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Genentech BioOncology® Access Solutions for COTELLIC and ZELBORAF is your resource for access and reimbursement support after COTELLIC and ZELBORAF are prescribed.

Coverage

Help understanding benefits and coverage, such as benefits investigations and prior authorization resources

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Reimbursement

Sample coding information and resources for denials and appeals

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Product Distribution

A list of authorized distributors and specialty pharmacies

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Online Patient Enrollment

Submit Genentech BioOncology Access Solutions forms and check the status of your service requests online using My Patient Solutions

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Our Commitment to Patients

Over the past 20+ years,
Genentech has helped over

million

patients access the Genentech medicines they need.

In 2018, we helped more than

270,000

patients access the Genentech medicines they need.

Communication assistance services

Genentech BioOncology Access Solutions employs a multilingual call center staff and offers teletypewriter (TTY) services for callers.
 

Important Safety Information & Indication

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.

The following can occur in patients treated with COTELLIC:

  • New primary malignancies, including cutaneous and non-cutaneous malignancies
  • Hemorrhage, including major hemorrhages
  • Cardiomyopathy, defined as symptomatic and asymptomatic decline in left ventricular ejection fraction
  • Severe dermatologic reactions, including rash and other skin reactions
  • Serous retinopathy and retinal vein occlusion
  • Hepatotoxicity
  • Rhabdomyolysis
  • Severe photosensitivity
  • Embryo-fetal toxicity

The following can occur in patients treated with ZELBORAF:

  • New primary malignancies including cutaneous squamous cell carcinoma, non-cutaneous squamous cell carcinoma, new primary melanoma, and other malignancies
  • Tumor promotion in BRAF wild-type melanomas
  • Serious hypersensitivity reactions including anaphylaxis
  • Severe dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
  • QT prolongation
  • Hepatotoxicity including liver injury leading to functional hepatic impairment (including coagulopathy or other organ dysfunction); increases in transaminases and bilirubin when concurrently administered with ipilimumab
  • Photosensitivity
  • Ophthalmologic reactions, including uveitis, blurry vision, and photophobia
  • Embryo-fetal toxicity
  • Radiation sensitization and radiation recall, including fatal cases in patients with visceral involvement
  • Renal failure, including acute interstitial nephritis and acute tubular necrosis
  • Dupuytren’s contracture and plantar fascial fibromatosis

USE IN SPECIFIC POPULATIONS: Lactation

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

  • Avoid concomitant administration of COTELLIC with strong or moderate CYP3A inducers or inhibitors.
  • Avoid concurrent use of ZELBORAF with strong CYP3A4 inhibitors, strong CYP3A4 inducers, and CYP1A2 and P-glycoprotein substrates with narrow therapeutic windows.

Most Common Adverse Reactions

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.