Bicalutamide (Page 4 of 5)

14 CLINICAL STUDIES

14.1 Bicalutamide 50 mg Daily in Combination with an LHRH-A

In a multi-center, double-blind, controlled clinical trial, 813 patients with previously untreated advanced prostate cancer were randomized to receive bicalutamide 50 mg once daily (404 patients) or flutamide 250 mg (409 patients) three times a day, each in combination with LHRH analogs (either goserelin acetate implant or leuprolide acetate depot).

In an analysis conducted after a median follow-up of 160 weeks was reached, 213 (52.7%) patients treated with bicalutamide-LHRH analog therapy and 235 (57.5%) patients treated with flutamide-LHRH analog therapy had died. There was no significant difference in survival between treatment groups (see Figure 1). The hazard ratio for time to death (survival) was 0.87 (95% confidence interval 0.72 to 1.05).

Figure 1 — The Kaplan-Meier probability of death for both antiandrogen treatment groups.

Bicalutamide Tablets, USP
(click image for full-size original)

There was no significant difference in time to objective tumor progression between treatment groups (see Figure 2). Objective tumor progression was defined as the appearance of any bone metastases or the worsening of any existing bone metastases on bone scan attributable to metastatic disease, or an increase by 25% or more of any existing measurable extraskeletal metastases. The hazard ratio for time to progression of bicalutamide plus LHRH analog to that of flutamide plus LHRH analog was 0.93 (95% confidence interval, 0.79 to 1.10).

Figure 2 — Kaplan-Meier curve for time to progression for both antiandrogen treatment groups.

Bicalutamide Tablets, USP
(click image for full-size original)

Quality of life was assessed with self-administered patient questionnaires on pain, social functioning, emotional well-being, vitality, activity limitation, bed disability, overall health, physical capacity, general symptoms, and treatment related symptoms. Assessment of the Quality of Life questionnaires did not indicate consistent significant differences between the two treatment groups.

14.2 Safety Data from Clinical Studies using Bicalutamide 150 mg

Bicalutamide 150 mg is not approved for use either alone or with other treatments.

Two identical multi-center, randomized, open-label trials comparing bicalutamide 150 mg daily monotherapy to castration were conducted in patients that had locally advanced (T3-4, NX, M0) or metastatic (M1) prostate cancer.

Monotherapy — M1 Group

Bicalutamide 150 mg daily is not approved for use in patients with M1 cancer of the prostate. Based on an interim analysis of the two trials for survival, the Data Safety Monitoring Board recommended that bicalutamide treatment be discontinued in the M1 patients because the risk of death was 25% (HR 1.25, 95% CI 0.87 to 1.81) and 31% (HR 1.31, 95% CI 0.97 to 1.77) higher in the bicalutamide treated group compared to that in the castrated group, respectively.

Locally Advanced (T3-4, NX, M0) Group

Bicalutamide 150 mg daily is not approved for use in patients with locally advanced (T3-4, NX, M0) cancer of the prostate. Following discontinuation of all M1 patients, the trials continued with the T3-4, NX, M0 patients until study completion. In the larger trial (N=352), the risk of death was 25% (HR 1.25, 95% CI 0.92 to 1.71) higher in the bicalutamide group and in the smaller trial (N=140), the risk of death was 36% (HR 0.64, 95% CI, 0.39 to 1.03) lower in the bicalutamide group.

In addition to the above two studies, there are three other ongoing clinical studies that provide additional safety information for bicalutamide 150 mg, a dose that is not approved for use. These are three multi-center, randomized, double-blind, parallel group trials comparing bicalutamide 150 mg daily monotherapy (adjuvant to previous therapy or under watchful waiting) with placebo, for death or time to disease progression, in a population of 8113 patients with localized or locally advanced prostate cancer.

Bicalutamide 150 mg daily is not approved for use as therapy for patients with localized prostate cancer who are candidates for watchful waiting. Data from a planned subgroup analysis of two of these trials in 1627 patients with localized prostate cancer who were under watchful waiting, revealed a trend toward decreased survival in the bicalutamide arm after a median follow-up of 7.4 years. There were 294 (37.7%) deaths in the bicalutamide treated patients versus 279 (32.9%) deaths in the placebo treated patients (localized watchful waiting group) for a hazard ratio of 1.16 (95% CI 0.99 to 1.37).

16 HOW SUPPLIED/STORAGE AND HANDLING

Bicalutamide tablets, USP are available as follows:

Bicalutamide tablets, USP 50 mg are white to off-white, round, biconvex, film coated tablets, debossed ‘B 50’ on one side and plain on other side and supplied in bottles of 30 tablets (NDC 16714-816-01) and bottles of 100 tablets (NDC 16714-816-02).

16.1 Storage and Handling

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Dispense in a tight, light-resistant container as defined in the USP.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Dose and Schedule

Inform patients that therapy with bicalutamide tablets and the LHRH analog should be started at the same time and that they should not interrupt or stop taking these medications without consulting their healthcare provider [see Dosage and Administration ( 2.1)] .

Hepatitis

Inform patients that bicalutamide tablets can cause hepatitis, which may result in hepatic failure and death. Advise patients that liver function tests should be monitored regularly during treatment and to report signs and symptoms of hepatitis [see Warnings and Precautions ( 5.1)] .

Hemorrhage with Concomitant Use of Coumarin Anticoagulant

Inform patients that serious bleeding has occurred with reported increased anticoagulant effects while taking bicalutamide tablets. