Fluticasone Umeclidinium Vilanterol

Fluticasone, Umeclidinium, and Vilanterol are combination prescription medications used to prevent airflow obstruction and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema. 

• Fluticasone, Umeclidinium, and Vilanterol are available under various brand names: Trelegy Ellipta

Common side effects of Fluticasone, Umeclidinium, and Vilanterol include:

• cold or flu symptoms such as runny or stuffy nose, sinus pain, sore throat, and cough.
• nausea, vomiting, stomach pain.
• constipation, diarrhea.
• urination problems.
• joint pain.
• hoarse voice.
• headache, back pain; 
• mouth pain, changes in the sense of taste.

Serious side effects of Fluticasone, Umeclidinium, and Vilanterol include:

• hives. 
• difficult breathing. 
• swelling of the face, lips, tongue, or throat.
• tremors, nervousness, chest pain, fast or pounding heartbeats.
• fever, chills, cough with mucus, feeling short of breath.
• sores or white patches in the mouth and throat, and pain when swallowing.
• wheezing, choking, or other breathing problems after using this medicine.
• painful or difficult urination.
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights.
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in the chest, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder--tiredness or weakness, feeling light-headed, nausea, vomiting.

Rare side effects of Fluticasone, Umeclidinium, and Vilanterol include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Powder for inhalation

• Kit contains 2 foil strips, each with 30 blisters: 1 strip contains fluticasone furoate (100 mcg or 200 mcg per blister); the other strip contains a combination of umeclidinium and vilanterol (62.5 mcg and 25 mcg per blister)
• 100 mcg/62.5 mcg/25 mcg
• 200 mcg/62.5 mcg/25 mcg

Chronic Obstructive Pulmonary Disease

Adult dosage

• Fluticasone furoate 100 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg is the only strength indicated for COPD
• 1 actuation (100 mcg/62.5 mcg/25 mcg) by orally inhalation once a day
• If shortness of breath occurs between doses, use an inhaled, short-acting beta2-agonist (. g, albuterol) for immediate relief

Asthma

Adult dosage

• Starting dose: 1 actuation of 100 mcg/62.5 mcg/25 mcg OR 200 mcg/62.5 mcg/25 mcg, depending on disease severity, previous asthma therapy (including inhaled corticosteroid dosage), current asthma symptoms, and risk of future exacerbation
• Not to exceed 1 actuation by oral inhalation once a day
• If asthma symptoms occur between doses, use an inhaled, short-acting beta2-agonist (. g, albuterol) for immediate relief
• Patients not adequately responding
• 100 mcg/62.5 mcg/25 mcg: May increase to 200 mcg/62.5 mcg/25 mcg once a day
• 200 mcg/62.5 mcg/25 mcg: Reevaluate and consider other therapeutic regimens and additional therapeutic options

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Fluticasone, Umeclidinium, and Vilanterol have severe interactions with the following drugs:
  • aclidinium
  • glycopyrrolate
  • glycopyrrolate inhaled
  • indacaterol, inhaled
  • lefamulin
  • tiotropium
• Fluticasone, Umeclidinium, and Vilanterol have serious interactions with at least 136 other drugs.
• Fluticasone, Umeclidinium, and Vilanterol have serious interactions with at least 76 other drugs.
• Fluticasone, Umeclidinium, and Vilanterol have severe interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Allergic to fluticasone, umeclidinium, vilanterol, or milk proteins. 
• Asthma

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fluticasone, Umeclidinium, and Vilanterol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fluticasone, Umeclidinium, and Vilanterol?”

Cautions

• This medicine is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.
• Fluticasone, umeclidinium, and vilanterol are not rescued medicine. It will not work fast enough to treat a bronchospasm attack.
• Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.
• If you have been using an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.
• Do not use a second inhaled bronchodilator that contains vilanterol or a similar medicine (such as formoterol, arformoterol, indacaterol, olodaterol, or salmeterol).
• Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a medicine that contains fluticasone (a steroid).

Pregnancy and Lactation

• There are insufficient data on pregnant women to inform a drug-associated risk
• In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small gestational age in neonate
• Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma
• May be used during late gestation and labor only if the potential benefit justifies the potential for risks related to beta-agonists interfering with uterine contractility
• Tell your doctor if you are pregnant.
• Lactation
  • There is no information available on the presence of fluticasone furoate, umeclidinium, or vilanterol in human milk; effects on the breastfed child; or milk production
  • Umeclidinium was detected in the plasma of offspring of lactating rats treated with umeclidinium, suggesting its presence in maternal milk
  • Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for treatment and any potential adverse effects on the breastfed child from fluticasone furoate, umeclidinium, or vilanterol or the underlying maternal condition
  • Tell your doctor if you are breastfeeding.