Posaconazole Vivanta (Posaconazole)
Generic Triazole Antifungal – 100 mg Gastro-resistant Tablet
⚡ Quick Facts
Key Takeaways
- Posaconazole Vivanta is a generic version of the originator product Noxafil gastro-resistant tablets and contains the identical active substance, posaconazole, at the same 100 mg strength.
- It is a second-generation triazole with broad-spectrum activity against Aspergillus, Candida, Fusarium, and certain Mucorales species, and is used both for prophylaxis in immunocompromised patients and as salvage therapy in refractory invasive fungal infections.
- The gastro-resistant (enteric-coated) tablets provide more consistent and predictable absorption than older posaconazole oral suspensions and should always be swallowed whole, never crushed, chewed, or broken.
- Posaconazole is a potent CYP3A4 inhibitor with numerous significant drug interactions; some combinations (e.g., simvastatin, ergot alkaloids, terfenadine, pimozide) are strictly contraindicated due to serious or life-threatening risks.
- Liver function tests should be performed before and during treatment, because hepatotoxicity, including rare cases of hepatic failure, has been reported with posaconazole therapy.
What Is Posaconazole Vivanta and What Is It Used For?
Quick answer: Posaconazole Vivanta is a generic oral triazole antifungal containing 100 mg of posaconazole per gastro-resistant tablet. It is prescribed to prevent and treat serious invasive fungal infections in patients with severely weakened immune systems, such as those undergoing leukemia chemotherapy or stem cell transplantation.
Posaconazole Vivanta is a generic medicinal product containing the active substance posaconazole. The originator product of posaconazole tablets is Noxafil (Merck Sharp & Dohme). For a generic product to be authorized in the European Union, United Kingdom, and other regulated markets, the manufacturer must demonstrate that it is bioequivalent to the originator product, meaning the active substance is delivered into the bloodstream at essentially the same rate and to the same extent. Therefore, Posaconazole Vivanta is clinically comparable to Noxafil gastro-resistant tablets at the same dose.
Posaconazole is a second-generation triazole antifungal first approved by the European Medicines Agency in 2005 and by the U.S. Food and Drug Administration in 2006. It belongs to the same pharmacological family as fluconazole, itraconazole, and voriconazole, but is distinguished by one of the broadest spectra of antifungal activity in the class. Posaconazole is active against many clinically important molds and yeasts, including Aspergillus species, Candida species (including some azole-resistant strains), Coccidioides, Fonsecaea, Fusarium, and some Mucorales (agents of mucormycosis). This wide spectrum makes posaconazole a preferred option in patients at risk of infection with multiple fungal pathogens.
The mechanism of action of posaconazole involves the inhibition of the fungal enzyme lanosterol 14-alpha-demethylase (CYP51), a cytochrome P450-like enzyme that catalyzes a crucial step in the biosynthesis of ergosterol. Ergosterol is an essential structural lipid of the fungal cell membrane, analogous to cholesterol in human cell membranes. By blocking ergosterol production, posaconazole causes the accumulation of abnormal methylated sterol precursors within the fungal cell, disrupting membrane integrity, increasing permeability, and ultimately leading to fungal cell death. Because human cell membranes contain cholesterol rather than ergosterol, posaconazole is selectively toxic to fungal organisms, although partial cross-reactivity with human CYP enzymes accounts for part of its adverse effect and drug-interaction profile.
Posaconazole Vivanta is authorized for both prophylaxis (prevention) and treatment of invasive fungal infections in appropriately selected patients. As a prophylactic agent, it is used in patients who are at high risk of developing these infections because of severe and prolonged immunosuppression. Typical candidates include adults receiving remission-induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who are expected to have prolonged severe neutropenia, as well as recipients of hematopoietic stem cell transplantation (HSCT) receiving immunosuppressive therapy for graft-versus-host disease. Landmark randomized trials published in the New England Journal of Medicine in 2007 demonstrated that posaconazole prophylaxis was superior to fluconazole and itraconazole in these populations, reducing invasive aspergillosis and, in AML/MDS patients, improving overall survival.
