COTELLIC and ZELBORAF Distribution
Authorized Specialty Distributors and Specialty Pharmacies
Genentech BioOncology® Access Solutions for COTELLIC and ZELBORAF works with specialty pharmacies (SPs) to help patients receive their medicines.
An SP may provide the following services:
- Reimbursement resources
- Clinical services to support patients throughout their treatment
- The ability to manage the specialty handling and shipping needs linked with many specialty therapies
You can work with your preferred SP or contact Genentech BioOncology
Access Solutions to learn which SP the patient’s health insurance plan
requires.
Distributors for Federal Accounts
Distributors for Hospitals
Distributors for Physician Offices and Federally Qualified Health Centers (Buy and Bill)
Distributors for Authorized Specialty Pharmacies
Distributors for Puerto Rico
Specialty Pharmacies
Genentech does not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item.
PAN=Patient Authorization and Notice of Request
for Transmission of Health Information to Genentech Access Solutions
and Genentech® Access to Care Foundation.
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.