Label: ALLERNAZE- triamcinolone acetonide spray, metered

For Intranasal Use Only

Triamcinolone acetonide, the active ingredient of AllerNaze, is a corticosteroid with the chemical name, 9α-Fluoro-11β,16α, 17, 21-tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16, 17-acetal with acetone (C24 H31 FO6 ). Its structural formula is:

Triamcinolone acetonide, USP, is a white crystalline powder, with a molecular weight of 434.51. It is practically insoluble in water, and sparingly soluble in dehydrated alcohol, in chloroform and in methanol. It has a melting point temperature range between 292° and 294°C.

AllerNaze is a metered-dose manual spray pump in an amber polyethylene terephthalate (PET) bottle with 0.05% w/v triamcinolone acetonide in a solution containing citric acid, edetate disodium, polyethylene glycol 3350, propylene glycol, purified water, sodium citrate, and 0.01% benzalkonium chloride as a preservative. AllerNaze pH is 5.3.

After initial priming (three sprays) of the AllerNaze metered pump delivery system, each spray will deliver 50 mcg of triamcinolone acetonide. If the pump was not used for more than 14 days, reprime with 3 sprays or until a fine mist is observed. Each 15 mL bottle contains 7.5 mg of triamcinolone acetonide to deliver 120 metered sprays. After 120 sprays, the amount of triamcinolone acetonide delivered per spray may not be consistent and the bottle should be discarded.

Triamcinolone acetonide is a more potent derivative of triamcinolone. Triamcinolone acetonide is approximately eight times more potent than prednisone in animal models of inflammation. The clinical significance of this is unclear.

Although the precise mechanism of corticosteroid antiallergic action is unknown, corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g. mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g. histamines, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

The efficacy of triamcinolone acetonide solution has been evaluated in 746 patients with seasonal or perennial allergic rhinitis who completed 8 controlled clinical trials.

In total, 1187 patients have been treated with triamcinolone acetonide solution in the clinical development program. Three adequate and well controlled multi-center trials involving 541 patients with seasonal allergic rhinitis who received doses of triamcinolone acetonide solution ranging from 50 mcg to 400 mcg once daily were conducted. These trials evaluated the total nasal symptom scores that included stuffiness, rhinorrhea, itching, and sneezing.

The results showed that patients who received ≥ 200 mcg daily of the active drug had statistically significant relief in the total nasal symptom score compared to those receiving placebo.

In one clinical trial that examined efficacy after 2 days of 200 or 400 mcg triamcinolone acetonide solution treatment, only the 400 mcg dose showed statistically significant improvement over placebo in the nasal symptoms of seasonal allergic rhinitis.

AllerNaze is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 12 years of age or older.

AllerNaze is contraindicated in patients with a hypersensitivity to any of its ingredients.

The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint or muscular pain, or both, lassitude and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions which require long-term corticosteroid treatment, too rapid a decrease in systemic corticosteroid may cause a severe exacerbation of their symptoms.

Patients who are on immunosuppressant drugs are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in children or adults on immunosuppressant doses of corticosteroids. In children, or adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG) as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

In adequate, well-controlled and uncontrolled studies, 1187 patients have received triamcinolone acetonide solution. The adverse reactions summarized below, are based upon seven placebo controlled clinical trials of 2-6 weeks duration in 847 patients with seasonal or perennial allergic rhinitis (504 patients received 200 mcg or 400 mcg per day of triamcinolone acetonide solution and 343 patients received vehicle placebo). Adverse events reported by 2% or more of patients (regardless of relationship to treatment) who received triamcinolone acetonide solution 200 or 400 mcg once daily and that were more common with triamcinolone acetonide solution than with placebo are displayed in the table below. Overall, the incidence and nature of adverse events with triamcinolone acetonide solution 400 mcg was comparable to that seen with triamcinolone acetonide solution 200 mcg and with vehicle placebo.

Adverse events reported by 2% or more of patients who received triamcinolone acetonide solution 200 or 400 mcg once daily and that were more common with placebo than with triamcinolone acetonide solution included: application site reaction (e.g. transient nasal burning and stinging), rhinitis, dysmenorrhea, pain (unspecified) and allergic reaction.

