Food and Drug Administration - January 29, 2010
On January 29, 2009, FDA approved revisions to the Kaletra
(lopinavir/ritonavir) package insert to include drug-drug
interaction information for concurrent Kaletra administration
with inhaled medicines such as salmeterol or salmeterol in
combination with fluticasone propionate (Serevent, Advair) and
sildenafil (Revatio).
Specifically, sildenafil (Revatio) when used for the treatment of
pulmonary arterial hypertension is listed under Contraindications
(Section 4, Table 3) because a safe and effective dose has not
been established when used with Kaletra. There is an increased
potential for sildenafil-associated adverse events, including
visual abnormalities, hypotension, prolonged erections and
syncope. Additionally, in Section 7 Drug Interactions, Table 9
was revised to include this information and differentiate use of
PDE5 inhibitors for pulmonary arterial hypertension and for
erectile dysfunction
Section 7 Drug Interactions Table 9 was revised to include the
following information on salmeterol.
Concurrent administration of salmeterol and Kaletra is not
recommended. The combination may result in increased risk of
cardiovascular adverse events associated with salmeterol,
including QT prolongation, palpitations and sinus tachycardia.
Section 17 Patient Counseling Information was revised to state:
If they are receiving sildenafil, tadalafil, or vardenafil they
may be at increased risk of associated adverse reactions
including hypotension, visual changes, and sustained erection,
and should promptly report any symptoms to their doctor
If they are taking or before they begin using Serevent
(salmeterol) and Kaletra, they should talk with their doctor
about problems these two medicines may cause when taken together.
The doctor may choose not to keep someone on Serevent
(salmeterol)
If they are taking or before they begin using Advair (salmeterol
in combination with fluticasone propionate) and Kaletra, they
should talk to their doctor about problems these two medicines
may cause when taken together. The doctor may choose not to keep
someone on Advair (salmeterol in combination with fluticasone
propionate).
Similar changes were made to the Medication Guide.
Kaletra is a product of Abbott Laboratories.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration