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January 31, 2007
- 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 (PI), as well
as corresponding changes to the Patient's Package Insert (PPI),
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 (see Error! Reference source not found.).
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.
You can access the
complete, revised label on the Daily Med site, at
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2705#nlm42232-9
Fuzeon is a
distributed by Roche Pharmaceuticals.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration |
