DRUGS & SUPPLEMENTS

Primbactam

Name: Primbactam drug & pharmaceuticals. Available Forms, Doses, Prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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Primbactam uses

Indications and usage
Dosage and administration
Dosage forms and strengths
Contraindications
Warnings and precautions
Adverse reactions
Drug interactions
Use in specific populations
Overdosage
Description
Clinical pharmacology
Nonclinical toxicology
Clinical studies
References
How supplied/storage and handling
Patient counseling information
Primbactam reviews

1 INDICATIONS AND USAGE

Primbactam^® 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 Primbactam and other antibacterial drugs, Primbactam should be used only to treat patients with CF known to have Pseudomonas aeruginosa in the lungs.

Primbactam 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)

2 DOSAGE AND ADMINISTRATION

Administer one dose 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 Primbactam for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of Primbactam) reconstituted with 1 mL of sterile diluent administered 3 times a day for a 28-day course (followed by 28 days off Primbactam therapy). Dosage is not based on weight or adjusted for age. Doses should be taken at least 4 hours apart.

Primbactam is administered by inhalation using an Altera^® Nebulizer System. Patients should use a bronchodilator before administration of Primbactam.

2.2 Instructions for Primbactam Reconstitution

Primbactam should be administered immediately after reconstitution. Do not reconstitute Primbactam until ready to administer a dose.

Take one amber glass vial containing Primbactam 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 Primbactam Administration

Primbactam is administered by inhalation using an Altera Nebulizer System. Primbactam should not be administered with any other nebulizer. Primbactam should not be mixed with any other drugs in the Altera Nebulizer Handset.

Primbactam is not for intravenous or intramuscular administration.

Patients should use a bronchodilator before administration of Primbactam. Short-acting bronchodilators can be taken between 15 minutes and 4 hours prior to each dose of Primbactam. Alternatively, long-acting bronchodilators can be taken between 30 minutes and 12 hours prior to administration of Primbactam. For patients taking multiple inhaled therapies, the recommended order of administration is as follows: bronchodilator, mucolytics, and lastly, Primbactam.

To administer Primbactam, 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 Primbactam 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.

3 DOSAGE FORMS AND STRENGTHS

A dose of Primbactam consists of a single-use vial of sterile, lyophilized Primbactam (75 mg) reconstituted with a 1 mL ampule of sterile diluent (0.17% sodium chloride). Reconstituted Primbactam is administered by inhalation.

Lyophilized Primbactam (75 mg/vial) (3)
Diluent (0.17% sodium chloride): 1 mL/ampule (3)

4 CONTRAINDICATIONS

Primbactam is contraindicated in patients with a known allergy to Primbactam.

Do not administer to patients with a known allergy to Primbactam. (4)

5 WARNINGS AND PRECAUTIONS

Allergic reaction to Primbactam was seen in clinical trials. Stop treatment if an allergic reaction occurs. Use caution when Primbactam is administered to patients with a known allergic reaction to beta-lactams.
Bronchospasm has been reported with Primbactam. Stop treatment if chest tightness develops during nebulizer use. (5.2)

5.1 Allergic Reactions

Severe allergic reactions have been reported following administration of Primbactam for injection to patients with no known history of exposure to Primbactam. In addition, allergic reaction with facial rash, facial swelling, and throat tightness was reported with Primbactam in clinical trials. If an allergic reaction to Primbactam occurs, stop administration of Primbactam and initiate treatment as appropriate.

Caution is advised when administering Primbactam to patients if they have a history of beta-lactam allergy, although patients with a known beta-lactam allergy have received Primbactam in clinical trials and no severe allergic reactions were reported. A history of allergy to beta-lactam antibiotics, such as penicillins, cephalosporins, and/or carbapenems, may be a risk factor, since cross-reactivity may occur.

5.2 Bronchospasm

Bronchospasm is a complication associated with nebulized therapies, including Primbactam. Reduction of 15% or more in forced expiratory volume in 1 second immediately following administration of study medication after pretreatment with a bronchodilator was observed in 3% of patients treated with Primbactam.

5.3 Decreases in FEV₁ After 28-Day Treatment Cycle

In clinical trials, patients with increases in FEV₁ during a 28-day course of Primbactam were sometimes treated for pulmonary exacerbations when FEV₁ declined after the treatment period. Healthcare providers should consider a patient's baseline FEV₁ measured prior to Primbactam therapy and the presence of other symptoms when evaluating whether post-treatment changes in FEV₁ are caused by a pulmonary exacerbation.

5.4 Development of Drug-Resistant Bacteria

Prescribing Primbactam in the absence of known Pseudomonas aeruginosa infection in patients with CF is unlikely to provide benefit and increases the risk of development of drug-resistant bacteria.

6 ADVERSE REACTIONS

Common adverse reactions occurring more frequently in Primbactam 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 cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Primbactam 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 Primbactam 3 times a day for 28 days.

Table 1 displays adverse reactions reported in more than 5% of patients treated with Primbactam 3 times a day in placebo-controlled trials. The listed adverse reactions occurred more frequently in CAYSTON-treated patients than in placebo-treated patients.

Event (Preferred Term)	Placebo (N=160) n (%)	Primbactam 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 Primbactam 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 Primbactam. Because these events have been reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

Arthralgia, joint swelling

7 DRUG INTERACTIONS

No formal clinical studies of drug interactions with Primbactam have been conducted.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B

No reproductive toxicology studies have been conducted with Primbactam. However, studies were conducted with Primbactam for injection. Primbactam 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 Primbactam 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 Primbactam therapy.

No adequate and well-controlled studies of Primbactam for injection or Primbactam in pregnant women have been conducted. Because animal reproduction studies are not always predictive of human response, Primbactam should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers

Following administration of Primbactam for injection, Primbactam 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 Primbactam following administration of Primbactam are approximately 1% of peak concentrations observed following IV Primbactam (500 mg). Therefore, use of Primbactam 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 Primbactam. Fifty-five patients under 18 years of age received Primbactam 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 Primbactam 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

Primbactam is known to be excreted by the kidney. Placebo-controlled clinical trials with Primbactam 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 Primbactam following administration of Primbactam, clinically relevant accumulation of Primbactam is unlikely to occur in patients with renal impairment. Therefore, Primbactam may be administered to patients with mild, moderate and severe renal impairment with no dosage adjustment.

10 OVERDOSAGE

No overdoses have been reported with Primbactam in clinical trials to date. In clinical trials, 225 mg doses of Primbactam via inhalation were associated with higher rates of drug-related respiratory adverse reactions, particularly cough. Since the peak plasma concentration of Primbactam following administration of Primbactam (75 mg) is approximately 0.6 mcg/mL, compared to a serum concentration of 54 mcg/mL following administration of Primbactam for injection (500 mg), no systemic safety issues associated with Primbactam overdose are anticipated.

11 DESCRIPTION

A dose of Primbactam consists of a 2 mL amber glass vial containing lyophilized Primbactam (75 mg) and lysine (46.7 mg), and a low-density polyethylene ampule containing 1 mL sterile diluent (0.17% sodium chloride). The reconstituted solution is for inhalation. The formulation contains no preservatives or arginine.

The active ingredient in Primbactam is Primbactam, a monobactam antibacterial. The monobactams are structurally different from beta-lactam antibiotics (e.g., penicillins, cephalosporins, carbapenems) due to a monocyclic nucleus. This nucleus contains several side chains; sulfonic acid in the 1-position activates the nucleus, an aminothiazolyl oxime side chain in the 3-position confers specificity for aerobic Gram-negative bacteria including Pseudomonas spp., and a methyl group in the 4-position enhances beta-lactamase stability.

Primbactam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. The structural formula is presented below:

Primbactam is a white to off-white powder. Primbactam is sterile, hygroscopic, and light sensitive. Once reconstituted with the supplied diluent, the pH range is 4.5 to 6.0.

Chemical Structure Figure 1

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Primbactam is an antibacterial drug [see Clinical Pharmacology ].

12.3 Pharmacokinetics

Sputum Concentrations

Sputum Primbactam concentrations exhibited considerable variability between patients receiving Primbactam (75 mg) in clinical trials. The mean sputum concentration 10 minutes following the first dose of Primbactam (n = 195 patients with CF) was 726 mcg/g. Mean sputum concentrations of Primbactam in patients receiving Primbactam 3 times a day for 28 days were 984 mcg/g, 793 mcg/g, and 715 mcg/g 10 minutes after dose administration on Days 0, 14, and 28, respectively, indicating no accumulation of Primbactam in sputum.

