12.5 mg/75 mg/50 mg film-coated tablets
ombitasvir/paritaprevir/ritonavir
What Viekirax is and what it is used for
Viekirax contains the active substances ombitasvir, paritaprevir and ritonavir. It is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus ).
The combined effect of the three active substances stops the hepatitis C virus from multiplying and infecting new cells, eventually removing the virus from the blood. Ombitasvir and paritaprevir block two proteins that are important for viruses to multiply. Ritonavir acts as a booster and prolongs the effect of paritaprevir in the body.
Viekirax tablets are often taken together with other antiviral drugs such as dasabuvir and ribavirin. Your doctor will tell you which of these medicines you should take with Viekirax.
It is very important that you also read the package leaflets for the other antiviral medicines that you take with Viekirax. If you have any questions about the medicine, ask your doctor or pharmacist.
2. What you need to know before you use Viekirax
Do not use Viekirax
- If you are allergic to ombitasvir, paritaprevir, ritonavir, or any of the other ingredients of this medicine (listed in section 6).
- If you have moderate to severe liver disease in addition to hepatitis C.
- If you are taking any of the medicines listed in the following table. This is because serious or life-threatening side effects can occur when Viekirax is taken with these medicines. These medicines can affect how Viekirax works and Viekirax can affect how these medicines work.
| Medicines you must not take with Viekirax | |
|---|---|
| Drug or active substance | Purpose of the medicine |
| alfuzosin | against enlarged prostate |
| amiodarone , disopyramide , dronedarone | used to counteract irregular heartbeats |
| astemizole, terfenadine | against allergic symptoms. These medicines may be available without a prescription. |
| atorvastatin, lovastatin, simvastatin , lomitapide | to lower blood cholesterol |
| carbamazepine, phenytoin , phenobarbital | against epilepsy |
| cisapride | for the relief of certain stomach problems |
| clarithromycin, fusidic acid, rifampicin, telithromycin | against bacterial infection |
| colchicine in patients with severe liver or kidney disease | for the treatment of gout attacks |
| conivaptan | so that the sodium level in the blood becomes normal |
| efavirenz, etravirine, lopinavir/ritonavir, saquinavir, tipranavir, nevirapine, indinavir, cobicistat | against HIV – infection |
| apalutamide, enzalutamide | against prostate cancer |
| ergotamine , dihydroergotamine | for migraine headaches |
| ergonovine, methylergometrine | used during childbirth |
| ethinylestradiol-containing medicines such as those found in most birth control pills or vaginal rings used as contraceptives | contraceptive |
| itraconazole, ketoconazole , posaconazole, voriconazole | against fungal infections |
| midazolam, triazolam (when taken by mouth) | against anxiety and sleep difficulties |
| mitotane | against symptoms from malignant tumors in the adrenal glands |
| pimozide, lurasidone | against schizophrenia |
| quetiapine | against schizophrenia, bipolar disorder, and severe depression |
| quinidine | against abnormal heart rhythm or malaria |
| ranolazine | for chronic angina (chest pain) |
| salmeterol | against asthma |
| sildenafil | when used to treat a heart and lung disease called ‘pulmonary arterial hypertension |
| St. John’s wort (hypericum perforatum) | herbal medicine for mild depression and mild concern. This medicine is available without a prescription. |
| ticagrelor | prevents the blood from clotting |
Do not take Viekirax if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Viekirax.
Warnings and precautions
Talk to your doctor or pharmacist before taking Viekirax if you:
- have a liver disease other than hepatitis C;
- have or have previously had an infection with the hepatitis B virus, as the doctor may then want to monitor you more closely.
- have diabetes. Your blood sugar levels may need to be monitored more closely and/or your diabetes medication may need to be adjusted after you start taking Viekirax. In some diabetic patients, blood sugar levels have fallen (hypoglycemia) after treatment with medicines such as Viekirax has been started.
