Firmagon Lyophilizate solution for subcutaneous injection 80mg vials, 1pc in a set

Composition

1 bottle contains:

Active ingredients:

degarelix 80 mg.

In a bottle of 80 mg of lyophilizate.

In a cardboard box 1 bottle.

Indications

Progressive hormone-dependent prostate cancer.

Contraindications

Hypersensitivity to degarelix.

Side effects

Nervous system disorders: common (≥ 1%, < 10%) – insomnia, dizziness, headaches; rarely (≥ 0.01%,

From the cardiovascular system: very often (≥ 10%) – hot flashes; rarely (≥ 0.01%,

From the digestive system: very often (≥ 10%) – nausea; often (≥ 1%, < 10%) – diarrhea, vomiting, flatulence, dry mouth, constipation, increased activity of hepatic transaminases; rarely (≥ 0.01%,

Respiratory system disorders: rare (≥ 0.01%,

Hematopoietic disorders: rare (≥ 0.01%,

Dermatological reactions: common (≥ 1%, < 10%) – increased sweating (including night sweats); rarely (≥ 0.01%,

Musculoskeletal disorders: rare (≥ 0.01%,

From the genital system: rarely (≥ 0.01%,

From the urinary system: rarely (≥ 0.01%,

Metabolic disorders: 6% – severe hypokalemia (≥ 5.8 mmol / L); 2% – decreased creatinine (≥177 mmol/L); 15% – increased blood urea nitrogen (≥10.7 mmol/L).

Other: very common (≥ 10%) – irritation at the injection site; often (≥ 1%, < 10%) – chills, fever, weakness, fatigue, colds; rarely (≥ 0.01%,

Interaction

Since the use of degarelix may increase the QT interval, the need for simultaneous use of degarelix and drugs that cause an increase in the QT interval or ventricular tachycardia (for example, quinidine, disopyramide), neuroleptics, antiarrhythmic drugs (for example, amiodarone, sotalol, dofetilide, ibutilide), as well as methadone, cisapride and moxifloxacin should be evaluated.

A clinically significant pharmacokinetic interaction between degarelix and agents affecting the CYP450 enzyme system is unlikely.

How to take, course of use and dosage

Enter subcutaneously, in the abdominal area with a periodic change of the injection site. The initial dose is 240 mg divided into 2 120 mg injections. A maintenance dose of 80 mg is used 1 month after the initial dose.

Degarelix is not intended for intravenous or intramuscular use.

Overdose

Symptoms: there are no data on the symptoms of acute overdose of degarelix.

Treatment: in case of overdose, the patient should be monitored and, if necessary, maintenance therapy should be used.

Special instructions

The use of degarelix has not been studied in patients with a history of a QTc interval of more than 450 msec, in patients with risk factors for developing ventricular arrhythmia of the “pirouette” type, when combined with drugs that can prolong the QT interval. If it is necessary to use degarelix in such cases, the expected benefit and risk of therapy should be carefully evaluated.

The therapeutic efficacy of degarelix should be evaluated by clinical parameters and serum PSA levels. Testosterone suppression occurs immediately after the initial dose, and the level of testosterone in the blood plasma drops to the level of testosterone during medical castration ( Long-term, up to 1 year, maintenance therapy provides testosterone suppression ( If the patient’s therapeutic effect is not clearly expressed, make sure that the level of testosterone in the blood serum remains sufficiently lowered. Degarelix does not cause fluctuations in testosterone levels, so there is no need to use antiandrogenic drugs at the beginning of treatment.

There is no need to change the dose for elderly patients or for patients with mild or moderate hepatic or renal impairment. Degarelix should be used with caution in patients with severe hepatic or renal insufficiency, as it has not been studied in this category of patients.

Changes in bone density with degarelix have not been studied, but patients undergoing orchiectomy or taking GnRH agonists show a decrease in bone density. Therefore, due to the suppression of testosterone caused by the use of degarelix, a decrease in bone density is possible.

The effect of degarelix on the level of insulin and glucose in the blood has not been studied. However, patients undergoing orchiectomy or taking GnRH agonists show a decrease in insulin sensitivity to glucose and, possibly, the development or exacerbation of diabetes mellitus. Therefore, regular monitoring of blood glucose levels is recommended during treatment with degarelix.

Use in pediatrics

There are no valid indications for the use of degarelix in children or adolescents.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

When using degarelix, fatigue and dizziness may occur, which may affect the patient’s ability to drive vehicles and other potentially dangerous activities.

Form of production

Lyophilizate for preparation of a solution for subcutaneous use

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Degarelix

Conditions of release from pharmacies

By prescription

Dosage form

lyophilizate for solution preparation