QNASL Nasal Spray

Treatment of Nasal Symptoms of Allergic Rhinitis

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

QNASL Nasal Aerosol is a nonaqueous nasal spray solution.

Each actuation of QNASL 40 mcg Nasal Aerosol delivers 40 mcg of beclomethasone dipropionate and each actuation of QNASL 80 mcg Nasal Aerosol delivers 80 mcg of beclomethasone dipropionate. Each strength is supplied in an 8.7 g canister containing 120 actuations; QNASL 40 mcg Nasal Aerosol is also supplied in a 4.9 g canister containing 60 actuations.

Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled clinical trials in pregnant women treated with QNASL Nasal Aerosol. Beclomethasone dipropionate was teratogenic and embryocidal in the mouse and rabbit although these effects were not observed in rats. QNASL Nasal Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans.

Beclomethasone dipropionate administered subcutaneously was teratogenic and embryocidal in the mouse and rabbit at doses approximately twice the maximum recommended human daily intranasal dose (MRHDID) in adults (on a mg/m2 basis at maternal doses of 0.1 and 0.025 mg/kg/day in mice and rabbits, respectively). No teratogenicity or embryocidal effects were seen in rats at approximately 460 times MRHDID (in adults on a mg/m2 basis at a maternal inhalation dose of 15 mg/kg/day).

Non-teratogenic Effects: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.

Nursing Mothers

It is not known whether beclomethasone dipropionate is excreted in human breast milk. However, other corticosteroids have been detected in human breast milk and thus caution should be exercised when QNASL Nasal Aerosol is administered to a nursing mother.

Pediatric Use

The safety and effectiveness of QNASL Nasal Aerosol in children 4 years and older have been established [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14)]. The safety and effectiveness of QNASL Nasal Aerosol in children younger than 4 years of age have not been established. Controlled pediatric clinical trials with QNASL Nasal Aerosol included 909 children 4 to 11 years of age and 188 adolescent patients 12 to 17 years of age [see Clinical Studies (14)].

Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA-axis function. The long-term effects of reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch-up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including QNASL Nasal Aerosol, should be monitored routinely (e.g., via stadiometry).

A 12-month, randomized, controlled clinical trial evaluated the effects of QVAR®, an orally inhaled HFA beclomethasone dipropionate product, without spacer versus chlorofluorocarbon-propelled (CFC) beclomethasone dipropionate with large volume spacer on growth in children with asthma ages 5 to 11 years. A total of 520 patients were enrolled, of whom 394 received HFA-beclomethasone dipropionate (100 to 400 mcg/day ex-valve) and 126 received CFC-beclomethasone dipropionate (200 to 800 mcg/day ex-valve). When comparing results at month 12 to baseline, the mean growth velocity in children treated with HFA-beclomethasone dipropionate was approximately 0.5 cm/year less than that noted with children treated with CFC-beclomethasone dipropionate via large volume spacer. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives.

The potential for QNASL Nasal Aerosol to cause reduction in growth velocity in susceptible patients or when given at higher than recommended dosages cannot be ruled out.

Geriatric Use

Clinical trials of QNASL Nasal Aerosol did not include sufficient numbers of subjects aged 65 years and older to determine whether they responded differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, administration to elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.5)]. There are no data available on the effects of acute or chronic overdosage with QNASL Nasal Aerosol.

QNASL Nasal Aerosol is supplied in 2 strengths and supplied as a pressurized aluminum canister inserted into a blue and white plastic nasal actuator with a built-in dose counter and white dust cap, as follows:

QNASL 40 mcg Nasal Aerosol contains 8.7 g of drug and excipients and provides 120 actuations (NDC 59310-206-12) and for the 60-actuation product, 4.9 g of drug and excipients (NDC 59310-206-06). Each actuation delivers 40 mcg of beclomethasone dipropionate from the nasal actuator and 50 mcg from the valve.

