Fulevex Caution For Usage

Incompatibilities: In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products.
Instructions for administration and Special precautions for disposal and other handling: 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 Fulvestrant injection at the dorsogluteal injection site (see Precautions).
Warning: Do not autoclave safety needle (BD SafetyGlide Shielding Hypodermic Needle) before use. Hands must remain behind the needle at all times during use and disposal.
The proper method of administration of Fulvestrant injection for intramuscular use is described in the following instructions.
For each syringe: 1. Remove glass syringe barrel from tray and check that it is not damaged.
2. Remove perforated patient record label from syringe.
3. Inspect drug product in glass syringe for any visible particulate matter or discoloration prior to use. Discard if particulate matter or discoloration is present.
4. Peel open the safety needle (SafetyGlide) outer packaging.
5. 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.
6. Pull the cap (A) off in a straight upward direction. DO NOT TOUCH THE STERILE SYRINGE TIP (Luer-Lok) (B).
7. 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: 8. Pull shield straight off needle to avoid damaging needle point.
9. Remove needle sheath.
10. Expel excess gas from the syringe (a small gas bubble may remain).
11. 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.
12. 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. NOTE: Activate away from self and others.
13. Discard the empty single use syringe into an approved sharps collector in accordance with applicable regulations and institutional policy.
Disposal: Pre-filled syringes are for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.