Food and Drug Administration - January 31, 2007
Richard Klein & Kimberly Struble

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 Precautions.).

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

SOURCE: Food and Drug Administration (FDA).

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