DALBAVANCIN HCL (dalbavancin hcl)

There are 0 contraindications.

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Clostridioides difficile infection

There are 3 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Child-pugh class B hepatic impairment
Child-pugh class C hepatic impairment
Disease of liver

There are 13 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal hepatic function tests Anaphylaxis Bleeding from wound Bone marrow depression Bronchospastic pulmonary disease Clostridioides difficile infection Drug-induced hepatitis Eosinophilia Gastrointestinal hemorrhage Hyperbilirubinemia Hypersensitivity drug reaction Increased alkaline phosphatase Thrombocytosis

There are 18 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Headache disorder Nausea	Fever Pruritus of skin Skin rash

Rare/Very Rare
Acute abdominal pain Back pain Black tarry stools Dizziness Flushing Hematoma Hypoglycemic disorder Oral candidiasis Petechiae Phlebitis after infusion Urticaria Vulvovaginal candidiasis

Category C. (See Users Guide.) There are no adequate and well-controlled studies of dalbavancin in pregnant women, and the drug should be used during pregnancy only if potential benefits justify potential risks to the fetus. In an embryofetal study in rats, delayed fetal maturation was observed at a dosage of 45 mg/kg daily (3.5 times the human dosage on an exposure basis). In a prenatal and postnatal development study in rats, increased embryolethality and increased offspring deaths during the first week postpartum were observed at a dosage of 45 mg/kg daily.

Dalbavancin is distributed into milk in lactating rats; it is not known whether the drug is distributed into human milk. Dalbavancin should be used with caution in nursing women.

In clinical studies evaluating dalbavancin for the treatment of acute bacterial skin and skin structure infections, efficacy and tolerability were similar to comparator treatments regardless of age. There were no substantial differences in the pharmacokinetics of dalbavancin according to age; therefore, dosage adjustments are not needed based solely on age. Dalbavancin is substantially eliminated by the kidneys; the risk of adverse effects may be greater in patients with impaired renal function. Dosage should be selected with caution since geriatric patients are more likely to have decreased renal function.