The adverse effects related to the irritation of nasal mucous membranes (i.e. application site reaction) did not usually interfere with treatment. In the controlled and uncontrolled studies, approximately 0.3% of patients discontinued because of irritation of nasal mucous membranes.

Like any other nasally administered corticosteroid, acute overdosing is unlikely in view of the total amount of active ingredient present. In the event that the entire contents of the bottle were administered all at once, via oral or nasal application, clinically significant adverse events would likely not result. The patient may experience some gastrointestinal upset. Chronic overdosage with any corticosteroid may result in signs or symptoms of hypercorticism (see PRECAUTIONS).

The recommended starting dose of AllerNaze for most patients is 200 mcg per day given as 2 sprays (approximately 50 mcg/spray) in each nostril once a day. The maximum dose should not exceed 400 mcg per day. If the 400 mcg dose is used, it may be given either as a once a day dosage (4 sprays in each nostril) or divided into two daily doses of two sprays/nostril twice a day.

The nasal spray pump must be primed before AllerNaze is used for the first time. To prime the pump, press down on the shoulder of the white nasal applicator using your forefinger and middle finger while supporting the base of the bottle with your thumb. Press down and release the pump until it sprays 3 times or until a fine mist is observed (see DIRECTIONS FOR USE).

Some patients may obtain relief of symptoms sooner when started on a 400 mcg per day dose of AllerNaze than with 200 mcg per day. Onset of significant relief of nasal symptoms was seen within two days after starting treatment at 400 mcg once daily. A starting dose of 400 mcg per day may be considered in patients when starting therapy with AllerNaze in cases where a faster onset of relief is desirable. Generally, maximum relief of symptoms may take several days or up to one week to occur.

After symptoms have been brought under control, patients should be titrated to the minimum effective dose to reduce the possibility of adverse effects.

If relief of symptoms is not achieved after 14-21 days of AllerNaze therapy given in an adequate dose, AllerNaze should be discontinued and alternative diagnosis and therapies considered.

AllerNaze is not recommended for use in persons under 12 years of age since its safety and effectiveness have not been established in this age group.

Each 15 mL bottle of AllerNaze (NDC 27437-143-01) contains 7.5 mg (0.50 mg/mL) of triamcinolone acetonide, USP and is fitted with a meter pump with white nasal applicator, teal blue dust cover and teal blue locking clip sealed in a foil pouch. The unit delivers 120 metered actuations and comes with a patient's instructions for use leaflet. The bottle should be discarded when the labeled number of actuations has been reached even though the bottle is not completely empty.

Keep out of reach of children.

Store at controlled room temperature: 20°-25°C (68°-77°F). Protect from freezing.

Use AllerNaze within 2 months after opening of the protective foil pouch or before expiration date, whichever comes first.

Rx only

Lupin Pharma
Baltimore, MD 21202
Tel: 1-800-399-2561
www.lupinpharmaceuticals.com

AllerNazeTM [AL-er-nāz]

(triamcinolone acetonide, USP)

Nasal Spray

INFORMATION FOR THE PATIENT

These instructions provide a summary of important information about AllerNaze. Please read it carefully before use. Ask your doctor or pharmacist if you have any additional questions.

What is AllerNaze?

AllerNaze is a prescription medicine called a corticosteroid used to treat seasonal and year-round allergies in adults and children age 12 and older. When AllerNaze is sprayed in your nose, this medicine helps lessen the symptoms of sneezing, runny nose, and nasal itching associated with nasal allergies.

Do not use AllerNaze if you

1. are pregnant or planning to become pregnant.

2. are breast feeding.

3. have had a reaction to triamcinolone acetonide or to any other nasal spray.

How do I use AllerNaze?

