TM Owner Astellas Pharma
Xtandi 40mg Capsule
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Indications & Clinical Uses
- Xtandi 40 mg capsules contain enzalutamide, an androgen receptor inhibitor taken by mouth for prostate cancer.
- In the US, Xtandi is indicated for castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, and non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk of metastasis; the EU label also covers high-risk non-metastatic castration-resistant disease and metastatic castration-resistant disease before and after docetaxel chemotherapy, among other stages, in adult men.
- The recommended dose is 160 mg once daily, taken as four 40 mg capsules, with or without food.
- Xtandi is also supplied as 40 mg and 80 mg tablets, and the capsule pack in this listing is the 40 mg capsule (120 capsules).
- It is marketed by Astellas Pharma US and Pfizer, and you take it yourself at home under specialist supervision.
Side Effects
- The most common reactions (10% or more and at least 2% more often than placebo) are musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhoea, high blood pressure, bleeding (haemorrhage), falls, fractures and headache.
- Serious effects need urgent attention: seizure (about 0.6% overall and 2.2% in people with predisposing factors), posterior reversible encephalopathy syndrome (PRES) with headache, confusion or vision changes, hypersensitivity reactions, ischaemic heart disease, falls and fractures, and dysphagia or choking.
- The EU label also lists second primary malignancies and severe skin reactions.
- The label carries no boxed warning.
- Seek urgent help for a seizure, chest pain, an allergic reaction or sudden confusion, and tell your team about falls or bone pain.
Precautions & Warnings
- Xtandi can cause seizures, so tell your healthcare provider about any history of seizures, brain injury, stroke or medicines that lower the seizure threshold, and ask about activities such as driving or swimming.
- Report signs of PRES, allergic reactions, heart disease symptoms, falls and difficulty swallowing.
- Xtandi can cause fetal harm and loss of pregnancy; men with female partners who could become pregnant should use effective contraception (in the EU, a condom) during treatment and for 3 months after the last dose.
- In the EU it is contraindicated in women who are or may become pregnant.
- Reproductive toxicity data suggest it may affect male fertility.
- Xtandi can interfere with digoxin immunoassays.
- Swallow the capsules whole with water: do not chew, dissolve, open, cut or crush them.
- Store at 20°C to 25°C in a dry place with the container tightly closed.
Avoid Interactions
- Medicines that increase exposure: strong CYP2C8 inhibitors should be avoided, or the Xtandi dose reduced to 80 mg daily if co-administration cannot be avoided.
- Medicines that reduce efficacy: strong CYP3A4 inducers should be avoided, or the Xtandi dose increased to 240 mg daily if unavoidable.
- Xtandi is itself a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer, so it can lower the levels and effect of many other medicines that depend on those enzymes; your prescriber or pharmacist will review your other medicines.
- Xtandi can also interfere with digoxin immunoassays.
- Tell your healthcare provider about all prescription medicines, over-the-counter products and herbal supplements before starting or changing any treatment.
References
Frequently Asked Questions
Xtandi (enzalutamide) is a prostate cancer medicine for adult men. In the US it treats castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, and non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence. The EU label also covers other prostate cancer stages.
The usual Xtandi dose is 160 mg once daily, taken as four 40 mg capsules, with or without food. Swallow the capsules whole with water; do not chew, dissolve, open, cut or crush them. Take it every day until your cancer progresses or side effects become unacceptable.
Common Xtandi (enzalutamide) side effects include muscle and bone pain, tiredness, hot flushes, constipation, poor appetite, diarrhoea, high blood pressure, bleeding, falls, fractures and headache. Seek urgent help for a seizure, sudden confusion or vision changes (PRES), an allergic reaction or heart-related chest pain.
Avoid strong CYP2C8 inhibitors with Xtandi (enzalutamide); if unavoidable, the dose drops to 80 mg daily. Avoid strong CYP3A4 inducers too, or the dose rises to 240 mg daily. Xtandi itself lowers levels of many other medicines, so tell your healthcare provider about everything you take.
Store Xtandi (enzalutamide) capsules at 20°C to 25°C in a dry place with the container tightly closed. The US pack of 40 mg capsules holds 120 capsules, which is a 30-day supply at 160 mg (four capsules) a day. The EU capsule pack differs: 28 capsules per wallet, with no special storage conditions.
Yes. Men taking Xtandi (enzalutamide) with a partner who could become pregnant should use effective contraception during treatment and for 3 months after the last dose. Xtandi can harm an unborn baby and may affect fertility. In the EU it is contraindicated in women who are or may become pregnant.
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