Elbasvir/Grazoprevir (Oral)

Elbasvir/grazoprevir combination is used in the treatment of patients with hepatitis C infection. It may be used with or without the drug, ribavirin.

Overview

Elbasvir/grazoprevir combination is a drug that is used to treat people suffering from chronic hepatitis C infection. This drug may be used independently or in tandem with another medicine called ribavirin.

The drug works by reducing the amount of the virus present in your body that is responsible for causing hepatitis C. Once the levels of virus are reduced, your body is more able to fight off the infection that causes the disease, enabling your liver to recover. Left untreated, complications can occur, including liver cancer or liver cirrhosis.

Note that this medication will not prevent you from spreading hepatitis C infection to others.

This drug causes serious birth defects and must not be taken by pregnant women, especially if it is to be used in conjunction with ribavirin.

In the US, elbasvir/grazoprevir combination is sold under the brand name, Zepatier. The medication comes in tablet form and is only available with a prescription from your medical practitioner.

Conditions treated

  • Hepatitis C virus

Type of medicine

  • Antiviral
  • Tablet

Side effects

As well as its desired effects, some drugs can also cause unwanted side effects. Not all patients experience the following effects, but if they do occur, you should consult your GP, as you might need further medical assistance:

  • Upper stomach pain
  • Unusual tiredness
  • Nausea and vomiting
  • Loss of appetite
  • Light-colored stools
  • Jaundice
  • Fever with or without chills
  • Dark urine

Some patients taking elbasvir/grazoprevir combination may notice that they suffer from headaches. Be assured that these effects usually resolve themselves once your body becomes acclimatized to the medication. Your doctor will suggest ways in which you can manage these effects. However, if the headaches persist and do not go away after a week or so, check with your doctor.

There may be other effects noted by some patients that are not mentioned in this guide. If you do suffer from any other effects, check with your medical practitioner.

Dosage

In order to clear up hepatitis C infection, you must complete your course of treatment with Zepatierâ„¢, with or without ribavirin, even if you begin to see signs of improvement after a day or so. Failure to complete the course of tablets could see the infection recurring. It is also important to maintain a constant level of the drug within your body, so you must take your tablets at the same times each day, preferably at regularly spaced intervals.

Your prescription of elbasvir/grazoprevir combination will be issued to you with a product information guide. Be sure to read the guide fully and ask your GP if you have any queries. Each tablet comprises 100 mg grazoprevir and 50 mg elbasvir.

The medicine can be taken with or without food. Do not chew or crush the tablets; swallow them whole.

Note that the dose of elbasvir/grazoprevir combination prescribed will vary between patients. You must follow the instructions given on the product label or your doctor's directions. The information given here is only a guide based on the average dosage rate. If your dose is different, do not change it unless instructed to do so by your GP.

Your dose of elbasvir/grazoprevir combination will depend on the strength of the tablets. In addition, the frequency of the doses and the overall length of your course of treatment with this medicine will depend on the condition that you are being treated for and how your body responds to the drug.

Tablets to treat chronic hepatitis C (with or without ribavirin):

  • Adults: Take one tablet daily.
  • Children: Your child's GP will determine the dose.

In the event that you miss one of your tablets, you should try to take it as soon as you can. If it is nearly time for your scheduled dose, miss it out and revert to your usual regimen. Never take twice the dose.

Interactions

Some drugs must never be taken together, as to do so may cause a serious interaction. However, sometimes it may be possible to use two medications together, although your doctor may change the dose or frequency of one or both.

Before you begin taking elbasvir/grazoprevir combination, you should tell your GP if you are taking any other drugs, especially any of those listed below:

  • Tipranavir
  • St John's Wort
  • Saquinavir
  • Ritonavir
  • Rifampin
  • Phenytoin
  • Mitotane
  • Lopinavir
  • Fosphenytoin
  • Enzalutamide
  • Eltrombopag
  • Efavirenz
  • Tacrolimus
  • Rosuvastatin
  • Primidone
  • Phenobarbital
  • Nafcillin
  • Modafinil
  • Ketoconazole
  • Etravirine
  • Darunavir
  • Cyclosporine
  • Conivaptan
  • Cobicistat
  • Carbamazepine
  • Bosentan
  • Atorvastatin
  • Atazanavir

Sometimes, it may not be advisable to eat certain food groups, or to use alcohol or tobacco with some drugs. You should discuss this aspect of your treatment plan with your medical practitioner.

