ZELBORAF Access Solutions can conduct a benefits investigation
(BI) to help you determine if a Genentech medicine is covered, if
prior authorizations (PAs) are required, which specialty pharmacy (SP)
the health insurance plan prefers and if patient assistance might be
Potential outcomes of a BI:
- Treatment is covered
- PA is required
- Treatment is denied
Both the Prescriber Service Form and the Patient Consent Form must be received before ZELBORAF Access Solutions can begin helping your patient.
ZELBORAF Access Solutions can help you identify if a prior
authorization (PA) is necessary and offer resources as you obtain it
for your patient. Both the Prescriber Service Form and the Patient
Consent Form must be received before ZELBORAF Access Solutions can
begin helping your patient.
If your patient’s request for a PA is not granted, your BioOncology Field Reimbursement Manager (BFRM) or ZELBORAF Access Solutions Specialist can work with you to determine your next steps. You can find more tips like this in Forms and Documents.
The completion and submission of coverage- or reimbursement-related
documentation are the responsibility of the patient and health care
provider. Genentech makes no representation or guarantee concerning
coverage or reimbursement for any service or item.
Important Safety Information & Indication
Unresectable or Metastatic Melanoma
ZELBORAF® (vemurafenib) is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma.
ZELBORAF® is indicated for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.
Important Safety Information
WARNINGS AND PRECAUTIONS
The following can occur in patients treated with ZELBORAF:
- New primary malignancies including cutaneous squamous cell carcinoma, noncutaneous 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
- Ophthalmologic reactions
- 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
Avoid concurrent use of ZELBORAF with strong CYP3A4 inhibitors, strong CYP3A4 inducers, and CYP1A2 and P-glycoprotein substrates with a narrow therapeutic window.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed while taking ZELBORAF and for 2 weeks after the final dose.
Most Common Adverse Reactions
The most common adverse reactions of any grade (≥30%) reported were arthralgia (53%), rash (37%), alopecia (45%), fatigue (38%), photosensitivity reaction (33%), nausea (35%), pruritus (23%), and skin papilloma (21%).
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 accompanying Full Prescribing Information for additional Important Safety Information.