As a therapeutic agent, Posaconazole Vivanta is indicated in adults for the treatment of several invasive fungal infections, primarily in patients who are refractory to or intolerant of first-line antifungal therapy. Authorized salvage-therapy indications include invasive aspergillosis not responding to amphotericin B or itraconazole; fusariosis refractory to amphotericin B; chromoblastomycosis and mycetoma refractory to itraconazole; and coccidioidomycosis refractory to amphotericin B, itraconazole, or fluconazole. Posaconazole is also used for the treatment of oropharyngeal candidiasis, including disease refractory to fluconazole or itraconazole. Use as salvage therapy reflects the fact that posaconazole is often reserved for difficult-to-treat infections where alternative options have already failed or are not tolerated.
Although the gastro-resistant tablet formulation (as used in Posaconazole Vivanta) is the preferred oral option in most clinical situations, posaconazole is also available internationally as a powder for oral suspension and as a concentrate for intravenous infusion. The tablet provides markedly more consistent absorption than the oral suspension and is not strongly affected by food intake or gastric acidity, making it more reliable for achieving effective plasma concentrations. This article focuses specifically on the Posaconazole Vivanta 100 mg gastro-resistant tablet formulation.
What Should You Know Before Taking Posaconazole Vivanta?
Quick answer: Before starting Posaconazole Vivanta, tell your doctor about all medicines you take, any liver or heart problems, any electrolyte disturbances, and whether you are pregnant or breastfeeding. Several medications must never be combined with posaconazole due to the risk of life-threatening interactions.
Contraindications
Posaconazole Vivanta must not be taken by anyone with a known hypersensitivity (allergy) to posaconazole or to any of the other ingredients of the tablet. Beyond this, posaconazole is strictly contraindicated in combination with a number of medicines because of the high risk of serious or life-threatening adverse effects. Posaconazole is a potent inhibitor of the cytochrome P450 3A4 (CYP3A4) enzyme, which handles the metabolism of a very large number of commonly prescribed drugs. When posaconazole is added to therapy, blood levels of these CYP3A4 substrates can rise substantially.
The following medications must not be used during treatment with Posaconazole Vivanta:
- Terfenadine and astemizole (antihistamines) – increased levels may prolong the QTc interval and provoke life-threatening arrhythmias such as torsades de pointes.
- Cisapride (gastrointestinal prokinetic) – risk of QTc prolongation and serious ventricular arrhythmias.
- Pimozide (antipsychotic) – risk of QTc prolongation and cardiac arrhythmias.
- Halofantrine (antimalarial) – risk of QTc prolongation and fatal arrhythmias.
- Quinidine (antiarrhythmic) – risk of QTc prolongation and torsades de pointes.
- Ergot alkaloids (ergotamine, dihydroergotamine) – risk of ergotism, with severe vasospasm and peripheral ischemia.
- Simvastatin, lovastatin, and atorvastatin – substantially elevated statin exposure increases the risk of rhabdomyolysis, a potentially fatal breakdown of skeletal muscle.
- Venetoclax during the dose ramp-up phase in chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) – risk of tumor lysis syndrome.
Warnings and Precautions
Before treatment with Posaconazole Vivanta is started, it is essential that your doctor is aware of your full medical history, including any underlying conditions and all medicines you take. Particular caution is required in the following situations:
Liver problems: Posaconazole is metabolized and eliminated largely through the liver. Hepatic reactions, including elevations of liver enzymes (ALT, AST, alkaline phosphatase, bilirubin), have been reported during treatment. Rare cases of severe hepatic injury, including hepatic failure with fatal outcome, have occurred, mostly in patients with serious underlying conditions such as hematologic malignancies. Liver function tests should be performed before starting Posaconazole Vivanta and at appropriate intervals during therapy. If significant liver-test abnormalities develop, your doctor will weigh the benefits of continuing posaconazole against the risk of further liver injury; treatment discontinuation may be required.
