Fulvestrant

Renal Impairment Negligible amounts of fulvestrant are eliminated in urine; therefore, a study in patients with renal impairment was not conducted. In the advanced breast cancer trials, fulvestrant concentrations in women with estimated creatinine clearance as low as 30 mL/min were similar to women with normal creatinine.

Dose Modification Monotherapy 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 (gluteal area) slowly (1 - 2 minutes) as one 5 mL injection on Days 1, 15, 29, and once monthly thereafter. Fulvestrant Injection has not been evaluated in patients with severe hepatic impairment (Child-Pugh class C) [see Warnings and Precautions and Use in Specific Populations].

Combination Therapy When Fulvestrant Injection is used in combination with palbociclib, abemaciclib, or ribociclib, refer to monotherapy dose modification instructions for Fulvestrant Injection. Refer to the Full Prescribing Information of co-administered palbociclib, abemaciclib, or ribociclib, for dose modification guidelines in the event of toxicities, for use with concomitant medications, and other relevant safety information.

Administration Technique 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 Warnings and Precautions and Adverse Reactions].

The proper method of administration of Fulvestrant Injection for intramuscular use is described in the following instructions. For each single-dose prefilled syringe: Remove glass syringe barrel from tray and check that it is not damaged. 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 TM ) outer packaging. Hold the syringe upright. Twist and remove the Luer tip cap (see Figure 1 ). Figure 1 Do Not Touch the Sterile Syringe Tip (Luer-Lok). Attach the safety needle to the syringe tip (Luer-Lok). Twist needle until firmly seated (see Figure 2 ).

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. Figure 2 For Administration: Pull needle cap straight off needle to avoid damaging needle point. 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 3 . Figure 3 After injection, immediately activate the lever arm to deploy the safety shield 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 safety shield has completely covered the needle (see Figure 4 ). NOTE: Activate away from self and others. Figure 4 Discard the empty syringe into an approved sharps collector in accordance with applicable regulations and institutional policy. Repeat steps 1 through 11 for second syringe.

Figure 1 Figure 2 Figure 3 Figure 4 How To Use Fulvestrant Injection For the 2 x 5 mL syringe package, the contents of both syringes must be injected to receive the 500 mg recommended dose. SAFETYGLIDE TM INSTRUCTIONS FROM BECTON DICKINSON SafetyGlide TM 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 TM Needle before use. Becton Dickinson guarantees the contents of their unopened or undamaged packages to be sterile, non-toxic, and non-pyrogenic.