Cotellic

Name: Cotellic

Brand names

  • Cotellic®

Warnings

Contraindications

None

Cautions

Refer to the Dosage Modification section for instructions on withholding, decreasing, or permanently discontinuing cobimetinib in the event of adverse reactions

New primary malignancies can occur; monitor for new malignancies prior to initiation of therapy, while on therapy, and for up to 6 months following the last dose (see Dosage Modifications)

Major hemorrhagic events reported; monitor for signs and symptoms of bleeding (see Dosage Modifications)

The risk of cardiomyopathy is increased in patients receiving cobimetinib with vemurafenib compared with vemurafenib as a single agent; safety has not been established in patients with decreased LVEF; evaluate LVEF before treatment, after 1 month of treatment, then q3 months thereafter during treatment (see Dosage Modifications)

May cause severe dermatologic reactions; monitor for severe rashes (see Dosage Modifications)

Serous retinopathy and retinal vein occlusion reported; perform an ophthalmological evaluation at regular intervals and for any visual disturbances (see Dosage Modifications)

Hepatotoxicity reported; monitor liver laboratory tests during treatment and as clinically indicated (see Dosage Modifications)

Monitor CPK periodically and as clinically indicated for signs and symptoms of rhabdomyolysis (see Dosage Modifications)

Severe photosensitivity may occur; advise patients to avoid sun exposure (see Dosage Modifications)

Avoid coadministration with moderate or strong CYP3A4 inhibitors or inducers; if unable to avoid short-term use of moderate CYP3A4 inhibitors, reduce cobimetinib dose (see Dosage Modifications)

Can cause fetal harm; advise females of reproductive potential of the potential risk to a fetus and to use effective contraception

Stability

Storage

Oral

Tablets

Room temperature <30°C.1

How is this medicine (Cotellic) best taken?

Use Cotellic (cobimetinib) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • If you throw up after taking a dose, do not repeat the dose. Take your next dose at your normal time.
  • To gain the most benefit, do not miss doses.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Dizziness.
  • Feeling tired or weak.
  • Stomach pain.
  • Headache.
  • A skin lump or growth.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Loss of eyesight.
  • Seeing halos or bright colors around lights.
  • Fever or chills.
  • Sunburn.
  • Skin irritation.
  • Bumps, thick, dry, or wrinkled skin.
  • Red, painful, or itchy skin that is hot to touch.
  • Have your skin checked. Tell your doctor if you have any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.

How do I store and/or throw out Cotellic?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Indications and Usage for Cotellic

Cotellic® is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.

Patient Counseling Information

See FDA-approved patient labeling (Patient Information).

Inform patients of the following:

New primary cutaneous malignancies: Advise patients to contact their health care provider immediately for change in or development of new skin lesions [see Warnings and Precautions (5.1)].

Hemorrhage: Instruct patients to contact their healthcare provider to seek immediate medical attention for signs or symptoms of unusual severe bleeding or hemorrhage [see Warnings and Precautions (5.2)].

Cardiomyopathy: Advise patients to report any history of cardiac disease and of the requirement for cardiac monitoring prior to and during Cotellic administration. Instruct patients to immediately report any signs or symptoms of left ventricular dysfunction to their healthcare provider [see Warnings and Precautions (5.3)].

Serious dermatologic reactions: Instruct patients to contact their healthcare provider to immediately report severe skin changes [see Warnings and Precautions (5.4)].

Serous retinopathy and retinal vein occlusion: Instruct patients to immediately contact their healthcare provider if they experience any changes in their vision [see Warnings and Precautions (5.5)].

Hepatotoxicity: Advise patients that treatment with Cotellic requires monitoring of their liver function. Instruct patients to report any signs or symptoms of liver dysfunction [see Warnings and Precautions (5.6)].

Rhabdomyolysis: Instruct patients to report any signs and symptoms of muscle pain or weakness to their healthcare provider [see Warnings and Precautions (5.7)].

Severe photosensitivity: Advise patients to avoid sun exposure, wear protective clothing, and use broad spectrum UVA/UVB sunscreen and lip balm (SPF ≥30) when outdoors [see Warnings and Precautions (5.8)].

Embryo-fetal toxicity: Advise females of reproductive potential of the potential risk to a fetus. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with Cotellic [see Warnings and Precautions (5.9), Use in Specific Populations (8.1)].

Females of reproductive potential: Advise females of reproductive potential to use effective contraception during treatment with Cotellic and for at least 2 weeks after the final dose of Cotellic [see Use in Specific Populations (8.3)].

Lactation: Advise females not to breastfeed during treatment with Cotellic and for 2 weeks after the final dose [see Use in Specific Populations (8.2)].

Distributed by:

Genentech USA, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990

Cotellic® is a registered trademark of Genentech, Inc.
©2016 Genentech, Inc. All rights reserved.

PATIENT INFORMATION
Cotellic® (co-TELL-ic)
(cobimetinib)
tablet
Important: If your healthcare provider prescribes vemurafenib, also read the Medication Guide that comes with vemurafenib.
What is Cotellic?
Cotellic is a prescription medicine that is used with the medicine vemurafenib, to treat a type of skin cancer called melanoma:
  • that has spread to other parts of the body or cannot be removed by surgery, and
  • that has a certain type of abnormal "BRAF" gene
Your healthcare provider will perform a test to make sure that Cotellic is right for you.
It is not known if Cotellic is safe and effective in children under 18 years of age.
Before you take Cotellic, tell your healthcare provider about all of your medical conditions, including if you:
  • have skin problems or history a of skin problems, other than melanoma
  • have bleeding problems, any medical conditions and/or on any medications that increase your risk of bleeding
  • have heart problems
  • have eye problems
  • have liver problems
  • have muscle problems
  • are pregnant or plan to become pregnant. Cotellic can harm your unborn baby.
    • Females who are able to become pregnant should use effective birth control during treatment with Cotellic and for 2 weeks after the final dose of Cotellic.
    • Talk to your healthcare provider about birth control methods that may be right for you.
    • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Cotellic.
  • are breastfeeding or plan to breastfeed. It is not known if Cotellic passes into your breast milk. Do not breastfeed during treatment with Cotellic and for 2 weeks after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect the blood levels of Cotellic.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Cotellic?
  • Take Cotellic exactly as your healthcare provider tells you. Do not change your dose or stop taking Cotellic unless your healthcare provider tells you to.
  • Take Cotellic one time a day for 21 days, followed by 7 days off treatment, to complete a 28-day treatment cycle.
  • Take Cotellic with or without food.
  • If you miss a dose of Cotellic or vomit after taking your dose, take your next dose as scheduled.
What should I avoid during treatment with Cotellic?
Avoid sunlight during treatment with Cotellic. Cotellic 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.
What are the possible side effects of Cotellic?
Cotellic may cause serious side effects, including:
  • Risk of new skin cancers. Cotellic may cause new skin cancers (cutaneous squamous cell carcinoma, keratoacanthoma, or basal cell carcinoma).
    Check your skin regularly and tell your healthcare provider right away if you have any skin changes including:
    • new wart
    • skin sore or reddish bump that bleeds or does not heal
    • change in size or color of a mole
    Your healthcare provider should check your skin before you start taking Cotellic, and every 2 months during treatment with Cotellic. Your healthcare provider may continue to check your skin for 6 months after you stop taking Cotellic. Your healthcare provider should also check for cancers that may not occur on the skin. Tell our healthcare provider about any new symptoms that develop during treatment with Cotellic and vemurafenib.
  • Bleeding problems. Cotellic can cause serious bleeding problems.
    Call your healthcare provider and get medical attention right away if you get any signs of bleeding, including:
  • red or black stools (looks like tar)
  • blood in your urine
  • headaches
  • cough up or vomit blood
  • stomach (abdominal) pain
  • unusual vaginal bleeding
  • dizziness or weakness
  • Heart problems. Your healthcare provider should do tests before and during treatment to check your heart function. Tell your healthcare provider if you get any of these signs and symptoms of heart problems:
