How does this medication work? What will it do for me?

This medication is a combination of 2 medications: glecaprevir and pibrentasvir. These medications both belong to the class of medications called direct-acting antivirals.

Together, these medications are used to treat chronic hepatitis C infection caused by specific genetic variants of the hepatitis C virus (HCV).

Glecaprevir and pibrentasvir work by blocking the reproduction of the virus at different stages. This helps to stop the virus from multiplying and allows the body to get rid of the virus.

This medication does not prevent the spread of hepatitis C through sexual contact or blood contamination, and it does not prevent you from being reinfected with the hepatitis C virus.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

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What form(s) does this medication come in?

Each pink, film-coated, oblong, biconvex tablet debossed with "NXT" on one side contains 100 mg of glecaprevir and 40 mg of pibrentasvir. Nonmedicinal ingredients: copovidone (type K 28), vitamin E polyethylene glycol succinate, colloidal silicon dioxide, propylene glycol monocaprylate (type II), croscarmellose sodium, sodium stearyl fumarate; film coating: hypromellose 2910, lactose monohydrate, titanium dioxide, polyethylene glycol 3350, and iron oxide red.

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How should I use this medication?

The recommended dose of this medication for adults and adolescents aged 12 and older is 3 tablets taken by mouth, once daily for 8, 12 or 16 weeks. The length of time you take glecaprevir - pibrentasvir depends on the type of HCV infection you have, other medications that you have previously used to treat HCV and whether you have cirrhosis (scar tissue) on your liver.

This medication should be taken with food. Swallow the tablets whole with some water. Do not crush, chew, or break the tablets.

Finish all this medication, even if you have started to feel better. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, and it is less than 18 hours since the missed dose, take it as soon as possible and continue with your regular schedule. If it is less than 6 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

If you vomit after taking a dose of this medication and it has been less than 3 hours since you took the dose, take another dose. If you vomit and it has been more than 3 hours since you took the dose, do not take another dose.

Store this medication in its original container at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to glecaprevir, pibrentasvir, or any ingredients of the medication
  • have severely reduced liver function
  • are taking any of the following medications:
    • atazanavir
    • atorvastatin
    • dabigatran
    • ethinyl estradiol
    • rifampin
    • simvastatin

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • diarrhea
  • headache
  • itchiness
  • nausea
  • tiredness

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., swelling of face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Hepatitis B (HBV) and hepatitis C co-infection: The safety and effectiveness of using this medication have not been established for people who also have hepatitis B infection. If you have hepatitis B infection, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Some of the medications used to treat HBV infection are affected by glecaprevir and pibrentasvir and may contribute to severe side effects.

Hepatitis B reactivation: People who have hepatitis B infection that is dormant may experience a return of the infection, causing further liver dysfunction or liver failure. If you have a history of hepatitis B infection, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this mediation, and whether any special monitoring is needed.

If you experience symptoms of worsening liver function, such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lactose intolerance: This medication is prepared with lactose. If you have lactose or galactose intolerance you should not take this medication.

Liver function: If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication is not recommended for people with reduced liver function.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Other medications for hepatitis B and hepatitis C: There are several combination medications available to treat viral infections causing hepatitis. They may also include ingredients that work the same way as the ingredients in this medication. Taking 2 combination medications is dangerous and can cause fatal drug interactions. With your doctor or pharmacist, review the ingredients of any medication that may be prescribed and compare it to the medications you are currently taking.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if glecaprevir - pibrentasvir passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under the age of 12.

What other drugs could interact with this medication?

There may be an interaction between glecaprevir - pibrentasvir and any of the following:

  • aliskiren
  • amiodarone
  • antihistamines (e.g., bilastine, cetirizine, desloratadine, loratadine)
  • antipsychotics (e.g., aripiprazole, clozapine, paliperidone, pimozide, risperidone)
  • apalutamide
  • azole antifungals (e.g., itraconazole, ketoconazole)
  • bosentan
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • carvedilol
  • cobicistat
  • colchicine
  • cyclosporine
  • dabigatran
  • diabetes medications (e.g., canagliflozin, gliclazide, glyburide, insulin, linagliptin, metformin, rosiglitazone, sitagliptin)
  • digoxin
  • edoxaban
  • elagolix
  • eltrombopag
  • enzalutamide
  • everolimus
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • flibanserin
  • gemfibrozil
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • lomitapide
  • loperamide
  • macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
  • medications to treat cancer (e.g., doxorubicin, etoposide, methotrexate, paclitaxel, trabectedin, venetoclax, vinblastine, vincristine)
  • modafinil
  • morphine
  • nadolol
  • naloxegol
  • other hepatitis C antivirals (e.g., , grazoprevir, ledipasvir, paritaprevir, sofosbuvir)
  • protein kinase inhibitors (e.g., afatinib, bosutinib, crizotinib, imatinib, nilotinib)
  • quinidine
  • quinine
  • rifabutin
  • rifampin
  • rifaximin
  • rivaroxaban
  • romidepsin
  • St. John's wort
  • seizure medications (e.g., carbamazepine, phenobarbital, phenytoin, primidone)
  • silodosin
  • sirolimus
  • "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
  • tacrolimus
  • tedizolid
  • teriflunomide
  • theophylline
  • tizanidine
  • tolvaptan
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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