Heart conditions and QTc prolongation: Posaconazole has been associated with prolongation of the QTc interval on electrocardiogram, particularly in patients with underlying risk factors. It should be used with caution in patients with pre-existing QTc prolongation (congenital or acquired), cardiomyopathy (especially with heart failure), sinus bradycardia, symptomatic arrhythmias, or any condition predisposing to clinically significant cardiac events. Electrolyte disturbances – especially in potassium, magnesium, or calcium – should be identified and corrected before starting treatment, because they potentiate QTc prolongation and risk of dangerous arrhythmias.
Severe diarrhea or vomiting: While the gastro-resistant tablet formulation is less affected by gastrointestinal factors than oral suspension, severe or protracted diarrhea or vomiting may still reduce posaconazole exposure. If you experience significant gastrointestinal symptoms during therapy, inform your doctor promptly. In high-risk patients (for example, those with graft-versus-host disease of the gut), therapeutic drug monitoring of posaconazole plasma concentrations may be recommended to confirm adequate exposure.
Photosensitivity: Posaconazole can increase sensitivity of the skin to ultraviolet (UV) radiation. During treatment you should minimize direct sun exposure, avoid tanning beds, and use protective clothing and broad-spectrum high-SPF sunscreen when outdoors. Seek medical advice if you develop an unusual rash, severe sunburn-like reaction, or other skin changes.
Renal impairment: Moderate or severe renal impairment can cause variable posaconazole exposure, especially when using formulations containing the solubilizing excipient cyclodextrin (for example, the IV formulation). With the oral tablet, dose adjustment is generally not required, but therapeutic drug monitoring may be considered in patients with severe renal dysfunction.
Pregnancy and Breastfeeding
Posaconazole Vivanta should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the fetus. Animal reproductive studies have shown evidence of toxicity including skeletal malformations at exposures overlapping with human therapeutic doses. There are no adequate, well-controlled studies of posaconazole in pregnant women. Women of childbearing potential must use effective contraception throughout treatment with Posaconazole Vivanta. If you become pregnant while taking this medicine, contact your doctor immediately to discuss the risks and benefits of continuing therapy.
It is not known whether posaconazole passes into human breast milk, but animal data show excretion into milk. As a precaution, breastfeeding should be discontinued when Posaconazole Vivanta is started. The decision whether to stop breastfeeding or to stop the medicine must take account of the benefit of breastfeeding for the infant and the benefit of antifungal therapy for the mother.
Driving and Operating Machinery
Posaconazole may cause side effects such as dizziness, drowsiness, blurred vision, or fatigue that could impair the ability to drive or operate machinery safely. You should observe your individual response to Posaconazole Vivanta before driving or engaging in activities that require full alertness, and avoid doing so if you experience these effects.
How Does Posaconazole Vivanta Interact with Other Drugs?
Quick answer: Posaconazole Vivanta is a potent inhibitor of the CYP3A4 enzyme and a substrate for P-glycoprotein. It has many clinically important drug interactions. Some combinations are absolutely contraindicated; others require careful dose adjustment or therapeutic drug monitoring.
Posaconazole is primarily metabolized by UDP-glucuronidation (UGT1A4, a phase II pathway) and is a substrate for the P-glycoprotein (P-gp) efflux transporter. Clinically, however, the dominant driver of posaconazole's drug-interaction profile is its role as a strong inhibitor of CYP3A4. CYP3A4 is responsible for the metabolism of roughly half of all clinically used medicines, so even modest inhibition can meaningfully alter the plasma concentrations of many co-administered drugs. Additional interactions arise from medicines that induce UGT or P-gp, which can reduce posaconazole exposure, sometimes to therapeutically ineffective levels.
