Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 3

HOS-120799 · Präparat HOS-095217

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 4

HOS-120800 · Präparat HOS-095217

No formal drug-drug interaction studies have been performed.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 4

HOS-120801 · Präparat HOS-095217

Since androgen deprivation treatment may prolong the QTc interval, the concomitant use of degarelix with medicinal products known to prolong the QTc interval or medicinal products able to induce torsades de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sotalol (HOS-085597) methadone (HOS-086198) dofetilide (HOS-085598) ibutilide (HOS-085599) quinidine (HOS-085593) disopyramide (HOS-085595) moxifloxacin (HOS-085604) amiodarone (HOS-085596)

Wechselwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 4

HOS-120803 · Präparat HOS-095217

Degarelix is not a substrate for the human CYP450 system and has not been shown to induce or inhibit CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4/5 to any great extent in vitro. Therefore, clinically significant pharmacokinetic drug-drug interactions in metabolism related to these isoenzymes are unlikely.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 5

HOS-120804 · Präparat HOS-095217

Summary of the safety profile

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 5

HOS-120805 · Präparat HOS-095217

The most commonly observed adverse reactions during degarelix therapy in the confirmatory phase III study (N=409) were due to the expected physiological effects of testosterone suppression, including hot flushes and weight increase (reported in 25% and 7%, respectively, of patients receiving treatment for one year), or injection site adverse reactions. Transient chills, fever or influenza like illness were reported to occur hours after dosing (in 3%, 2% and 1% of patients, respectively).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 5

HOS-120806 · Präparat HOS-095217

The injection site adverse reactions reported were mainly pain and erythema, reported in 28% and 17% of patients, respectively, less frequently reported were swelling (6%), induration (4%) and nodule (3%). These events occurred primarily with the starting dose whereas during maintenance therapy with the 80 mg dose, the incidence of these events pr 100 injections was: 3 for pain and <1 for erythema, swelling, nodule and induration. The reported events were mostly transient, of mild to moderate intensity and led to very few discontinuations (<1%). Serious injection site reactions were very rarely reported such as injection site infection, injection site abscess or injection site necrosis that could require surgical treatment/drainage.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 5

HOS-120807 · Präparat HOS-095217

Tabulated list of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 5

HOS-120808 · Präparat HOS-095217

The frequency of undesirable effects listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000) and very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 5

HOS-120809 · Präparat HOS-095217

Table 1: Frequency of adverse drug reactions reported in 1,259 patients treated for a total of 1781 patient years (phase II and III studies) and from post-marketing reports MedDRA Very common Common Uncommon Rare System Organ Class (SOC) Blood and Anaemia* Neutropenic lymphatic fever system disorders Immune system Hypersensitivity Anaphylactic disorders reactions Metabolism and Weight Hyperglycemia/Diabetes nutrition increase* mellitus, cholesterol disorders increased, weight decreased, appetite decreased, changes in blood calcium Psychiatric Insomnia Depression, libido disorders decreased* Nervous system Dizziness, Mental impairment, disorders headache hypoaesthesia Eye disorders Vision blurred Cardiac Cardiac arrhythmia (incl. Myocardial disorders atrial fibrillation), infarction, palpitations, cardiac failure QT prolongation*(see sections 4.4 and 4.5)

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Firmagon

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HOS-120810 · Präparat HOS-095217

5  Vascular Hot flush* Hypertension, vasovagal disorders reaction (incl. hypotension) Respiratory, Dyspnoea thoracic and mediastinal disorders Gastrointestinal Diarrhoea, Constipation, vomiting, disorders nausea abdominal pain, abdominal discomfort, dry mouth Hepatobiliary Liver Bilirubin increased, disorders transamina alkaline phosphatase ses increased increased Skin and Hyperhidro Urticaria, skin nodule, subcutaneous sis (incl. alopecia, pruritus, erythema tissue disorders night sweats)*, rash Musculoskeletal Musculosk Osteoporosis/osteopenia, Rhabdomyo- , connective eletal pain arthralgia muscular lysis tissue and bone and weakness, muscle spasms, disorders discomfort joint swelling/stiffness Renal and Pollakiuria, micturition urinary urgency, dysuria, nocturia, disorders renal impairment, incontinence Reproductive Gynaecom Testicular pain, breast pain, system and astia*, pelvic pain, genital breast disorders testicular irritation, ejaculation failure atrophy*, erectile dysfunction * General Injection site Chills, Malaise, peripheral oedema disorders and adverse pyrexia, administration reactions fatigue*, site conditions Influenza- like illness *Known physiological consequence of testosterone suppression

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 6

HOS-120811 · Präparat HOS-095217

Description of selected adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 6

HOS-120812 · Präparat HOS-095217

Changes in laboratory parameters Changes in laboratory values seen during one year of treatment in the confirmatory phase III study (N=409) were in the same range for degarelix and a GnRH-agonist (leuprorelin) used as comparator. Markedly abnormal (>3*ULN) liver transaminase values (ALT, AST and GGT) were seen in 2-6% of patients with normal values prior to treatment, following treatment with both medicinal products. Marked decrease in haematological values, hematocrit (≤0.37) and hemoglobin (≤115 g/l) were seen in 40% and 13-15%, respectively, of patients with normal values prior to treatment, following treatment with both medicinal products. It is unknown to what extent this decrease in haematological values was caused by the underlying prostate cancer and to what extent it was a consequence of androgen deprivation therapy. Markedly abnormal values of potassium (≥5.8 mmol/l), creatinine (≥177 μmol/l) and BUN (≥10.7 mmol/l) in patients with normal values prior to treatment, were seen in 6%, 2% and 15% of degarelix treated patients and 3%, 2% and 14% of leuprorelin treated patients, respectively.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 6–7

HOS-120813 · Präparat HOS-095217

6 Changes in ECG measurements Changes in ECG measurements seen during one year of treatment in the confirmatory phase III study (N=409) were in the same range for degarelix and a GnRH-agonist (leuprorelin) used as comparator. Three (<1%) out of 409 patients in the degarelix group and four (2%) out of 201 patients in the leuprorelin 7.5 mg group, had a QTcF ≥ 500 msec. From baseline to end of study the median change in QTcF for degarelix was 12.0 msec and for leuprorelin was 16.7 msec. The lack of intrinsic effect of degarelix on cardiac repolarisation (QTcF), heart rate, AV conduction, cardiac depolarisation, or T or U wave morphology was confirmed in a thorough QT study in healthy subjects (N=80) receiving an i.v. infusion of degarelix over 60 min, reaching a mean Cmax of 222 ng/mL, approx. 3-4- fold the Cmax obtained during prostate cancer treatment.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-120814 · Präparat HOS-095217

Reporting of suspected adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Firmagon

FIRMAGON 80 mg powder and solvent for solution for injection FIRMAGON 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-120815 · Präparat HOS-095217

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.