Life saving drugs are pharmaceuticals used to treat diseases and improve the quality of life. They are made from natural substances or artificially produced in the laboratory. Examples include alkaloids, vaccines, glandular extracts, and steroid hormones.
Today, most big pharma companies have specialty medicines and biologics accounting for 50% of their revenues. This is an important trend given long development times and complex manufacturing processes.
Abiraterone
Abiraterone is a powerful drug that treats prostate cancer by blocking testosterone production in the body. It is a key part of the treatment for men with advanced prostate cancer and is widely used by patients in the UK as it is available on the NHS. But it wasn’t an easy road for the researchers who developed it – and there were many setbacks along the way.
The drug works by targeting a specific enzyme in the body called 17 alpha-hydroxylase/C17,20-lyase (CYP17). This stops the enzyme from converting cholesterol into androgens in prostate cells and prevents them from growing. This shrinks hormone-sensitive tumours and allows chemotherapy drugs to reach and destroy cancer cells.
CYP17 inhibition also reduces levels of cortisol, which is important for normal bodily functions such as keeping blood pressure and blood sugar under control. This means patients may require steroid therapy to keep these levels in check.
It is often given in combination with other treatments such as chemotherapies. You can puchase medicine from Abiraterone manufacturer in india. It is given by infusion into a vein (intravenous injection) over 2 hours, usually every two weeks. It takes between 2 and 6 hours for it to enter the bloodstream. Patients will have blood tests to check how well it is working and to see if the dose is right for them.
Abiraterone is associated with some side effects including fatigue, hot flushes, rash and sweating. The drug can also lower the amount of sperm you produce, so patients are advised to use condoms and other methods of contraception if they have a partner. The drug can also cause damage to the kidneys and liver, and can be passed on to any unborn babies you may have.
In a trial of 58 patients with metastatic castration-resistant prostate cancer, abiraterone was combined with chemotherapy drugs and resulted in a greater than 50% reduction in PSA levels. This led to a significant improvement in survival over the standard hormone therapy alone.
The study was published in 2021 and was led by Professor Johann de Bono at the ICR. Patients were given either abiraterone or another popular prostate cancer drug called enzalutamide. Both drugs significantly improved survival but abiraterone was found to be more effective, and also took longer for the cancer to reappear in patients after the treatment finished.
Abiraterone Side Effects
Abiraterone is a drug used in the treatment of prostate cancer. It is often given in combination with other drugs, and can be used as a first-line treatment for patients with advanced prostate cancer. It is also sometimes used as a second-line treatment for people who have failed to respond to other hormone therapies or chemotherapy. Abiraterone is not a cure, but it can significantly improve survival in some patients.
In the randomized placebo-controlled trial COU-AA-301, abiraterone significantly improved progression-free survival (PFS) compared to placebo plus prednisone, the primary endpoint of the study. In this group, the median rPFS was 22.9 months for abiraterone and 10.9 months for placebo plus prednisone. Abiraterone was particularly effective in men who had previously been treated with docetaxel.
Side effects of abiraterone can include hot flashes, joint and muscle pain, fatigue, low blood sugar, headache, and sore throat. Some people may experience diarrhea or vomiting. It is important to tell your doctor or nurse if you experience any of these symptoms, so they can help you manage them.
Other possible side effects include stomach upset, dry mouth, cough, and hair loss. It is important to drink plenty of fluids while taking abiraterone, as this can help prevent dehydration. It is also important to avoid alcohol and herbal supplements that can affect liver and kidney function while taking abiraterone.
People with severe hepatic impairment may need to be given a lower dose of the drug. In a single-dose study in healthy volunteers, abiraterone pharmacokinetics were altered by hepatic impairment and increased by up to 17-fold when taken with food.
Women who are pregnant or breastfeeding should not take abiraterone. It has been shown to cause birth defects in animal studies. It has also been found to be a risk factor for prostate cancer in some men. People who have a history of prostate cancer should talk to their doctor before starting this treatment. They may want to discuss other options, such as surgery or radiation therapy.
Abiraterone Dosage
The dosage of abiraterone depends on the condition for which it is being used. Doctors may prescribe a lower or higher dose than that indicated on the label. Doctors should carefully review the patient’s health history before prescribing this medication. This will help determine whether it is safe for the patient to take.
The drug can also interact with a number of drugs and other substances. Patients should inform their doctors of any other medications they are taking, including over-the-counter medications and supplements. Those who are pregnant or breastfeeding should not take abiraterone. It can cause harm to a developing fetus. In animal reproduction studies, oral administration of abiraterone acetate to pregnant rats caused embryo-fetal lethality (increased post-implantation losses and resorptions, decreased number of live fetuses) at dosages of 10, 30 and 100 mg/kg/day throughout the period of organogenesis. These maternal exposures are about 0.03, 0.1 and 0.3 times the AUC of abiraterone administered to humans at the recommended dose of 1,000 mg/day (see Data).
Although there is no formal large equivalence study of 250 mg/day with food versus 1,000 mg/day fasting, cumulative evidence from smaller phase I studies of PK and PD effects and the small randomized trial14 support the clinical efficacy of the lower dose. However, the long-term repercussions of lower levels of abiraterone in blood from taking the drug with food are unknown.
In addition, a large number of doctors are unaware that lower-dose oxaliplatin manufacturer is an option for treatment of mCRPC patients. The low-dose treatment has the potential to increase access and lead to significant cost savings, especially in resource-constrained countries.
In addition, it could reduce the risk of serious adverse reactions. Nevertheless, there is a need for additional well-planned studies of cost-effective newer therapeutics in oncology. This should be a priority in light of the rising cost of cancer care and growing incidence of prostate cancer worldwide. The results of such a study would provide valuable information for patients, healthcare providers and insurers. Further, a multidisciplinary approach is required to deliver prostate cancer care in many settings. This includes urologists, medical oncologists and radiation oncologists.
Abiraterone Availability
In February 2018, the FDA approved two powerful oral drugs, abiraterone acetate and enzalutamide, for treating metastatic castration-resistant prostate cancer (mCRPC). These life-prolonging therapies block the body’s ability to make testosterone. This has led to tumor responses in mCRPC patients who no longer respond to standard hormone therapy. However, these life-prolonging treatments are not a cure. The authors of a recent article in Clinical Pharmacokinetics1 raised concerns about their use, including drug-drug interactions and potential hepatotoxicity.
The researchers analyzed the binding interaction of abiraterone with CYP17A1 using computational chemistry and crystallographic data. They found that abiraterone interacts with the active site of CYP17A1 with a favorable binding energy of 10 kcal/mol. However, the interactions with CYP2D6 and other enzymes in the metabolism are less favorable. These drug-drug interactions may limit the effectiveness of abiraterone in combination with other agents.
Another issue is the possibility of hepatotoxicity, especially in patients with hepatic impairment. This is why oncologists must carefully review the hepatotoxicity profiles of these drugs before prescribing them. Moreover, they must also monitor the patient’s liver function regularly. In addition, they should be aware of the potential interactions between abiraterone and acetaminophen or alcohol.
Despite these issues, there is hope that the development of new drugs will help improve treatment outcomes for mCRPC patients. Although some patients achieve a PSA reduction with abiraterone alone, the majority requires further treatment. One option is to combine abiraterone with chemotherapy, but it has been difficult to assess its efficacy in real-life settings.
Abiraterone can cause changes in certain hormone levels and lead to problems like low potassium and fluid buildup. Your doctor will check your blood pressure and potassium levels and monitor for symptoms of fluid build up, such as pain or swelling in the arms or legs. Your doctor may also prescribe a steroid to lower your risk of these side effects. You should also tell your doctor about any other health conditions you have and any medicines you are taking, including nonprescription and herbal products. For example, St. John’s wort can interfere with how well abiraterone works.