Qnasl

QNASL Nasal Aerosol is a corticosteroid indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 4 years of age and older. (

Administer QNASL Nasal Aerosol by the intranasal route only. The dose counter should read “120” for QNASL 80 mcg Nasal Aerosol 120-actuation product and “60” for QNASL 40 mcg Nasal Aerosol 60-actuation product. QNASL Nasal Aerosol does not require priming. See accompanying illustrated Patient Information and Instructions for Use leaflet for proper use of QNASL Nasal Aerosol.

QNASL Nasal Aerosol is a nonaqueous nasal spray solution.

Each actuation of QNASL 80 mcg Nasal Aerosol delivers 80 mcg of beclomethasone dipropionate and each actuation of QNASL 40 mcg Nasal Aerosol delivers 40 mcg of beclomethasone dipropionate. QNASL 80 mcg Nasal Aerosol is supplied in a 10.6 g canister containing 120 actuations; QNASL 40 mcg Nasal Aerosol is supplied in a 6.8 g canister containing 60 actuations.

There are no adequate and well-controlled studies with QNASL Nasal Aerosol or beclomethasone dipropionate in pregnant women. No published studies, including studies of large birth registries, have to date related the use of inhaled corticosteroids (ICS) or intranasal corticosteroids to any increases in congenital malformations or other adverse perinatal outcomes.  Thus, available human data do not establish the presence or absence of drug‑associated risk to the fetus.  In animal reproduction studies, beclomethasone dipropionate resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or greater than approximately 1.5 times the maximum recommended human dose (MRHD) in adults (0.32 mg/day)

The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown.  In the US general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2‑4% and 15‑20%, respectively.

Clinical Considerations

There are no specific human data regarding any adverse effects of intranasal beclomethasone dipropionate on labor and delivery.

In an embryofetal development study in pregnant rats, beclomethasone dipropionate administration during organogenesis from gestation days 6 to 15 at inhaled doses 350 times the MRHD in adults and higher (on a mg/m² basis at maternal doses of 11.5 and 28.3 mg/kg/day) produced dose‑dependent gross injury (characterized by red foci) of the adrenal glands in fetuses.  There were no findings in the adrenal glands of rat fetuses at an inhaled dose that was 75 times the MRHD in adults (on a mg/m² basis at a maternal dose of 2.4 mg/kg/day).  There was no evidence of external or skeletal malformations or embryolethality in rats at inhaled doses up to 860 times the MRHD (on a mg/m² basis at maternal doses up to 28.3 mg/kg/day).

In an embryofetal development study in pregnant mice, beclomethasone dipropionate administration from gestation days 1 to 18 at subcutaneous doses equal to and greater than 1.5 times the MRHD in adults (on a mg/m² basis at maternal doses of 0.1 mg/kg/day and higher) produced adverse developmental effects (increased incidence of cleft palate).  A no-effect dose in mice was not identified. In a second embryofetal development study in pregnant mice, beclomethasone dipropionate administration from gestation days 1 to 13 at subcutaneous doses equal to and greater than 5 times the MRHD in adults (on a mg/m² basis at a maternal dose of 0.3 mg/kg/day) produced embryolethal effects (increased fetal resorptions) and decreased pup survival.

In an embryofetal development study in pregnant rabbits, beclomethasone dipropionate administration during organogenesis from gestation days 7 to 16 at subcutaneous doses  equal to and greater than 1.5 times the MRHD in adults (on a mg/m² basis at maternal doses of 0.025 mg/kg/day and higher) produced external and skeletal malformations and embryolethal effects (increased fetal resorptions).  There were no effects in fetuses of pregnant rabbits administered a subcutaneous dose 0.4 times the MRHD in adults (on a mg/m² basis at a maternal dose of 0.006 mg/kg/day).

Systemic and local corticosteroid use may result in the following:

• Epistaxis, nasal discomfort, nasal ulcerations,
  Candida albicans
  infection, and impaired wound healing
  [see Warnings and Precautions (5.1)]
• Eye Disorders
  [see Warnings and Precautions (5.2)]
• Hypercorticism, adrenal suppression, and growth reduction
  [see Warnings and Precautions (5.5) (5.6)
  ,
  Use in Specific Populations (8.4)]
• Immunosuppression
  [see Warnings and Precautions (5.4)]