Revefenacin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Uma Maveli[2]
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Black Box Warning
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WARNING: Serious Case of Paradoxical Bronchospasm
See full prescribing information for complete Boxed Warning.
Life-threatening paradoxical bronchospasm
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Overview
Revefenacin is a anticholinergics that is FDA approved for the treatment of 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. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Headache, Cough, Problems regarding the upper respiratory system, Back Pain.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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
Recommended Vaccination and Prophylaxis
Recommended Weight-Based Dosage Regimen - OCPD
Recommended Weight-Based Dosage Regimen - aHUS
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
Preparation of Revefenacin
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
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Revefenacin Off-Label Guideline-Supported Use and Dosage (Adult) in the drug label.
Non–Guideline-Supported Use
There is limited information regarding Revefenacin Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Revefenacin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Revefenacin Off-Label Guideline-Supported Use and Dosage (Pediatric) in the drug label.
Non–Guideline-Supported Use
There is limited information regarding Revefenacin Off-Label Non-Guideline-Supported Use and Dosage (Pediatric) in the drug label.
Contraindications
- Revefenacin is contraindicated in patients with hypersensitivity to revefenacin or any component of this product.
Warnings
|
WARNING: Serious Case of Paradoxical Bronchospasm
See full prescribing information for complete Boxed Warning.
Life-threatening paradoxical bronchospasm
|
Deterioration of Disease and Acute Episodes
Worsening of Narrow-Angle Glaucoma
Worsening of Urinary Retention
Immediate Hypersensitivity Reactions
Infusion Reactions
Adverse Reactions
Clinical Trials Experience
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Atypical Hemolytic Uremic Syndrome (aHUS)
Immunogenicity
Postmarketing Experience
There is limited information regarding Yupelri Postmarketing Experience in the drug label.
Drug Interactions
- Anticholinergic medicines coadministered with Yupelri (Revefenacin) can cause heightened Anticholinergic Adverse effects.
- Additionally, OATP1B1 and OATP1B3 inhibitors could potentially harm and increase the exposure of a metabolite, so it is not recommended that these be coadministered with Yupelri
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There are no available data on Revefencain use in pregnant women to inform a drugassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Revefenacin in women who are pregnant.
Labor and Delivery
Nursing Mothers
There is no FDA guidance on the use of Revefenacin with respect to nursing.
Pediatric Use
Geriatic Use
Gender
There is no FDA guidance on the use of Revefenacin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Revefenacin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Revefenacin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Revefenacin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Revefenacin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Revefenacin in patients who are immunocompromised.
Administration and Monitoring
Administration
- After intravenous administration of revefenacin, the reported volume of distribution is 218 L which suggests an extensive distribution to the tissues
Monitoring
IV Compatibility
There is limited information regarding the compatibility of Revefenacin and IV administrations.
Overdosage
Common signs and symptoms of overdosage of Revefenacin:
- nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure, obstipation and difficulties in voiding
- If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
Revefenacin
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| Mol. mass | 55768.94 Da |
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Mechanism of Action
Structure
Pharmacodynamics
Pharmacokinetics
Distribution
The reported volume of distribution is 218 L which suggests an extensive distribution to the tissues
Elimination
There are two phases of elimination: Kinetics Elimination: rapid declining plasma concentration followed by slow bi-exponential elimination. Renal Elimination: the amount excreted in urine is the unchanged drug, <0.2% of the administered dose. Following the IV administration, 54% of dose is recovered in feces and 27* in urine
Specific Populations
In clinical trials that tested Yupelri effect on pregnant rats and rabbits at exposures that would be 209 times the maximum exposure compared to the maximum human dose, it produced no birth defects or harm.
Nonclinical Toxicology
Impairment of Fertility
- There are no studies performed on humans and the harm rate is unknown for pregnant women. However, studies performed on pregnant rats and rabbits resulted in slim to 0 fetal harm.
Clinical Studies
Chronic Obstructive Pulmonary Disease (COPD)
OCPD Study 301 [ALXN1210-PNH-301; NCT02946463]
OCPD Study [ALXN1210-PNH-302; NCT03056040]
Study in Adult Patients with Chronic Obstructive Pulmonary Disease [ALXN1210-aHUS-311; NCT02949128]
- The clinical trials are secured and conducted in many different conditions, so it cannot be compared to other drugs undergoing clinical trials
- There were two 12-week trials and one 52-week trial
- The patients received a total of 175 mcg of Yupelri one-time daily
- 12-week trials: There were two 12-week trials. They are replicated trials that use placebo.
- These trials were conducted on patients with moderate to severe COPD. There were a total of 395 patients, ages ranging from 41-88. The demographics are 50% male, and 90% Caucasian out of the total patients. 13% of the Yupelri treated patients discontinued the trial due to adverse reactions, and 19% of the placebo patients.
- 52-week trial: This was one 52-week length trial that provided the subjects with a 18 mcg dose of tiotropium daily once. There were 335 subjects treated with 175 mcg of Yupelri daily, and 356 patients with the dose of tiotropium mentioned above.
Study in Pediatric Patients with Chronic Obstructive Pulmonary Disease [ALXN1210-aHUS-312; NCT03131219]
- There is limited information regarding Revefenacin Studies in Pediatric Patients
How Supplied
- YUPELRI inhalation solution: as a sterile, clear, colorless, aqueous solution for nebulization in low-density polyethylene unit-dose vials
- Each vial: 175 mcg of revefenacin in 3 mL of aqueous solution.
Storage
- Revefenacin is stored as a preservative-free aqueous solution product
- The storage condition is dry, dark and at 0 - 4 C for short term (days to weeks) or -20 C for long term (months to years)
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Serious Side Effects
- Get medical help right away if these symptoms show up
- Wheezing
- Choking
- Blurred Vision
- Tunnel Vision
- Eye Pain, Redness
- Difficulty Urinating or Emptying your bladder
- Inform Patients to report side effects to the FDA at: 1-800-FDA-1088
Other Infections
- Counsel patients of the increased risk of infections, particularly those due to encapsulated bacteria, especially Neisseria species.
Discontinuation
- Patients who express Paradoxical Bronchospasm, which means breathing or wheezing will worsen, should discontinue Revefenacin and initiate therapy with another agent
Infusion reactions
- Advise patients that administration of Revefenacin may result in infusion reactions.
- Headache, Cough, Problems regarding the upper respiratory system, Back Pain are all examples of infusion reactions
Precautions with Alcohol
Alcohol-Revefenacin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
Ultomiris
Look-Alike Drug Names
There is limited information regarding Ultomiris Look-Alike Drug Names in the drug label.
Drug Shortage Status
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.