Plasma Concentrations

Plasma Primbactam concentrations exhibited considerable variability between patients receiving Primbactam (75 mg) in the clinical trials. The mean plasma concentration one hour following the first dose of Primbactam (at approximately the peak plasma concentration) was 0.59 mcg/mL. Mean peak plasma concentrations in patients receiving Primbactam 3 times a day for 28 days were 0.55 mcg/mL, 0.67 mcg/mL, and 0.65 mcg/mL on Days 0, 14, and 28, respectively, indicating no systemic accumulation of Primbactam. In contrast, the serum concentration of Primbactam following administration of Primbactam for injection (500 mg) is approximately 54 mcg/mL.

Absorption

Evaluation of plasma and urine Primbactam concentrations following administration of Primbactam indicates low systemic absorption of Primbactam. Approximately 10% of the total Primbactam dose is excreted in the urine as unchanged drug, as compared to 60–65% following intravenous administration of Primbactam for injection.

Distribution

The protein binding of Primbactam in serum is approximately 56% and is independent of dose.

Metabolism

Following intramuscular administration of Primbactam for injection 500 mg every 8 hours for 7 days, approximately 6% of the dose was excreted as a microbiologically inactive open β-lactam ring hydrolysis product in an 8-hour urine collection on the last day of multiple dosing.

Excretion

The elimination half-life of Primbactam from plasma is approximately 2.1 hours following administration of Primbactam to adult patients with CF, similar to what has been reported for Primbactam for injection. Approximately 10% of the total Primbactam dose is excreted in the urine as unchanged drug. Systemically absorbed Primbactam is eliminated about equally by active tubular secretion and glomerular filtration. Following administration of a single intravenous dose of radiolabeled Primbactam for injection, about 12% of the dose was recovered in the feces.

12.4 Microbiology

Mechanism of Action

Primbactam exhibits activity in vitro against Gram-negative aerobic pathogens including P. aeruginosa. Primbactam binds to penicillin-binding proteins of susceptible bacteria, which leads to inhibition of bacterial cell wall synthesis and death of the cell. Primbactam activity is not decreased in the presence of CF lung secretions.

Susceptibility Testing

A single sputum sample from a patient with CF may contain multiple morphotypes of P. aeruginosa and each morphotype may have a different level of in vitro susceptibility to Primbactam. There are no in vitro susceptibility test interpretive criteria for isolates of P. aeruginosa obtained from the sputum of CF patients.¹

Development of Resistance

No changes in the susceptibility of P. aeruginosa to Primbactam were observed following a 28-day course of Primbactam in the placebo-controlled trials.

Cross-Resistance

No cross-resistance to other classes of antibiotics, including aminoglycosides, quinolones, and beta-lactams, was observed following a 28-day course of Primbactam in the Phase 3 placebo-controlled trials or in an open-label follow-on trial of up to nine 28-day courses of 75 mg Primbactam 3 times a day.

Other

No trends in the treatment-emergent isolation of other bacterial respiratory pathogens (Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans, and Staphylococcus aureus) were observed in clinical trials. There was a slight increase in the isolation of Candida spp. following up to nine 28-day courses of Primbactam therapy.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

A 104-week rat inhalation toxicology study to assess the carcinogenic potential of Primbactam demonstrated no drug-related increase in the incidence of tumors. Rats were exposed to Primbactam for up to 4 hours per day. Peak plasma levels of Primbactam averaging approximately 6.8 mcg/mL were measured in rats at the highest dose level. This is approximately 12-fold higher than the average peak plasma level measured in humans following Primbactam therapy.

Genetic toxicology studies performed in vitro demonstrated that Primbactam did not induce structural chromosome aberrations in CHO cells and did not induce mutations at the TK locus in mouse lymphoma L5178Y TK^+/- cells. Likewise, genetic toxicology studies performed in vivo did not reveal evidence of mutagenic potential.

Primbactam did not impair the fertility of rats when administered at doses that would provide systemic exposures far in excess of peak plasma levels measured in humans following Primbactam therapy.

14 CLINICAL STUDIES

Primbactam was evaluated over a period of 28 days of treatment in a randomized, double-blind, placebo-controlled, multicenter trial that enrolled patients with CF and P. aeruginosa. This trial was designed to evaluate improvement in respiratory symptoms. Patients 7 years of age and older and with FEV₁ of 25% to 75% predicted were enrolled. All patients received Primbactam or placebo on an outpatient basis administered with the Altera Nebulizer System. All patients were required to take a dose of an inhaled bronchodilator (beta-agonist) prior to taking a dose of Primbactam or placebo. Patients were receiving standard care for CF, including drugs for obstructive airway diseases.

