INOmax

>10%

Hypotension (13%)

Withdrawal (12%)

1-10%

Atelectasis (9%)

Hematuria (8%)

Hyperglycemia (8%)

Sepsis (7%)

Infection (6%)

Cellulitis (5%)

Stridor (5%)

Frequency Not Defined

Intracranial hemorrhage, due to platelet aggregation inhibition

Seizure

Gastrointestinal hemorrhage due to platelet aggregation inhibition

Methemoglobinemia

Hematuria due to platelet aggregation inhibition

Acute lung injury, atelectasis, hypoxemia, pulmonary edema, pulmonary hemorrhage, pulmonary toxicity due to nitrogen dioxide formation

Postmarketing Reports

Accidental exposure to nitric oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache

Pregnancy Category: C

Lactation: not known if excreted in breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of inhaled nitric oxide in newborn babies with respiratory failure.

Geriatric

Use of inhaled nitric oxide is not indicated in geriatric patients.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Riociguat

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Prilocaine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart failure or
• Lung or breathing problems—Use with caution. May increase risk for more serious side effects.

• Heart problem (eg, babies dependent on right-to-left shunt)—Should not be given to patients with this condition.

Inomax® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>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.

Dosage

Term and near-term neonates with hypoxic respiratory failure

The recommended dose of Inomax is 20 ppm. Maintain treatment up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from Inomax therapy.

Doses greater than 20 ppm are not recommended [see Warnings and Precautions (5.2)].

Administration

Training in Administration

The user of Inomax and Nitric Oxide Delivery Systems must satisfactorily complete a comprehensive periodic training program for health care professionals provided by the delivery system and drug manufacturers. Health professional staff that administers nitric oxide therapy have access to supplier-provided 24 hour/365 days per year technical support on the delivery and administration of Inomax at 1-877-566-9466.

Nitric Oxide Delivery Systems

Inomax must be administered using a calibrated Inomax DSIR® Nitric Oxide Delivery System. Only validated ventilator systems should be used in conjunction with Inomax. Consult the Nitric Oxide Delivery System label or call 1-877-566-9466/visit Inomax.com for a current list of validated systems.

Keep available a backup battery power supply and an independent reserve nitric oxide delivery system to address power and system failures.

Monitoring

Measure methemoglobin within 4-8 hours after initiation of treatment with Inomax and periodically throughout treatment [see Warnings and Precautions (5.2)].

Monitor for PaO2 and inspired NO2 during Inomax administration [see Warnings and Precautions 5.3)].

Weaning and Discontinuation

Avoid abrupt discontinuation of Inomax [see Warnings and Precautions (5.1)]. To wean Inomax, downtitrate in several steps, pausing several hours at each step to monitor for hypoxemia.

Inomax (nitric oxide) gas is available in a 800 ppm concentration.

Inomax is contraindicated in neonates dependent on right-to-left shunting of blood.

Inomax (nitric oxide gas) is a drug administered by inhalation. Nitric oxide, the active substance in Inomax, is a pulmonary vasodilator. Inomax is a gaseous blend of nitric oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm). Inomax is supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square inch gauge [psig]).

The structural formula of nitric oxide (NO) is shown below:

Rx only

Inomax®
nitric oxide
FOR
INHALATION

800 PPM

CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated
for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve
after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS.

WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under
the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and
is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and
with the hazards, contraindications and side effects and the precautions to be taken.

FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is
difficult, give oxygen. Get medical help.

RETURN WITH 25 PSIG.
TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY AUTHORIZED BY INO Therapeutics LLC

Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs).
DO NOT REMOVE THIS PRODUCT LABEL.

Store at 25°C (77°F)
[see USP Controlled Room Temperature].

Volume 1963 Liters

Mallinckrodt™
Pharmaceuticals

Manufactured by:
Mallinckrodt Manufacturing LLC
1060 Allendale Dr.
Port Allen, LA 70767 USA
For Product Inquiry 1-877-KNOW INO
(566-9466)

UN 1956
Compressed Gas, N.O.S.
(Nitric Oxide, Nitrogen)
2.2
Net Weight: 2.5 Kg

NDC 64693-002-02

MADE IN USA

Label No. SPC-LBL-0060 R8