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PART III: PATIENT MEDICATION INFORMATION

PrSUNVEPRATM

Asunaprevir capsules

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Read this carefully before you start taking SUNVEPRA and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about SUNVEPRA.

What is SUNVEPRA used for?

PrSUNVEPRA is used to treat chronic (long-lasting) infection with the hepatitis C virus (HCV), genotypes 1 and 4, in adults. SUNVEPRA is used with other medicines that also treat chronic HCV infection. These medicines are DAKLINZA alone or DAKLINZA with peginterferon alfa and ribavirin.

People with hepatitis C infection have the virus in their blood and in their liver.

SUNVEPRA should not be taken alone.

SUNVEPRA has not been studied in children under 18 years of age.

How does SUNVEPRA work?

PrSUNVEPRA used with other medicines has been shown to cure chronic HCV infection in most patients. Cure means the HCV is removed from your blood (remains at an undetectable level) for 3 months after finishing all treatment.

SUNVEPRA blocks a protein from the virus that is needed to make new virus, and this helps to lower the virus level in your body.

What are the ingredients in SUNVEPRA?

Medicinal ingredients: Asunaprevir

Non-medicinal ingredients: Butylated hydroxytoluene (BTE), glycerol monocaprylocaprate Type 1, medium-chain triglycerides and polysorbate 80. The capsule shell contains gelatin, glycerin, sorbital sorbitan solution and titanium dioxide.

SUNVEPRA comes in the following dosage forms:

PrSUNVEPRA is available as capsules. Each capsule contains 100 mg of asunaprevir. Asunaprevir is the medicinal ingredient. SUNVEPRA 100 mg capsules are oval, opaque white to pale-yellow, soft-gelatin capsules with “BMS” in black on one line and “711” in black on a second line below “BMS”.

Do not use SUNVEPRA if:

  • you are allergic to asunaprevir or any other ingredients in this product (see “What are the ingredients in SUNVEPRA”)
  • you have certain liver problems other than hepatitis C, as determined by your healthcare provider. Be sure to tell your healthcare provider of any liver problems you have or have had.
  • you are taking certain medicines (see “Do not take SUNVEPRA if you take a medicine that contains any of the following:” below).
  • your healthcare provider advises you to take ribavirin and peginterferon alfa with SUNVEPRA and DAKLINZA, and you or your partner are pregnant or may become pregnant. Ribavirin may cause birth defects or death of your unborn baby.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SUNVEPRA. Talk about any health conditions or problems you may have, including if you:

  • have had a liver transplant, liver disease, or liver problems
  • have hepatitis B or HIV
  • have kidney disease
  • have any other medical condition
  • are pregnant or plan to become pregnant (see “Pregnancy”).
  • are breastfeeding or plan to breastfeed. It is not known if SUNVEPRA passes into your breast milk. You and your healthcare provider should decide if you will take SUNVEPRA or breastfeed. You should not do both.
  • are taking any medications

Pregnancy

If you are taking SUNVEPRA with DAKLINZA, peginterferon alfa and ribavirin: You or your sexual partner should not become pregnant during treatment and for 6 months after treatment ends.

-Females and males must use 2 effective forms of birth control during treatment and for the 6 months after treatment with peginterferon alfa and ribavirin. Talk with your healthcare provider about forms of birth control that may be used during this time. Some oral birth control pills may not work with SUNVEPRA.

-Females must have a negative pregnancy test before starting treatment with peginterferon alfa and ribavirin, every month while being treated, and every month for 6 months after your treatment ends.

-If you or your female partner becomes pregnant while taking SUNVEPRA tell your healthcare provider right away.

If you are NOT taking peginterferon alfa and ribavirin, the following information about pregnancy applies:

-The effects of SUNVEPRA on pregnancy and the unborn child are not known. If you can become pregnant, talk with your healthcare provider what forms of birth control to use. Some oral birth control pills may not work with SUNVEPRA.

Liver Enzymes

Some people taking SUNVEPRA have abnormal results on tests that show how well the liver is working. Your healthcare provider may request that you have blood tests every 2 weeks for the first 12 weeks and then every 4 weeks while you take SUNVEPRA. If the test results are not at normal levels, your healthcare provider may instruct you to stop taking SUNVEPRA.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

PrSUNVEPRA and other medicines may affect each other. This can cause you to have too much or too little of SUNVEPRA or the other medicine in your body. The medicines may not work well or you may have side effects. Do not start taking a new medicine without telling your healthcare provider or pharmacist.

Do not take SUNVEPRA if you take a medicine that contains any of the following:

Antipsychotic agent: thioridazine♦

Anticonvulsants: phenytoin (Dilantin, Phenytek♦), carbamazepine (Carbatrol♦, Epitol♦, Equetro♦, Tegretol), phenobarbital (Luminal♦), oxcarbazepine (Oxtellar XR♦, Trileptal)

Anti-infective agents: rifampin (Rifadin, Rifamate♦, Rifater, Rimactane♦, rifabutin (Mycobutin), rifapentine (Priftin♦), nafcillin♦, clarithromycin (Biaxin, Prevpac♦), erythromycin (E.E.S., Eryc, Ery-Tab, Erythrocin, Erythrocin Stearate), telithromycin♦

Endothelin receptor antagonist: bosentan (Tracleer)

Glucocorticoid, systemic: dexamethasone (when administered by injection or taken by mouth)

Herbal products: St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort

HIV non-nucleoside reverse transcriptase inhibitors: efavirenz (Sustiva, Atripla), etravirine (Intelence), nevirapine (Viramune)

HIV protease inhibitors: atazanavir (Reyataz), darunavir/ritonavir, indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), fosamprenavir (Telzir)

Pharmacokinetic enhancer: Cobicistat or cobicistat-containing regimen

Wakefulness promoting agent: modafinil (Provigil)

Antifungal agents: ketoconazole (when taken by mouth) (Nizoral), itraconazole (when taken by mouth) (Sporanox, Onmel♦), voriconazole (when taken by mouth or administered by injection) (Vfend), fluconazole (when taken by mouth or administered by injection) (Diflucan), posaconazole (Posanol)

Calcium channel blocker: diltiazem (Cardizem, Dilacor XR, Tiazac), verapamil (Covera-HS♦, Calan♦, Verelan)

Immunosuppressants: cyclosporine (Neoral, Sandimmune)

Lipid-lowering agent: gemfibrozil

Other drugs that may interact with SUNVEPRA and may require dosage adjustment of the other drug include:

  • dabigatran (Pradaxa) (used to prevent blood clots),
  • dextromethorphan (a cough suppressant that is an ingredient in many over-the co cold medicines, for example, Dimetapp, Robitussin, Theraflu, etc.)
  • digoxin (Digifab, Digox, Lanoxin), flecainide (Tambocor), propafenone (Rhyth (medicines to treat irregular heartbeats)
  • hormonal contraceptives
  • midazolam (medicine used as a sedative or to prevent convulsions)
  • rosuvastatin (Crestor), atorvastatin (Caduet, Lipitor, Liptruzet◻), fluvastatin (Les simvastatin (Zocor), pitavastatin◻, pravastatin (Pravachol) (medicines that l cholesterol)
  • amitriptyline   , imipramine, nortriptyline (Aventyl) (medicines to treat depression)

♦ Not marketed in Canada

This is not a complete list of medicines that could interact with SUNVEPRA. Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

How to take SUNVEPRA:

Do not take PrSUNVEPRA alone to treat chronic hepatitis C infection. SUNVEPRA should be used together with DAKLINZA or with DAKLINZA, peginterferon alfa, and ribavirin.

Take SUNVEPRA exactly as your healthcare provider tells you to take it. Do not take more or fewer capsules than what your healthcare provider tells you to take.

Do not stop taking SUNVEPRA without first talking with your healthcare provider.

Usual adult dose:

Take 1 capsule of SUNVEPRA (100 mg) 2 times each day with or without food.

Overdose:

If you think you have taken too much SUNVEPRA, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

It is important not to miss a dose of PrSUNVEPRA.  If you do miss a dose and it is:

  • less than 8 hours from the time you usually take SUNVEPRA, take the missed dose as soon as possible. Take the next dose at the usual time.
  • more than 8 hours from the time you usually take SUNVEPRA, skip the missed dose. Take the next dose at the usual time.

Do not take two doses of SUNVEPRA at the same time to make up for the missed dose.

What are possible side effects from using SUNVEPRA?

These are not all the possible side effects you may feel when taking PrSUNVEPRA. If you have any side effects not listed here, contact your healthcare professional. Please also see “Do not use SUNVEPRA if”.

Liver problems. Some people taking SUNVEPRA have abnormal results on tests that show how well the liver is working.

The most common side effects when SUNVEPRA is taken in combination with DAKLINZA include:

  • headache
  • tiredness

The most common side effects when SUNVEPRA is taken in combination with DAKLINZA, peginterferon alfa, and ribavirin include:

  • tiredness
  • headache
  • itching
  • unusual weakness
  • flu-like symptoms
  • difficulty sleeping (insomnia)
  • low red blood cell count
  • rash
  • hair loss
  • irritability
  • nausea

When SUNVEPRA is used with peginterferon alfa and ribavirin, the following effects have occurred:

Serious side effects and what to do about them
Symptom / effect* Talk to your healthcare professional Stop taking drug and get immediate medical help
Only if severe In all cases
VERY COMMON
Effect: Low red blood cell counts (anemia)
Symptoms:
-Tiredness
-Headache
-Shortness of breath
-Dizziness
-Looking pale
   
Effect: Low white blood cell counts (neutropenia)
Symptoms:
-Increased infections
   
COMMON
Effect: Low blood platelet (thrombocytopenia)
Symptoms:
-Bruising and increased tendency to bleed
   

*These side effects are commonly associated with peginterferon alfa and ribavirin therapy.

This is not a complete list of side effects. If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting suspected side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online atMedEffect
  • By calling 1-866-234-2345 (toll-free);
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      • Canada Vigilance Program
        Health Canada
        Postal Locator 0701C
        Ottawa, ON K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE:Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store PrSUNVEPRA at room temperature (15° to 30°C) and protect from light.

Store SUNVEPRA in the original container.

Keep SUNVEPRA and all medicines out of the reach and sight of children.

If you want more information about SUNVEPRA:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website http://www.bmscanada.ca, or by calling 1-866-463-6267

This leaflet was prepared by Bristol-Myers Squibb Canada.

Last revised: 09-March-2016

TM of Bristol-Myers Squibb Holdings Ireland used under license by Bristol-Myers Squibb Canada.

Other brands listed are trademarks of their respective owners.