Astepro Side Effects

Please note - some side effects for Astepro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Astepro - for the Consumer

Astepro Spray

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Astepro Spray:

Bitter taste; drowsiness; fatigue; headache; mild nasal bleeding, burning, discomfort, or stinging; sudden sneezing attack.

Seek medical attention right away if any of these SEVERE side effects occur when using Astepro Spray:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); repeated or persistent nosebleeds; severe nasal irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Astepro Side Effects - for the Professional

Astepro

Use of Astepro Nasal Spray has been associated with somnolence [see Warnings and Precautions (5.1)].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.

Astepro Nasal Spray 0.1%
The safety data described below reflect exposure to Astepro Nasal Spray 0.1% in 713 patients 12 years of age and older from 2 clinical trials of 2 weeks to 12 months duration. In a 2-week, double-blind, placebo-controlled, and active-controlled (Astelin® Nasal Spray; azelastine hydrochloride) clinical trial, 285 patients (115 males and 170 females) 12 years of age and older with seasonal allergic rhinitis were treated with Astepro Nasal Spray 0.1% one or two sprays per nostril daily. In the 12 month open-label, active-controlled (Astelin Nasal Spray) clinical trial, 428 patients (207 males and 221 females) 12 years of age and older with perennial allergic rhinitis and/or nonallergic rhinitis were treated with Astepro Nasal Spray 0.1% two sprays per nostril twice daily. The racial and ethnic distribution for the 2 clinical trials was 82% white, 8% black, 6% Hispanic, 3% Asian, and <1% other.

Adults and Adolescents 12 Years of Age and Older
In the two week clinical trial, 835 patients 12 years of age and older with seasonal allergic rhinitis were treated with one of six treatments: one spray per nostril of either Astepro Nasal Spray 0.1%, Astelin Nasal Spray or placebo twice daily; or 2 sprays per nostril of Astepro Nasal Spray 0.1%, Astelin Nasal Spray, or placebo twice daily. Overall, adverse reactions were more common in the Astepro Nasal Spray 0.1% treatment groups (21-28%) than in the placebo groups (16-20%). Overall, less than 1% of patients discontinued due to adverse reactions and withdrawal due to adverse reactions was similar among the treatment groups.

Table 1 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with Astepro Nasal Spray 0.1% in the controlled clinical trial described above.

Table 1. Adverse Reactions Reported in ≥2% Incidence in a Placebo-Controlled Trial of 2 Weeks’ Duration with Astepro Nasal Spray 0.1% in Adult and Adolescent Patients with Seasonal Allergic Rhinitis

	1 spray twice daily			2 sprays twice daily
	Astepro Nasal Spray 0.1% (N=139)	Astelin Nasal Spray (N=137)	Vehicle Placebo (N=137)	Astepro Nasal Spray 0.1% (N=146)	Astelin Nasal Spray (N=137)	Vehicle Placebo (N=138)
Bitter Taste	8 (6%)	13 (10%)	2 (2%)	10 (7%)	11 (8%)	3 (2%)
Epistaxis	3 (2%)	8 (6%)	3 (2%)	4 (3%)	3 (2%)	0 (0%)
Headache	2 (1%)	5 (4%)	1 (<1%)	4 (3%)	3 (2%)	1 (<1%)
Nasal Discomfort	0 (0%)	3 (2%)	1 (<1%)	2 (1%)	6 (4%)	0 (0%)
Fatigue	0 (0%)	1 (<1%)	1 (<1%)	3 (2%)	3 (2%)	1 (<1%)
Somnolence	2 (1%)	2 (2%)	0 (0%)	3 (2%)	2 (1%)	0 (0%)