QNASL 80 mcg Nasal Aerosol contains 8.7 g of drug and excipients and provides 120 actuations (NDC 59310-210-12). Each actuation delivers 80 mcg of beclomethasone dipropionate from the nasal actuator and 100 mcg from the valve.

Each canister of QNASL Nasal Aerosol has a built-in spray counter, which starts at 124 and counts down each time a spray is released for the 120 actuation product and 64 for the 60 actuation product. After the 4 initial priming sprays, the spray counter should read 120 sprays or 60 sprays for the respective products. The correct amount of medication in each intranasal dose cannot be ensured after the counter reads 0; therefore, the device should be discarded when the counter reads 0.

Do not remove the QNASL Nasal Aerosol canister from the actuator. The QNASL Nasal Aerosol canister should only be used with the QNASL Nasal Aerosol actuator and the actuator should not be used with any other drug product.

CONTENTS UNDER PRESSURE

Do not puncture. Do not store near heat or open flame. Do not expose to temperatures higher than 49°C (120°F) as this may cause bursting of the canister. Never throw the device into a fire or an incinerator.

Store at 25°C (77°F); excursions are permitted between 15° and 30°C (59° and 86°F).

Keep out of reach of children.

See FDA-Approved Patient Labeling accompanying the product.

Local Nasal Effects

Inform patients that treatment with QNASL Nasal Aerosol may lead to adverse reactions, including epistaxis, nasal ulceration, and nasal discomfort. Candida infection may also occur with treatment with QNASL Nasal Aerosol. In addition, nasal beclomethasone dipropionate products are known to be associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use QNASL Nasal Aerosol until healing has occurred [see Warnings and Precautions (5.1)].

Eye Disorders

Inform patients that blurred vision, glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Patients should inform their health care providers if a change in vision is noted while using QNASL Nasal Aerosol [see Warnings and Precautions (5.2)].

Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, and rash have been reported following administration of beclomethasone dipropionate nasally administered and inhalationally administered products. Angioedema, urticaria, and rash have been reported following administration of QNASL Nasal Aerosol. If any such reactions occur, patients should discontinue use of QNASL Nasal Aerosol [see Warnings and Precautions (5.3)].

Immunosuppression

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4)].

Use Daily for Best Effect

Patients should use QNASL Nasal Aerosol on a regular, once-daily basis since its effectiveness depends on its regular use. QNASL Nasal Aerosol may not have an immediate effect on rhinitis symptoms. The patient should not increase the prescribed dosage but should contact their physician if symptoms do not improve or if the condition worsens.

Keep Spray Out of Eyes or Mouth

Patients should be informed to avoid spraying QNASL Nasal Aerosol in their eyes or mouth.

Teva Respiratory, LLC
Frazer, PA 19355 USA

©2017, Teva Respiratory, LLC. All rights reserved.

QNASL® is a registered trademark of Teva Respiratory, LLC.

Manufactured for Teva Respiratory, LLC
Frazer, PA 19355
By: 3M Drug Delivery Systems
Northridge, CA 91324

United States Patent Nos. 7,780,038

PE3533 Rev. 07/2017

PATIENT INFORMATION QNASL (kyoo nay' zel) (beclomethasone dipropionate) Nasal Aerosol

QNASL Nasal Aerosol is available in 2 different strengths: • QNASL Nasal Aerosol 40 mcg is only for use in children 4 years to 11 years of age and should be given under the supervision of a parent, guardian or caregiver. • QNASL Nasal Aerosol 80 mcg is only for use in adolescents and adults 12 years of age and older.

What is QNASL Nasal Aerosol? QNASL Nasal Aerosol is a prescription medicine that treats seasonal nasal and year-round nasal allergy symptoms in children 4 years of age and older and adults. QNASL Nasal Aerosol contains beclomethasone dipropionate, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body that reduce inflammation. When QNASL Nasal Aerosol is sprayed into the nose, it may help reduce the nasal symptoms of allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, runny nose, itching, and sneezing. It is not known if QNASL Nasal Aerosol is safe and effective in children under 4 years of age.

