Enfuvirtide
Label Changes Important
additions have been made to the Fuzeon (enfuvirtide) for injection product label
to include 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 Physician's Insert, as well as corresponding changes to the Patient's Package
Insert, to provide additional safety information regarding the use of the Biojector
2000 to administer Fuzeon as follows: 1.
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. 2.
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. 3.
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. 4.
The following section under DOSAGE AND ADMINISTRATION changed from: Adults:
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 into moles, scar tissue, bruises, or the navel. Additional detailed information
regarding the administration of Fuzeon is described in the FUZEON Injection Instructions. To: Adults:
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. 5.
The second to last 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). 6.
The following was added under the HOW SUPPLIED section: Biojector
is a trademark of Bioject Medical Technologies, Inc. Patient Package Insert (compared
to S-007 final printed labeling) 7.
The following bullet under How should I use Fuzeon? Section was changed
from: Do
not inject FUZEON in the same area as you did the time before. Do not inject FUZEON
into the following areas: around the navel (belly button), scar tissue, a bruise,
or a mole, and where there is an injection site reaction. To: 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. 8.
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. 9.
The following sentence was added under the Changes since the last version of this
leaflet section: Clarification
of appropriate injection sites for FUZEON and addition of side effects when injecting
with Biojector 2000 needle-free device. 10.
The following statement was added to the last page: Biojector
is a trademark of Bioject Medical Technologies, Inc. Access
the complete, revised label. | 
