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FOSRENOL contains lanthanum carbonate with molecular formula
La2(CO3)3 xH2O (on average x=4-5
moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum
carbonate is described as white to almost white powder. Lanthanum carbonate is
practically insoluble in water and is insoluble in organic solvents; it dissolves
in dilute mineral acids with effervescence.
Each FOSRENOL, white to off-white, chewable tablet
contains lanthanum carbonate hydrate equivalent to 500, 750, or 1000 mg of
elemental lanthanum and the following inactive ingredients: colloidal silicon
dioxide NF, dextrates (hydrated) NF, magnesium stearate NF.
FOSRENOL Oral Powder is a white to off-white powder
containing lanthanum carbonate hydrate equivalent to 750 or 1000mg of elemental
lanthanumand the following inactive ingredients: colloidal silicon dioxide NF,
dextrates (hydrated) NF,magnesiumstearate NF.
Indications & Dosage
FOSRENOL is Â phosphate binder indicated to reduce serum
phosphate in patients with end stage renal disease (ESRD).
Management of elevated serum phosphorous levels in end
stage renal disease patients 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 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 1500 mg. Titrate the dose every 2-3 weeks until an acceptable serum phosphate
level is reached. Monitor serum phosphate levels as needed during dose
titration and on a regular basis thereafter. In clinical studies of ESRD
patients, FOSRENOL doses up to 4500 mg were evaluated.
Most patients required a total daily dose between 1500 mg
and 3000 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 FOSRENOL Chewable Tablets
Chew or crush FOSRENOL Chewable Tablets completely
before swallowing. Do not swallow intact FOSRENOL Chewable Tablets.
Information For FOSRENOL Oral Powder
Sprinkle FOSRENOL Oral Powder on a small quantity of
applesauce or other similar food and consume immediately. Do not open until
ready to use. Do not store FOSRENOL Oral Powder for future use once mixed with
food. As FOSRENOL Oral Powder is insoluble, do not attempt to dissolve in
liquid for administration. Â Consider using the oral powder formulation in
patients with poor dentition.
Dosage Forms And Strengths
FOSRENOL Chewable Tablets: 500 mg, 750 mg, and 1000 mg.
FOSRENOL Oral Powder: 750 mg and 1000 mg.
Storage And Handling
FOSRENOL Chewable Tablets
FOSRENOL is supplied as a chewable tablet in three dosage
strengths for oral administration: 500 mg tablets, 750 mg tablets, and 1000 mg
tablets. Each chewable tablet is white to off-white round, flat with a bevelled
edge, and debossed on one side with 'S405' and 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.
1000 mg Patient Pack (9 bottles of 10 tablets, NDC
54092-254-10, per each patient pack) NDC 54092-254-90.
FOSRENOL Oral Powder
FOSRENOL Oral Powder is supplied in two dosage strengths
for oral administration: 750 mg and 1000 mg. Each 750 mg and 1000 mg stick pack
contains 2.1 g and 2.8 g oral powder, respectively, packed in a polyethylene
terephthalate/aluminium/ polyethylene laminate.
Carton of 10 Stick Packs
Patient Pack of 9 Cartons
Store at 25°C (77°F): excursions permitted to
15-30°C (59-86°F). [See USP controlled room temperature].
Manufactured by Patheon
Manufacturing Services LLC, 5900 Martin Luther King Jr. Highway, Greenville, NC
27834. Manufactured for Shire US Inc., 300 Shire Way, Lexington, MA 02421, USA. Revised: Dec 2015.
Overall, the safety profile of FOSRENOL has been studied
in over 5200 subjects in completed clinical trials. The most common adverse
reactions for FOSRENOL were gastrointestinal events, such as nausea, vomiting,
and abdominal pain and they generally abated over time with continued dosing.
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. In double-blind,
placebo-controlled studies where a total of 180 and 95 ESRD patientswere
randomized to FOSRENOL chewable tablet and placebo, respectively, for 4-6 weeks
of treatment, the most common reactions that were more frequent ( ≥ 5% difference)
in the FOSRENOL group were nausea, vomiting, and abdominal pain (Table 1).
