antibiotics at least one hour before or four hours after lanthanum. Risk D: Consider therapy modification

Tetracyclines: Lanthanum may decrease the serum concentration of Tetracyclines. Management: Administer oral tetracycline antibiotics at least 2 hours before or after lanthanum. Risk D: Consider therapy modification

Thyroid Products: Lanthanum may decrease the serum concentration of Thyroid Products. Management: Separate the administration of thyroid products and lanthanum by at least 4 hours. Risk D: Consider therapy modification

Pregnancy Considerations

Environmental studies suggest lanthanum may cross the placenta (Huo 2017).

If a reduction of serum phosphate is needed in pregnant patients with end-stage renal disease, agents other than lanthanum are preferred. Discontinuation of phosphate binders may be required in patients on intensified hemodialysis during pregnancy (Burgner 2019; Hladunewich 2016; Tangren 2018; Wiles 2019).

Breastfeeding Considerations

It is not known if lanthanum is present in breast milk.

According to the manufacturer, use of a non-lanthanum phosphate binder is recommended in patients who are breastfeeding.

Dietary Considerations

Take with or immediately after meals.

Monitoring Parameters

Serum calcium, phosphorus, and parathyroid hormone (PTH): Frequency of measurement may be dependent upon the presence and magnitude of abnormalities, the rate of progression of chronic kidney disease (CKD), and the use of treatments for chronic kidney disease-mineral and bone disorder (CKD-MBD) (KDIGO 2017):

CKD stage G3a to G3b: Serum calcium and phosphate: Every 6 to 12 months; PTH: Frequency based on baseline level and progression of CKD

CKD stage G4: Serum calcium and phosphate: Every 3 to 6 months; PTH: Every 6 to 12 months

CKD stage G5 and G5D: Serum calcium and phosphate: Every 1 to 3 months; PTH: Every 3 to 6 months

Reference Range

Note: Due to the complexity and interdependency of the laboratory parameters used for therapeutic decisions in chronic kidney disease-mineral and bone disorder (CKD-MBD) patients, serial assessments of phosphate, calcium, and parathyroid hormone (PTH) levels should be considered together (KDIGO 2017).

Calcium (total): Normal range: Adults: 8.5 to 10.5 m/dL (2.12 to 2.62 mmol/L) (IOM 2011). Avoid hypercalcemia for chronic kidney disease (CKD) stages G3a to G5D (KDIGO 2017).

Phosphorus: 2.5 to 4.5 mg/dL (0.81 to 1.45 mmol/L). Lower elevated phosphorus levels toward the normal range for CKD stages G3a to G5D (KDIGO 2017).

PTH:

CKD stage G3a to G5: Optimal PTH level is unknown; evaluate patients with progressively elevated intact PTH levels or if levels are consistently above the normal range (assay-dependent) (KDIGO 2017).

Dialysis patients: Maintain intact parathyroid hormone (iPTH) within 2 to 9 times the upper limit of normal for the assay used (KDIGO 2017).

Mechanism of Action

Disassociates in the upper gastrointestinal tract to lanthanum ions (La3+) which bind to dietary phosphate resulting in insoluble lanthanum phosphate complexes and a net decrease in serum phosphate and calcium levels.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: <0.002%

