Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.3 · PDF-Seite 4

HOS-109307 · Präparat HOS-093179

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 · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 5

HOS-109308 · Präparat HOS-093179

Studies in vitro show that caspofungin is not an inhibitor of any enzyme in the cytochrome P450 (CYP) system. In clinical studies, caspofungin did not induce the CYP3A4 metabolism of other substances. Caspofungin is not a substrate for P-glycoprotein and is a poor substrate for cytochrome P450 enzymes. However, caspofungin has been shown to interact with other medicinal products in pharmacological and clinical studies (see below).

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): caspofungin (HOS-109306)

Wechselwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 5

HOS-109309 · Präparat HOS-093179

In two clinical studies performed in healthy adult subjects, cyclosporin A (one 4 mg/kg dose or two 3 mg/kg doses 12 hours apart) increased the AUC of caspofungin by approximately 35 %. These AUC increases are probably due to reduced uptake of caspofungin by the liver. Caspofungin did not increase the plasma levels of cyclosporin. There were transient increases in liver ALT and AST of less than or equal to 3-fold the upper limit of normal (ULN) when caspofungin and cyclosporin were co-administered, that resolved with discontinuation of the medicinal products. In a retrospective study of 40 patients treated during marketed use with caspofungin and cyclosporin for 1 to 290 days (median 17.5 days), no serious hepatic adverse reactions were noted (see section 4.4). Close monitoring of liver enzymes should be considered if the two medicinal products are used concomitantly.

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): caspofungin (HOS-109306)

Wechselwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 5

HOS-109310 · Präparat HOS-093179

Caspofungin reduced the trough concentration of tacrolimus by 26 % in healthy adult volunteers. For patients receiving both therapies, standard monitoring of tacrolimus blood concentrations and appropriate tacrolimus dosage adjustments are mandatory.

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): caspofungin (HOS-109306) tacrolimus (HOS-085202)

Wechselwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 5

HOS-109311 · Präparat HOS-093179

Clinical studies in healthy adult volunteers show that the pharmacokinetics of caspofungin are not altered to a clinically relevant extent by itraconazole, amphotericin B, mycophenolate, nelfinavir, or tacrolimus. Caspofungin did not influence the pharmacokinetics of amphotericin B, itraconazole, rifampicin or mycophenolate mofetil. Although safety data are limited it appears that no special precautions are needed when amphotericin B, itraconazole, nelfinavir or mycophenolate mofetil are co-administered with caspofungin.

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): nelfinavir (HOS-084520) caspofungin (HOS-109306) amphotericin B (HOS-109312) itraconazole (HOS-084516) tacrolimus (HOS-085202) mycophenolate (HOS-085189) mycophenolate mofetil (HOS-085154)

Wechselwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 5

HOS-109316 · Präparat HOS-093179

Rifampicin caused a 60 % increase in AUC and 170 % increase in trough concentration of caspofungin on the first day of co-administration when both medicinal products were initiated together in healthy adult volunteers. Caspofungin trough levels gradually decreased upon repeated administration. After two weeks’ administration rifampicin had limited effect on AUC , but trough levels were 30 % lower than in adult subjects who received caspofungin alone. The mechanism of interaction could possibly be due to an initial inhibition and subsequent induction of transport proteins. A similar effect could be expected for other medicinal products that induce metabolic enzymes. Limited data from population pharmacokinetics studies indicate that concomitant use of caspofungin with the inducers efavirenz, nevirapine, rifampicin, dexamethasone, phenytoin, or carbamazepine may result in a decrease in caspofungin AUC. When co-administering inducers of metabolic enzymes, an increase in the daily dose of caspofungin to 70 mg, following the 70 mg loading dose, should be considered in adult patients (see section 4.2).

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): caspofungin (HOS-109306) carbamazepine (HOS-085618) dexamethasone (HOS-084535) efavirenz (HOS-087947) nevirapine (HOS-088064) phenytoin (HOS-084531)

Wechselwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 5

HOS-109317 · Präparat HOS-093179

All adult drug-drug interaction studies described above were conducted at a 50 or 70 mg daily caspofungin dose. The interaction of higher doses of caspofungin with other medicinal products has not been formally studied.

