INCIVEK, in combination with peginterferon alfa and ribavirin, is indicated for the
treatment of genotype 1 chronic hepatitis C in adult patients with compensated
liver disease, including cirrhosis, who are treatment naïve or who have previously
been treated with interferon-based treatment, including prior null responders,
partial responders, and relapsers.
The following points should be considered when initiating treatment with INCIVEK:
INCIVEK must not be administered as monotherapy and must only be
prescribed with both peginterferon alfa and ribavirin
A high proportion of previous null responders (particularly those with
cirrhosis) did not achieve a Sustained Virologic Response (SVR) and had
telaprevir resistance–associated substitutions emerge on treatment with
INCIVEK combination treatment
INCIVEK efficacy has not been established for patients who have previously
failed therapy with a treatment regimen that includes INCIVEK or other HCV
NS3/4A protease inhibitors
IMPORTANT SAFETY INFORMATION
Contraindications to peginterferon alfa and ribavirin also apply to INCIVEK
INCIVEK combination treatment is contraindicated in women who are or may
become pregnant. Ribavirin may cause fetal harm when administered to a pregnant
woman. If ribavirin is used during pregnancy or in the event of a pregnancy while on
treatment, inform the patient of the potential hazard to a fetus. INCIVEK combination
treatment is also contraindicated in men whose female partners are pregnant.
INCIVEK is contraindicated when combined with drugs that 1) are highly
dependent on C YP3A for clearance and for which elevated plasma concentrations
are associated with serious and/or life-threatening events and 2) strongly induce
CYP3A and thus may lead to lower exposure and loss of efficacy of INCIVEK.
Contraindicated medications are alfuzosin, rifampin, dihydroergotamine,
ergonovine, ergotamine, methylergonovine, cisapride, St. John’s wort,
atorvastatin, lovastatin, simvastatin, pimozide, sildenafil (Revatio®) or tadalafil
(Adcirca®) for pulmonary arterial hypertension, oral midazolam, and/or triazolam.
Warnings and precautions
Pregnancy: Ribavirin may cause birth defects and/or death of the exposed fetus.
Extreme care must be taken to avoid pregnancy in female patients and in female
partners of male patients. Ribavirin therapy should not be started unless a report
of a negative pregnancy test has been obtained just before initiation of therapy.
Female patients of childbearing potential and their male partners as well as male
patients and their female partners must use 2 effective contraceptive methods
during combination treatment and for 6 months after all treatment has ended.
Female patients should have monthly pregnancy tests during treatment and
during the 6-month period after stopping all treatment. Female patients may
continue hormonal contraceptives but they may not be reliable during INCIVEK
dosing and for up to two weeks after stopping INCIVEK. During this time, female
patients of childbearing potential should use 2 effective non-hormonal methods
INCIVEK HAS ARRIVED
Serious skin reactions, including Drug Rash with Eosinophilia and Systemic
Symptoms (DRESS) and Stevens-Johnson syndrome (SJS) were reported in less
than 1% of subjects receiving INCIVEK combination treatment. These reactions
required hospitalization and all patients recovered. Presenting signs of these
reactions may include rash, facial edema, target lesions, mucosal ulcerations,
and evidence of internal organ involvement. If serious skin reactions occur,
all components of INCIVEK combination treatment must be discontinued
immediately and the patient referred for urgent medical care.
Rash developed in 56% of patients who received INCIVEK combination treatment.
Severe rash was reported in 4% of patients treated with INCIVEK combination
treatment. Severe rash may have a prominent eczematous component. Patients
with rash should be followed for progression of rash or development of systemic
symptoms. If rash becomes severe or systemic symptoms develop, discontinue
INCIVEK. Peginterferon alfa and ribavirin may be continued.
Anemia has been reported with peginterferon alfa and ribavirin treatment.
Adding INCIVEK is associated with additional decrease in hemoglobin compared
to peginterferon alfa and ribavirin alone. Hemoglobin values of ≤ 10 g/dL were
observed in 36% of subjects, and < 8. 5 g/dL in 14% of subjects who received
INCIVEK combination treatment. Hemoglobin should be monitored at baseline and
at weeks 2, 4, 8, and 12, or as clinically appropriate. Use the labeled ribavirin
dose modification guidelines to manage anemia; if ribavirin dose reductions
are inadequate, consider discontinuing INCIVEK. If ribavirin is permanently
discontinued, INCIVEK must also be permanently discontinued. The dose of
INCIVEK must not be reduced and must not be restarted if discontinued.
The most common adverse reactions seen with an incidence ≥5% with INCIVEK
over controls were rash (56%), fatigue (56%), pruritus (47%), nausea (39%),
anemia (36%), diarrhea (26%), vomiting (13%), hemorrhoids (12%), anorectal
discomfort (11%), dysgeusia (10%), and anal pruritus (6%).
Please see the Brief Summary on the adjacent pages.
INCIVEK combination treatment = INCIVEK + pegIFN-RBV for 12 weeks, and an
additional 12 or 36 weeks of pegIFN-RBV.
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INCIVEK and the Blue Arro w logo are trademarks of Vertex Pharmaceuticals Incorporated.
The brands listed are trademarks of their respective owners.