A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Faslodex Indications, Dosage, Storage, Stability - Fulvestrant
Faslodex Indications, Dosage, Storage, Stability - Fulvestrant
INDICATIONS
AND USAGE
FASLODEX is indicated for the treatment of hormone receptor
positive metastatic breast cancer in postmenopausal women with disease
progression following antiestrogen therapy.
DOSAGE AND ADMINISTRATION
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 "Directions for Use of SafetyGlide."
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.
For the 2 x 2.5 mL syringe package only, both syringes
must be administered to receive the 250 mg recommended monthly dose.
SAFETYGLIDE™ INSTRUCTIONS FROM BECTON DICKINSON
SafetyGlide™ is a trademark of Becton Dickinson
and Company Reorder number 305917
CAUTION CONCERNING SAFETYGLIDE™
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.
WARNING CONCERNING SAFETYGLIDE™
Do not autoclave SafetyGlide™ Needle before use.
Hands must remain behind the needle at all times during use and disposal.
DIRECTIONS FOR USE OF SAFETYGLIDE™
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.
Immediately activate needle protection device upon withdrawal
from patient by pushing lever arm completely forward until needle tip
is fully covered.
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.
For greatest safety, use a one-handed technique and activate
away from self and others.
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, non-toxic and non-pyrogenic.
HOW SUPPLIED
One 5 mL clear neutral glass (Type 1) barrel containing
5 mL (50 mg/mL) FASLODEX Injection for intramuscular injection and fitted
with a tamper evident closure.
NDC 0310-0720-50 5 mL Prefilled Syringes
Two 5 mL clear neutral glass (Type 1) barrels, each containing
2.5 mL (50 mg/mL) of FASLODEX Injection for intramuscular injection and
fitted with a tamper-evident closure.
NDC 0310-0720-25 Two 5 mL Prefilled Syringes containing
2.5 mL
The syringes are presented in a tray with polystyrene
plunger rod and a safety needle (Safety Glide™) for connection to
the barrel.
Storage
Store in a refrigerator, 2°-8°C (36°F -46°F). Store in
original container. Distributed by: AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850 Manufactured for:
IPR Pharmaceuticals Inc. Carolina, PR by: Vetter Pharma-Fertigung GMBH
& Co. KG Ravensburg, Germany Made in Germany, Rev 04/25/02
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