Telaprevir Side Effects

Some side effects of telaprevir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to telaprevir: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking telaprevir: 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 of telaprevir may include:

• tired feeling;

• nausea, vomiting, diarrhea, altered sense of taste;

• rectal itching, burning, or discomfort; 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.

For Healthcare Professionals

Applies to telaprevir: oral tablet

General

Telaprevir must be administered in combination with peginterferon alfa and ribavirin. The prescribing information for peginterferon alfa and ribavirin should be consulted for associated side effects.

Serious side effects have been reported in 3% of patients receiving telaprevir combination therapy compared to none of the patients receiving peginterferon alfa and ribavirin alone. The serious side effects reported most frequently were skin disorders (rash and/or pruritus) and anemia. Telaprevir was discontinued due to side effects in 14% of patients. The side effects leading to discontinuation most often were rash, anemia, fatigue, pruritus, nausea, and vomiting.

Most of the following side effects were reported in patients receiving telaprevir combination therapy with an incidence at least 5% greater than those receiving peginterferon alfa and ribavirin alone.

Dermatologic

Rash developed most often during the first 4 weeks, but was reported at any time during telaprevir combination therapy. Rash events led to discontinuation of telaprevir alone and telaprevir combination therapy in 6% and 1% of patients, respectively. Severe rash may have a prominent eczematous component.

Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued telaprevir combination therapy after serious skin reaction was identified.

Presenting signs of DRESS have included rash, fever, facial edema, and evidence of internal organ involvement (e.g., hepatitis, nephritis), with or without eosinophilia. Presenting signs of SJS have included fever, target lesions, and mucosal erosions or ulcerations (e.g., conjunctivae, lips).

Very common (10% or more): Rash (all grades: 56%), pruritus (47%)
Common (1% to 10%): Severe rash (e.g., generalized rash or rash with vesicles or bullae or ulcerations other than Stevens-Johnson syndrome; 4%)
Uncommon (0.1% to 1%): Serious skin reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS], Stevens-Johnson syndrome [SJS]; less than 1%)
Frequency not reported: Fatal and nonfatal serious skin reactions (including SJS, DRESS, toxic epidermal necrolysis), dry skin
Postmarketing reports: Toxic epidermal necrolysis, erythema multiforme

Hematologic

Very common (10% or more): Anemia (36%), decreased mean platelet counts (all grades: 47%), decreased hemoglobin levels (10 g/dL or less: 36%; less than 8.5 g/dL: 14%), decreased lymphocyte counts (499/mm3 or less: 15%), decreased absolute neutrophil counts (749/mm3 or less: 12%)
Common (1% to 10%): Decreased total white cell counts (1499/mm3 or less: 8%), decreased mean platelet counts (49,999/mm3 or less: 3%)

The addition of telaprevir to peginterferon alfa and ribavirin was associated with a further decrease in hemoglobin levels. Decreased hemoglobin levels occurred during the first 4 weeks of therapy and the lowest values were reached at the end of telaprevir dosing. After telaprevir dosing was completed, hemoglobin levels gradually increased to levels observed with peginterferon alfa and ribavirin (10 g/dL or less: 17%; less than 8.5 g/dL: 5%). In clinical trials, time to onset of hemoglobin levels 10 g/dL or less was earlier with telaprevir combination therapy (56 days [range 8 to 365 days]) compared to therapy with peginterferon alfa and ribavirin (63 days [13 to 341 days]).

In patients receiving telaprevir combination therapy, 32% had ribavirin dose modification (reduction, interruption, or discontinuation) due to anemia, 6% received a blood transfusion, 4% discontinued telaprevir, and 1% discontinued telaprevir combination therapy. In patients receiving peginterferon alfa and ribavirin alone, 12% had ribavirin dose modification due to anemia, 1% received a blood transfusion, and less than 1% discontinued therapy. Anemia requiring ribavirin dose reduction, blood transfusion, and/or erythropoiesis stimulating agent has been reported as early as 10 days after initiation of telaprevir combination therapy.

Decreased total white blood cell, absolute neutrophil, absolute lymphocyte, and platelet counts have been associated with peginterferon alfa. Decreased total white cell counts (1499/mm3 or less) have been reported in 5% of patients treated with peginterferon alfa. Decreased absolute neutrophil counts (749/mm3 or less) have been reported in 15% of patients treated with peginterferon alfa and ribavirin alone. Decreased platelet counts have been reported in 36% (all grades) and 1% (49,999/mm3 or less) of patients treated with peginterferon alfa and ribavirin alone.

Metabolic

Very common (10% or more): Elevated uric acid levels (73%)
Common (1% to 10%): Uric acid level shifts from baseline to 12.1 mg/dL or greater (7%)
Uncommon (0.1% to 1%): Gout/gouty arthritis (less than 1%)
Frequency not reported: Metabolic and nutrition disorders (unspecified)

Gastrointestinal

Very common (10% or more): Nausea (39%), diarrhea (26%), vomiting (13%), hemorrhoids (12%), anorectal discomfort (11%)
Common (1% to 10%): Anal pruritus (6%)
Frequency not reported: Rectal burning, anorexia, abdominal discomfort, constipation

Anorectal side effects have been reported in 29% of patients. The majority of anorectal side effects (e.g., hemorrhoids, anorectal discomfort, anal pruritus, and rectal burning) were of mild to moderate severity; less than 1% led to discontinuation of therapy and all resolved during or after completion of telaprevir dosing.

Other

Very common (10% or more): Fatigue (56%)
Frequency not reported: Pyrexia, influenza-like illness, infections and infestations (unspecified)

Hepatic

Bilirubin levels increased most steeply during the first 1 to 2 weeks of telaprevir, stabilized, and returned to baseline levels between weeks 12 and 16.

Elevated bilirubin has been reported in 28% (all grades) and 2% (2.6 times ULN or greater) of patients treated with peginterferon alfa and ribavirin alone.

Very common (10% or more): Elevated bilirubin (all grades: 41%)
Common (1% to 10%): Elevated bilirubin (2.6 times ULN or greater: 4%)

Nervous system

Very common (10% or more): Dysgeusia (10%)
Frequency not reported: Headache

Psychiatric

Frequency not reported: Depression, insomnia

Musculoskeletal

Frequency not reported: Myalgia, musculoskeletal disorders (unspecified)

Ocular

Frequency not reported: Ocular events (unspecified)

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