Our Key Products
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.
PrDAKLINZA™ is used:
PrDAKLINZA™ is used:
What is a Notice of Compliance with Conditions (NOC/c)?
An NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada.
Products approved under Health Canada's NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. In addition, they either respond to a serious unmet medical need in Canada or have demonstrated a significant improvement in the benefit/risk profile over existing therapies. Health Canada has provided access to this product on the condition that sponsors carry out additional clinical trials to verify the anticipated benefit within an agreed upon time frame.
What is DAKLINZA used for?
PrDAKLINZA 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?
PrDAKLINZA 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:
PrDAKLINZA 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 the ingredients in DAKLINZA")
- you are taking certain medicines (see "Do not take DAKLINZA if you take a medicine that 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 medicines you take).
- have a rare hereditary problem of galactose intolerance (severe lactase deficiency or glucose-galactose malabsorption) as this product contains lactose.
Heart block and a severe lowering of the heart beat have occurred in patients taking amiodarone with DAKLINZA and sofosbuvir. Your doctor will decide if amiodarone can be used with DAKLINZA and sofosbuvir. Contact your doctor if you suffer certain side effects while taking this combination (see “What are the possible side effects from using DAKLINZA?” section).
If you are taking DAKLINZA with sofosbuvir (SOVALDI), do not take other medicines that contain sofosbuvir, such as HARVONI.
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 for the 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:
PrDAKLINZA 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♦)
- St. 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), and atazanavir/cobicistat (Evotaz). You may need a lower dose of DAKLINZA.
- atorvastatin (Caduet, Lipitor, Liptruzet♦)
- boceprevir (Victrelis)
- bosentan (Tracleer)
- clarithromycin (Biaxin, Prevpac♦)
- combination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate (Stribild). You may need a lower dose of DAKLINZA.
- 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)
- fluvastatin (Lescol)
- itraconazole (Sporanox, Onmel♦)
- ketoconazole (when taken by mouth) (Nizoral). You may need a lower dose of DAKLINZA.
- modafinil (Provigil)
- nevirapine (Viramune)
- pitavastatin (Livalo♦)
- posaconazole (Noxafil♦)
- pravastatin (Pravachol)
- rosuvastatin (Crestor)
- simvastatin (Simcor♦, Vytorin♦, Zocor)
- telaprevir (Incivek)
- telithromycin (Ketek♦)
- verapamil (Covera-HS♦, Calan♦, Verelan)
♦ 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 PrDAKLINZA 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.
It is important not to miss a dose of PrDAKLINZA. 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 PrDAKLINZA. If you have any side effects not listed here, contact your healthcare professional. Please also see section "Do not use DAKLINZA if".
Daklinza in combination with sofosbuvir and amiodarone may cause serious side effects, including:
Slow heart rate (bradycardia). Get medical help right away if you take amiodarone with sofosbuvir and DAKLINZA and get any of the following symptoms:
- Fainting or near fainting
- chest pain
- dizziness or lightheadedness
- not feeling well
- shortness of breath
When DAKLINZA is used in conjunction with sofosbuvir and ribavirin, common or very common side effects include headache, fatigue, nausea, rash, diarrhea and difficulty in sleeping.
The following serious 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|
Effect: Low red blood cell counts (anemia)
-Shortness of breath
*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:
Store PrDAKLINZA 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.
This leaflet was prepared by Bristol-Myers Squibb Canada
Last Revised May 13, 2016
™ of Bristol-Myers Squibb Holdings Ireland used under license by Bristol-Myers Squibb Canada.
Other brands listed are trademarks of their respective owners.