What Are The Side Effects
Like all treatments, apalutamide can cause side effects. These may affect each person differently, and youre unlikely to get all the possible side effects. Before you start treatment, your hospital healthcare team will explain the possible side effects. Knowing what to expect can help you deal with them. You can find more information in the leaflet that comes with your medicine or from the Electronic Medicines Compendium.
The most common side effects of apalutamide are:
- falls and fractures
- loss of appetite and weight loss.
There is also a small increased risk of having a seizure . Speak to your hospital healthcare team about whether you have an increased risk of having a seizure, if its safe for you to drive or operate machines or if you have had seizures before. Apalutamide may not be suitable for you if you have a history of seizures.
Speak to your hospital healthcare team if you have any side effects from taking apalutamide, even if theyre not listed above. They may be able to help you manage any side effects.
If your partner is pregnant or there is a chance your they could become pregnant, use contraception when having sex. Use a condom together with another form of contraception while you are taking apalutamide, and for three months after. This is because apalutamide could harm the baby.
Erleada First Treatment For Nonmetastatic Prostate Cancer
On February 14, 2018, apalutamide was approved by the US Food and Drug Administration for the treatment of patients with nonmetastatic CRPC that is progressing despite treatment with appropriate hormone therapy.2
Apalutamide, a new-generation oral androgen receptor inhibitor, is the first nonhormone therapy drug to receive FDA approval for the treatment of nonmetastatic CRPC.2 The FDA approval of apalutamide is the first time the FDA used the clinical end point of metastasisfree survival as the basis for a drug approval. Apalutamide was granted a priority review by the FDA.
This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment, said Richard Pazdur, MD, Director of the FDAs Oncology Center of Excellence. In the trial supporting approval, Erleada had a robust effect on this endpoint.2
The practice guidelines from the National Comprehensive Cancer Network recently added apalutamide as part of the systemic therapy regimen for the treatment of patients with nonmetastatic CRPC.7 The NCCN guidelines recommend that the risks and benefits of apalutamide treatment should be discussed with patients, and that supportive care for bone health should be used.7
Erleada Use With Other Drugs
In people whove had surgery to remove their testicles, Erleada can be taken alone. But in people who havent had this surgery, Erleada must be taken in combination with another type of drug.
This other type of drug is called a gonadotropin-releasing hormone analog. It belongs to a kind of treatment called analog androgen deprivation therapy .
Male hormones encourage prostate cancer cells to grow and spread. Erleada and GnRH analogs work in different ways to lower the level and effects of androgens in the body. This helps to stop prostate cancer cells from growing and spreading.
Most of the male hormones made in the body are produced in the testicles. GnRH analogs prevent the testicles from making androgens , which lowers the levels of androgens in the body.
Examples of GnRH analogs include:
- LHRH agonists, such as leuprolide or histrelin
- LHRH antagonists, such as degarelix
Small amounts of male hormones are made in other parts of the body besides the testicles and also inside cancer cells. Erleada works by blocking the effects of these hormones on prostate cancer cells. This prevents the hormones from helping the cells to grow and spread.
There arent any known interactions between Erleada and alcohol. However, drinking too much alcohol can cause many of the same side effects caused by Erleada.
Using alcohol and Erleada together can increase your risk for:
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Side Effects And Risks
Erleada and Xtandi work in very similar ways in the body. Therefore, they have some similar common and serious side effects.
More common side effects
These lists contain examples of more common side effects that can occur with Erleada, with Xtandi, or with both drugs .
- Can occur with Erleada:
- ischemic heart disease
How To Use Erleada Tablet
If you have difficulty swallowing the tablets whole, you may mix the whole tablets in 4 ounces of applesauce. Stir the mixture but make sure not to crush the tablets. Wait 15 minutes, and then stir the mixture again. Wait another 15 minutes and stir the mixture for a third time. Make sure the tablets are well mixed with no solid chunks remaining. Swallow the mixture right away using a spoon. After taking the mixture, rinse the container with 2 ounces of water and drink the mixture right away. Repeat the rinse to make sure you take the full dose of the medication. The applesauce/drug mixture should be used within 1 hour of making. Do not store for future use.
The dosage is based on your medical condition and response to treatment. Do not increase your dose or take this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
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Erleada Improves Survival Without Damaging Quality Of Life In Prostate Cancer Trial
Posted: 28 May 2021 | Hannah Balfour |
Data shows metastatic castration-sensitive prostate cancer patients treated with Erleada® were 35 percent less likely to die and had maintained quality of life.
