Incruse Ellipta

Umeclidinium is an anticholinergic that works by relaxing muscles in the airways to improve breathing.

Umeclidinium is used to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease).

Umeclidinium may also be used for purposes not listed in this medication guide.

Umeclidinium is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack. Use only a fast acting inhalation medicine for an attack.

You should not use this medicine if you are allergic to umeclidinium or milk proteins.

To make sure this medicine is safe for you, tell your doctor if you have:

• narrow-angle glaucoma;
• heart disease;
• enlarged prostate; or
• bladder obstruction or other urination problems.

FDA pregnancy category C. It is not known whether umeclidinium will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether umeclidinium passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Umeclidinium is not approved for use by anyone younger than 18 years old.

Dosage Forms & Strengths

powder for inhalation

• 62.5mcg/actuation

Chronic Obstructive Pulmonary Disease

Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

62.5 mcg (1 actuation) inhaled PO qDay

Dosage Modifications

Renal impairment (including severe [CrCl <30 mL/min]): No dosage adjustment required

Moderate hepatic impairment (Child-Pugh 7-9): No dosage adjustment required

Severe hepatic impairment: Unknown, not evaluated

Geriatric patients: No dosage adjustment required

Administration

Inhaler is not reusable

Store at room temperature between 68-77°F (20-25°C); excursions permitted from 59-86°F (15-30°C)

Store in a dry place away from direct heat or sunlight

Before the inhaler is used for the first time, the counter should show the number 30 (7 if a sample or institutional pack); this is the number of doses in the inhaler

See prescribing information for detailed description regarding how to administer

Safety and efficacy not established

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:

• Antihistamines such as diphenhydramine (Benadryl, Sominex, in Advil PM, in Tylenol PM), chlorpheniramine (Chlor-Trimeton), or doxylamine (Unisom)
• Atropine
• Other medications for COPD including aclidinium (Tudorza Pressair), ipratropium (Atrovent HFA), and tiotropium (Spiriva)
• Medications for irritable bowel disease such as dicyclomine (Bentyl) or hyoscyamine (Anaspaz, Cystospaz, Levsin)
• Medications for motion sickness such as dimenhydrinate (Dramamine) or scopolamine
• Medications for Parkinson's disease such as benztropine (Cogentin) or trihexyphenidyl (Artane, Parkin, Pacitane)
• Medications for urinary problems such as oxybutynin (Ditropan, Driptane, Lyrinel XL), tolterodine (Detrol, Detrusitol), or solifenacin (Vesicare)

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

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Incruse Ellipta crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Incruse Ellipta.

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. Do not use more than 1 inhalation in a single day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: hives, rash, severe itching; 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;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• rapid heartbeats;

• painful or difficult urination; or

• little or no urinating.

Common side effects may include:

• stuffy or runny nose, sinus pain, sneezing;

• sore throat, cough;

• bruising or skin discoloration;

• mouth pain, tooth pain;

• joint pain;

• stomach pain; or

• altered sense of taste.

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.

Bronchospasm in COPD

Long-term maintenance treatment of reversible bronchospasm associated with COPD, including chronic bronchitis and/or emphysema.1 2 3 4 5 6 8 10

Not indicated for treatment of acute bronchospasm (i.e., as rescue therapy for treatment of acute episodes of bronchospasm).1 2

Other Uses

Not indicated for treatment of asthma†; safety and efficacy in asthma not established.2

Contraindications

• Known hypersensitivity to umeclidinium or any ingredient in the formulation.1 2

• Known severe hypersensitivity to milk proteins.1 2

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity reactions may occur.1 2 Anaphylactic reactions reported following oral inhalation of other powder preparations containing lactose in patients with severe milk protein allergy.1 2 (See Contraindications under Cautions.)

Use of Fixed Combinations

When used in fixed combination with vilanterol, consider the cautions, precautions, contraindications, and interactions associated with vilanterol.2

Deterioration of Disease and Acute Episodes

Do not initiate umeclidinium alone or in fixed combination with vilanterol in patients with acutely deteriorating COPD, which may be life-threatening.1 2

Do not use for relief of acute symptoms.1 2 Not studied in patients with acute symptoms; do not use extra doses of the drug in such situations.1 2 Use a short-acting, inhaled β2-agonist as needed for acute symptoms.1 2

Failure to respond to a previously effective dosage of umeclidinium alone or in fixed combination with vilanterol or to a supplemental short-acting, inhaled β2-agonist may indicate worsening COPD.1 2 Immediately reevaluate the patient and treatment regimen.1 2 Do not use extra or increased dosages in such situations.1 2

Paradoxical Bronchospasm

Acute, life-threatening paradoxical bronchospasm may occur.1 2

If paradoxical bronchospasm occurs, immediately treat patient with an inhaled, short-acting bronchodilator; discontinue therapy with umeclidinium (alone or in fixed combination with vilanterol); institute alternative therapy.1 2

Ocular Effects

Use caution in patients with acute angle-closure glaucoma.1 2 Possible worsening of acute angle-closure glaucoma manifested by ocular pain or discomfort, blurred vision, visual halos, or colored images in association with red eyes from conjunctival congestion and corneal edema.1 2 (See Advice to Patients.)

GU Effects

Use caution in patients with urinary retention.1 2 May worsen symptoms and signs (e.g., urinary retention, dysuria) associated with prostatic hyperplasia or bladder neck obstruction.1 2 (See Advice to Patients.)

Cardiovascular Effects

Atrial fibrillation reported in <1% of patients; reported more frequently with umeclidinium than with placebo.1 5

Prolongation of QTc not observed in healthy individuals.1 2 9

Specific Populations

Category C.1 2

Use during labor only if potential benefit outweighs potential risk.1 2

May be distributed into milk in rats; not known whether distributed into human milk.1 2 Discontinue nursing or the drug, taking into account the importance of the drug to the woman.1 2

Not indicated for use in pediatric patients.1 2 Safety and efficacy not established.1 2

No overall differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1 2 (See Geriatric Patients under Dosage and Administration.)

Exposure not substantially altered in patients with moderate hepatic impairment (Child-Pugh score of 7–9).1 2 Not studied in patients with severe hepatic impairment.1 2 (See Absorption under Pharmacokinetics.)

Exposure not substantially altered in patients with severe renal impairment (Clcr <30 mL/minute).1 2 11

Common Adverse Effects

Umeclidinium: nasopharyngitis,1 upper respiratory tract infection,1 cough,1 arthralgia.1

Umeclidinium/vilanterol fixed combination: Pharyngitis,2 sinusitis,2 lower respiratory tract infection,2 constipation,2 diarrhea,2 extremity pain,2 muscle spasms,2 neck pain,2 chest pain.2

• When used in fixed combination with vilanterol, importance of informing patients of important cautionary information about vilanterol.2

• Provide copy of the manufacturer’s patient information (medication guide) to all patients each time drug is dispensed.1 2 Importance of instructing patients to read the patient information prior to initiation of therapy and each time prescription is refilled.1 2

• Importance of informing clinician of any history of hypersensitivity reactions to umeclidinium or severe allergy to milk proteins.1 2

• Importance of adequate understanding of proper storage and inhalation techniques, including use of the inhalation delivery systems.1 2

• Importance of advising patients that if a dose is missed, to take the dose as soon as it is remembered; importance of not doubling the dose and of not taking more than one dose in a 24-hour period.1 2

• Importance of all patients being provided with and instructed in the use of a short-acting, inhaled β2-adrenergic agonist as supplemental therapy for acute symptoms.1 2

• Importance of contacting a clinician immediately if symptoms worsen or if the short-acting β2-agonist becomes less effective or more inhalations than usual are required to relieve symptoms.1 2

• Importance of patients not discontinuing therapy without medical supervision, since symptoms may recur after discontinuance.1 2

• Importance of not using umeclidinium to relieve acute symptoms or exacerbations of COPD.1 2

• Importance of discontinuing umeclidinium and informing a clinician if paradoxical bronchospasm occurs.1 2

• Importance of informing a clinician immediately if eye pain or discomfort, blurred vision, visual halos, or colored images in association with red eyes from conjunctival congestion or corneal edema occur.1 2

• Importance of informing a clinician immediately if urinary retention or dysuria occurs.1 2

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., eye drops) and herbal supplements, as well as any concomitant illnesses (e.g., urinary retention, enlarged prostate, angle-closure glaucoma).1 2

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2

• Importance of informing patients of other important precautionary information.1 2 (See Cautions.)

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to use as you have been told by the doctor or read the package insert.
• For breathing in only.
• Take Incruse Ellipta at the same time of day.
• To gain the most benefit, do not miss doses.
• Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Do not take out the inhaler from the foil tray until right before first use.
• If using more than 1 type of puffer (inhaler), ask the doctor which puffer to use first.
• Do not breathe out into the puffer (inhaler). Close the inhaler after you use your dose.
• Do not take the device apart or wash it. Do not use it with a spacer. Do not breathe out into the device.
• Clean mouthpiece by wiping with a dry tissue or cloth. Do not wash or put in water.
• Have your puffer (inhaler) use checked with your doctor at each visit. Read and follow facts on how to use the puffer. Make sure you use the puffer the right way.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.
• Do not use more than 1 time a day.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Bruising or dark areas of skin.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Shakiness.
• Change in eyesight, eye pain, or very bad eye irritation.
• Seeing halos or bright colors around lights.
• Eye redness.
• Not able to pass urine or change in how much urine is passed.
• Passing urine more often.
• Pain when passing urine.
• This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using Incruse Ellipta, use a rescue inhaler and get medical help right away.

The use of Incruse Ellipta is contraindicated in the following conditions:

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance:

1 inhalation (62.5 mcg) orally once a day
Maximum dose: 1 inhalation every 24 hours

Use: Treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Incruse Ellipta with a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with this medicine, especially:

• atropine;

• cold or allergy medicine that contains an antihistamine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;

• bladder or urinary medicines--darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin; or

• bronchodilators--aclidinium, ipratropium, tiotropium.

This list is not complete. Other drugs may interact with umeclidinium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

There was no evidence of teratogenic effects in rats and rabbits at approximately 50 and 200 times the maximum recommended human daily inhaled dose (MRHDID) in adults. There are no adequate and well-controlled studies in pregnant women. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B1 US FDA pregnancy category: C Comments: Patients should contact their physicians if they become pregnant while taking this drug.