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Faslodex

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Faslodex

Faslodex

INDICATIONS

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

Recommended Dose

The recommended dose is 500 mg to be administered intramuscularly into the buttocks slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on days 1, 15, 29 and once monthly thereafter [see Clinical Studies].

Dose Modification

Hepatic Impairment

A dose of 250 mg is recommended for patients with moderate hepatic impairment (Child-Pugh class B) to be administered intramuscularly into the buttock slowly (1 - 2 minutes) as one 5 mL injection on days 1, 15, 29 and once monthly thereafter.

FASLODEX has not been evaluated in patients with severe hepatic impairment (Child-Pugh class C) [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

Administration Technique

The proper method of administration of FASLODEX for intramuscular use is described in the instructions that follow:

  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.

How To Use FASLODEX

For the 2 x 5 mL syringe package, the contents of both syringes must be injected to receive the 500 mg recommended 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™

For each syringe:

Remove glass syringe barrel from tray and check that it is not damaged.

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.

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.

Figure 1

Syringe luer connector - Illustration

Figure 2

Activate needle protection device -  Illustration

Figure 3

Needle ‘bevel up’ position - Illustration

HOW SUPPLIED

Dosage Forms And Strengths

FASLODEX, an injection for intramuscular administration, is supplied as 5-mL prefilled syringes containing 50 mg/mL fulvestrant.

Storage And Handling

FASLODEX is supplied as two 5-mL clear neutral glass (Type 1) barrels, each containing 250 mg/5 mL of FASLODEX solution for intramuscular injection and fitted with a tamper evident closure.

NDC 0310-0720-10

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

Storage

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

Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Manufactured for: AstraZeneca UK Limited Macclesfield, Cheshire, England. By: Vetter Pharma-Fertigung GMBH & Co. KG Ravensburg, Germany. Rev. 12/2011

Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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