NUZYRA (omadacycline tosylate)

There are 0 contraindications.

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Clostridioides difficile infection
Idiopathic intracranial hypertension
Pregnancy

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Azotemia

There are 14 severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests Increased alanine transaminase Increased aspartate transaminase	Anemia Atrial fibrillation Elevated serum lipase Hyperbilirubinemia Hypersensitivity drug reaction Thrombocytosis

Rare/Very Rare
Acute eruptions of skin Acute pancreatitis Anaphylaxis Clostridioides difficile infection Idiopathic intracranial hypertension

There are 23 less severe adverse reactions.

More Frequent	Less Frequent
Constipation Diarrhea Headache disorder Hypertension Injection site sequelae Insomnia Nausea Vomiting	Acute abdominal pain Dysgeusia Dyspepsia Erythema Fatigue Hyperhidrosis Lethargy Oral candidiasis Pain in oropharynx Pruritus of skin Tachycardia Urticaria Vertigo Vulvovaginal candidiasis

Rare/Very Rare
Skin photosensitivity

The manufacturer recommends that women of childbearing potential use an effective form of contraception while receiving omadacycline. Omadacycline, like other tetracyclines, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth if administered during the second or third trimester of pregnancy. There are insufficient data on the use of omadacycline in pregnant women to inform a drug-associated risk of major birth defects and miscarriages.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and may have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity also has been noted in animals that received tetracyclines early in pregnancy. In rats and rabbits, use of omadacycline during the period of organogenesis resulted in fetal loss and/or congenital malformations at dosages resulting in area under the plasma concentration-time curve (AUC) exposures 7 and 3 times higher, respectively, than clinical exposures reported with IV doses of 100 mg or oral doses of 300 mg.

Reduced fetal weight occurred in rats at all administered doses. In a fertility study in rats, use of omadacycline during mating and early pregnancy resulted in embryo loss at a dosage of 20 mg/kg daily and systemic exposures approximately equal to clinical exposures. Omadacycline has caused tooth discoloration in rats. Patients should be advised of potential risks to the fetus if omadacycline is used during the second or third trimester of pregnancy.

It is not known if omadacycline is distributed into human milk, affects the breast-fed infant, or affects milk production. Tetracyclines are distributed into human milk; however, the extent of absorption of tetracyclines, including omadacycline, by the breast-fed infant is not known. Because other antibacterial options are available to treat community-acquired pneumonia and skin and skin structure infections in lactating women and because of the potential for serious adverse effects in the breast-fed infant, breast-feeding isnot recommended during omadacycline treatment and for 4 days after the last dose of the drug.

Of the total number of patients who received omadacycline in phase 3 clinical trials, 18.6% were 65 years of age or older, including 8.6% who were 75 years of age or older.

In the clinical trial evaluating omadacycline in adults with community-acquired bacterial pneumonia, the clinical success rate at the early clinical response time point in patients 65 years of age or older (75.5 or 78.7% in those treated with omadacycline or moxifloxacin, respectively) was lower than that reported in patients younger than 65 years of age (85.2 or 86.3%, respectively). All deaths in this study occurred in patients older than 65 years of age. No substantial difference in omadacycline exposures were observed between healthy geriatric individuals and younger adults following a single 100-mg IV dose of omadacycline. Dosage adjustments based on age are not necessary.