Revefenacin
Generic Name: revefenacin
Brand Names:
Yupelri
11 DESCRIPTION YUPELRI is a sterile, clear, colorless, aqueous solution of revefenacin. Revefenacin, the active component of YUPELRI, is an anticholinergic. The chemical name for revefenacin is 1-(2-{4-[(4-carbamoylpiperidin-1-yl)methyl]- N -methylbenzamido}ethyl)piperidin-4-yl N -({1,1’-biphenyl}-2-yl)carbamate; its structural formula is: Revefenacin has a molecular weight of 597.76 and its empirical formula is C 35 H 43 N 5 O 4 .
Overview
11 DESCRIPTION YUPELRI is a sterile, clear, colorless, aqueous solution of revefenacin. Revefenacin, the active component of YUPELRI, is an anticholinergic. The chemical name for revefenacin is 1-(2-{4-[(4-carbamoylpiperidin-1-yl)methyl]- N -methylbenzamido}ethyl)piperidin-4-yl N -({1,1’-biphenyl}-2-yl)carbamate; its structural formula is: Revefenacin has a molecular weight of 597.76 and its empirical formula is C 35 H 43 N 5 O 4 .
Uses
1 INDICATIONS AND USAGE YUPELRI is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). YUPELRI is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) .
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage is 175 mcg YUPELRI (one 175 mcg unit‑dose vial) administered by oral inhalation once daily by nebulizer using a mouthpiece. Administration Overview YUPELRI should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor (See Instructions for Use) . The safety and efficacy of YUPELRI have been established in clinical trials when administered using the PARI LC ® Sprint nebulizer with a mouthpiece and the PARI Trek ® S compressor. The safety and efficacy of YUPELRI delivered from non‑compressor based nebulizer systems have not been established. The YUPELRI unit-dose vial should only be removed from the foil pouch and opened IMMEDIATELY BEFORE USE.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Paradoxical bronchospasm [see Warnings and Precautions (5.2) ] • Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.3) ] • Worsening of urinary retention [see Warnings and Precautions (5.4) ] • Immediate hypersensitivity reactions [ see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence greater than or equal to 2% and more common than placebo) include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS • Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of YUPELRI with other anticholinergic-containing drugs. ( 7.1 ) • Transporter-related drug interactions: Coadministration of YUPELRI with OATP1B1 and OATP1B3 inhibitors (e.g. rifampicin, cyclosporine, etc.) may lead to an increase in exposure of the active metabolite. Therefore, coadministration with YUPELRI is not recommended. ( 7.2 , 12.3 ) 7.1 Anticholinergics There is potential for an additive interaction with concomitantly used anticholinergic medicines.
Warnings
5 WARNINGS AND PRECAUTIONS • Do not initiate YUPELRI in acutely deteriorating COPD or to treat acute symptoms. ( 5.1 ) • If paradoxical bronchospasm occurs, discontinue YUPELRI and institute alternative therapy. ( 5.2 ) • Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. ( 5.3 ) • Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur. ( 5.4 ) • Immediate hypersensitivity reactions may occur. 4 CONTRAINDICATIONS YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product. YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with YUPELRI in pregnant women. Women should be advised to contact their physician if they become pregnant while taking YUPELRI. In animal reproduction studies, subcutaneous administration of revefenacin to pregnant rats and rabbits during the period of organogenesis produced no evidence of fetal harm at respective exposures approximately 209 times the exposure at the maximum recommended human dose (MRHD) (on an area under the curve [AUC] basis) (see Data ) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Inhalation solution: YUPELRI is supplied as a 175 mcg/3 mL sterile, clear, colorless, aqueous solution in unit-dose low‑density polyethylene vials. Each vial is overwrapped in a foil pouch and supplied in cartons containing either 30 individually pouched unit‑dose vials (NDC 49502-806-93) or 7 individually pouched unit-dose vials (NDC 49502-806-77).
Frequently Asked Questions
What is Revefenacin used for?▼
1 INDICATIONS AND USAGE YUPELRI is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). YUPELRI is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) .
What are the side effects of Revefenacin?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Paradoxical bronchospasm [see Warnings and Precautions (5.2) ] • Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.3) ] • Worsening of urinary retention [see Warnings and Precautions (5.4) ] • Immediate hypersensitivity reactions [ see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence greater than or equal to 2% and more common than placebo) include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Revefenacin during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with YUPELRI in pregnant women. Women should be advised to contact their physician if they become pregnant while taking YUPELRI. In animal reproduction studies, subcutaneous administration of revefenacin to pregnant rats and rabbits during the period of organogenesis produced no evidence of fetal harm at respective exposures approximately 209 times the exposure at the maximum recommended human dose (MRHD) (on an area under the curve [AUC] basis) (see Data ) .
What are the important warnings for Revefenacin?▼
5 WARNINGS AND PRECAUTIONS • Do not initiate YUPELRI in acutely deteriorating COPD or to treat acute symptoms. ( 5.1 ) • If paradoxical bronchospasm occurs, discontinue YUPELRI and institute alternative therapy. ( 5.2 ) • Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. ( 5.3 ) • Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur. ( 5.4 ) • Immediate hypersensitivity reactions may occur. 4 CONTRAINDICATIONS YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product. YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.