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Daptomycin Hospira is a brand name for Daptomycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1). - Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). - Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is…
Verbatim from this product's EMA label. Tap a section to expand.
Clinical studies in patients employed infusion of daptomycin over at least 30 minutes. There is no clinical experience in patients with the administration of daptomycin as an injection over 2 minutes. This mode of administration was only studied in healthy subjects.
2). 1). - cSSTI with concurrent SAB: daptomycin 6 mg/kg is administered once every 24 hours. See below for dose adjustments in patients with renal impairment. The duration of therapy may need to be longer than 14 days in accordance with the perceived risk of complications in the individual patient.
- Known or suspected RIE due to Staphylococcus aureus: daptomycin 6 mg/kg is administered once every 24 hours. See below for dose adjustments in patients with renal impairment. The duration of therapy should be in accordance with available official recommendations.
6). Daptomycin should not be used more frequently than once a day. 4). Special population Renal impairment Daptomycin is eliminated primarily by the kidney. Due to limited clinical experience (see table and footnotes below) daptomycin should only be used in adult patients with any degree of renal impairment (creatinine clearance [CrCl] < 80 mL/min) when it is considered that the expected clinical benefit outweighs the potential risk.
2). The dose regimen for daptomycin in paediatric patients with renal impairment has not been established. 1 < 30 mL/min 6 mg/kg every 48 hours (1, 2) cSSTI = complicated skin and soft-tissue infections; SAB = S. 2). (2) The same dose adjustments, which are based on PK data in volunteers including PK modelling results, are recommended for adult patients on haemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD).
2). 2). No data are available in patients with severe hepatic impairment (Child-Pugh Class C). Therefore caution should be exercised if daptomycin is given to such patients. 4). Paediatric population (1 to 17 years of age) Table 2 Recommended dose regimens for paediatric patients based on age and indication Age group Indication cSSTI without SAB cSSTI associated with SAB Dose regimen Duration of therapy Dose regimen Duration of therapy 12 to 17 years 5 mg/kg once every 24 hours infused over 30 minutes Up to 14 days 7 mg/kg once every 24 hours infused over 30 minutes (1) 7 to 11 years 7 mg/kg once every 24 hours infused over 30 minutes 9 mg/kg once every 24 hours infused over 30 minutes 2 to 6 years 9 mg/kg once every 24 hours infused over 12 mg/kg once every 24 hours infused over 5 60 minutes 60 minutes 1 to < 2 years 10 mg/kg once every 24 hours infused over 60 minutes 12 mg/kg once every 24 hours infused over 60 minutes cSSTI = complicated skin and soft-tissue infections; SAB = S.
Summary of the safety profile In clinical studies, 2,011 adult subjects received daptomycin. Within these studies, 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.
In paediatric studies, 372 patients received daptomycin, of whom 61 received a single dose and 311 received a therapeutic regimen for cSSTI or SAB (daily doses ranged from 4 mg/kg to 12 mg/kg). e. considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported at similar frequencies for daptomycin and comparator regimens.
The most frequently reported adverse reactions (frequency common (≥ 1/100 to < 1/10)) are: Fungal infections, urinary tract infection, candida infection, anaemia, anxiety, insomnia, dizziness, headache, hypertension, hypotension, gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension, liver function tests abnormal (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP)), rash, pruritus, limb pain, serum creatine phosphokinase (CPK) increased, infusion site reactions, pyrexia, asthenia.
Less frequently reported, but more serious, adverse reactions include hypersensitivity reactions, eosinophilic pneumonia (occasionally presenting as organising pneumonia), drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema and rhabdomyolysis.
Tabulated list of adverse reactions The following adverse reactions were reported during therapy and during follow-up with frequencies corresponding to 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); very rare (< 1/10,000); not known (cannot be estimated from the available data): Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
General If a focus of infection other than cSSTI or RIE is identified after initiation of daptomycin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.
Anaphylaxis/hypersensitivity reactions Anaphylaxis/hypersensitivity reactions have been reported with daptomycin. If an allergic reaction to daptomycin occurs, discontinue use and institute appropriate therapy. 6 Pneumonia It has been demonstrated in clinical studies that daptomycin is not effective in the treatment of pneumonia.
Daptomycin Hospira is therefore not indicated for the treatment of pneumonia. 1). The safety and efficacy of daptomycin in children and adolescents aged below 18 years with RIE due to Staphylococcus aureus have not been established. The efficacy of daptomycin in patients with prosthetic valve infections or with left-sided infective endocarditis due to Staphylococcus aureus has not been demonstrated.
g. debridement, removal of prosthetic devices, valve replacement surgery) without delay. Enterococcal infections There is insufficient evidence to be able to draw any conclusions regarding the possible clinical efficacy of daptomycin against infections due to enterococci, including Enterococcus faecalis and Enterococcus faecium.
In addition, dose regimens of daptomycin that might be appropriate for the treatment of enterococcal infections, with or without bacteraemia, have not been identified. Failures with daptomycin in the treatment of enterococcal infections that were mostly accompanied by bacteraemia have been reported.
1). Non-susceptible micro-organisms The use of antibacterials may promote the overgrowth of non-susceptible micro-organisms. If superinfection occurs during therapy, appropriate measures should be taken. 8). If CDAD is suspected or confirmed, daptomycin may need to be discontinued and appropriate treatment instituted as clinically indicated.
1.
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aureus bacteraemia; (1) Minimum duration of Daptomycin Hospira for paediatric SAB should be in accordance with the perceived risk of complications in the individual patient. The duration of Daptomycin Hospira may need to be longer than 14 days in accordance with the perceived risk of complications in the individual patient.
In the paediatric SAB study, the mean duration of IV Daptomycin Hospira was 12 days, with a range of 1 to 44 days. The duration of therapy should be in accordance with available official recommendations. 6). Daptomycin Hospira should not be used more frequently than once a day.
4). 3). 6) and administered over a 2-minute period. In paediatric patients aged 7 to 17 years, Daptomycin […]
11 Table 3 Adverse reactions from clinical studies and post-marketing reports System organ class Frequency Adverse reactions Infections and infestations Common: Fungal infections, urinary tract infection, candida infection Uncommon: Fungaemia Not known*: Clostridioides difficile-associated diarrhoea** Blood and lymphatic system disorders Common: Anaemia Uncommon: Thrombocythaemia, eosinophilia, international normalised ratio (INR) increased, leukocytosis Rare: Prothrombin time (PT) prolonged Not known*: Thrombocytopaenia Immune system disorders Not known*: Hypersensitivity**, manifested by isolated spontaneous reports including, but not limited to angioedema, pulmonary eosinophilia, sensation of oropharyngeal swelling, anaphylaxis**, infusion reactions including the following symptoms: tachycardia, wheezing, pyrexia, rigors, systemic flushing, vertigo, syncope and metallic taste Metabolism and nutrition disorders Uncommon: Decreased appetite, hyperglycaemia, electrolyte imbalance Psychiatric disorders Common: Anxiety, insomnia Nervous system disorders Common: Dizziness, headache Uncommon: Paraesthesia, taste disorder, tremor, eye irritation Not known*: Peripheral neuropathy** Ear and labyrinth disorders Uncommon: Vertigo Cardiac disorders Uncommon: Supraventricular tachycardia, extrasystole Vascular disorders Common: Hypertension, hypotension Uncommon: Flushes Respiratory, thoracic and mediastinal disorders Not known*: Eosinophilic pneumonia1**, cough Gastrointestinal disorders Common: Gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension Uncommon: Dyspepsia, glossitis Hepatobiliary disorders Common: Liver function tests abnormal2 (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP)) Rare: Jaundice Skin and subcutaneous tissue disorders Common: Rash, pruritus Uncommon: Urticaria Not known*: Acute generalised exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS)**, vesiculobullous rash with or without mucous membrane involvement (SJS or TEN)** 12 System organ class Frequency Adverse reactions Musculoskeletal and connective tissue disorders Common: Limb pain, serum creatine phosphokinase (CPK)2 increased Uncommon: Myositis, increased myoglobin, muscular weakness, muscle pain, arthralgia, serum lactate dehydrogenase (LDH) increased, muscle cramps Not known*: Rhabdomyolysis3 ** Renal and urinary disorders Uncommon: Renal impairment, including renal failure and renal insufficiency, serum creatinine increased Not known*: Tubulointerstitial nephritis (TIN)** Reproductive system and breast disorders Uncommon: Vaginitis General disorders and administration site conditions Common: Infusion site reactions, pyrexia, asthenia Uncommon: Fatigue, pain * Based on post-marketing reports.
Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known. 4. 1 While the exact incidence of eosinophilic pneumonia associated with daptomycin is unknown, to date the reporting rate of spontaneous reports is very low (< 1/10,000).
2 In some cases of myopathy involving raised CPK and muscle symptoms, the patients also presented with elevated transaminases. These transaminase increases were likely to be related to the skeletal muscle effects. The majority of transaminase elevations were of Grade 1-3 toxicity and resolved upon discontinuation of treatment.
3 When clinical information on the patients was available to make a judgement, approximately 50% of the cases occurred in patients with pre-existing renal impairment, or in those receiving concomitant medicinal products known to cause rhabdomyolysis.
The safety data for the administration of daptomycin via 2-minute intravenous injection are derived from two […]
5). 3). 5%). Therefore, it is recommended that: - Plasma CPK should be measured at baseline and at regular intervals (at least once weekly) during therapy in all patients. g. every 2-3 days at least during the first two weeks of treatment) in patients who are at higher risk of developing myopathy.
g. HMG-CoA reductase inhibitors, fibrates and ciclosporin). - It cannot be ruled out that those patients with CPK greater than 5 times upper limit of normal at baseline may be at increased risk of further increases during daptomycin therapy.
This should be taken into account when initiating daptomycin therapy and, if daptomycin is given, these patients should be monitored more frequently than once weekly. - Daptomycin Hospira should not be administered to patients who are taking other medicinal products associated with myopathy unless it is considered that the benefit to the patient outweighs the risk.
- Patients should be reviewed regularly while on therapy for any signs or symptoms that might represent myopathy. - Any patient that develops unexplained muscle pain, tenderness, weakness or cramps should have CPK levels monitored every 2 days.
Daptomycin Hospira should be discontinued in the presence of unexplained muscle symptoms if the CPK level reaches greater than 5 times upper limit of normal. 3). 3). 8). In most reported cases associated with daptomycin, patients developed fever, dyspnoea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organising pneumonia.
The majority of cases occurred after more than 2 weeks of treatment with daptomycin and improved when daptomycin was discontinued and steroid therapy was initiated. Recurrence of eosinophilic pneumonia upon re-exposure has been […]