What is Olysio?

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with simeprevir. HBV reactivation has been reported in hepatitis C virus (HCV)/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated

Simeprevir is used in combination with injectable peginterferon alfa (Pegasys®, Pegintron®) and ribavirin (Copegus®, Rebetol®), or with sofosbuvir (Sovaldi®), to treat chronic hepatitis C infection. These medicines are used in patients with liver disease (including cirrhosis) who have not been treated before or who have received other medicines that did not work well. Simeprevir is an antiviral agent.

This medicine is available only with your doctor's prescription.

To help clear up your infection completely, simeprevir must be taken together with peginterferon alfa and ribavirin, or with sofosbuvir, for the full time of treatment, even if you begin to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, simeprevir must be used on a regular schedule.

This medicine should come with a patient information leaflet. Read and follow the information carefully. Ask your doctor if you have any questions.

Swallow the capsule whole. Do not crush, break, or chew it. Take this medicine with food.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For hepatitis C virus infection, in combination with peginterferon alfa and ribavirin, or with sofosbuvir:
    • Adults—150 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or forget to take your medicine and it is less than 12 hours from the time your regular dose was scheduled, take the capsule as soon as you can. If you miss a dose and it is more than 12 hours from the time your regular dose was scheduled, skip the missed dose and take your next dose at the regular time. Call your doctor if you have questions about this.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of simeprevir in the pediatric population. Safety and efficacy have not been established.

Although appropriate studies on the relationship of age to the effects of simeprevir have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone
• Afatinib
• Aliskiren
• Ambrisentan
• Amiodarone
• Amprenavir
• Apixaban
• Aprepitant
• Atazanavir
• Atorvastatin
• Boceprevir
• Bosentan
• Ceritinib
• Ciprofloxacin
• Cisapride
• Clarithromycin
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Daclatasvir
• Darunavir
• Delavirdine
• Digoxin
• Diltiazem
• Disopyramide
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Efavirenz
• Erythromycin
• Etravirine
• Ezetimibe
• Fexofenadine
• Flecainide
• Fluconazole
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Glyburide
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ketoconazole
• Lapatinib
• Ledipasvir
• Levomilnacipran
• Loperamide
• Lopinavir
• Methotrexate
• Mexiletine
• Miconazole
• Midazolam
• Mifepristone
• Milk Thistle
• Modafinil
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nateglinide
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nilotinib
• Oxcarbazepine
• Paliperidone
• Phenobarbital
• Phenytoin
• Pixantrone
• Posaconazole
• Primidone
• Propafenone
• Propranolol
• Quinidine
• Ranolazine
• Repaglinide
• Rifampin
• Rifapentine
• Ritonavir
• Rivaroxaban
• Romidepsin
• Rosuvastatin
• Saquinavir
• Saxagliptin
• Sildenafil
• Silodosin
• Simvastatin
• Sirolimus
• Sitagliptin
• St John's Wort
• Tadalafil
• Talinolol
• Telaprevir
• Telithromycin
• Ticagrelor
• Tipranavir
• Tolvaptan
• Triazolam
• Valsartan
• Vardenafil
• Verapamil
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Voriconazole
• Warfarin

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hepatitis B, history of—Use with caution. May cause this condition to become active again.

• Liver disease, moderate or severe—Use is not recommended in patients with this condition.

• Liver transplant, history of—It is not known if this medicine will work in patients with this condition.

• Sulfa allergy, history of—Use with caution. May increase risk for rash or photosensitivity reactions.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine together with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using these medicines, tell your doctor right away.

To make sure you are not pregnant, your doctor may ask you to have a pregnancy test before you start using this medicine. You must have a negative pregnancy test before you will be allowed to use this medicine with ribavirin. Two forms of birth control must be used during treatment and for 6 months after treatment ends. You should test for pregnancy every month while you are using this medicine, and for 6 months after your treatment ends.

Do not take Olysio® in combination with sofosbuvir together with amiodarone. Using these medicines together may slow your heartbeat (bradycardia). Symptoms include fainting, dizziness, lightheadedness, trouble breathing, chest pain, or tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause rashes and skin reactions to sunlight, which can be severe and must be treated in the hospital. This usually occurs during the first 4 weeks of treatment with simeprevir, peginterferon alfa, and ribavirin combination. Stay out of the sun as much as possible. Use a sunscreen or sun-blocking lotion when you are outdoors. Wear protective clothing and hats. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, milk thistle, St. John's wort) or vitamin supplements.