Encastry® (enzalutamide)

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Soft Gel Capsule : 40 mg

Tablets : 40 mg, 80 mg

Enzalutamide is an androgen receptor inhibitor. Enzalutamide decreased proliferation and induced cell death of prostate cancer cells in vitro, and decreased tumor volume in animal model.

INDICATIONS

Enzalutamide is indicated for the treatment of patients with:

Castration-resistant prostate cancer (CRPC)
Metastatic castration-sensitive prostate cancer (mCSPC)

It is not known if Enzalutamide is safe and effective in females and children.

DOSAGE AND ADMINISTRATION

160 mg (four 40 mg capsules) Enzalutamide administered orally once daily. Enzalutamide can be taken with or without food. Swallow capsules whole, do not chew, dissolve, or open the capsules.
Patients receiving Enzalutamide should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

WARNINGS AND PRECAUTIONS

• Seizure. Enzalutamide has been associated with an increased risk of seizure and loss of consciousness. Conditions that may predispose to seizures and medications that may lower the seizure threshold should be discussed. Patient should avoid activities where a sudden loss of consciousness could cause serious harm to themselves or others.

• Posterior Reversible Encephalopathy Syndrome (PRES). Patients receiving Enzalutamide may be at risk of developing a condition involving the brain called PRES. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, decreased alertness, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. The healthcare provider will do a test to check for PRES.

• Hypersensitivity. Enzalutamide may be associated with allergic reactions, including edema of the face, tongue, lip or throat.

• Ischemic Heart Disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with Enzalutamide. The healthcare provider will monitor for signs and symptoms of heart problems during treatment with Enzalutamide. Patients with chest pain or discomfort at rest or with activity or shortness of breath during treatment with Enzalutamide should call their healthcare provider or go to the nearest emergency room right away.

• Hypertension. Enzalutamide is associated with an increased incidence of hypertension.

• Falls and Fractures. Enzalutamide treatment may increase the incidence of dizziness/vertigo, falls and fractures. Falls were not caused by loss of consciousness (fainting) or seizures. The healthcare provider will monitor risks for falls and fractures during treatment with Enzalutamide.

Call your healthcare provider right away if you have any of aforementioned symptoms.

The most common side effects
The most common side effects in people who take Enzalutamide include:
• Weakness or feeling more tired than usual
• Back pain
• Hot flashes
• Constipation
• Joint pain
• Decreased appetite
• Diarrhea
• High blood pressure
• Asthenia/fatigue
• Arthralgia
• Acute coronary syndrome
• Headache
• Memory loss
• Skin reactions

DRUG INTERACTIONS

Strong CYP2C8 inhibitors: Co-administration of Enzalutamide with strong CYP2C8 inhibitors (gemfibrozil) should be avoided if possible, as they can increase the plasma exposure to Enzalutamide. If co-administration of Enzalutamide with a strong CYP2C8 inhibitor cannot be avoided, the dose of Enzalutamide should be reduced.
Strong CYP3A4 inducers: Co-administration of strong CYP3A4 inducers (carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine) with Enzalutamide should be avoided if possible. St John’s wort may decrease Enzalutamide exposure and should be avoided. If co-administration of a strong CYP3A4 inducer with Enzalutamide cannot be avoided, the dose of Enzalutamide should be increased.
CYP3A4, CYP2C9 and CYP2C19 inducers: Enzalutamide is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. At steady state, Enzalutamide reduced the plasma exposure to midazolam (CYP3A4 substrate), warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate). Concomitant use of Enzalutamide with narrow therapeutic index drugs that are metabolized by CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin, clopidogrel) should be avoided, as Enzalutamide may decrease their exposure. If co-administration with warfarin cannot be avoided, conduct additional INR monitoring.

Brochure

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