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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dasabuvir sodium monohydrate,ombitasvir,paritaprevir,Ribavirin,Ritonavir

Available from:

Abbvie Pty Ltd

INN (International Name):

dasabuvir sodium monohydrate,ombitasvir,paritaprevir,Ribavirin,Ritonavir

Patient Information leaflet

VIEKIRA PAK-RBV
_A combination therapy containing paritaprevir, ritonavir, ombitasvir,
dasabuvir and ribavirin_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Viekira Pak-RBV.
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-RBV
IS USED FOR
Viekira Pak-RBV 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 3 different
types of tablets. These must be taken
according to the instructions given by
your doctor.
Viekira Pak-RBV 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-RBV
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE VIEKIRA PAK-RBV IF
YOU ARE PREGNANT OR YOUR FEMALE
PARTNER IS PREGNANT (IF YOU ARE
MALE).
RIBAVIRIN MAY CAUSE BIRTH DEFECTS
AND/OR DEATH OF AN UNBORN BABY.
EXTREME CARE MUST BE TAKEN TO
AVOID PREGNANCY DURING TREATMENT
AND FOR 6 MONTHS AFTER COMPLETION
OF TREATMENT WITH RIBAVIRIN.
TWO RELIABLE FORMS OF
CONTRACEPTION MUST BE USED DURING
THIS TIME.
DO NOT TAKE VIEKIRA PAK-RBV IF
YOU HAVE AN ALLERGY TO:
•
ANY MEDICINE CONTAINING
PARITAPREVIR, RITONAVIR,
OMBITASVIR, DASABUVIR OR
RIBAVIRIN; OR
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some symptoms of an allergic
reaction includ

Summary of Product characteristics

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PRODUCT INFORMATION
VIEKIRA PAK-RBV COMBINATION THERAPY PACK
NAME OF THE MEDICINE
VIEKIRA PAK-RBV is a composite pack containing
paritaprevir/ritonavir/ombitasvir 75/50/12.5 mg
tablets, dasabuvir 250 mg tablets and 200 mg, 400 mg or 600 mg
ribavirin tablets.
Refer to DOSAGE AND ADMINISTRATION for populations requiring
ribavirin.
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