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TAVNEOS is a brand name for Avacopan, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TAVNEOS (avacopan capsules) is indicated for: • the 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 background therapy including…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Treatment with TAVNEOS should be initiated and monitored by healthcare professionals experienced in the diagnosis and treatment of ANCA-associated vasculitis (GPA and MPA). Serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase and total bilirubin and Hepatitis B virus (HBV) serology should be obtained prior to initiating treatment with TAVNEOS to establish baseline liver function.
For patients with evidence of prior or current HBV infection, consult with a physician with expertise in managing hepatitis B regarding monitoring and consideration for HBV treatment before or during treatment with TAVNEOS. TAVNEOS is not recommended for use in patients with cirrhosis, especially with severe hepatic impairment (Child-Pugh Class C) (see 7 WARNINGS AND PRECAUTIONS, Hepatic ).
Treatment with TAVNEOS should be re-assessed clinically if alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is more than 3 times the upper limit of normal. Obtain liver function tests (ALT, AST, alkaline phosphatase and total bilirubin) before initiating treatment with TAVNEOS, and monitor every 4 weeks after start of therapy for the first 6 months of treatment and as clinically indicated thereafter.
2 Recommended Dose and Dosage Adjustment The recommended dose of TAVNEOS is 30 mg (3 capsules of 10 mg each) taken orally twice daily with food. 2 × 109/L), • a patient has an active, serious infection. Treatment may be resumed once drug-induced liver injury has been ruled out and upon normalization of values and based on an individual benefit/risk assessment.
If treatment is resumed, hepatic transaminases and total bilirubin are to be monitored closely. 5, • ALT or AST > 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (> 5%), • an association between avacopan and hepatic dysfunction has been established.
Pediatric patients. Health Canada has not authorized an indication for pediatric use. Patients with renal impairment. No dosage adjustment is required in patients with mild, moderate, or severe renal impairment. Avacopan has not been studied in patients with ANCA-associated vasculitis who are on dialysis.
Patients with hepatic impairment. Avacopan should be used with caution in patients with mild or moderate hepatic impairment. If a positive benefit-risk assessment is made, no dose adjustment is required in these patients. 3 Pharmacokinetics: Special Populations and Conditions ; Hepatic Insufficiency).
). 2 Recommended Dose and Dosage Adjustment). , chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and benefits before administrating TAVNEOS to a patient with a liver disease.
1 Special Populations). Immune Angioedema TAVNEOS may cause angioedema (see 8 ADVERSE REACTIONS). In clinical trials, two cases of angioedema occurred, including one serious event requiring hospitalization. If angioedema occurs, discontinue TAVNEOS immediately, provide appropriate therapy, and monitor for airway compromise.
TAVNEOS must not be re-administered unless another cause has been established. Educate patients on recognizing the signs and symptoms of a hypersensitivity reaction and to seek immediate medical care should they develop. Immunization The safety of immunization with live vaccines, following avacopan has not been studied.
Administer vaccination preferably prior to initiation of treatment with avacopan. Infection Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. 8%). Avoid use of TAVNEOS in patients with an active serious infection, including localized infections.
Consider the risks and benefits of treatment prior to initiating TAVNEOS in patients: - With chronic or recurrent infections - Who have been exposed to tuberculosis - With a history of a serious or an opportunistic infection TAVNEOS avacopan Page 8 of 29 Unclassified / Non classifié - Who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or - With underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with TAVNEOS. Interrupt TAVNEOS if a patient develops a serious or opportunistic infection and treat accordingly. TAVNEOS may be resumed once the infection is controlled.
, Driving and Operating Machinery 11/2024 7 WARNINGS AND PRECAUTIONS, Hepatic 11/2024 TABLE OF CONTENTS. RECENT MAJOR LABEL CHANGES .........................................................................................................
2 TABLE OF CONTENTS. .......................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................................
4 1 INDICATIONS .......................................................................................................................... 4 2 CONTRAINDICATIONS .............................................................................................................
4 4 DOSAGE AND ADMINISTRATION ............................................................................................. 6 5 OVERDOSAGE .........................................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................................. 6 7 WARNINGS AND PRECAUTIONS .............................................................................................. 9 8 ADVERSE REACTIONS ..............................................................................................................
