Genosyl

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 2/15/2022
Genosyl Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Genosyl?

Genosyl (nitric oxide) is a vasodilator used to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (greater than 34 weeks' gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

What Are Side Effects of Genosyl?

Side effects of Genosyl include:

Dosage for Genosyl

The recommended dose of Genosyl is 20ppm, maintained for up to 14 days or until the underlying oxygen desaturation has resolved.

Genosyl In Children

The safety and efficacy of Genosyl for inhalation has been demonstrated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension. Additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy. No information about its effectiveness in other age populations is available.

What Drugs, Substances, or Supplements Interact with Genosyl?

Genosyl may interact with other medicines such as:

  • prilocaine,
  • sodium nitroprusside, and
  • nitroglycerine

Tell your doctor all medications and supplements you use.

Genosyl During Pregnancy and Breastfeeding

Genosyl is not indicated for use in the adult population so is unlikely to be used in pregnant or breastfeeding women. Consult your doctor.

Additional Information

Our Genosyl (nitric oxide), for Inhalation Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Genosyl Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in the label;

Hypoxemia [see WARNINGS AND PRECAUTIONS]

Worsening Heart Failure [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Controlled studies have included 325 patients on nitric oxide doses of 5 to 80 ppm and 251 patients on placebo. Total mortality in the pooled trials was 11% on placebo and 9% on nitric oxide gas for inhalation, a result adequate to exclude nitric oxide mortality being more than 40% worse than placebo.

In both the NINOS and CINRGI studies, the duration of hospitalization was similar in nitric oxide gas for inhalation and placebo-treated groups.

From all controlled studies, at least 6 months of follow-up is available for 278 patients who received nitric oxide gas and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment on the need for re-hospitalization, special medical services, pulmonary disease, and neurological sequelae.

In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.

In CINRGI, the only adverse reaction (>2% higher incidence on nitric oxide gas for inhalation than on placebo) was hypotension (14% vs. 11%).

Postmarketing Experience

Post marketing reports of accidental exposure to nitric oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache.

Read the entire FDA prescribing information for Genosyl (Nitric Oxide for Inhalation Use)

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© Genosyl Patient Information is supplied by Cerner Multum, Inc. and Genosyl Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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