Asmanex HFA

Name: Asmanex HFA

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Asmanex HFA Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

wheezing, choking, or other breathing problems after using this medication;
skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist); or
worsening asthma symptoms.

Common side effects may include:

headache;
increased sinus allergy symptoms (runny nose, stuffy nose, sinus pain), sore throat, nosebleed;
muscle or joint pain, back pain;
upset stomach;
changes in menstrual periods; or
hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Asmanex HFA Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take macrolide antibiotics, antifungal medicines, or anti-HIV medicines such as:

ritonavir
atazanavir
clarithromycin
telithromycin
indinavir
ketoconazole
itraconazole
nefazodone
nelfinavir
saquinavir

This is not a complete list of Asmanex HFA drug interactions. Ask your doctor or pharmacist for more information.

Other Requirements

Store Asmanex HFA at room temperature between 68°F to 77°F (20°C to 25°C).
The contents of your Asmanex HFA are under pressure. Do not puncture. Do not use or store near heat or open flame. Storage above 120°F may cause the canister to burst.
Do not throw container into fire or incinerator.
Keep Asmanex HFA and all medicines out of the reach of children.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What should I avoid while using Asmanex HFA (mometasone inhalation)?

Mometasone can weaken your immune system. This can make it easier for you to get sick from being around others who are ill.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using mometasone.

Commonly used brand name(s)

In the U.S.

Asmanex HFA
Asmanex Twist

In Canada

Asmanex Twisthaler
Azmax Twisthaler

Available Dosage Forms:

Aerosol Powder
Powder

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Mometasone

What are some things I need to know or do while I take Asmanex HFA?

Tell all of your health care providers that you take Asmanex HFA. This includes your doctors, nurses, pharmacists, and dentists.
Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
Have a bone density test as you have been told by your doctor. Talk with your doctor.
Have your eye pressure checked if you are on this medicine for a long time. Talk with your doctor.
It may take a few weeks to see the full effect.
If you have been taking Asmanex HFA for many weeks, talk with your doctor before stopping. You may want to slowly stop this medicine.
You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like Asmanex HFA. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
When changing from an oral steroid to another form of a steroid, there may be very bad and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, or low blood sugar may happen. Call your doctor right away if you have any of these signs. If you have a bad injury, have surgery, or any type of infection, you may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you may need extra steroids.
Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Clinical Studies

Asthma

The safety and efficacy of Asmanex HFA was demonstrated in two randomized, double-blind, placebo- or active-controlled multi-center clinical trials of 12 and 26 weeks' duration, conducted as part of a mometasone furoate/formoterol fumarate 100/5 mcg or 200/5 mcg combination product development program. A total of 1509 patients 12 years of age and older with persistent asthma (mean baseline FEV1 of 66% to 73% predicted) were evaluated.

Trial 1: Clinical Trial with Asmanex HFA 100 mcg

This 26-week, placebo-controlled trial conducted as part of a mometasone furoate/formoterol fumarate combination product asthma program evaluated 781 patients 12 years of age and older. Of these patients, 192 patients received Asmanex HFA 100 mcg and 196 patients received placebo, each administered as 2 inhalations twice daily by metered dose inhalation aerosols. All other maintenance therapies were discontinued. The study included a 2- to 3-week run-in period with Asmanex HFA 100 mcg, 2 inhalations twice daily. Patients ranged from 12 to 76 years of age, 41% were male and 59% female, and 72% were Caucasian and 28% non-Caucasian. Patients had persistent asthma and were not well controlled on medium dose of inhaled corticosteroids prior to randomization. Mean FEV1 and mean percent predicted FEV1 were similar among all treatment groups (2.33 L, 73%). Thirteen (7%) patients receiving Asmanex HFA 100 mcg and 46 (23%) patients receiving placebo discontinued the study early due to treatment failure.

The change in mean trough FEV1 from baseline to Week 12 compared to placebo was assessed to evaluate the efficacy of Asmanex HFA 100 mcg. The change from baseline to week 12 in the mean trough FEV1 was greater among patients receiving Asmanex HFA 100 mcg 2 inhalations twice daily than among those receiving placebo (treatment difference from placebo 0.12 L and 95% confidence interval [0.05, 0.20]).

