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Tavneos
avacopan
Adult Dosing .
Dosage forms: CAP: 10 mg
granulomatosis with polyangiitis, adjunct tx
- [30 mg PO bid]
- Info: do not open cap; give with food; D/C if AST or ALT >3x ULN or alk phos >2x ULN
microscopic polyangiitis, adjunct tx
- [30 mg PO bid]
- Info: do not open cap; give with food; D/C if AST or ALT >3x ULN or alk phos >2x ULN
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hepatic impairment, Child-Pugh Class C
- infection, active severe
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: opportunistic infection history
- caution: TB infection risk
- caution: residents of area with endemic TB
- caution: residents of area with endemic mycosis
- caution: travelers in area with endemic TB
- caution: travelers in area with endemic mycosis
- caution: HBV infection
- caution: HBV infection history
- caution: HCV infection
- caution: autoimmune hepatitis, uncontrolled
Drug Interactions .
Overview
avacopan
complement inhibitor
- CYP3A4 substrate
- CYP3A4 inhibitor, moderate
- immunomodulatory effects
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- angioedema
- hepatotoxicity
- drug-induced liver injury
- vanishing bile duct syndrome
- HBV reactivation
- infection, serious
Common Reactions
- nausea
- headache
- HTN
- diarrhea
- vomiting
- hepatotoxicity
- LFTs elevated
- rash
- fatigue
- upper abdominal pain
- dizziness
- Cr incr.
- paresthesia
- CK elevated
Safety/Monitoring .
Monitoring Parameters
HBV screening at baseline; LFTs at baseline, then q2wk x1mo, then qmo x5mo, then as clinically indicated; signs/symptoms of hepatitis or HBV reactivation during tx and x6mo after D/C if current or prior HBV infection
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; possible risk of spontaneous abortion and skeletal variation based on animal data at 0.6x and 5x MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for avacopan: liver primarily; CYP450: 3A4 substrate; Info: active metabolite
Excretion: for avacopan: feces 77% (7% unchanged), urine 10% (<0.1% unchanged); Half-life: 97.6h (parent drug), 55.6h (active metabolite)
Subclass: Complement Inhibitors, Rheumatologic
Mechanism of Action
for avacopan: exact mechanism of action unknown; selectively inhibits complement 5a receptor, preventing C5a-mediated neutrophil activation and migration (complement 5a receptor antagonist)
Formulary .
No Formulary Selected
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