Ombitasvir/paritaprevir/ritonavir - oral
Ombitasvir/paritaprevir/ritonavir - oral
Although this product helps many people with hepatitis C, it may rarely cause serious liver problems. Also, people who have another liver problem called hepatitis B may get worse. Before starting this product, tell your doctor if you have ever had hepatitis B. Tell your doctor right away if you have new or worsening symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, dark urine or yellowing eyes/skin.
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 your doctor has prescribed this product because he or she 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:
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:
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. Two reliable forms of birth control (such as condoms, birth control pills) must be used whenever at least one sexual partner is using these medicines together, and for 6 months after stopping treatment (see also Drug Interactions section). 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. Breast-feeding while using this product with ribavirin is not recommended. Consult your doctor before breast-feeding.
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:
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), cisapride, 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), cobicistat, elagolix, mitotane, rifampin, St. John's wort, 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
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. A pregnancy test should also be taken every month while using this product and for 6 months after treatment ends to make sure no pregnancy occurs.
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.
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Information last revised January 2019.
Copyright(c) 2019 First Databank, Inc.
Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.
The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.