Long-Term (12 Month) Safety Trial:
In the 12 month, open-label, active-controlled, long-term safety trial, 862 patients 12 years of age and older with perennial allergic and/or nonallergic rhinitis were treated with Astepro Nasal Spray 0.1% two sprays per nostril twice daily or Astelin Nasal Spray two sprays per nostril twice daily. The most frequently reported adverse reactions were headache, bitter taste, epistaxis, and nasopharyngitis and were generally similar between treatment groups. Focused nasal examinations were performed and showed that the incidence of nasal mucosal ulceration in each treatment group was approximately 1% at baseline and approximately 1.5% throughout the 12 month treatment period. In each treatment group, 5-7% of patients had mild epistaxis. No patients had reports of nasal septal perforation or severe epistaxis. Twenty-two patients (5%) treated with Astepro Nasal Spray 0.1% and 17 patients (4%) treated with Astelin Nasal Spray discontinued from the trial due to adverse events.

Astepro Nasal Spray 0.15%
The safety data described below reflect exposure to Astepro Nasal Spray 0.15% in 1858 patients (12 years of age and older) with seasonal or perennial allergic rhinitis from 8 clinical trials of 2 weeks to 12 months duration. In 7 double-blind, placebo-controlled clinical trials of 2 to 4 weeks duration, 1544 patients (560 males and 984 females) with seasonal or perennial allergic rhinitis were treated with Astepro Nasal Spray 0.15% two sprays per nostril once or twice daily. In the 12 month open-label, active-controlled clinical trial, 466 patients (156 males and 310 females) with perennial allergic rhinitis were treated with Astepro Nasal Spray 0.15% two sprays per nostril twice daily. Of these 466 patients, 152 had participated in the 4-week placebo-controlled perennial allergic rhinitis clinical trials. The racial distribution for the 8 clinical trials was 80% white, 13% black, 2% Asian, and 5% other.

Adults and Adolescents 12 Years of Age and Older
In the 7 placebo controlled clinical trials of 2 to 4 week duration, 2343 patients with seasonal allergic rhinitis and 540 patients with perennial allergic rhinitis were treated with two sprays per nostril of either Astepro Nasal Spray 0.15% or placebo once or twice daily. Overall, adverse reactions were more common in the Astepro Nasal Spray 0.15% treatment groups (16-31%) than in the placebo groups (11-24%). Overall, less than 2% of patients discontinued due to adverse reactions and withdrawal due to adverse reactions was similar among the treatment groups.

Table 2 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with Astepro Nasal Spray 0.15% in the seasonal and perennial allergic rhinitis controlled clinical trials.

Table 2. Adverse Reactions with ≥2% Incidence in Placebo-Controlled Trials of 2 to 4 Weeks’ Duration with Astepro Nasal Spray 0.15% in Adult and Adolescent Patients With Seasonal or Perennial Allergic Rhinitis

	2 sprays twice daily		2 sprays once daily
	Astepro Nasal Spray 0.15% (N=523)	Vehicle Placebo   (N=523)	Astepro Nasal Spray 0.15% (N=1021)	Vehicle Placebo   (N=816)
Bitter Taste	31 (6%)	5 (1%)	38 (4%)	2 (<1%)
Nasal Discomfort	18 (3%)	12 (2%)	37 (4%)	7 (1%)
Epistaxis	5 (1%)	7 (1%)	21 (2%)	14 (2%)
Sneezing	9 (2%)	1 (<1%)	14 (1%)	0 (0%)

In the above trials, somnolence was reported in <1% of patients treated with Astepro Nasal Spray 0.15% (11 of 1544) or vehicle placebo (1 of 1339).

Long-Term (12 Month) Safety Trial:
In the 12 month, open-label, active-controlled, long-term safety trial, 466 patients (12 years of age and older) with perennial allergic rhinitis were treated with Astepro Nasal Spray 0.15% two sprays per nostril twice daily and 237 patients were treated with mometasone nasal spray two sprays per nostril once daily. The most frequently reported adverse reactions (>5%) with Astepro Nasal Spray 0.15% were bitter taste, headache, sinusitis, and epistaxis. Focused nasal examinations were performed and no nasal ulcerations or septal perforations were observed. In each treatment group, approximately 3% of patients had mild epistaxis. No patients had reports of severe epistaxis. Fifty-four patients (12%) treated with Astepro Nasal Spray 0.15% and 17 patients (7%) treated with mometasone nasal spray discontinued from the trial due to adverse events.

