Patient Assistance
Genentech® Access to Care Foundation (GATCF)
The Genentech Access to Care Foundation (GATCF) was established to help patients with unmet medical needs who are uninsured or rendered uninsured by payer denial and who meet specific financial and medical criteria to receive proper medical treatment.
We are committed to helping ease the financial burdens that some patients and their families may experience in gaining access to our medicines. In support of the commitment, GATCF provides free medicine to qualified patients.
- GATCF has defined specific insurance, financial and medical criteria that must be met for individual patients to be eligible for assistance
- Insurance: the patient must be uninsured or rendered uninsured by payer denial
- Financial: the patient must have an annual household adjusted gross income (AGI) < $100,000
- Medical: the patient must meet medical criteria
- Key points to remember about GATCF
- Patients are eligible for free medicine for 1 year; patients must reapply yearly
- GATCF assists with the medication only, not the administration costs
To see if a patient qualifies for GATCF, there are two forms that the doctor will need to complete. The completed forms should be faxed to 800-305-1830. For questions, please call us at 866-247-5084.
- The Statement of Medical Necessity (SMN) - a form with basic patient, insurance and prescription information used when contacting a patient's health insurance plan to determine their reimbursement coverage and eligibility for treatment
- The Patient Authorization and Notice of Release of Information (PAN) - a form signed and dated by your patient that gives written permission for GATCF to discuss his or her case with you
Indication
FUZEON (enfuvirtide) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
This indication is based on results from two controlled studies of 48-weeks' duration. Subjects enrolled were treatment-experienced adults; many had advanced disease. There are no studies of FUZEON in antiretroviral-naive patients.
Important Safety Information
FUZEON is contraindicated in patients with known hypersensitivity to FUZEON or any of its components.
Local Injection Site Reactions (ISRs)
The majority of subjects (98%) receiving FUZEON in randomized, controlled, open-label, multicenter clinical trials had at least one local injection site reaction; ISRs occurred throughout treatment with FUZEON. Manifestations may include pain and discomfort, induration, erythema, nodules and cysts, pruritus, and ecchymosis. Reactions are often present at more than one injection site.
Administration with Biojector® 2000
Nerve pain (neuralgia and/or paresthesia) lasting up to 6 months associated with administration at anatomical sites where large nerves course close to the skin, bruising and hematomas have occurred with use of the Biojector 2000 needle-free device for administration of FUZEON. Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding.
Pneumonia
An increased rate of bacterial pneumonia was observed in subjects treated with FUZEON in the Phase III clinical trials compared to the control arm. Three subject deaths in the FUZEON arm were attributed to pneumonia; all three had serious concomitant AIDS-related illnesses that contributed to their deaths. Because it was unclear whether the higher incidence rate of pneumonia was related to FUZEON use, an observational study in 1850 HIV-infected patients was conducted to evaluate the risk of pneumonia in patients treated with FUZEON. Based on this observational study, it is not possible to exclude an increased risk of pneumonia in patients treated with FUZEON compared to non-FUZEON treated patients. It is unclear if the increased incidence of pneumonia is related to FUZEON use. However, because of these findings, patients with HIV-1 infection should be carefully monitored for signs and symptoms of pneumonia, especially if they have underlying conditions that may predispose them to pneumonia. Risk factors for pneumonia included low initial CD4 cell count, high initial viral load, intravenous drug use, smoking and a prior history of lung disease.
Hypersensitivity Reactions
Systemic hypersensitivity reactions have been associated with FUZEON therapy and may recur on re-challenge. Hypersensitivity reactions have occurred in < 1% of patients and have included combinations of rash, fever, nausea and vomiting, chills, rigors, hypotension and elevated serum liver transaminases. Other adverse events that may be immune-mediated and have been reported in subjects receiving FUZEON include primary immune complex reaction, respiratory distress, glomerulonephritis and Guillain-Barre syndrome. Patients developing signs and symptoms suggestive of a systemic hypersensitivity reaction should discontinue FUZEON treatment and should seek medical evaluation immediately. Therapy with FUZEON should not be restarted following systemic signs and symptoms consistent with a hypersensitivity reaction. Risk factors that may predict the occurrence or severity of hypersensitivity to FUZEON have not been identified.
Non-HIV Infected Individuals
There is a theoretical risk that FUZEON use may lead to the production of anti-enfuvirtide antibodies which cross-react with HIV gp41. This could result in a false positive HIV test with an ELISA assay; a confirmatory western blot test would be expected to be negative. FUZEON has not been studied in non-HIV infected individuals.
Immune Reconstitution Syndrome
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including FUZEON.
Most Common Adverse Events
Local Injection Site Reactions (ISRs)
In clinical trials, ISRs were the most frequently reported adverse event (98%) and occurred throughout treatment with FUZEON. Four percent of patients discontinued treatment because of ISRs. Signs/symptoms may include pain and discomfort, induration, erythema, nodules and cysts, pruritus, ecchymosis and infection. Eleven percent of patients had local reactions that required analgesics or limited usual activities.
Other Adverse Events
Excluding ISRs, the events most frequently reported in patients receiving FUZEON plus a background regimen were diarrhea (38 per 100 patient-years, or 32%), nausea (27 per 100 patient-years, or 23%) and fatigue (24 per 100 patient-years, or 20%). These events were seen at a lower incidence than in patients receiving a background regimen without FUZEON: diarrhea (73 per 100 patient-years), nausea (50 per 100 patient-years) and fatigue (38 per 100 patient-years).
FUZEON is not a cure for HIV infection or AIDS. FUZEON does not prevent the transmission of HIV.
For more information on FUZEON, please see full Prescribing Information, go to www.FUZEON.com or call 1.877.4.FUZEON (1.877.438.9366).
