Viekira Pak Oral: Side Effects, Uses, Warnings

Side Effects

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 product 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.

How long does it take for this medicine to take effect?

The pharmacokinetic profiles of the components of Viekira Pak suggest that the drugs reach their peak plasma concentrations within 4 to 5 hours post-administration. However, the clinical effect on the HCV viral load, indicative of the onset of action, typically manifests over weeks to months of treatment. It’s crucial to understand that the direct antiviral action at a molecular level starts soon after the first dose, but measurable clinical outcomes, such as a reduction in viral load, may take longer to observe.

How long do the effects of this medicine last?

The duration of the antiviral effect of Viekira Pak is designed to last throughout the treatment period, which is typically 12 to 24 weeks, depending on the patient’s HCV genotype, presence of cirrhosis, and prior treatment history. The goal is to achieve a sustained virologic response (SVR), defined as undetectable HCV RNA in the patient’s blood 12 to 24 weeks after completing treatment, effectively indicating the virus has been cleared. The effects of achieving an SVR are long-lasting and potentially lifelong, significantly reducing or eliminating the risk of liver disease progression.

Is it safe to consume alcohol while taking this medicine?

There are no specific studies that have addressed the interaction between alcohol consumption and Viekira Pak. However, considering the liver is the primary site of HCV infection and damage, and given the hepatotoxic potential of alcohol, patients are generally advised to avoid alcohol consumption during treatment. Alcohol can exacerbate liver damage, potentially diminishing the efficacy of the treatment and leading to adverse outcomes.

Is this a habit forming medicine?

Viekira Pak does not contain any narcotic or psychoactive components and has no known potential for abuse or dependency. Its use is strictly for the treatment of HCV and is not associated with habit formation.

Can this medicine be taken during pregnancy?

Viekira Pak falls under FDA Pregnancy Category B for ombitasvir, paritaprevir, and ritonavir, and Category C for dasabuvir, indicating no evidence of harm to the fetus in animal studies but lacking adequate and well-controlled studies in pregnant women. It is recommended to avoid its use during pregnancy due to the potential risks and the lack of comprehensive human data. If treatment with Viekira Pak is considered necessary, it should be initiated only after a thorough risk-benefit analysis.

Can this medicine be taken while breast-feeding?

It is unknown whether the components of Viekira Pak are excreted in human breast milk. Due to the potential for adverse reactions in nursing infants from Viekira Pak, and the importance of the drug to the mother, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the medication to the mother.

Uses

This product contains 2 different tablets. One tablet contains 3 medications (“multi-drug”): ombitasvir, paritaprevir, and ritonavir. The other tablet contains dasabuvir.This product is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Ombitasvir, paritaprevir, and dasabuvir 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.

How to use Viekira Pak

Read the Medication Guide provided by your pharmacist before you start taking this product and each time you get a refill. Follow the instructions very closely since this product contains tablets with different drugs. If you have any questions, ask your doctor or pharmacist.

Take this product by mouth with meals as directed by your doctor. Take the multi-drug tablets and dasabuvir once every morning. Then take dasabuvir once every evening.

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(s) 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.

Warnings

Although this product is used to treat hepatitis C, it may rarely cause serious liver problems. It may make other liver problems (such as hepatitis B) get worse. Before starting this product, tell your doctor if you have ever had hepatitis B or any other liver problems. 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.

Interactions

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: efavirenz, ethinyl estradiol-containing products (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 product 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, cobicistat, elagolix, gemfibrozil, mitotane, rifampin, St. John’s wort, thioridazine, among others.

Do not take this product with other products that contain ritonavir.

Precautions

Before taking this product, tell your doctor or pharmacist if you are allergic to any of the drugs; 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.

This product, in combination with ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may harm an unborn baby. Reliable forms of birth control must be used whenever at least one sexual partner is using these medicines together . Female patients should continue using birth control for 9 months after stopping treatment. Male patients should continue 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 this product passes into breast milk. Consult your doctor before breast-feeding.

Overdose

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. 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.

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. 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.

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