Postmarketing Experience

During the post approval use of Astepro Nasal Spray 0.1% and 0.15%, the following adverse reactions have been identified. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported include: abdominal pain, nasal burning, nausea, sweet taste, and throat irritation.

Additionaly, the following adverse reactions have been identified during the post approval use of the Astelin brand of azelastine hydrochloride 0.1% nasal spray (total daily dose 0.55 mg to 1.1 mg). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported include the following: anaphylactoid reaction, application site irritation, atrial fibrillation, blurred vision, chest pain, confusion, dizziness, dyspnea, facial edema, hypertension, involuntary muscle contractions, nervousness, palpitations, paresthesia, parosmia, paroxysmal sneezing, pruritus, rash, disturbance or loss of sense of smell and/or taste, tachycardia, tolerance, urinary retention, and xerophthalmia.

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Side Effects by Body System - for Healthcare Professionals

General

General side effects have included allergic reactions, back pain, herpes simplex, viral infection, malaise, pain in extremities, abdominal pain, and pyrexia. Azelastine nasal spray has been generally well tolerated with the number of patients in clinical trials withdrawn due to adverse effects similar to placebo.

Gastrointestinal

The bitter or altered taste is thought to be primarily related to the direct effects of azelastine reaching the mouth versus a systemic effect.

Gastrointestinal side effects have included constipation, gastroenteritis, glossitis, ulcerative stomatitis, vomiting, increased SGPT levels, aphthous stomatitis, diarrhea, and toothache. A bitter taste occurred in 19.7% of patients. Nausea and dry mouth occurred in 2.8% of patients on azelastine.

Nervous system

Nervous system side effects have included headache (14.8%) and somnolence (11.5%). Dizziness has also occurred infrequently. Hyperkinesia and hypokinesia have also been reported.

Local

Local side effects have included nasal burning (4.1%), paroxysmal sneezing (3.1%), and epistaxis (2.0%).

Respiratory

Respiratory side effects which occurred in clinical trials with a frequency greater than placebo included pharyngitis (3.5%) and rhinitis (2.3%). Bronchospasm, coughing, throat burning, laryngitis, bronchitis, dry throat,
nocturnal dyspnea, nasopharyngitis, nasal congestion, pharyngolaryngeal pain, sinusitis, nasal dryness, paranasal sinus hypersecretion, and post nasal drip have also been reported.

Endocrine

Endocrine side effects have included reports of weight increase in 2% of patients treated with azelastine.

Cardiovascular

Cardiovascular side effects have included infrequent reports of flushing, hypertension and tachycardia. Azelastine has not been shown to have significant effects on the QTc interval. Postmarketing reports have included atrial fibrillation and palpitations.

Other

Other side effects included the loss of the sense of smell in one patient receiving azelastine nasal spray. The effects lasted three days and resolved during the course of therapy.

Dermatologic

Dermatologic side effects have included contact dermatitis, eczema, hair and follicle infection, furunculosis, and skin laceration.

Metabolic

Metabolic side effects have included increased appetite.

Musculoskeletal

Musculoskeletal side effects have included myalgia, temporomandibular dislocation and rheumatoid arthritis.

Psychiatric

Psychiatric side effects have included anxiety, depersonalization, depression, nervousness, sleep disorder, and abnormal thinking.

Ocular

Ocular side effects have included conjunctivitis, eye abnormality, eye pain, and watery eyes.

Genitourinary

Genitourinary side effects have included albuminuria, amenorrhea, breast pain, hematuria, and increased urinary frequency.

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