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News > Medscape Medical News > Approvals


FDA SAFETY CHANGES: DEPODUR, NEORAL, LEXIVA

Yael Waknine

November 04, 2009

0




November 4, 2009 — The US Food and Drug Administration (FDA) has approved safety
labeling revisions to advise of the need for individualized dosing in patients
receiving morphine sulfate extended-release liposome injection, cyclosporine
drug interactions with repaglinide, and the potential risks for nephrolithiasis
and elevated triglyceride and cholesterol levels in patients receiving treatment
with fosamprenavir calcium.



On September 24, the FDA approved safety labeling revisions for cyclosporine
capsules and oral solution (Neoral; Novartis Pharmaceuticals, Inc) to warn of
drug interactions with repaglinide.

Cyclosporine may increase the plasma concentrations of repaglinide and thereby
increase the risk for hypoglycemia, the FDA warned. Repaglinide appears to be a
substrate for the hepatic uptake transporter organic anion-transporting protein
(OATP1B1). Drugs that inhibit OATP1B1, such as cyclosporine, may therefore also
increase plasma concentrations of repaglinide and the potential for
exposure-related adverse events.

In a pharmacokinetic study of 12 healthy volunteers, coadministration of two
100-mg cyclosporine doses 12 hours apart increased the maximal exposure and
total exposure to a single dose of 0.25 mg of repaglinide by 1.8-fold (range,
0.6 - 3.7-fold) and 2.4-fold (range, 1.2 - 5.3-fold), respectively. Close
monitoring of blood glucose levels is advisable for a patient taking
cyclosporine and repaglinide concomitantly.



Cyclosporine is indicated for the prophylaxis of organ rejection in kidney,
liver, and heart allogeneic transplant, and has been used in combination with
azathioprine and corticosteroids. Cyclosporine may also be used for the
treatment of methotrexate-resistant, severe rheumatoid arthritis and severe
recalcitrant plaque psoriasis in patients who have failed or cannot tolerate
systemic therapy.



Repaglinide is indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus.



Fosamprenavir (Lexiva) Linked to Reports of Nephrolithiasis and Elevated
Cholesterol Levels



On September 11, the FDA approved safety labeling revisions for fosamprenavir
calcium tablets and oral suspension (Lexiva; GlaxoSmithKline) to warn of the
potential risk for nephrolithiasis.



Cases of nephrolithiasis have been reported during postmarketing surveillance,
the FDA said, noting that estimates of frequency cannot be made because the
events were reported voluntarily during clinical practice. Temporary
interruption or discontinuation of therapy should be considered for patients in
whom signs or symptoms of kidney stones develop.



The FDA also warned that treatment with fosamprenavir and ritonavir has been
linked to increases in triglyceride and cholesterol levels. Triglyceride and
cholesterol levels should therefore be evaluated at baseline and at periodic
intervals during therapy, and lipid disorders should be managed as clinically
appropriate.



Fosamprenavir is a protease inhibitor prodrug indicated in combination with
other antiretroviral agents for the treatment of HIV-1 infection.



DepoDur Prescribing Information



Neoral Prescribing Information



Lexiva Prescribing Information



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Cite this: FDA Safety Changes: DepoDur, Neoral,
Lexiva - Medscape - Nov 04, 2009.

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AUTHORS AND DISCLOSURES


AUTHORS AND DISCLOSURES


JOURNALIST

YAEL WAKNINE



Yael Waknine is a freelance writer for Medscape.



Yael Waknine has disclosed no relevant financial relationships.






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