When taking Viekirax together with dasabuvir, tell your doctor if you get the following symptoms as they may be signs of worsening liver problems:
- nausea, vomiting, or losing your appetite
- have yellow-colored skin or yellow-colored eyes
- your urine is darker than usual
- confusion
- notices swelling in the stomach area
If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before taking Viekirax.
Tell the doctor if you have previously been depressed or mentally ill. Depression with suicidal ideation and suicidal behavior has been reported in some patients taking this medicine, especially in those with a history of depression or mental illness, or in those taking ribavirin with this medicine. You or your healthcare provider should also tell your doctor immediately if your behavior or mood changes and if you have suicidal thoughts.
Blood samples
Your doctor will take blood samples before, during, and after your treatment with Viekirax. This is so that your doctor can:
- Decide which other medicines to take with Viekirax and for how long.
- Confirm that the treatment has worked and that you are no longer carrying the hepatitis C virus.
- Discover the side effects of Viekirax or other antiviral drugs (such as “dasabuvir” and “ribavirin”) that your doctor has prescribed for you to use together with Viekirax.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age. The use of Viekirax in children and adolescents has not yet been studied.
Other medicines and Viekirax
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There are certain medicines that you must not take with Viekirax – see the previous table “Medicines you must not take with Viekirax”.
Before taking Viekirax, tell your doctor or pharmacist if you are using any of the following medicines in the table below. Your doctor may need to change the dose of one of these medicines. Tell your doctor or pharmacist before taking Viekirax if you are also using hormonal contraceptives. See the section on contraception below.
| Medicines that you must tell your doctor about before taking Viekirax | |
|---|---|
| Drug or active substance | Purpose of the medicine |
| alprazolam, diazepam | against anxiety, panic attacks, and sleep problems |
| ciclosporin, everolimus, sirolimus, tacrolimus | to inhibit the immune system |
| cyclobenzaprine, carisoprodol | against muscle cramps |
| colchicine in patients with normal renal and hepatic function | for the treatment of gout attacks or familial Mediterranean fever |
| digoxin , amlodipine, nifedipine, valsartan, diltiazem, verapamil, candesartan, losartan | against heart problems or high blood pressure |
| encorafenib | against skin cancer |
| furosemide | against fluid accumulation in the body |
| fostamatinib | against low platelet counts |
| hydrocodone | against pain |
| levothyroxine | against thyroid problems |
| rilpivirine, darunavir, atazanavir | against HIV – infection |
| omeprazole, lansoprazole, esomeprazole | against stomach ulcers or other stomach problems |
| ibrutinib, imatinib | for the treatment of certain types of blood cancer |
| fluvastatin, pitavastatin, pravastatin, rosuvastatin | to lower blood cholesterol |
| dabigatran, warfarin | to thin the blood |
| fexofenadine | against hay fever |
| s-mephenytoin | against epilepsy |
| sulfasalazine | against inflammatory stomach diseases |
| repaglinide | to lower blood sugar |
| erythromycin | against bacterial infection |
| steroid or corticosteroid medicines (eg fluticasone ) | against many different diseases, including serious diseases and allergies |
| trazodone | against anxiety and depression |
| warfarin and other similar medicines called vitamin K antagonists* | to thin the blood |
* Your doctor may need to take blood samples from you more often to see how well your blood is clotting.
If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before taking Viekirax.
Pregnancy, breastfeeding, and fertility
Pregnancy and contraception
The effect of Viekirax on pregnancy is not known. Viekirax should not be used during pregnancy or by women of childbearing potential who are not using effective contraception.
- You or your partner must use an effective method of contraception during treatment. Contraceptives containing ethinylestradiol cannot be used together with Viekirax. Ask your doctor which birth control method is best for you.
Extreme caution is required if Viekirax is taken together with ribavirin. Ribavirin can cause serious birth defects. Ribavirin remains in the body for a long time after treatment has ended and an effective method of contraception is required both during treatment and for some time afterward.
- There is a risk of birth defects when ribavirin is used by female patients who become pregnant.
- There is also a risk of birth defects if ribavirin is used by a male patient whose female partner becomes pregnant.
- Read the contraceptive method section of the ribavirin package insert very carefully. Both men and women must read the information.
- If you or your partner become pregnant during treatment with Viekirax and ribavirin or in the months that follow, contact your doctor immediately.
Breast-feeding
You should not breastfeed during treatment with Viekirax. It is not known whether the active substances in Viekirax (ombitasvir, paritaprevir, and ritonavir) pass into breast milk.
Driving ability and use of machinery
Some patients have reported fatigue when using Viekirax with other medicines for hepatitis C infection. If you feel tired, do not drive or use machines.
How to use Viekirax
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Viekirax tablets are usually taken with other antiviral drugs such as “dasabuvir” and “ribavirin”.
How much to take
The recommended dose is two tablets taken together in the morning.
How to take
- Take the tablets in the morning with food. The type of food is not important.
- Swallow the tablets whole with water.
- The tablets should not be chewed, crushed, or split as they may have a bitter taste.
How long you should use Viekirax
You will take Viekirax for 8, 12, or 24 weeks. Your doctor will tell you how long your treatment will last. Do not stop taking Viekirax unless your doctor tells you to. You must complete the entire treatment. This will give the drugs the best chance of curing the hepatitis C virus infection.
If you have used too much Viekirax
If you accidentally take more than the recommended dose, contact your doctor or the nearest hospital immediately. Take the medication packaging with you so that you can easily describe what you have taken.
If you forget to use Viekirax
You mustn’t miss a dose of this medicine. If you miss a dose and it is:
- more than 12 hours until the next dose – take the missed dose with food as soon as possible.
- less than 12 hours until the next dose – do not take the missed dose, take your next dose as usual, with food.
Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Stop taking Viekirax and contact your doctor or seek medical attention immediately if any of the following happen:
Side effects when Viekirax is used with or without dasabuvir and with or without ribavirin:
Frequency not known: cannot be estimated from the available data
- The severe allergic reaction may include signs such as:
- Difficulty breathing or swallowing
- Dizziness or a feeling of inebriation which may be due to low blood pressure
- Swelling of the face, lips, tongue, or throat
- Skin rash and itching
- Worsened liver problems. Symptoms include:
- Nausea, vomiting, or loss of appetite
- Yellowing of the skin or eyes
- Your urine is darker than normal
- Confusion
- Noticed swelling in your stomach area
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist if you experience any of the following side effects.
Side effects when Viekirax is used with dasabuvir:
Common: may affect up to 1 in 10 people
- Itching
Rare: may affect up to 1 in 1,000 people
- Swelling of layers of skin that can affect any part of the body including the face, tongue, or throat, and can make it difficult to swallow or breathe ( angioedema )
Side effects when Viekirax is used with dasabuvir and ribavirin:
Very common: may affect more than 1 in 10 people
- Feeling of tiredness
- Nausea
- Itching
- Sleep problems ( insomnia )
- The feeling of weakness or lack of energy ( asthenia )
- Diarrhea
Common: may affect up to 1 in 10 people
- Anemia (low number of red blood cells )
- Vomiting
Uncommon: may affect up to 1 in 100 people
- Dehydration
Rare: may affect up to 1 in 1,000 people
- Swelling of layers of skin that can affect any part of the body including the face, tongue, or throat, and can make it difficult to swallow or breathe ( angioedema )
How to store Viekirax
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- One tablet contains 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir.
- Other ingredients are:
- Tablet core: copovidone, tocopherol, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E 551), sodium stearyl fumarate.
- Tablet film coating: poly(vinyl alcohol) (E 1203), macrogol (3350), talc (E 553b), titanium dioxide (E 171) and red iron oxide (E 172).
Appearance and package sizes of the medicine
Viekirax tablets are pink, oblong film-coated tablets of dimensions 18.8 mm x 10.0 mm, imprinted with ‘AV1’.
Viekirax tablets are packaged in blisters containing 2 tablets. One box contains 56 tablets (a multipack box with 4 inner boxes of 14 tablets each).
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
Information provided by:
AbbVie AB
Phone: +46 (0)8 684 44 600