Table 1: Adverse Reactions* That Were More Common on
FOSRENOL in Placebo- Controlled, Double-Blind Studies With Treatment Periods of
* expressed as the event rate for each term
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 FOSRENOL was studied in two long-term,
open-labeled clinical trials, which included 1215 patients treated with
FOSRENOL and 944 with alternative therapy. Fourteen percent (14%) of FOSRENOL
treated patients 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
In a crossover study in 72 healthy individuals comparing
Fosrenol chewable tablets to Fosrenol 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%).
The following adverse reactions have been identified
during post-approval use of FOSRENOL. 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: constipation, dyspepsia, allergic skin reactions, hypophosphatemia,
and tooth injury while chewing the tablet.
Lanthanumin FOSRENOL has the potential to bind to drugs
with anionic (e.g., carboxyl, carbonyl and hydroxyl) groups. FOSRENOL may
decrease the bioavailability of tetracyclines or fluoroquinolones via this
There are no empirical data on avoiding drug interactions
between FOSRENOL and most concomitant oral drugs. 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. The duration of separation depends upon
the absorption characteristics of the medication concomitantly administered,
such as the time to reach peak systemic levels and whether the drug is an
immediate release or an extended release product. Â Consider monitoring clinical
responses or blood levels of concomitant medications that have a narrow
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), thyroid hormones, ACE-inhibitors,
statin lipid regulators and anti-malarials.
Co-administration of FOSRENOL with quinolone antibiotics
may reduce the extent of their absorption. The bioavailability of oral
ciprofloxacin was decreased by approximately 50% when taken with FOSRENOL in a
single dose study in healthy volunteers. Administer oral quinolone antibiotics
at least 1 hour before or 4 hours after FOSRENOL. When oral quinolones are
given for short courses, consider eliminating the doses of FOSRENOL that would
be normally scheduled near the time of quinolone intake to improve quinolone
absorption [see CLINICAL PHARMACOLOGY].
The bioavailability of levothyroxine was decreased by
approximately 40%when taken together with FOSRENOL. Administer thyroid hormone
replacement therapy at least 2 hours before or 2 hours after dosing with
FOSRENOL and monitor thyroid stimulating hormone (TSH) levels [see CLINICAL
Warnings & Precautions
Included as part of the PRECAUTIONS section.
Gastrointestinal Adverse Effects
There have been reports of serious cases of
gastrointestinal obstruction, ileus, and fecal impaction reported in
association with lanthanum, some requiring surgery or hospitalization.
Risk factors for gastrointestinal obstruction identified
from post-marketing reports in patients taking FOSRENOL Chewable Tablets
include altered gastrointestinal anatomy (e.g., history of gastrointestinal
surgery, colon cancer), hypomotility disorders (e.g., constipation, ileus,
diabetes) and concomitant medications (e.g., calcium channel blockers). Some
cases were reported in patients with no history of gastrointestinal disease.
Advise patients who are prescribed FOSRENOL Chewable
Tablets to chew the tablet completely to reduce the risk of serious adverse
gastrointestinal events such as those described above.
Patients with acute peptic ulcer, ulcerative colitis,
Crohn's disease or bowel obstruction were not included in FOSRENOL clinical
studies [see CONTRAINDICATIONS].
FOSRENOL has radio-opaque properties and therefore may
give the appearance typical of an imaging agent during abdominal X-ray
Patient Counseling Information
Advise the patient to read the FDA-approved patient
labelling (Medication Guide). Advise patients to take FOSRENOL with or
immediately after meals [see DOSAGE AND ADMINISTRATION].
Instruct patients on concomitant medications that should
be dosed apart from FOSRENOL [see DRUG INTERACTIONS]
Instruct patients who are prescribed FOSRENOL Chewable
Tablets to chew or crush tablets completely before swallowing. Emphasize
that FOSRENOL Chewable Tablets should not be swallowed intact. Consider
crushing FOSRENOL Chewable Tablets completely or prescribing the oral powder
formulation for patients with poor dentition [see DOSAGE AND ADMINISTRATION].
Instruct patients who are prescribed FOSRENOL Oral Powder
to sprinkle powder on a small quantity of applesauce or other similar food.
Patients should be instructed to consume the entire dose immediately. FOSRENOL
Oral Powder is insoluble so no attempt should be made to dissolve the powder in
liquid for administration [see DOSAGE AND ADMINISTRATION].
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 FOSRENOL
from the dosing of the affected drug by several hours [see DRUG INTERACTIONS].
Advise patients to notify their physician that they are
taking FOSRENOL prior to an abdominal x-ray [see WARNINGS AND PRECAUTIONS].
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Oral administration of lanthanum carbonate to rats for up
to 104 weeks, at doses up to 1500 mg of the salt per kg/day [2.5 times the MRHD
of 5725 mg, on a mg/m² basis, assuming a 60-kg patient] revealed no evidence of
carcinogenic potential. In the mouse, oral administration of lanthanum
carbonate for up to 99 weeks, at a dose of 1500 mg/kg/day (1.3 times the MRHD)
was associated with an increased incidence of glandular stomach adenomas in
Lanthanum carbonate tested negative for mutagenic
activity in an in vitro Ames assay using Salmonella typhimurium and Escherichia
coli strains and in vitro HGPRT gene mutation and chromosomal aberration assays
in Chinese hamster ovary cells. Lanthanum carbonate also tested negative in an
oral mouse micronucleus assay at doses up to 2000 mg/kg (1.7 times the MRHD),
and in micronucleus and unscheduled DNA synthesis assays in rats given IV lanthanum
chloride at doses up to 0.1 mg/kg, a dose that produced plasma lanthanum
concentrations > 2000 times the peak human plasma concentration. Lanthanum
carbonate, at doses up to 2000 mg/kg/day (3.4 times the MRHD), did not affect
fertility or mating performance of male or female rats.
Use In Specific Populations
Pregnancy Category C. No adequate and
well-controlled studies have been conducted in pregnant women. The effect of
FOSRENOL on the absorption of vitamins and other nutrients has not been studied
in pregnant women. FOSRENOL is not recommended for use during pregnancy.
Studies in pregnant rabbits showed that oral
administration of lanthanum carbonate at 1500 mg/kg/day (5 times the maximum
recommended daily human dose (MRHD) of 5725 mg, on a mg/m² basis, assuming a 60
kg patient) was associated with increased post-implantation loss, reduced fetal
weights, and delayed fetal ossification [see Nonclinical Toxicology].
Labor And Delivery
No FOSRENOL treatment-related effects on labor and
delivery were seen in animal studies. The effects of FOSRENOL on labor and
delivery in humans is unknown.
It is not known whether lanthanum carbonate is excreted
in human milk. As many drugs are excreted in human milk, consider the
possibility of infant exposure when FOSRENOL is administered to a nursing
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, while 9.3% (159) were ≥ 75. No overall
differences in safety or effectiveness were observed between patients ≥ 65
years of age and younger patients.
Overdosage & Contraindications
The symptoms associated with overdose are adverse
reactions such as headache, nausea and vomiting. In clinical trials in healthy
adults, GI symptoms were reported with daily doses up to 6000 mg/day of lanthanum
carbonate administered with food. Given the topical activity of lanthanum in
the gut, and the excretion in feces of the majority of the dose, 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 2000 mg/kg (1.7, 3.4, and 11.3
times the MRHD, respectively, on a mg/m² basis).
Contraindicated in bowel obstruction, including ileus and
Mechanism Of Action
FOSRENOL is a phosphate binder that reduces absorption of
phosphate by forming insoluble lanthanum phosphate complexes that pass through
the gastrointestinal (GI) tract unabsorbed. Both serum phosphate and calcium
phosphate product are reduced as a consequence of the reduced dietary phosphate
In vitro studies have shown that lanthanum binds
phosphate in the physiologically relevant pH range of 3 to 7. In simulated
gastric fluid, lanthanum binds approximately 97% of the available phosphate at
pH 3-5 and 67% at pH 7, when lanthanum is present in a two-fold molar excess to
phosphate. Bile acids have not been shown to affect the phosphate binding
affinity of lanthanum. In order to bind dietary phosphate, FOSRENOL must be
administered with or immediately after meals.
