Fosrenol Adverse Reactions

lanthanum carbonate




Full Prescribing Info
Adverse Reactions
The safety of FOSRENOL for use in patients with end-stage renal failure (ESRF) in both hemodialysis and peritoneal dialysis patients has been examined in three short-term, placebo-controlled, double-blind studies, three long-term, comparator-controlled studies, and three long-term open-label studies. These studies have provided a total safety database of 1754 patients treated with lanthanum carbonate hydrate and represents a mean exposure of 272.1 days (median 184.0 days, range 1-1123 days).
The most common adverse events (≥5% in either treatment group) in two long-term open-label phase III trials that included 1215 patients treated with lanthanum carbonate hydrate and 944 with alternative therapy are detailed in Table 4.
The adverse events in the long-term, open label, active controlled, study of FOSRENOL vs. alternative therapy (Study 307) have been adjusted for mean exposure differences between the treatment groups (with a mean exposure of 1.0 years on lanthanum and 1.4 years on alternative therapy). The adjustment for mean exposure was achieved by multiplying the observed adverse event rates in the alternative therapy group by 0.74. (See Table 4.)

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Overall, approximately 24% of all ESRF patients who participated in these clinical studies reported a drug related adverse reaction, as determined by the investigator. No individual ADR was reported at a frequency greater than 10%.
The most commonly reported adverse drug reactions, with the exception of headache and allergic skin reactions, are gastrointestinal in nature; these are minimized by taking FOSRENOL with food and generally abated with time with continued dosing (see Dosage & Administration).
The following convention was used for frequency of adverse drug reactions: Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥1/10,000 to < 1/1,000); Very rare (< 1/10,000), not known (cannot be estimated from the available data). (See Table 5.)

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Post marketing experience: During post-approval use of FOSRENOL, cases of Allergic Skin Reactions (including skin rashes, urticaria and pruritus) have been reported which show a close temporal relationship to lanthanum carbonate therapy. In clinical trials, Allergic Skin Reactions were seen in both FOSRENOL and placebo/active comparator groups at a frequency of Very Common (≥1/10).
Although there have been a number of additional isolated reactions reported, none of these reactions are considered unexpected in this patient population.
Transient QT changes have been observed but these were not associated with any adverse events.
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