Protein binding: >99%

Metabolism: Not metabolized

Half-life elimination: Plasma: 53 hours; Bone: 2-3.6 years

Excretion: Feces primarily; urine <2%

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Fosrenol;
  • (AT) Austria: Fosrenol;
  • (BE) Belgium: Fosrenol;
  • (BG) Bulgaria: Fosrenol;
  • (CH) Switzerland: Fosrenol;
  • (CN) China: Fosrenol;
  • (CZ) Czech Republic: Fosrenol;
  • (DE) Germany: Fosrenol | Lanthan Mylan;
  • (EE) Estonia: Calafos | Fosrenol;
  • (ES) Spain: Fosrenol;
  • (FI) Finland: Fosrenol;
  • (FR) France: Fosrenol | Lanthane mylan;
  • (GB) United Kingdom: Fosrenol | Lanthanum;
  • (GR) Greece: Fosrenol;
  • (HK) Hong Kong: Fosrenol;
  • (HU) Hungary: Fosrenol;
  • (ID) Indonesia: Fosrenol;
  • (IE) Ireland: Foznol;
  • (IN) India: Fosbait | Foschek | Fosend;
  • (IT) Italy: Foznol;
  • (JP) Japan: Fosrenol | Lanthanum carbonate towa | Lanthanum carbonate yd;
  • (KR) Korea, Republic of: Fosrenol;
  • (LB) Lebanon: Fosrenol;
  • (LT) Lithuania: Fosrenol;
  • (LU) Luxembourg: Fosrenol;
  • (LV) Latvia: Calafos | Fosrenol;
  • (MY) Malaysia: Fosrenol;
  • (NL) Netherlands: Fosrenol | Lanthaan mylan;
  • (NO) Norway: Fosrenol;
  • (NZ) New Zealand: Fosrenol;
  • (PH) Philippines: Fosrenol;
  • (PR) Puerto Rico: Fosrenol;
  • (PT) Portugal: Fosrenol;
  • (RO) Romania: Fosrenol;
  • (RU) Russian Federation: Fosrenol;
  • (SE) Sweden: Fosrenol | Lanthanum mylan;
  • (SG) Singapore: Fosrenol;
  • (SI) Slovenia: Fosrenol;
  • (SK) Slovakia: Fosrenol;
  • (TH) Thailand: Fosrenol;
  • (TR) Turkey: Antax;
  • (ZA) South Africa: Fosrenol
  1. Behets GJ, Verberckmoes SC, D'Haese PC, et al. Lanthanum Carbonate: A New Phosphate Binder. Curr Opin Nephrol Hypertens. 2004;13:403-409. [PubMed 15199290]
  2. Burgner A, Hladunewich MA. Women's reproductive health for the nephrologist. Am J Kidney Dis. 2019;74(5):675-681. doi:10.1053/j.ajkd.2019.04.017 [PubMed 31221529]
  3. Fosrenol (lanthanum) [prescribing information]. Lexington, MA: Takeda Pharmaceuticals America Inc; December 2023.
  4. Fosrenol (lanthanum) [product monograph]. Toronto, Ontario, Canada: Takeda Canada Inc; April 2023.
  5. Hladunewich M, Schatell D. Intensive dialysis and pregnancy. Hemodial Int. 2016;20(3):339-348. doi:10.1111/hdi.12420 [PubMed 27061443]
  6. Huo W, Zhu Y, Li Z, Pang Y, Wang B, Li Z. A pilot study on the association between rare earth elements in maternal hair and the risk of neural tube defects in north China. Environ Pollut. 2017;226:89‐93. doi:10.1016/j.envpol.2017.03.046 [PubMed 28411498]
  7. Institute of Medicine (IOM). Dietary Reference Intakes for Calcium and Vitamin D. The National Academies Press; 2011.
  8. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease—mineral and bone disorder (CKD-MBD). Kidney Int. 2017;7(suppl 1):1-59. doi:10.1016/j.kisu.2017.04.001
  9. Kovesdy CP, Lu JL, Wall BM, et al. Changes with lanthanum carbonate, calcium acetate, and phosphorus restriction in CKD: a randomized controlled trial. Kidney Int Rep. 2018;3(4):897-904. doi:10.1016/j.ekir.2018.03.011 [PubMed 29989014]
  10. Lanthanum carbonate chewable tablets [prescribing information]. Warren , NJ: Cipla USA Incl; January 2022.
  11. Refer to manufacturer's labeling.
  12. Tangren J, Nadel M, Hladunewich MA. Pregnancy and end-stage renal disease. Blood Purif. 2018;45(1-3):194-200. doi:10.1159/000485157 [PubMed 29478065]
  13. Wiles K, de Oliveira L. Dialysis in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2019;57:33-46. doi:10.1016/j.bpobgyn.2018.11.007 [PubMed 30606688]
Topic 10219 Version 207.0

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