FDA-filed SPL labeling · retrieved through openFDA

Cobimetinib

Cobimetinib (Cotellic) is a targeted cancer medicine used to treat certain melanomas and rare blood cell tumors called histiocytic neoplasms.

Brand name Cotellic
Drug class Kinase Inhibitors
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJul 29, 2026
AvailabilityRx
Earliest approval/marketing year 2015
FDA-listed product records 4
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Cobimetinib at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Cobimetinib is a targeted therapy that blocks a key cancer cell growth signal and is used for certain melanomas (with a BRAF mutation, alongside vemurafenib) and rare histiocytic cancers. It requires close monitoring for serious risks including heart, eye, liver, skin, and bleeding problems throughout the course of treatment. Be sure to tell your care team about all other medications and supplements you take, avoid strong sun exposure, and keep all follow-up appointments so your doctors can catch any complications early.

📖 Cobimetinib: Patient Information Guide

A plain-language walkthrough of Cobimetinib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What It Treats

Cobimetinib is used along with vemurafenib (Zelboraf) to treat certain types of melanoma (a type of skin cancer) that cannot be treated with surgery or that has spread to other parts of the body. Cobimetinib is also used to treat histiocytic neoplasms (conditions that cause an overproduction and accumulation of a type of white blood cell in parts of the body). Cobimetinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

💊How to Take It

Cobimetinib comes as a tablet to take by mouth with or without food. It is usually taken once daily for the first 21 days of a 28-day cycle. Take cobimetinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cobimetinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you vomit after taking cobimetinib do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose of cobimetinib or permanently or temporarily stop your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with cobimetinib.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

If You Miss a Dose

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

🍽️Food, Alcohol & Dietary Advice

Do not eat grapefruit or drink grapefruit juice while taking this medication.

⚠️Warnings & Precautions

Before taking cobimetinib,

  • tell your doctor and pharmacist if you are allergic to cobimetinib, any other medications, or any of the ingredients in cobimetinib tablets. Ask your pharmacist for a list of the ingredients.

  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

  • tell your doctor what herbal products you are taking, especially St. John's Wort. Do not take St. John's Wort while you are taking cobimetinib.

  • tell your doctor if you have or have ever had have skin conditions other than melanoma; bleeding problems; vision problems; any condition that affects your muscles; or heart or liver disease.

  • you should know that cobimetinib may decrease fertility in men and women. However, you should not assume that you or your partner cannot become pregnant. Tell your doctor if you are pregnant or plan to become pregnant. Use a reliable method of birth control to prevent pregnancy during your treatment and for 2 weeks after you stop taking cobimetinib. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking cobimetinib, call your doctor immediately. Cobimetinib may harm the fetus.

  • tell your doctor if you are breastfeeding. You should not breastfeed while taking cobimetinib and for 2 weeks after your last dose.

  • plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, lip balm and sunscreen (SPF 30 or higher). Cobimetinib may make your skin sensitive to sunlight. Tell your doctor right away if you get a sunburn.

🤒Side Effects in Detail
  • Cobimetinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

    • mouth ulcers

    • hair loss

    • diarrhea

    • nausea

    • vomiting

    • heartburn or indigestion

    • dry mouth

    • mouth pain

    • fever, chills, sore throat, frequent or painful urination, or other signs of infection

    • falling

  • Some side effects can be serious. If you experience any of these symptoms or those in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

    • rash that covers a large area of your body, blisters, or peeling skin

    • changes in skin appearance

    • new wart

    • skin sore or red bump that bleeds or does not heal

    • change in size or color of a mole

    • unusual bleeding or bruising tarry or black stools, blood in urine, unusual vaginal bleeding, stomach pain, headache or dizziness

    • coughing or wheezing; rapid, irregular, or pounding heartbeat; shortness of breath; tiredness; or swelling of the face, arms, legs, ankles, or feet

    • muscle spasms, pain, or weakness

    • changes in vision, including seeing halos (blurred outline around objects), blurred vision, or loss of vision

    • yellowing of the skin or eyes, dark-colored (tea-colored) urine, pain in upper right part of the stomach, nausea, vomiting, or loss of appetite

  • Cobimetinib may increase the risk that you will develop new skin cancers. Talk to your doctor about the risks of taking this medication.

  • Cobimetinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

  • If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

🚑If You Take Too Much

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

📦Storage & Disposal

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Other Uses

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

ℹ️Good to Know

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response during and after therapy. Your doctor will check your skin for any changes before, every 2 months during your treatment, and for up to 6 months after treatment.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

📄 Written from Cobimetinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

138

Supplements & herbs that interact with Cobimetinib

138 supplements and herbal products have documented interactions with Cobimetinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 94
  • Minor · 41
Every supplement checked against Cobimetinib — ranked by severity The full interaction hub: 3 major · 94 moderate · 41 minor · every one linked to its full report. Check Cobimetinib against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Cobimetinib: frequently asked questions

Common questions about Cobimetinib, answered from its official FDA-filed labeling.