• Use AllerNaze on a regular schedule exactly as prescribed by your doctor
• Do not use more AllerNaze or take it more often than your doctor tells you. It usually takes several days to one week of regular use to feel the medicine working.
• Protect your eyes from the spray.
• If your symptoms do not improve, or if they become worse, contact your doctor.
• Do not stop taking AllerNaze without contacting your doctor.
• AllerNaze does not relieve the red and itchy eye symptoms that some people have with allergic rhinitis. Ask your doctor for advice on treatment.
• Tell your doctor if you have irritation, burning or stinging inside your nose that does not go away when using AllerNaze.
• You may have nosebleeds after using AllerNaze. If so, contact your doctor right away.

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

Patient Instructions for Use

Read these instructions carefully before use. The following instructions tell you how to prepare your AllerNaze spray pump so that it is ready for your use.

Open the foil pouch and remove the pump unit. See Figure A for a picture of the spray pump, the cap, and the safety clip.

Priming the Pump:

The pump needs to be primed before using it for the first time and then again if you have not used the spray for 2 weeks. You will prime the pump the same way each time.

1. Remove the blue plastic cap and the blue safety clip from the nasal applicator of the spray pump unit. See Figure B.

2. Prime the pump by holding the bottle with your thumb on the bottom and your index and middle fingers on top, on either side of the white nasal applicator. See Figure C.

3. Point the bottle up and away from your eyes. Press down on either side of the white nasal applicator using your forefinger and middle finger, while supporting the base of the bottle with your thumb.

4. Press down and release the pump several times until you get 3 sprays or until a fine mist is seen. A fine mist can only be made by a rapid and firm pumping action. See Figure C.

Using the spray correctly:

1. Gently blow your nose to clear it before using the medication.

2. Remove the blue plastic cap and the blue safety clip from the nasal applicator. See Figure D.

3. Prime the pump. See Figures A, B, and C in the “Priming the Pump” section.

4. Tilt your head backward slightly. Breathe out slowly.

5. Use a finger on your other hand to close your nostril on the side not receiving the medication. See Figure E.

6. Insert spray tip into one nostril, as shown in the illustration. Do not insert too far back. Do not spray AllerNaze directly onto the nasal tissue inside your nose; aim the spray to the back of your nose. See Figure F.

7. Breathe in through the nostril and while breathing in press the applicator once to release the spray. You will need to press firmly and rapidly. Breathe out through your mouth.

8. If the doctor has prescribed 2 sprays on each side, repeat Step 7 (above) in the same nostril and then switch to use the nasal spray in the other nostril.

9. Do not blow your nose for 15 minutes.

10. After use, wipe the spray bottle applicator off with a tissue and put the cap and safety clip back on to the bottle.

If your nasal passages are severely swollen, your doctor may recommend a decongestant nasal spray or nose drops for 3 or 4 days before using AllerNaze.

CLEANING the nasal applicator:

If the nasal applicator becomes blocked, and does not spray, remove it and allow it to soak in warm water for 10-15 minutes. Then rinse the applicator with clean warm water, allow it to air dry and put it back on the bottle. Do not try to unblock the applicator by inserting a pin or other sharp object. This could change the amount of medicine you spray and cause an overdose.

STORING and discarding AllerNaze:

• Store between 68º to 77º F (20º to 25º C).
• Do not freeze.
• Use AllerNaze within 2 months after opening the protective foil pouch or before the expiration date on the box or label, whichever comes first.
• After using 120 sprays of AllerNaze throw the bottle away – the dose may not be accurate.

Information about nasal symptoms of allergies (allergic rhinitis):

Allergic rhinitis is a condition that causes swelling and increased watery fluid in the nose and nasal passages. This can result in sneezing, runny nose, itching, and difficulty in breathing through the nose.

This response is caused by an allergy to pollen that comes from many types of plants including trees, grasses, and weeds. Allergic responses of this type may also be caused by mold spores, house dust mites, animal dander, and other substances.

Lupin Pharma
Baltimore, MD 21202
Tel: 1-800-399-2561
www.lupinpharmaceuticals.com                                              2000002549

NDC 27437-143-01

AllerNaze™

(triamcinolone acetonide, USP)

NASAL SPRAY, 50mcg

Lupin Pharma