One 90 mg subcutaneous injection twice daily |
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Brand name: Fuzeon
Common name: T-20, enfuvirtide
Class: fusion inhibitor
Standard dose: One subcutaneous (under the skin) injection of 90 mg (1 ml) twice daily into the upper arm, thigh or abdomen. No food restrictions (take with or without food). Take missed dose as soon as possible, but do not double up on next dose.
AWP: $2,152.21 / 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)
AIDS Treatment Information Service: 1 (800) HIV–0440 (448–0440) |
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Potential side effects and toxicity: The most common are Injection Site Reactions (ISRs), which occur in virtually all patients. The severity of reactions is variable, and for most is mild to moderate. Symptoms could include itching, swelling, redness, pain or tenderness, hardened skin or bumps; others include headache and fever. 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. Allergic 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. Report cough, fever or trouble breathing to your healthcare provider right away.
Potential drug interactions: To date none that require dose adjustment have been reported.
Tips: To minimize injection site reactions, inject where you can pinch an inch. 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. Careful reconstitution of drug is also helpful. The drug must be carefully reconstituted for 30–45 minutes (for the two daily doses—refrigerate the dose—after reconstitution—that will be taken later, and then allow it to warm to room temperature before using). Never shake—it will foam. Follow 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. Fuzeon can be taken at the same time as other anti-HIV drugs. Always rotate injection sites frequently. Never inject into moles, scars, bruises, nodules or the navel. Research is needed in alternate site subcutaneous areas, such as the buttocks or the upper back.
Fuzeon is the first in a new class of anti-HIV compounds called fusion inhibitors. Fusion inhibitors block fusion of HIV with host cells before the virus enters the cell and begins its replication process. Because of injections, this drug will most likely be used in the heavily-treatment experienced and salvage therapy options. However, because the drug is so good, it should be studied (and used more) in people with earlier disease or those on their second or third regimen. Two large Phase III studies showed good viral load decrease when added to an optimized antiviral combination in heavily treatment-experienced people, including those with protease inhibitor-resistant virus and those who’ve taken all three current drug classes. Participants used 3 to 5 antivirals in addition to Fuzeon and both genotype and phenotype tests. |
Doctor
Fuzeon is a novel anti-HIV drug, the first in the class known as fusion inhibitors. If it were not administered as an injection, it no doubt would be a first-line therapy, because of its tolerability and potency. Currently, it is prescribed in salvage therapies, though it works best if it can be paired with another agent that the patient is not resistant to. —Ross Slotten, MD |
Activist
When the first T-20 data came out, the graphs showed how much better it performed with one, preferably two, new agents than as the only new agent in a regimen. It seemed like a moot point to me: people with two new agents available wouldn’t likely opt for a drug that costs a mint, is injected twice daily, leaves big lumps behind and isn’t that durable…would they? Well, maybe they should—it appears T-20 may do better the earlier it’s started. In my circle, a ritual has emerged when someone starts T-20: we ooh and aah at the initial viral load drop (many people taking the drug haven’t seen their numbers so low in years), followed by deep sighs some weeks or months later when the viral load breaks through and starts to climb. There’s a lot of hope—and lives—pinned on T-20 and tipranavir for people with multi-drug resistance. —Heidi M. Nass |
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