Fuzeon
Common Name: enfuvirtide or T-20
Brand Name: Fuzeon
Class: HIV fusion inhibitor (a type of entry inhibitor)
Standard dose: One subcutaneous (under the skin) injection of 90 mg (1 ml) twice daily (every 12 hours) into the upper arm, thigh or abdomen. Can be taken with or without food, with no food restrictions. Take missed dose as soon as possible, unless it is almost time for your next dose. Do not double up on your next dose.
AWP: $2,973.04 / month for 90 mg kit
Manufacturer contact: Roche Pharmaceuticals and Trimeris, www.rocheusa.com, www.trimeris.com,
www.fuzeon.com, 1 (877) 4–FUZEON (438–9366)
Potential side effects and toxicity: The most common are Injection Site Reactions (ISRs), which occur in virtually all patients. The severity of reaction is variable, and for most is mild to moderate. Symptoms could include itching, swelling, redness, pain or tenderness, hardened skin or bumps. Bumps termed “nodules” seem to occur more frequently and severely in areas of high muscle mass (most notably the center of the stomach—the abs—and the legs). They will hurt with movement. Other side effects may include diarrhea, nausea, and fatigue. Hypersensitivity (allergic-like) reactions are possible. In studies, pneumonia happened more often in the patients on Fuzeon. It is unclear if this was related to the use of Fuzeon, so report cough, fever, or trouble breathing to your health care provider immediately. Immune Reconstitution Inflammatory Syndrome (IRIS) may occur as the immune system regains strength; signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is initiated. Report symptoms of illness, such as shingles and TB, to a health care provider.
Potential drug interactions: To date, none that are clinically significant have been found.
Tips: With other powerful, newer drugs on the market, the twice-daily injectable Fuzeon has truly become a medicine of last resort. In fact, some specialists have been taking patients off Fuzeon and putting them on newer drugs, like Isentress. Several studies have shown good results with this strategy. Fuzeon is intended for treatment of HIV in patients who are treatment-experienced. Store kit at room temperature. Preparing and injecting the Fuzeon can be complicated, so ask your health care provider how to do it. First, the drug needs to be dissolved with sterile water (provided in the kit), which may take up to 45 minutes. Never shake the vial with the Fuzeon, it will foam. Instead, roll it gently in your hands. You can store your second dose in the refrigerator, but it must be used within 24 hours (allow it to warm to room temperature before using). Before injecting, it is important to make sure that the Fuzeon powder is completely dissolved. To minimize injection site reactions, inject where you can pinch an inch (upper arm, stomach, or thigh). If not, then be sure to use half the length of the needle. Inject slowly and apply a gentle massage after injection. Try using vibrating devices after injections. Follow proper hygiene instructions to avoid infection. ISR may worsen when injection is repeated in the same spot or given deeper than intended, for example, into the muscle. Always rotate injection sites frequently. Never inject into moles, scars, bruises, nodules, or the navel. Switching to smaller needles, like insulin syringes, may also help with ISRs. Fuzeon can be taken at the same time as other anti-HIV drugs.
Fuzeon is the first and only anti-HIV compound on the market called a fusion inhibitor. Fusion inhibitors block fusion of HIV with a cell before the virus enters the cell and begins its replication process. Fusion inhibitors are a type of entry inhibitor, another one of which is in the pharmacy (Selzentry, taken orally). Because of injections, Fuzeon will most likely be used in the heavily treatment-experienced and salvage therapy options. U.S. HIV treatment guidelines support the use of Fuzeon with an active boosted protease inhibitor in patients who are heavily treatment-experienced. The guidelines supported the approach as it resulted in better and more prolonged virologic suppression than other regimens. Evidence included several studies of new boosted protease inhibitors in treatment-experienced patients which found an enhanced virologic response when used in conjunction with Fuzeon. This reinforces the principle of using two or more active drugs, if possible, when changing therapy, to make it more effective. Please see package insert for more complete potential side effects and interactions.
Doctor
Fuzeon (enfuvirtide, also known as T-20) was approved as a twice-daily injection for use in combination with other antiretroviral drugs in the treatment of HIV infection in 2003. Fuzeon was the first drug approved in the class of antiretrovirals called “entry inhibitors.” Since this class of drugs stops the virus from entering the CD4 cell, they were a significant step forward for HIV therapy, especially for those whose HIV was no longer fully susceptible to the drugs in the other classes. Studies done with this drug clearly and consistently demonstrated that when it was added to a new combination of one or two other newer drugs, the rate of re-establishing virologic suppression was enhanced. Nevertheless, the need to take this drug as a (self-administered) injection twice daily led to a rapid fall off in its use as soon as there were enough medications that were similarly active and taken in the usual way (by mouth). Even though there was exploration of novel “needleless” injection devices, there is very little current enthusiasm to use this drug as long as enough active “oral” medications are available. —Cal Cohen, MD
Activist
The first entry inhibitor, Fuzeon has become the drug of last resort for patients with multiple drug resistance who have run out of options. Being in a new class, it’s guaranteed to be effective for salvage patients who need to construct a new regimen—and the recent approval of both Isentress and Intelence means that many have been able to construct an effective regimen and reach undetectable for the first time. The drawback, of course, is the twice-daily injections—which can result in painful injection site reactions that can take so long to heal that some patients literally run out of available skin to inject. But the drug is literally a lifesaver, and even when added to a failing regimen, Fuzeon seems to help boost T-cell counts—buying time until more new drugs become available. —Jeff Taylor