In five Phase I pharmacodynamic studies comparing the
reduction frombaseline of urinary phosphorus excretion in healthy volunteers
(N=143 taking lanthanum carbonate), it was shown that the mean intestinal
phosphate binding capacity of lanthanum ranged from 235 to 468 mg
phosphorus/day when lanthanum was administered at a dose of 3 g per day with
food. By comparison, in one study with an untreated control group (n=10) and
another study with a placebo group (n=3), the corresponding mean changes from baseline
were 3 mg phosphorus/day and 87 mg phosphorus/day, respectively. In healthy subjects
FOSRENOL Oral Powder was found to be similar to FOSRENOL Chewable Tablets,
based on urinary phosphate excretion.
Absorption And Distribution
Following single or multiple dose oral administration of
FOSRENOL to healthy subjects, the concentration of lanthanum in plasma was very
low (bioavailability < 0.002%). Following oral administration in patients,
the mean lanthanum Cmax was 1.0 ng/mL. During long-term administration (52
weeks) in ESRD patients, the mean lanthanum concentration in plasma was
approximately 0.6 ng/mL. There was minimal increase in plasma lanthanum
concentrations with increasing doses within the therapeutic dose range. The
timing of food intake relative to lanthanum administration (during and 30 minutes
after food intake) has a negligible effect on the systemic level of lanthanum.
Systemic exposure to lanthanum was approximately 30%
higher following administration of FOSRENOL Oral Powder when compared to
FOSRENOL Chewable Tablets. However, systemic exposure to lanthanum from both
formulations in this study was within the range seen in previous
pharmacokinetic studies of Chewable Tablets in healthy individuals.
In vitro, lanthanum is highly bound ( > 99%) to human
plasma proteins, including human serum albumin, α1-acid glycoprotein, and
transferrin. Binding to erythrocytes in vivo is negligible in rats.
In animal studies, lanthanum concentrations in several
tissues, particularly gastrointestinal tract, mesenteric lymph nodes, bone and
liver, increased over time to levels several orders ofmagnitude higher than
those in plasma. The level of lanthanum in the liver was higher in renally
impaired rats due to higher intestinal absorption. Lanthanum was found in the
lysosomes and the biliary canal consistent with transcellular transport. Steady
state tissue concentrations in bone and liver were achieved in dogs between 4
and 26 weeks. Relatively high levels of lanthanumremained in these tissues for
longer than 6 months after cessation of dosing in dogs. There is no evidence
from animal studies that lanthanum crosses the blood-brain barrier.
In 105 bone biopsies from patients treated with FOSRENOL
for up to 4.5 years, rising levels of lanthanum were noted over time. Estimates
of elimination half-life from bone ranged from 2.0 to 3.6 years. Steady state
bone concentrations were not reached during the period studied.
Metabolism And Elimination
Lanthanum is not metabolized. Lanthanum was cleared from
plasma of patients undergoing dialysis with an elimination half-life of 53
hours following discontinuation of therapy.
No information is available regarding the mass balance of
lanthanum in humans after oral administration. In rats and dogs, the mean recovery
of lanthanum after an oral dose was about 99% and 94%, respectively, and was
essentially all from feces. Biliary excretion is the predominant route of
elimination for circulating lanthanum in rats. In healthy volunteers
administered intravenous lanthanum as the soluble chloride salt (120 μg),
renal clearance was less than 2% of total plasma clearance.
FOSRENOL has a low potential for systemic drug-drug
interactions because of the very low bioavailability of lanthanum and because it
is not a substrate or inhibitor of major cytochrome P450 enzyme groups involved
in drug metabolism (CYP1A2, CYP2C9/10, CYP2C19, CYP2D6 and CYP3A4/5). FOSRENOL
does not alter gastric pH. Therefore, FOSRENOL drug interactions based on
altered gastric pH are not expected.
