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Noxafil 100mg Tablet
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Indications & Clinical Uses
- Noxafil 100 mg (posaconazole) is a triazole antifungal medicine supplied as delayed-release tablets.
- It is used to prevent invasive Aspergillus and Candida fungal infections in patients aged 2 years and older who weigh more than 40 kg and are at high risk because of severely weakened immune systems, such as those with prolonged neutropenia from chemotherapy for haematological cancers or recipients of a stem-cell transplant with graft-versus-host disease.
- The tablet form is also used to treat invasive aspergillosis in patients whose infection has not responded to, or who cannot take, other standard antifungal treatments.
- A separate oral suspension form of Noxafil is approved for oropharyngeal candidiasis (oral thrush) in patients aged 13 and older; the tablets and suspension are absorbed differently and are not interchangeable dose-for-dose.
- Noxafil is usually started and monitored by a specialist in infectious diseases, haematology or oncology.
Side Effects
- In studies of Noxafil tablets used for prevention of fungal infection, common side effects (affecting up to 1 in 10 people) included diarrhoea, fever, nausea, low blood potassium, cough, swelling of the legs or feet, skin rash and nosebleeds.
- There is no boxed warning for Noxafil, but it can prolong the heart's QT interval, which can trigger a dangerous irregular heartbeat, so tell your healthcare provider about any history of heart rhythm problems and any medicines you take that affect the heart rhythm.
- Liver problems can occur, sometimes serious, so unusual tiredness, loss of appetite, yellowing of the skin or eyes, dark urine or pain in the upper right abdomen should be reported promptly.
- Severe diarrhoea or vomiting can reduce how much Noxafil is absorbed and increase the risk of breakthrough fungal infection, so report ongoing gut symptoms.
- Seek urgent care for a fast or irregular heartbeat, fainting, or signs of a severe allergic reaction.
Precautions & Warnings
- Do not take Noxafil if you have ever had an allergic reaction to posaconazole, and never take it together with sirolimus, pimozide, quinidine, certain statins, ergot alkaloids, or venetoclax during its initial dose ramp-up for chronic lymphocytic leukaemia, as these combinations are contraindicated.
- Before starting, tell your healthcare provider about any heart rhythm problems, low potassium or magnesium, liver disease, or other medicines you take, since Noxafil can prolong the QT interval and cause liver toxicity; liver function and electrolytes are usually checked periodically during treatment.
- If you take ciclosporin or tacrolimus, blood levels of these medicines need closer monitoring because Noxafil raises their concentration.
- Noxafil tablets are for oral use only and are usually taken with food, as this markedly improves absorption.
- Safety in pregnancy has not been established, and effective contraception is advised for women of childbearing potential during treatment.
- Store tablets at 20°C to 25°C, away from moisture and heat.
Avoid Interactions
- Posaconazole is a strong inhibitor of the CYP3A4 enzyme, so it markedly increases blood levels of medicines broken down by this pathway, including sirolimus, pimozide, quinidine, certain statins (such as simvastatin and lovastatin), ergot alkaloids and some calcium-channel blockers, several of which must never be combined with Noxafil because of the risk of serious toxicity, including dangerous heart rhythm changes; combined use with QT-prolonging drugs metabolised by CYP3A4 should also be avoided.
- Ciclosporin, tacrolimus, midazolam and digoxin all need closer monitoring or dose adjustment when given with Noxafil.
- Strong inducers of CYP3A4 or drugs that reduce stomach acid, such as rifabutin, phenytoin, efavirenz and some proton pump inhibitors, can lower posaconazole levels and reduce its antifungal effect, so are generally avoided unless the benefit clearly outweighs the risk.
- Always give your healthcare provider and pharmacist a full list of your medicines, including herbal supplements, before starting Noxafil.
References
Frequently Asked Questions
Noxafil (posaconazole) tablets prevent invasive Aspergillus and Candida infections in people aged 2 and over, weighing over 40 kg, who have severely weakened immune systems, such as from chemotherapy or a stem-cell transplant. Tablets also treat aspergillosis that hasn't responded to other antifungal treatment.
Noxafil delayed-release tablets are taken by mouth, usually once daily after an initial twice-daily loading dose, and are best taken with food to improve absorption. Swallow tablets whole; do not crush, chew or split them. Follow your prescriber's exact dosing schedule for your condition.
Common side effects include diarrhoea, fever, nausea, low blood potassium, cough and leg swelling. Noxafil can affect heart rhythm (QT prolongation) and, rarely, cause liver problems. Get urgent help for a fast or irregular heartbeat, fainting, or yellowing of the skin or eyes.
Never take Noxafil with sirolimus, pimozide, quinidine, certain statins, ergot medicines, or venetoclax during its dose ramp-up, as these combinations are dangerous. Noxafil strongly raises levels of many other drugs through CYP3A4, so tell your prescriber about every medicine and supplement you use.
Yes. Your healthcare provider usually checks liver function and blood electrolytes such as potassium and magnesium during treatment, since Noxafil can affect the liver and heart rhythm. If you take ciclosporin or tacrolimus, blood levels of those medicines are also monitored more closely.
Noxafil tablets are approved for children aged 2 and older who weigh more than 40 kg, for prevention of invasive fungal infection. Dosing is the same as for adults at that weight. A separate oral suspension is used for oral thrush in patients aged 13 and over.
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