Cutivate

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Cutivate uses

• Warning: asthma-related death
• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Cutivate reviews

WARNING: ASTHMA-RELATED DEATH

Long-acting beta₂-adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in ADVAIR^® HFA Inhalation Aerosol, increase the risk of asthma-related death. Data from a large placebo-controlled U.S. trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 subjects on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

Therefore, when treating patients with asthma, physicians should only prescribe Cutivate for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Cutivate) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Cutivate for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids .

WARNING: ASTHMA-RELATED DEATH

See full prescribing information for complete boxed warning

• Long-acting beta₂-adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in Cutivate Inhalation Aerosol, increase the risk of asthma-related death. A U.S. trial showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 out of 13,179 subjects on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. (5.1)
• When treating patients with asthma, only prescribe Cutivate for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Cutivate) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Cutivate for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids. (1, 5.1)

1 INDICATIONS AND USAGE

Cutivate is indicated for the treatment of asthma in patients aged 12 years and older.

LABA, such as salmeterol, one of the active ingredients in Cutivate, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients . Therefore, when treating patients with asthma, physicians should only prescribe Cutivate for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Cutivate) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Cutivate for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

Important Limitation of Use

Cutivate is NOT indicated for the relief of acute bronchospasm.

Cutivate is a combination product containing a corticosteroid and a LABA indicated for treatment of asthma in patients aged 12 years and older.

Important limitation:

• Not indicated for relief of acute bronchospasm. (1)

2 DOSAGE AND ADMINISTRATION

Cutivate should be administered as 2 inhalations twice daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

More frequent administration or a greater number of inhalations (more than 2 inhalations twice daily) of the prescribed strength of Cutivate is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. Patients using Cutivate should not use additional LABA for any reason.

If asthma symptoms arise in the period between doses, an inhaled, short-acting beta₂-agonist should be taken for immediate relief.

For patients aged 12 years and older, the dosage is 2 inhalations twice daily, approximately 12 hours apart.

The recommended starting dosages for Cutivate for patients aged 12 years and older are based upon patients’ asthma severity.

The maximum recommended dosage is 2 inhalations of Cutivate 230/21 twice daily.

Improvement in asthma control following inhaled administration of Cutivate can occur within 30 minutes of beginning treatment, although maximum benefit may not be achieved for 1 week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, replacing the current strength of Cutivate with a higher strength may provide additional improvement in asthma control.

If a previously effective dosage regimen fails to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the current strength of Cutivate with a higher strength, adding additional inhaled corticosteroid, initiating oral corticosteroids) should be considered.

Prime Cutivate before using for the first time by releasing 4 sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 4 weeks or when it has been dropped, prime the inhaler again by releasing 2 sprays into the air away from the face, shaking well for 5 seconds before each spray.

• For oral inhalation only. (2)
• Treatment of asthma in patients aged 12 years and older: 2 inhalations of Cutivate 45/21, 115/21, or 230/21 twice daily. Starting dosage is based on asthma severity. (2)

3 DOSAGE FORMS AND STRENGTHS

Inhalation Aerosol. Purple plastic inhaler with a light purple strapcap containing a pressurized metered-dose aerosol canister containing 60 or 120 metered inhalations and fitted with a counter. Each actuation delivers a combination of Cutivate propionate (45, 115, or 230 mcg) and salmeterol (21 mcg) from the mouthpiece.

Inhalation Aerosol. Inhaler containing a combination of Cutivate propionate (45, 115, or 230 mcg) and salmeterol (21 mcg) as an aerosol formulation for oral inhalation. (3)

4 CONTRAINDICATIONS

The use of Cutivate is contraindicated in the following conditions:

• Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required .
• Hypersensitivity to any of the ingredients .

• Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. (4)
• Hypersensitivity to any ingredient. (4)

5 WARNINGS AND PRECAUTIONS

• LABA increase the risk of asthma-related death and asthma-related hospitalizations. Prescribe only for recommended patient populations.
• Do not initiate in acutely deteriorating asthma or to treat acute symptoms. (5.2)
• Do not use in combination with an additional medicine containing a LABA because of risk of overdose. (5.3)
• Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. (5.4)
• Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia. (5.5)
• Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. (5.6)
• Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Cutivate. (5.7)
• Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Cutivate slowly. (5.8)
• If paradoxical bronchospasm occurs, discontinue Cutivate and institute alternative therapy. (5.10)
• Use with caution in patients with cardiovascular or central nervous system disorders because of beta-adrenergic stimulation. (5.12)
• Assess for decrease in bone mineral density initially and periodically thereafter. (5.13)
• Monitor growth of pediatric patients. (5.14)
• Close monitoring for glaucoma and cataracts is warranted. (5.15)
• Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia. (5.16, 5.18)
• Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. (5.17)

5.1 Asthma-Related Death

LABA, such as salmeterol, one of the active ingredients in Cutivate, increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, physicians should only prescribe Cutivate for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Cutivate) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Cutivate for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

A large placebo-controlled U.S. trial that compared the safety of salmeterol with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in subjects receiving salmeterol. The Salmeterol Multicenter Asthma Research Trial (SMART) was a randomized double-blind trial that enrolled LABA-naive subjects with asthma to assess the safety of salmeterol 42 mcg twice daily over 28 weeks compared with placebo when added to usual asthma therapy. A planned interim analysis was conducted when approximately half of the intended number of subjects had been enrolled (N = 26,355), which led to premature termination of the trial. The results of the interim analysis showed that subjects receiving salmeterol were at increased risk for fatal asthma events (Table 1 and Figure 1). In the total population, a higher rate of asthma-related death occurred in subjects treated with salmeterol than those treated with placebo (0.10% versus 0.02%; relative risk: 4.37 [95% CI: 1.25, 15.34]).

Post hoc subpopulation analyses were performed. In Caucasians, asthma-related death occurred at a higher rate in subjects treated with salmeterol than in subjects treated with placebo (0.07% versus 0.01%; relative risk: 5.82 [95% CI: 0.70, 48.37]). In African Americans also, asthma-related death occurred at a higher rate in subjects treated with salmeterol than those treated with placebo (0.31% versus 0.04%; relative risk: 7.26 [95% CI: 0.89, 58.94]). Although the relative risks of asthma-related death were similar in Caucasians and African Americans, the estimate of excess deaths in subjects treated with salmeterol was greater in African Americans because there was a higher overall rate of asthma-related death in African American subjects (Table 1). Given the similar basic mechanisms of action of beta₂-agonists, the findings seen in the SMART trial are considered a class effect.

Post hoc analyses in pediatric subjects aged 12 to 18 years were also performed. Pediatric subjects accounted for approximately 12% of subjects in each treatment arm. Respiratory-related death or life-threatening experience occurred at a similar rate in the salmeterol group (0.12% [2/1,653]) and the placebo group (0.12% [2/1,622]; relative risk: 1.0 [95% CI: 0.1, 7.2]). All-cause hospitalization, however, was increased in the salmeterol group (2% [35/1,653]) versus the placebo group (less than 1% [16/1,622]; relative risk: 2.1 [95% CI: 1.1, 3.7]).

The data from the SMART trial are not adequate to determine whether concurrent use of inhaled corticosteroids, such as Cutivate propionate, the other active ingredient in Cutivate, or other long-term asthma control therapy mitigates the risk of asthma-related death.

Table 1. Asthma-Related Deaths in the 28-Week Salmeterol Multicenter Asthma Research Trial (SMART)

	Salmeterol n (%a)	Placebo n (%a)	Relative Riskb (95% Confidence Interval)	Excess Deaths Expressed per 10,000 Subjectsc (95% Confidence Interval)
Total populationd
Salmeterol: n = 13,176	13 (0.10%)		4.37 (1.25, 15.34)	8 (3, 13)
Placebo: n = 13,179		3 (0.02%)
Caucasian
Salmeterol: n = 9,281	6 (0.07%)		5.82 (0.70, 48.37)	6 (1, 10)
Placebo: n = 9,361		1 (0.01%)
African American
Salmeterol: n = 2,366	7 (0.31%)		7.26 (0.89, 58.94)	27 (8, 46)
Placebo: n = 2,319		1 (0.04%)

^a Life-table 28-week estimate, adjusted according to the subjects’ actual lengths of exposure to trial treatment to account for early withdrawal of subjects from the trial.

^b Relative risk is the ratio of the rate of asthma-related death in the salmeterol group and the rate in the placebo group. The relative risk indicates how many more times likely an asthma-related death occurred in the salmeterol group than in the placebo group in a 28-week treatment period.

^c Estimate of the number of additional asthma-related deaths in subjects treated with salmeterol in SMART, assuming 10,000 subjects received salmeterol for a 28-week treatment period. Estimate calculated as the difference between the salmeterol and placebo groups in the rates of asthma-related death multiplied by 10,000.

^d The total population includes the following ethnic origins listed on the case report form: Caucasian, African American, Hispanic, Asian, and “Other.” In addition, the total population includes those subjects whose ethnic origin was not reported. The results for Caucasian and African American subpopulations are shown above. No asthma-related deaths occurred in the Hispanic (salmeterol n = 996, placebo n = 999), Asian (salmeterol n = 173, placebo n = 149), or “Other” (salmeterol n = 230, placebo n = 224) subpopulations. One asthma-related death occurred in the placebo group in the subpopulation whose ethnic origin was not reported (salmeterol n = 130, placebo n = 127).

Figure 1. Cumulative Incidence of Asthma-Related Deaths in the 28-Week Salmeterol Multicenter Asthma Research Trial (SMART), by Duration of Treatment

• The counter starts at either 124 or 064, depending on which size inhaler you have. The number will count down by 1 each time you spray the inhaler. The counter will stop counting at 000.
• Do not try to change the numbers or take the counter off the metal canister. The counter cannot be reset, and it is permanently attached to the canister.
• The purple plastic actuator sprays the medicine from the canister. The actuator has a protective cap that covers the mouthpiece. See Figure A. Keep the protective cap on the mouthpiece when the canister is not in use. The strap keeps the cap attached to the actuator.
• Do not use the actuator with a canister of medicine from any other inhaler.
• Do not use an Cutivate canister with an actuator from any other inhaler.

Before using your Cutivate inhaler

• Take Cutivate out of the foil pouch just before you use it for the first time. Safely throw away the pouch and the drying packet that comes inside the pouch.
• The inhaler should be at room temperature before you use it.

Priming your Cutivate inhaler

• Before you use Cutivate for the first time, you must prime the inhaler so that you will get the right amount of medicine when you use it.
• To prime the inhaler, take the cap off the mouthpiece and shake the inhaler well for 5 seconds. Then spray the inhaler 1 time into the air away from your face. See Figure C. Avoid spraying in eyes.

• Shake and spray the inhaler like this 3 more times to finish priming it. The counter should now read 120 or 060, depending on which size inhaler you have. See Figure D.

• You must prime your inhaler again if you have not used it in more than 4 weeks or if you drop it. Take the cap off the mouthpiece and shake the inhaler well for 5 seconds. Then spray it 1 time into the air away from your face. Shake and spray the inhaler like this 1 more time to finish priming it.

How to use your Cutivate inhaler

Follow these steps every time you use Cutivate.

• Step 1. Make sure the canister fits firmly in the actuator. The counter should show through the window in the actuator.
  • Shake the inhaler well for 5 seconds before each spray.
• Take the cap off the mouthpiece of the actuator. Look inside the mouthpiece for foreign objects, and take out any you see.
• Step 2. Hold the inhaler with the mouthpiece down. See Figure E.

• Step 3. Breathe out through your mouth and push as much air from your lungs as you can. Put the mouthpiece in your mouth and close your lips around it. See Figure F.
• Step 4. Push the top of the canister all the way down while you breathe in deeply and slowly through your mouth. See Figure F.

