About Omadacycline Dosing

This content provides a supplementary overview of the information used by the Omadacycline Dose Calculator. It outlines standard dosing recommendations for omadacycline (Nuzyra®) for its approved indications: Community-Acquired Bacterial Pneumonia (CABP) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI). All information is for educational purposes and should not replace clinical judgment or official prescribing information.

Outputs Explained

The calculator provides tailored dosing regimens based on the selected indication and patient’s hepatic function (Child-Pugh classification). The output specifies:

• IV Dosing: Details for intravenous administration, including the loading dose and subsequent daily maintenance dose.
• Oral Dosing: Recommendations for the oral formulation, including the loading dose and daily maintenance dose.
• IV-to-Oral Switch: Guidance on transitioning a patient from intravenous to oral therapy once clinically appropriate.
• Specific Adjustments: Important warnings or modifications, particularly for patients with severe (Child-Pugh C) hepatic impairment being treated for CABP.

How to Use the Calculator

To determine the appropriate dosing schedule, follow these steps:

1. Select Indication: Choose whether the patient is being treated for Community-Acquired Bacterial Pneumonia (CABP) or Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
2. Select Hepatic Function: Choose the patient’s liver function status, categorized as Normal/Mild (Child-Pugh A), Moderate (Child-Pugh B), or Severe (Child-Pugh C).
3. Calculate: Click the “Calculate” button to generate the dosing regimen.
4. Review Results: The tool will display the recommended IV, oral, and IV-to-oral switch dosing, along with any relevant clinical notes or warnings.

Dosing Overview

For Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

No dosage adjustment is required for patients with any degree of hepatic impairment.

• Intravenous (IV) Route: 100 mg every 12 hours for 2 doses (loading), followed by 100 mg once daily.
• Oral Route: 450 mg once daily for 2 days (loading), followed by 300 mg once daily.

For Community-Acquired Bacterial Pneumonia (CABP)

Dosing adjustments are necessary for patients with severe hepatic impairment.

• Normal to Moderate Hepatic Impairment (Child-Pugh A/B):
  • Intravenous (IV) Route: 100 mg every 12 hours for 2 doses (loading), followed by 100 mg once daily.
  • Oral Route: 450 mg once daily for 2 days (loading), followed by 300 mg once daily.
• Severe Hepatic Impairment (Child-Pugh C):
  • Intravenous (IV) Route: The IV loading and maintenance doses are the same as for patients with normal hepatic function. Use with caution.
  • Oral Route: Oral omadacycline has not been studied in this population for CABP and is therefore not recommended.

Switching from IV to Oral Therapy

For clinically stable patients who can tolerate oral medication, therapy may be switched from intravenous to oral. The recommended oral dose after initial IV treatment is 300 mg once daily. This switch is not recommended for patients with CABP and severe (Child-Pugh C) hepatic impairment.

Missed Dose

If a dose of omadacycline is missed, the patient should take it as soon as possible. If it is almost time for the next scheduled dose, the patient should skip the missed dose and resume the regular dosing schedule. Patients should not take two doses at the same time to make up for a missed one. Advise patients to contact their healthcare provider for specific instructions.

Safety Alerts

Tetracycline-Class Warnings

Omadacycline is a tetracycline-class antibacterial and carries associated risks, including potential for fetal harm, permanent tooth discoloration and enamel hypoplasia in children, and inhibition of bone growth. It may also cause photosensitivity and Clostridioides difficile-associated diarrhea (CDAD).

Administration

• Oral: Administer with water on an empty stomach (at least 4 hours after and 2 hours before the next meal). Separate administration from dairy products, antacids, or supplements containing polyvalent cations (e.g., calcium, iron, magnesium) by at least 4 hours.
• Intravenous: The 100 mg dose should be infused over 30 minutes.

Frequently Asked Questions (FAQ)

Does omadacycline require dose adjustment for kidney problems?

No, omadacycline does not require any dosage adjustment for patients with any degree of renal impairment, including those on hemodialysis.

Can I take oral omadacycline with food or milk?

No. Oral omadacycline must be taken on an empty stomach. You should wait at least 4 hours after a meal to take it and at least 2 hours before your next meal. You must also avoid taking it within 4 hours of consuming dairy, antacids, or mineral supplements.

What is the omadacycline dose for a CABP patient with severe liver disease (Child-Pugh C)?

For these patients, the IV formulation should be used. The recommended dose is 100 mg IV every 12 hours for two doses, then 100 mg IV once daily. The oral formulation has not been studied in this specific population and is not recommended.

What is the typical length of treatment with omadacycline?

The total duration of therapy for both ABSSSI and CABP is generally 7 to 14 days, as determined by the treating healthcare provider based on the patient’s clinical response.

Why is there a boxed warning for omadacycline?

The boxed warning highlights an observed increase in all-cause mortality in patients with CABP treated with omadacycline compared to moxifloxacin in a clinical trial. The risk was primarily seen in older patients with other health conditions.

How is the IV loading dose for omadacycline administered?

The loading dose consists of two 100 mg IV infusions given 12 hours apart.

What is the maintenance dose for oral omadacycline?

After the initial loading dose period (450 mg daily for 2 days), the standard oral maintenance dose is 300 mg once daily.

Can children be treated with omadacycline?

The safety and effectiveness of omadacycline in pediatric patients have not been established. Due to its classification as a tetracycline, it may cause permanent tooth discoloration and affect bone growth in children.

References

1. NUZYRA® (omadacycline) Prescribing Information. U.S. Food and Drug Administration. Revised: 01/2023.
2. NUZYRA® (omadacycline) Official Healthcare Professional Website. Paratek Pharmaceuticals, Inc.
3. Nuzyra (omadacycline) European Public Assessment Report (EPAR). European Medicines Agency.
4. Stets R, Popescu M, Gonong JR, et al. Omadacycline for Community-Acquired Bacterial Pneumonia. N Engl J Med. 2019;380(6):517-527. doi:10.1056/NEJMoa1800201