Dalvance (dalbavancin HCl)

Dosage of dalbavancin hydrochloride is expressed in terms of dalbavancin.

Dalbavancin hydrochloride is administered by IV infusion.

Formal drug interaction studies have not been conducted with dalbavancin to date.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Antibiotics/Fecal Microbiota

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Fecal microbiota is a suspension of live bacteria, which may be compromised by concurrent use of antibiotics.(1)

CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota. Antibacterial treatment should be completed for 24 to 72 hours before initiating treatment with fecal microbiota. Do not use antibiotics for up to 8 weeks after fecal microbiota.(1)

DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota.

Antibiotics/Fecal Microbiota Spores

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1)

CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1)

DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores.

Antimicrobials/Live Typhoid Vaccine

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1)

CLINICAL EFFECTS: Vaccination may be ineffective.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3)

DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Myelosuppressives; Immunomodulators/Sodium Iodide I 131

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1)

CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1)

DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1)

There are no moderate interactions for this drug.

Dalbavancin is contraindicated in patients with known hypersensitivity to the drug.

There are no contraindication contraindications for this drug.

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

• Child-pugh class B hepatic impairment
• Child-pugh class C hepatic impairment
• Disease of liver

Adverse effects reported in 2% or more of patients receiving dalbavancin include nausea, vomiting, diarrhea, headache, rash, and pruritus.

Rare or 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

More Frequent

• Diarrhea
• Headache disorder
• Nausea

Less Frequent

• Fever
• Pruritus of skin
• Skin rash

Rare or Very Rare

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

No enhanced messaging available.

Safety and efficacy of dalbavancin have not been established in pediatric patients.

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.

Dosage adjustments are not needed in geriatric patients based solely on age. Dosage should be selected with caution since geriatric patients are more likely to have decreased renal function than younger adults. (See Geriatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

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.