The trial enrolled 164 patients with CF and P. aeruginosa. The mean age was 30 years, and the mean baseline FEV₁% predicted was 55%; 43% were females and 96% were Caucasian. These patients were randomized in a 1:1 ratio to receive either Primbactam (75 mg) or volume-matched placebo administered by inhalation 3 times a day for 28 days. Patients were required to have been off antibiotics for at least 28 days before treatment with study drug. The primary efficacy endpoint was improvement in respiratory symptoms on the last day of treatment with Primbactam or placebo. Respiratory symptoms were also assessed two weeks after the completion of treatment with Primbactam or placebo. Changes in respiratory symptoms were assessed using a questionnaire that asks patients to report on symptoms like cough, wheezing, and sputum production.

Improvement in respiratory symptoms was noted for CAYSTON-treated patients relative to placebo-treated patients on the last day of drug treatment. Statistically significant improvements were seen in both adult and pediatric patients, but were substantially smaller in adult patients. Two weeks after completion of treatment, a difference in respiratory symptoms between treatment groups was still present, though the difference was smaller.

Pulmonary function, as measured by FEV₁ (L), increased from baseline in patients treated with Primbactam. The treatment difference at Day 28 between CAYSTON-treated and placebo-treated patients for percent change in FEV₁ (L) was statistically significant at 10% (95% CI: 6%, 14%). Improvements in FEV₁ were comparable between adult and pediatric patients. Two weeks after completion of drug treatment, the difference in FEV₁ between Primbactam and placebo groups had decreased to 6% (95% CI: 2%, 9%).

Figure 1 Adjusted Mean Percent Change in FEV₁ from Baseline to Study End (Days 0–42)

15 REFERENCES

Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically-Eighth Edition; Approved Standard. CLSI Document M7-A8. CLSI, Wayne, PA 19087. January, 2009.

16 HOW SUPPLIED/STORAGE AND HANDLING

Each kit for a 28-day course of Primbactam contains 84 sterile vials of Primbactam and 88 ampules of sterile diluent packed in 2 cartons, each carton containing a 14-day supply. The four additional diluent ampules are provided in case of spillage.

Package Configuration	Dosage Strength	NDC
28-Day Kit	75 mg	61958-0901-1

Primbactam 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, Primbactam and diluent may be stored at room temperature (up to 25 °C / 77 °F) for up to 28 days. Do not separate the Primbactam vials from the diluent ampules. Primbactam should be protected from light.

Do not use Primbactam if it has been stored at room temperature for more than 28 days. Do not use Primbactam beyond the expiration date stamped on the vial. Do not use diluent beyond the expiration date embossed on the ampule.

Primbactam should be used immediately upon reconstitution. Do not reconstitute more than one dose at a time.

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

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling

Patients should be advised that Primbactam is for inhalation use only and that Primbactam should only be administered using the Altera Nebulizer System. Patients should be instructed only to reconstitute Primbactam with the provided diluent and not mix other drugs with Primbactam in the Altera Nebulizer System.

Patients should be advised to complete the full 28-day course of Primbactam even if they are feeling better. Inform the patient that if they miss a dose, they should take all 3 daily doses as long as the doses are at least 4 hours apart.

Patients should be advised to use a bronchodilator prior to administration of Primbactam. Patients taking several inhaled medications should be advised to use the medications in the following order of administration: bronchodilator, mucolytics, and lastly, Primbactam.

Patients should be advised to tell their doctor if they have new or worsening symptoms. Patients who believe they are experiencing an allergic reaction to Primbactam should be advised to contact their doctor immediately.

Patients should be counseled that antibacterial drugs including Primbactam should only be used to treat bacterial infections. They do not treat viral infection (e.g., the common cold). When Primbactam is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Primbactam or other antibacterial drugs in the future.

Figure 1 Figure 2, 3, 4, 5 Figure 6 Figure 7, 8 Figure 9

Manufactured by: Gilead Sciences, Inc., Foster City, CA 94404

Primbactam is a trademark of Gilead Sciences, Inc. All other trademarks referenced herein are the property of their respective owners.

50-814-GS-002

FDA-Approved Patient Labeling

PATIENT INFORMATION

Primbactam^® (kay-stun)

(aztreonam for inhalation solution)

Read this Patient Information before you start taking Primbactam and each time you get a refill. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is Primbactam?

