Tavneos
- Generic Name: avacopan capsules
- Brand Name: Tavneos
Tavneos (Avacopan Capsules) side effects drug center
Tavneos Side Effects Center
What Is Tavneos?
Tavneos (avacopan) is a complement 5a receptor (C5aR) antagonist indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. Tavneos does not eliminate glucocorticoid use.
What Are Side Effects of Tavneos?
Side effects of Tavneos include:
- nausea,
- headache,
- high blood pressure (hypertension),
- diarrhea,
- vomiting,
- rash,
- fatigue,
- upper abdominal pain,
- dizziness,
- increased blood creatinine, and
- numbness and tingling.
Dosage for Tavneos
The recommended dosage of Tavneos is 30 mg (three 10 mg capsules) twice daily, with food.
Tavneos In Children
The safety and effectiveness of Tavneos in pediatric patients have not been established.
What Drugs, Substances, or Supplements Interact with Tavneos?
Tavneos may interact with other medicines such as:
- strong and moderate CYP3A4 enzyme inducers,
- strong CYP3A4 enzyme inhibitors, and
- sensitive CYP3A4 substrates.
Tell your doctor all medications and supplements you use.
Tavneos During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Tavneos; it is unknown how it might affect a fetus. It is unknown if Tavneos passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Tavneos (avacopan) Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tavneos Professional Information
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Hepatitis B Virus (HBV) Reactivation [see WARNINGS AND PRECAUTIONS]
- Serious Infections [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because the clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The identification of potential adverse drug reactions was based on safety data from the phase 3 clinical trial in which 330 patients with ANCA-associated vasculitis were randomized 1:1 to either TAVNEOS or prednisone [see Clinical Studies]. The mean age of patients was 60.9 years (range of 13 to 88 years), with a predominance of men (56.4%) and Caucasians (84.2%). The cumulative exposure to TAVNEOS was 138.7 patient-years. Additionally, two phase 2 trials were conducted in ANCA-associated vasculitis. The cumulative clinical trial exposure from the phase 2 and 3 trials equals 212.3 patient-years.
The most frequent serious adverse reactions reported more frequently in patients treated with TAVNEOS than with prednisone were pneumonia (4.8% TAVNEOS vs. 3.7% prednisone), GPA (3.0% TAVNEOS vs. 0.6% prednisone), acute kidney injury (1.8% TAVNEOS vs. 0.6% prednisone), and urinary tract infection (1.8% TAVNEOS vs. 1.2% prednisone). Within 52 weeks, 4 patients in the prednisone treatment group (2.4%) and 2 patients in the TAVNEOS group (1.2%) died. There were no deaths in the phase 2 trials.
In the phase 3 trial, seven patients (4.2%) in the TAVNEOS treatment group and 2 patients (1.2%) in the prednisone treatment group discontinued treatment due to hepatic-related adverse reactions, including hepatobiliary adverse reactions and liver enzymes abnormalities. The most frequent adverse reaction that led to drug discontinuation reported by > 1 patient and more frequently reported in patients treated with TAVNEOS was hepatic function abnormal (1.8%).
The most common adverse reactions that occurred in ≥5% of patients and higher in the TAVNEOS group as compared with the prednisone group are listed in Table 1.
Table 1: Adverse Reactions Reported in ≥5% of Patients and Higher in TAVNEOS Group vs. Prednisone Group in Phase 3 Trial
| Adverse Reaction | Prednisone (N=164) n (%) |
TAVNEOS (N=166) n (%) |
| Nausea | 34 (20.7) | 39 (23.5) |
| Headache | 23 (14.0) | 34 (20.5) |
| Hypertension | 29 (17.7) | 30 (18.1) |
| Diarrhea | 24 (14.6) | 25 (15.1) |
| Vomiting | 21 (12.8) | 25 (15.1) |
| Rash | 13 (7.9) | 19 (11.4) |
| Fatigue | 15 (9.1) | 17 (10.2) |
| Upper abdominal pain | 10 (6.1) | 11 (6.6) |
| Dizziness | 10 (6.1) | 11 (6.6) |
| Blood creatinine increased | 8 (4.9) | 10 (6.0) |
| Paresthesia | 7 (4.3) | 9 (5.4) |
| N=number of patients randomized to treatment group in the Safety Population; n=number of patients in specified category. | ||
Hepatotoxicity And Elevated Liver Function Tests
In the phase 3 trial, a total of 19 patients (11.6%) in the prednisone group and 22 patients (13.3%) in the TAVNEOS group had hepatic-related adverse reactions, including hepatobiliary adverse reactions and liver enzyme abnormalities. Study medication was paused or discontinued permanently due to hepatic-related adverse reactions in 5 patients (3.0%) in the prednisone group and 9 patients (5.4%) in the TAVNEOS group. Serious hepatic-related adverse reactions were reported in 6 patients (3.7%) in the prednisone group and 9 patients (5.4%) in the TAVNEOS group. A serious hepatic-related adverse reaction was reported in 1 patient in the TAVNEOS group in the phase 2 studies.
Angioedema
In the phase 3 trial, 2 patients (1.2%) in the TAVNEOS group had angioedema; one event was a serious adverse reaction requiring hospitalization.
Elevated Creatine Phosphokinase
In the phase 3 trial, 1 patient (0.6%) in the prednisone group and 6 patients (3.6%) in the TAVNEOS group had increased creatine phosphokinase. One TAVNEOS-treated patient discontinued treatment due to increased creatine phosphokinase.
DRUG INTERACTIONS
CYP3A4 Inducers
Avacopan exposure is decreased when co-administered with strong CYP3A4 enzyme inducers such as rifampin [see CLINICAL PHARMACOLOGY]. Avoid coadministration of strong and moderate CYP3A4 inducers with TAVNEOS.
CYP3A4 Inhibitors
Avacopan exposure is increased when co-administered with strong CYP3A4 enzyme inhibitors such as itraconazole [see CLINICAL PHARMACOLOGY]. Administer TAVNEOS 30 mg once daily when coadministered with strong CYP3A4 inhibitors.
CYP3A4 Substrates
Avacopan is a CYP3A4 inhibitor. Closely monitor patients for adverse reactions and consider dose reduction of sensitive CYP3A4 substrates with a narrow therapeutic window when coadministered with TAVNEOS [see CLINICAL PHARMACOLOGY].
Read the entire FDA prescribing information for Tavneos (Avacopan Capsules)
&Copy; Tavneos Patient Information is supplied by Cerner Multum, Inc. and Tavneos Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.