d with tigecycline. Treatment was discontinued due to adverse reactions in 5 % of patients.
In clinical trials, the most common drug-related treatment emergent adverse reactions were reversible nausea (20 %) and vomiting (14 %), which usually occurred early (on treatment days 1-2) and were generally mild or moderate in severity.
Adverse reactions reported with Tygacil, including clinical trials and post-marketing experience, are listed below:
Frequency categories are expressed as: 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)
For adverse reactions identified from post-marketing experience with Tygacil derived from spontaneous reports for which the frequency cannot be estimated, the frequency grouping is categorized as not known.
b. Tabulated summary of adverse reactions
Infections and infestations:
Common: Pneumonia, abscess, infections
Uncommon: Sepsis/septic shock
Blood and the lymphatic system disorders:
Common: Prolonged activated partial thromboplastin time (aPTT), Prolonged prothrombin time (PT)
Uncommon: Increased International Normalised Ratio (INR)
Not known: thrombocytopenia
Immune system disorders:
Not known: Anaphylaxis/anaphylactoid reactions (see sections 4.3 and 4.4)
Metabolism and nutrition disorders:
Common: Hypoglycaemia
Uncommon: Hypoproteinaemia
Nervous system disorders:
Common: Dizziness
Vasclar disorders:
Common: Phlebitis
Uncommon: Thrombophlebitis
Gastrointestinal disorders:
Very common: Nausea, vomiting, diarrhoea
Common: Abdominal pain, dyspepsia, anorexia
Uncommon: Acute pancreatitis (see section 4.4)
Hepato-biliary disorders:
Common: Elevated aspartate aminotransferase (AST) in serum, and elevated alanine aminotransferase (ALT) in serum, hyperbilirubinaemia
Uncommon: Jaundice, liver injury, mostly cholestatic
Not known: Hepatic failure (see section 4.4)
Skin and subcutaneous tissue disorders:
Common: Pruritus, rash
Not known: Severe skin reactions, including Stevens-Johnson Syndrome
General disorders and administration site conditions:
Common: Headache
Uncommon: Injection site reaction, injection site inflammation, injection site pain, injection site oedema, injection site phlebitis
Investigations:
Common: Elevated amylase in serum, increased blood urea nitrogen (BUN)
c. Description of selected adverse reactions
Antibiotic Class Effects:
Pseudomembranous colitis which may range in severity from mild to life threatening (see section 4.4)
Overgrowth of non-susceptible organisms, including fungi (see section 4.4)
Tetracycline Class Effects:
Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics. Tetracycline class adverse reactions may include photosensitivity, pseudotumour cerebri, pancreatitis, and anti-anabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia (see section 4.4).
Tigecycline may be associated with permanent tooth discolouration if used during tooth development (see section 4.4).
In Phase 3 clinical studies, infection-related serious adverse events were more frequently reported for subjects treated with tigecycline (6.7 %) vs comparators (4.6 %). Significant differences in sepsis/septic shock with tigecycli |