Clinically judged deteriorations in asthma or reductions in lung function were also assessed to evaluate the efficacy of Asmanex HFA 100 mcg. Deteriorations in asthma were defined as any of the following: a 20% decrease in FEV1; a 30% decrease in PEF on two or more consecutive days; emergency treatment, hospitalization, or treatment with systemic corticosteroids or other asthma medications not allowed per protocol. Sixty-five (34%) patients who received Asmanex HFA 100 mcg reported an event compared to 109 (56%) patients who received placebo.

Treatment of asthma patients with Asmanex HFA 100 mcg, two inhalations twice daily also resulted in fewer nocturnal awakenings and improved morning peak flow compared to those who received placebo.

Trial 2: Clinical Trial with Asmanex HFA 200 mcg

This 12-week randomized, double-blind, active-controlled trial also conducted as part of a mometasone furoate/formoterol fumarate combination product asthma program evaluated a total of 728 patients 12 years of age and older comparing Asmanex HFA 200 mcg (n=240 patients), mometasone furoate/formoterol fumarate 200 mcg/5 mcg (n=255 patients), and mometasone furoate/formoterol fumarate 100 mcg/5 mcg (n=233 patients), each administered as 2 inhalations twice daily by metered dose inhalation aerosols. All other maintenance therapies were discontinued. This trial included a 2- to 3-week run-in period with Asmanex HFA 200 mcg, 2 inhalations twice daily. Patients had persistent asthma and were uncontrolled on high-dose inhaled corticosteroids prior to study entry. Patients ranged from 12 to 84 years of age, 44% were male and 56% female, and 89% were Caucasian and 11% non-Caucasian. Mean FEV1 and mean percent predicted FEV1 values were similar among all treatment groups (2.05 L, 66%). The number of patients who discontinued the trial early due to treatment failure were 11 (5%) in the mometasone furoate/formoterol fumarate 100 mcg/5 mcg group, 8 (3%) in the mometasone furoate/formoterol fumarate 200 mcg/5 mcg group, and 13 (5%) in the Asmanex HFA 200 mcg group.

In order to assess the added benefit of a higher dose of mometasone in the 200 mcg/actuation mometasone furoate product compared to the lower dose 100 mcg/actuation product, trough FEV1 at 12 weeks was compared between the combination mometasone furoate/formoterol fumarate 200 mcg/5 mcg and 100 mcg/5 mcg treatment groups as a secondary endpoint. Improvement in trough FEV1 from baseline to week 12 in patients who received mometasone furoate 200 mcg in combination with formoterol fumarate 5 mcg was numerically greater than among patients who received mometasone furoate 100 mcg in combination with formoterol fumarate 5 mcg (treatment difference of 0.05 L and 95% confidence interval [-0.02, 0.10]).

Other Studies

In addition to Trial 1 and Trial 2, the safety and efficacy of mometasone furoate MDI 100 mcg and 200 mcg, in comparison to placebo were demonstrated in three other 12-week, placebo-controlled trials which evaluated the mean change in FEV1 from baseline as a primary endpoint.

Instructions for Use

ASMANEX® HFA
(mometasone furoate)
Inhalation Aerosol

Read these Instructions for Use before you start using Asmanex HFA 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 your treatment.

The parts of your Asmanex HFA:

There are 2 main parts to your Asmanex HFA inhaler: the metal canister that holds the medicine and the blue plastic actuator that sprays the medicine from the canister.

The inhaler also has a pink cap that covers the mouthpiece of the actuator (see Figure 1). The cap from the mouthpiece must be removed before use. The inhaler contains "120" actuations (puffs).

Figure 1

The inhaler comes with a dose counter located on the plastic actuator (see Figure 1). The counter display will show the number of actuations (puffs) of medicine remaining. The first time you use Asmanex HFA the dose counter will show "124" actuations remaining. Each time you press the canister, a puff of medicine is released and the counter will count down by 1. The counter will stop counting at 0.

Important Information:

Use Asmanex HFA exactly as your healthcare provider tells you to.
Remove the cap from the mouthpiece of the actuator before using Asmanex HFA.
Do not remove the canister from the actuator because:
- you may not receive the correct amount of medication.
- the dose counter may not function properly.
- if you try to insert the canister back into the actuator this may cause the dose counter to count down by 1 and may discharge a puff.
Use the Asmanex HFA canister only with the actuator supplied with the product. Do not use parts of the Asmanex HFA inhaler with parts from any other inhalation medicine.

