Microsoft word - zelborafcie.doc

PrZELBORAFTM
www.rochecanada.com Submission Control No: 157084 Copyright 2012, Hoffmann-La Roche Limited TMTrade-Mark of F. Hoffmann-La Roche AG, used under license Manufactured under license from Plexxikon Inc., a member of the Daiichi Sankyo group Table of Contents
PART III: CONSUMER INFORMATION .3 
IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
effect on the ECG can lead to disturbances in heart rhythm
(arrhythmias/dysrhythmias) that could result in dizziness,
PrZELBORAFTM
palpitations (sensation of rapid, pounding, or irregular heart
(vemurafenib film-coated tablets)
beat), fainting or death. These heart rhythm disturbances are
more likely in patients with risk factors, such as heart
This leaflet is part III of a three-part "Product Monograph"
disease, or in the presence of certain interacting drugs. In
published when ZELBORAF was approved for sale in Canada
general, females and people more than 65 years in age are at
and is designed specifically for Consumers. This leaflet is a
higher risk. It is important to follow the instructions of your
summary and will not tell you everything about ZELBORAF.
doctor with regard to dosing or any special tests. You will
Contact your doctor or pharmacist if you have any questions
need to have electrocardiograms (ECGs) and blood tests to
about the drug.
measure your levels of potassium, calcium, and magnesium
at regular intervals during treatment with ZELBORAF. If
you experience any symptoms of a possible heart rhythm
ABOUT THIS MEDICATION
disturbance, such as dizziness, palpitations (sensation of
rapid, pounding, or irregular heart beat), fainting, or
What the medication is used for:
seizures, you should seek immediate medical attention.
ZELBORAF is used in adult patients to treat a type of skin cancer (unresectable or metastatic melanoma) that has a change ZELBORAF may cause changes in your skin, including a new
(mutation) in the “BRAF” gene and that cannot be removed by melanoma and cutaneous squamous cell carcinoma. Talk to your surgery or has spread to other parts of the body. doctor if there are any changes in your skin while taking ZELBORAF and up to six months after the last dose. Patients should have their cancer tested for this change in the “BRAF” gene before starting treatment with ZELBORAF. You may also become more sensitive to sunlight and get sunburns that can be severe while taking ZELBORAF. During What it does:
treatment, avoid going out in the sun or if you go into the sun,
ZELBORAF targets proteins made from the mutated BRAF gene wear clothing which protects your skin, including your and slows down or stops the growth of cancer cells. head and face, arms and legs, including hands and feet use a lip balm and a broad spectrum sunscreen When it should not be used:
(minimum of SPF 30, re-applied every 2 to 3 hours). Do not take ZELBORAF if you are allergic (hypersensitive) to vemurafenib or any of the other ingredients of ZELBORAF. See ZELBORAF may also cause severe allergic reaction. Symptoms “What the non-medicinal ingredients are”. include swelling of the face, lips or tongue, difficulty breathing, What the medicinal ingredient is:
BEFORE you use ZELBORAF talk to your doctor or
pharmacist if:
What the non-medicinal ingredients are:
 You have any heart disorder, including an irregular
colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl heartbeat, an abnormal electrical signal called cellulose, hydroxypropyl methylcellulose acetate succinate “prolongation of the QT interval” or a family history of (HPMC-AS), magnesium stearate, iron oxide red, macrogol 3350, QT prolongation or sudden cardiac death at <50 years; polyvinyl alcohol, talc, titanium dioxide. you have a personal history of fainting spells; What dosage forms it comes in:
you have electrolyte disturbances (e.g., low Film-coated tablets / 240 mg vemurafenib levels) or conditions that could lead to WARNINGS AND PRECAUTIONS
electrolyte disturbances (e.g., vomiting, diarrhea, dehydration); Serious Warnings and Precautions
you have an eating disorder or are following a strict diet; ZELBORAF should only be prescribed by a doctor who is you have diabetes, especially with associated experienced in the use of anti-cancer drugs. ZELBORAF has an effect on the electrical activity of the heart
 You have liver or kidney problems;
known as QT/QTc prolongation.
 You have eye problems;

ZELBORAF has not been studied in patients with severe liver
You are pregnant or are planning to become
impairment.
pregnant. ZELBORAF may harm an unborn child.
Female patients who can get pregnant must use an
Patients taking ZELBORAF have reported second cancers.
effective birth control method while taking ZELBORAF and for at least six months after the last ZELBORAF has an effect on the electrical activity of the heart
dose. If you are pregnant, think you may be pregnant, known as QT/QTc prolongation. This effect can be measured
as a change in the electrocardiogram (ECG). Drugs with this
IMPORTANT: PLEASE READ
or plan to get pregnant while taking ZELBORAF tell your PROPER USE OF THIS MEDICATION
You are breast-feeding or plan to breast-feed. It is not
Usual dose:
known if ZELBORAF passes into your breast milk. You The usual dose is 960 mg (4 tablets) twice a day. Take 4 tablets and your doctor should decide if you will take in the morning. Then take 4 tablets in the evening about 12 hours later. Take ZELBORAF consistently with or without food. Swallow the tablets whole with a glass of water. Do not crush or ZELBORAF is not recommended for children and adolescents. The effects of ZELBORAF in people younger than 18 years old Overdose:
INTERACTIONS WITH THIS MEDICATION
If you take more ZELBORAF than you should or in case of drug overdose, contact a health care practitioner, hospital Before starting treatment, please tell your doctor if you are
emergency department or regional Poison Control Centre taking or have recently taken any other medicines (including
immediately, even if there are no symptoms. prescription and non-prescription medicines, vitamins, and herbal supplements). This is very important, as using more than one Missed Dose:
medicine at the same time can strengthen or weaken the effect of If you forget a dose and it is more than 4 hours before your next dose, just take your dose as soon as you remember it. Take the In particular, please tell your doctor if you are taking:
If it is less than 4 hours before your next dose, skip the missed  A medicine used to prevent blood clots called warfarin. dose. Then take the next dose at the usual time.  A medicine for cough called dextromethorphan Do not take a double dose to make up for a forgotten dose. Do  A sedative used during surgery called midazolam  Medicines that may affect your heartbeat such as: medicines for heart rhythm problems (anti- SIDE EFFECTS AND WHAT TO DO ABOUT THEM
arrhythmics) such as quinidine, amiodarone medicines for depression such as amitriptyline, Like all medicines, ZELBORAF can cause side effects, although medicines for psychoses such as ziprasidone and Very common side effects of ZELBORAF include: medicines for infections such as erythromycin, clarithromycin, moxifloxacin, or ketoconazole, medicines for nausea and vomiting such as a type of skin cancer (cutaneous squamous cell carcinoma). Tell your doctor right away if you have any other cancer drugs such as sunitinib or nilotinib skin changes including a new wart, a skin sore or reddish bump, or a sore that bleeds or does not heal. asthma drugs such as formoterol or salmeterol being more sensitive to sunlight, sun burn Medicines for seizures such as phenytoin or  pain in joint or muscle, musculoskeletal pain  HIV medicines such as atazanavir, saquinavir, ritonavir or  Other antibiotics such as rifampin or rifabutin You should also speak to your doctor before starting any new Grapefruit, grapefruit juice, or products containing grapefruit extract should be avoided while receiving ZELBORAF. Excessive use of caffeine should be avoided.  redness, skin peeling or blisters on hand and feet  a type of skin cancer (basal cell carcinoma) IMPORTANT: PLEASE READ
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
 irregular heartbeat (atrial fibrillation) HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect
Talk with
your doctor or
pharmacist
tingling or burning feeling in hands and feet (neurophathy call your
doctor or
 eye problems such as inflammation of the eye pharmacist
Changes in
heartbeat (QT
prolongation;
Liver problems. Tell your doctor right away if:
abnormal
your skin or the whites of your eyes turn yellow heartbeats, feel
dizzy or faint,
seizures)
Allergic reactions
Uncommon
 Changes in your heartbeat (called QT prolongation), very
fast or abnormal heartbeats. Seek medical attention right away if
you have abnormal heartbeats, feel dizzy or faint or have seizures.  Allergic reactions may occur. Tell your doctor right away if
you get a rash, feel faint, have trouble breathing or have swelling This is not a complete list of side effects. For any unexpected
effects while taking ZELBORAF, contact your doctor or
pharmacist.
Call your health care provider right away, if you have any of
the symptoms listed above.
HOW TO STORE IT
Keep out of the reach and sight of children. SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
Do not use ZELBORAF after the expiry date which is stated on the carton and the blister after “EXP”. The expiry date refers to Symptom / effect
Talk with
your doctor or
pharmacist
call your
Store between 15- 30C, in the original package. Protect from doctor or
pharmacist
Medicines should not be disposed of via wastewater or Cutaneous
household waste. Ask your pharmacist how to dispose of squamous cell
medicines no longer required. These measures will help to cancer including
keratoacanthomas

Abnormal liver
function tests
(if the liver tests are particularly abnormal you may experience the following: skin/whites of the eye turn yellow, feel tired, urine turns dark or brown, nausea or vomiting or not wanting to eat) IMPORTANT: PLEASE READ
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with
the use of health products to the Canada Vigilance Program by
one of the following 3 ways:
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Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
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 0701D
Ottawa, Ontario
Postage paid labels, Canada Vigilance Reporting Form
and the adverse reaction reporting guidelines are
available on the MedEffect™ Canada Web site at
www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management
of side effects, contact your health professional. The Canada
Vigilance Program does not provide medical advice.
MORE INFORMATION

This document plus the full product monograph, prepared for
health professionals can be found at: www.rochecanada.com
or by contacting the sponsor, Hoffmann-La Roche, at:
1-888-762-4388
This leaflet was prepared by Hoffmann-La Roche.
Last revised: October 11, 2012
TMZELBORAF is a Trade-Mark of F. Hoffmann-La Roche AG,
used under license
Manufactured under license from Plexxikon Inc., a member of the
Daiichi Sankyo group

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