Is Ryaltris (azelastine and fluticasone) safe to use in a pregnant woman with a history of allergic rhinitis?

Ryaltris Safety in Pregnancy

Ryaltris (azelastine-fluticasone combination) should not be used during pregnancy due to insufficient safety data on azelastine in pregnant women, despite fluticasone having reassuring pregnancy data. Instead, use intranasal corticosteroid monotherapy (budesonide, fluticasone, or mometasone) as first-line treatment, with second-generation oral antihistamines (loratadine or cetirizine) as safe alternatives when additional symptom control is needed. 1

Why Ryaltris Is Not Recommended

• Limited human pregnancy data exists for azelastine, the antihistamine component of Ryaltris, making it impossible to assess fetal risk adequately. 2
• While fluticasone propionate (the corticosteroid component) has reassuring safety data in pregnancy, the combination product has not been studied in pregnant populations. 2
• Safer alternatives with extensive pregnancy safety data are readily available and equally effective for allergic rhinitis management. 1

Recommended Treatment Algorithm for Allergic Rhinitis in Pregnancy

First-Line Therapy

• Initiate saline nasal rinses as primary therapy for all pregnant patients—completely safe with proven efficacy for symptom relief. 1
• Add intranasal corticosteroid spray if saline alone provides inadequate relief:
  • Budesonide (Pregnancy Category B with most extensive human data) 2
  • Fluticasone propionate (extensive reassuring data) 2
  • Mometasone (safe at recommended doses) 2, 1
• Use intranasal corticosteroids regularly for maintenance rather than as-needed dosing for optimal efficacy. 1

Second-Line Therapy

• Add second-generation oral antihistamines if intranasal corticosteroids provide insufficient control:
  • Loratadine (most studied with 2,147 first-trimester exposures showing no increased malformation risk) 3
  • Cetirizine (well-studied, considered safe) 1, 4
• First-generation antihistamines should be avoided due to sedative and anticholinergic properties. 2, 5

Additional Safe Options

• Sodium cromolyn (Pregnancy Category B) may be considered, though requires frequent four-times-daily dosing and has reduced efficacy compared to intranasal corticosteroids. 2
• Montelukast (Pregnancy Category B) can be used if there was favorable pre-pregnancy response, though primarily reserved for patients with concurrent asthma. 2

Critical Medications to Avoid

• Oral decongestants (phenylephrine, pseudoephedrine) are contraindicated, especially in the first trimester, due to associations with fetal gastroschisis, small intestinal atresia, and maternal hypertension. 1, 5, 6
• Topical decongestants (oxymetazoline) should be avoided throughout pregnancy due to reported fetal heart rate changes and lack of adequate safety studies. 6
• Aspirin and NSAIDs are Category D and must be discontinued due to risks of premature ductus arteriosus closure and intrauterine growth restriction. 1, 5

Timing Considerations

• The first trimester (weeks 1-12) carries the highest teratogenic risk, requiring particular caution with any medication use. 1, 5
• Intranasal corticosteroids have demonstrated no increased risk of major malformations, preterm delivery, low birth weight, or pregnancy-induced hypertension in meta-analyses, making them safe throughout all trimesters. 2, 6

Important Clinical Pearls

• Untreated severe allergic rhinitis poses greater maternal-fetal risks than appropriate pharmacotherapy, particularly when it triggers asthma exacerbations—approximately one-third of pregnant women with asthma experience worsening symptoms during pregnancy, often triggered by untreated allergic rhinitis. 1
• A meta-analysis of 200,000 first-trimester antihistamine exposures failed to show increased teratogenic risk, providing strong reassurance for their use when needed. 3
• Allergen immunotherapy can be continued at maintenance doses if already established before pregnancy, but should not be initiated or dose-escalated during pregnancy due to anaphylaxis risk. 2, 1