FDA label change for lopinavir/r (Kaletra)

On 29 January 2010, the FDA revised the Kaletra (lopinavir/ritonavir) package insert to include drug-drug interaction information 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).

The revised label will be posted to the FDA website (Kaletra):

Source: FDA list serve (29 January 2010)

Links to other websites are current at date of posting but not maintained.