The power of an immunotherapy can be added to COTELLIC + ZELBORAF9

Learn more about this combination and appropriate patients >

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We focus on access so you can focus on health

At Genentech Access Solutions, we are dedicated to ensuring our medications are accessible for the patients who need them. We can help your patients and practice address each patient’s coverage scenario.

  • Is your patient insured?

  • Does the patient's insurance cover his or her Genentech medicine?

  • Does your patient have commercial insurance?

  • Has your patient already been referred to the Genentech Oncology Co-pay Assistance Program and is either ineligible or no longer receiving assistance?

  • Has your patient already been referred to an independent co-pay assistance foundation and is either ineligible or no longer receiving assistance?

  • Is the patient 18 years of age or older?

Your Patient Might Qualify for a Referral to the Genentech Oncology Co-pay Assistance Program

If eligible commercially insured patients need assistance with their out-of-pocket costs, COTELLIC and ZELBORAF Access Solutions can refer them to the Genentech Oncology Co-pay Assistance Program.*

 

Learn More

 

*Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their medications and or administration of their Genentech medication. Patient must be taking the Genentech medication for an FDA-approved indication. See full Terms and Conditions at CopayAssistanceNow.com.

Your Patient Might Qualify for a Referral to an Independent Co-pay Assistance Foundation

For eligible patients with commercial or public health insurance, COTELLIC and ZELBORAF Access Solutions offers referrals to independent co-pay assistance foundations.*

 

Learn More

 

*Genentech does not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from COTELLIC and ZELBORAF Access Solutions. The foundations to which we refer patients are not exhaustive or indicative of Genentech’s endorsement or financial support. There may be other foundations to support the patient's disease state.

Your Patient Might Qualify for a Referral to the Genentech Patient Foundation

The Genentech Patient Foundation provides free Genentech medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.*

 

Learn More

 

*To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine should try to pursue other forms of financial assistance, if available, and meet certain income requirements. Uninsured patients and insured patients without coverage for their medicine must meet a different set of income requirements.

Genentech Access to Care Foundation (GATCF)

GATCF provides free medicine to eligible patients who are uninsured, rendered uninsured by payer denial, or underinsured. To qualify, patients must meet specific criteria. For more information, call (888) 249-4918 or visit Genentech-Access.com/Oncology*.

*To be eligible for free medicine from GATCF, insured patients must have exhausted all other forms of patient assistance (including Genentech brand-specific co-pay cards and support from independent co-pay assistance foundations) and meet additional criteria.

Genentech Oncology Co-pay Card

Commercially insured patients may be eligible for the Genentech Oncology Co-pay Card† if they:

  • Are taking COTELLIC + ZELBORAF for an FDA-approved indication
  • Are over the age of 18
  • Do not have a government-funded health insurance plan (eg, Medicare, Medicare Advantage, Medicaid, TRICARE)
  • Are not receiving assistance from the GATCF or other charitable organizations
  • Do not reside in a state where co-pay cards are prohibited


†In order to be eligible for the Genentech Oncology Co-pay Card, the patient must confirm that they meet the eligibility criteria and agree to the rules set forth in the terms and conditions for the program. Please visit CopayAssistanceNow.com for the full list of terms and conditions.

Co-pay assistance foundations

Genentech Access Solutions offers referrals to independent co-pay assistance foundations‡ for eligible patients who are commercially or publicly insured, including those covered by Medicare and Medicaid.

Key points to remember about independent co-pay assistance foundation referrals:

  • Eligibility requirements, all aspects of the application process, turnaround times and the amount of assistance offered can vary by foundation
  • If the patient is denied assistance by one co-pay assistance foundation, he or she can be referred to a different foundation, if one is available
  • Patients referred for co-pay assistance need not be enrolled in Genentech Access Solutions and can simply call for a referral


To view a list of potential independent co-pay assistance foundations, visit Genentech-Access.com/Oncology.

‡Genentech does not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from Genentech Access Solutions. The foundations to which we refer patients are not exhaustive or indicative of Genentech's endorsement or financial support. There may be other foundations to support the patient's disease state.

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INDICATIONS AND USAGE

COTELLIC (cobimetinib) is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with ZELBORAF (vemurafenib).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Review the Full Prescribing Information for ZELBORAF for information on the serious risks of ZELBORAF.

New Primary Malignancies

New primary malignancies, cutaneous and non-cutaneous, can occur with COTELLIC in combination with ZELBORAF and with ZELBORAF as a single agent.

Cutaneous Malignancies

  • In Trial 1, the following cutaneous malignancies or premalignant conditions occurred in the COTELLIC with ZELBORAF arm and the ZELBORAF arm, respectively: cutaneous squamous cell carcinoma (cuSCC) or keratoacanthoma (KA) (6% and 20%), basal cell carcinoma (4.5% and 2.4%), and second primary melanoma (0.8% and 2.4%). Among patients receiving COTELLIC with ZELBORAF, the median time to detection of first cuSCC/KA was 4 months (range: 2 to 11 months), and the median time to detection of basal cell carcinoma was 4 months (range: 27 days to 13 months). The time to onset in the 2 patients with second primary melanoma was 9 months and 12 months.
  • Perform dermatologic evaluations prior to initiation of therapy and every 2 months while on therapy. Manage suspicious skin lesions with excision and dermatopathologic evaluation. No dose modifications are recommended for COTELLIC. Conduct dermatologic monitoring for 6 months following discontinuation of COTELLIC when administered with ZELBORAF.

Non-cutaneous Malignancies

  • Based on its mechanism of action, ZELBORAF may promote growth and development of malignancies.
  • Monitor patients receiving COTELLIC, when administered with ZELBORAF, for signs or symptoms of non-cutaneous malignancies.

Other Malignancies

  • Based on its mechanism of action, ZELBORAF may promote malignancies associated with activation of RAS through mutation or other mechanisms.
  • Monitor patients receiving ZELBORAF closely for signs or symptoms of other malignancies.

Tumor Promotion in BRAF Wild-Type Melanoma

In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells that are exposed to BRAF inhibitors.

Hemorrhage

Hemorrhage, including major hemorrhages defined as symptomatic bleeding in a critical area or organ, can occur with COTELLIC.

  • In Trial 1, the incidence of Grade 3-4 hemorrhages was 1.2% in patients receiving COTELLIC with ZELBORAF and 0.8% in patients receiving ZELBORAF. Hemorrhage (all Grades) was 13% in patients receiving COTELLIC with ZELBORAF and 7% in patients receiving ZELBORAF.
  • Withhold COTELLIC for Grade 3 hemorrhagic events. If improved to Grade 0 or 1 within 4 weeks, resume COTELLIC at a lower dose level. Discontinue COTELLIC for Grade 4 hemorrhagic events and any Grade 3 hemorrhagic events that do not improve.

Cardiomyopathy

  • Cardiomyopathy, defined as symptomatic and asymptomatic decline in left ventricular ejection fraction (LVEF), can occur with COTELLIC. The safety of COTELLIC has not been established in patients with a baseline LVEF that is either below institutional lower limit of normal (LLN) or below 50%.
  • Grade 2 or 3 decrease in LVEF occurred in 26% of patients receiving COTELLIC with ZELBORAF and 19% of patients receiving ZELBORAF.
  • Evaluate LVEF prior to initiation, 1 month after initiation, and every 3 months thereafter until discontinuation of COTELLIC. Manage events of left ventricular dysfunction through treatment interruption, reduction, or discontinuation. In patients restarting COTELLIC after a dose reduction or interruption, evaluate LVEF at approximately 2 weeks, 4 weeks, 10 weeks, and 16 weeks, and then as clinically indicated.

Hypersensitivity Reactions

  • Anaphylaxis and other serious hypersensitivity reactions can occur during treatment and upon re-initiation of treatment with ZELBORAF. Severe hypersensitivity reactions included generalized rash and erythema, hypotension, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
  • Permanently discontinue ZELBORAF in patients who experience a severe hypersensitivity reaction.

Severe Dermatologic Reactions

COTELLIC:

  • Severe rash and other skin reactions can occur with COTELLIC. In Trial 1, Grade 3 to 4 rash occurred in 16% of patients receiving COTELLIC with ZELBORAF and in 17% of patients receiving ZELBORAF, including Grade 4 rash in 1.6% of patients receiving COTELLIC with ZELBORAF and 0.8% of the patients receiving ZELBORAF.
  • Interrupt, reduce the dose, or discontinue COTELLIC for severe dermatologic reactions.

ZELBORAF:

  • Severe dermatologic reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, can occur in patients receiving ZELBORAF.
  • Permanently discontinue ZELBORAF in patients who experience a severe dermatologic reaction.

Serous Retinopathy and Retinal Vein Occlusion

Ocular toxicities can occur with COTELLIC, including serous retinopathy (fluid accumulation under layers of the retina).

