Changes to US product label for T-20 (enfuvirtide)
5 February 2007. Related: Antiretrovirals.
On 31 January, the FDA announced that important additions have been made to the product label for T-20 (enfuvirtide, Fuzeon) mainly relating to injection guidance and also use of Biojector (not currently approved in Europe).
This includes a description of nerve bundle pain, hematoma, and cautionary wording regarding Biojector use in patients with coagulopathy. The changes add language to the Precautions, Adverse Reactions, and Dosage and Administration sections of the Physicians Insert (PI), as well as corresponding changes to the Patients Package Insert (PPI), to provide additional safety information regarding the use of the Biojector 2000 to administer Fuzeon, including:
The following section was added under PRECAUTIONS: Administration with Biojector(r) 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 (see ADVERSE REACTIONS) 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 postinjection bleeding.
The following bullet was added under PRECAUTIONS, Information for Patients section
*Patients and caregivers should be instructed on the preferred anatomical sites for administration (upper arm, abdomen, anterior thigh). FUZEON should not be injected near any anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior or medial sections of the buttocks, skin abnormalities, including directly over a blood vessel, into moles, scar tissue, bruises, or near the navel, surgical scars, tattoos or burn sites.
The following paragraph was added under ADVERSE REACTIONS, Local Injection Site Reactions section:
Biojector 2000 Needle-Free Device – Adverse events associated with the use of the Biojector 2000 needle-free device for administration of FUZEON have included: 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.
The following section under DOSAGE AND ADMINISTRATION change to: (changes in italic)
The recommended dose of FUZEON is 90 mg (1 mL) twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen. Each injection should be given at a site different from the preceding injection site, and only where there is no current injection site reaction from an earlier dose. FUZEON should not be injected near any anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior or medial section of the buttocks, skin abnormalities, including directly over a blood vessel, into moles, scar tissue, bruises, or near the navel, surgical scars, tattoos or burn sites. Additional detailed information regarding the administration of FUZEON is described in the FUZEON Injection Instructions.
The paragraph under Subcutaneous Administration now reads:
The reconstituted solution should be injected subcutaneously in the upper arm, abdomen or anterior thigh. The injection should be given at a site different from the preceding injection site and only where there is no current injection site reaction. Also, do not inject near any anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior or medial sections of the buttocks, skin abnormalities, including directly over a blood vessel, into moles, scar tissue, bruises or near the navel, surgical scars, tattoos or burn sites. A vial is suitable for single use only; unused portions must be discarded (see FUZEON Injection Instructions).
The following bullet under How should I use FUZEON? (additions in italic)
Do not inject FUZEON in the same area as you did the time before. Do not inject FUZEON into the following areas: near the elbow, knee, groin, the lower or inner buttocks, directly over a blood vessel, around the navel (belly button), scar tissue, a bruise, a mole, a surgical scar, tattoo or burn site, or where there is an injection site reaction.
The following section was added under What are the possible side effects of FUZEON?
Injection using Biojector(r) 2000 – Shooting nerve pain and tingling lasting up to 6 months from injecting close to large nerves or near joints, and bruising and/or collections of blood under the skin have been reported with use of the Biojector 2000 needle-free device to inject FUZEON. If you are taking any blood thinners, or have hemophilia or any other bleeding disorder, you may be at higher risk of bruising or bleeding after using the Biojector.
For further details including reference table please see the full article:
http://www.fda.gov/oashi/aids/listserve/listserve2007.html#13107
Source: Food and Drug Administration
An archive of past list serve announcements is available on the FDA web site:
http://www.fda.gov/oashi/aids/listserve/archive.html
The complete, revised label can be accessed on the Daily Med site, at:
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2705#nlm42232-9