1 What is Olysio?

Brand: Olysio

Generic: Simeprevir

Olysio is an antiviral agent used in combination with injectable peginterferon alfa (PegasysВ®, PegintronВ®) and ribavirin (CopegusВ®, RebetolВ®), or with sofosbuvir (SovaldiВ®), for the treatment of chronic hepatitis C infection.

These drugs are used in patients with liver disease who have not been treated before or who have received other drugs that did not work well. This drug requires a prescription.

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2 What to Know Before Using

If you are about to start Olysio, speak with your doctor about what you need to know. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Studies in children regarding the correlation of age to the effects of simeprevir have not been performed while safety and efficacy have not been established.

No problems in the elderly have been recorded to date. Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate.

Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Abiraterone
  • Afatinib
  • Aliskiren
  • Ambrisentan
  • Amiodarone
  • Amprenavir
  • Apixaban
  • Aprepitant
  • Atazanavir
  • Atorvastatin
  • Boceprevir
  • Bosentan
  • Ceritinib
  • Ciprofloxacin
  • Cisapride
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclosporine
  • Dabrafenib
  • Daclatasvir
  • Darunavir
  • Dasabuvir
  • Delavirdine
  • Digoxin
  • Diltiazem
  • Disopyramide
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Dronedarone
  • Efavirenz
  • Eliglustat
  • Erythromycin
  • Etravirine
  • Ezetimibe
  • Fexofenadine
  • Flecainide
  • Fluconazole
  • Fosamprenavir
  • Fosaprepitant
  • 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
  • Nintedanib
  • 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
  • Topotecan
  • Triazolam
  • Valsartan
  • Vardenafil
  • Verapamil
  • Vinblastine
  • Vincristine
  • Vincristine Sulfate Liposome
  • or Voriconazole

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco. Inform your healthcare professional if you have any other medical problems such as liver disease, history of liver transplant, or sulfa allergy.

3 Proper Usage

To use Olysio properly, you must follow all instructions given by your doctor. This drug must be taken together with peginterferon alfa and ribavirin, or with sofosbuvir, for the full time of treatment to ensure complete drug therapy.

This drug must be used on a regular schedule to keep it at a maintained level in the blood for optimal effects. The capsule must be swallowed whole. Crushing, breaking, or chewing it is not recommended. This drug must be taken with food.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults with hepatitis C virus infection using the combination with peginterferon alfa and ribavirin, or with sofosbuvir, are given 50 milligrams once a day. Use and dose in children must be determined by your healthcare professional. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Olysio, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

Unwanted effects can be screened using blood tests. Using this drug with ribavirin while you are pregnant can harm your unborn baby. These drugs may also cause birth defects if the father is using it when his sexual partner becomes pregnant.

Inform you healthcare professional immediately if a pregnancy occurs while you are using these drugs. You will be advised to undergo a pregnancy test to make sure you are not pregnant. You must have a negative pregnancy test before you will be allowed to use this drug with ribavirin.

It is recommended to use two forms of birth control during treatment and for 6 months after treatment ends. You should test for pregnancy every month while you are using this drug, and for 6 months after your treatment ends.

Takin OlysioВ® in combination with sofosbuvir together with amiodarone is not recommended, as these drugs together may cause bradycardia which can manifest as fainting, dizziness, lightheadedness, trouble breathing, chest pain, or tiredness or weakness.

Check with your healthcare professional immediately if you have symptoms of a serious liver problem such as pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin.

This drug 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.

It is advised to stay out of the sun as much as possible and use a sunscreen or sun-blocking lotion when you are outdoors. Wear protective clothing and hats. Consult with your healthcare professional before taking any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Olysio. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, or scaly skin, difficult or labored breathing, increased sensitivity of the skin to sunlight, rash with flat lesions or small raised lesions on the skin, rash, itching skin redness or other discoloration of the skin, severe sunburn, or tightness in the chest.

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.