FASLODEX is indicated for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Adults (including the elderly)

The recommended dose is 250 mg to be administered intramuscularly into the buttock at intervals of one month as either a single 5 mL injection or two concurrent 2.5 mL injections (see HOW SUPPLIED). The injection should be administered slowly.

Patients with Hepatic Impairment

FASLODEX has not been studied in patients with moderate or severe hepatic compromise. No dosage adjustment is recommended in patients with mild hepatic impairment (see CLINICAL PHARMACOLOGY-Hepatic Impairment and PRECAUTIONS-Hepatic Impairment sections).

Instructions for Intramuscular use, handling and disposal

1. Remove glass syringe barrel from tray and check that it is not damaged.
2. Remove perforated patient record label from syringe.
3. Peel open the safety needle (SafetyGlide®) outer packaging. For complete SafetyGlide® instructions refer below to the ²Directions for Use of SafetyGlide®².
4. Break the seal of the white plastic cover on the syringe luer connector to remove the cover with the attached rubber tip cap (see Figure 1).
5. Twist to lock the needle to the luer connector.
6. Remove needle sheath.
7. Remove excess gas from the syringe (a small gas bubble may remain).
8. Administer intramuscularly slowly in the buttock.
9. Immediately activate needle protection device upon withdrawal from patient by pushing lever arm completely forward until needle tip is fully covered (see Figure 2).
10. Visually confirm that the lever arm has fully advanced and the needle tip is covered. If unable to activate, discard immediately into an approved sharps collector.
11. Repeat steps 1 through 10 for second syringe.

SafetyGlide® is a trademark of Becton Dickinson and Company

Reorder number 305917

Federal (USA) law restricts this device to sale by or on the order of a physician. To help avoid HIV (AIDS), HBV (Hepatitis), and other infectious diseases due to accidental needlesticks, contaminated needles should not be recapped or removed, unless there is no alternative or that such action is required by a specific medical procedure.

Do not autoclave SAFETYGLIDE® Needle before use. Hands must remain behind the needle at all times during use and disposal.

Peel apart packaging of the SAFETYGLIDE®, break the seal of the white plastic cover on the syringe Luer connector and attach the SAFETYGLIDE® needle to the Luer Lock of the syringe by twisting.

Transport filled syringe to point of administration.

Pull shield straight off needle to avoid damaging needle point.

Administer injection following package instruction.

For user convenience, the needle 'bevel up' position is orientated to the lever arm, as shown in Figure 3.

Immediately activate needle protection device upon withdrawal from patient by pushing lever arm completely forward until needle tip is fully covered (Figure 2).

Visually confirm that the lever arm has fully advanced and the needle tip is covered. If unable to activate, discard immediately into an approved sharps collector.

Activation of the protective mechanism may cause minimal splatter of fluid that may remain on the needle after injection.

After single use, discard in an approved sharps collector in accordance with applicable regulations and institutional policy.

Becton Dickinson guarantees the contents of their unopened or undamaged packages to be sterile, nontoxic and non-pyrogenic.

Figure 1

Figure 2

Figure 3

FASLODEX is supplied in two different packaging configurations:

1. FASLODEX is supplied as one clear neutral glass (Type 1) barrel containing 250 mg/5mL (50 mg/mL) FASLODEX injection for intramuscular injection and fitted with a tamper evident closure.
NDC 0310-0720-50

2. FASLODEX is also supplied as two clear neutral glass (Type 1) barrels each containing 125 mg/2.5 mL (50 mg/mL) FASLODEX Injection for intramuscular injection and fitted with a tamper-evident closure. PLEASE NOTE: THE SYRINGES ARE SUPPLIED HALF FULL. BOTH SYRINGES MUST BE ADMINISTERED TO RECEIVE THE 250 MG RECOMMENDED MONTHLY DOSE.
NDC 0310-0720-25

The syringes are presented in a tray with polystyrene plunger rod and a safety needles (SafetyGlide®) for connection to the barrel.

REFRIGERATE, 2°-8°C (36°-46°F). TO PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE.

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