Generic name: FULVESTRANT 50mg in 1mL
Dosage form: injection
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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 (14)].
Combination Therapy with Palbociclib
When FASLODEX is used in combination with palbociclib, 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. The recommended dose of palbociclib is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib should be taken with food. Please refer to the full prescribing information of palbociclib.
Pre/perimenopausal women treated with the combination FASLODEX plus palbociclib should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards [see Clinical Studies (14)].
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.
Combination Therapy with Palbociclib
When FASLODEX is used in combination with palbociclib, refer to monotherapy dose modification instructions for FASLODEX. Refer to the full prescribing information of palbociclib for its dose modification, management of toxicities, and for use with concomitant medication.
The proper method of administration of FASLODEX for intramuscular use is described in the instructions that follow:
- Remove glass syringe barrel from tray and check that it is not damaged.
- Remove perforated patient record label from syringe.
- Peel open the safety needle (SafetyGlide™) outer packaging. For complete SafetyGlide™ instructions refer below to the "Directions for Use of SafetyGlide™".
- 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).
- Twist to lock the needle to the luer connector.
- Remove needle sheath.
- Remove excess gas from the syringe (a small gas bubble may remain).
- Administer intramuscularly into the buttock slowly.
- Immediately activate needle protection device upon withdrawal from patient by pushing lever arm completely forward until needle tip is fully covered (see 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.
- 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.
Important Administration Information
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. Hands must remain behind the needle at all times during use and disposal.
Do not autoclave SafetyGlide™ Needle before use.
Parenteral drug products should be visually inspected for any particulate matter and discoloration prior to administration, whenever solution and container permit.
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.