In an in vitro investigation, lanthanum did not form
insoluble complexes when mixed in simulated gastric fluid with warfarin,
digoxin, furosemide, phenytoin, metoprolol and enalapril. Clinical studies have
shown that FOSRENOL (three doses of 1000mg on the day prior to exposure and one
dose of 1000 mg on the day of co-administration) administered 30 minutes
earlier did not alter the pharmacokinetics of oral warfarin (10 mg), digoxin
(0.5 mg), or metoprolol (100 mg). Potential pharmacodynamic interactions
between lanthanum and these drugs (e.g., bleeding time or prothrombin time)
were not evaluated. None of the drug interaction studies were done with the maximum
recommended therapeutic dose of lanthanum carbonate. No drug interaction studies
assessed the effects of drugs on phosphate binding by lanthanum carbonate.
In a randomized, two–way crossover study in healthy
volunteers examining the interaction potential of a single oral dose of
ciprofloxacin (750 mg) alone and with lanthanum carbonate (1 g TID), the
maximum plasma concentration of ciprofloxacin was reduced by 56%and the area
under the ciprofloxacin plasma concentration-time curve was reduced by 54%. The
24-h urinary recovery of ciprofloxacin was reduced 52% by FOSRENOL [see DRUG
In a single-dose crossover study of levothyroxine (1mg)
with or without simultaneous administration of a single dose of FOSRENOL
(500mg) in six euthyroid normal healthy volunteers, the area under the serum T4
concentration-time curve was decreased by 40% [see DRUG INTERACTIONS].
Fat Soluble Vitamins
FOSRENOL appears not to affect the availability of fat
soluble vitamins (A, D, E and K) or other nutrients [see Clinical Studies].
Citrate did not increase the absorption of lanthanum.
In pregnant rats, oral administration of lanthanum
carbonate at doses as high as 2000 mg/kg/day (3.4 times the MRHD) resulted in
no evidence of harm to the fetus. In pregnant rabbits, oral administration of
lanthanum carbonate at 1500 mg/kg/day (5 times the MRHD) was associated with a
reduction in maternal body weight gain and food consumption, increased
post-implantation loss, reduced fetal weights, and delayed fetal ossification.
Lanthanumcarbonate administered to rats fromimplantation through lactation at
2000 mg/kg/day (3.4 times the MRHD) caused delayed eye opening, reduction in
body weight gain, and delayed sexual development (preputial separation and
vaginal opening) of the offspring.
The effectiveness of FOSRENOL in reducing serum
phosphorus in ESRD patients was demonstrated in one short-term,
placebo-controlled, double-blind dose-ranging study, two placebo-controlled
randomized withdrawal studies and two long-term, activecontrolled, open-label
studies in both hemodialysis and peritoneal dialysis (PD) patients.
Double-Blind Placebo-Controlled Studies
One hundred and forty-four patients with chronic renal
failure undergoing hemodialysis and with elevated phosphate levels were
randomized to double-blind treatment at a fixed dose of lanthanum carbonate of
225 mg (n=27), 675 mg (n=29), 1350 mg (n=30) or 2250 mg (n=26) or placebo
(n=32) in divided doses with meals. Fifty-five percent of subjects were male,
71% black, 25% white and 4% of other races. The mean age was 56 years and the
duration of dialysis ranged from 0.5 to 15.3 years. Steady-state effects were
achieved after two weeks. The effect after six weeks of treatment is shown in
Figure 1: Difference in Phosphate Reduction in the
FOSRENOL and Placebo Group in a 6-Week, Dose-Ranging, Double-Blind Study in
ESRD Patients (with 95% Confidence Intervals)
One-hundred and eighty-five patients with end stage renal
disease undergoing either hemodialysis (n=146) or peritoneal dialysis (n=39)
were enrolled in two placebo-controlled, randomized withdrawal studies.
