NUBEQA 300 mg film-coated tablets – Summary of Product Characteristics (SmPC) – (emc)

NUBEQA 300 mg film-coated tablets are a vital medication for men diagnosed with specific types of prostate cancer. This article elaborates on the main characteristics, usage, and important information pertaining to this medication, ensuring that patients and healthcare professionals have a comprehensive understanding of NUBEQA.

These tablets contain darolutamide and are prescribed primarily for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). Understanding its characteristics is crucial for effective treatment.

What is NUBEQA 300 mg film-coated tablets used for?

NUBEQA 300 mg film-coated tablets are mainly used in the treatment of prostate cancer. They are specifically beneficial for patients dealing with non-metastatic castration-resistant prostate cancer and those with metastatic hormone-sensitive prostate cancer.

The active ingredient, darolutamide, functions as an androgen receptor inhibitor. This means it works to block the action of male hormones, which can contribute to the growth of prostate cancer cells.

NUBEQA is often prescribed in conjunction with docetaxel, providing a synergistic effect that enhances treatment efficacy. Patients who have been diagnosed should discuss their treatment options with their healthcare provider to determine the best course of action.

What are the side effects of NUBEQA?

Like any medication, NUBEQA may cause side effects. It’s essential for patients to be aware of these potential reactions. Common side effects include:

  • Fatigue
  • Nausea
  • Skin rash
  • Diarrhea
  • Changes in liver function tests

While most side effects are manageable, patients should report any severe reactions to their healthcare provider immediately. Monitoring liver function is particularly important, as NUBEQA can impact liver health.

In rare cases, seizures have been reported, emphasizing the need for patients to inform their doctor of any history of neurological conditions.

What is the recommended dosage of NUBEQA?

The typical recommended dosage for NUBEQA is 600 mg per day. This is usually administered as two 300 mg tablets taken twice daily. It is crucial to adhere to the prescribed dosage to ensure effective treatment.

Patients should take NUBEQA with food to enhance absorption and minimize the risk of gastrointestinal discomfort. It’s essential that missed doses are not doubled; instead, patients should take the next scheduled dose as directed.

Adhering to the prescribed treatment plan can significantly impact the effectiveness of NUBEQA. Patients should consult their healthcare provider if they have any concerns about their dosage.

What precautions should be taken when using NUBEQA?

When using NUBEQA, several precautions should be considered to ensure patient safety:

  • Regular monitoring for ischaemic heart disease
  • Assessment of liver and renal function
  • Avoiding use in women and pediatric patients
  • Consultation with a doctor regarding potential drug interactions

Patients should avoid using NUBEQA if they are allergic to any of its components or are pregnant. Effective contraception is essential for sexually active men whose partners may become pregnant during treatment.

Moreover, it is crucial to maintain open communication with healthcare providers about any pre-existing conditions or medications being taken. This will help mitigate potential risks.

How should NUBEQA 300 mg tablets be taken?

NUBEQA 300 mg tablets should be taken whole and not crushed or chewed. Taking these tablets with food is recommended to optimize their absorption and reduce the likelihood of gastrointestinal side effects.

If a dose is missed, patients are advised to take it as soon as they remember, unless it is close to the time for their next dose. In that case, they should skip the missed dose and continue with their regular schedule. Doubling up on doses is not advised.

For the best results, consistency in taking NUBEQA is key. Patients should establish a routine that helps them remember to take their medication as prescribed.

What is the price of NUBEQA 300 mg film-coated tablets?

The price of NUBEQA 300 mg film-coated tablets can vary based on location, pharmacy, and insurance coverage. It’s advisable for patients to check with their local pharmacies for the most accurate pricing information.

Many insurance plans may cover part of the cost, so it’s beneficial for patients to inquire about their specific coverage options. Some pharmaceutical companies may also offer assistance programs that can help reduce out-of-pocket costs.

Patients should not hesitate to discuss financial concerns with their healthcare provider, as they may have resources or suggestions to assist with medication affordability.

Related questions about NUBEQA 300 mg film-coated tablets

What is the classification of NUBEQA?

NUBEQA is classified as an androgen receptor inhibitor, specifically targeting the growth of prostate cancer cells. This classification highlights its role in hormone therapy and cancer treatment protocols.

What kind of drug is NUBEQA?

NUBEQA is a prescription drug designed for men diagnosed with specific forms of prostate cancer. It contains darolutamide and is primarily used to manage non-metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer.

Where is NUBEQA manufactured?

NUBEQA is manufactured by Bayer, a global pharmaceutical company known for developing innovative therapies for various medical conditions, including cancer.

What are the ingredients in NUBEQA?

The active ingredient in NUBEQA is darolutamide, which is formulated with several inactive ingredients that assist in tablet formation and stability. Understanding the components can help patients and healthcare providers make informed decisions about treatment.

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