2 Clinical Trial Adverse Reactions ........................................................................................ 3 Less Common Clinical Trial Adverse Reactions .................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry And Other Quantitative Data ...........................................................................................................................................
TAVNEOS is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Geriatric patients. No dose adjustment is required in geriatric patients. Patients taking strong CYP3A4 inhibitors. 4 Drug-Drug Interactions). Patients taking CYP3A4 substrates. 4 Drug-Drug Interactions). 4 Administration TAVNEOS is for oral use.
The capsules should be taken with food in the morning and the evening. The capsules should be swallowed whole with water and must not be crushed, chewed, or opened. 5 Missed Dose If a patient misses a dose, the missed dose should be taken as soon as possible, unless within three hours of the next scheduled dose.
If within three hours, then the missed dose should not be taken.
Pneumocystis jirovecii pneumonia prophylaxis:
Pneumocystis jirovecii pneumonia prophylaxis is recommended for adult patients with GPA or MPA during TAVNEOS treatment, as appropriate according to local clinical practice guidelines. 1 Dosing Considerations and 7 WARNINGS AND PRECAUTIONS, Hepatic ).
1 Dosing Considerations and 7 WARNINGS AND PRECAUTIONS).
Reproductive Health:
Female and Male Potential • Fertility There are no data on the effects of avacopan on human fertility. Fertility/early embryo development, embryo/foetal development, and pre- and post-natal development studies conducted with avacopan in hamsters or rabbits generally showed no evidence of reproductive toxicity or teratogenicity, at doses up to 1,000 mg/kg/day in hamsters and 200 mg/kg/day in rabbits; the only exceptions were an increased incidence of skeletal variations at 1,000 mg/kg/day avacopan in hamster and of abortion at 200 mg/kg/day avacopan in rabbits (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology ).
1 Pregnant Women Avacopan is not recommended during pregnancy and in women of childbearing potential not using contraception. There are no data from the use of avacopan in pregnant women. In animal studies designed to assess effects of avacopan upon embryo-fetal development with pregnant hamsters (dosed by the oral route during the period of organogenesis from gestation day 6 to 12), there was an increased incidence of skeletal variations (short thoracolumbar supernumerary rib) at the highest dose tested (500 mg/kg BID, which is equivalent to an exposure of 5 times the maximum recommended human dose calculated on an AUC basis with 1000 mg/kg/day).
In a prenatal and postnatal development study with pregnant hamsters (orally dosed from gestation day 6 to lactation day 20), avacopan had no effects on the growth and development of offspring with exposures up to approximately 5 times the maximum recommended human dose (based on maternal doses of up to 1000 mg/kg/day).
An embryo-fetal development study with pregnant rabbits dosed by the oral route during the period of organogenesis from gestation day 6 to 18 was conducted. 6 times the maximum recommended human dose (based on AUCs with the maternal oral doses of 30 mg/kg/day and higher) (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology ).
2 Breast-feeding The safety of avacopan when used during pregnancy or breastfeeding has not been evaluated in humans. There are no data on the use of avacopan in lactating women and it is unknown whether avacopan is excreted in human milk.
37. The no-observed-adverse-effect-level (NOAEL) for viability, growth, and reproduction in F1 offspring was 1,000 mg/kg/day (500 mg/kg twice daily) (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and […]
5 Post-Market Adverse Reactions ........................................................................................ 12 9 DRUG INTERACTIONS............................................................................................................
2 Drug Interactions Overview .............................................................................................. 3 Drug-Behavioural Interactions ..........................................................................................
4 Drug-Drug Interactions ..................................................................................................... 5 Drug-Food Interactions .....................................................................................................
6 Drug-Herb Interactions ..................................................................................................... 7 Drug-Laboratory Test Interactions ....................................................................................
14 10 CLINICAL PHARMACOLOGY ................................................................................................... 1 Mechanism of Action ..................................................................................................
2 Pharmacodynamics .................................................................................................... 3 Pharmacokinetics .......................................................................................................
16 11 STORAGE, STABILITY AND DISPOSAL ..................................................................................... 18 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................................
18 PART II: SCIENTIFIC INFORMATION ................................................................................................... 19 13 PHARMACEUTICAL INFORMATION........................................................................................
19 14 CLINICAL TRIALS.................................................................................................................... 1 Clinical Trials by Indication .........................................................................................
19 15 MICROBIOLOGY […]