FASLODEX 50 MG

What is FASLODEX?

FASLODEX 50 MG contains FULVESTRANT : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02248624, held by ASTRAZENECA CANADA INC, supplied as SOLUTION for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 14-Jun-2004. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is FASLODEX used for?

FASLODEX® (fulvestrant) is indicated for the: • treatment of estrogen receptor-positive, human epidermal growth receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or • hormonal treatment of locally advanced or metastatic breast cancer in postmenopausal women, regardless of age, who have disease progression following prior anti-estrogen therapy.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Adult Females: The recommended dose regimen of FASLODEX (fulvestrant) is 500 mg to be administered intramuscularly as two 5 mL (250 mg/5 mL) injections, one in each buttock (gluteal area) (see Administration). The recommended dosing schedule is as follows: FASLODEX 500 mg dose to be administered on days 0, 14, 28 and then every 28 days thereafter. Instructions for use, handling and disposal: Caution should be taken if FASLODEX is injected at the dorsogluteal site due to the proximity of the underlying sciatic nerve and large blood vessels. It is recommended that the injection be administered slowly. Administer the injection according to the local guidelines for performing large volume intramuscular injections. 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. For the 2 x 5 mL syringe package, the contents of both syringes must be injected to receive the 500 mg recommended dose. For each syringe: 1. Remove syringe barrel from tray and ensure it is not damaged. 2. Inspect product prior to administration and discard if there are any visible particles or discolouration. 3. Peel open the safety needle (SafetyGlide™) outer packaging. 4. Hold the syringe upright on the ribbed part (C). With the other hand, take hold of the cap (A) and carefully tilt back and forth until the cap disconnects and can be pulled off, do not twist (Figure 1 and 2). 5. Pull the cap (A) off in a straight upward direction. To maintain sterility, do not touch the syringe tip (Luer-Lok) (B) (Figure 2). 6. Attach the safety needle to the syringe tip (Luer-Lok) and twist until firmly seated (Figure 3). Check that the needle is locked to the Luer connector before moving or tilting the syringe out of the vertical plane to avoid spillage. 7. Pull shield straight off needle to avoid damaging needle point (keep needle shield on if transporting). 8. Expel excess gas from syringe (a small gas bubble may remain). 9. Administer intramuscularly slowly (1-2 minutes/injection) into the buttock (gluteal area). For convenience, the needle bevel-up position is oriented to the lever arm (Figure 4). 10. 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. Visually confirm that the needle shielding has completely covered the needle (Figure 5). NOTE: Activate away from self and others. 11. Discard empty syringe into sharps collector. 12. Repeat steps 1-11 in the other buttock with the second syringe.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store refrigerated at 2 to 8°C. Store in original package and do not break the seal, in order to protect it from light. Single use. Discard unused portion.

How is it supplied?

FASLODEX is available in a package of two 250 mg/5 mL (50 mg/mL) pre-filled syringes. Each syringe is presented in a tray with polystyrene plunger rod and a 21G x 1 ½ inches (0.8mm x 40mm) safety needle (SafetyGlideTM) for connection to the barrel.

Contraindications

• Patients with known hypersensitivity to fulvestrant or to any of the excipients. For a complete listing of ingredients, see the Dosage Forms, Composition and Packaging section of the Product Monograph. • Pregnant or lactating women.

Warnings and precautions

Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with FASLODEX injection. Caution should be taken while administering FASLODEX at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve and large blood vessels. Hepatic failure (in some cases fatal) has been reported in patients treated with FASLODEX. Liver function tests should be performed on a regular basis or when clinically indicated. Hypersensitivity reactions including angioedema and urticaria may occur. These reactions may occur shortly after injection, or in one reported case of angioedema, several days after injection. Local injection site reactions (e.g. pruritus, urticaria) may occur even after prior uneventful injections, and have been reported to develop with time into a systemic allergic response (e.g. widespread urticaria). FASLODEX therapy may need to be discontinued. Due to the mode of action of fulvestrant, there is a potential risk of osteoporosis. FASLODEX can cause fetal harm if administered to a pregnant woman. Women of childbearing potential should use effective contraception during treatment with FASLODEX and for 2 years after the last dose. If a patient becomes pregnant while receiving FASLODEX she should be apprised of the potential hazard to the fetus, or the potential risk for loss of pregnancy. FASLODEX is found in rats' milk at levels significantly higher than those in rat plasma. It is not known if fulvestrant is excreted in human milk. However, since many drugs are excreted in human milk, and because of the potential for serious adverse reactions from FASLODEX in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug.

What can be used instead?

Other Canadian products sharing ATC code L02BA03 FULVESTRANT. 6 of 12 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies FULVESTRANT worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. FULVESTRANT appears in 105 registered pack listings across 13 markets, published on 11 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.