Product image of Erleada (Apalutamide) 60mg Tablet supplied by GNH India

Erleada

Active Ingredient:
Apalutamide
Form:
Tablet
Brand:
Erleada
Origin:
Switzerland

Erleada (Apalutamide Tablet) 60mg

Apalutamide, the active ingredient in Erleada, is a nonsteroidal antiandrogen presented as a 60mg tablet for oral use. It is used in the treatment of prostate cancer, specifically in non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC).

GNH India supplies Erleada as a licensed, GDP-compliant international pharmaceutical supplier serving oncology centres worldwide.

Strength

60mg

Pack Size

112s

Storage

Ambient

Manufacturer / TM Owner

Janssen - Cilag AG

1
Pack/s
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Indications & Clinical Uses

Erleada is indicated for the treatment of prostate cancer. It acts by inhibiting androgen receptor signaling, which is crucial in the progression of prostate cancer.

  • Non-metastatic castration-resistant prostate cancer (nmCRPC): Delays the development of metastatic disease in patients who have not responded to castration therapy.
  • Metastatic castration-sensitive prostate cancer (mCSPC): Used in combination with androgen deprivation therapy (ADT) to improve survival outcomes in patients with metastatic disease.

How It Works

  • Erleada works by selectively inhibiting the androgen receptor, preventing it from binding to DNA and reducing the transcription of genes that promote tumor growth in prostate cancer cells. This action helps to slow down the progression of the disease.

Side Effects

Erleada may cause various side effects, ranging from common to serious.

Common Side Effects

  • Fatigue: A common complaint among patients taking Erleada.
  • Rash: Skin irritation or rash may occur.
  • Nausea: Some patients experience mild to moderate nausea.
  • Diarrhea: Gastrointestinal disturbances are relatively common.
  • Weight loss: Some patients may experience a decrease in body weight.
  • Hypophagia: Reduced appetite is a known side effect.
  • Kramper: Muscle cramps can occur during treatment.
  • Restless legs syndrome: Some patients report this condition.

Serious or Rare Side Effects

  • Agranulocytosis: A severe reduction in white blood cells.
  • Stevens-Johnson syndrome: A serious skin reaction.
  • Interstitial lung disease: A rare but serious lung condition.
  • Forlænget QT-interval: Prolonged QT interval on electrocardiogram.
  • Toksisk epidermal nekrolyse (TEN): A severe skin and mucous membrane reaction.

Precautions & Warnings

Erleada should be used with caution and under medical supervision. Patients should be aware of potential risks and follow their healthcare provider's advice.

  • Pregnancy: Erleada is contraindicated in pregnant women due to the risk of fetal harm.
  • Breastfeeding: Not recommended due to potential risks to the infant.
  • Liver function: Regular monitoring of liver function is advised.
  • Falls and fractures: Patients should be cautious as there is an increased risk of falls and fractures.
  • Store below 25°C: Keep in the original pack, protect from moisture and light.

Avoid Interactions

Erleada may interact with other medications, potentially altering their effects or increasing the risk of side effects.

Major Interactions (Avoid)

  • Strong CYP2C8 inhibitors: Can increase the concentration of Erleada, leading to increased side effects.
  • Strong CYP3A4 inducers: Can decrease the effectiveness of Erleada.
  • Strong CYP3A4 inhibitors: Can increase the concentration of Erleada, leading to increased side effects.

Moderate Interactions (Monitor Closely)

  • Moderate CYP2C8 inhibitors: May increase the concentration of Erleada, requiring close monitoring.
  • Moderate CYP3A4 inducers: May decrease the effectiveness of Erleada, requiring close monitoring.
  • Moderate CYP3A4 inhibitors: May increase the concentration of Erleada, requiring close monitoring.

Frequently Asked Questions

Erleada is used in the treatment of prostate cancer, specifically for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). It helps to delay the development of metastatic disease and improve survival outcomes in combination with androgen deprivation therapy (ADT).

Apalutamide works by selectively inhibiting the androgen receptor, preventing it from binding to DNA and reducing the transcription of genes that promote tumor growth in prostate cancer cells. This action helps to slow down the progression of the disease.

The usual dose of Erleada is determined by a healthcare provider based on the patient's condition and response to treatment. It is typically taken as a 240 mg once-daily dose, but the prescriber sets the exact regimen.

Erleada is contraindicated in pregnant women due to the risk of fetal harm. It is also not recommended for use during breastfeeding due to potential risks to the infant. Patients should consult their healthcare provider for more information.

To order Erleada from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets and will ask the buyer to confirm trade or institutional credentials. The team will then reply with pricing, availability, shipping, and the import paperwork.

Erleada is one of several treatments for prostate cancer, including abiraterone, enzalutamide, and darolutamide. Each has its own mechanism of action and side effect profile. Erleada is specifically indicated for nmCRPC and mCSPC and is used in combination with ADT to improve survival outcomes.

Erleada should be stored below 25°C, kept in the original pack, and protected from moisture and light. It is important to follow the storage instructions provided to maintain the efficacy and safety of the medication.

Erleada is administered orally, typically as a 240 mg once-daily dose. The tablet can be taken with or without food, as directed by the healthcare provider. It is important to follow the prescribed dosage and administration instructions.

The most serious risks associated with Erleada include agranulocytosis, Stevens-Johnson syndrome, interstitial lung disease, and toxic epidermal necrolysis (TEN). Patients should be monitored closely for these and other serious side effects.

Erleada should not be used by pregnant women or those who may become pregnant due to the risk of fetal harm. It is also not recommended for use during breastfeeding. Patients with a history of severe hypersensitivity to apalutamide or any of its components should avoid using Erleada.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

References

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