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 (gluteal area) 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 (gluteal area) 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 (gluteal area) 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.
Administer the injection according to the local guidelines for performing large volume intramuscular injections.
NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering FASLODEX at the dorsogluteal injection site [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].
The proper method of administration of FASLODEX for intramuscular use is described in the following instructions.
For each syringe:
- Remove glass syringe barrel from tray and check that it is not damaged.
- Remove perforated patient record label from syringe.
- Inspect drug product in glass syringe for any visible particulate matter or discoloration prior to use. Discard if particulate matter or discoloration is present.
- Peel open the safety needle (SafetyGlide™) outer packaging.
- Hold the syringe upright on the ribbed part (C). With the other hand, take hold of the cap (A) and carefully tilt cap back and forth (DO NOT TWIST CAP) until the cap disconnects for removal (see Figure 1).
- Pull the cap (A) off in a straight upward direction. DO NOT TOUCH THE STERILE SYRINGE TIP (Luer-Lok) (B) (see Figure 2).
- Attach the safety needle to the syringe tip (Luer-Lok). Twist needle until firmly seated (see Figure 3). Confirm that the needle is locked to the Luer connector before moving or tilting the syringe out of the vertical plane to avoid spillage of syringe contents.
- For Administration:
- Pull shield straight off needle to avoid damaging needle point.
- Remove needle sheath.
- Expel excess gas from the syringe (a small gas bubble may remain).
- Administer intramuscularly slowly (1-2 minutes/injection) into the buttock (gluteal area). For user convenience, the needle ‘bevel up’ position is orientated to the lever arm, as shown in Figure 4.
- After injection, immediately activate the lever arm to deploy the needle shielding by applying a single-finger stroke to the activation assisted lever arm to push the lever arm completely forward. Listen for a click. Confirm that the needle shielding has completely covered the needle (see Figure 5).
- NOTE: Activate away from self and others.
- Discard the empty single use syringe into an approved sharps collector in accordance with applicable regulations and institutional policy.
- Repeat steps 1 through 13 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.
Becton Dickinson guarantees the contents of their unopened or undamaged packages to be sterile, non-toxic and non-pyrogenic.