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Label Changes for:

Technivie (ombitasvir, paritaprevir and ritonavir) Tablets

June 2016

Changes have been made to the CONTRAINDICATIONS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

June 2016

CONTRAINDICATIONS

Table 2 (Drugs that are Contraindicated with TECHNIVIE)

Four drug classes added; please refer to label.

  • Anti-anginal  (Ranolazine)                                                                                                     
  • Antiarrhythmic(Dronedarone)                                                                                                 
  • Antipsychotic (Lurasidone, and Pimozide)                                                                                
  • GI Motility Agent (Cisapride)        

DRUG INTERACTIONS

Established and Other Potential Drug Interactions

Table 4. Established Drug Interactions Based on Drug Interaction Trials

Two drug classes added; please refer to label.

  • ANTIDIABETIC DRUGS (metformin)
  • MUSCLE RELAXANTS (carisoprodol, and cyclobenzaprine)

The following two drug classes had drugs added; please refer to label.

  • NARCOTIC ANALGESICS (Hydrocodone/acetaminophen)                       
  • SEDATIVES/HYPNOTICS (Diazepam)
Drugs without Clinically Significant Interactions with TECHNIVIE
  • No dosage adjustments are recommended when TECHNIVIE is co-administered with the following medications: addition of abacavir, dolutegravir, lamivudine, sofosbuvir, sulfamethoxazole, and trimethoprim.

PATIENT COUNSELING INFORMATION

Pregnancy
  • Advise patients to avoid pregnancy during treatment and within 6 months of stopping treatment with TECHNIVIE with ribavirin. (addition)
Administration (additional subsection)
  • Advise patients to take TECHNIVIE every day at the regularly scheduled time with a meal without regard to fat or calorie content.
  • Inform patients that it is important not to miss or skip doses and to take TECHNIVIE for the duration that is recommended by the healthcare provider.

MEDICATION GUIDE

Who should not take TECHNIVIE?

Do not take TECHNIVIE if you: (addition)

  • cisapride (Propulsid┬«)

How should I take TECHNIVIE? (additions)

  • It is important that you do not miss or skip doses of TECHNIVIE during treatment.
  • If you take too much TECHNIVIE, call your healthcare provider or go to the nearest hospital emergency room right away.
     

 

January 2016

DRUG INTERACTIONS

Established and Other Potential Drug Interactions
  • *update the Table 4 with patient monitoring information with the concomitant use of angiotensin receptor blockers and calcium channel blockers

 

October 2015

CONTRAINDICATIONS

  • bullet updated...In patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity
  • Table updated with information regarding contraindication of Colchicine

WARNINGS AND PRECAUTIONS

Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
  • TECHNIVIE is not indicated in patients with cirrhosis. Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with ombitasvir, paritaprevir, ritonavir with and without dasabuvir and with and without ribavirin. Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy. Reported cases typically occurred within one to four weeks of initiating therapy and were characterized by the acute onset of rising direct serum bilirubin levels without ALT elevations in association with clinical signs and symptoms of hepatic decompensation. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Discontinue treatment in patients who develop evidence of hepatic decompensation.
  • TECHNIVIE is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C).

ADVERSE REACTIONS

  • added bullet...Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
Post-Marketing Experience

The following adverse reactions have been identified during post approval use of TECHNIVIE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Immune System Disorders: Hypersensitivity reactions (including angioedema)
  • Hepatobiliary Disorders: Hepatic decompensation, hepatic failure

PATIENT COUNSELING INFORMATION

Risk of ALT Elevations or Hepatic Decompensation and Failure
  • Inform patients to watch for early warning signs of liver inflammation or failure, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice, onset of confusion, abdominal swelling, and discolored feces, and to consult their health care professional without delay if such symptoms occur

 

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