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Cellulitis: physician submitted case

John F, New York

53-year-old diabetic with cellulitis

"I chose ORBACTIV® to treat John's foot infection entirely in the outpatient setting. His infection cleared within a few days and he was able to return to work.”

—Dr. David Davidson

Background

  • John is a 53-year-old male who lives in New York. A piece of skin came off his big toe while he was taking a shower. He went to Urgent Care a few days later because of swelling in his foot. He has no health insurance.

Presentation

  • John presented to the ED with acute cellulitis of the right foot. John takes insulin for his Type 1 Diabetes and is also on anti-hypertensive medication. He occasionally misses doses of both.

Evaluation

  • BP: 191/107 mmHg
  • Pulse: 107/min
  • BMI: 43.46 kg/m2
  • Glucose: 295 mg/dL
  • Temp: 98.3°F
  • WBC: 14,500/mcL
  • ESR: 65 mm/hr
  • Resp: 20/min

Resolution of John’s cellulitis following administration of single dose ORBACTIV® on 02.26.2017

02.26.2017

02.27.2017

03.01.2017

The treating physician is a paid consultant of Melinta Therapeutics, Inc. This case study is an actual patient who was treated with a single 1200mg dose of ORBACTIV®. No additional treatments were given to the patient for this infection. Results presented are consistent with results observed in the SOLO trials of patients with ABSSSI. In the SOLO I and SOLO II trials the clinical response rates at 14-24 days for patients receiving ORBACTIV® were 79.6% and 82.7% respectively. Click here to see clinical study results from the SOLO trials. Individual results may vary.

Background

  • John is a 53-year-old male who lives in New York. A piece of skin came off his big toe while he was taking a shower. He went to Urgent Care a few days later because of swelling in his foot. He has no health insurance.

Presentation

  • John presented to the ED with acute cellulitis of the right foot. John takes insulin for his Type 1 Diabetes and is also on anti-hypertensive medication. He occasionally misses doses of both.

Evaluation

  • BP: 191/107 mmHg
  • Pulse: 107/min
  • BMI: 43.46 kg/m2
  • Glucose: 295 mg/dL
  • Temp: 98.3°F
  • WBC: 14,500/mcL
  • ESR: 65 mm/hr
  • Resp: 20/min

INDICATION

ORBACTIV® (oritavancin) is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and -resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).

Important Safety Information

Contraindications

Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV® administration because the activated partial thromboplastin time (aPTT) test results are expected to remain falsely elevated for approximately 120 hours (5 days) after ORBACTIV® administration.

ORBACTIV® is contraindicated in patients with known hypersensitivity to ORBACTIV®.

Warnings and Precautions

Coagulation test interference: ORBACTIV® has been shown to artificially prolong aPTT for up to 120 hours, and may prolong PT and INR for up to 12 hours, and ACT for up to 24 hours. ORBACTIV® has also been shown to elevate D-dimer concentrations up to 72 hours.

Hypersensitivity reactions have been reported with the use of antibacterial agents including ORBACTIV®. Discontinue infusion if signs of acute hypersensitivity occur. Monitor closely patients with known hypersensitivity to glycopeptides.

Infusion Related Reactions: Administer ORBACTIV® over 3 hours to minimize infusion-related reactions. Stopping or slowing the infusion may result in cessation of these reactions.

Clostridium difficile-associated diarrhea: Evaluate patients if diarrhea occurs.

Concomitant warfarin use: ORBACTIV® has been shown to artificially prolong PT and INR for up to 12 hours. Patients should be monitored for bleeding if concomitantly receiving ORBACTIV® and warfarin.

Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.

Prescribing ORBACTIV® in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions (≥3%) in patients treated with ORBACTIV® were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.

See Full Prescribing Information

INDICATION

ORBACTIV® (oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and -resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).

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