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): caspofungin (HOS-109306)

Wechselwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 5

HOS-109318 · Präparat HOS-093179

In paediatric patients, results from regression analyses of pharmacokinetic data suggest that co-administration of dexamethasone with caspofungin may result in clinically meaningful reductions in caspofungin trough concentrations. This finding may indicate that paediatric patients will have similar reductions with inducers as seen in adults. When caspofungin is co-administered to paediatric patients (12 months to 17 years of age) with inducers of drug clearance, such as rifampicin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a caspofungin dose of 70-mg/m2 daily (not to exceed an actual daily dose of 70 mg) should be considered.

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): caspofungin (HOS-109306) carbamazepine (HOS-085618) dexamethasone (HOS-084535) efavirenz (HOS-087947) nevirapine (HOS-088064) phenytoin (HOS-084531)

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109319 · Präparat HOS-093179

Hypersensitivity reactions (anaphylaxis and possibly histamine-mediated adverse reactions) have been reported (see section 4.4).

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109320 · Präparat HOS-093179

Also reported in patients with invasive aspergillosis were pulmonary oedema, adult respiratory distress syndrome (ARDS), and radiographic infiltrates.

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109321 · Präparat HOS-093179

Adult patients In clinical studies, 1,865 adult individuals received single or multiple doses of caspofungin: 564 febrile neutropaenic patients (empirical therapy study), 382 patients with invasive candidiasis, 228 patients with invasive aspergillosis, 297 patients with localised Candida infections, and 394 individuals enrolled in Phase I studies. In the empirical therapy study patients had received chemotherapy for malignancy or had undergone hematopoietic stem-cell transplantation (including 39 allogeneic transplantations). In the studies involving patients with documented Candida infections, the majority of the patients with invasive Candida infections had serious underlying medical conditions (e.g., haematologic or other malignancy, recent major surgery, HIV) requiring multiple concomitant medications. Patients in the non-comparative Aspergillus study often had serious predisposing medical conditions (e.g., bone marrow or peripheral stem cell transplants, haematologic malignancy, solid tumours or organ transplants) requiring multiple concomitant medications.

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109322 · Präparat HOS-093179

Phlebitis was a commonly reported local injection-site adverse reaction in all patient populations. Other local reactions included erythema, pain/tenderness, itching, discharge, and a burning sensation.

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109323 · Präparat HOS-093179

Reported clinical and laboratory abnormalities among all adults treated with caspofungin (total 1,780) were typically mild and rarely led to discontinuation.

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109324 · Präparat HOS-093179

Tabulated list of adverse reactions

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109325 · Präparat HOS-093179

The following adverse reactions were reported during clinical studies and/or post-marketing use:

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6

HOS-109326 · Präparat HOS-093179

System Organ Common (≥1/100 to Uncommon (≥1/1,000 to <1/100) Not known Class <1/10) (cannot be estimated from available data)

