VIEKIRA PAK paritaprevir/ritonavir/ombitasvir 75mg/50mg/12.5mg film-coated tablets and dasabuvir (as sodium salt) 250mg film-coa

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dasabuvir sodium monohydrate,ombitasvir,paritaprevir,Ritonavir

Available from:

Abbvie Pty Ltd

INN (International Name):

dasabuvir sodium monohydrate,ombitasvir,paritaprevir,Ritonavir

Patient Information leaflet

VIEKIRA PAK
_A combination therapy containing paritaprevir, ritonavir, ombitasvir
and dasabuvir_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Viekira Pak.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
this medicine against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VIEKIRA PAK IS
USED FOR
Viekira Pak is used to treat chronic
(lasting a long time) hepatitis C
infection in adults including those
with cirrhosis (scarring of the liver).
Hepatitis C is a liver disease caused
by a virus which infects and damages
liver cells.
This treatment consists of 2 different
types of tablets.
These must be taken according to the
instructions given by your doctor
Viekira Pak works by lowering the
amount of hepatitis C virus in your
body. It removes the virus from your
blood over a period of time.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
IT HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
BEFORE YOU TAKE
VIEKIRA PAK
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE VIEKIRA PAK IF YOU
HAVE AN ALLERGY TO:
•
ANY MEDICINE CONTAINING
PARITAPREVIR, RITONAVIR,
OMBITASVIR OR DASABUVIR
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
Some symptoms of an allergic
reaction include :
•
hives, skin rash or itching;
•
shortness of breath, wheezing,
difficulty breathing or a tight
feeling in your chest;
•
swelling of the face, lips or
tongue, which may cause
difficulty in swallowing or
breathing.
DO NOT TAKE VIEKIRA PAK IF YOU
TAKE A MEDICINE THAT CONTAINS:
•
alfuzosin hydrochloride
•
ranolazine
•
amiodarone, quinidine,
dronedarone
•
astemizole, terfenadine
•
blonanserin, lura

Summary of Product characteristics

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PRODUCT INFORMATION
VIEKIRA PAK COMBINATION THERAPY PACK
NAME OF THE MEDICINE
VIEKIRA PAK is a composite pack containing
paritaprevir/ritonavir/ombitasvir 75/50/12.5 mg tablets,
and dasabuvir 250 mg tablets.
CHEMICAL STRUCTURE AND DESCRIPTION OF EACH ACTIVE PHARMACEUTICAL
INGREDIENT
PARITAPREVIR
Paritaprevir drug substance is manufactured as a dihydrate, however it
is dehydrated during the
drug
product
manufacturing
process
and
is
amorphous
and
anhydrous
in
the
final
product.
Paritaprevir dihydrate is chemically designated
(2_R_,6_S_,12_Z_,13a_S_,14a_R_,16a_S_)-_N_- (Cyclopropylsulfonyl)-
6-{[(5-methylpyrazin-2-yl)carbonyl]amino}-5,16-dioxo-2-(phenanthridin-6-yloxy)-
1,2,3,6,7,8,9,10,11,13a,14,15,16,16atetradecahydrocyclopropa[_e_]pyrrolo[1,2-_a_][1,4]
diazacyclopentadecine-14a(5_H_)-carboxamide dihydrate.
The molecular formula is C
40
H
43
N
7
O
7
S•2H
2
O (dihydrate) and the molecular weight for the drug
substance is 801.91 (dihydrate).
Paritaprevir dihydrate has the following structural formula:
CAS Number: 1456607-71-8
Paritaprevir dihydrate is a white to off-white powder with very low
water solubility. Paritaprevir
dihydrate has a pKa of 4.6 at 25°C.
RITONAVIR
Ritonavir
is
chemically
designated
as
[5_S_-(5_R_*,8_R_*,10_R_*,11_R_*)]10-Hydroxy-2-methyl-5-(1-
methyethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmehyl)-2,4,7,12-
tetraazatridecan-13-oic acid,5-thiazolylmethyl ester.
The molecular formula is C
37
H
48
N
6
O
5
S
2
and the molecular weight is 720.95.
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Ritonavir has the following structural formula:
CAS Number: 155213-67-5
Ritonavir is a white to light tan powder practically insoluble in
water and freely soluble in methanol
and ethanol. Ritonavir has a pKa of 2.8.
OMBITASVIR
Ombitasvir drug substance is manufactured as a hydrate, however it is
dehydrated during the drug
product manufacturing process and is amorphous and anhydrous in the
final product. Ombitasvir
hydrate
is
chemically
designat