Anoro is a combination of a long-acting anticholinergic medicine (Umeclidinium) and a long-acting beta-agonist (Vilanterol).

It is used as a maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Umeclidinium and vilanterol Dose in Adults

Anoro dose in the treatment of COPD:

• Oral inhalation: Dry powder inhaler:
  • One inhalation (umeclidinium 62.5 mcg/vilanterol 25 mcg) given once daily
  • The maximum dose is 1 inhalation/day

Umeclidinium and vilanterol Dose in Children

Not recommended for use in children. 

Anoro Pregnancy Risk Factor: C

• This combination has not been used in animal reproduction studies.
• If administered during labor, beta-agonists can affect uterine contractionility.

Use of Anoro (Umeclidinium, vilanterol) during breastfeeding

• It is unknown if enough umeclidinium and vilanterol are absorbed after inhalation to make breast milk detectable.
• According to the manufacturer the decision to stop or continue breastfeeding during therapy must consider the risks to infants, the benefits to the mother, and the benefits to the mother.

Umeclidinium and vilanterol Dose in Renal Disease:

No dosage adjustment required 

Anoro dose in liver disease:

• Mild to moderate impairment:

  • No dosage adjustment required.

• Severe impairment:

  • There are no dosage adjustments given in the manufacturer's labeling (has not been studied).

Side Effects of Anoro (Umeclidinium and vilanterol) Include:

• Cardiovascular:

  • Chest Pain

• Central Nervous System:

  • Headache
  • Vertigo

• Endocrine & Metabolic:

  • Diabetes Mellitus

• Gastrointestinal:

  • Diarrhea
  • Abdominal Pain
  • Nausea
  • Toothache
  • Constipation

• Genitourinary:

  • Urinary Tract Infection

• Neuromuscular & Skeletal:

  • Limb Pain
  • Arthralgia
  • Back Pain
  • Muscle Spasm
  • Neck Pain

• Respiratory:

  • Pharyngitis
  • Cough
  • Lower Respiratory Tract Infection
  • Pleuritic Chest Pain
  • Sinusitis

Contraindication to Anoro (Umeclidinium and vilanterol Include):

• Hypersensitivity to umeclidinium or vilanterol or any component of the formulation
• Milk proteins can cause severe hypersensitivity
• monotherapy (without the use of a concomitant inhaled corticosteroid) in the treatment of asthma.

Warnings and precautions

• Asthma-related Deaths:
  • In the treatment of asthma, monotherapy with a long-acting beta-2 agonist (LABA), is not recommended.
  • Umeclidinium/vilanterol is not advised for the treatment of asthma.
  • There is no evidence to suggest that LABA may increase the risk of death in patients suffering from chronic obstructive lung disease (COPD).
• Bronchospasm
  • Inhaled bronchodilating drugs can cause life-threatening paradoxical bronchospasm
  • This should be distinguished from an inadequate response.
  • If paradoxical bronchospasm is experienced, it should be stopped.
• Hypersensitivity
  • Anaphylaxis may be severe, with angioedema and rash possible.
  • If you notice signs or symptoms of hypersensitivity reactions, stop immediately.
• Serious effects/fatalities:
  • Limit your use of LABAs in combination with any other medications.
  • Excessive use of inhaled sympathomimetics has been linked to serious adverse reactions, including death.
• Cardiovascular disease
  • Patients with heart disease (eg, arrhythmias or coronary insufficiency) should be cautious.
  • Beta-agonists can increase blood pressure and heart beat.
  • Beta-2 agonists can also produce changes in the ECG (eg, T wave flattening, QTc prolongation, ST-segment depression).
• Diabetes:
  • Patients with diabetes mellitus should be cautious.
  • beta-2 agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.
• Glaucoma:
  • Patients with narrow-angle vision should be cautious.
  • Increase intraocular pressure
• Hyperthyroidism:
  • Patients with hyperthyroidism should be cautious; beta-2 agonists can stimulate thyroid activity.
• Hypokalemia
  • Hypokalemia patients should be treated with caution
  • Beta-2 agonists can cause a temporary decrease in serum potassium
• Seizures:
  • Patients with seizure disorders should be treated cautiously
  • beta-2 agonists may result in CNS stimulation/excitation.
• Urinary retention
  • Patients with urinary retention should be treated with caution
  • Particularly in patients with bladder neck obstruction or prostatic hyperplasia, look out for signs and symptoms such as urinary retention.

Umeclidinium and vilanterol: Drug Interaction

Monitor:

• FEV1
• peak flow, and/or other pulmonary function tests
• serum potassium
• serum glucose
• blood pressure, heart rate
• CNS stimulation
• signs/symptoms of glaucoma
• hypersensitivity reactions
• urinary retention

How to administer Anoro (Umeclidinium and vilanterol)?

Oral inhalation: Dry powder inhaler:

• For oral inhalation only
• Give at the same time each day
• there is no need to shake the inhaler
• Remove the inhaler from a sealed pouch immediately prior to first use.
• Each time the cover of the inhaler is opened, a ‘click’ should be heard and the counter will count down by 1 number
• The dose is ready to be inhaled.
• If a "click" is heard but the counter does not count down, the inhaler will not deliver the medicine.
• Only open inhaler cover when ready for administration; opening and closing the device without inhaling will result in a lost dose
• Do not close the inhaler cover until the dose has been inhaled.
• Refer to the product labeling for additional administration instructions.

Mechanism of action of Anoro (Umeclidinium and vilanterol):

Umeclidinium

• It is an anticholinergic medicine with a long-lasting effect that inhibits the activity of acetylcholine (M-3) receptors in bronchial smooth muscles. This causes bronchodilation.

Vilanterol:

• It is a beta-agonist that acts long-lastingly and relaxes the bronchial smooth muscles by selective action on beta-receptors. This has little effect on heart beat.

Absorption: Umeclidinium and vilanterol:

• Systemic, primarily via lungs

Distribution: IV:

• Umeclidinium: 86 L; Vilanterol: 165 L

Protein binding:

• Umeclidinium: 89%; Vilanterol: 94%

Metabolism:

• Hepatic via CYP2D6 (umeclidinium) and CYP3A4 (vilanterol)

Half-life elimination:

• 11 hours

Excretion:

• Via Urine (<1% umeclidinium; 70% vilanterol); feces (92% umeclidinium; 30% vilanterol)

International Brands of Umeclidinium and vilanterol:

• Anoro
• Anoro Ellipta
• Laventair

Umeclidinium and vilanterol Brands in Pakistan:

No Brands Available in Pakistan.