New patient-reported outcomes data shows patients with metastatic castration-sensitive prostate cancer treated with Janssens Erleada® plus androgen deprivation therapy had a significant improvement in their overall survival, reduced the risk of death by 35 percent compared with ADT alone.
The Phase III TITAN study set out to determine if the addition of Erleada to ADT provides superior efficacy in improving radiographic progression-free survival or overall survival for participants with mHSPC. PRO data was from the pre-specified final analysis of the study, it was used to assess whether side effects from the treatment had a negative effect on patients health-related quality of life and if it worsened side effect burden, consistent with ADT alone. Erleada is an androgen receptor inhibitor.
The randomised, placebo-controlled, double-blind study enrolled 1,052 patients in 23 countries across 260 sites in North America, Latin America, South America, Europe and Asia Pacific. Patients with mCSPC were randomised 1:1 and received either Erleada plus ADT , or placebo plus ADT .
How Will I Be Monitored While I Take Erleada
Before you start Erleada, your doctor will order certain tests to check your prostate cancer. During Erleada treatment, they will monitor your response to the medication on a regular basis.
They will use the following tests to monitor the cancer and see how it responds to treatment:
- PSA test. Your doctor will likely order prostate-specific antigen tests for you. A PSA test will check your prostate cancers response to treatment. Both normal prostate cells and abnormal cancer cells make a protein called PSA, which appears in your blood. The levels of PSA in your blood are higher when prostate cancer is growing. With this test, your doctor will take a blood sample and measure your PSA levels.
- Digital rectal exam. Your doctor can check the size of your prostate by doing a digital rectal exam. This exam allows your doctor to check the size of your prostate and see if you have any pain in your prostate.
- Imaging tests. Your doctor may order an imaging test to check the size of your prostate. These tests also help your doctor see the organs around your prostate gland.
- Prostate biopsy. Your doctor may order a biopsy to be taken from your prostate. The biopsy results help your doctor identify what type and stage of prostate cancer you have. This test is sometimes needed to see if the prostate cancer is improving with treatment.
- Hormone levels. Your doctor may order blood tests to check your levels of male hormones during prostate cancer treatment.
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New Imaging Techniques May Change Diagnoses
While apalutamideand, potentially, enzalutamidegives men with nonmetastatic castration resistant disease a new treatment option, this patient population may decrease in the future, Dr. Dahut noted. Thats because traditional imaging techniques such as a CAT scan may not be able to detect tiny metastatic tumors, he explained. But a technique being used in research studies can catch smaller tumors. If molecular imaging tests become part of clinical care, more men with prostate cancer might be classified as having metastatic disease.
“It’s highly likely that apalutamide would be active” in men with metastatic castration-resistant prostate cancer, Dr. Dahut speculated. Trials to evaluate apalutamide in this patient population are already underway, Dr. Smith noted.
Fda Approves Apalutamide For The Treatment Of Metastatic Hormone
September 18, 2019 Last night the U.S. Food and Drug Administration approved apalutamide for the treatment of metastatic hormone-sensitive prostate cancer . Apalutamide has previously received FDA-approval for the treatment of non-metastatic castration-resistant prostate cancer .
PCF funded the initial synthesis of apalutamide at UCLA by chemist Michael Jung, PhD, in collaboration with prostate cancer physician-scientist Charles Sawyers, MD .
mHSPC refers to men whose prostate cancer has spread to areas of the body outside of the prostate itself, and who are responsive to testosterone-lowering agents. This may refer to men who have had prior surgery or radiation and recurred, or men who were initially diagnosed with disease that was already metastatic . Patients who are hormone-sensitive may have previously received androgen deprivation therapy for a certain amount of time, but their cancer has not yet developed resistance to ADT.
This approval is based on results from the randomized phase 3 TITAN clinical trial, which was presented at the 2019 American Society of Clinical Oncology Annual Meeting, held in June, and published in the prestigious medical journal, The New England Journal of Medicine.
More information on this approval can be found here.
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What Is The Dosage For Erleada
- The recommended dose of Erleada is 240 mg administered orally once daily. Swallow the tablets whole. Erleada can be taken with or without food.
- Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had a bilateral orchiectomy.
- If a patient experiences a greater than or equal to Grade 3 toxicity or an intolerable side effect, hold dosing until symptoms improve to less than or equal to Grade 1 or original grade, then resume at the same dose or a reduced dose , if warranted.
Alternate Method Of Administration
For patients who have difficulty swallowing tablets whole, the recommended dose of Erleada tablets may be mixed in applesauce.
Consume the mixture within one hour of preparation. Do not store Erleada that is mixed with applesauce.