Primbactam is a prescription inhaled antibiotic. Primbactam is used to improve breathing symptoms in people with cystic fibrosis (CF) who have Pseudomonas aeruginosa (P. aeruginosa) in their lungs.

Primbactam is only for infections caused by bacteria. It is not for infections caused by viruses, such as the common cold.

Primbactam is used only with the Altera^® Nebulizer System.

It is not known if Primbactam is safe and effective in children under the age of 7.

Who should not take Primbactam?

Do not take Primbactam if you are allergic to Primbactam (AZACTAM^®).

What should I tell my doctor before taking Primbactam?

Before taking Primbactam, tell your doctor if you:

are allergic to any antibiotics.
are pregnant or plan to become pregnant.
are breast-feeding or plan to breast feed. Talk to your doctor about the best way to breast feed your baby if you take Primbactam.

Tell your doctor about all the medicine you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Primbactam?

Take Primbactam exactly as prescribed by your doctor.
The dose of Primbactam for both adults and children 7 years of age and older is one vial of Primbactam, mixed with one ampule of saline (diluent) 3 times a day.
Doses of Primbactam should be taken at least 4 hours apart (for example: morning, after school, and before bed).
Primbactam should be taken for 28 days.
Primbactam is taken as a breathing treatment (inhalation) with the Altera Nebulizer System. Do not use any other nebulizer for your Primbactam treatment.
You should use an inhaled bronchodilator (a type of medicine used to relax and open your airways) before taking a dose of Primbactam. If you do not have an inhaled bronchodilator, ask your doctor to prescribe one for you.
If you are taking several medicines or treatments to treat your cystic fibrosis, you should take your medicines or other treatments in this order:
- bronchodilator
- mucolytics (medicines to help clear mucus from your lungs)
- Primbactam
You should take Primbactam as prescribed, in courses of 28 days on Primbactam, followed by at least 28 days off Primbactam, as directed by your doctor.
Do not mix Primbactam with any other medicines in your Altera Nebulizer System.
Do not mix Primbactam with the saline until right before you are ready to use it. Do not mix more than one dose of Primbactam at a time.
Each treatment should take about 2 to 3 minutes.
If you miss a dose of Primbactam, you can still take all 3 daily doses as long as they are at least 4 hours apart.
It is important for you to finish taking the full 28-day course of Primbactam even if you are feeling better. If you skip doses or do not finish the full 28-day course of Primbactam, your infection may not be fully treated and Primbactam may not work as well as a treatment for infections in the future.
See the end of this Patient Information leaflet for the Patient Instructions for Use on how to take Primbactam the right way.

What are the possible side effects of Primbactam?

Primbactam can cause serious side effects, including:

Severe allergic reactions. Stop your treatment with Primbactam and call your doctor right away if you have any symptoms of an allergic reaction, including:
- Rash or swelling of your face
- Throat tightness
Trouble breathing right after treatment with Primbactam (bronchospasm). To decrease the chance of this happening, be sure to use your inhaled bronchodilator medicine before each treatment with Primbactam. See "How should I take Primbactam?"

Common side effects of Primbactam include:

Cough
Nasal congestion
Wheezing
Sore throat
Fever. Fever may be more common in children than in adults.
Chest discomfort
Stomach area (abdominal) pain
Vomiting

Other possible side effects of Primbactam include:

Swelling or pain of joints

Tell your doctor if you have any new or worsening symptoms while taking Primbactam. Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of Primbactam. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Primbactam?

Each Primbactam kit contains enough vials of Primbactam and ampules of saline for 28 days of treatment. There are 4 extra saline ampules in case some saline spills.
Always keep your Primbactam and saline together.
Store Primbactam and saline in the refrigerator at 36 °F to 46°F (2 °C to 8 °C) until needed.
When you remove Primbactam and saline from the refrigerator, they may be stored at room temperature (less than 77 °F) for up to 28 days. Do not use any Primbactam that has been stored at room temperature for more than 28 days.
Keep Primbactam away from light.
Do not use Primbactam after the expiration date on the vial. Do not use the saline after the expiration date on the ampule.

Keep Primbactam and all medicines out of the reach of children.

General information about Primbactam

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Primbactam for a condition for which it was not prescribed. Do not give Primbactam to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Primbactam. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Primbactam that is written for health professionals.

For more information, call 1-877-7CAYSTON (1-877-722-9786).

What are the ingredients in Primbactam?

