Anandron® 50mg Blister

Product Description

INDICATIONS AND CLINICAL USE

Anandron^® (nilutamide) is indicated in the treatment of metastatic prostatic carcinoma (Stage D2) in conjunction with surgical castration.

This medication is typically used only once a day. However, your doctor or pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed.

It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. This medication may be taken with or without food.

If you drink alcohol, moderate consumption is recommended. Talk to your pharmacist or doctor to find out exactly how much alcohol you can drink.

CONTRAINDICATIONS

Anandron^® (nilutamide is contraindicated in:

− patients with known hypersensitivity to the drug, or to any constituents of the drug product

− patients with severe hepatic dysfunction

− patients with severe respiratory insufficiency

− women and children.

WARNINGS

The hepatic and respiratory state of the patient should be evaluated and the necessity to report any respiratory symptoms as soon as they appear should be emphasized. Cases of interstitial lung disease such as pneumonitis and pulmonary fibrosis have been reported with the use of Anandron^® (nilutamide). Some cases of pulmonary fibrosis were fatal. Baseline imaging (eg. chest X-ray) should be performed prior to therapy. Baseline pulmonary function tests may be considered. In the event of dyspnea or worsening of pre-existing dyspnea, treatment with Anandron^® should be discontinued and appropriate medical treatment should be initiated. If interstitial lung disease is diagnosed, Anandron^® must be discontinued to reduce the risk of progression to pulmonary fibrosis; corticosteroid treatment may be considered. Cases of hepatic dysfunction have been reported with the use of Anandron^®. If clinical symptoms give rise to a suspicion of liver dysfunction, transaminases should be measured. If an increase in serum transaminases above three times the upper limit of normal laboratory range is shown, treatment must be interrupted.

ADVERSE REACTIONS

The most common side-effects affect the eyes. The patient may notice that your eyes require more time to adapt to darkness, especially when there is a sudden change in lighting (for example, driving through a tunnel). When it occurs, this problem is almost always temporary and may be improved by wearing tinted glasses. However, until the patient’s eyes accommodate better to the dark, the patient should be very careful when driving or operating machinery. Some patients may develop breathing problems or a worsening of a pre-existing breathing problem. Symptoms may include shortness of breath, coughing, chest pain and fever. Fatal cases due to pulmonary problems have been reported during Anandron^® treatment. It is important that the patient contacts you immediately if they have any breathing difficulties while taking Anandron^®. In rare cases, Anandron^® may cause an increase in liver tests and, very rarely, hepatitis. Symptoms that may suggest a liver problem include: persistent lack of appetite, nausea (queasiness), vomiting, abdominal pain or tenderness, jaundice (yellow eyes and/or skin), dark urine, itching or unexplained flu-like symptoms.