Who should not use QNASL Nasal Aerosol? Do not use QNASL Nasal Aerosol if you or your child is allergic to beclomethasone dipropionate or any of the ingredients in QNASL Nasal Aerosol. See the end of this leaflet for a complete list of ingredients in QNASL Nasal Aerosol.

What should you tell your or your child’s healthcare provider before using QNASL Nasal Aerosol? Before using QNASL Nasal Aerosol, tell the healthcare provider about all of your medical conditions, including if you or your child: • has had recent nose problems such as nasal sores, nasal surgery, or a nasal injury. • has or have had eye problems, such as blurred vision, increased pressure in their eye (glaucoma) or cataracts. • has tuberculosis or any untreated fungal, bacterial, or viral infections, or eye infections caused by herpes. • has not had or been vaccinated for chickenpox or measles. • is pregnant or plans to become pregnant. It is not known if QNASL Nasal Aerosol will harm an unborn baby. Talk to the healthcare provider if you or your child is pregnant or plans to become pregnant. • is breastfeeding or plans to breastfeed. It is not known if QNASL Nasal Aerosol passes into breast milk. Talk to the healthcare provider about the best way to feed the baby if you or your child is using QNASL Nasal Aerosol. Tell the healthcare provider about all of the medicines you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. QNASL Nasal Aerosol and other medicines may affect each other and cause side effects. QNASL Nasal Aerosol may affect the way other medicines work, and other medicines may affect the way QNASL Nasal Aerosol works. Especially tell the healthcare provider if you or your child takes other corticosteroid medicines. Ask the healthcare provider for a list of these medicines if you are not sure.

How should you or your child use QNASL Nasal Aerosol? • QNASL Nasal Aerosol 40 mcg is only for use in children 4 years to 11 years of age and should be given under the supervision of a parent, guardian or caregiver. • QNASL Nasal Aerosol 80 mcg is only for use in adolescents and adults 12 years of age and older. • Read the step-by-step Instructions for Use at the end of this leaflet for specific information about the right way to use QNASL Nasal Aerosol. • QNASL Nasal Aerosol is for use in the nose only. Do not spray it in your eyes or mouthand do not let your child spray it in their eyes or mouth. • Use QNASL Nasal Aerosol exactly as the healthcare provider tells you or your child to use it. Do not use more of your medicine or take it more often or let your child use more of the medicine or take it more often than the healthcare provider tells you. • QNASL Nasal Aerosol must be primed before it is used for the first time and if you or your child does not use it for 7 or more days in a row. Do not prime the QNASL Nasal Aerosol every day. • QNASL Nasal Aerosol 40 mcg comes in 120 sprays or 60 sprays. QNASL Nasal Aerosol 80 mcg comes in 120 sprays only: o The 120-actuation product has a spray counter which should read 124 sprays before priming and 120 sprays after priming. o The 60-actuation product has a spray counter which should read 64 sprays before priming and 60 sprays after priming. • Do not use the QNASL Nasal Aerosol after the spray counter reads 0. You or your child may not get the right amount of medicine. • The usual dose of QNASL Nasal Aerosol: o 40 mcg is 1 spray in each nostril, 1 time a dayfor children who are 4 years to 11 years of age. Your child should not use more than a total of 2 sprays per day. o 80 mcg is 2 sprays in each nostril, 1 time a day for adolescents and adults 12 years of age and older. You should not use more than a total of 4 sprays per day. You and your child will get the best results if they keep using QNASL Nasal Aerosol regularly each day. If you or your child’s symptoms do not improve or get worse, call the healthcare provider.

