ated with salmeterol.
Narcotic Analgesic/Opioid Dependence: methadone, buprenorphine ↑ or ↓ methadone
↑ or ↓ buprenorphine Plasma concentrations of methadone or buprenorphine may increase or decrease when coadministered with VICTRELIS. However, the combination has not been studied. Clinical monitoring is recommended as the dose of methadone or buprenorphine may need to be altered during concomitant treatment with VICTRELIS.
Oral hormonal contraceptives: drospirenone/ethinyl estradiol ↑ drospirenone*
↓ ethinyl estradiol* The effect of boceprevir on other progestins is unknown; however, increases in exposure are anticipated.
Concentrations of ethinyl estradiol decreased in the presence of boceprevir. Systemic hormonal contraceptives should not be relied upon as an effective method of contraception in women during treatment with VICTRELIS. Two alternative effective methods of contraception should be used during combination treatment with ribavirin, and may include intrauterine devices and barrier methods [see Use in Specific Populations (8.1)].
PDE5 inhibitors: sildenafil, tadalafil, vardenafil ↑ sildenafil
↑ tadalafil
↑ vardenafil Increases in PDE5 inhibitor concentrations are expected, and may result in an increase in adverse events, including hypotension, syncope, visual disturbances, and priapism.
Use of REVATIO® (sildenafil) or ADCIRCA® (tadalafil) for the treatment of pulmonary arterial hypertension (PAH) is contraindicated with VICTRELIS [see Contraindications (4)].
Use of PDE5 inhibitors for erectile dysfunction:
Use with caution in combination with VICTRELIS with increased monitoring for PDE5 inhibitor-associated adverse events. Do not exceed the following doses:
Sildenafil: 25 mg every 48 hours
Tadalafil: 10 mg every 72 hours
Vardenafil: 2.5 mg every 24 hours
Sedative/hypnotics: alprazolam; IV midazolam ↑ midazolam
↑ alprazolam Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during coadministration of VICTRELIS. A lower dose of IV midazolam or alprazolam should be considered.
*These combinations have been studied; see Clinical Pharmacology (12.3) for magnitude of interaction.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
VICTRELIS must be administered in combination with peginterferon alfa and ribavirin [see Dosage and Administration (2)].
Pregnancy Category X: Use with Ribavirin and Peginterferon Alfa
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; and therefore ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant [see Contraindications (4), Warnings and Precautions (5.1) and ribavirin Package Inserts]. Interferons have abortifacient effects in animals and should be assumed to have abortifacient potential in humans [see peginterferon alfa Package Inserts].
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination. Women of childbearing potential and their male partners should not receive ribavirin unless they are using effective contraception (two reliable forms) during treatment with ribavirin and for 6 months after treatment. Systemic hormonal contraceptives may not be as effective in women whi |
