What Holkira Pak is used for and how to use it
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Holkira Pak - Consumer Medicine Information

Manufacture: AbbVie
Country: Canada
Condition: Hepatitis C, Hepatitis C, Chronic (Hepatitis C)
Class: Antiviral agents
Form: Tablets
Ingredients: ombitasvir, paritaprevir, ritonavir, colloidal silicon dioxide/anhydrous colloidal silica, copovidone, propylene glycol monolaurate, sodium stearyl fumarate, sorbitan monolaurate, vitamin E polyethylene glycol succinate, iron oxide red, polyethylene glycol/macrogol, polyvinyl alcohol, purified water, talc, and titanium dioxide

ombitasvir/paritaprevir/ritonavir film-coated tablets and dasabuvir film-coated tablets

What is HOLKIRA PAK used for?

HOLKIRA PAK is used for the treatment of chronic (lasting a long time) hepatitis C virus (HCV) genotype 1 infection in adults 18 years of age and older.

Your healthcare provider may also prescribe ribavirin in addition to HOLKIRA PAK to treat your HCV infection. This will depend on the type of hepatitis C virus you have, and whether or not you have cirrhosis (liver scarring).

How does HOLKIRA PAK work?

HOLKIRA PAK in combination with ribavirin has been shown to cure chronic hepatitis C infection in the majority of patients. Cure means the hepatitis C virus is cleared from your blood (remains at an undetectable level) when measured three months after finishing all treatment.

HOLKIRA PAK combines three types of anti-HCV drugs to block multiple steps in the replication process of the hepatitis C virus. This prevents the virus particles from duplicating themselves, allowing your body to clear (remove) the virus from your blood.

Curing chronic hepatitis C can help reduce the risk of illness and death associated to liver disease.

While HOLKIRA PAK can cure chronic hepatitis C infection, it does not protect you from HCV reinfection. Talk with your healthcare provider about ways to prevent reinfection with the hepatitis C virus.

Does HOLKIRA PAK reduce the risk of passing HCV to others?

No. During treatment for hepatitis C virus infection, the virus may still be passed to other individuals, such as through shared use of needles or through unprotected sex. Talk with your healthcare provider about ways to prevent spreading the hepatitis C virus.

What are the ingredients in HOLKIRA PAK?

Ombitasvir/paritaprevir/ritonavir film-coated tablets

Medicinal ingredients: ombitasvir, paritaprevir and ritonavir.

The tablet contains the following non-medicinal ingredients: colloidal silicon dioxide/anhydrous colloidal silica, copovidone, propylene glycol monolaurate, sodium stearyl fumarate, sorbitan monolaurate, vitamin E polyethylene glycol succinate.

The tablet coating contains the following non-medicinal ingredients: iron oxide red, polyethylene glycol/macrogol, polyvinyl alcohol, purified water, talc, and titanium dioxide.

The tablets do not contain gluten.

Dasabuvir film-coated tablets

Medicinal ingredients: dasabuvir (as dasabuvir sodium monohydrate).

The tablet contains the following non-medicinal ingredients: colloidal silicon dioxide/anhydrous colloidal silica, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

The tablet coating contains the following non-medicinal ingredients: iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol/macrogol, polyvinyl alcohol, purified water, talc, and titanium dioxide.

The tablets do not contain gluten.

HOLKIRA PAK comes in the following dosage forms

HOLKIRA PAK contains two different tablets, ombitasvir/paritaprevir/ritonavir 12.5/75/50 mg tablets and dasabuvir 250 mg tablets that must be used together to treat chronic hepatitis C infection.

Do not use HOLKIRA PAK if

  • your doctor advises taking ribavirin with HOLKIRA PAK, and you are pregnant or your partner is pregnant. Ribavirin may cause birth defects or death of your unborn baby.
  • you are allergic to paritaprevir, ombitasvir, dasabuvir or ritonavir or any of the non-medicinal ingredients in HOLKIRA PAK (refer to the subheading “What are the ingredients in HOLKIRA PAK?” for a complete listing).
  • you have severe liver problems.
  • you are taking any of the following drugs:
    • alfuzosin hydrochloride (Xatral)
    • astemizole
    • avasimibe
    • bosentan (Tracleer)
    • carbamazepine (Tegretol)
    • cisapride
    • efavirenz-containing medicines (Sustiva, Atripla)
    • ergot containing medicines including:
      • ergotamine tartrate
      • ergotamine (Bellergal Spacetabs)
      • dihydroergotamine mesylate (Migranal)
      • methylergonovine
    • ethinyl estradiol-containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception
    • etravirine (Intelence)
    • fusidic acid (systemic)
    • gemfibrozil
    • lovastatin
    • midazolam (when taken by mouth)
    • modafinil (Alertec)
    • nafcillin
    • phenytoin (Dilantin)
    • phenobarbital
    • pimozide (Orap)
    • rifampin (Rifadin, Rifater, Rofact)
    • salmeterol (Advair Diskus, Serevent Diskus)
    • sildenafil citrate (Revatio) for the lung problem, pulmonary artery hypertension (PAH)
    • simvastatin
    • St. John's wort (Hypericum perforatum) or products containing St. John's wort
    • terfenadine
    • triazolam

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

  • are using a medicine containing ethinyl estradiol for contraception or for other reasons. You must not use medicines that contain ethinyl estradiol while taking HOLKIRA PAK. Your doctor will ask you to stop or consider changing to a different type of contraceptive medicine during your treatment.
  • have liver problems other than hepatitis C infection.
  • have any other medical condition.
  • have had a liver transplant.
  • are breastfeeding or plan to breastfeed. It is not known if HOLKIRA PAK passes into your breast milk. You and your healthcare provider should decide if you will take HOLKIRA PAK or breastfeed. You should not do both.

Pregnancy

  • You or your partner should not become pregnant while taking HOLKIRA PAK with ribavirin and for six months after treatment is over.
    • Females and males must use two forms of effective birth control during treatment and for six months after treatment with HOLKIRA PAK and ribavirin. The use of certain types of birth control pills may not be acceptable. Talk to your healthcare provider about forms of birth control that may be used during this time.
    • Females must have a negative pregnancy test before starting treatment with HOLKIRA PAK and ribavirin, every month while being treated, and for six months after the treatment ends.
    • If you or your female partner becomes pregnant while taking HOLKIRA PAK and ribavirin or within six months after you stop taking these medicines, tell your healthcare provider right away.

Other warnings you should know about

Let your healthcare provider know if you develop nausea, vomiting, loss of appetite, yellowing of your skin or eyes, or darkening of your urine while on treatment with HOLKIRA PAK.

If HOLKIRA PAK is administered with ribavirin, the warnings and precautions for ribavirin also apply to this combination regimen. Refer to the ribavirin Patient Medication Information for a full list of the warnings and precautions for ribavirin.

It is not known if taking HOLKIRA PAK is safe and effective in children under 18 years of age.

Your doctor may do blood tests before you start your treatment and regularly during your treatment. These blood tests are done to help your doctor to check if the treatment is working for you.

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

HOLKIRA PAK should not be administered with other ritonavir-containing medicines (Norvir, Kaletra). When co-administered with HOLKIRA™ PAK, atazanavir or darunavir should be taken without ritonavir.

The following may interact with HOLKIRA PAK

  • alfentanil
  • alprazolam (Xanax)
  • amiodarone
  • amlodipine (Norvasc)
  • atazanavir (Reyataz)
  • atorvastatin (Lipitor)
  • cyclosporine (Neoral, Sandimmune)
  • darunavir (Prezista)
  • digoxin (Lanoxin)
  • disopyramide (Rythmodan)
  • fentanyl (Abstral, Duragesic)
  • flecainide
  • fluticasone (Advair, Flonase, Flovent Diskus, Flovent HFA)
  • fluvastatin (Lescol)
  • furosemide (Lasix)
  • ketoconazole
  • lidocaine (systemic)
  • lopinavir/ritonavir (Kaletra) – should not be taken with HOLKIRA PAK
  • omeprazole (Losec)
  • pitavastatin
  • pravastatin (Pravachol)
  • propafenone (Rythmol)
  • quetiapine (Seroquel)
  • quinidine
  • rilpivirine (Edurant, Complera) – should not be taken with HOLKIRA PAK
  • rosuvastatin (Crestor)
  • sirolimus (Rapamune)
  • tacrolimus (Prograf)
  • warfarin (Coumadin)

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.

Know all the medicines that you take. Keep a list of them with you to show your healthcare provider and pharmacist when you get a new medicine.

If you had a change in dose of one of your usual medications during HOLKIRA PAK treatment, you should ask your doctor about changing back to your original dose when you are finished with HOLKIRA PAK treatment.

If you stopped one of your usual medications during HOLKIRA PAK treatment, you should ask your doctor about starting this medication again after you are finished with HOLKIRA PAK treatment.

How to take HOLKIRA PAK

  • Take HOLKIRA PAK exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.
  • Do not stop taking HOLKIRA PAK to ensure that your medicine continues to work against the virus, unless your doctor tells you to. If you think there is a reason to stop taking HOLKIRA PAK, talk to your healthcare provider before doing so.
  • Take HOLKIRA PAK at about the same time every day.
  • Take HOLKIRA PAK tablets with food. The type of food is not important.
  • Swallow HOLKIRA PAK tablets whole with water if needed. Do not chew, break, or crush HOLKIRA PAK tablets.
  • Usual dose

    • Every day in the morning, take the two pink ombitasvir/paritaprevir/ritonavir 12.5 mg/75 mg/50 mg tablets with one of the beige dasabuvir 250 mg tablets with food.
    • Every day in the evening, take the remaining beige dasabuvir 250 mg tablet with food.
    • HOLKIRA PAK is taken for either 12 or 24 weeks. Your healthcare provider will tell you exactly how long you need to take HOLKIRA PAK.
    • If your doctor has also prescribed ribavirin, the doctor will provide you dosage directions.

Overdose

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

Missed Dose

  • If you do miss a dose of the pink ombitasvir/paritaprevir/ritonavir tablets and it is:
  • less than 12 hours from the time you usually take ombitasvir/paritaprevir/ritonavir, take the missed dose with food as soon as possible. Then take your next dose at your usual time.
  • more than 12 hours from the time you usually take ombitasvir/paritaprevir/ritonavir, do not take the missed dose. Take your next dose as usual with food.
  • If you do miss a dose of the beige dasabuvir tablets and it is:
    • less than 6 hours from the time you usually take dasabuvir, take the missed dose with food as soon as possible. Then take your next dose at your usual time.
    • more than 6 hours from the time you usually take dasabuvir, 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 forgotten dose.

What are possible side effects from using HOLKIRA PAK?

These are not all the possible side effects you may feel when taking HOLKIRA PAK. If you experience any side effects not listed here, contact your healthcare professional. Please also see Other warnings you should know about.

Increased liver enzymes have occurred when HOLKIRA PAK is taken with certain medications. Contact your doctor immediately if you develop symptoms such as stomach pain, nausea, vomiting, weakness, fatigue, yellowing of the skin and eyes, and pale-coloured feces.

Side effects of HOLKIRA PAK:

  • feeling tired (fatigue)
  • headache

Side effects of HOLKIRA PAK used with ribavirin:

  • feeling tired (fatigue)
  • headache
  • itching
  • feeling weak or lack of energy (asthenia)
  • nausea
  • trouble sleeping

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 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 at MedEffect (www.healthcanada.gc.ca/medeffect);
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada Postal Locator 0701D
      Ottawa, ON
      K1A 0K9

    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (www.healthcanada.gc.ca/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 between 2 and 30°C. Protect from moisture.

Keep HOLKIRA PAK out of the reach and sight of children.

If you want more information about HOLKIRA PAK

  • Talk to your healthcare professional
  • Find the most recent version of the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (www.healthcanada.gc.ca); the manufacturer’s website abbvie.ca, or by calling 1-888-704-8271.