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Nubeqa 300mg Tablet
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Indications & Clinical Uses
- Nubeqa 300 mg (darolutamide) is an androgen-receptor inhibitor tablet used to treat prostate cancer in adult men.
- It is approved for non-metastatic castration-resistant prostate cancer (nmCRPC), where the cancer has stopped responding to hormone therapy but has not yet spread on scans, and for metastatic castration-sensitive prostate cancer (mCSPC), where it is combined with androgen deprivation therapy (a luteinising-hormone-releasing hormone analogue or surgical castration) either alone or together with docetaxel chemotherapy.
- Nubeqa is not used to treat women or children and has no role outside prostate cancer.
- It is taken as two 300 mg tablets twice daily with food, alongside ongoing hormone therapy, and treatment is usually continued for as long as the cancer responds and side effects remain manageable, under the supervision of an oncologist or urologist.
Side Effects
- There is no boxed warning for Nubeqa.
- When combined with docetaxel chemotherapy, common side effects (affecting 10% or more of patients) include constipation, rash, reduced appetite, bleeding, weight increase and high blood pressure.
- Across all uses, laboratory changes such as raised liver enzymes, low neutrophil count and raised bilirubin are common, along with fatigue.
- Seizures have occurred in a small proportion of patients (up to about 1 in 125), so tell your healthcare provider if you have a history of seizures or conditions that increase seizure risk, and avoid activities where sudden loss of consciousness could cause serious harm, such as driving or operating machinery, until you know how Nubeqa affects you.
- Because Nubeqa is combined with hormone therapy, hot flushes and fatigue related to testosterone suppression are also common.
- Report any new or worsening seizure activity, severe rash, or unusual bleeding straight away.
Precautions & Warnings
- Nubeqa can cause fetal harm and loss of pregnancy, so it must never be given to, or handled unprotected by, a pregnant woman; men taking Nubeqa whose partner could become pregnant must use effective contraception during treatment and for one week after the final dose, and should not donate sperm during this time.
- Blood counts and liver function are monitored periodically, especially when Nubeqa is combined with docetaxel.
- Tell your healthcare provider about any history of seizures, as Nubeqa can lower the seizure threshold; discontinuation should be discussed if a seizure occurs during treatment.
- Because Nubeqa is combined with ongoing androgen deprivation therapy, cardiovascular risk factors such as blood pressure and cholesterol should be monitored, as hormone therapy itself carries cardiovascular risk.
- Tablets are stored at 20°C to 25°C, with brief excursions to 15°C–30°C permitted, in a tightly closed container.
- There is no specific driving restriction, but caution is advised if you feel fatigued or dizzy.
Avoid Interactions
- Nubeqa is a substrate of CYP3A4 and P-glycoprotein (P-gp), so combined strong or moderate inducers of these pathways, such as rifampicin, carbamazepine, phenytoin or St John's Wort, substantially lower darolutamide levels and reduce its effect and should generally be avoided; if an inducer cannot be avoided, closer monitoring for reduced efficacy is needed.
- Combined strong CYP3A4 and P-gp inhibitors, such as itraconazole or clarithromycin, raise darolutamide levels and increase the risk of side effects, so patients should be monitored more closely if these are used together.
- Nubeqa itself inhibits the transporter protein BCRP, which can raise blood levels of medicines such as rosuvastatin roughly fivefold, and may also raise levels of drugs handled by the OATP1B1/1B3 transporters; dose reduction or closer monitoring of these medicines may be needed.
- Always give your healthcare provider and pharmacist a complete, up-to-date list of every prescription medicine, over-the-counter product and herbal supplement you use before and during Nubeqa treatment.
References
Frequently Asked Questions
Nubeqa (darolutamide) treats prostate cancer in men: non-metastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer, given together with ongoing hormone therapy and sometimes chemotherapy. It works by blocking androgen receptors that prostate cancer cells use to grow.
Nubeqa is taken as two 300 mg tablets by mouth twice a day, with food, alongside continued hormone (androgen deprivation) therapy. Swallow the tablets whole. Take doses about 12 hours apart and keep taking your hormone therapy injections as scheduled.
Common side effects include fatigue, changes in liver blood tests, and low neutrophil counts; when combined with chemotherapy, constipation, rash and bleeding are also common. Seizures occur in a small number of patients, so avoid driving or risky activities until you know how Nubeqa affects you.
Avoid strong CYP3A4 or P-gp inducers such as rifampicin or St John's Wort, which reduce how well Nubeqa works, and be cautious with strong inhibitors like itraconazole, which raise its levels. Nubeqa must not be given to pregnant women; men need contraception during treatment and for a week after.
Your healthcare provider periodically checks liver function tests and blood counts, especially if Nubeqa is combined with chemotherapy. Blood pressure and cardiovascular risk factors are also monitored, since Nubeqa is used alongside long-term hormone therapy, which itself affects heart and metabolic health.
Nubeqa can cause fetal harm if a partner becomes pregnant, so men must use effective contraception during treatment and for 1 week after the last dose, and avoid sperm donation. Nubeqa combined with hormone therapy can also reduce fertility; discuss fertility preservation before starting treatment.
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