Bedapt Daptomycin Adverse Reactions

Clinical Trials Experience: During clinical trials of Daptomycin for injection, the following adverse drug reactions were reported during therapy and during follow-up. The adverse drug reactions are organized by system organ class, and the frequency categories for these adverse drug reactions are reported in the table as follows: Very common: ≥1/10 (≥10%); Common: ≥1/100 and <1/10 (≥1% and <10%); Uncommon: ≥1/1000 and <1/100 (≥0.1% and <1%); Rare: ≥1/10,000 and <1/1000 (≥0.01% and <0.1%); Very rare: <1/10,000 (<0.01%). (See Table 7.)

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Post-marketing Experience: The following adverse drug reactions, not previously listed, have been reported during worldwide post-marketing experience: Blood and lymphatic system disorders: Thrombocytopenia.
Immune system disorders: Hypersensitivity, manifested by isolated spontaneous reports including, but not limited to angioedema, pulmonary eosinophilia, vesicobullous rash with mucous membrane involvement and sensation of oropharyngeal swelling.
Infections and infestations: Clostridioides difficile-associated diarrhea.
Anaphylaxis: Infusion reactions including the following symptoms: tachycardia, wheezing, pyrexia, rigors, systemic flushing, vertigo, syncope and metallic taste.
Investigations: Myoglobin increased, platelet count decreased.
Musculoskeletal, connective tissue, and bone disorders: Rhabdomyolysis.
Nervous system disorders: Peripheral neuropathy.
Renal and urinary disorders: Tubulointerstitial nephritis (TIN).
Respiratory, thoracic, and mediastinal disorders: Cough, Eosinophilic pneumonia, Organizing pneumonia.
Skin and subcutaneous tissue disorders: Vesiculobullous rash with or without mucous membrane involvement (Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN)), Drug reaction with eosinophilia and systemic symptoms (DRESS), Acute generalized exanthematous pustulosis.
Interference with Laboratory Tests: Clinically relevant plasma concentrations of daptomycin have been observed to cause a significant concentration-dependent false prolongation of prothrombin time (PT) and elevation of International Normalized Ratio (INR) when certain recombinant thromboplastin reagents are utilized for the assay. The possibility of an erroneously elevated PT/INR result due to interaction with a recombinant thromboplastin reagent may be minimized by drawing specimens for PT or INR testing near the time of trough plasma concentrations of daptomycin. However, sufficient daptomycin concentrations may be present at trough to cause interaction.
If confronted with an abnormally high PT/INR result in a patient being treated with Daptomycin for injection, it is recommended that clinicians: 1. Repeat the assessment of PT/INR, requesting that the specimen be drawn just prior to the next Daptomycin for injection dose (i.e., at trough concentration). If the PT/INR value obtained at trough remains substantially elevated above what would otherwise be expected, consider evaluating PT/INR utilizing an alternative method.
2. Evaluate for other causes of abnormally elevated PT/INR results.