ORBACTIV Powder for solution for injection (2020)

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Melinta Therapeutics, LLC

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1. Indications and Usage

1.1 Acute Bacterial Skin and Skin Structure Infections ORBACTIV (oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) ...

2. Dosage and Administration

2.1 Recommended Dosage The recommended dosing for ORBACTIV is a single 1200 mg dose administered by intravenous infusion over 3 hours in patients 18 years and older. 2.2 Preparation of ORBACTIV for Intravenous ...

3. Dosage Forms and Strengths

ORBACTIV is supplied as sterile, white to off-white lyophilized powder equivalent to 400 mg of oritavancin in a single-dose 50 mL clear glass vial.

4. Contraindications

4.1 Intravenous Unfractionated Heparin Sodium Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV administration because the activated partial thromboplastin ...

5. Warnings and Precautions

5.1 Coagulation Test Interference ORBACTIV has been shown to artificially prolong aPTT for up to 120 hours, PT and INR for up to 12 hours, and activated clotting time (ACT) for up to 24 hours following ...

6. Adverse Reactions

The following adverse reactions are also discussed in the Warnings and Precautions section of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2)] Infusion Related Reactions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of ORBACTIV cannot be directly compared to rates in the clinical trials of ...

7. Drug Interactions

7.1 Effect of ORBACTIV on CYP Substrates A screening drug-drug interaction study indicated that ORBACTIV is a nonspecific, weak inhibitor (CYP2C9 and CYP2C19) or inducer (CYP3A4 and CYP2D6) of several ...

8.1. Pregnancy

Risk Summary There are no available data on ORBACTIV use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction ...

8.2. Lactation

Risk Summary There are no data on the presence of oritavancin in human milk, the effects on the breastfed-child, or the effects on milk production. ORBACTIV is present in the breast milk of rats (see ...

8.4. Pediatric Use

Safety and effectiveness of ORBACTIV in pediatric patients (younger than 18 years of age) has not been studied.

8.5. Geriatric Use

The pooled Phase 3 ABSSSI clinical trials of ORBACTIV did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Other reported ...

8.6. Renal Impairment

No dosage adjustment of ORBACTIV is needed in patients with mild or moderate renal impairment [see Dosage and Administration (2.1), Clinical Pharmacology (12.3)]. The pharmacokinetics of ORBACTIV ...

8.7. Hepatic Impairment

No dosage adjustment of ORBACTIV is needed in patients with mild or moderate hepatic impairment. The pharmacokinetics of ORBACTIV in patients with severe hepatic insufficiency has not been studied ...

10. Overdosage

In the ORBACTIV clinical program there was no incidence of accidental overdose of ORBACTIV. Based on an in vitro hemodialysis study, ORBACTIV is unlikely to be removed from blood by hemodialysis. In the ...

11. Description

ORBACTIV (oritavancin) for injection contains oritavancin diphosphate, a semisynthetic lipoglycopeptide antibacterial drug. The chemical name for oritavancin is [4"R]22O-N3''[(4'-chloro[1,1'-biphenyl]-4-yl)methyl] ...

12.1. Mechanism of Action

Oritavancin is an antibacterial drug [see Microbiology (12.4)].

12.2. Pharmacodynamics

The antimicrobial activity of oritavancin appears to correlate with the ratio of area under the concentration-time curve to minimal inhibitory concentration (AUC/MIC) based on animal models of infection. ...

12.3. Pharmacokinetics

The population PK analysis was derived using data from the two Phase 3 ABSSSI clinical trials in 297 patients. The mean pharmacokinetic parameters of oritavancin in patients following a single 1200 mg ...

12.4. Microbiology

ORBACTIV is a semi-synthetic, lipoglycopeptide antibacterial drug. ORBACTIV exerts a concentration-dependent bactericidal activity in vitro against S. aureus, S. pyogenes, and E. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been conducted to determine the carcinogenic potential of oritavancin. No mutagenic or clastogenic potential of oritavancin was found in a battery of tests, including ...

14. Clinical Studies

14.1 Acute Bacterial Skin and Skin Structure Infections (ABSSSI) A total of 1987 adults with clinically documented ABSSSI suspected or proven to be due to Gram-positive pathogens were randomized into two ...

16.1. How Supplied

ORBACTIV is supplied as single-dose 50 mL capacity glass vials containing sterile lyophilized powder equivalent to 400 mg of oritavancin (NDC 70842-140-01). Three vials are packaged in a carton to supply ...

16.2. Storage and Handling

ORBACTIV vials should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature (CRT)].

17. Patient Counseling Information

Allergic Reactions Patients should be advised that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. They should inform their ...