APALUTAMIDE

Background and Date of Approval

Apalutamide is an anticancer medication belonging to the androgen receptor inhibitors class. The FDA approved this medicine for medical use on 17 September 2019.

Uses

It is indicated for treating patients with certain types of prostate cancer whose cancer has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone (male reproductive hormone) or whose cancer has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone.

How is it administered?

Apalutamide is an orally administered drug. Take medicine as informed by your physician. It is generally taken with or without food once a day. Take the tablet at around the same time every day. Swallow the tablets whole; do not split, chew, or crush them. Do not stop taking Apalutamide without talking to your doctor.

Side Effects

The common side effects are increased cholesterol levels, increased blood pressure, swelling in the lower legs or hands, rash and reddening of the skin, decreased body weight and loss of appetite, diarrhea and nausea, muscle pain, tiredness, and dizziness. Other serious side effects are anemia, heart disease, stroke or mini-stroke, increased blood sugar levels, decreased white blood cells, fractures of bones, seizures and cerebrovascular events, severe skin reactions, and frequent falls.

Warnings

Ischemic cardiovascular events have occurred in patients receiving this medicine. Monitoring for any heart problems during the treatment is necessary. Report to your physician if you have shortness of breath or pain in the chest that radiates to the jaw and shoulders because this may be a sign of heart problems. This medicine may increase your risk of fractures and frequent falls. Apalutamide is indicated for use in only men; if administered to female patients, it may cause severe embryo-fetal toxicity.

Precautions

Inform your physician if you have any symptoms of chest pain, indigestion, heart attack, trouble walking, and numbness in the face and body. Apalutamide is not recommended in pregnant women because this may cause harm to your unborn baby. This tablet may be taken with or without food. This medicine may cause fertility problems in males. Males should not become fathers or donate sperm during the treatment and for 3 months after the last done. Use effective birth control methods. Inform your healthcare professional about all your medicines, including prescription, over-the-counter, nutritional or supplements, and herbal products. Certain medications may interact with Apalutamide and reduce effectiveness by causing undesirable side effects.

Word of Advice

Store Apalutamide in its original package at room temperature (20°C to 25°C). Keep tablets out of reach of children and pets. If you miss a dose, do not take a double dose to make up for the missed one. In case of overdose or accidental ingestion, contact your hospital or doctor immediately for medical advice. Before starting treatment, inform your doctor if you have heart, kidney, liver, or lung disorders. Your doctor may prescribe additional medicines unless you have had surgery to reduce testosterone levels. Continue taking this medicine along with all other medications your doctor has prescribed. Apalutamide may cause birth defects if a male partner uses this medicine while planning for pregnancy. Use effective contraceptive methods during treatment and for 3 months after the final dose. Your doctor will monitor your progress and the effects of this medicine at regular appointments. Attend all scheduled visits. Do not discontinue this medicine, even temporarily, without consulting your doctor first.

References

Highlights Of Prescribing Information - Apalutamide. (2019).Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210951s001lbl.pdf [Accessed January 13, 2023]. 2021 (2021). Apalutamide: MedlinePlus Drug Information . [online] medlineplus.gov. Available at: https://medlineplus.gov/druginfo/meds/a618018.html [Accessed January 13, 2023]. PATIENT INFORMATION ERLEADA ® (er lee'dah) (apalutamide). (2022). [online] Available at: https://www.janssenlabels.com/package-insert/product-patient-information/ERLEADA-ppi.pdf [Accessed January 13, 2023]. www.cancer.gov. (2018). Apalutamide - National Cancer Institute . [online] Available at: https://www.cancer.gov/about-cancer/treatment/drugs/apalutamide [Accessed January 13, 2023].

Frequently Asked Questions

What are the common side effects of apalutamide?

Decreased weight, loss of appetite, rash, tiredness, and dizziness are the few common side effects of apalutamide. Inform your doctor if you have had these side effects for a long time.

Is Apalutamide indicated only for males?

This medicine is not indicated to use in females. It is commonly used in men for treating certain types of prostate cancer.

How is Apalutamide administered?

Apalutamide is currently available only in tablet form. It should be taken by mouth. Take the tablet as prescribed by your physician. Do not chew or break the tablet. Swallow it as a whole.

Are there any special precautions I should know before starting the treatment with Apalutamide?

Inform your physician about all the medical conditions you have and about all the medicines that you take. Do not plan for pregnancy if you are taking Apalutamide. Use effective birth control methods.

Can Apalutamide cause infertility?

Yes, Apalutamide may cause infertility in certain males. Inform your healthcare professional before starting the treatment if you and your female partner are planning for pregnancy

How long do I need to take Apalutamide?

It is advised to take as long as your doctor advises to take Apalutamide. Do not stop taking the tablet without consulting the physician.

Available Brands 10

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS