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

Manufacture: Bristol-Myers Squibb
Country: Canada
Condition: Hepatitis C, Chronic (Hepatitis C)
Class: Antiviral agents
Form: Tablets
Ingredients: daclatasvir, anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry Green and silicon dioxide. The Opadry Green contains the following inactive ingredients: FD & C blue #2 / indigo carmine aluminum lake, hypromellose, iron oxide (yellow), polyethylene glycol 400 and titanium dioxide

(daclatasvir tablets)

What is DAKLINZA used for

DAKLINZA is used to treat chronic (long-lasting) infection with the hepatitis C virus (HCV) genotypes 1, 2 and 3. DAKLINZA is used with other medicines that also treat chronic HCV infection.

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

DAKLINZA should not be taken alone.

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

How does DAKLINZA work

DAKLINZA 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.

DAKLINZA 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 DAKLINZA

Medicinal ingredients: Daclatasvir tablets, 30, 60 mg (as daclatasvir dihydrochloride).

Non-medicinal ingredients: Anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry Green and silicon dioxide. The Opadry Green contains the following inactive ingredients: FD & C blue #2 / indigo carmine aluminum lake, hypromellose, iron oxide (yellow), polyethylene glycol 400 and titanium dioxide.

DAKLINZA comes in the following dosage forms:

DAKLINZA is available as tablets. Each tablet contains daclatasvir as the active ingredient. Tablets are available in two strengths. DAKLINZA 60 mg tablets are light green, biconvex, pentagonal and debossed with “BMS” on one side and “215” on the other. DAKLINZA 30 mg tablets are green, biconvex, pentagonal and debossed with “BMS” on one side and “213” on the other.

Do not use DAKLINZA if

  • you are allergic to daclatasvir or any other ingredients in this product (see “What are theingredients in DAKLINZA”)
  • you are taking certain medicines (see “Do not take DAKLINZA if you take a medicinethat contains:” below)

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

  • have liver problems other than hepatitis C infection.
  • have hepatitis B or HIV.
  • have had a liver transplant.
  • 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 DAKLINZA passes into your breast milk. You and your healthcare provider should decide if you will take DAKLINZA or breastfeed. You should not do both.
  • are taking any medications (see Tell your healthcare professional about all medicinesyou take).
  • have a rare hereditary problem of galactose intolerance (severe lactase deficiency or glucose-galactose malabsorption) as this product contains lactose.

If you are taking DAKLINZA with sofosbuvir (SOVALDI), do not take other medicines that contain sofosbuvir, such as HARVONI.

Pregnancy

Pregnancy when DAKLINZA is taken with ribavirin

Ribavirin may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. 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 forthe 6 months after treatment with ribavirin. Talk with 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 ribavirin, every month while being treated, and every month for 6 months after your treatment ends.

Pregnancy when DAKLINZA is NOT taken with ribavirin

If you are NOT taking ribavirin with DAKLINZA, the following information about pregnancy applies:

  • The effects of DAKLINZA on pregnancy and the unborn child are not known. DAKLINZA should not be used during pregnancy. If you can become pregnant, use effective birth control during and for 5 weeks after your treatment with DAKLINZA ends.

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

The following may interact with DAKLINZA

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

Do not take DAKLINZA if you take a medicine that contains:

  • carbamazepine (Carbatrol, Epitol, Equetro, Tegretol) or oxcarbazepine (Oxtellar XR, Trileptal)
  • dexamethasone (when administered by injection or taken by mouth)
  • phenobarbital (Luminal)
  • phenytoin (Dilantin, Phenytek)
  • rifabutin (Mycobutin)
  • rifampin (Rifadin, Rifamate, Rifater, Rimactane)
  • rifapentine (Priftin)
  • John’s wort (Hypericum perforatum) or a product that contains St. John’s wort

Other drugs that may interact with DAKLINZA include:

  • amiodarone (Cordarone, Pacerone)
  • atazanavir (Reyataz)/ritonavir (Norvir). You may need a lower dose of DAKLINZA.
  • atorvastatin (Caduet, Lipitor, Liptruzet)
  • boceprevir (Victrelis)
  • bosentan (Tracleer)
  • clarithromycin (Biaxin, Prevpac)
  • dabigatran etexilate mesylate (Pradaxa)
  • digoxin (Digifab, Digox, Lanoxin)
  • ditiazem (Cardizem, Cardizem CD, Cardizem LA, Tiazac, Cartia XT, Dilacor XR, Dilt-CD, Diltzac, Taztia XT)
  • efavirenz (Sustiva, Atripla). You may need a higher dose of DAKLINZA.
  • etravirine (Intelence)
  • erythromycin
  • fluvastatin (Lescol)
  • itraconazole (Sporanox, Onmel)
  • ketoconazole (when taken by mouth) (Nizoral). You may need a lower dose of

DAKLINZA.

  • modafinil (Provigil)
  • nafcillin
  • nevirapine (Viramune)
  • pitavastatin (Livalo)
  • posaconazole (Noxafil)
  • pravastatin (Pravachol)
  • rosuvastatin (Crestor)
  • simvastatin (Simcor, Vytorin, Zocor)
  • telaprevir (Incivek)
  • telithromycin (Ketek)
  • verapamil (Covera-HS, Calan, Verelan)
  • voriconazole

Not marketed in Canada

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

How to take DAKLINZA

Do not take DAKLINZA alone to treat chronic hepatitis C infection. DAKLINZA should be used together with other medicines for chronic HCV infection such as sofosbuvir (with or without ribavirin).

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

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

Usual adult dose

The usual dose is one 60 mg tablet once each day with or without food. A 30 mg tablet is available if your doctor prescribes a lower or higher dose.

Overdose

If you think you have taken too much DAKLINZA, 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 DAKLINZA. If you do miss a dose and it is:

  • less than 20 hours from the time you usually take DAKLINZA, take the missed dose as soon as possible. Take the next dose at the usual time.
  • more than 20 hours from the time you usually take DAKLINZA, skip the missed dose. Take the next dose at the usual time.

Do not take 2 doses of DAKLINZA at the same time to make up for the missed dose.

What are possible side effects from using DAKLINZA

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

The most common side effects when DAKLINZA is taken in combination with sofosbuvir (some patients in studies of this regimen also received ribavirin) include:

  • tiredness
  • headache
  • nausea

When DAKLINZA is used in conjunction with sofosbuvir and ribavirin, the following effects have occurred:

Serious side effects and what to do about them

Symptom / effect*Talk to your healthcare professionalStop taking drug and get immediate medical help
Only if severeIn all cases
VERY COMMON
Effect: Low red blood cell counts (anemia)
Symptoms:

— Tiredness
— Headache
— Shortness of breath
— Dizziness
— Looking pale




*These side effects are commonly associated with 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 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;
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
                     Health Canada, Postal Locator 0701E
                     Postal Locator 0701E
                     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 DAKLINZA at room temperature (15° to 30°C) in the original container.

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

If you want more information about DAKLINZA

  • 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.