Revefenacin

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Uma Maveli[2]

|genericName=generic name |aOrAn=a |drugClass= anticholinergics |indicationType= treatment |hasBlackBoxWarning=Yes |adverseReactions Side Effects

• Headache
• Cough
• Problems regarding the upper respiratory system
• Back Pain

|blackBoxWarningTitle= WARNING: SERIOUS MENINGOCOCCAL INFECTIONS |blackBoxWarningBody=<i><span style="color:#FF0000;"></span></i> Life-threatening meningococcal infections/sepsis

• Comply with the most current Advisory Committee on Immunization Practices (ACIP)

recommendations for meningococcal vaccination in patients with complement deficiencies

• Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of

ULTOMIRIS, unless the risks of delaying ULTOMIRIS therapy outweigh the risks of developing a meningococcal infection

• Vaccination reduces, but does not eliminate, the risk of meningococcal infection
  • Monitor patients for early signs of meningococcal infections, and evaluate immediately if infection is

suspected ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the ULTOMIRIS REMS, prescribers must enroll in the program Enrollment in the ULTOMIRIS REMS program and additional information are available by telephone: 1- 888-765-4747 or at www.ultomirisrems.com.

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Revefenacin is indicated for:

• The treatment of patients with chronic obstructive pulmonary disorder
  • Should not be given to patients experiencing life threatening episodes
  • In other words, Revefenacin should not be used as a rescue drug
• Discontinue the drug if patients appears to suffer from paradoxical bronchospasm or hypersensitivity reactions

Limitations of Use

• Revefenacin delivered via jet nebulizer can result in "longer administration time, variability in residual volume and particle size, daily cleaning requirements, limited portability, and need for device assembly"
  • The benefits may outweigh this because some patients are required to use nebulizers

Dosage

• The agreed dosage is 175 micrograms per day
  • Taken via a standard jet nebulizer (turns liquid medication into mist) connected to an air compressor
  • Makes it easy for patients with pulmonary problems

• The dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS); but the subsequent doses should be administered according to the original schedule.

Dosing Considerations

• Patients are not allowed to use nephrotoxic or hepatotoxic medications for 4 weeks before drug administration
  • They may use the following medications: acetaminophen, ibuprofen, milk of magnesia (magnesium hydroxide), and routine vitamins and minerals

Administration of Revefenacin

• Only administer as an intravenous infusion.
• Intravenous solution in healthy volunteers
  • Volume of distribution was 218 L
  • Intravenous solution radioactivity:
  • 54% came out as solid waste
  • 27% came out as liquid waste

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There is limited information regarding Revefenacin Off-Label Guideline-Supported Use and Dosage (Adult) in the drug label.

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There is limited information regarding Revefenacin Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label.

|contraindications= There is limited information regarding Revefenacin Contraidications

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Clinical Studies

Trials:

• Revefenacin proved to have long duration of action and low systemic exposure (doesn't affect the whole body) for patients struggling with Chronic Obstructive Pulmonary Disease or COPD
• 88 mcg of this drug can result in constructive bronchodilation (to helps patients breathe better)

Pharmacology trials:

• Evaluted human recombitance mAChRs (muscarinic cholinergic receptor) by testing it on airway tissues from rats, guinea pigs, and humans
  • Revefenacin proved high affinity for the human tissue and competed against those five human recombinant mAChRs
  • This drug attacked "mAChRs mediated contractile responses"
  • This shows that revefenacin produces long-lasting attacking effects on this tissue from rats, guinea pigs, and humans

Overdose

There is limited information regarding Revefenacin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Use in Specific Populations

• Revefencin is not affected majorly by age, weight, or gender
• Hepatic impariment has not been studied to see if there are necessary precautions to take
• Patients with renal impariment
  • Mesure for antimuscarinic adverse events or the inhibitting of acetocholine, a neurotransmitter in the PNS

Carcinogenesis, Mutagenesis, Impairment of Fertility

• No animal studies were performed to evaluate the effects of Revefenacin on carcinogenesis, or mutagenesis.
• Effects of Revefenacin upon fertility have not been studied in animals.
  • Intravenous injections of male and female mice with a murine anti-C5 antibody at up to 0.8-2.2 times the equivalent of the clinical dose of ULTOMIRIS had no adverse effects on mating or fertility.

Clinical Studies

Trials:

• Revefenacin proved to have long duration of action and low systemic exposure (doesn't affect the whole body) for patients struggling with Chronic Obstructive Pulmonary Disease or COPD
• 88 mcg of this drug can result in constructive bronchodilation (to helps patients breathe better)

Pharmacology trials:

• Evaluted human recombitance mAChRs (muscarinic cholinergic receptor) by testing it on airway tissues from rats, guinea pigs, and humans
  • Revefenacin proved high affinity for the human tissue and competed against those five human recombinant mAChRs
  • This drug attacked "mAChRs mediated contractile responses"
  • This shows that revefenacin produces long-lasting attacking effects on this tissue from rats, guinea pigs, and humans

Conclusion:

• Revefenacin has the potential to be a daily dose broncholdilator for patients struggling from COPD

Infusion reactions

• Side Effects
  • Headache
  • Cough
  • Problems regarding the upper respiratory system
  • Back Pain

Patient Counseling Information

• Currently Running a 52 week phase three trial for patients with severe OCPD

Precautions with Alcohol

There is limited information on Alcohol-Revefencin interactions. Talk to your doctor for further instruction on consuming alcohol with Revefenacin.

Brand Names

• Yupelri