INCIVEK*
Manufacturer DetailsGENERIC*
USA AND CANADA
Compositions:
Telaprevir-mg,
Telaprevir-mg,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | unit |
List of Related Indications:
- Treat certain adults with chronic Hepatitis C infection
List Of Drugs:
- Telaprevir- Incivek - @- Anti-viral (May 2011)
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Co-administration of INCIVEK combination treatment with other drugs can alter
the concentration of other drugs and other drugs may alter the concentrations
of telaprevir
Indication:
INCIVEK (telaprevir) Film Coated Tablets, for oral use
Initial U.S. Approval: 2011
WARNING: SERIOUS SKIN REACTIONS
See full prescribing information for complete boxed warning.
Fatal and non-fatal serious skin reactions, including Stevens Johnson
Syndrome (SJS),
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS),
and Toxic Epidermal Necrolysis (TEN), have been reported in patients
treated with INCIVEK combination treatment
Fatal cases have been reported in patients with progressive rash and
systemic symptoms who continued to receive INCIVEK combination treatment
after a serious skin reaction was identified.
For serious skin reactions, including rash with systemic symptoms or a
progressive severe rash, INCIVEK, peginterferon alfa, and ribavirin must be
discontinued immediately. Discontinuing other medications known to be
associated with serious skin reactions should be considered.
Patients should be promptly referred for urgent medical care.
Drug Name- Incivek
Active Ingredient - Telaprevir
To treat certain adults with chronic Hepatitis C infection
Indication-
Treat certain adults with chronic Hepatitis C infection
Approved by FDA on 23-5-2011 (Ref- FDA approved List- 2011)
Adverse Reaction:
The most common adverse drug reactions to INCIVEK (incidence at least
5% higher with INCIVEK than in controls) were rash, pruritus, anemia, nausea,
hemorrhoids, diarrhea, anorectal discomfort, dysgeusia, fatigue, vomiting,
and anal pruritus.
Contra-Indications:
CONTRAINDICATIONS
All contraindications to peginterferon alfa and ribavirin also apply since INCIVEK
must be administered with peginterferon alfa and ribavirin.
Pregnant women and men whose female partners are pregnant: Because ribavirin
may cause birth defects and fetal death, telaprevir in combination with peginterferon
alfa and ribavirin is contraindicated in pregnant women and in men whose female
partners are pregnant.
Co-administration with drugs that:
-are highly dependent on CYP3A for clearance and for which elevated plasma
concentrations are associated with serious and/or life-threatening events.
-strongly induce CYP3A which may lead to lower exposure and loss of
efficacy of INCIVEK
WARNINGS AND PRECAUTIONS
Serious Skin Reactions/Rash: Fatal and non-fatal serious skin reactions
(including SJS, DRESS, and TEN) have been reported.
Patients with mild to moderate rash should be monitored for progression.
If rash progresses and becomes severe, INCIVEK should be discontinued.
For serious skin reactions, including rash with systemic symptoms or a
progressive severe rash, INCIVEK, peginterferon alfa, and ribavirin must be
discontinued immediately.
Consider discontinuing other medications known to be associated with
serious skin reactions.
Anemia: Monitor hemoglobin prior to and at regular intervals during INCIVEK
combination treatment.
Follow dose modifications for ribavirin; discontinue INCIVEK if required.
Pregnancy: Use with Ribavirin and Peginterferon alfa: Ribavirin may cause birth
defects and fetal death; avoid pregnancy in female patients and female partners
of male patients. Patients must have a negative pregnancy test prior to initiating
therapy, use at least 2 effective methods of contraception, and undergo
monthly pregnancy tests.
Dosages/ Overdosage Etc:
Indication-
Treat certain adults with chronic Hepatitis C infection
INDICATIONS AND USAGE
INCIVEK is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated,
in combination with peginterferon alfa and ribavirin, for the treatment of
genotype 1 chronic hepatitis C (CHC) in adult patients with compensated
liver disease, including cirrhosis, who are treatment-naïve or who have
been previously treated with interferon-based treatment, including prior
null responders, partial responders, and relapsers.
INCIVEK must not be used as monotherapy and must only be used in combination
with peginterferon alfa and ribavirin.