  • Symptomatic and asymptomatic serous retinopathy was identified in 26% of patients receiving COTELLIC with ZELBORAF. The majority of these events were reported as chorioretinopathy (13%) or retinal detachment (12%).
  • Perform an ophthalmologic evaluation at regular intervals and any time a patient reports new or worsening visual disturbances. If serous retinopathy is diagnosed, interrupt COTELLIC until visual symptoms improve. Manage serous retinopathy with treatment interruption, dose reduction, or with treatment discontinuation.

QT Prolongation

  • Concentration-dependent QT prolongation occurred in an uncontrolled, open-label QT substudy of ZELBORAF in previously treated patients with BRAF V600E mutation-positive metastatic melanoma. QT prolongation may lead to an increased risk of ventricular arrhythmias, including Torsade de Pointes.
  • Do not start treatment with ZELBORAF in patients with uncorrectable electrolyte abnormalities, QTc >500 ms, or long QT syndrome, or in patients who are taking medicinal products known to prolong the QT interval. Prior to and following treatment initiation or after dose modification of ZELBORAF for QTc prolongation, evaluate ECG and electrolytes (including potassium, magnesium, and calcium) after 15 days, monthly during the first 3 months, and then every 3 months thereafter or more often as clinically indicated.
  • Withhold ZELBORAF in patients who develop QTc >500 ms (Grade 3). Upon recovery to QTc ≤500 ms (Grade ≤2), restart at a reduced dose. Permanently discontinue treatment with ZELBORAF if the QTc interval remains >500 ms and increased >60 ms from pretreatment values after controlling cardiac risk factors for QT prolongation (eg, electrolyte abnormalities, congestive heart failure, and bradyarrhythmias).

Hepatotoxicity

Hepatotoxicity can occur with COTELLIC in combination with ZELBORAF and with ZELBORAF as a single agent.

  • The incidences of Grade 3 or 4 liver laboratory abnormalities in Trial 1 among patients receiving COTELLIC with ZELBORAF compared with patients receiving ZELBORAF were 11% vs 5% for alanine aminotransferase, 8% vs 2.1% for aspartate aminotransferase, 1.6% vs 1.2% for total bilirubin, and 7% vs 3.3% for alkaline phosphatase.
  • Liver injury leading to functional hepatic impairment, including coagulopathy or other organ dysfunction, can occur with ZELBORAF.
  • Monitor liver laboratory tests, including transaminases, alkaline phosphatase, and bilirubin, before initiation of COTELLIC in combination with ZELBORAF and monthly during treatment, or more frequently as clinically indicated. Manage Grade 3 or 4 liver laboratory abnormalities with dose interruption, reduction, or discontinuation of COTELLIC and ZELBORAF.

Concurrent Administration with Ipilimumab

The safety and effectiveness of ZELBORAF in combination with ipilimumab have not been established.

Rhabdomyolysis

Rhabdomyolysis can occur with COTELLIC.

  • In Trial 1, Grade 3 or 4 creatine phosphokinase (CPK) elevations, including asymptomatic elevations over baseline, occurred in 14% of patients receiving COTELLIC with ZELBORAF and 0.5% of patients receiving ZELBORAF.
  • Obtain baseline serum CPK and creatinine levels prior to initiating COTELLIC, periodically during treatment, and as clinically indicated. If CPK is elevated, evaluate for signs and symptoms of rhabdomyolysis or other causes. Depending on the severity of symptoms or CPK elevation, dose interruption or discontinuation of COTELLIC may be required.

Severe Photosensitivity

Photosensitivity, including severe cases, can occur with COTELLIC in combination with ZELBORAF and with ZELBORAF as a single agent.

  • In Trial 1, photosensitivity was reported in 47% of patients receiving COTELLIC with ZELBORAF: 43% of patients with Grades 1 or 2 photosensitivity and the remaining 4% with Grade 3 photosensitivity.
  • Advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum UVA/UVB sunscreen and lip balm (SPF ≥30) when outdoors. Manage intolerable Grade ≥2 photosensitivity with dose modifications.

Other Ophthalmologic Reactions

  • Uveitis, blurry vision and photophobia can occur in patients treated with ZELBORAF.
  • Treatment with steroid and mydriatic ophthalmic drops may be required to manage uveitis. Monitor patients for uveitis.

Embryo-Fetal Toxicity

  • Based on its mechanism of action and findings from animal reproduction studies, COTELLIC can cause fetal harm when administered to a pregnant woman. Based on its mechanism of action, ZELBORAF can cause fetal harm when administered to a pregnant woman.
  • Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with COTELLIC and ZELBORAF and for 2 weeks after the final dose of COTELLIC or ZELBORAF (whichever is taken later).

