The package insert of the medicine Faslodex

the package insert of the medicine Faslodex. Active principles Fulvestranto.

what For?

Is indicated for the treatment of women of any age who are post-menopausal, suffering from breast cancer, locally advanced or metastatic, previously treated with therapy endocrine, regardless of whether the post-menopause occurred naturally or was induced.

Contraindications

When should I not use?

FASLODEX is contraindicated to patients with known hypersensitivity to the drug or any component of the formula.

Dosage

How to use?

Adult (Including Elderly):The recommended dose is 250 mg to be administered intramuscularly in the buttock at intervals of 1 month, in injection only in 5 ml. It is recommended that the injection be administered slowly.

Children:Not recommended for use in children or adolescents, as safety and efficacy have not been established in these age groups.

Patients with Renal impairment:No dose adjustment is recommended for patients with clearance creatinine greater than 30 ml/min. The safety and efficacy have not been evaluated in patients with clearance of creatinine less than 30 ml/min (see item Precautions and Warnings).

Patients with Hepatic impairment:No dose adjustment is recommended for patients with liver failure mild. The safety and efficacy have not been evaluated in patients with hepatic impairment moderate to severe (see item Precautions and Warnings).

Elderly:it is Not necessary dose adjustment for older patients.

Interactions That Require Dose adjustments:there are No interactions drug-drug known that require dose adjustment.

Instructions for Use
·Remove the glass syringe from the packaging and check it is not damaged.

·Remove the needle (SafetyGlide TM ) of the package.

·Break the seal of the white plastic that covers the connector for the syringe to remove the rubber protection (see Figure 1). Put the needle (SafetyGlide TM ) and rotate it to fasten it to the connector.

·Remove the wrap from the needle.

·Remove excess air from syringe (a small air bubble may remain).

·For convenient use, the bevel should be oriented to the top, as shown in Figure 2.

· * * Give in the buttock.

·Activate immediately the protection system of the needle after the application, by pushing the lever until the needle is completely covered (see Figure 3).

·visually Confirm that the device is protecting completely the needle. If this does not happen, immediately discard the needle in an appropriate container.

Side Effects

What are the evils that can cause me?

Approximately 47% of the patients presented adverse reactions. However, only 0.9% dospacientes the therapy was discontinued due to adverse events. The adverse events most commonly reported were hot flashes, nausea and reactions at the injection site and were generally mild.

The adverse reactions observed in clinical studies are presented below:
Very common (> 10%):
Cardiovascular:
·Heat waves, which were predominantly mild.

Common (> 1 to £ 10):
General:
·Reactions at the injection site included pain, mild and transient inflammation and in 7% of patients (1% of injections), when administered injections only of 5 ml.

·Headache, usually mild.

·Asthenia, usually mild or moderate.

Gastrointestinal:
·Gastrointestinal disorders including nausea, vomiting, diarrhea and anorexia, were generally mild.

Skin:
·Rash, usually mild.

Urogenital:
·Infections of the urinary tract, usually mild.

Warnings and Precautions

what should I know before using?

Fulvestranto is metabolized primarily in the liver. In clinical studies in patients with breast cancer advanced, FASLODEX was administered to patients with hepatic impairment mild (concentration of alanine aminotransferase greater than the upper limit of normal but less than two times the upper limit) and there was no defined relationship between the clearance of fulvestranto and liver failure. The safety profile in patients with hepatic light was similar to that seen in patients without liver failure.

care Must be taken with the use of FASLODEX in patients with hepatic insufficiency of moderate to severe, in which the clearance can be changed.

care Must be taken before treating the patients who have clearance of creatinine less than 30 ml/min (see section Pharmacokinetic Properties).

caution Should be used before treating patients with bleeding, thrombocytopenia or use of anticoagulants.

Use during pregnancy and lactation
As expected with a antiestrogênio powerful, studies in animals have shown reproductive toxicity (see section safety Data pre-clinical). Fulvestranto is found in the milk of rats at levels significantly higher than plasma levels. The potential risk for humans is unknown. In addition, the use of FASLODEX should be avoided in pregnant or lactating women.

Overdose

what to do if someone use a larger amount than is recommended?

there is No experience in humans with overdosage. Studies in animals do not show other effects in addition to those related directly or indirectly to the activity antiestrogênica, which were evident with high doses of fulvestranto. In case of overdosage, the patients should be treated symptomatically.