Cotellic - Consumer Medicine Information
|Ingredients:||Cobimetinib Fumarate, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol 3350 (macrogol 3350), Polyvinyl Alcohol, Talc, and Titanium Dioxide.|
What Is Cotellic Used For
Cotellic is used to treat adult patients with a type of skin cancer called melanoma that hasspread to other parts of the body or cannot be removed by surgery.
- It is used in combination with another anti–cancer medicine called ZELBORAF. Youshould also read the patient medication information leaflet that comes with ZELBORAF.
- It can only be used in patients whose cancer has a specific type of change (mutation) in agene called “BRAF”. You should have your cancer tested for this change in the “BRAF”gene before starting treatment with Cotellic in combination with ZELBORAF.
How does Cotellic work
Cotellic targets a protein called “MEK” that is important in controlling cancer cell growth.When Cotellic is used in combination with ZELBORAF (which targets proteins made fromthe changed “BRAF” gene), it further slows down or stops the growth of your cancer.
What are the Ingredients in Cotellic
Medicinal ingredients: cobimetinib fumarate
Non–medicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate,microcrystalline cellulose, polyethylene glycol 3350 (macrogol 3350), polyvinyl alcohol, talc,and titanium dioxide.
Cotellic Comes in the Following Dosage Forms
Tablets, 20 mg
Do Not Use Cotellic If
Serious Warnings and Precautions
Side effects of Cotellic in combination with ZELBORAF, which have sometimes beenserious or life-threatening, include:
- Heart problems that can lead to inadequate pumping of the blood by your heart
- Bleeding problems, including bleeding in a critical area or organ of your body
- Eye problems
Cotellic has not been studied in patients with liver problems.
Cotellic should not be used with certaintypes of drugs that can increase the bloodlevel of Cotellic.
Cotellic in combination with ZELBORAF should be prescribed and managed by adoctor who knows how to use anti–cancer drugs.
- You are allergic to cobimetinib or any of the other ingredients in Cotellic
To help avoid side effects and ensure proper use, talk to your healthcare professionalbefore you take Cotellic. Talk about any health conditions or problems you may have,including if you:
- have melanoma cancer in your brain that has not been treated
- have any heart problems
- have high blood pressure (hypertension)
- have any health conditions or are on any medicines that increase your risk of bleeding
- have any liver problems
- have any allergies to medications
- have any muscle problems
- have any eye problems or related risk factors such as high cholesterol levels, for seriouseye problems that may occur with Cotellic
- are planning to have a child in the future. Cotellic may reduce your fertility.
- have any previous or current skin problems, including skin cancers other than melanoma
- have high blood sugar levels (diabetes)
- have any other medical conditions
- are pregnant, think you may be pregnant, or plan on becoming pregnant. Cotellic canharm your unborn baby
- Female patients who take Cotellic should use two forms of birth controlduring treatment with Cotellic and for at least 3 months after stoppingCotellic.
- Talk to your healthcare professional about birth control methods that may be rightfor you.
- Tell your healthcare professional right away if you become pregnant or think youare pregnant during treatment with Cotellic
- are breastfeeding or plan to breastfeed. It is not known if Cotellic passes into yourbreast milk. You and your healthcare professional should decide if you will takeCotellic or breastfeed. You should not do both
Other Warnings You Should Know About During Treatment
Driving and Using Machines
Cotellic can affect your ability to drive or usemachines. Avoid driving, using tools or operating machines if you have problems withyour vision or other problems that might affect your ability, e.g. if you feel dizzy or tired.Talk to your doctor if you are not sure
Increased Sensitivity to Sunlight
Avoid sunlight while you are taking Cotellic.Cotellic in combination with ZELBORAF can make your skin sensitive to sunlight.You may burn more easily and get severe sunburns. To help protect against sunburn:
- When you go outside, wear clothes that protect your skin, including your head,face, hands, arms, and legs.
- Use lip balm and a broad–spectrum sunscreen with SPF 30 or higher
Cotellic contains lactose (a type of sugar). If you have been told by yourhealthcare professional that you have intolerance to lactose, talk to your healthcareprofessional before taking this medicine.
Children and Adolescents
Cotellic is not recommended for children andadolescents. The effects of Cotellic in people younger than 18 years old are notknown.
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 Cotellic
Some types of medicines can affect a type of protein in the body called CYP3A. This proteinbreaks down Cotellic in the body. Use of these medicines while on Cotellic may make itmore likely that you will have side effects, or may affect how Cotellic works
- Drugs used to treat fungal infections (itraconazole, ketoconazole, posaconazole,voriconazole, fluconazole, miconazole)
- Antibiotics used to treat infections (clarithromycin, erythromycin, rifampin)
- Drugs used to treat HIV infection (lopinavir, ritonavir, fosamprenavir, delavirdine,efavirenz, etravirine)
- Drugs used to treat heart problems (amiodarone, diltiazem, verapamil)
- Drugs used to treat seizures (fits) (carbamazepine, phenytoin)
- Bosentan, used to treat high blood pressure in the blood vessels between the heart and thelungs
- Modafinil, used to treat sleep disorders
- Imatinib, an anti–cancer drug
- Cyclosporine, used to decrease your body’s immune reaction
- St. John’s Wort (Hypericum perforatum) used to treat depression and other conditions
- You should not drink grapefruit juice, eat grapefruit or take any products containinggrapefruit extract while you are on Cotellic in combination with ZELBORAF
How to Take Cotellic
- Always take Cotellic exactly as your healthcare professional has told you. Checkwith your healthcare professional if you are not sure.
- Swallow Cotellic tablets whole with a glass of water.
- Cotellic can be taken with or without food.
Usual Adult Dose
- The recommended dose of Cotellic is 60 mg (3 tablets) taken once daily for 21 days,followed by a 7 day break with no Cotellic treatment (28 day cycle – 3 weeks on, 1week off)
- During the 7 day break with no Cotellic treatment, you should keep takingZELBORAF as directed by your healthcare professional.
- Start your next Cotellic treatment cycle after the 7 day break.
If you vomit (throw up) after taking Cotellic, do not take an extra dose of Cotellic onthat day. Continue to take Cotellic as normal, the next day.
|If you think you have taken too much Cotellic, contact your healthcare professional,hospital emergency department or regional Poison Control Centre immediately, even if thereare no symptoms.|
If you forget to take Cotellic and:
- If it is more than 12 hours before your next dose, take the missed dose as soon as youremember.
- If it is less than 12 hours before your next dose, skip the missed dose. Take the next doseat the usual time.
- Do not take a double dose to make up for a missed dose.
What are Possible Side Effects From Using Cotellic
These are not all the possible side effects you may feel when taking Cotellic. Tell yourhealthcare professional if any of the side effects listed bothers you or does not go away. If youexperience any side effects not listed here, contact your healthcare professional. Please also seethe warnings above.
Very common side effects of Cotellic – these may affect more than 1 in 10 people:
See also the table below called Serious side effects and what to do about them.
Common side effects of Cotellic – these may affect up to 1 in 10 people:
- Increased sugar level (shown in blood tests)
See also the table below called Serious side effects and what to do about them.
Your healthcare professional will take blood tests while you are taking Cotellic. The mostcommon changes to blood tests include:
- increased blood levels of liver enzymes (GGT, ALT, or AST)
- increased blood level of enzyme from muscle [creatinine phosphokinase (CPK)]
- decreased blood level of phosphate, sodium or potassium
- increased blood level of liver or bone enzyme (alkaline phosphatase)
- decreased blood level of a type of white blood cell (lymphocyte)
- decreased blood level of red blood cells
Serious Side Effects and What to Do About Them
|Symptom ⁄ effect||Talk to your
drug and get
Diarrhea: increased number of stools, loose or watery stools
|Hypertension (high blood pressure): new or worsening high blood
pressure, severe headache, lightheadedness, dizziness
|Photosensitivity (increased sensitivity to sunlight): red, painful,
itchy skin that is hot to touch (sunburn), sun rash, skin irritation,
bumps or tiny papules, thickened, dry, wrinkled skin
Eye problems: blurred vision, distorted vision, partly missing
vision, halos, any other vision changes. These problems can arise
–Serous retinopathy (a build–up of fluid under the retina of
–Retinal vein occlusion (a blockage in a blood vessel carrying
blood away from the retina): blurred or reduced vision, usually
affects one eye, can occur suddenly
|Heart problems: These problems can arise from:
–Left ventricular dysfunction (inadequate pumping of blood
by the heart): persistent coughing or wheezing, shortness of
breath, tiredness, increased heart rate, swelling of your ankles
and feet–Atrial fibrillation (irregular heartbeat): feeling that your
heart is racing or fluttering, weakness, decreased ability to
exercise, tiredness, dizziness, lightheadedness, confusion,
difficulty breathing, chest pain
|Bleeding problems: blood in the urine, unusual or excessive vaginal
bleeding, bleeding of the gums, abdominal pain, red or black stools
that look like tar, headache, dizziness, or feeling weak.
|Allergic reactions: itchy rash, hives, redness of skin, swelling of the
face, lips, tongue, or throat, difficulty swallowing or breathing
|Rash: a rash that covers a large area of your body, blisters, or
|Pneumonitis (inflammation of the lungs): difficulty breathing,
may be accompanied by cough, fever or chills
|Basal cell carcinoma, cutaneous squamous cell carcinoma, and
keratoacanthoma (types of skin cancer): new wart, skin sore or
reddish bump that bleeds or does not heal
|Abnormal liver test or liver injury: yellowing of your skin or the
white of your eyes, dark or brown (tea coloured) urine, nausea or
vomiting, feeling tired or weak, loss of appetite
|Increased serum creatine phosphokinase (CPK) levels (increased
blood levels of an enzyme from muscle) and rhabdomyolysis (a
rapid breakdown of muscle): unexplained muscle aches, muscle
spasms and weakness, dark, reddish–coloured urine.
New primary melanoma: mole which has irregular shape, border,
or colour, is growing, or changing shape or colour
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 http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php
- 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
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
- Keep out of reach and sight of children.
- Store Cotellic between 15–30°C.
- Do not take this medicine after the expiry date which is stated on the blister pack after“EXP”. The expiry date refers to the last day of that month.
- Do not throw away any unused medicine in the garbage or down the drain or toilet. Askyour pharmacist how to best dispose of medicines that you no longer require. Thesemeasures will help to protect the environment.
If You Want More Information About Cotellic
- 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 Page 37 of 37 (http://www.hc-sc.gc.ca/index-eng.php) the manufacturer’s website (www.rochecanada.com), or by calling 1-888-762-4388.