How does this medication work? What will it do for me?
Simeprevir is an antiviral agent. Specifically, it belongs to the class of medications known as protease inhibitors. Protease is an enzyme that is needed by viruses for reproduction. Simeprevir blocks the action of protease, slowing the growth of the virus.
This medication is used in combination with peginterferon alfa and ribavirin, to treat chronic (long-term) hepatitis C caused by "genotype 1" and “genotype 4” strains of the hepatitis C virus.
Simeprevir has also been granted a notice of compliance with conditions (NOC/c) by Health Canada. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.
The NOC/c approval for simeprevir allows this medication to be used in combination with sofosbuvir to treat people who have not previously taken medication for hepatitis C or who have had poor results taking other medications for hepatitis C. This approval applies only the treatment of patients with chronic hepatitis C caused by the “genotype 1” strain of the hepatitis C virus.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each white capsule, marked with "TMC435 150" in black ink contains 154.4 mg of simeprevir sodium salt, which is equivalent to 150 mg simeprevir. Nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, magnesium stearate and sodium lauryl sulphate; capsule: gelatin and titanium dioxide (E171); ink: iron oxide black (E172) and shellac (E904).
How should I use this medication?
The recommended dose of simeprevir is 150 mg taken once daily with food. The capsule should be swallowed whole with fluids and not crushed or chewed. Ideally, simeprevir should be taken at the same time each day.
Simeprevir must be taken in combination with peginterferon-alfa and ribavirin or sofosbuvir. It is usually taken for 12 weeks, at which time, your doctor will determine the effectiveness of the combination of medications with blood tests. At this time, your doctor will determine how much longer you will need to continue to take peginterferon alfa and ribavirin.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor and not reduced. Reducing the dose may cause the medication to fail. If you miss a dose, and it is within 12 hours of the missed dose, take it as soon as possible with food and continue with your regular schedule. If it is more than 12 hours past the time of your missed dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature in its original package, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take simeprevir if you:
- are allergic to simeprevir or any ingredients of the medication
- cannot take peginterferon alfa, ribavirin, or sofosbuvir
- are pregnant or plan to become pregnant
- are the male partner of a woman who is, or may become pregnant or is planning to become pregnant
- have galactose intolerance (a rare hereditary condition)
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- feeling very tired
- increased sensitivity to sunlight (sunburn, blistering, redness)
- skin rash
- trouble sleeping
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Birth control: The effect of simeprevir on the development of an unborn baby has not been studied, however simeprevir must be used with interferon alfa and ribavirin. Treatment with ribavirin can cause severe birth defects to an unborn child. Both partners should use a reliable form of birth control while taking this medication and for 6 months afterwards (the time it takes for ribavirin to be cleared from the body).
For women, your doctor will not give you simeprevir until you have had a negative pregnancy test. Your doctor should have you continue to do monthly pregnancy tests to ensure that you do not become pregnant while using this medication.
Methods of birth control that use hormones, such as a birth control pill, patch, or injection, may not be fully reliable as simeprevir interacts with many medications and may change the way that your body uses the hormones. If you are taking ribavirin along with simeprevir, at least 2 forms of non-hormonal birth control (condom, diaphragm) must be used while you are taking this medication.
Hepatitis C virus response: Only genotype 1 and genotype 4 hepatitis C viruses have been studied and determined to respond to simeprevir. The safety and effectiveness of using simeprevir to treat other strains of hepatitis C virus have not been determined.
Infection with hepatitis B: The safety and effectiveness of treatment with simeprevir have not been established for people who also have human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
Liver function: Simeprevir is not recommended for people with active, worsening liver disease, or moderately-to-severely reduced liver function. If you have a history of reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Organ transplantation: The safety and effectiveness of treatment with simeprevir have not been established for people with liver or other organ transplants. Simeprevir may interact with medications used to prevent rejection of the transplanted organ.
Skin reactions: Simeprevir may cause skin rash or itchiness with or without a rash. It may also make your skin more sensitive to ultraviolet light from the sun or tanning beds. While you are taking simeprevir, avoid unnecessary exposure to sunlight. If you notice any unusual skin rash or peeling, contact your doctor.
Pregnancy: Simeprevir has not been studied for use by pregnant women and it must be taken with peginterferon alfa and ribavirin. Ribavirin has been shown to cause serious problems in the developing fetus. As a result, simeprevir (plus peginterferon alfa and ribavirin) should not be used by pregnant women or by men whose partners are pregnant. Both partners should use a reliable form of birth control while taking this medication and for 6 months afterwards. Tell your doctor immediately if you become pregnant while using this medication.
Breast-feeding: It is not known if simeprevir passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Breast-feeding should be stopped before starting treatment with simeprevir.
Children: The safety and effectiveness of using this medication have not been established for children.
What other drugs could interact with this medication?
There may be an interaction between simeprevir and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Galexos