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Kaletra (lopinavir/ritonavir) label update: drug interaction information

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On January 17, 2013, FDA approved revisions to the Kaletra (lopinavir/ritonavir) labels to include new drug interaction information. The following updates were included.

Anticoagulants: Rivaroxaban. Avoid concomitant use of rivaroxaban and Kaletra. Coadministration of Kaletra and rivaroxaban is expected to result in increased exposure of rivaroxaban which may led to risk of increased bleeding

Anticonvulsants: Lamotrigine and valproate. Coadministration of Kaletra and lamotrigine or valproate may decrease the exposure of lamotrigine or valproate. A dose increase of the lamotrigine or valproate may be needed when coadministered with Kaletra and therapeutic concentration monitoring for lamotrigine may be indicated; particularly during dosage adjustments.

Corticosteroids (systemic); Budesonide and prednisone. Concomitant use may result in increased steroid concentrations and reduced serum cortisol concentrations. Concomitant use of glucocorticoids that are metabolized by CYP3A, particularly for long-term use, should consider the potential benefit of treatment versus the risk of systemic corticosteroid effects. Concomitant use may increase the risk for development of systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.

HCV-Protease Inhibitor: Boceprevir. It is not recommended to coadminister Kaletra and boceprevir. Concomitant administration of Kaletra and boceprevir reduced boceprevir, lopinavir and ritonavir steady-state exposures

HCV-Protease Inhibitor: Telaprevir. It is not recommended to coadminister Kaletra and telaprevir. Concomitant administration of Kaletra and telaprevir reduced steady-state telaprevir exposure, while the steady-state lopinavir exposure was not affected.

Inhalded or Intransal Steroids: e.g. Budesonide: Concomitant use of Kaletra and fluticasone or other glucocorticoids that are metabolized by CYP3A is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects. Concomitant use may result in increased steroid concentrations and reduce serum cortisol concentrations. Systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression have been reported during postmarketing use in patients when certain ritonavir-containing products have been coadministered with fluticasone propionate or budesonide.

PDE5 Inhibitors: Avanafil. Do not use Kaletra with avanafil because a safe and effective avanafil dosage regimen has not been established.

Drug interaction or clinical studies reveal no clinically significant interaction between Kaletra and raltegravir.

 

The updated labeling will be made available through Drugs@FDA.

 

Kaletra is a product of Abbott Laboratories.

 

Richard Klein
Office of Special Health Issues
Food and Drug Administration

 

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

 

Posting ulang dengan mengutip persis dari sumbernya: FDA

 

Why should there be an HIV prevention program in Papua?

Becak Race 2010

Becak Race 20

There are several points to be considered that HIV prevention programs are absolutely necessary in Papua:

• HIV prevalence among the Papuans is higher than with other tribes who live in Papua that is equal to 2.8% compared to 1.5% (Papua IBBS, 2006)

• In areas where the prevalence is difficult geographical conditions is higher than the easily accessible areas (Papua IBBS, 2006)

• UNAIDS report in 2009 stating that Papua has the possibility arises that general epidemic is an epidemic that swept all ages due to the prevalence rate 15 times higher compared with other regions in Indonesia

• Only 50 of 100 Papuans who have heard about HIV and AIDS information is complete and correct. With this amount any misconceptions about HIV and AIDS is still found. (WV Annual Report, 2006)

• Use and knowledge of condoms as a means of prevention is still very low, only 2.8% of Papuans who use condoms during intercourse (Papua IBBS, 2006)

• Sexual intercourse at an early age occur among young people of Papua. Surveys show the majority of first sexual intercourse carried out before reaching the age of 15 years (Papua IBBS, 2006)

• Condition basic health facilities that have not been up in various service areas, especially in peripheral areas. (WV Annual Report, 2009)

Although many people believe that conditions in Papua are very concerned that prevention is not deemed necessary, prevention program is still a major need.
Well, therapy is important. But do not forget, before treatment or therapy is started there is an element of compliance that must be considered. To obey, one needs a thorough information. Information that complete and correct, that should be provided.

 
After all, appropriate therapy in infected persons is also one effective method of prevention.

Written by Willy Sitompul