Schedule H

Intravenous

• IV injection: 500 mg per vial (powder for reconstitution)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

► Acute Bacterial Skin and Skin Structure Infections (ABSSSI) due to Gram-positive organisms, including MRSA

Parameter Two-Dose Regimen Single-Dose Regimen

Starting dose 1000 mg IV over 30 minutes on Day 1 1500 mg IV over 30 minutes (one-time)

Titration Not applicable Not applicable

Usual maintenance dose 500 mg IV on Day 8 Not applicable (single dose)

Maximum dose 1500 mg total (1000 mg + 500 mg) 1500 mg total

Key Clinical Notes:

• Both regimens demonstrate equivalent efficacy in clinical trials

• No requirement for daily infusion or oral switch — suitable for early discharge or OPAT settings

• NOT effective against Gram-negative organisms — avoid in polymicrobial or Gram-negative infections

• Ensure culture/sensitivity confirms Gram-positive aetiology before initiating

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Level Evidence Basis

Osteomyelitis (OFF-LABEL) 1500 mg IV on Day 1; optional repeat 1500 mg IV on Day 8 based on clinical response Single or 2-dose schedule Specialist only Limited Indian experience; supported by global observational cohort studies

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

NOT APPROVED for use below 18 years in India

Age Group Recommendation

<18 years Not recommended — paediatric safety and pharmacokinetics under evaluation globally; NOT standard practice in India

Secondary Indications — Paediatric Doses (Off-label)

• Not recommended in children under 18 years pending adequate safety data

• No off-label paediatric indications established in Indian practice

CrCl ≥30 mL/min No dose adjustment required

CrCl <30 mL/min (not on dialysis) Single-dose regimen: Reduce to 1000 mg IV

Two-dose regimen: Reduce to 750 mg IV on Day 1, then 375 mg IV on Day 8

Haemodialysis Not significantly removed by dialysis; dose timing not dependent on dialysis schedule

• Known hypersensitivity to dalbavancin

• History of hypersensitivity to other glycopeptide antibiotics (vancomycin, teicoplanin)

• History of anaphylaxis to glycopeptides

• Infusion-related reactions: Administer over minimum 30 minutes to minimise risk; rapid infusion may cause "red man syndrome"-like reactions

• INR interference: May cause false elevation of INR on laboratory testing (not true coagulopathy) — interpret INR results with caution in patients on warfarin

• QT prolongation: Theoretical class effect — exercise caution in patients with known QT prolongation or on other QT-prolonging agents

• Severe renal impairment: Risk of accumulation if repeated dosing is considered

• Superinfection: Monitor for emergence of resistant organisms or fungal overgrowth

Parameter Details

Risk category (India) Not formally assigned

Safety statement Human data lacking; animal studies show no teratogenicity

When to use Only if clearly needed and benefit outweighs risk

Preferred alternatives Vancomycin (if IV treatment essential in pregnancy)

Monitoring Fetal growth if prolonged or repeated use considered

Parameter Details

Compatibility Likely excreted in breast milk (based on glycopeptide class)

Recommendation Avoid or use alternative agent, especially if nursing a neonate

Preferred alternatives Clindamycin or vancomycin (short-course)

Infant monitoring Gastrointestinal upset, oral thrush, diarrhoea

• No specific dosage adjustment required based solely on age

• Assess renal function (CrCl) before dosing — higher prevalence of renal impairment in elderly

• Monitor for volume overload with IV fluid administration

• Increased risk of infusion-related reactions — ensure slow infusion rate

Interacting Drug/Class Effect Recommendation

None established No major CYP450 interactions — drug not metabolised via hepatic enzymes No known interactions requiring absolute avoidance

Interacting Drug/Class Effect Recommendation

Warfarin False elevation of INR on laboratory testing (interference, not true anticoagulant effect) Use alternative INR testing method or interpret with caution; do not adjust warfarin dose based on falsely elevated INR

Nephrotoxic agents (aminoglycosides, amphotericin B, NSAIDs, contrast agents) Additive nephrotoxicity risk Monitor renal function closely if co-administered

• Nausea

• Headache

• Diarrhoea

• Pruritus

• Infusion site reactions (pain, erythema, phlebitis)

• Rash

• Vomiting

Adverse Effect Action Required

Hypersensitivity/anaphylaxis Discontinue immediately; manage with standard anaphylaxis protocol

Hepatotoxicity (rare) Monitor LFTs; discontinue if significant transaminase elevation

Clostridioides difficile-associated diarrhoea (CDAD) Consider discontinuation; initiate appropriate treatment

Severe infusion reactions Stop infusion; administer supportive care

Phase Parameters

Baseline Renal function (serum creatinine, CrCl), liver function tests (ALT, AST, bilirubin), clinical assessment of infection site, culture and sensitivity results

During infusion Observe for infusion-related reactions (flushing, urticaria, hypotension)

After initiation Clinical response at Day 3–5; LFTs if repeated dosing used

Long-term (if repeat courses) Renal and hepatic function; signs of C. difficile colitis; emergence of resistant organisms

• Dalvance (Pfizer) — limited private availability

• Available under import license in select major tertiary care centres

• NLEM Status: Not listed

• Government availability: Not routinely available; imported on demand in certain institutes

• OPAT advantage: Long half-life (~14 days) allows single-dose or two-dose therapy — ideal for outpatient parenteral antibiotic therapy and early discharge settings

• Spectrum limitation: Covers MRSA, MSSA, streptococci, and enterococci (except VanA-resistant) but offers NO Gram-negative coverage — always confirm Gram-positive aetiology

• Cost consideration: High cost limits use — reserve for situations where vancomycin or linezolid are unsuitable (e.g., poor venous access, non-adherence to daily dosing, OPAT requirement)

• Renal check mandatory: Assess CrCl prior to dosing even for single-dose regimens

• INR caution: Inform laboratory if patient is on warfarin — dalbavancin may interfere with certain INR assay methods

• Not for empiric use: Not recommended for empiric polymicrobial or hospital-acquired infections without culture guidance

dalbavancin; MRSA; ABSSSI; skin infection; lipoglycopeptide; long-acting antibiotic; OPAT; single-dose antibiotic; Gram-positive; vancomycin-alternative; NLEM-excluded

RxIndia v0.4 — 10 Jan 2025

• CDSCO Product List and approved indications

• Indian Pharmacopoeia (availability confirmation)

• AIIMS and tertiary infectious disease prescribing protocols

• Goodman & Gilman's Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine (bacterial infections chapter)

• Product package insert (Dalvance, Pfizer)

• Selected international RCTs and observational studies (for off-label osteomyelitis indication — marked clearly as off-label)

• Clinical experience reports from infectious disease units in India