• Step 5. After the spray comes out, take your finger off the canister. After you have breathed in all the way, take the inhaler out of your mouth and close your mouth.
  • Step 6. Hold your breath for about 10 seconds, or for as long as is comfortable. Breathe out slowly as long as you can.
    • Wait about 30 seconds and shake the inhaler well for 5 seconds. Repeat steps 2 through 6.
• Step 7. Rinse your mouth with water after breathing in the medicine. Spit out the water. Do not swallow it. See Figure G.

• Step 8. Put the cap back on the mouthpiece after every time you use the inhaler. Make sure it snaps firmly into place.

Cleaning your Cutivate inhaler

Clean your inhaler at least 1 time each week after your evening dose. You may not see any medicine build-up on the inhaler, but it is important to keep it clean so medicine build-up will not block the spray. See Figure H.

Figure H

• Step 9. Take the cap off the mouthpiece. The strap on the cap will stay attached to the actuator. Do not take the canister out of the plastic actuator.
• Step 10. Use a dry cotton swab to clean the small circular opening where the medicine sprays out of the canister. Carefully twist the swab in a circular motion to take off any medicine. See Figure I.

Figure I

• Step 11. Wipe the inside of the mouthpiece with a clean tissue dampened with water. Let the actuator air-dry overnight.

Step 12. Put the cap back on the mouthpiece after the actuator has dried.

Replacing your Cutivate inhaler

• When the counter reads 020, you should refill your prescription or ask your healthcare provider if you need another prescription for Cutivate.
• When the counter reads 000, throw the inhaler away. You should not keep using the inhaler when the counter reads 000 because you may not receive the right amount of medicine.
• Do not use the inhaler after the expiration date, which is on the packaging it comes in.

For correct use of your Cutivate inhaler, remember:

• The canister should always fit firmly in the actuator.
• Breathe in deeply and slowly to make sure you get all the medicine.
• Hold your breath for about 10 seconds after breathing in the medicine. Then breathe out fully.
• After each dose, rinse your mouth with water and spit it out. Do not swallow the water.
• Do not take the inhaler apart.
• Always keep the protective cap on the mouthpiece when your inhaler is not in use.
• Always store your inhaler with the mouthpiece pointing down.
• Clean your inhaler at least 1 time each week.

If you have questions about Cutivate or how to use your inhaler, call GlaxoSmithKline (GSK) at 1-888-825-5249 or visit www.advair.com.

ADVAIR is a registered trademark of the GSK group of companies.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2017 the GSK group of companies. All rights reserved.

ADH:1IFU

• This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: February 2017

Figure A Figure B Figure C Figure D Figure E Figure F Figure G Figure H Figure I

Cutivate pharmaceutical active ingredients containing related brand and generic drugs:

• Fluticasone Propionate

Cutivate available forms, composition, doses:

• Cream; Topical; Fluticasone Propionate 0.05%
• Lotion; Topical; Fluticasone Propionate 0.05%
• Ointment; Topical; Fluticasone Propionate 0.05%

Cutivate destination | category:

• Human:
• Adrenals
• Anti-inflammatory agents
• Antiasthmatic and COPD preparations
• Corticosteroids
• Nasal decongestants and other nasal preparations
• Topical corticosteroids

Cutivate Anatomical Therapeutic Chemical codes:

• D07AC17 - Fluticasone
• R01AD08 - Fluticasone
• R03BA05 - Fluticasone

Cutivate pharmaceutical companies:

• Altana Pharma
• Firma Chun Cheong
• GlaxoSmithKline
• Nycomed
• PharmaDerm
• UCB Pharma
• Zuellig Pharma

References

1. Dailymed."FLUTICASONE PROPIONATE CREAM [PERRIGO NEW YORK INC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
3. "FLUTICASONE PROPIONATE". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Cutivate?

Depending on the reaction of the Cutivate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cutivate not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Cutivate addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Cutivate, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Cutivate consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology