Patient leaflet - Maviret
1. What Maviret is and what it is used for
Maviret is an antiviral medicine used to treat adults and children 3 years and older with long-term (‘chronic’) hepatitis C. This is an infectious disease that affects the liver, caused by the hepatitis C virus. Maviret contains the active substances glecaprevir and pibrentasvir.
Maviret works by stopping the hepatitis C virus from multiplying and infecting new cells. This allows the infection to be eliminated from the body.
2. What you need to know before you take Maviret
Do not take Maviret if:
- you are allergic to glecaprevir, pibrentasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
- you have severe liver problems other than from hepatitis C.
- you are taking the following medicines:
- atazanavir (for HIV infection)
- atorvastatin or simvastatin (to lower blood cholesterol)
- carbamazepine, phenobarbital, phenytoin, primidone (normally used for epilepsy)
- dabigatran etexilate (to prevent blood clots)
- ethinyl oestradiol-containing medicines (such as contraception medicines, including vaginal rings and tablets)
- rifampicin (for infections)
- St. John’s wort (Hypericum perforatum), (herbal remedy used for mild depression).
Do not take Maviret if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Maviret.
Warnings and precautions
Talk to your doctor if you have the following because your doctor may want to check you more closely:
- liver problems other than hepatitis C
- current or previous infection with the hepatitis B virus
- diabetes. You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Maviret. Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Maviret.
Blood tests
Your doctor will test your blood before, during and after your treatment with Maviret. This is so that your doctor can decide if:
- you should take Maviret and for how long
- your treatment has worked and you are free of the hepatitis C virus.
Children
Do not give this medicine to children under 3 years of age or weighing less than 12 kg. The use of Maviret in children under 3 years of age or weighing less than 12 kg has not yet been studied.
Other medicines and Maviret
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor or pharmacist before taking Maviret, if you are taking any of the medicines in the table below. The doctor may need to change your dose of these medicines.
| Medicines you must tell your doctor about before taking Maviret | |
| Medicine | Purpose of the medicine |
| ciclosporin, tacrolimus | to suppress the immune system |
| darunavir, efavirenz, lopinavir, ritonavir | for HIV infection |
| digoxin | for heart problems |
| fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin | to lower blood cholesterol |
| warfarin and other similar medicines* | to prevent blood clots |
*Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Maviret.
Pregnancy and contraception
The effects of Maviret during pregnancy are not known. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine, as the use of Maviret in pregnancy is not recommended. Contraceptive medicines that contain ethinylestradiol must not be used in combination with Maviret.
Breast-feeding
Talk to your doctor before taking Maviret if you are breast-feeding. It is not known whether the two medicines in Maviret pass into breast milk.
Driving and using machines
Maviret should not affect your ability to drive or use any tools or machines.
Maviret contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
3. How to take Maviret
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long you need to take Maviret for. Maviret tablets are intended for adults, children 12 years and older, or children weighing 45 kg or more. Maviret coated granules are intended for children aged 3 years to less than 12 years and weighing 12 kg to less than 45 kg.
How much to take
The recommended dose for adults, children aged 12 years and older, or children weighing at least 45 kg is three tablets of Maviret 100mg/40mg taken together, once a day.
Three tablets in one blister is the daily dose.
How to take
- Take the tablets with food.
- Swallow the tablets whole.
- Do not chew, crush or break the tablets as it may affect the amount of Maviret in your blood.
If you are sick (vomit) after taking Maviret it may affect the amount of Maviret in your blood. This may make Maviret work less well.
- If you vomit less than 3 hours after taking Maviret, take another dose.
- If you vomit more than 3 hours after taking Maviret, you do not need to take
another dose until your next scheduled dose.
If you take more Maviret than you should
If you accidentally take more than the recommended dose, contact your doctor or go to the nearest hospital straight away. Take the medicine pack with you so that you can show the doctor what you have taken.
If you forget to take Maviret
It is important not to miss a dose of this medicine.
If you do miss a dose, work out how long it is since you should have last taken Maviret:
- If you notice within 18 hours of the time you usually take Maviret take the dose as soon as
possible. Then take the next dose at your usual time.
- If you notice 18 hours or more after the time you usually take Maviret, wait and take the next dose at your usual time. Do not take a double dose (two doses too close together).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist if you notice any of the following side effects:
Very common: may affect more than 1 in 10 people
- feeling very tired (fatigue)
- headache
Common: may affect up to 1 in 10 people
- feeling sick (nausea)
- diarrhoea
- feeling weak or lack of energy (asthenia)
Uncommon: may affect up to 1 in 100 people
- swelling of the face, lips, tongue, throat, abdomen, arms or legs
Not known: cannot be estimated from the available data
- itching
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Maviret
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.
This medicine does not require any special storage.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Maviret contains
- The active substances are glecaprevir and pibrentasvir. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir.
- The other ingredients are:
-
– Tablet core: copovidone (Type K 28), vitamin E polyethylene glycol succinate, silica, anhydrous colloidal, propylene glycol monocaprylate (type II), croscarmellose sodium, sodium stearyl fumarate.
-
– Tablet film-coating: hypromellose (E464), lactose monohydrate, titanium dioxide, macrogol 3350, iron oxide red (E172).
What Maviret looks like and contents of the pack
Maviret tablets are pink, oblong, curved on both sides (biconvex), film-coated tablets with dimensions of 18.8 mm x 10.0 mm and debossed on one side with ‘NXT’.
Maviret tablets are packed into foil blisters, each containing 3 tablets. Maviret is available in a pack of 84 tablets as 4 cartons, each containing 21 film-coated tablets.
Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
Manufacturer
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
or
AbbVie Logistics B.V
Zuiderzeelaan 53
8017 JV Zwolle
Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien AbbVie SA Tél/Tel: +32 10 477811 | Lietuva AbbVie UAB Tel: +370 5 205 3023 |
| Efc^rapufl A6Bu EOOfl Tea.: +359 2 90 30 430 | Luxembourg/Luxemburg AbbVie SA Belgique/Belgien Tel/Tel: +32 10 477811 |
| Česká republika AbbVie s.r.o. Tel: +420 233 098 111 | Magyarorszag AbbVie Kft. Tel.: +36 1 455 8600 |
| Danmark AbbVie A/S Tlf: +45 72 30–20–28 | Malta V.J.Salomone Pharma Limited Tel: +356 22983201 |
| Deutschland AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (gebührenfrei) | Nederland AbbVie B.V. Tel: +31 (0)88 322 2843 |
Tel: +49 (0) 611 / 1720–0
| Eesti AbbVie OÜ Tel: +372 623 1011 | Norge AbbVie AS Tlf: +47 67 81 80 00 |
| EXXáSa AbbVie OAPMAKEYTIKH A.E. Tql: +30 214 4165 555 | Österreich AbbVie GmbH Tel: +43 1 20589–0 |
| Espana AbbVie Spain, S.L.U. Tel: +34 91 384 09 10 | Polska AbbVie Polska Sp. z o.o. Tel.: +48 22 372 78 00 |
| France AbbVie Tél: +33 (0)1 45 60 13 00 | Portugal AbbVie, Lda. Tel: +351 (0)21 1908400 |
| Hrvatska AbbVie d.o.o. Tel: +385 (0)1 5625 501 | Romania AbbVie S.R.L. Tel: +40 21 529 30 35 |
| Ireland AbbVie Limited Tel: +353 (0)1 4287900 | Slovenija AbbVie Biofarmacevtska družba d.o.o. Tel: +386 (1)32 08 060 |
| island Vistor hf. Simi: +354 535 7000 | Slovenská republika AbbVie s.r.o. Tel: +421 2 5050 0777 |
| Italia AbbVie S.r.l. Tel: +39 06 928921 | Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411 200 |
| Kvnpog Lifepharma (Z.A.M.) Ltd Tql: +357 22 34 74 40 | Sverige AbbVie AB Tel: +46 (0)8 684 44 600 |
| Latvija AbbVie SIA Tel: +371 67605000 | United Kingdom (Northern Ireland) AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561090 |
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.