Before using your Asmanex HFA:

Remove the cap from the mouthpiece of the actuator before using Asmanex HFA (see Figure 2). Check the mouthpiece for objects before use. Make sure the canister is fully inserted into the actuator.

Figure 2

Priming your Asmanex HFA Inhaler:

Before you use Asmanex HFA for the first time, you must prime the inhaler.

1. To prime the inhaler, hold it in the upright position away from your face, and press down firmly and fully on the top of the canister until it stops moving in the actuator. Do this 4 times to release a total of 4 actuations (puffs) into the air. 2. Shake the inhaler well before each of the priming actuations. After priming 4 times, the dose counter should read "120". 3. If you do not use your Asmanex HFA for more than 5 days, you will need to prime it again before use.

Using your Asmanex HFA:

4. Remove the cap from the mouthpiece of the actuator (see Figure 3). Check the mouthpiece for objects before use. Make sure the canister is fully inserted into the actuator. 5. Shake the inhaler well before each use. 6. Breathe out as fully as you comfortably can through your mouth. Push out as much air from your lungs as possible. Hold the inhaler in the upright position and place the mouthpiece into your mouth (see Figure 4). Close your lips around the mouthpiece.


Figure 3	Figure 4

7. Take a deep breath (inhale) in slowly through your mouth. While doing this, press down firmly and fully on the top of the canister until it stops moving in the actuator. Take your finger off the canister. 8. When you have finished breathing in, hold your breath as long as you comfortably can, up to 10 seconds. Then remove the inhaler from your mouth and breathe out through your nose, while keeping your lips closed. 9. Wait at least 30 seconds to take your second puff of Asmanex HFA. 10. Shake the inhaler well again and repeat steps 6 through 8 to take your second puff of Asmanex HFA.

After using your Asmanex HFA inhaler:

11. Replace the cap over the mouthpiece right away after use (see Figure 5).

Figure 5

12. After you finish taking Asmanex HFA (2 puffs), rinse your mouth with water.

Reading the counter:

The dose counter identifies the number of inhalations (puffs) left in your inhaler (see Figure 6).
The counter will count down each time you release a puff of medicine (either when preparing your Asmanex HFA inhaler for use or when using the medicine).

Figure 6

When to replace your Asmanex HFA:

It is important that you pay attention to the number of inhalations (puffs) left in your Asmanex HFA inhaler by reading the counter.
When the counter reads "20", you should refill your prescription or ask your healthcare provider if you need a new prescription for Asmanex HFA.
Throw away Asmanex HFA after the counter reaches "0", indicating that you have used the number of actuations on the product label and box. Your inhaler may not feel empty and it may continue to operate, but you will not get the right amount of medicine if you keep using it.
Never try to change the numbers on the counter or remove the counter from the actuator.
Do not use the inhaler after the expiration date.

How to clean your Asmanex HFA:

The mouthpiece should be cleaned using a dry wipe after every 7 days of use.

Routine cleaning instructions:

Remove the cap off the mouthpiece. Wipe the inside and outside surfaces of the actuator mouthpiece with a clean, dry, lint-free tissue or cloth. Do not wash or put any parts of your inhaler in water. Put the cap back on the mouthpiece after cleaning.
Do not remove the canister from the actuator.
Do not attempt to unblock the actuator with a sharp object, such as a pin.

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

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by: 3M Health Care Ltd., Loughborough, United Kingdom.

For patent information: www.merck.com/product/patent/home.html

The trademarks depicted herein are owned by their respective companies.

Revised: 08/2015
usppi-mk0887-ao-1508r001

PRINCIPAL DISPLAY PANEL - 100 mcg Canister Carton

NDC 0085-4333-01

Asmanex® HFA
(mometasone furoate)
Inhalation Aerosol

100 mcg per actuation

For oral inhalation only

Asmanex HFA canister to be used
with Asmanex HFA actuator only.

SHAKE WELL BEFORE USING.

Rx only

120 Metered Actuations
Net Wt. 13g

PRINCIPAL DISPLAY PANEL - 200 mcg Canister Carton

NDC 0085-4334-01