What are the possible side effects of QNASL Nasal Aerosol? QNASL Nasal Aerosol may cause serious side effects, including: • nose bleeds or nasal ulcers. The healthcare provider should check the inside of you or your child’s nose (nasal mucosa) while taking QNASL Nasal Aerosol for problems. Talk to the healthcare provider if the nose bleeds or has nasal ulcers. • fungal infections (thrush) in the nose, mouth, or throat. Tell the healthcare provider if you or your child has any redness or white colored patches in the mouth or throat. • slow wound healing. You or your child should not use QNASL Nasal Aerosol until the nose has healed if there was a sore in the nose, had surgery on the nose, or the nose has been injured. • eye problems. If you or your child has had glaucoma, cataracts or blurred vision in the past, you or your child should have regular eye exams while using QNASL Nasal Aerosol. • serious allergic reactions. Stop using QNASL Nasal Aerosol and call the healthcare provider right away or get emergency medical help right away if you or your child get any of the following signs and symptoms of a serious allergic reaction: ○ hives ○ swelling of your lips, tongue or face ○ rash ○ breathing problems • immune system effects and a higher chance for infections. Tell your or your child’s healthcare provider about any signs or symptoms of infection such as: ○ fever ○ pain ○ body aches ○ chills ○ feeling tired ○ nausea ○ vomiting • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency can happen in people who take higher doses of QNASL than recommended over a long period of time. Symptoms of adrenal insufficiency may include: ○ tiredness ○ weakness ○ dizziness ○ nausea ○ vomiting • slowed growth in children. Children should have their growth checked regularly while using QNASL Nasal Aerosol. The most common side effects with QNASL Nasal Aerosol 40 mcg in children who are 4 years to 11 years of age include: • Epistaxis (nose bleeding) • headache • fever • upper respiratory tract infection • pain or swelling of your nose or throat (Nasopharyngitis) The most common side effects with QNASL Nasal Aerosol 80 mcg in adolescents and adults 12 years of age and older include: • nasal discomfort • nose bleeds (epistaxis) • headache Tell the healthcare provider if you or your child has any side effect that bothers you or that does not go away. These are not all the possible side effects of QNASL Nasal Aerosol. For more information, ask the healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store QNASL Nasal Aerosol? • Store QNASL Nasal Aerosol at room temperature between 59˚F to 86˚F (15˚C to 30˚C). • Do not puncture the QNASL Nasal Aerosol canister. • Do not store the QNASL Nasal Aerosol canister near heat or a flame. Temperatures above 120˚F (49˚C) may cause the canister to burst. • Do not throw the QNASL Nasal Aerosol canister into a fire or an incinerator. • Safely throw away medicine that is out of date or no longer needed. Keep QNASL Nasal Aerosol and all medicines out of the reach of children.

General information about the safe and effective use of QNASL Nasal Aerosol Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use QNASL Nasal Aerosol for a condition for which it was not prescribed. Do not give QNASL Nasal Aerosol to other people, even if they have the same symptoms that you or your child has. It may harm them. You can ask your pharmacist or healthcare provider for information about QNASL Nasal Aerosol that is written for health professionals.

What should I know about allergic rhinitis? "Rhinitis" means inflammation of the lining of the nose. Allergic rhinitis is sometimes called "hay fever." Allergic rhinitis can be caused by allergies to pollen, animal dander, house dust mites, mold spores, and other things. If your child has allergic rhinitis, their nose becomes stuffy, runny, and itchy. He/she may also sneeze a lot. Your child may also have red, itchy, watery eyes or an itchy throat; or blocked, itchy ears.

What are the ingredients in QNASL Nasal Aerosol? Active ingredient: beclomethasone dipropionate Inactive ingredient: propellant HFA-134a and ethanol

For more information, go to www.QNASL.com or call 1-855-55-QNASL (1-855-557-6275).

PLEASE SEE REVERSE SIDE FOR INSTRUCTIONS FOR USE.

INSTRUCTIONS FOR USE

QNASL (kyoo nay' zel) 80 mcg
(beclomethasone dipropionate)
Nasal Aerosol

Read these Instructions for Use for QNASL Nasal Aerosol before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Note: For Use in the Nose Only.

• Do not spray QNASL Nasal Aerosol in your eyes, mouth or directly onto your nasal septum (the wall between your 2 nostrils).

