Apalutamide
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DRUG STATUS
Approvals
US(FDA), UK(BNF)
Essential Medicine
NO
Teratogenicity
Unlisted
Pharmaceutical Class
NA
Apalutamide
Know More About This Medicine -
Click HereSummary
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
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 adult men to manage prostate cancer that has spread to other parts of the body or has not responded to other treatments.
How does Apalutamide work?
Apalutamide is an androgen receptor inhibitor that binds to the ligand-binding domain of the androgen receptor. It prevents the receptor from moving to the cell nucleus, inhibits DNA binding, and impedes androgen receptor-mediated transcription. This action decreases tumor cell proliferation and increases apoptosis, leading to reduced tumor volume.
Is Apalutamide effective?
Apalutamide has been shown to be effective in treating metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). Clinical trials demonstrated significant improvements in overall survival and progression-free survival in patients treated with Apalutamide compared to placebo.
How does one know if Apalutamide is working?
The benefit of Apalutamide is evaluated through regular medical appointments and laboratory tests to monitor the patient's response to treatment. Healthcare providers may assess prostate-specific antigen (PSA) levels and conduct imaging studies to evaluate the effectiveness of the medication in controlling cancer progression.
Directions for Use
What is the usual dose of Apalutamide?
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. Apalutamide is not indicated for use in children, and its safety and effectiveness in pediatric patients have not been established.
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 mentioned, but patients should follow their healthcare provider's advice regarding diet and medication use.
For how long do I take Apalutamide?
The duration of use for Apalutamide is not specified in the provided content, as it depends on the individual's response to treatment and the progression of the disease. Patients should continue taking Apalutamide as prescribed by their healthcare provider and should not stop without consulting their doctor.
How long does it take for Apalutamide to start working?
The content does not specify how long it takes for Apalutamide to start working. The onset of action can vary depending on the individual and the progression of the disease. Patients should follow their healthcare provider's instructions and attend regular check-ups to monitor the effectiveness of the treatment.
How should I store Apalutamide?
Apalutamide should be stored at room temperature between 68°F to 77°F (20°C to 25°C) in its original package to protect from light and moisture. The bottle contains a desiccant to keep the medication dry, and it should not be discarded. Keep the medication out of reach of children.
Warnings and Precautions
Who should avoid taking Apalutamide?
Important warnings for Apalutamide include the risk of seizures, falls, fractures, and severe cutaneous adverse reactions. It 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.
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 interactions.
Can I take Apalutamide with vitamins or supplements?
The content does not specifically mention interactions between Apalutamide and vitamins or supplements. However, patients should inform their healthcare provider about all supplements they are taking, as Apalutamide can interact with various substances and affect their efficacy or increase side effects.
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 Apalutamide be taken safely while breastfeeding?
The safety and efficacy of Apalutamide have not been established in females, and it is unknown whether Apalutamide or its metabolites are present in human milk. Therefore, Apalutamide should not be used during breastfeeding, as a risk to the breastfed child cannot be excluded.
Is Apalutamide safe for the elderly?
The content indicates that no overall differences in effectiveness were observed between older and younger patients. However, elderly patients may experience a higher incidence of certain side effects, such as falls. It is important for elderly patients to be monitored closely for side effects and to discuss any concerns with their healthcare provider.
Is it safe to exercise while taking Apalutamide?
The content does not specifically address whether Apalutamide limits the ability to exercise. However, since fatigue and muscle weakness are common side effects, these could potentially impact exercise ability. Patients should discuss any concerns about exercise with their healthcare provider.
Is it safe to drink alcohol while taking Apalutamide?
The provided content does not specifically mention the effects of alcohol on the safety or effectiveness of Apalutamide. It is generally advisable to consult with a healthcare provider regarding alcohol consumption while taking any medication, as alcohol can interact with medications and affect their efficacy or increase side effects.