Dosing Recommendations
Doxycycline Take at least 1 hour before Velphoro.
Oral drugs that should not be prescribed with Velphoro
Levothyroxine
Oral medications not listed in TABLE 1
There are no empirical data on avoiding drug interactions between Velphoro 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 separating the administration of the two drugs. The necessary 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. Where possible, consider monitoring for clinical response and/or blood levels of concomitant medications that have a narrow therapeutic range.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category B: Reproduction studies have been performed in rats and rabbits at doses up to 16 and 4 times, respectively, the human maximum recommended clinical dose on a body weight basis, and have not revealed evidence of impaired fertility or harm to the fetus due to Velphoro [see Nonclinical Toxicology (13.2)]. However, Velphoro at a dose up to 16 times the maximum clinical dose was associated with an increase in post-implantation loss in pregnant rats. Animal reproduction studies are not always predictive of human response.
There are no adequate and well-controlled studies in pregnant women.
8.2 Labor and Delivery
No Velphoro treatment-related effects on labor and delivery were seen in animal studies with doses up to 16 times the maximum recommended clinical dose on a body weight basis. The effects of Velphoro on labor and delivery in humans are not known.
8.3 Nursing Mothers
Since the absorption of iron from Velphoro is minimal [see Clinical Pharmacology (12.3)], excretion of Velphoro in breast milk is unlikely.
8.4 Pediatric Use
The safety and efficacy of Velphoro have not been established in pediatric patients.
8.5 Geritric Use
Of the total number of subjects in two active-controlled clinical studies of Velphoro (N=835), 29.7% (n=248) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
10 OVERDOSAGE
There are no reports of overdosage with Velphoro in patients. Since the absorption of iron from Velphoro is low [see Clinical Pharmacology (12.3)], the risk of systemic iron toxicity is low. Hypophosphatemia should be treated by standard clinical practice.
Velphoro has been studied in doses up to 3,000 mg per day.
11 DESCRIPT