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Incivek

"Feb. 21, 2012 -- More Americans die as a result of hepatitis C infection annually than from HIV-related causes, pointing out the need for expanded screening and improved access to care for hepatitis C, government researchers report.

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Incivek

Incivek Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Incivek (telaprevir) is a drug of the protease inhibitor class prescribed to treat chronic hepatitis C in adults with stable liver problems, who have not been treated before or who have failed previous treatment. Incivek can cause serious side effects such as birth defects, skin reactions and anemia. Take INCIVEK exactly as your healthcare provider tells you.

Incivek is known to have serious or life-threatening reactions with certain medications such as some cholesterol-lowering medications and some medications prescribed for heart health. Do not take Incivek if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant. You must have a negative pregnancy test before starting treatment, every month during treatment, and for six months after your treatment ends. Tell your doctor if you are breastfeeding. It is not known if Incivek passes into your breast milk. You and your healthcare provider should decide if you will take Incivek or breastfeed. You should not do both.

Our Incivek Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Incivek in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • tired feeling;
  • nausea, vomiting, diarrhea, altered sense of taste;
  • rectal itching, burning, or discomfort; or
  • altered sense of taste; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Incivek (Telaprevir Film-Coated Tablets) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Incivek FDA Prescribing Information: Side Effects
(Adverse Reactions)

INDICATIONS

Chronic Hepatitis C

INCIVEK® (telaprevir), 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-nave or who have previously been treated with interferon-based treatment, including prior null responders, partial responders, and relapsers [see Clinical Studies, including definitions of these terms].

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 [see WARNINGS AND PRECAUTIONS].
  • 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 [see Microbiology and Clinical Studies].
  • 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 [see Microbiology].

DOSAGE AND ADMINISTRATION

INCIVEK/Peginterferon Alfa/Ribavirin Combination Treatment

The recommended dose of INCIVEK tablets is 1125 mg (three 375-mg tablets) taken orally twice daily (10-14 hours apart) with food (not low fat) [see CLINICAL PHARMACOLOGY]. For specific dosage instructions for peginterferon alfa and ribavirin, refer to their respective prescribing information.

Duration of Treatment

The recommended duration of treatment with INCIVEK is 12 weeks in combination with peginterferon alfa and ribavirin. HCV RNA levels should be monitored at weeks 4 and 12 to determine combination treatment duration and assess for treatment futility (Tables 1 and 2).

Table 1: Recommended Treatment Duration (See also Table 2 for Treatment Futility Rules)

Treatment-Nave and Prior Relapse Patients
HCV RNAa Triple Therapy INCIVEK, peginterferon alfa and ribavirin Dual Therapy peginterferon alfa and ribavirin Total Treatment Duration
Undetectable (Target Not Detected) at Weeks 4 and 12 First 12 weeks Additional 12 weeks 24 weeks
Detectable (1000 IU/mL or less) at Weeks 4 and/or 12 First 12 weeks Additional 36 weeks 48 weeks
Prior Partial and Null Responder Patients
  Triple Therapy INCIVEK, peginterferon alfa and ribavirin Dual Therapy peginterferon alfa and ribavirin Total Treatment Duration
All Patients First 12 weeks Additional 36 weeks 48 weeks
aIn clinical trials, HCV RNA in plasma was measured using a COBAS® TaqMan® assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 10 IU/mL. See Laboratory Tests for a description of HCV RNA assay recommendations.

For the purpose of assessing response-guided therapy eligibility at weeks 4 and 12 (see Table 1), an “undetectable” HCV RNA (Target Not Detected) result is required; a confirmed “detectable but below limit of quantification” HCV RNA result should not be considered equivalent to an “undetectable” HCV RNA (Target Not Detected) result [see Laboratory Tests].

Treatment-nave patients with cirrhosis who have undetectable HCV RNA (Target Not Detected) at weeks 4 and 12 of INCIVEK combination treatment may benefit from an additional 36 weeks of peginterferon alfa and ribavirin (48 weeks total) [see Clinical Studies].

Dose Reduction

To prevent treatment failure, the dose of INCIVEK must not be reduced or interrupted. Refer to the respective prescribing information for dose modification of peginterferon alfa and ribavirin [see WARNINGS AND PRECAUTIONS].

Discontinuation of Dosing

Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions [see Microbiology]. Discontinuation of therapy is recommended in all patients with (1) HCV RNA levels of greater than 1000 IU/mL at Treatment Week 4 or 12; or (2) confirmed detectable HCV RNA levels at Treatment Week 24 (see Table 2).

Table 2: Treatment Futility Rules: All Patients

HCV RNA Action
Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)
Week 24: Detectable Discontinue peginterferon alfa and ribavirin

If peginterferon alfa or ribavirin is discontinued for any reason, INCIVEK must also be discontinued.

HOW SUPPLIED

Dosage Forms And Strengths

Each tablet contains 375 mg of telaprevir. Tablets are available as purple, film-coated, capsule-shaped tablets debossed with the characters “V 375” on one side.

Storage And Handling

INCIVEK® (telaprevir) is supplied as purple film-coated capsule-shaped tablets containing 375 mg of telaprevir. Each tablet is debossed with the characters “V 375” on one side and is packaged as follows:

28-day packer contains 4 weekly cartons of 7 blister strips each (6 tablets per blister strip): twice-daily dose NDC 51167-100-03

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Manufactured for Vertex Pharmaceuticals Incorporated Cambridge, MA 02139. Revised: 10/2013.

Read the entire FDA prescribing information for Incivek (Telaprevir Film-Coated Tablets) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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