observed in patients taking daptomycin, consideration should be given to a possible in vitro interaction with the laboratory test. The possibility of erroneous results may be minimised by drawing samples for PT or INR testing near the time of trough plasma concentrations of daptomycin. Pregnancy and lactation No clinical data on pregnancies are available for daptomycin. Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/fetal development, parturition or postnatal development.Cubicin should not be used during pregnancy unless clearly necessary i.e., only if the potential benefit outweighs the possible risk.It is not known whether daptomycin is excreted in human milk. Therefore, breastfeeding should be discontinued during treatment with Cubicin.
Adverse Reactions
Clinical StudiesIn clinical studies, 2,011 subjects received Cubicin. Within these trials, 1,221 subjects received a daily dose of 4 mg/kg, of whom 1,108 were patients and 113 were healthy volunteers; 460 subjects received a daily dose of 6 mg/kg, of whom 304 were patients and 156 were healthy volunteers. Adverse reactions (i.e. considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported at similar frequencies for Cubicin and comparator regimens.For subjects who received Cubicin, the adverse reactions that were most frequently reported during therapy plus follow-up were: headache, nausea, vomiting, diarrhoea, fungal infections, rash, infusion site reaction, increased creatine phosphokinase (CPK) and abnormal liver enzymes; alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase.The following adverse reactions were reported during therapy and during follow-up with frequencies corresponding to Common = 1/100, 1/1,000, 1/10,000, < 1/1,000, Very rare = 1/10,000:Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.Infections and Infestations - Common: Fungal infections, Uncommon: Urinary tract infection.Blood and lymphatic system disorders - Uncommon: Thrombocythaemia, anaemia, eosinophilia.Metabolism and nutrition disorders - Uncommon: Anorexia, hyperglycaemia.Psychiatric disorders - Uncommon: Anxiety, insomnia.Nervous system disorders - Common: Headache, Uncommon: Dizziness, paraesthesiae, taste disorder.Cardiac disorders - Uncommon: Supraventricular tachycardia, extrasystoleVascular disordersUncommon: Flushes, hypertension, hypotensionGastrointestinal disordersCommon: Nausea, vomiting, diarrhoeaUncommon: Constipation, abdominal pain, dyspepsia, glossitisHepatobiliary disordersUncommon: JaundiceSkin and subcutaneous tissue disordersCommon: RashUncommon: Pruritis, urticariaMusculoskeletal, connective tissue and bone disordersUncommon: Myositis, muscle weakness, muscle pain, arthralgiaRenal and urinary disorders Uncommon: Renal insufficiencyReproductive system and breast disordersUncommon: VaginitisGeneral disorders and administration site conditionsCommon: Infusion site reactionsUncommon: Pyrexia, weakness, fatigue, painInvestigationsCommon: Liver function tests abnormal (increased AST, ALT and alkaline phosphatase), increased CPKUncommon: Electrolyte imbalance, increased serum creatinine, increased myoglobin, lactic dehydrogenase (LDH) increasedPost-MarketingAdverse reactions t
