Nubeqa

The active ingredient in Nubeqa is darolutamide. Most prostate cancer cells require testosterone to multiply and spread. Testosterone is a male sex hormone known as an androgen.

Nubeqa (darolutamide) is an androgen receptor inhibitor (or antiandrogen). It's a hormone therapy that works by preventing testosterone from attaching to prostate cancer cells. Cancer cells will lack the fuel they require to develop and disseminate effectively if testosterone is not present. If your prostate cancer has spread to other parts of the body (metastasis), darolutamide is used with androgen deprivation therapy (ADT) for treating hormone-relapsed non-metastatic prostate cancer, and it showed lower discontinuation rates due to adverse events compared to placebo plus ADT.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Nubeqa. However, the following is a synopsis of the general guidelines for the use of Nubeqa:

• Take with food.
• Swallow the tablet whole; do not chew, crush, or break it.
• If you have not undergone castration surgery (to reduce the quantity of testosterone in your body), your doctor may prescribe a gonadotropin-releasing hormone (GnRH) medication such as Eligard, Lupron, Trelstar, Zoladex, or Vantas. Continue using your GnRH as recommended.

The most common side effects of Nubeqa seen in clinical trials as compared to placebo include:

• Lower white blood cell count (neutropenia).
• Low blood calcium levels.
• Lower red blood cell count.
• High blood sugar levels (hypertension)
• Tiredness.
• Higher liver labs.
• Weight gain.
• High blood pressure.

Some individuals may experience serious side effects while using Nubeqa. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Seizures
• Heart problems include chest pain, rapid heartbeat, shortness of breath, arm or shoulder pain, swelling of the legs or feet, unexpected weight gain, perspiration, exhaustion, dizziness, nausea, or vomiting.
• Serious bleeds include persistent bleeding or bruising, a substantial amount of bleeding, blood in the urine, vomiting blood, and bloody or black and tarry faeces.
• Severe skin responses include painful blisters, wounds, and peeling skin.
• Allergic reactions to the medication, such as skin rash or hives.

These are not all of the possible side effects of Nubeqa. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Nubeqa, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Liver disease.
• Kidney disease.
• If you have not had a bilateral orchiectomy (removal of both testicles), this medication should be given with a gonadotropin-releasing hormone analog.

Taking Nubeqa may raise the risk of ischemic heart disease, which occurs when blood flow to the heart is limited. This could cause a heart attack or stroke. If you have pre-existing illnesses such as high blood pressure, diabetes, or high cholesterol, you may be more likely to experience this adverse effect.

Nubeqa begins to work after the first dose. Because of the way the medicine works, you will most likely not feel it in your body. However, your doctor will monitor you during therapy to ensure that the drug is effective in treating your illness.

When Nubeqa is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Docetaxel.
• Apalutamide.
• Enzalutamide.

Adults: A usual dose is 600 mg administered orally twice each day. The recommended darolutamide dose is 600 mg (two 300 mg tablets) taken orally, twice daily, with food until disease progression or unacceptable toxicity.

A dosage of darolutamide of 1,200 mg/day has been found to result in a mean decrease in prostate-specific antigen (PSA) levels of more than 90% in men with prostate cancer.

If you have kidney or liver problems, your dosage may vary.

Store at room temperature and keep out of reach of children.

Bayer is the company that manufactures Nubeqa.

There are no generic versions of Nubeqa available.

Take Nubeqa exactly as prescribed by your healthcare provider. If you suffer certain side effects, your healthcare provider may alter your dose, temporarily suspend, or completely discontinue your therapy with Nubeqa.

Darolutamide may harm an unborn child or result in a miscarriage; therefore, women cannot use Nubeqa. If your sex partner can become pregnant, use an effective contraceptive. Continue using birth control for at least one week following your last dose.

It may be more difficult for you to fall pregnant while using Nubeqa. You should continue to take birth control to avoid conception because the medication can harm an unborn child.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.