This medication is used to treat chronic (long-lasting)
hepatitis C, a viral infection of the liver. Ombitasvir and paritaprevir
work by reducing the amount of hepatitis C virus in your body, which helps
your immune system fight the infection and may help your liver recover.
Ritonavir is used to increase ("boost") the levels of paritaprevir. This
helps paritaprevir work better. This product may also be used with a
certain other medication (ribavirin). Chronic hepatitis C infection can
cause serious liver problems such as scarring (cirrhosis) or liver
cancer.
It is not known if this treatment can prevent you from
passing the virus to others. Do not share needles, and practice "safer sex"
(including the use of latex condoms) to lower the risk of passing the virus
to others.
Read the Medication Guide provided by your pharmacist
before you start taking this product and each time you get a refill. If you
have any questions, ask your doctor or pharmacist.
Take this medication by mouth with a meal as directed by
your doctor, usually once daily in the morning.
This product works best when the amount of drug in your
body is kept at a constant level. Take this product at evenly spaced
intervals. To help you remember, take it at the same time each day. Do not
skip any doses.
Continue to take this product for the full length of
time prescribed, even if symptoms disappear after a short time. Stopping
the medication too early may result in a return of the
infection.
See also Warning section.
Tiredness, weakness, nausea, mild itching, or difficulty
sleeping may occur. If any of these effects last or get worse, tell your
doctor or pharmacist promptly.
Remember that this product has been prescribed because
your doctor has judged that the benefit to you is greater than the risk of
side effects. Many people using this product do not have serious side
effects.
This medication can commonly cause a rash that is
usually not serious. However, you may not be able to tell it apart from a
rare rash that could be a sign of a severe reaction. Tell your doctor right
away if you develop any rash.
A very serious allergic reaction to this product is
rare. However, get medical help right away if you notice any symptoms of a
serious allergic reaction, including:
- rash
- itching/swelling (especially of the face/tongue/throat)
- severe dizziness
- trouble breathing
This is not a complete list of possible side effects. If
you notice other effects not listed above, contact your doctor or
pharmacist.
In the US - Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088 or at
www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about
side effects. You may report side effects to Health Canada at
1-866-234-2345.
Before taking this product, tell your doctor or
pharmacist if you are allergic to ombitasvir, paritaprevir, or ritonavir;
or if you have any other allergies. This product may contain inactive
ingredients, which can cause allergic reactions or other problems. Talk to
your pharmacist for more details.
Before using this product, tell your doctor or
pharmacist your medical history, especially of:
- other liver problems (such as hepatitis B)
- HIV infection
- diabetes
If you have diabetes, your blood sugar may be lower with
hepatitis C treatment. This can increase your risk of low blood sugar, so
your doctor may adjust your diabetes treatment plan. Tell your doctor right
away if you have symptoms of low blood sugar such as sudden sweating,
shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling
hands/feet.
Before having surgery, tell your doctor or dentist about
all the products you use (including prescription drugs, nonprescription
drugs, and herbal products).
During pregnancy, this product should be used only when
clearly needed. Discuss the risks and benefits with your
doctor.
If this product is used in combination with ribavirin,
it must not be used during pregnancy by either the pregnant woman or her
male partner. Ribavirin may harm an unborn baby. Reliable forms of birth
control must be used whenever at least one sexual partner is using these
medicines together (see also Drug Interactions section). Female patients
should keep using birth control for 9 months after stopping treatment. Male
patients should keep using birth control for 6 months after stopping
treatment. If you or your partner becomes pregnant, or if you think you or
your partner may be pregnant, tell your doctor right away.
It is unknown if the medications in this product pass
into breast milk. Consult your doctor before breastfeeding.
Drug interactions may change how your medications work
or increase your risk for serious side effects. This document does not
contain all possible drug interactions. Keep a list of all the products you
use (including prescription/nonprescription drugs and herbal products) and
share it with your doctor and pharmacist. Do not start, stop, or change the
dosage of any medicines without your doctor's approval.
Some products that may interact with this drug
include:
- atazanavir
- efavirenz
- products that contain ethinyl estradiol (such as combined
birth control pills, patch, or ring)
If you are using hormonal birth control containing a
certain type of estrogen (ethinyl estradiol), it must be stopped before
starting treatment with this product. Use other reliable forms of birth
control during treatment with this product and for 2 weeks after stopping
treatment. Ethinyl estradiol-containing birth control may be restarted
after that time. Talk to your doctor for more details.
This medication can slow down the removal of other
medications from your body, which may affect how they work. Examples of
affected drugs include certain alpha blockers (such as alfuzosin,
silodosin), certain benzodiazepines (midazolam, triazolam), colchicine,
ergot alkaloids (such as dihydroergotamine, ergotamine), certain heart
drugs (dronedarone, ranolazine), lurasidone, pimozide, rilpivirine,
salmeterol, certain drugs used to treat erectile dysfunction-ED or
pulmonary hypertension (avanafil, sildenafil), certain "statin" cholesterol
drugs (atorvastatin, lovastatin, simvastatin), certain drugs that weaken
the immune system (such as everolimus, sirolimus, tacrolimus,
temsirolimus), among others.
Other medications can affect the removal of this product
from your body, which may affect how this product works. Examples include
certain drugs used to treat seizures (such as carbamazepine, phenobarbital,
phenytoin, primidone), apalutamide, belzutifan, cobicistat, elagolix,
mitotane, rifampin, St. John's wort, thioridazine, among
others.
Do not take this product with other products that
contain ritonavir.
If someone has overdosed and has serious symptoms such
as passing out or trouble breathing, call 911. Otherwise, call a poison
control center right away. US residents can call 1-800-222-1222. Canada
residents can call 1-844-764-7669.
Do not share this product with others.
Lab tests (such as liver function, tests for hepatitis B
and C) should be done before you start using this medication, while you are
using it, and after completing treatment. Keep all medical and lab
appointments.
If you are using this product with ribavirin, it is
recommended that female patients or female partners of male patients take a
pregnancy test before starting treatment. Pregnancy tests should continue
to be done while using this medication and for some time after this
medication is stopped to make sure no pregnancy occurs (for 9 months for
female patients and for 6 months for female partners of male
patients).
If you miss a dose, take it with a meal as soon as you
remember. If it is near the time of the next dose, skip the missed dose.
Take your next dose at the regular time. Do not double the dose to catch
up.
Store at room temperature away from light and moisture.
Do not store in the bathroom. Keep all medications away from children and
pets.
Do not flush medications down the toilet or pour them
into a drain unless instructed to do so. Properly discard this product when
it is expired or no longer needed. Consult your pharmacist or local waste
disposal company.