VIEKIRA XR(dasabuvir, ombitasvir, paritaprevir, and ritonavir)extended-release tablets(三十八)
s must be taken with a meal.
Swallow VIEKIRA XR tablets whole. Do not split, crush, or chew the tablets.
Do not drink alcohol within 4 hours of taking VIEKIRA XR.
VIEKIRA XR comes in monthly cartons that contain enough medicine for 28 days.
Each monthly carton of VIEKIRA XR contains 4 smaller cartons.
Each of the 4 smaller cartons contains enough child resistant daily dose packs of medicine to last for 7 days (1 week).
Each daily dose pack contains all of your VIEKIRA XR medicine for 1 day (3 tablets). Follow the instructions on each daily dose pack about how to remove the tablets.
It is important that you do not miss or skip doses of VIEKIRA XR during treatment.
If you take too much VIEKIRA XR, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of VIEKIRA XR?
VIEKIRA XR can cause serious side effects, including:
Hepatitis B virus reactivation. See “What is the most important information I should know about VIEKIRA XR?”
Common side effects of VIEKIRA XR when used with ribavirin include:
tiredness
nausea
itching
skin reactions such as redness or rash
sleep problems
feeling weak
Common side effects of VIEKIRA XR when used without ribavirin include:
nausea
itching
sleep problems
These are not all the possible side effects of VIEKIRA XR. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store VIEKIRA XR?
Store VIEKIRA XR at or below 86°F (30°C).
Keep VIEKIRA XR and all medicines out of the reach of children.
General information about the safe and effective use of VIEKIRA XR
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VIEKIRA XR for a condition for which it was not prescribed. Do not give VIEKIRA XR to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about VIEKIRA XR that is written for health professionals.
What are the ingredients in VIEKIRA XR?
Active ingredients: dasabuvir, ombitasvir, paritaprevir, and ritonavir
Inactive ingredients:
The extended release layer contains: copovidone, K value 28, hypromellose 2208, 17,700 (mPa*s), colloidal silicon dioxide/colloidal anhydrous silica, and magnesium stearate.
The immediate release layer contains: copovidone, K value 28, vitamin E polyethylene glycol succinate, propylene glycol monolaurate, sorbitan monolaurate, colloidal silicon dioxide/colloidal anhydrous silica.
The tablet coating contains: hypromellose (6 mPa*s), hypromellose (15 mPa*s), polyethylene glycol 400, hydroxypropyl cellulose, polysorbate 80, polyethylene glycol 3350/macrogol 4000, talc, titanium dioxide, colloidal silicon dioxide/colloidal anhydrous silica and iron oxide yellow.
Manufactured by AbbVie Inc., North Chicago, IL 60064.
VIEKIRA XR and NORVIR are trademarks of AbbVie Inc. All other brands listed are trademarks of their respective owners and are not trademarks of AbbVie Inc. The makers of these brands are not affiliated with and do not endorse AbbVie Inc. or its products.
For more information go to www.viekira.com or call 1-844-843-5472.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
03-B505 Issued: March 2017
PRINCIPAL DISPLAY PANEL
NDC 0074–0063–28
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