NORTH CHICAGO, Ill., Oct. 22, 2015 /PRNewswire/ -- In consultation with the U.S. Food and Drug Administration (FDA), the U.S. Product Inserts (USPI) for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets) have been updated from ‘not recommended in Child-Pugh B patients’ to a contraindication in patients with Child-Pugh B cirrhosis. Patients classified as Child-Pugh C will remain contraindicated as they have been since approval.
The updated USPI for VIEKIRA PAK also includes a recommendation for physicians to assess evidence of hepatic decompensation prior to treatment and during treatment in cirrhotic patients.
Because post-marketing events are reported voluntarily during clinical practice, estimates of frequency cannot be made and a causal relationship between treatment and these events has not been established.
VIEKIRA PAK with and without ribavirin (RBV) remains indicated for genotype 1 (GT1) HCV patients with compensated cirrhosis, including Child-Pugh A. The safety and efficacy of VIEKIRA PAK, with and without RBV, has been studied in Phase 3 trials in more than 2,300 patients and is one of the recommended regimens in the AASLD guidelines for these patients. TECHNIVIE in combination with RBV is indicated for genotype 4 (GT4) HCV patients without cirrhosis.
The USPIs for VIEKIRA PAK and TECHNIVIE were updated following post-marketing reports of hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, in patients receiving AbbVie’s HCV treatment, with or without RBV. Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy.
AbbVie will issue a Dear Health Care Provider letter to inform US healthcare providers of the updates. A copy of letter is available here.
For VIEKIRA PAK Full Prescribing Information, including the Medication Guide, click here.
For TECHNIVIE Full Prescribing Information, including the Medication Guide, click here.
Media: Jackie Finley
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and
TECHNIVIE™ (ombitasvir, paritaprevir and ritonavir) tablets IMPORTANT INFORMATION
VIEKIRA PAK® is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection, including people who have a certain type of cirrhosis (compensated).
TECHNIVIE™ is a prescription medicine used with ribavirin to treat adults with genotype 4 chronic hep C
virus infection without cirrhosis.
VIEKIRA and TECHNIVIE are not for people with certain types of liver problems, such as those with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a doctor before taking VIEKIRA or TECHNIVIE.
IMPORTANT SAFETY INFORMATION
When taking VIEKIRA or TECHNIVIE in combination with ribavirin, people should read the
Medication Guide that comes with ribavirin, especially the important pregnancy information.
What is the most important information to know about VIEKIRA and TECHNIVIE?
• VIEKIRA and TECHNIVIE may cause severe liver problems, especially in people with certain types of cirrhosis. These severe liver problems can lead to the need for a liver transplant, or can lead to death.
• VIEKIRA and TECHNIVIE can cause increases in liver function blood test results, especially if people use ethinyl estradiol-containing medicines (such as some birth control products).
− Ethinyl estradiol-containing medicines (combination birth control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho Tri-Cyclen® Lo, Ortho Evra®; hormonal vaginal rings such as NuvaRing®; and the hormone replacement therapy medicine, Fem HRT®) must be stopped before starting treatment with VIEKIRA or TECHNIVIE. If these medicines are used as a method of birth control, another method must be used during treatment with VIEKIRA or TECHNIVIE, and for about 2 weeks after treatment with VIEKIRA or TECHNIVIE ends. A doctor can provide instruction on when to begin taking ethinyl estradiol-containing medicines.
• A doctor should do blood tests to check liver function during the first 4 weeks of treatment and then as needed.
• A doctor may tell people to stop taking VIEKIRA or TECHNIVIE if signs or symptoms of liver problems develop. A doctor must be notified right away if any of the following symptoms develop or if they worsen during treatment with VIEKIRA or TECHNIVIE: tiredness, weakness, loss of appetite, nausea, vomiting, yellowing of the skin or eyes, color changes in stools, confusion, or swelling of the stomach area.
VIEKIRA or TECHNIVIE must not be taken if people:
• have certain liver problems
• have had a severe skin rash after taking ritonavir (Norvir®)
• take any of the following medicines: alfuzosin hydrochloride (Uroxatral®) • carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) • colchicine (Colcrys®) • efavirenz (Sustiva®, Atripla®) • ergot- containing medicines, including ergotamine tartrate (Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®, Wigraine®, Wigrettes®), dihydroergotamine mesylate (D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®, Methergine®) • ethinyl estradiol-containing medicines • lovastatin (Advicor®, Altoprev®, Mevacor®) • midazolam (when taken by mouth) • phenytoin (Dilantin®, Phenytek®) • phenobarbital (Luminal®) • pimozide (Orap®) • rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) • sildenafil citrate (Revatio®), when taken for pulmonary artery hypertension (PAH) • simvastatin (Zocor®, Vytorin®, Simcor®) • St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort • triazolam (Halcion®) • gemfibrozil (Lopid®) with VIEKIRA only
What should people tell a doctor before taking VIEKIRA or TECHNIVIE?
• If they have liver problems other than hep C infection, HIV infection, or any other medical conditions.
• If they have had a liver transplant. If they take the medicines tacrolimus (Prograf®) or cyclosporine (Gengraf®, Neoral®, Sandimmune®), a doctor should check blood levels and, if needed, may change the dose of these medicines or how often they are taken, both during and after treatment with VIEKIRA or TECHNIVIE.
• If they are pregnant or plan to become pregnant or if they are breastfeeding or plan to breastfeed. It is not known if VIEKIRA or TECHNIVIE will harm a person’s unborn baby or pass into breast milk. A doctor should be consulted about the best way to feed a baby if taking VIEKIRA or TECHNIVIE.
− Pregnant females who have both hep C and HIV infection, and have been prescribed VIEKIRA, should talk with a doctor about enrolling in the antiretroviral pregnancy registry.
• About all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with VIEKIRA and TECHNIVIE.
− A new medicine must not be started without telling a doctor. A doctor will provide instruction on whether it is safe to take VIEKIRA or TECHNIVIE with other medicines.
− When VIEKIRA or TECHNIVIE are finished, a doctor should be consulted on what to do if one of the usual medicines taken was stopped or if the dose changed during VIEKIRA or TECHNIVIE treatment.
What are the common side effects of VIEKIRA and TECHNIVIE?
• VIEKIRA with ribavirin side effects include tiredness, nausea, itching, skin reactions such as redness or rash, sleep problems, and feeling weak. VIEKIRA without ribavirin side effects include nausea, itching, and sleep problems.
• TECHNIVIE with ribavirin side effects include feeling weak, tiredness, nausea, and sleep problems.
These are not all of the possible side effects of VIEKIRA and TECHNIVIE. A doctor should be notified if there is any side effect that is bothersome or that does not go away.
This is the most important information to know about VIEKIRA and TECHNIVIE. For more information, talk with a doctor.
People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.