Major Interactions (Contraindicated)
The following combinations must never be used together with Posaconazole Vivanta:
| Drug | Interaction Type | Clinical Effect |
|---|---|---|
| Terfenadine | CYP3A4 substrate – increased levels | QTc prolongation, torsades de pointes, sudden cardiac death |
| Astemizole | CYP3A4 substrate – increased levels | QTc prolongation, torsades de pointes, sudden cardiac death |
| Cisapride | CYP3A4 substrate – increased levels | QTc prolongation, serious ventricular arrhythmias |
| Pimozide | CYP3A4 substrate – increased levels | QTc prolongation, cardiac arrhythmias |
| Halofantrine | CYP3A4 substrate – increased levels | QTc prolongation, risk of fatal arrhythmias |
| Quinidine | CYP3A4 substrate – increased levels | QTc prolongation, torsades de pointes |
| Ergotamine / Dihydroergotamine | CYP3A4 substrate – increased levels | Ergotism: severe vasospasm, peripheral ischemia, gangrene |
| Simvastatin / Lovastatin / Atorvastatin | CYP3A4 substrate – increased levels | Rhabdomyolysis, acute kidney injury, myopathy |
| Venetoclax (during CLL/SLL dose ramp-up) | CYP3A4 substrate – markedly increased levels | Tumor lysis syndrome, metabolic emergency, renal failure |
Drugs That Reduce Posaconazole Vivanta Effectiveness
A number of medicines can lower the plasma concentration of posaconazole either by inducing metabolizing enzymes (especially UGT) or by affecting absorption and transport. When posaconazole concentrations fall, patients may experience treatment failure, which is particularly dangerous during prophylaxis in neutropenic patients. Co-administration with strong enzyme inducers should generally be avoided:
- Rifampicin – a strong inducer that can dramatically reduce posaconazole plasma concentrations. Concurrent use should be avoided.
- Rifabutin – reduces posaconazole plasma levels, while posaconazole increases rifabutin levels. Avoid the combination; if unavoidable, monitor closely for reduced antifungal efficacy and for rifabutin toxicity (uveitis, myelosuppression).
- Phenytoin – reduces posaconazole exposure, while posaconazole can increase phenytoin levels. If co-administration is unavoidable, therapeutic drug monitoring of both agents is recommended.
- Carbamazepine – potent enzyme inducer, may substantially reduce posaconazole concentrations. Avoid concurrent use when possible.
- Phenobarbital / primidone – strong inducers; avoid the combination.
- Efavirenz – substantially reduces posaconazole exposure. Alternative antiretroviral therapy should be considered.
- Fosamprenavir – decreases posaconazole levels; therapeutic drug monitoring recommended if co-administration cannot be avoided.
- Flucloxacillin – may reduce posaconazole exposure through enzyme induction; consider monitoring of posaconazole levels.
Drugs Whose Levels May Be Increased by Posaconazole Vivanta
Because posaconazole is a potent CYP3A4 inhibitor, it can raise plasma concentrations of many commonly used medicines. The following examples require dose adjustments or enhanced monitoring when taken with Posaconazole Vivanta:
- Ciclosporin – posaconazole increases ciclosporin trough concentrations. On starting posaconazole, the ciclosporin dose is usually reduced (often to about three-quarters of the original dose) with frequent therapeutic drug monitoring.
- Tacrolimus – posaconazole increases tacrolimus trough concentrations by approximately 121%. The tacrolimus dose is usually reduced to about one-third of the original on starting posaconazole, with close monitoring.
- Sirolimus – co-administration is generally not recommended; posaconazole can increase sirolimus exposure up to roughly nine-fold. If unavoidable, sirolimus dose must be substantially reduced with intensive monitoring.
- Vincristine and vinblastine – posaconazole can increase vinca alkaloid levels, raising the risk of severe neurotoxicity (peripheral neuropathy, seizures, paralytic ileus). Dose reduction of the vinca alkaloid may be required.
- Midazolam and other benzodiazepines – midazolam exposure can rise approximately five-fold, increasing risk of excessive sedation and respiratory depression. Dose reduction or use of alternative agents is recommended.
- Calcium channel blockers (felodipine, nifedipine, amlodipine, verapamil, diltiazem) – increased levels may cause hypotension and peripheral edema; monitor blood pressure and heart rate, and consider dose reduction.
- Digoxin – posaconazole may increase digoxin levels through P-glycoprotein inhibition; monitor digoxin serum concentrations.
- Sulfonylureas (glipizide, glibenclamide) – increased exposure may cause hypoglycemia; intensify glucose monitoring and consider dose reduction of the sulfonylurea.
What Is the Correct Dosage of Posaconazole Vivanta?
Quick answer: For adults, the standard dose is 300 mg (three 100 mg tablets) twice on Day 1 as a loading dose, followed by 300 mg once daily thereafter. Tablets must be swallowed whole and can be taken with or without food. Dosing in children and patients with organ impairment must always be supervised by a specialist.
The dosage of Posaconazole Vivanta should always be determined by a physician experienced in antifungal therapy and must not be altered without medical advice. Dosing depends on the patient's age, weight, clinical indication, and body system function. Inadequate dosing may lead to subtherapeutic plasma concentrations and risk of treatment failure, while excessive dosing may increase the risk of adverse effects and drug interactions.
Adults
Loading Dose (Day 1)
300 mg (three 100 mg gastro-resistant tablets) taken twice on the first day, approximately 12 hours apart. Tablets may be taken with or without food. They must be swallowed whole with water and must not be crushed, chewed, split, or dissolved, since this would damage the gastro-resistant coating, alter absorption, and reduce tolerability.
Maintenance Dose (Day 2 onwards)
300 mg (three 100 mg tablets) taken once daily. Treatment duration depends on the indication. For prophylaxis, treatment is typically continued throughout the period of severe immunosuppression (for example, until resolution of neutropenia or until immunosuppression after HSCT is reduced). For treatment of an active fungal infection, duration is guided by clinical response and microbiological findings.
Children
Posaconazole gastro-resistant tablets are authorized in children aged 2 years and older who weigh at least 14 kg and can swallow a tablet whole. Dosing is based on body weight. Below is the standard weight-banded regimen for prophylaxis of invasive fungal infections; your child's physician will confirm the precise dose for your child's indication.
| Body Weight | Loading Dose (Day 1) | Maintenance Dose (Day 2 onwards) |
|---|---|---|
| 14 kg to <20 kg | 100 mg (1 tablet) twice on Day 1 | 100 mg (1 tablet) once daily |
| 20 kg to <30 kg | 200 mg (2 tablets) twice on Day 1 | 100 mg (1 tablet) once daily |
| 30 kg to <40 kg | 200 mg (2 tablets) twice on Day 1 | 200 mg (2 tablets) once daily |
| ≥40 kg | 300 mg (3 tablets) twice on Day 1 | 300 mg (3 tablets) once daily |
For both children and adults at risk of variable absorption – for example those with severe mucositis, active gastrointestinal graft-versus-host disease, or clinical non-response – measurement of posaconazole plasma trough concentrations may be recommended. A trough target of approximately ≥0.7 mg/L is commonly cited for prophylaxis and ≥1.0 mg/L for salvage therapy, though exact targets depend on institutional protocols and clinical context.
Elderly
No specific dose adjustment is needed for elderly patients based on age alone. However, elderly patients are more likely to have coexisting conditions such as reduced kidney or liver function, electrolyte disturbances, cardiac disease, or polypharmacy. These factors can significantly influence the risk-benefit balance of posaconazole and often warrant closer monitoring, especially of liver function tests, electrolytes, and the electrocardiogram.
Patients with Liver or Kidney Impairment
In patients with mild, moderate, or severe hepatic impairment, dose adjustment of Posaconazole Vivanta tablets is generally not required, but they should be used with caution and only when benefits outweigh risks. Close monitoring of liver function tests is especially important in these patients. For renal impairment, dose adjustment of the oral tablet is also generally not required, although variability in exposure may be greater at severe levels of dysfunction. As noted above, the oral tablet avoids the cyclodextrin-related concerns that limit intravenous posaconazole in patients with severe renal impairment.
Missed Dose
If you forget to take a dose of Posaconazole Vivanta, take it as soon as you remember. However, if it is nearly time for your next scheduled dose, skip the missed dose and continue with your normal dosing schedule. Do not take a double dose to make up for a missed one. Consistent dosing is important for maintaining adequate drug levels and preventing breakthrough infections. If you repeatedly forget doses, talk to your doctor; in some cases therapeutic drug monitoring is used to reassess exposure.
