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Voydeya 50mg and 100mg tablets (150mg dose = 50mg + 100mg) Tablet
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Indications & Clinical Uses
- Voydeya (danicopan) is an oral complement factor D inhibitor used as add-on therapy to the C5 inhibitors ravulizumab or eculizumab for extravascular haemolysis (red blood cells destroyed outside the blood vessels, mainly in the liver and spleen) in adults with paroxysmal nocturnal haemoglobinuria (PNH).
- It is not effective as a stand-alone treatment.
- The US label describes tablets in two strengths, 50 mg and 100 mg: the starting 150 mg dose is one 50 mg plus one 100 mg tablet, taken three times a day with or without food, and it can be increased to 200 mg three times daily according to your haemoglobin response after 4 weeks.
- The sheet lists a 150 mg tablet, which does not appear in the US label.
- Voydeya is available only through a restricted REMS programme because of serious infection risk, and treatment is supervised by a haematology specialist.
Side Effects
- BOXED WARNING: Voydeya increases the risk of serious infections, especially those caused by encapsulated bacteria such as Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae type b; life-threatening and fatal infections can occur.
- In studies the most common side effects were headache (11%, versus 10% on placebo), vomiting (7%) and fever (7%).
- Liver enzyme (ALT) elevations occurred in about 14% of patients, and raised cholesterol was seen in about 30% of patients with normal cholesterol at the start.
- Seek immediate medical care for fever, rash, chest pain with cough, stiff neck, headache with nausea, confusion or sensitivity to light, and carry the Patient Safety Card given to you.
Precautions & Warnings
- Vaccinate against Neisseria meningitidis and Streptococcus pneumoniae (and Haemophilus influenzae type b, per ACIP guidance) at least 2 weeks before starting Voydeya.
- Do not start Voydeya if you have an unresolved serious infection caused by encapsulated bacteria.
- Voydeya is available only through the Voydeya REMS programme, which requires prescriber enrolment, patient counselling and a Patient Safety Card to be carried during treatment and for one week after the last dose.
- Liver tests and cholesterol are monitored before and during treatment.
- Animal studies showed no developmental harm at 18 to 25 times the recommended dose, but tell your provider if you are pregnant or planning pregnancy.
- Do not breastfeed during treatment and for 3 days after the last dose.
- Store in the original container at 20°C to 25°C.
Avoid Interactions
- Medicines that increase exposure or risk: rosuvastatin and other BCRP substrates, where the rosuvastatin dose must not exceed 10 mg once daily with Voydeya, and P-glycoprotein substrates, whose dose may need adjustment when small concentration changes matter.
- Voydeya must be used with ravulizumab or eculizumab and is not a stand-alone replacement.
- Other immune-suppressing treatments may add to the infection risk, so review them with your specialist.
- Medicines that reduce efficacy: none were identified in the label sections reviewed.
- Do not stop or skip your ravulizumab or eculizumab without medical advice.
- Tell your healthcare provider about all prescription medicines, herbal products and supplements before starting Voydeya.
References
Frequently Asked Questions
Voydeya (danicopan) is an add-on tablet for adults with paroxysmal nocturnal haemoglobinuria (PNH) who still have extravascular haemolysis while taking ravulizumab or eculizumab. It is not used alone. It is available only through a restricted REMS programme, and treatment is supervised by a specialist.
Take Voydeya (danicopan) by mouth three times a day, with or without food, at about the same times daily. The usual starting dose is 150 mg, which is one 50 mg and one 100 mg tablet. Your specialist may raise it to 200 mg three times daily after 4 weeks.
The most common Voydeya side effects are headache, vomiting and fever. Voydeya (danicopan) can also raise liver enzymes and cholesterol. Get emergency care for fever, rash, stiff neck, headache with nausea, confusion, chest pain with cough or sensitivity to light, which can signal a serious infection.
Do not use Voydeya (danicopan) without first having the required meningococcal and pneumococcal vaccines, at least 2 weeks before starting. Do not take more than 10 mg of rosuvastatin daily with it. Do not breastfeed during treatment or for 3 days after the last dose.
If you miss a dose of Voydeya (danicopan), take it as soon as you remember. If it is within 3 hours of your next dose, skip the missed dose and take the next one at the usual time. Never take a double dose.
Yes. Voydeya carries a boxed warning for serious infections, especially those caused by encapsulated bacteria such as meningococcus and pneumococcus, which can be fatal. You need vaccines at least 2 weeks before starting, and you must carry the Patient Safety Card during treatment and for one week after the last dose.
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