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 6–7

HOS-109327 · Präparat HOS-093179

6 System Organ Common (≥1/100 to Uncommon (≥1/1,000 to <1/100) Not known Class <1/10) (cannot be estimated from available data) Blood and haemoglobin decreased, anaemia, thrombocytopaenia, lymphatic system haematocrit decreased, coagulopathy, leukopaenia, disorders white blood cell count eosinophil count increased, platelet decreased count decreased, platelet count increased, lymphocyte count decreased, white blood cell count increased, neutrophil count decreased Metabolism and hypokalaemia fluid overload, hypomagnesaemia, nutrition anorexia, electrolyte imbalance, disorders hyperglycaemia, hypocalcaemia, metabolic acidosis Psychiatric anxiety, disorientation, insomnia disorders Nervous system headache dizziness, dysgeusia, paraesthesia, disorders somnolence, tremor, hypoaesthesia Eye disorders ocular icterus, vision blurred, eyelid oedema, lacrimation increased Cardiac disorders palpitations, tachycardia, arrhythmia, atrial fibrillation, cardiac failure congestive Vascular phlebitis thrombophlebitis, flushing, hot disorders flush, hypertension, hypotension Respiratory, dyspnoea nasal congestion, pharyngolaryngeal thoracic and pain, tachypnoea, bronchospasm, mediastinal cough, dyspnoea paroxysmal disorders nocturnal, hypoxia, rales, wheezing Gastrointestinal nausea, diarrhoea, abdominal pain, abdominal pain disorders vomiting upper, dry mouth, dyspepsia, stomach discomfort, abdominal distension, ascites, constipation, dysphagia, flatulence Hepatobiliary elevated liver values cholestasis, hepatomegaly, disorders (alanine aminotransferase, hyperbilirubinaemia, jaundice, aspartate hepatic function abnormal, aminotransferase, blood hepatotoxicity, liver disorder, alkaline phosphatase, gamma-glutamyltransferase bilirubin conjugated, increased blood bilirubin) Skin and rash, pruritus, erythema, erythema multiforme, rash macular, Toxic subcutaneous hyperhidrosis rash maculo-papular, rash pruritic, epidermal tissue disorders urticaria, dermatitis allergic, pruritus necrolysis generalised, rash erythematous, rash and Stevens- generalised, rash morbilliform, skin Johnson lesion syndrome (see section 4.4) Musculoskeletal arthralgia back pain, pain in extremity, bone and connective pain, muscular weakness, myalgia tissue disorders Renal and renal failure, renal failure acute

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 7–8

HOS-109328 · Präparat HOS-093179

7 System Organ Common (≥1/100 to Uncommon (≥1/1,000 to <1/100) Not known Class <1/10) (cannot be estimated from available data) urinary disorders General disorders pyrexia, chills, infusion- pain, catheter site pain, fatigue, and site pruritus feeling cold, feeling hot, infusion administration site erythema, infusion site site conditions induration, infusion site pain, infusion site swelling, injection site phlebitis, oedema peripheral, tenderness, chest discomfort, chest pain, face oedema, feeling of body temperature change, induration, infusion site extravasation, infusion site irritation, infusion site phlebitis, infusion site rash, infusion site urticaria, injection site erythema, injection site oedema, injection site pain, injection site swelling, malaise, oedema Investigations blood potassium blood creatinine increased, red decreased, blood albumin blood cells urine positive, protein decreased total decreased, protein urine present, prothrombin time prolonged, prothrombin time shortened, blood sodium decreased, blood sodium increased, blood calcium decreased, blood calcium increased, blood chloride decreased, blood glucose increased, blood magnesium decreased, blood phosphorus decreased, blood phosphorus increased, blood urea increased, activated partial thromboplastin time prolonged, blood bicarbonate decreased, blood chloride increased, blood potassium increased, blood pressure increased, blood uric acid decreased, blood urine present, breath sounds abnormal, carbon dioxide decreased, immunosuppressant drug level increased, international normalised ratio increased, urinary casts, white blood cells urine positive, and pH urine increased.

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8

HOS-109329 · Präparat HOS-093179

Caspofungin has also been evaluated at 150 mg daily (for up to 51 days) in 100 adult patients (see section 5.1). The study compared caspofungin at 50 mg daily (following a 70-mg loading dose on Day 1) versus 150 mg daily in the treatment of invasive candidiasis. In this group of patients, the safety of caspofungin at this higher dose appeared generally similar to patients receiving the 50-mg daily dose of caspofungin. The proportion of patients with a serious drug-related adverse reaction or a drug-related adverse reaction leading to caspofungin discontinuation was comparable in the 2 treatment groups.

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

Nebenwirkungen · Cancidas (previously Caspofungin MSD)

CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 8–9

HOS-109330 · Präparat HOS-093179

8 Paediatric Patients Data from 5 clinical studies completed in 171 paediatric patients suggest that the overall incidence of clinical adverse experiences (26.3 %; 95 % CI -19.9, 33.6) is not worse than reported for adults treated with caspofungin (43.1 %; 95 % CI -40.0, 46.2). However, paediatric patients probably have a different adverse event profile compared to adult patients. The most common drug-related clinical adverse experiences reported in paediatric patients treated with caspofungin were pyrexia (11.7 %), rash (4.7 %) and headache (2.9 %).

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