Data from FDA - Curated by EPG Health - Last updated 06 July 2018

Indication(s)

1 INDICATIONS AND USAGE CAYSTON® is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa.

Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV1 <25 % or >75 % predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CAYSTON and other antibacterial drugs, CAYSTON should be used only to treat patients with CF known to have Pseudomonas aeruginosa in the lungs.

CAYSTON is a monobactam antibacterial indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa.

Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV1 <25 % or >75 % predicted, or patients colonized with Burkholderia cepacia.

(1)

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Advisory information

contraindications
4 CONTRAINDICATIONS CAYSTON is contraindicated in patients with a known allergy to aztreonam. Do not administer to patients with a known allergy to aztreonam. (4)
Adverse reactions

6 ADVERSE REACTIONS Common adverse reactions (more than 5 %) occurring more frequently in CAYSTON patients are cough, nasal congestion, wheezing, pharyngolaryngeal pain, pyrexia, chest discomfort, abdominal pain and vomiting.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD5, option 3 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drugs can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of CAYSTON was evaluated in 344 patients from two placebo-controlled trials and one open-label follow-on trial.

In controlled trials, 146 patients with CF received 75 mg CAYSTON 3 times a day for 28 days.

Table 1 displays adverse reactions reported in more than 5 % of patients treated with

CAYSTON 3 times a day in placebo-controlled trials.

The listed adverse reactions occurred more frequently in CAYSTON-treated patients than in placebo-treated patients.

Table 1 Adverse Reactions Reported in more than 5 % of Patients Treated with CAYSTON in the Placebo-Controlled Trials Event (Preferred Term) Placebo (N=160) n (%) CAYSTON 75 mg 3 times a day (N=146) n (%) Cough 82 (51 %) 79 (54 %) Nasal congestion 19 (12 %) 23 (16 %) Wheezing 16 (10 %) 23 (16 %) Pharyngolaryngeal pain 17 (11 %) 18 (12 %) Pyrexia 9 (6 %) 19 (13 %) Chest discomfort 10 (6 %) 11 (8 %) Abdominal Pain 8 (5 %) 10 (7 %) Vomiting 7 (4 %) 9 (6 %) Adverse reactions that occurred in less than 5 % of patients treated with CAYSTON were bronchospasm (3 %) [see Warnings and Precautions (5.2)] and rash (2 %).

6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following possible adverse reactions have been identified during post-approval use of CAYSTON.

Because these events have been reported voluntarily from a population of unknown size, estimates of frequency can not be made.

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Arthralgia, joint swelling

Usage information

Dosing and administration

2 DOSAGE AND ADMINISTRATION Administer one dose (one single use vial and one ampule of diluent) 3 times a day for 28 days.

(2.1) Use dose immediately after reconstitution.

(2.2) Administer only with the Altera® Nebulizer System.

Do not administer with any other type of nebulizer.

(2.3) 2.1 Dosing Information The recommended dose of CAYSTON for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of aztreonam) reconstituted with 1 mL of sterile diluent administered 3 times a day for a 28-day course (followed by 28 days off CAYSTON therapy).

Dosage is not based on weight or adjusted for age.

Doses should be taken at least 4 hours apart.

CAYSTON is administered by inhalation using an Altera® Nebulizer System.

Patients should use a bronchodilator before administration of CAYSTON. 2.2 Instructions for CAYSTON Reconstitution CAYSTON should be administered immediately after reconstitution.

Do not reconstitute CAYSTON until ready to administer a dose.

Take one amber glass vial containing CAYSTON and one diluent ampule from the carton.

To open the glass vial, carefully remove the metal ring by lifting or pulling the tab and remove the gray rubber stopper.

Twist the tip off the diluent ampule and squeeze the liquid into the glass vial.

Replace the rubber stopper, then gently swirl the vial until contents have completely dissolved.

The empty vial, stopper, and diluent ampule should be disposed of properly upon completion of dosing.

2.3 Instructions for CAYSTON Administration CAYSTON is administered by inhalation using an Altera Nebulizer System.

CAYSTON should not be administered with any other nebulizer.

CAYSTON should not be mixed with any other drugs in the Altera Nebulizer Handset.

CAYSTON is not for intravenous or intramuscular administration.

Patients should use a bronchodilator before administration of CAYSTON. Short-acting bronchodilators can be taken between 15 minutes and 4 hours prior to each dose of CAYSTON.

Alternatively, long-acting bronchodilators can be taken between 30 minutes and 12 hours prior to administration of CAYSTON.

