tant administration of telaprevir and tenofovir disoproxil fumarate resulted in increased tenofovir exposure. Increased clinical and laboratory monitoring are warranted. Tenofovir disoproxil fumarate should be discontinued in patients who develop tenofovir-associated toxicities.
HORMONAL CONTRACEPTIVES/ESTROGEN
ethinyl estradiol*
norethindrone ↓ ethinyl estradiol
↔ norethindrone
Exposure to ethinyl estradiol was decreased when co-administered with telaprevir. Two effective non-hormonal methods of contraception should be used during treatment with telaprevir.
Patients using estrogens as hormone replacement therapy should be clinically monitored for signs of estrogen deficiency. Refer also to Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1), and Patient Counseling Information (17.1).
IMMUNOSUPPRESSANTS
cyclosporine*
sirolimus
tacrolimus* ↑ cyclosporine
↑ sirolimus
↑ tacrolimus
Plasma concentrations of cyclosporine and tacrolimus are markedly increased when co-administered with telaprevir. Plasma concentration of sirolimus may be increased when co-administered with telaprevir, though this has not been studied. Significant dose reductions and prolongation of the dosing interval of the immunosuppressant to achieve the desired blood levels should be anticipated. Close monitoring of the immunosuppressant blood levels, and frequent assessments of renal function and immunosuppressant-related side effects are recommended when co-administered with telaprevir. Tacrolimus may prolong the QT interval. The use of telaprevir in organ transplant patients has not been studied.
INHALED BETA AGONIST
salmeterol ↑ salmeterol Concentrations of salmeterol may be increased when co-administered with telaprevir. Concurrent administration of salmeterol and telaprevir is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
NARCOTIC ANALGESIC
methadone* ↓ R-methadone
Concentrations of methadone were reduced when co-administered with telaprevir. No adjustment of methadone dose is required when initiating co-administration of telaprevir. However, clinical monitoring is recommended as the dose of methadone during maintenance therapy may need to be adjusted in some patients.
PDE5 INHIBITORS
sildenafil
tadalafil
vardenafil ↑ PDE5 inhibitors Concentrations of PDE5 inhibitors may be increased when co-administered with telaprevir. For the treatment of erectile dysfunction, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg dose in 72 hours, or tadalafil at a single dose not exceeding 10 mg dose in 72 hours can be used with increased monitoring for PDE5 inhibitor-associated adverse events.
QT interval prolongation has been reported with vardenafil. Caution is warranted and clinical monitoring is recommended.
Co-administration of sildenafil and telaprevir in the treatment of pulmonary arterial hypertension is contraindicated [see Contraindications (4)].
Co-administration of tadalafil and telaprevir in the treatment of pulmonary arterial hypertension is not recommended.
In addition to the drugs included in Table 5, the interaction between INCIVE |