The parts of your QNASL Nasal Aerosol

The QNASL Nasal Aerosol device comes as a canister that fits into a nasal actuator with a built-in spray counter and protective dust cap. (See Figure A).

• Do not use the QNASL Nasal Aerosol actuator with a canister of medicine from any other inhaler. • Do not use the QNASL Nasal Aerosol canister with an actuator from any other inhaler. • Do not remove the QNASL Nasal Aerosol canister from the actuator.

Priming your QNASL Nasal Aerosol for Use

Your QNASL Nasal Aerosol device must be primed before you use it for the first time or if it has not been used for more than 7 days in a row.

• Remove your QNASL Nasal Aerosol device from its package. • Remove the protective dust cap from the device by pulling it straight off. • Hold the nasal actuator upright between your thumb and forefinger (index finger). The canister should be on top and the white nasal actuator tip on bottom (See Figure B). • If you have never used your QNASL Nasal Aerosol device before, spray it 4 times into the air, away from your eyes and face, by pressing down fully on the top of the canister 4 times (See Figure C). • After the first time you prime your QNASL Nasal Aerosol device, the spray counter should read 120 (See Figure D). • Your QNASL Nasal Aerosol device is now ready to use. • Do not prime your QNASL Nasal Aerosol device every day. • If you have used your QNASL Nasal Aerosol device before, but it has not been used in more than 7 days, it must be reprimed. To reprime your QNASL Nasal Aerosol device, spray 2 times into the air, away from your eyes and face, by pressing down fully on the top of the canister 2 times. Your QNASL Nasal Aerosol device is now ready to use.

Using Your QNASL Nasal Aerosol Device

Step 1: Blow your nose to clear your nostrils.

Step 2: Remove the protective dust cap from your QNASL Nasal Aerosol device by pulling it straight off.

Step 3: Inspect the nasal actuator tip to make sure it is clear of foreign objects.

Step 4: Hold your QNASL Nasal Aerosol device upright and insert the nasal actuator tip into one nostril (See Figure E).

Step 5: Point the QNASL Nasal Aerosol device slightly away from the wall between your nostrils (nasal septum) while holding your other nostril closed (See Figure F).

Step 6: Hold your breath and press down firmly and completely on the canister to release 1 spray (See Figure G). Continue to hold your breath for 5 seconds after releasing the spray and then breathe out slowly through your mouth. Take the QNASL Nasal Aerosol device out of your nostril.

Step 7: Repeat steps 3-6 for the second spray in the same nostril.

Step 8: Repeat steps 3-7 for your other nostril.

Step 9: You should not blow your nose for the next 15 minutes.

Note: The spray counter will count down each time there is a spray released from your QNASL Nasal Aerosol device.

Step 10: Clean and store your device. See "Cleaning Your QNASL Nasal Aerosol device."

Cleaning Your QNASL Nasal Aerosol device

• Wipe the nasal actuator tip with a clean, dry tissue or cloth (See Figure H). • Do not wash or put any part of the QNASL Nasal Aerosol canister or actuator in water. • Replace the protective dust cap. • Keep your device clean and dry at all times.

How to know when to stop using your QNASL Aerosol device

• The QNASL Nasal Aerosol device has a spray counter, which is there to let you know how many sprays of medicine you have left. • Do not use your QNASL Nasal Aerosol device when 0 is shown in the spray counter window (See Figure I). • Throw away your QNASL Nasal Aerosol device when the spray counter reaches 0. • Do not throw your QNASL Nasal Aerosol canister into a fire or an incinerator. • Talk with your healthcare provider before your QNASL Nasal Aerosol medicine runs out to see if you should get a refill.

Manufactured for: Teva Respiratory, LLC

Frazer, PA 19355

By: 3M Drug Delivery Systems

Northridge, CA 91324

©2017 Teva Respiratory, LLC

All rights reserved.

QNASL is a registered trademark of Teva Respiratory, LLC

Rev. 07/2017          PE 3534

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.