For patients taking multiple inhaled therapies, the recommended order of administration is as follows:

bronchodilator, mucolytics, and lastly, CAYSTON.

To administer CAYSTON, pour the reconstituted solution into the handset of the nebulizer system.

Turn the unit on.

Place the mouthpiece of the handset in your mouth and breathe normally only through your mouth.

Administration typically takes between 2 and 3 minutes.

Further patient instructions on how to administer CAYSTON are provided in the FDA-approved patient labeling.

Instructions on testing nebulizer functionality and cleaning the handset are provided in the Instructions for Use included with the nebulizer system.

Use in special populations

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B No reproductive toxicology studies have been conducted with CAYSTON.

However, studies were conducted with aztreonam for injection.

Aztreonam has been shown to cross the placenta and enter fetal circulation.

No evidence of embryo or fetotoxicity or teratogenicity has been shown in studies with pregnant rats and rabbits.

In rats receiving aztreonam for injection during late gestation and lactation, no drug induced changes in maternal, fetal or neonatal parameters were observed.

These animal reproduction and developmental toxicity studies used parenteral routes of administration that would provide systemic exposures far in excess of the average peak plasma levels measured in humans following CAYSTON therapy.

No adequate and well-controlled studies of aztreonam for injection or CAYSTON in pregnant women have been conducted.

Because animal reproduction studies are not always predictive of human response, CAYSTON should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers Following administration of aztreonam for injection, aztreonam is excreted in human milk at concentrations that are less than one percent of those determined in simultaneously obtained maternal serum.

Peak plasma concentrations of aztreonam following administration of CAYSTON (75 mg) are approximately 1 % of peak concentrations observed following IV aztreonam (500 mg).

Therefore, use of CAYSTON during breastfeeding is unlikely to pose a risk to infants.

8.4 Pediatric Use Patients 7 years and older were included in clinical trials with CAYSTON. Fifty-five patients under 18 years of age received CAYSTON in placebo-controlled trials.

No dose adjustments were made for pediatric patients.

Pyrexia was more commonly reported in pediatric patients than in adult patients.

Safety and effectiveness in pediatric patients below the age of 7 years have not been established.

8.5 Geriatric Use Clinical trials of CAYSTON did not include CAYSTON-treated patients aged 65 years of age and older to determine whether they respond differently from younger patients.

8.6 Use in Patients with Renal Impairment Aztreonam is known to be excreted by the kidney.

Placebo-controlled clinical trials with CAYSTON excluded patients with abnormal baseline renal function (defined as serum creatinine greater than 2 times the upper limit of normal range).

Given the low systemic exposure of aztreonam following administration of CAYSTON, clinically relevant accumulation of aztreonam is unlikely to occur in patients with renal impairment.

Therefore, CAYSTON may be administered to patients with mild, moderate and severe renal impairment with no dosage adjustment.

Pregnancy and lactation

8.3 Nursing Mothers Following administration of aztreonam for injection, aztreonam is excreted in human milk at concentrations that are less than one percent of those determined in simultaneously obtained maternal serum.

Peak plasma concentrations of aztreonam following administration of CAYSTON (75 mg) are approximately 1 % of peak concentrations observed following IV aztreonam (500 mg).

Therefore, use of CAYSTON during breastfeeding is unlikely to pose a risk to infants.

Interactions

7 DRUG INTERACTIONS No formal clinical studies of drug interactions with CAYSTON have been conducted.

More information

Category Value
Authorisation number NDA050814
Orphan designation No
Product NDC 61958-0901
Date Last Revised 29-05-2014
Type HUMAN PRESCRIPTION DRUG
RXCUI 901614
Storage and handling

CAYSTON vials and diluent ampules should be stored in the refrigerator at 2 °C to 8 °C (36 °F to 46 °F) until needed.

Once removed from the refrigerator, CAYSTON and diluent may be stored at room temperature (up to 25 °C/77 °F) for up to 28 days.

Do not separate the CAYSTON vials from the diluent ampules.

CAYSTON should be protected from light.

Do not use CAYSTON if it has been stored at room temperature for more than 28 days.

Do not use CAYSTON beyond the expiration date stamped on the vial.

Do not use diluent beyond the expiration date embossed on the ampule.

CAYSTON should be used immediately upon reconstitution.

Do not reconstitute more than one dose at a time.

Do not use diluent or reconstituted CAYSTON if it is cloudy or if there are particles in the solution.

Marketing authorisation holder Gilead Sciences, Inc.