  • persistent coughing or wheezing
  • shortness of breath
  • swelling of your ankles and feet
  • tiredness
  • increased heart rate
  • Severe rash. Tell your healthcare provider right away if you get any of these symptoms:
    • a rash that covers a large area of your body
    • blisters
    • peeling skin
  • Eye problems. Tell your healthcare provider right away if you get any of these symptoms:
  • blurred vision
  • partly missing vision or loss of vision
  • see halos
  • any other vision changes
Your healthcare provider should check your eyes if you notice any of the symptoms above.
  • Liver problems. Your healthcare provider should do blood tests to check your liver function before and during treatment. Tell your healthcare provider right away if you get any of these symptoms:
  • yellowing of your skin or the white of your eyes
  • dark or brown (tea color) urine
  • nausea or vomiting
  • feeling tired or weak
  • loss of appetite
  • Muscle problems (rhabdomyolysis). Cotellic can cause muscle problems that can be severe. Treatment with Cotellic may increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and may be a sign of muscle damage. Your healthcare provider should do a blood test to check your levels of CPK before and during treatment. Tell your healthcare provider right away if you get any of these symptoms:
  • muscle aches or pain
  • muscle spasms and weakness
  • dark, reddish urine
  • Skin Sensitivity to sunlight (photosensitivity). Skin sensitivity to sunlight during treatment with Cotellic is common and can sometimes be severe. Tell your healthcare provider if you get any of these symptoms:
  • red, painful, itchy skin that is hot to touch
  • sun rash
  • skin irritation
  • bumps or tiny papules
  • thicken, dry, wrinkled skin
See "What should I avoid during treatment with Cotellic?" for information on protecting your skin during treatment with Cotellic.
The most common side effects of Cotellic include:
  • diarrhea
  • nausea
  • fever
  • vomiting
Your healthcare provider will take blood tests during treatment with Cotellic. The most common changes to blood tests include:
  • increased blood levels of liver enzymes (GGT, ALT, or AST)
  • increased blood level of enzyme from muscle (creatine phosphokinase)
  • 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)
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Cotellic.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Genentech at 1-888-835-2555.
How should I store Cotellic?
  • Store Cotellic at room temperature below 30°C (86°F).
  • Ask your healthcare provider or pharmacist how to safely throw away (dispose of) any unused or expired Cotellic.
Keep Cotellic and all medicine out of the reach of children.
General information about the safe and effective use of Cotellic
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Cotellic for a condition for which it was not prescribed. Do not give Cotellic to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Cotellic that is written for health professionals.
What are the ingredients in Cotellic?
Active ingredient: cobimetinib fumarate
Inactive ingredients:
Tablet Core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate
Coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc
Distributed by: Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990.
Cotellic® is a registered trademark of Genentech, Inc.
©2016 Genentech, Inc. All rights reserved. For more information go to www.Cotellic.com or call 1-877-436-3683.
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: May 2016

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

What is Cotellic?

Cotellic (cobimetinib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Cotellic is used to treat a certain type of metastatic melanoma (skin cancer) that has spread to other parts of the body and cannot be removed with surgery.

Cotellic is usually given together with another medicine called vemurafenib (Zelboraf).

Cotellic is used only if your tumor has a specific genetic marker, for which your doctor will test.

Cotellic dosing information

Usual Adult Dose for Melanoma - Metastatic:

60 mg orally once a day for first 21 days of each 28-day cycle

Duration of therapy: Until disease progression or unacceptable toxicity

Comments: The presence of BRAF V600E or V600K mutation in tumor specimens should be confirmed with an FDA-approved test prior to treatment initiation; information on FDA-approved tests available at http://www.fda.gov/CompanionDiagnostics.

Use: In combination with vemurafenib, indicated for treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

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