Active ingredient: Primbactam

Inactive ingredient: lysine, sodium chloride (diluent)

PATIENT INSTRUCTIONS FOR USE

Primbactam^®

(aztreonam for inhalation solution)

Be sure that you read, understand and follow the Patient Instructions for Use below for the right way to take Primbactam. If you have any questions, ask your doctor or pharmacist.

You will need the following supplies (Figure 1):

1 amber colored Primbactam vial covered by a metal seal with a blue cap or a metal seal only
1 ampule of saline (diluent)
Altera Nebulizer System

Check to make sure that your Altera Nebulizer System works properly before starting your treatment with Primbactam. See the manufacturer's instructions for use that comes with your Altera Nebulizer System. This should have complete information about how to put together (assemble), prepare, use, and care for your Altera Nebulizer System.

Step 1 Preparing your Primbactam for inhalation

Mix (reconstitute) Primbactam with the saline only when ready to take a dose. Take one amber vial of Primbactam and one ampule of saline from the carton. Separate the saline ampules by gently pulling apart.
Look at the ampule of saline. If it looks cloudy do not use it. Throw away this ampule and get another ampule of saline.
Gently tap the vial so that the powder settles to the bottom of the vial. This helps you get the proper dose of medicine. Open the amber drug vial by lifting up the metal flap or blue cap on the top (Figure 2) and pulling down (Figure 3) to carefully remove the entire metal ring from the vial (Figure 4). Safely dispose of the ring in household garbage. Carefully remove the rubber stopper (Figure 5).
Open the ampule of saline by twisting off the tip. Squeeze out the contents completely into the vial (Figure 6). Next, close the vial with the rubber stopper and gently swirl the vial until the powder has completely dissolved and the liquid is clear.
After mixing Primbactam with the saline, check to make sure the diluted medicine is clear. If it is cloudy or has particles in it, do not use this medicine. Throw away this dose of medicine and start over again with a new vial of Primbactam and a new ampule of saline.
Use Primbactam right away after you mix with the saline.

Step 2 Taking your Primbactam treatment

See the manufacturer's instructions for use that comes with your Altera Nebulizer System for complete instructions on taking a treatment, and how to clean and disinfect your Altera Nebulizer Handset.

Make sure the handset is on a flat, stable surface.
Remove the rubber stopper from the vial, then pour all of the mixed Primbactam and saline into the Medication Reservoir of the handset (Figure 7). Be sure to completely empty the vial, gently tapping the vial against the side of the Medication Reservoir if necessary. Close the Medication Reservoir (Figure 8).
Begin your treatment by sitting in a relaxed, upright position. Hold the handset level, and place the Mouthpiece in your mouth. Close your lips around the Mouthpiece (Figure 9).
Breathe in and out normally (inhale and exhale) through the Mouthpiece. Avoid breathing through your nose. Continue to inhale and exhale comfortably until the treatment is finished.
The empty vial, stopper and saline ampule should be disposed of in household garbage upon completion of dosing.

Manufactured by: Gilead Sciences, Inc., Foster City, CA 94404

Primbactam is a trademark of Gilead Sciences, Inc. All other trademarks referenced herein are the property of their respective owners.

50-814-GS-002

Principal Display Panel - Primbactam 28 Day Carton - Representative Label

NDC 61958-0901-1

GILEAD

Primbactam ^®

(aztreonam for

inhalation solution)

75 mg/vial

For Oral Inhalation Only

Store Refrigerated, 2 °C to 8 °C (36 °F to 46 °F)

Contains:

84 Single-Use Vials of Primbactam for Inhalation Solution

88 Diluent Ampules of Sodium Chloride 0.17%, 1 mL

(4 extra ampules provided in case of spillage)

For use only with the Altera^® Nebulizer System

28-Day Supply

R_x only

Primbactam pharmaceutical active ingredients containing related brand and generic drugs:

Aztreonam

Primbactam available forms, composition, doses:

Primbactam destination | category:

Human:
Beta-Lactams
Monobactams

Primbactam Anatomical Therapeutic Chemical codes:

J01DF01 - Aztreonam

Primbactam pharmaceutical companies:

Menarini

References

Dailymed."CAYSTON (AZTREONAM) KIT [GILEAD SCIENCES, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
Dailymed."AZTREONAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"aztreonam". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Primbactam?

Depending on the reaction of the Primbactam after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Primbactam not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Primbactam addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Primbactam, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Primbactam consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.