Xydalba

HOS-216655 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile In Phase 2/3 clinical studies, 2 473 adult patients received dalbavancin administered as either a single infusion of 1 500 mg or as 1 000 mg followed one week later by 500 mg. The most common adverse reactions occurring in ≥ 1 % of patients treated with dalbavancin were nausea (2.4 %), diarrhoea (1.9 %), and headache (1.3 %) and were generally of mild or moderate severity. Tabulated list of adverse reactions (Table 1) The following adverse reactions have been identified in Phase 2/3 clinical trials with dalbavancin. Adverse reactions are classified according to System Organ Class and frequency. Frequency categories are derived according to the following conventions: 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). 5 Table 1. System Organ Class Common Uncommon Rare Infections and vulvovaginal mycotic infection, infestations urinary tract infection, fungal infection, Clostridioides (formerly Clostridium) difficile colitis, oral candidiasis Blood and lymphatic anaemia, thrombocytosis, system disorders eosinophilia, leucopenia, neutropenia Immune system anaphylactoid disorders reaction Metabolism and decreased appetite nutrition disorders Psychiatric disorders insomnia Nervous system headache dysgeusia, dizziness disorders Vascular disorders flushing, phlebitis Respiratory, thoracic cough bronchospasm and mediastinal disorders Gastrointestinal nausea, diarrhoea constipation, abdominal pain, disorders dyspepsia, abdominal discomfort, vomiting Skin and subcutaneous pruritus, urticaria, rash tissue disorders

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HOS-216651 · has-contraindication-information · PDF-Seite 3

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

HOS-216650 · has-indication-information · PDF-Seite 2

Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients from birth (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

HOS-216653 · has-interaction-information · PDF-Seite 4

Results from an in vitro receptor screening study do not indicate a likely interaction with other therapeutic targets or a potential for clinically relevant pharmacodynamic interactions (see section 5.1). Clinical drug-drug interaction studies with dalbavancin have not been conducted. Potential for other medicinal products to affect the pharmacokinetics of dalbavancin. Dalbavancin is not metabolised by CYP enzymes in vitro, therefore co-administered CYP inducers or inhibitors are unlikely to influence the pharmacokinetics of dalbavancin. It is not known if dalbavancin is a substrate for hepatic uptake and efflux transporters. Co-administration with inhibitors of these transporters may increase the exposure to dalbavancin. Examples of such transporter inhibitors are boosted protease inhibitors, verapamil, quinidine, itraconazole, clarithromycin and cyclosporine. Potential for dalbavancin to affect the pharmacokinetics of other medicinal products. The interaction potential of dalbavancin on medicinal products metabolised by CYP enzymes is expected to be low since it is neither an inhibitor nor an inducer of CYP enzymes in vitro. There are 4 no data on dalbavancin as an inhibitor of CYP2C8. It is not known if dalbavancin is an inhibitor of transporters. Increased exposure to transporter substrates sensitive for inhibited transporter activity, such as statins and digoxin, cannot be excluded if combined with dalbavancin.

HOS-216654 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no data from the use of dalbavancin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Xydalba is not recommended during pregnancy, unless the potential expected benefit clearly justifies the potential risk to the foetus. Breast-feeding It is unknown whether dalbavancin is excreted in human milk. However, dalbavancin is excreted in the milk of lactating rats and may be excreted in human breast milk. Dalbavancin is not well absorbed orally; however, an impact on the gastrointestinal flora or mouth flora of a breast-feeding infant cannot be excluded. A decision must be made whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Xydalba taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility Studies in animals have shown reduced fertility (see section 5.3). The potential risk for humans is unknown.

HOS-216652 · has-warning-information · PDF-Seite 3

Hypersensitivity reactions Dalbavancin should be administered with caution in patients known to be hypersensitive to other glycopeptides since cross-hypersensitivity may occur. If an allergic reaction to dalbavancin occurs, administration should be discontinued and appropriate therapy for the allergic reaction should be instituted. Clostridioides (formerly Clostridium) difficile-associated diarrhoea Antibacterial-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the treatment with dalbavancin (see section 4.8). In such circumstance, the discontinuation of dalbavancin and the use of supportive measures together with the administration of specific treatment for Clostridioides (formerly Clostridium) difficile should be considered. These patients must never be treated with medicinal products that suppress the peristalsis. Infusion-related reactions Xydalba is to be administered via intravenous infusion, using a total infusion time of 30 minutes to minimise the risk of infusion-related reactions. Rapid intravenous infusions of glycopeptide 3 antibacterial agents can cause reactions including flushing of the upper body, urticaria, pruritus, and/or rash. Stopping or slowing the infusion may result in cessation of these reactions. Renal impairment Information on the efficacy and safety of dalbavancin in patients with creatinine clearance < 30 ml/min is limited. Based on simulations, dose adjustment is needed for adult patients with chronic renal impairment whose creatinine clearance is < 30 ml/min and who are not receiving regular haemodialysis (see sections 4.2 and 5.2). There is insufficient information to recommend dosage adjustment for patients 3 months to 18 years old with creatinine clearance less than 30 ml/min/1.73 m2 and for patients < 3 months old with renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal, or urine output < 0.5 mL/kg/h, or requirement for dialysis. Mixed infections In mixed infections in which Gram-negative bacteria are suspected patients should also be treated with an appropriate antibacterial agent(s) against Gram-negative bacteria (see section 5.1). Non-susceptible organisms The use of antibiotics may promote the over

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