Faslodex solution for injections 250 mg/5 ml. filled syringe 5 ml. №2

Description

Faslodex Pharmacological action of the drug 

Antineoplastic drug, antiestrogen. Fulvestrant is a competing estrogen receptor antagonist. The level of affinity for receptors is comparable to estradiol. Fulvestrant blocks the trophic effect of estrogens without showing its own estrogen-like activity. The mechanism of action is associated with the suppression of the activity and degradation of estrogen receptors.

Fulvestrant also significantly reduces the expression of progesterone receptors. Fulvestrant has no endometrial stimulating effect in postmenopausal women. The effects of long-term fulvestrant therapy on postmenopausal endothelium have not been established. There is also no data on endometrial morphology.

There are no data on the effect of long-term use of fulvestrant on bone tissue.

Faslodex Indications for the use of the drug 

locally advanced or disseminated breast cancer with positive estrogen receptors in postmenopausal women with progression after or during antiestrogen therapy.

Faslodex Contraindications for use

severe liver dysfunction;

pregnancy;

lactation period;

children under 18 years of age;

hypersensitivity to fulvestrant or any other component of the drug.

Method of administration and dosage of the drug Fazlodex

The drug is administered intramuscularly by slow (within 1-2 minutes) injection. The contents of 2 syringes are sequentially injected into the right and left gluteal regions.

For adult women (including the elderly), the recommended dose is 500 mg once a month. In the first month of therapy – 500 mg 2 times a month (second administration – 2 weeks after the first administration of the drug).

In the case of mild or moderate renal dysfunction (CC ≥ 30 ml / min), dose adjustment is not required. The safety and efficacy of the drug in patients with severe renal impairment (CC <30 ml / min) have not been established.

The use of Fazlodeks® in patients with mild or moderate liver dysfunction does not require dose adjustment, but requires caution. The safety and efficacy of the drug in patients with severely impaired liver function have not been established.

Rules for use and handling of the drug

Do not autoclave the needle supplied with the drug! Do not touch the needle while using it.

1. Remove the glass body of the syringe from the blister strip packaging and make sure it is not damaged. Rip open the outer packaging of the SafetyGlide. Break the jumper of the white plastic syringe tip cap and remove the cap with the rubber tip plug attached.

2. Using a twisting motion, secure the needle to the tip of the syringe. Remove the needle sheath strictly in the direction of the needle so as not to damage the needle tip. Visually assess the condition of the parenteral solution for particles and discoloration before use. Remove excess gas bubbles from the syringe.

3. Slowly inject the solution into the gluteus muscle for 1-2 minutes. For convenience, the bevel plane of the needle tip matches the position of the lever on the safety device.

4. After removing the needle from the gluteal muscle, immediately activate the needle protector by pushing the lever to the extreme forward position until the needle tip is completely closed. When the protective mechanism is activated, minimal splashing of liquid is possible, which may remain on the needle after injection. Visually make sure that the lever is in the extreme position and the tip of the needle is completely closed. If the needle guard cannot be activated, immediately place the needle in a standard needle container.