Lexiva (fosamprenavir calcium) tablet and oral suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

February 2013

Summary View

 

DRUG INTERACTIONS

• Information for coadministration of Lexiva/ritonavir with telaprevir, boceprevir, and maraviroc added to Table 7

 

February 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Immune Reconstitution Syndrome

• Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

DRUG INTERACTIONS

Established and Other Potentially Significant Drug Interactions (Table)

• HMG-CoA reductase inhibitors: Atorvastatin; Titrate atorvastatin dose carefully and use the lowest necessary dose; do not exceed atorvastatin 20 mg/day.

PATIENT COUNSELING INFORMATION

Information About Therapy With Lexiva

• Lexiva is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using Lexiva.
• Patients should be advised to avoid doing things that can spread HIV-1 infection to others.
• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades…
• Lexiva does not cure HIV-1 infection and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using Lexiva.

What should I tell my healthcare provider before taking Lexiva before taking Lexiva

• Do not breastfeed. We do not know if Lexiva can be passed to your baby in your breast milk and whether...

 

May 2011

Summary View

 

PRECAUTIONS

Drug Interactions

• Raltegravir

 

April 2010

Summary View

 

CONTRAINDICATIONS

Table 1. Drugs Contraindicated With Lexiva

• Alpha 1-adrenoreceptor antagonist- alfuzosin: Potentially increased alfuzosin concentrations can result in hypotension.
• PDE5 Inhibitors: Sildenafil for treatment of pulmonary arterial hypertension; A safe and effective dose for the treatment of pulmonary arterial hypertension has not been established with Lexiva. There is an increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope).

PRECAUTIONS- DRUG INTERACTIONS

Table 6. Established and Other Potentially Significant Drug Interactions

• Inhaled beta agonist-salmeterol: Concurrent administration of salmeterol and Lexiva is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia. 
• Endothelin receptor antagonists-Bosentan: new dosing recommendations for bosentan when prescribed with Lexiva.
• PDE5 inhibitors: Use of PDE5 inhibitors for pulmonary arterial hypertension (PAH): Use of Revatio, (sildenafil) for the treatment of pulmonary hypertension dosing recommendations in table.
• Colchicine (Antigout): Patients with renal or hepatic impairment should not be given colchicine with Lexiva. Addition of new dosing recommendations for colchicine when prescribed for the prophylaxis of gout and for for the treatment of familial Mediterranean fever or gout.