Sixty-four percent of subjects were male, 28% black, 62% white and 10% of other
races. The mean age was 58.4 years and the duration of dialysis ranged from 0.2
to 21.4 years. After titration of lanthanum carbonate to achieve a phosphate
level between 4.0 and 5.6 mg/dL in one study (doses up to 2250 mg/day) or ≤ 5.9
mg/dL in the second study (doses up to 3000 mg/day) and maintenance through 6
weeks, patients were randomized to lanthanum or placebo. During the
placebo-controlled, randomized withdrawal phase (four weeks), the phosphorus
concentration rose in the placebo group by 1.7 mg/Dl in one study and 1.9 mg/dL
in the other study relative to patients who remained on lanthanum carbonate
Open-Label Active-Controlled Studies
Two long-term open-label studies were conducted,
involving a total of 2028 patients with ESRD undergoing hemodialysis. Patients
were randomized to receive FOSRENOL or alternative phosphate binders for up to
sixmonths in one study and two years in the other. The daily FOSRENOL doses,
divided and taken with meals, ranged from 375 mg to 3000mg. Doses were titrated
to reduce serumphosphate levels to a target level. The daily doses of the
alternative therapy were based on current prescribing information or those
commonly utilized. Both treatment groups had similar reductions in serum phosphate
of about 1.8mg/dL. Maintenance of reduction was observed for up to three years
in patients treated with FOSRENOL in long-term, open-label extensions.
No effects of FOSRENOL on serum levels of 25-dihydroxy
vitamin D3, vitamin A, vitamin B12, vitamin E and vitamin K were observed in
patients who were monitored for 6 months.
Paired bone biopsies (at baseline and at one or two
years) in 69 patients randomized to either FOSRENOL or calcium carbonate in one
study and 99 patients randomized to either FOSRENOL or alternative therapy in a
second study showed no differences in the development of mineralization defects
between the groups.
Vital status was known for over 2000 patients, 97% of
those participating in the clinical program during and after receiving
treatment. The adjusted yearly mortality rate (rate/years of observation) for
patients treated with FOSRENOL or alternative therapy was 6.6%.
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
FOSRENOL may cause a bowel blockage or severe
constipation which can be serious, and sometimes lead to surgery or treatment in
You may have a higher risk of bowel blockage or severe constipation
if you take FOSRENOL and have:
a history of bowel surgery or colon cancer
a history of bowel blockage, decreased movement of your bowel,
constipation, or diabetes
Do not swallow FOSRENOL Chewable Tablets whole. Chew
tabletscompletely before swallowing. If you can not chew tablets completely,
youmay crush the tablets thoroughly before swallowing, or discuss the oral powder
formulationwith 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 tellmy healthcare provider before taking
FOSRENOL may not be right for you. Before starting
FOSRENOL, tell your healthcare provider if you:
have a history of bowel surgery or colon cancer
have a history of a bowel blockage, ileus or
constipation, or diabetes
have stomach ulcers, ulcerative colitis, or Crohn's
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. It is not known if FOSRENOL will harm your unborn baby
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:
Know themedicines you take. Keep a list of themand show
it to your healthcare provider and pharmacist when you get a new medicine.
How should I take FOSRENOL?
Take FOSRENOL exactly as prescribed by your healthcare
Your healthcare provider will tell you how much FOSRENOL to
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.
Oral Powder – Sprinkle powder on a small quantity of applesauce
or other similar food. Consume the entire dose immediately. FOSRENOL Oral
Powder will not dissolve in liquid.
Take FOSRENOL with or right after meals
If you take an antacid medicine, take the antacid 2 hours
before or 2 hours after you take FOSRENOL
If you take medicine for your thyroid (levothyroxine),
take the thyroid medicine 2 hours before or 2 hours after you take FOSRENOL
If you take an antibiotic medicine, take the antibiotic 1
hour before or 4 hours after you take FOSRENOL
What are possible or reasonably likely side effects of
See “What is the most important information I should
know about FOSRENOL?”
The most common side effects of FOSRENOL include:
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 FOSRENOL. Formore
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 FOSRENOL?
Store FOSRENOL between 59°F to 86°F (15°C to 30°C).
Keep FOSRENOL and all medicines out of the reach of
General information about FOSRENOL
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use FOSRENOL for a condition for
which it was not prescribed. Do not give FOSRENOL to other people, even if they
have the same condition. It may harm them.
This Medication Guide summarizes the most important
information about FOSRENOL. If you would like more information, talk with your healthcare
provider. You can ask your pharmacist or healthcare provider for information
about FOSRENOL that is written for healthcare professionals.
For more information go to www.FOSRENOL.com or call 1-800-828-2088.