Omadacycline (Nuzyra) is a broad-spectrum antibiotic that belongs to the class of drugs called tetracyclines. Other drugs in the same class include doxycycline and tetracycline It has been approved by the FDA in 2018 for skin infections and community-acquired pneumonia.

Omadacycline (Nuzyra) Uses:

• , Community-acquired Pneumonia:

  • Used for Treatment of community-acquired bacterial pneumonia (CABP) in adult patients caused by susceptible Streptococcus pneumoniae, Mycoplasma pneumoniae, H. parainfluenzae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Klebsiella pneumoniae, Legionella pneumophila and Chlamydophila pneumoniae.

• Skin and skin structure infections:

  • Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adult patients caused by susceptible Staphylococcus aureus (methicillinsusceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.

Omadacycline (Nuzyra) Dose in Adults

Omadacycline (Nuzyra) Dose in the treatment of community-acquired Pneumonia:

• Loading dose:

  • IV: 200 milligrams as a single dose on day 1 or 100 milligrams twice a day on day 1

• Maintenance dose:

  • IV:
    • 100 milligram once a day
    • 300 milligram once a day
• Duration of therapy:
  • 7-14 days

Omadacycline (Nuzyra) dose in Skin and skin structure infections:

• Loading dose:

  • IV:
    • 200 milligram as a single dose on day 1 or 100 mg twice a day on day 1
  • P/O:
    • 450 mg once daily on days 1 and 2

• Maintenance dose of Omadacycline (Nuzyra):

  • IV:
    • 100 mg once a day
  • P/O:
    • 300 mg once a day
  • Duration of therapy:
    • 7-14 days

Use in Children:

Not indicated

Omadacycline (Nuzyra) Pregnancy Risk Category: N (Not assigned)

• Tetracyclines are important in the development of long tubular bone and teeth.
• In utero exposure can cause permanent discoloration (yellow-gray, or brown) of the teeth. It is more likely to occur in the second and third trimesters, as well as after prolonged or repeated exposures.
• Reversible inhibition of bone development may be possible after maternal use of Tetracyclines in the 2nd and 3rd Trimesters.
• Due to the possibility of adverse pregnancy outcomes with omadacycline treatment, the manufacturer recommends that females of reproductive potential use effective contraception.

Omadacycline use during breastfeeding:

• It is unknown if omadacycline can be found in breast milk.
• Tetracyclines are generally avoided by breastfeeding women as they can cause tooth discoloration or inhibit bone growth.
• Breastfeeding is not recommended by the manufacturer because of the risk of adverse events. It is also not recommended for use for the first four days following the last dose.

Dose in Kidney Disease:

• No dosage adjustment is required.

Dose in Liver Disease:

• No dosage adjustment is required.

Common Side Effects of Omadacycline (Nuzyra):

• Gastrointestinal:

  • Nausea
  • Vomiting

Less Common Side Effects of Omadacycline (Nuzyra):

• Cardiovascular:

  • Hypertension
  • Insomnia
  • Atrial Fibrillation
  • Tachycardia

• Central Nervous System:

  • Headache
  • Fatigue
  • Lethargy
  • Vertigo

• Dermatologic:

  • Erythema
  • Hyperhidrosis
  • Pruritus
  • Urticaria

• Endocrine & Metabolic:

  • Increased Gamma-Glutamyl Transferase

• Gastrointestinal:

  • Diarrhea
  • Constipation
  • Abdominal Pain
  • Dysgeusia
  • Dyspepsia
  • Increased Serum Lipase
  • Oral Candidiasis

• Genitourinary:

  • Vulvovaginal Candidiasis

• Hematologic & Oncologic:

  • Anemia
  • Thrombocythemia

• Hepatic:

  • Increased Serum Alanine Aminotransferase
  • Increased Serum Aspartate Aminotransferase
  • Increased Serum Alkaline Phosphatase
  • Increased Serum Bilirubin

• Hypersensitivity:

  • Hypersensitivity Reaction

• Local:

  • Infusion Site Reaction

• Neuromuscular & Skeletal:

  • Increased Creatine Phosphokinase

• Respiratory:

  • Oropharyngeal Pain

Contraindications to Omadacycline (Nuzyra):

• Tetracyclines are important in the development of long tubular bone and teeth.
• Permanent discoloration of the teeth can result from in utero exposure (yellow-gray or brown). This is more common in the second and third trimesters.
• Reversible inhibition of bone development may be possible after maternal use of Tetracyclines in the 2nd and 3rd Trimesters.
• Due to the possibility of adverse pregnancy outcomes with omadacycline treatment, the manufacturer recommends that females of reproductive potential use effective contraception.

Omadacycline use during breastfeeding:

• It's not known if omadacycline is found in breast milk.
• Tetracyclines are generally avoided by breastfeeding women as they can cause tooth discoloration or inhibit bone growth.
• Manufacturers do not recommend breastfeeding due to the potential for adverse events. It is not recommended to be used for the first four days after the last dose.

Monitoring Parameters:

• Periodic renal and hepatic function tests

How to administer Omadacycline (Nuzyra)?

IV:

•  Allow diluted infusion solution to reach room temperature prior to infusion if stored under refrigeration.
• Infuse 200 mg dose over a total of 60 mins & 100 mg dose over a total of 30 mins through a dedicated line or Y-site.
• If no dedicated line available, flush line with NS or D5W before and after infusion of omadacycline.

P/O:

• Take the drug with water on an empty stomach (after fasting ≥4 hours).
• After administration, avoid food and drink (except water) for two hours and avoid dairy and other products with multivalent cations (eg, antacids, multivitamins) for 4 hours after administration.

Mechanism of action of Omadacycline (Nuzyra):

• It inhibits protein synthesis by binding to the 30S subunit of susceptible bacteria.

Absorption:

• Absorption rates and extents of food decrease

Distribution:

• Plasma concentrations are higher in tissues than plasma.

Protein binding:

• 20 percent,
• not concentration-dependent

Metabolism:

• Not metabolized

Bioavailability:

• P/O:
• 34.5 percent following a single 300 mg dose

Half-life elimination:

• IV:
• ~16 hours
• P/O:
• 13.45-16.83 hours

Time to peak: IV:

• ~0.5 hours.
• P/O:
• 2.5 hours.

Excretion: IV:

• Urine (27 percent as unchanged drug)

P/O:

• Feces: (77.5 percent to 84.0 percent).
• Urine: ~14.4 percent (range 10.8 percent to 17.4 percent)

International Brands of Omadacycline:

• Nuzyra

Omadacycline Brand Names in Pakistan:

No Brands Available in Pakistan.