Overdose
If you take more Posaconazole Vivanta than prescribed, or if someone else (particularly a child) accidentally takes your medicine, seek immediate medical attention or contact a poison information center. There is no specific antidote for posaconazole overdose; treatment is supportive and aimed at managing symptoms. Posaconazole is not removed by hemodialysis, so dialysis is not an effective means of clearing the drug. In clinical studies, posaconazole plasma concentrations do not increase proportionally beyond a ceiling dose, but overdose-related adverse effects can nonetheless occur and should be treated as a medical emergency.
What Are the Side Effects of Posaconazole Vivanta?
Quick answer: Common side effects of Posaconazole Vivanta include nausea, vomiting, diarrhea, headache, fatigue, and changes in laboratory tests (liver enzymes, electrolytes). Less common but serious side effects include liver injury, QTc prolongation, seizures, and severe allergic or skin reactions.
Like all medicines, Posaconazole Vivanta can cause side effects, although not everyone who takes it will experience them. Side effects are categorized below by frequency using the international standard classification used in summaries of product characteristics. Tell your doctor promptly if you notice any side effect, especially those listed in the "uncommon" or "rare" groups or in the safety warning box, which may indicate a serious reaction.
Common Side Effects
- Headache
- Nausea and vomiting
- Diarrhea
- Abdominal pain, dyspepsia
- Decreased appetite
- Dry mouth, altered taste (dysgeusia)
- Flatulence
- Fatigue, asthenia
- Fever (pyrexia)
- Dizziness
- Rash, pruritus
- Elevated liver enzymes (ALT, AST, alkaline phosphatase, bilirubin)
- Low potassium (hypokalemia)
- Low magnesium (hypomagnesemia)
- Neutropenia
Uncommon Side Effects
- Anemia, thrombocytopenia
- Hypersensitivity (allergic) reactions
- Hyperglycemia
- Peripheral neuropathy (numbness, tingling)
- Tremor, somnolence
- Seizures (convulsions)
- Visual disturbances, blurred vision
- QTc prolongation on ECG, palpitations
- Hypertension or hypotension
- Pancreatitis
- Hepatitis, jaundice, cholestasis
- Increased serum creatinine, renal impairment
- Musculoskeletal pain, muscle weakness
- Hair loss (alopecia)
Rare Side Effects
- Hepatic failure, hepatic necrosis
- Adrenal insufficiency
- Pseudoaldosteronism (mineralocorticoid excess: hypertension and hypokalemia)
- Pulmonary hypertension
- Heart failure
- Torsades de pointes, sudden cardiac death
- Cerebrovascular accident (stroke)
- Deep vein thrombosis, pulmonary embolism
- Hemolytic uremic syndrome (HUS)
- Thrombotic thrombocytopenic purpura (TTP)
- Stevens-Johnson syndrome and other severe cutaneous reactions
Contact your doctor immediately or go to the nearest emergency department if any of the following occur during treatment with Posaconazole Vivanta:
- Signs of liver problems: persistent nausea or vomiting, loss of appetite, abdominal (especially upper-right) pain, yellowing of the skin or eyes (jaundice), dark urine, pale stools, or easy bruising.
- Signs of a severe allergic reaction: swelling of the face, lips, tongue or throat; difficulty breathing or swallowing; widespread hives; rapid heartbeat; or sudden drop in blood pressure.
- Signs of heart rhythm problems: fast, slow or irregular heartbeat; palpitations; fainting or near-fainting; dizziness; or chest pain.
- Signs of severe skin reactions: widespread rash with blistering or peeling, especially involving the mouth, eyes, or genitals.
- Signs of adrenal insufficiency or pseudoaldosteronism: extreme fatigue, muscle weakness, dizziness on standing, weight loss, darkening of the skin, or unexplained high blood pressure with low potassium.
How Should You Store Posaconazole Vivanta?
Quick answer: Store Posaconazole Vivanta tablets at room temperature, below 30 °C, in the original blister packaging, out of reach of children. Do not use after the expiry date printed on the packaging, and dispose of unused medicine via a pharmacy.