A high proportion of previous null responders (particularly those with cirrhosis)
did not achieve Sustained Virologic Response (SVR) and had telaprevir
resistance-associated substitutions emerge on treatment with INCIVEK.
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.
DOSAGE AND ADMINISTRATION
750 mg taken 3 times a day (7-9 hours apart) with food (not low fat).
INCIVEK must be administered with both peginterferon alfa and ribavirin
for all patients for 12 weeks, followed by a response-guided regimen of either
12 or 36 additional weeks of peginterferon alfa and ribavirin depending
on viral response and prior response status.
DOSAGE FORMS AND STRENGTHS
375 mg tablets
Patient Information:
PATIENT COUNSELING INFORMATION
1. Serious Skin Reactions/Rash
Patients should be informed that INCIVEK combination treatment may cause rash.
The rash can be serious, may be accompanied by fever and skin breakdown,
may require urgent treatment in a hospital, and may result in death
2. Patients should promptly report any report any skin changes or itching to their
healthcare provider.
3. Patients should not stop INCIVEK due to rash unless instructed by their healthcare
provider.
4.Patients must be advised of the teratogenic/embryocidal risks of ribavirin and should
be advised that extreme care must be taken to avoid pregnancy in female patients
and in female partners of male patients both during treatment and for 6 months
after the completion of all treatment.
5.Women of childbearing potential must be counseled about use of effective
contraception (2 methods) prior to initiating treatment.
6.Patients (both male and female) should be advised to notify their health
care provider immediately in the event of a pregnancy [see Contraindications
7. Patients should be advised INCIVEK must be administered in combination with
both peginterferon alfa and ribavirin. If peginterferon alfa and/or ribavirin is
discontinued for any reason, INCIVEK must also be discontinued.
8.Patients should be advised that the dose of INCIVEK must not be reduced or
interrupted, as it may increase the possibility of treatment failure.
The recommended dose of INCIVEK tablets is 750 mg (two 375-mg tablets)
taken orally 3 times a day (7-9 hours apart) with food containing approximately
20 grams of fat.
9.Patients should be advised that the fat content of the meal or snack is critical
for the absorption of telaprevir.
10.Food that is taken with INCIVEK should be ingested within 30 minutes prior to
each INCIVEK dose.
Examples of some foods that could be taken with INCIVEK include: a bagel
with cream cheese, ½ cup nuts, 3 tablespoons peanut butter,
1 cup ice cream, 2 ounces American or cheddar cheese, 2 ounces
potato chips, or ½ cup trail mix.
11.Patients should be informed about what to do in the event they miss a dose
of INCIVEK:
12.In case a dose of INCIVEK is missed within 4 hours of the time it is usually taken,
patients should be instructed to take the prescribed dose of INCIVEK with food
as soon as possible.
13.If more than 4 hours has passed since INCIVEK is usually taken, the missed dose
should NOT be taken and the patient should resume the usual dosing schedule.
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
Telaprevir is a direct-acting antiviral (DAA) agent against the hepatitis C virus
2. Pharmacokinetics
The pharmacokinetic properties of telaprevir have been evaluated in healthy adult
subjects and in subjects with chronic hepatitis C.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1.Pregnancy Category X:
Animal studies have shown that ribavirin causes birth defects and/or fetal deaths
while peginterferon alfa is abortifacient
Because INCIVEK must be used in combination with ribavirin and
peginterferon alfa, the contraindications and warnings applicable to those
drugs are applicable to combination treatment. Extreme care must be taken
to avoid pregnancy in female patients and in female partners of male patients.
INCIVEK/Peginterferon Alfa/Ribavirin Combination Treatment
2. Nursing Mothers
It is not known whether telaprevir is excreted in human breast milk.
Because of the potential for adverse reactions in nursing infants, nursing
must be discontinued prior to initiation of treatment. .
3. Pediatric Use
The safety, efficacy and pharmacokinetic profile of INCIVEK in pediatric patients
have not been established.
4. Geriatric Use
Clinical trials of INCIVEK did not include sufficient numbers of subjects aged 65
and over to determine whether they respond differently from younger subjects
In general, caution should be exercised in the administration and monitoring
of INCIVEK in geriatric patients reflecting the greater frequency of decreased
hepatic function, and of concomitant disease or other drug therapy
