Volibris

Volibris

ambrisentan

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Ambrisentan
Indications/Uses
Pulmonary arterial HTN (PAH) in adults classified as WHO functional class II & III.
Dosage/Direction for Use
5 mg once daily, may be increased to 10 mg daily if necessary. Dose should be limited to 5 mg once daily when co-administered w/ cyclosporine A.
Administration
May be taken with or without food: Swallow whole, do not chew/crush/split.
Contraindications
Hypersensitivity to ambrisentan & soya. Idiopathic pulmonary fibrosis, w/ or w/o secondary pulmonary HTN. Severe hepatic impairment (w/ or w/o cirrhosis). Baseline values of AST &/or ALT >3 x ULN. Women of childbearing potential who are not using reliable contraception. Pregnancy & lactation.
Special Precautions
Patients w/ WHO functional class I & IV PAH. Risk of reduction in Hb conc & haematocrit; peripheral oedema; pulmonary veno-occlusive disease. Evaluate ALT & AST prior to therapy. Discontinue in case of clinically significant ALT &/or AST elevation or if ALT &/or AST elevation is accompanied by signs or symptoms of hepatic injury. Concomitant use w/ rifampicin. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Contains Allura red AC Aluminium Lake (E129) & lecithin derived from soya. Severe renal or hepatic impairment. May affect male fertility. Minor or moderate influence on the ability to drive & use machines. Childn & adolescents <18 yr.
Adverse Reactions
Headache; peripheral oedema, fluid retention. Anaemia (decreased Hb, decreased haematocrit); dizziness; cardiac failure, palpitation; hypotension, flushing; epistaxis, dyspnoea, upper resp (eg, nasal, sinus) congestion, sinusitis, nasopharyngitis, rhinitis; abdominal pain, constipation, nausea, vomiting, diarrhoea; increased hepatic transaminases; rash; chest pain/discomfort, asthenia & fatigue.
Drug Interactions
Increased exposure w/ cyclosporine A. Transient increase in exposure w/ rifampicin. Use w/ caution when co-administered w/ other treatments for PAH (eg, prostanoids & soluble guanylate cyclase stimulators).
MIMS Class
Other Antihypertensives
ATC Classification
C02KX02 - ambrisentan ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.
Presentation/Packing
Form
Volibris FC tab 10 mg
Packing/Price
30's
Form
Volibris FC tab 5 mg
Packing/Price
30's
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