Viekira Pak

What is Viekira Pak?

• VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor used for the treatment of adult patients with chronic hepatitis C virus (HCV):

genotype 1b without cirrhosis or with compensated cirrhosis genotype 1a without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

What are the uses of this medicine?

This medicine is used for the treatment of adult patients with chronic hepatitis C virus (HCV):

• genotype 1b without cirrhosis or with compensated cirrhosis
• genotype 1a without cirrhosis or with compensated cirrhosis for use in combination with ribavirin.

How does this medicine work?

VIEKIRA PAK combines three direct-acting hepatitis C virus antiviral agents with distinct mechanisms of action. Ombitasvir

• Ombitasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly.

Paritaprevir

• Paritaprevir is an inhibitor of the HCV NS3/4A protease which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication.

Dasabuvir

• Dasabuvir is a non-nucleoside inhibitor of the HCV RNA-dependent RNA polymerase encoded by the NS5B gene, which is essential for replication of the viral genome.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have moderate or severe liver problems

• take any of the following medicines:

alfuzosin hydrochloride apalutamide atorvastatin carbamazepine cisapride colchicine in people who have certain kidney or liver problems dronedarone efavirenz

• ergot containing medicines including:

ergotamine dihydroergotamine methylergonovine

• ethinyl estradiol-containing medicines:

combination birth control pills or transdermal systems hormonal vaginal rings hormone replacement therapy everolimus gemfibrozil lomitapide lovastatin lurasidone midazolam, when taken by mouth phenytoin phenobarbital pimozide ranolazine rifampin sildenafil citrate, when taken for pulmonary artery hypertension (PAH) simvastatin sirolimus St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort tacrolimus triazolam

• have had a severe skin rash after taking ritonavir

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

• Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with VIEKIRA PAK.
• Assess for laboratory and clinical evidence of hepatic decompensation.

Recommended Dosage:

• VIEKIRA PAK is ombitasvir, paritaprevir, ritonavir fixed dose combination tablets copackaged with dasabuvir tablets.
• The recommended oral dosage of VIEKIRA PAK is two ombitasvir, paritaprevir, ritonavir 12.5/75/50 mg tablets once daily (in the morning) and one dasabuvir tablet twice daily (morning and evening). Take VIEKIRA PAK with a meal without regard to fat or calorie content.
• VIEKIRA PAK is used in combination with ribavirin (RBV) in certain patient populations as shown below. When administered with VIEKIRA PAK, the recommended dosage of RBV is based on weight: 1000 mg/day for subjects <75 kg and 1200 mg/day for those ≥75 kg, divided and administered twice-daily with food.

Patient Population	Treatment*	Duration
Genotype 1a,
without cirrhosis	VIEKIRA PAK + ribavirin	12 weeks
Genotype 1a,
with compensated cirrhosis	VIEKIRA PAK + ribavirin	24 weeks**
Genotype 1b,
with or without
compensated cirrhosis	VIEKIRA PAK	12 weeks

Administration

1. Take VIEKIRA PAK exactly as your healthcare provider tells you to take it. Do not change your dose.
2. Do not stop taking VIEKIRA PAK without first talking with your healthcare provider.
3. Take VIEKIRA PAK tablets every day, with a meal.
4. VIEKIRA PAK comes in monthly cartons that contain enough medicine for 28 days.
5. Each monthly carton of VIEKIRA PAK contains 4 smaller cartons.
6. Each of the 4 smaller cartons contains enough daily dose packs of medicine to last for 7 days (1 week).
7. Each daily dose pack contains all of your VIEKIRA PAK medicine for 1 day (4 tablets). Follow the instructions on each child resistant daily dose pack about how to remove the tablets.

Take VIEKIRA PAK tablets with a meal as follows:

1. Take the 2 pink tablets (ombitasvir, paritaprevir, and ritonavir), with 1 of the beige tablets (dasabuvir), at about the same time every morning.
2. Take the second beige tablet (dasabuvir), at about the same time every evening.
3. It is important that you do not miss or skip doses of VIEKIRA PAK during treatment.
4. If you take too much VIEKIRA PAK, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Tablets:

• Ombitasvir, paritaprevir, ritonavir: 12.5/75/50 mg
• Dasabuvir: 250 mg

This medicine is available in fallowing brand namesː

• VIEKIRA PAK

What side effects can this medication cause?

Common side effects of VIEKIRA PAK when used with ribavirin include:

• tiredness
• nausea
• itching
• skin reactions such as redness or rash
• sleep problems
• feeling weak

Common side effects of VIEKIRA PAK when used without ribavirin include:

• nausea
• itching
• sleep problems

VIEKIRA PAK can cause serious side effects, including:

• Hepatitis B virus reactivation
• Severe liver problems
• Increase in your liver function blood tests

What special precautions should I follow?

• Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
• Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported mostly in patients with advanced cirrhosis. Monitor for clinical signs and symptoms of hepatic decompensation.
• During clinical trials with VIEKIRA PAK with or without ribavirin, elevations of ALT to greater than 5 times the upper limit of normal (ULN) occurred. Discontinue ethinyl estradiol-containing medications prior to starting VIEKIRA PAK (alternative contraceptive methods are recommended). Perform hepatic laboratory testing on all patients during the first 4 weeks of treatment. For ALT elevations on VIEKIRA PAK, monitor closely and follow recommendations in full prescribing information.
• If VIEKIRA PAK is administered with ribavirin, the warnings and precautions for ribavirin also apply to this combination regimen.
• The concomitant use of VIEKIRA PAK and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of VIEKIRA PAK.

What to do in case of emergency/overdose?

Management of overdosage:

• In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted immediately.

Can this medicine be used in pregnancy?

• If VIEKIRA PAK is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant.
• No adequate human data are available to establish whether or not VIEKIRA PAK poses a risk to pregnancy outcomes.

Can this medicine be used in children?

• Safety and effectiveness of VIEKIRA PAK in pediatric patients less than 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

Ombitasvir, paritaprevir, and ritonavir tablets:

• Active ingredients: ombitasvir, paritaprevir, and ritonavir
• Inactive ingredients: copovidone, K value 28, vitamin E polyethylene glycol succinate, propylene glycol monolaurate Type I, sorbitan monolaurate, colloidal silicon dioxide/colloidal anhydrous silica, sodium stearyl fumarate, polyvinyl alcohol, polyethylene glycol 3350/macrogol 3350, talc, titanium dioxide, and red iron oxide.

Dasabuvir tablets:

• Active ingredients: dasabuvir
• Inactive ingredients: microcrystalline cellulose (D50-100 um), microcrystalline cellulose (D50-50 um), lactose monohydrate, copovidone, croscarmellose sodium, colloidal silicon dioxide/anhydrous colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350/macrogol 3350, talc and iron oxide yellow, iron oxide red and iron oxide black.

Who manufactures and distributes this medicine?

• Manufactured by AbbVie Inc., North Chicago, IL 60064.
• VIEKIRA PAK and NORVIR are trademarks of AbbVie Inc.

What should I know about storage and disposal of this medication?

• Store VIEKIRA PAK at or below 86°F (30°C). Do not remove tablets from the daily dose pack until you are ready to take them.
• Keep VIEKIRA PAK and all medicines out of the reach of children.

Antiviral agents

Drugs for HIV Infection, in the Subclass Antiretroviral Agents

• Fusion Inhibitors (HIV)
  • Enfuvirtide, Maraviroc

• Integrase Inhibitors (HIV)
  • Dolutegravir, Elvitegravir, Raltegravir

• Monoclonal Antibodies
  • Ibalizumab

• Nonnucleoside Reverse Transcriptase Inhibitors (HIV)
  • Delavirdine, Efavirenz, Etravirine, Nevirapine, Rilpivirine

• Nucleoside Analogues (HIV)
  • Abacavir, Didanosine, Emtricitabine, Lamivudine, Stavudine, Tenofovir, Zidovudine

• Protease Inhibitors (HIV)
  • Amprenavir, Atazanavir, Darunavir, Fosamprenavir, Indinavir, Lopinavir, Nelfinavir,Ritonavir, Saquinavir, Tipranavir

Drugs for Hepatitis B

• • Alpha Interferon, Adefovir, Emtricitabine, Entecavir, Lamivudine, Telbivudine, Tenofovir

Drugs for Hepatitis C

• Interferon Based Therapies
  • Alpha Interferon and Peginterferon, Ribavirin

HCV NS5A Inhibitors

• Daclatasvir, Elbasvir, Ledipasvir, Ombitasvir, Pibrentasvir, Velpatasvir

HCV NS5B (Polymerase) Inhibitors

• Dasabuvir, Sofosbuvir

HCV Protease Inhibitors

• Asunaprevir, Boceprevir, Glecaprevir, Grazoprevir, Paritaprevir, Simeprevir, Telaprevir, Voxilaprevir

Combination Therapies

• Epclusa, Harvoni, Mavyret, Technive, Viekira Pak, Vosevi, Zepatier

Drugs for Herpes Virus Infections (HSV, CMV, others)

• Acyclovir, Cidofovir, Famciclovir, Foscarnet, Ganciclovir, Valacyclovir, Valganciclovir

Drugs for Influenza

• Amantadine, Oseltamivir, Peramivir, Rimantadine, Zanamivir

• Dailymed label info on Viekira Pak
• FDA Viekira Pak

Viekira Pak Resources
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