Do not take any of the following medicines while you are taking ZepatierTM:

  • Tegretol®
  • Sustiva®
  • Sandimmune®
  • Rimactane®
  • Reyataz®
  • Neoral®
  • Kaletra®
  • Invirase®
  • Gengraf®
  • Dilantin®
  • Rifadin®

Warnings

Before you decide to use any form of medicine, you should weigh up the benefits against the risks. To ensure that you are fully informed, talk to your doctor about this aspect of your care.

If you have ever suffered any odd reactions to elbasvir/grazoprevir combination or to any other prescription or over the counter drug, you must tell your GP. In addition, you should mention any allergies that you know you have to certain food groups, animal by-products, food colors, or food preservatives.

Elderly patients

Elbasvir/grazoprevir combination should be used with caution in geriatric patients, as they are more likely to have liver problems and other age related health conditions that could affect how this drug works.

Pregnancy and breastfeeding

If you are pregnant, you must tell your doctor before you start taking elbasvir/grazoprevir combination. If you are taking elbasvir/grazoprevir combination together with ribavirin, you must not use it while you are pregnant as it may cause birth defects in your baby. Note that if your sexual partner is taking elbasvir/grazoprevir combination, you must use an effective form of contraception such as contraceptive pills or condoms. Do not try to become pregnant or stop using contraception until at least six months following the conclusion of your treatment with elbasvir/grazoprevir combination.

Female patients and female partners of men who are taking this drug with ribavirin must have a pregnancy test before treatment. You should also be tested for pregnancy each month during the course of treatment and for six months following it.

Although it is unknown if elbasvir/grazoprevir combination or ribavirin passes into breast milk, you should not breastfeed while you are taking these drugs. Ask your GP or midwife for further advice on alternative forms of feeding for your infant. Do not express breast milk for use at a later date.

Medical history

Some existing or historical medication conditions can affect how elbasvir/grazoprevir combination works. Tell your doctor if you have any history of severe to moderate liver disease. If so, you must not take elbasvir/grazoprevir combination.

While you are taking elbasvir/grazoprevir combination, you must attend your doctor for regular progress checks to make sure that the drug is working correctly. You may also need to have blood taken so that it can be checked for unwanted effects.

If you notice any of the following effects, you should see your doctor straight away, as these symptoms could be signs of a serious liver disease:

  • Pale stools
  • Feeling weak or very tired
  • Tenderness or pain in the upper stomach area
  • Dark urine
  • Poor appetite
  • Nausea
  • Vomiting
  • Jaundice

You should not take any other form of medication while you are using elbasvir/grazoprevir combination, including over the counter drugs, vitamin supplements, and herbal remedies.

Do not share your medication with anyone else.

Prior to starting to use elbasvir/grazoprevir combination, you should have tests for liver function, hepatitis B, and hepatitis C. These tests should take place before, during and for six months following your treatment. Do not miss any of your clinic or hospital appointments for these tests.

Storage

You should store your supply of elbasvir/grazoprevir combination in its original container. Keep the tablets out of heat and direct sunlight, and do not store them in a bathroom. Do not allow the tablets to become damp, as moisture will affect how this drug works.

Be sure to keep all your medicines well out of the reach of children and pets. If a pet does eat any of your tablets, contact your emergency vet for more advice immediately.

Dispose of any unwanted or out of date tablets responsibly. Do not throw them down the drain or toilet. Do not discard tablets in your trash where they could be found by children and mistaken for sweets. Wrap unwanted pills in a sealed bag and place them in the bottom of your garbage can. Alternatively, ask your pharmacist to dispose of the drugs for you.

Summary

Elbasvir/grazoprevir is a combination medicine that may be used to treat patients who are suffering from long-term hepatitis C infection. This drug may be used on its own or together with another drug called ribavirin.

It is important that you discuss your medical history in full with your GP, before you begin taking this drug. There are many other medicines that should not be used at the same time as elbasvir/grazoprevir combination. In addition, there are a number of medical conditions that may be adversely affected by using this drug.

Elbasvir/grazoprevir combination causes serious birth defects, when used with ribavirin. If you are pregnant, do not take this medication. If your male partner is taking this drug, you must use an effective form of contraception throughout treatment and for six months afterwards.

Throughout your course of treatment with elbasvir/grazoprevir combination, you will need to attend for regular check-ups, including blood tests to make sure that the medication is working and that you are not suffering from side effects.

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