Use of Biojector 2000, a needle-free device to administer the anti-HIV drug T-20 (enfuvirtide, Fuzeon), has caused long-lasting nerve pain, bruising and bleeding below the skin in some patients.
T-20 is the only antiretroviral not available in an oral formulation. There are concerns that both patients and doctors are reluctant to consider the drug because it is administered using needles. Furthermore, many patients using T-20 have developed injection site reactions in the long term. Biojector 2000 avoids the use of needles. The device is placed against the skin and T-20 is pushed under the skin using high pressure.
A small study has also shown that use of Biojector 2000 reduces injection-site reactions in individuals taking T-20.
However, some patients have reported problems with Biojector 2000, prompting an alert to be issued about its possible side-effects. There is also concern that patients taking blood-thinning medications or those with bleeding disorders may be at an increased risk of bleeding or bruising if using Biojector 2000 to administer T-20.
Product labelling for T-20 has been updated by the US Food and Drug Administration to reflect this new information. The label now advises against injecting T-20 at sites where large nerves - such as the elbow, knee, groin and parts of the buttocks - are close to the skin.
Patients are also cautioned not to inject T-20 near to moles, scars, burns, tattoos, above blood vessels or near the belly button. Recommended injection sites are the abdomen, upper arm, and outer thigh.