What is Cobimetinib used for?
1 INDICATIONS AND USAGE COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. ( 1.2 , 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
How is Cobimetinib taken?
2 DOSAGE AND ADMINISTRATION Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of COTELLIC with vemurafenib for patients with melanoma. ( 2.1 ) The recommended dose is 60 mg orally once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity. Take COTELLIC with or without food. ( 2.2 ) 2.1 Patient Selection for Treatment of Melanoma Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with COTELLIC with vemurafenib.
What are the side effects of Cobimetinib?
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: New Primary Cutaneous Malignancies [see Warnings and Precautions (5.1) ] Hemorrhage [see Warnings and Precautions (5.2) ] Cardiomyopathy [see Warnings and Precautions (5.3) ] Serious Dermatologic Reactions [see Warnings and Precautions (5.4) ] Serous Retinopathy and Retinal Vein Occlusion [see Warnings and Precautions (5.5) ] Hepatotoxicity [see Warnings and Precautions (5.6) ] Rhabdomyolysis [see Warnings and Precautions (5.7) ] Severe Photosensitivity [see Warnings and Precauti…
What should I know before taking Cobimetinib?
5 WARNINGS AND PRECAUTIONS Review the Full Prescribing Information for vemurafenib for information on the serious risks of vemurafenib. New primary malignancies, cutaneous and non-cutaneous : Monitor patients for new malignancies prior to initiation of therapy, while on therapy, and for up to 6 months following the last dose of COTELLIC. ( 5.1 ) Hemorrhage : Major hemorrhagic events can occur with COTELLIC. Monitor for signs and symptoms of bleeding.
Can I take Cobimetinib while pregnant?
8.1 Pregnancy Risk Summary Based on findings from animal reproduction studies and its mechanism of action, COTELLIC can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ]. There are no available data on the use of COTELLIC during pregnancy. In animal reproduction studies, oral administration of cobimetinib in pregnant rats during organogenesis was teratogenic and embryotoxic at exposures (AUC) that were 0.9 to 1.4-times those observed in humans at the recommended human dose of 60 mg [see Data ] . Advise pregnant women of the potential risk to a fetus.
How should I store Cobimetinib?
Store at room temperature below 30°C (86°F).
Is Cobimetinib available over the counter?
Cobimetinib is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Cobimetinib first available?
Cobimetinib has been available in the United States since at least 2015, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Cobimetinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Cobimetinib comes

Cobimetinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Cotellic
Available strengths 1 strength
4 FDA-listed product records

📊 Cobimetinib across the U.S. market

How Cobimetinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
1
Manufacturers
1
Brand names
4
FDA-listed product records
2015
First marketed

📈 How widely Cobimetinib is used

A general measure of how commonly Cobimetinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Cobimetinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

168
Medicaid prescriptions filled (Q1–Q4 2025)
$988,902 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cobimetinib prescribed? Of the 1,596 medications we measure, Cobimetinib ranks #1,463 by Medicaid prescriptions — more than 8% of them.

Where Cobimetinib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Cobimetinib product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

cobimetinib 20 MG Oral Tablet

168 Medicaid prescriptions (Q1–Q4 2025) 100% of Cobimetinib prescriptions shown $988,902 gross reimbursement (before rebates) ≈ $5,886 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1722370

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cobimetinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Cobimetinib NDCs with Medicaid activity.

🔍 Compare Cobimetinib products

A representative set of FDA-listed product records for Cobimetinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Tablet
20 mg Oral Genentech, Inc. × 4 listings NDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Cobimetinib NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Cobimetinib RxCUI 1722365 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Tablet RxCUI 1722369 In current FDA listings
    Clinical drug / strength (SCD) 20 MG RxCUI 1722370

Look up RxCUI 1722365 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Cotellic

🏭 Manufacturers & labelers

Genentech, Inc. 4

RxNorm drug class

Cobimetinib belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Mitogen-activated protein kinase (MEK) inhibitors
How it works Kinase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 29, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cobimetinib.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Cobimetinib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
4
Distinct labelers/manufacturers represented
1
Linked representative label
Genentech, Inc.
Linked label effective
Jul 29, 2026
Composite sections available
22
Linked SPL Set ID
c387579e-cee0-4334-bd1e-73f93ac1bde6
Linked SPL Document ID
59075332-49ef-4998-98c4-81e61f57d424
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Genentech, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.