Apalutamide
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
NO
Pharmaceutical Class
NA
Controlled Drug Substance
NO
Apalutamide
Summary
Apalutamide is used to treat certain types of prostate cancer, specifically metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer.
Apalutamide works by inhibiting androgen receptors which are involved in the growth and spread of prostate cancer cells. By blocking these receptors, it helps to slow down or stop the progression of the disease.
The usual daily dose of Apalutamide for adults is 240 mg taken orally once a day. This can be administered as one 240 mg tablet or four 60 mg tablets.
Common side effects of Apalutamide include fatigue, skin rash, hypertension, hot flush, arthralgia, diarrhea, fall, and weight decreased. Serious adverse effects include seizures, severe cutaneous reactions and interstitial lung disease.
Apalutamide may cause seizures and is contraindicated in women who are or may become pregnant due to the risk of fetal harm. Patients should be monitored for cardiovascular events and interstitial lung disease.
Indications and Purpose
How does Apalutamide work?
Apalutamide works by inhibiting androgen receptors, which are proteins in the body that bind to male hormones like testosterone. By blocking these receptors, Apalutamide prevents the hormones from stimulating the growth of prostate cancer cells, thereby slowing down or stopping the progression of the disease.
How does one know if Apalutamide is working?
The benefit of Apalutamide is evaluated through regular medical check-ups and laboratory tests ordered by your doctor. These tests help monitor the body's response to the medication and assess the effectiveness of the treatment in managing prostate cancer.
Is Apalutamide effective?
Apalutamide has been shown to be effective in treating prostate cancer in clinical trials. In the TITAN study, it significantly improved overall survival and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer. In the SPARTAN study, it significantly improved metastasis-free survival in patients with non-metastatic castration-resistant prostate cancer.
What is Apalutamide?
Apalutamide is used to treat certain types of prostate cancer, including metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer. It works by inhibiting androgen receptors, blocking the effects of male hormones that promote the growth of cancer cells. This helps to slow down or stop the progression of the cancer.
What is Apalutamide used for?
Apalutamide is indicated for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). It is used in combination with androgen deprivation therapy to manage these conditions in adult men.
Directions for Use
For how long do I take Apalutamide?
The duration of use for Apalutamide varies depending on the individual's response to treatment and the progression of prostate cancer. Patients are generally advised to continue taking Apalutamide as long as it is effective and tolerated, under the guidance of their healthcare provider.
How do I take Apalutamide?
Apalutamide should be taken orally once a day, with or without food, at the same time each day. The tablets should be swallowed whole and not crushed or split. There are no specific food restrictions while taking Apalutamide, but patients should follow any dietary advice given by their healthcare provider.
How long does it take for Apalutamide to start working?
The time it takes for Apalutamide to start working can vary among individuals. In clinical studies, some patients experienced a reduction in prostate-specific antigen (PSA) levels within a few weeks of starting treatment. However, the full therapeutic effect may take longer to become apparent, and regular monitoring by a healthcare provider is essential.
How should I store Apalutamide?
Apalutamide should be stored at room temperature between 68°F to 77°F (20°C to 25°C). It should be kept in its original package to protect from light and moisture. The bottle contains a desiccant packet to keep the medicine dry, which should not be discarded. Keep the medication out of reach of children.
What is the usual dose of Apalutamide?
The usual daily dose of Apalutamide for adults is 240 mg taken orally once a day. It can be administered as one 240 mg tablet or four 60 mg tablets. Apalutamide is not indicated for use in children, and its safety and effectiveness in pediatric patients have not been established.
Warnings and Precautions
Can Apalutamide be taken safely while breastfeeding?
Apalutamide is not recommended for use in women, and there is no information on its presence in human milk or its effects on a breastfed child. Therefore, it should not be used during breastfeeding.
Can Apalutamide be taken safely while pregnant?
Apalutamide is contraindicated in women who are or may become pregnant due to the risk of fetal harm. Animal studies have shown that Apalutamide can cause fetal abnormalities and embryo-fetal lethality. Male patients with female partners of reproductive potential should use effective contraception during treatment and for 3 months after the last dose.
Can I take Apalutamide with other prescription drugs?
Apalutamide is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9, which can lead to reduced effectiveness of medications metabolized by these enzymes. It can also decrease the exposure of drugs that are substrates of P-gp, BCRP, or OATP1B1. Patients should inform their healthcare provider of all medications they are taking to avoid potential interactions.
Is Apalutamide safe for the elderly?
Elderly patients may experience a higher incidence of falls and fractures while taking Apalutamide. It is important for healthcare providers to evaluate the risk of falls and fractures in elderly patients before starting treatment and to monitor them regularly. Bone-targeted agents may be considered to manage fracture risk.
Is it safe to exercise while taking Apalutamide?
Apalutamide may cause fatigue and muscle weakness, which could potentially limit the ability to exercise. If you experience these side effects, it is important to discuss them with your healthcare provider. They can provide guidance on managing these symptoms and advise on safe levels of physical activity.
Who should avoid taking Apalutamide?
Important warnings for Apalutamide include the risk of seizures, falls, fractures, and severe skin reactions. It is contraindicated in women who are or may become pregnant due to the risk of fetal harm. Patients should be monitored for signs of cardiovascular and cerebrovascular events, and those with a history of seizures should not use this medication.
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