Radiation Sensitization and Radiation Recall

  • Radiation sensitization and recall, in some cases severe, have been reported in patients treated with radiation prior to, during, or subsequent to ZELBORAF. Fatal cases have been reported in patients with visceral organ involvement.
  • Monitor patients closely when ZELBORAF is administered concomitantly or sequentially with radiation treatment.

Renal Failure

  • Renal failure, including acute interstitial nephritis and acute tubular necrosis, can occur with ZELBORAF.
  • Measure serum creatinine before initiation of ZELBORAF and periodically during treatment.

Dupuytren’s Contracture and Plantar Fascial Fibromatosis

  • Dupuytren’s contracture and plantar fascial fibromatosis have been reported with ZELBORAF. The majority of cases were mild to moderate, but severe, disabling cases have also been reported.
  • Events should be managed with dose reduction, treatment interruption, or treatment discontinuation.

USE IN SPECIFIC POPULATIONS: Lactation

Because of the potential for serious adverse reactions in a breastfed infant, including malignancy, severe dermatologic reactions, QT prolongation, hepatotoxicity, photosensitivity, and ophthalmologic toxicity from ZELBORAF, advise women not to breastfeed during treatment with COTELLIC and ZELBORAF and for 2 weeks after the final dose of COTELLIC or ZELBORAF (whichever is taken later).

DRUG INTERACTIONS

COTELLIC:

  • Avoid concurrent use of strong or moderate CYP3A inhibitors.
  • Avoid concurrent use of strong or moderate CYP3A inducers including but not limited to carbamazepine, efavirenz, phenytoin, rifampin, and St. John’s Wort.

ZELBORAF:

  • Avoid coadministration with strong CYP3A4 inhibitors or strong inducers and replace these drugs with alternative drugs when possible.
  • Avoid concomitant use with drugs having a narrow therapeutic window that are predominantly metabolized by CYP1A2.
  • Avoid concurrent use of P-glycoprotein (P-gp) substrates known to have narrow therapeutic indices.

Most Common Adverse Reactions for COTELLIC

The most common (≥20%) adverse reactions with COTELLIC were diarrhea (60%), photosensitivity reaction (46%), nausea (41%), pyrexia (28%) and vomiting (24%). The most common (≥5%) Grade 3-4 laboratory abnormalities were increased GGT (21%), increased CPK (14%), hypophosphatemia (12%), increased ALT (11%), lymphopenia (10%), increased AST (8%), increased alkaline phosphatase (7%), and hyponatremia (6%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see both Full COTELLIC Prescribing Information and Full ZELBORAF Prescribing Information for additional Important Safety Information.

    • COTELLIC Prescribing Information. Genentech, Inc. 2016. 

      COTELLIC Prescribing Information. Genentech, Inc. 2016. 

    • Larkin J, Ascierto PA, Dréno B, et al. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014;371:1867-1876.

      Larkin J, Ascierto PA, Dréno B, et al. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014;371:1867-1876.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

    • ZELBORAF Prescribing Information. Genentech, Inc. 2017.

      ZELBORAF Prescribing Information. Genentech, Inc. 2017.

    • Department of Health and Human Services (DHHS). New Drug Application (NDA) approval 202429 [letter]. Food and Drug Administration. 2011.

      Department of Health and Human Services (DHHS). New Drug Application (NDA) approval 202429 [letter]. Food and Drug Administration. 2011.

    • Bollag G, Tsai J, Zhang J, et al. Vemurafenib: the first drug approved for BRAF-mutant cancer. Nat Rev Drug Discov. 2012;11:873-886.

      Bollag G, Tsai J, Zhang J, et al. Vemurafenib: the first drug approved for BRAF-mutant cancer. Nat Rev Drug Discov. 2012;11:873-886.

    • Santarpia L, Lippman SL, El-Naggar AK. Targeting the mitogen-activated protein kinase RAS-RAF signaling pathway in cancer therapy. Expert Opin Ther Targets. 2012;16:103-119.

      Santarpia L, Lippman SL, El-Naggar AK. Targeting the mitogen-activated protein kinase RAS-RAF signaling pathway in cancer therapy. Expert Opin Ther Targets. 2012;16:103-119.

    • Chen G, Davies MA. Targeted therapy resistance mechanisms and therapeutic implications in melanoma. Hematol Oncol Clin North Am. 2014;28:523-536.

      Chen G, Davies MA. Targeted therapy resistance mechanisms and therapeutic implications in melanoma. Hematol Oncol Clin North Am. 2014;28:523-536.

    • TECENTRIQ Prescribing Information. Genentech, Inc. 2020.

      TECENTRIQ Prescribing Information. Genentech, Inc. 2020.