Product Description
XTANDI contains the active ingredient Enzalutamide. It is used in the treatment of advanced prostate cancer in patients who no longer responds to a hormone therapy or surgery to reduce testosterone and who is at high risk of cancer spreading to other parts of the body.
It belongs to a class of medicines called androgen receptor inhibitors. It works by blocking androgens from binding to their receptors, preventing nuclear translocation of androgen receptors and interaction with DNA. Enzalutamide treatment slows the growth of prostate cancer cells, promotes cancer cell death, and can lead to tumor regression.
Inform the doctor if you have any infection, history of seizures, brain injury, stroke, or brain tumors, high blood pressure, heart diseases, diabetes, kidney diseases, liver diseases.
Inform the doctor about all your medical conditions, prescription and non-prescription drugs, vitamin supplements, herbal medications, since Xtandi can interact with them. Xtandi can cause an allergic reaction in some patients therefore it is necessary to read the complete composition list and consult the doctor in case of any ingredient that induces allergies. This medicine can increase your skin’s sensitivity to the sun. To protect yourself, it’s recommended to use sunscreen and wear protective clothing when outdoors.
Consult the doctor if you are planning, on a pregnancy or breastfeeding.
It is advisable to avoid driving and operating heavy machinery during the course of Xtandi.
Indications of XTANDI
XTANDI is indicated in the treatment of advanced prostate cancer in patients who no longer responds to a hormone therapy or surgical treatment to lower testosterone and who is at high risk of cancer spreading to other parts of the body.
Therapeutic Effects of XTANDI
XTANDI contains Enzalutamide, an antineoplastic drug which belongs to the group of medicines called androgen receptor inhibitors, works by inhibiting androgen binding to androgen receptors; and consequently, inhibits nuclear translocation of androgen receptors and their interaction with DNA. Enzalutamide treatment decreases the growth of prostate cancer cells and can induce cancer cell death and tumour regression
Directions for Use
XTANDI Capsule should be taken with or without food preferably at the same time each day. The capsule should be swallowed whole with water and should not be crushed, chewed, or opened.
Taking the medicine regularly at the same time increases their effectiveness. A dose of this medicine should not be missed as it can affect your recovery. Take a missed dose as soon as possible, but skip it if the next dose is near; continue with your regular schedule. The dosage and duration of treatment will depend on the individual’s condition and response to the medication.
Your doctor will decide the dose and frequency of administration based on your health condition.
Storage
- XTANDI should be stored below 30°C temperature at room temperature. Do not freeze.
- Avoid extreme heat or cold.
- Keep the medicine in the original container to protect from light and moisture.
- Keep XTANDI out of sight and reach of children.
Common:
- Headache
- Muscle and joint pain
- Feeling more tired than usual
- Hot flashes
- Constipation
- Loss of appetite
- Diarrhoea
- High blood pressure
- Anxiety
- Bleeding problems
- Falls
- Bone fractures
Serious:
- Hypersensitivity
- Seizures
- Posterior reversible encephalopathy syndrome (PRES)
- Heart disease
- Falls and fractures
Contraindications
XTANDI is contraindicated in patients with a known hypersensitivity to XTANDI or any of the excipients.
Safety Advices for XTANDI
Unsafe
It is recommended to avoid alcohol while being treated with XTANDI Capsule. Alcohol can hinder the liver’s ability to metabolize medication. It is best to avoid alcohol as Xtandi can worsen any liver-related side effect and may elevate liver damage. Consult your doctor if you have history of Alcohol intake.
Unsafe
XTANDI is not recommended for use in pregnancy as it may cause embryo-fetal toxicity and harm your foetus. Hence, if you are pregnant or planning pregnancy, inform your doctor before taking XTANDI Capsule.
Unsafe
Avoid breastfeeding your baby while on the treatment with XTANDI, as it may pass through breast milk. Consult your doctor if you are breastfeeding before taking this medication.
Unsafe
XTANDI may cause drowsiness in some patients. Therefore, avoid driving or operating machines that require mental concentration until you are not alert.
Consult Your Doctor
If you have any lung-related symptoms, such as cough, shortness of breath, and difficulty breathing, consult your doctor. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Caution
If you have a pre-existing or a history of liver problems, consult your doctor before taking this medicine. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Consult Your Doctor
If you have a pre-existing or a history of kidney problems, consult your doctor before taking this medicine. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Unsafe
XTANDI is not recommended for children below 18 years as the safety and effectiveness were not established. Consult your doctor before taking the medicine.
- 1. Briggs GG, Freeman RK, editors. A Reference Guide to Fetal and Neonatal Risk: Drugs in Pregnancy and Lactation. 10th ed. Philadelphia, PA: Wolters Kluwer Health; 2015. pp. 474-75.
- 2. Astellas Pharma Ltd, [Revised on Oct 2020] [Accessed on 8th Apr 2021], https://www.astellas.us/docs/12a005-enz-wpi.pdf
- 3. Enzalutamide. Netherlands: Astellas Pharma Europe B.V.; [Accessed on 27 Mar. 2019] (online), https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf
- 4. PubChem. Enzalutamide. [Accessed 27 Mar. 2019] (online), https://pubchem.ncbi.nlm.nih.gov/compound/Enzalutamide
- 5. CiplaMed. Enzalutamide [Prescribing Information]. 2022. [Accessed 20 Feb. 2024] (online), https://www.ciplamed.com/product-index/Xylutide

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