Posaconazole Vivanta 100 mg gastro-resistant tablets do not require any special refrigeration or specialized storage conditions. Keep the tablets in their original blister packaging to protect them from moisture and light, and store them at room temperature, typically below 30 °C (86 °F). Avoid places with extreme heat or prolonged direct sunlight, such as car dashboards or windowsills. Do not store the medicine in the bathroom, where humidity can be high and may affect the stability of the gastro-resistant coating.
Keep Posaconazole Vivanta out of the sight and reach of children at all times. An accidental overdose in a child could be serious. The expiry date (EXP) printed on the carton and blister refers to the last day of that month; do not use the medicine after that date.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused or expired Posaconazole Vivanta according to your local regulations. These measures help protect the environment and prevent accidental ingestion or misuse by others.
What Does Posaconazole Vivanta Contain?
Quick answer: Each Posaconazole Vivanta gastro-resistant tablet contains 100 mg of the active substance posaconazole, together with inactive ingredients (excipients) such as hypromellose acetate succinate and microcrystalline cellulose, plus a film coating with a gastro-resistant polymer and titanium dioxide.
Active Substance
Each gastro-resistant tablet contains 100 mg of posaconazole as the active pharmaceutical ingredient. Posaconazole is a second-generation triazole antifungal, chemically a modification of itraconazole designed to improve the spectrum of activity and bioavailability.
Excipients (Inactive Ingredients)
Posaconazole Vivanta gastro-resistant tablets also contain several excipients to ensure stability, appropriate release of the active ingredient in the small intestine, and acceptable tablet properties. Typical excipients for posaconazole gastro-resistant tablets include:
- Tablet core: hypromellose acetate succinate (which provides the pH-dependent, delayed-release behavior), microcrystalline cellulose, low-substituted hydroxypropylcellulose, silica (colloidal anhydrous), croscarmellose sodium, and magnesium stearate.
- Tablet coating: polyvinyl alcohol, macrogol (polyethylene glycol), titanium dioxide (E171), talc, and iron oxide pigments (such as iron oxide yellow, E172) used as colorants.
The exact list of excipients in Posaconazole Vivanta should be confirmed from the current patient information leaflet or summary of product characteristics for the specific product licensed in your country. The gastro-resistant coating is a critical feature of this formulation: it prevents the tablet from dissolving in the acidic environment of the stomach and instead allows posaconazole to be released in the less acidic environment of the small intestine, where it is efficiently absorbed. This is why the tablets must always be swallowed whole – crushing, chewing, or breaking them would destroy the enteric coating, alter absorption kinetics, and reduce tolerability.
If you have been told by a healthcare professional that you have an intolerance to certain sugars, food additives, or excipients (for example a sodium-restricted diet, or hereditary metabolic disorders), check the current patient information leaflet for the specific pack of Posaconazole Vivanta you have received. Discuss any relevant dietary restrictions with your doctor or pharmacist before starting treatment.
Frequently Asked Questions
Posaconazole Vivanta is a generic triazole antifungal used for two main purposes. First, as prophylaxis of invasive fungal infections in severely immunocompromised patients, especially adults and children (from 2 years, ≥14 kg) receiving remission-induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), or immunosuppressive therapy for graft-versus-host disease after hematopoietic stem cell transplantation. Second, as salvage therapy for serious invasive fungal infections – including invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, and coccidioidomycosis – in patients who are refractory to or cannot tolerate first-line antifungal treatment. Posaconazole is also used for oropharyngeal candidiasis in certain situations. Because Posaconazole Vivanta contains the same active substance as the originator Noxafil gastro-resistant tablets, it is approved for the same indications.
Posaconazole Vivanta is a generic version of Noxafil gastro-resistant tablets. Both products contain the same active substance (posaconazole), at the same strength (100 mg per tablet), in the same dosage form (gastro-resistant tablet), and are used for the same indications at the same doses. For a generic medicinal product to be authorized, the manufacturer must demonstrate bioequivalence to the reference product, meaning the active substance is absorbed into the bloodstream at essentially the same rate and to the same extent. Therefore, efficacy and safety are expected to be clinically comparable between Posaconazole Vivanta and Noxafil. The main differences are the marketing authorization holder (Vivanta Generics) and typically the price. Some excipients and the appearance of the tablet may differ, but these do not affect the clinical performance.