What Are The Disadvantages Of Apalutamide
Severe side effects: Early results suggest that apalutamide has a disadvantage in terms of various severe side effects:
- Infections: Infections occurred in about 10 out of 100 men who took apalutamide, compared to about 2 out of 100 men in the placebo group.
- Complications resulting from surgical procedures: About 8 out of 100 men who took apalutamide had complications such as a fall or pain after their procedure. This happened in about 2 out of 100 men in the placebo group.
- Diseases of the skin and subcutaneous tissue: The study suggests that apalutamide has a disadvantage here: About 7 out of 100 men who took apalutamide developed severe diseases of the skin and subcutaneous tissue, such as severe rashes. This happened in less than 1 out of 100 men in the placebo group.
Side effects: Early study results also suggest that apalutamide has a disadvantage in terms of various non-severe side effects:
- Joint pain
- Diseases of the nervous system
- Underactive thyroid
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In 2020, the Institute for Quality and Efficiency in Health Care last looked into the advantages and disadvantages of apalutamide in men with non-metastatic castration-resistant prostate cancer.
To answer this question, the manufacturer provided early results of an ongoing study involving 1,207 men: 806 of them received apalutamide and 401 had a fake treatment . All of the men continued using hormone blockers.
Bayer Bags Swift Ok For Nubeqa In Metastatic Prostate Cancer
Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a 3 billion blockbuster.
The US regulator has approved Nubeqa in combination with docetaxel chemotherapy for the treatment of metastatic hormone-sensitive prostate cancer , adding to its earlier indication in non-metastatic castration-resistant prostate cancer .
The new use in more advanced prostate cancer patients puts the oral androgen receptor inhibitor in direct contention with other drugs in the class, notably Pfizer/Astellas Xtandi and Johnson & Johnsons Erleada .
Bayer and its development partner for Nubeqa Finlands Orion Pharma reckon that their drug may have a safety advantage that will help it wrest market share from Xtandi and Erleada, although the incumbents are well-entrenched and widely prescribed by doctors.
The latest approval is based on the ARASENS trial, which showed that adding the drug to standard androgen deprivation therapy and docetaxel chemo led to a statistically significant improvement in overall survival compared to ADT plus docetaxel and placebo.
The risk of death was significantly lower by around 33% in the Nubeqa group compared to the placebo group, according to the results, which were published in the New England Journal of Medicine in February.
Don’t miss your daily pharmaphorum news.
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Can Erleada Be Crushed
Erleada tablets should not be crushed, split, or chewed. They should be swallowed whole.
However, if you have trouble swallowing pills, you can mix Erleada tablets in applesauce to dissolve them. To do this, follow these steps:
If you dissolve Erleada in applesauce, be sure to take the mixture within 1 hour of preparing it. Dont store the mixture and take it later.
Erleada In Clinical Trials
A Phase 3 clinical trial called TITAN is testing Erleada plus ADT versus ADT alone in patients with mHSPC. Patients are treated until disease progression or the occurrence of treatment-related toxicity. The primary outcomes of the study are overall survival and progression-free survival.
Preliminary results from the trial, which were published in The New England Journal of Medicine, revealed that Erleada plus ADT therapy significantly improved overall survival compared to ADT alone with a 33% reduction in the risk of death. The two-year overall survival rates, after a median follow-up of 22.7 months, were 82% for Erleada plus ADT compared to 74% for ADT alone.
The safety of Erleada plus ADT was consistent with previous studies 42% of patients who received Erleada plus ADT experienced grade 3 or 4 adverse events, compared to 41% for patients receiving only ADT. The most common adverse events were high blood pressure and skin rash. Eight percent of patients in the Erleada group discontinued treatment due to adverse events, compared with 5% in the ADT-only group.
The trial is still ongoing and expected to be completed in July 2021.
Several clinical trials are recruiting prostate cancer patients now, or in the near future, to further test the effects of Erleada treatment in different populations and in combination with other therapies.
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This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care . The reviews were commissioned by the German Federal Joint Committee as part of the âearly benefit assessment of medications.â On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of apalutamide .
Institute for Quality and Efficiency in Health Care . Apalutamide â Benefit assessment according to Â§35a Social Code Book V. Dossier assessment Commission A19-09. April 29, 2019. .
Institute for Quality and Efficiency in Health Care . Apalutamide â Addendum to commission A19-09 Commission A19-51. July 11, 2019. .
Institute for Quality and Efficiency in Health Care . Apalutamide â Benefit assessment according to Â§35a Social Code Book V . Dossier assessment Commission A20-36. June 29, 2020. .
IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.
Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.
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