No. Posaconazole Vivanta tablets are gastro-resistant (enteric-coated) and must be swallowed whole with water. The gastro-resistant coating is specifically designed to keep the tablet intact in the acidic stomach and to release posaconazole only in the less acidic small intestine, where it is best absorbed. Crushing, splitting, chewing or dissolving the tablet would destroy this coating, change how quickly and how completely the drug is absorbed, and can increase gastrointestinal side effects. If you cannot swallow tablets, speak with your doctor – posaconazole is also available in other formulations (oral suspension, intravenous solution) that may be suitable, although the tablet is generally the preferred oral option because of its more reliable absorption.
Posaconazole Vivanta should not be used during pregnancy unless the expected benefit to the mother clearly outweighs the potential risk to the fetus. Animal reproductive studies have shown toxicity including skeletal malformations at clinically relevant exposures; adequate and well-controlled studies in pregnant women have not been performed. Women of childbearing potential must use effective contraception during treatment. If you become pregnant while on Posaconazole Vivanta, contact your doctor as soon as possible to discuss the risks and benefits of continuing therapy. Because posaconazole may be excreted into breast milk (demonstrated in animals) and the effects in a nursing infant are unknown, breastfeeding should be discontinued when Posaconazole Vivanta is started. The decision between stopping breastfeeding or stopping the medicine should be made with your doctor.
If you miss a dose of Posaconazole Vivanta, take it as soon as you remember. If it is nearly time for your next scheduled dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten one. Maintaining stable posaconazole blood concentrations is important, particularly when the medicine is being used for prophylaxis in neutropenic patients, because inadequate exposure can allow breakthrough fungal infections. If you frequently forget doses, consider using a medication reminder or pill organizer, and discuss this with your doctor or pharmacist. In high-risk patients, your doctor may request therapeutic drug monitoring to check that posaconazole levels remain in the effective range.
The most important interactions fall into three groups. First, absolutely contraindicated combinations: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine (QTc prolongation and risk of fatal arrhythmias), ergot alkaloids (ergotism), simvastatin, lovastatin and atorvastatin (rhabdomyolysis), and venetoclax during the CLL dose ramp-up phase (tumor lysis syndrome). Second, drugs that lower posaconazole exposure and may cause treatment failure: rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital, efavirenz, and fosamprenavir. Third, drugs whose levels rise with posaconazole and require dose reduction or enhanced monitoring: ciclosporin, tacrolimus, sirolimus, vincristine, midazolam and other benzodiazepines, calcium channel blockers, digoxin, and sulfonylureas. Always give your doctor and pharmacist a complete list of all prescription drugs, over-the-counter medicines, supplements, and herbal products before starting Posaconazole Vivanta.
References
- European Medicines Agency (EMA). Noxafil – Summary of Product Characteristics (reference product for posaconazole gastro-resistant tablets). Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/noxafil. Last updated 2025.
- Cornely OA, Maertens J, Winston DJ, et al. Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia. New England Journal of Medicine. 2007;356(4):348-359. doi:10.1056/NEJMoa061094
- Ullmann AJ, Lipton JH, Vesole DH, et al. Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease. New England Journal of Medicine. 2007;356(4):335-347. doi:10.1056/NEJMoa061098
- Walsh TJ, Raad I, Patterson TF, et al. Treatment of invasive aspergillosis with posaconazole in patients who are refractory to or intolerant of conventional therapy: an externally controlled trial. Clinical Infectious Diseases. 2007;44(1):2-12. doi:10.1086/508774
- Patterson TF, Thompson GR 3rd, Denning DW, et al. Practice guidelines for the diagnosis and management of aspergillosis: 2016 update by the Infectious Diseases Society of America (IDSA). Clinical Infectious Diseases. 2016;63(4):e1-e60. doi:10.1093/cid/ciw326
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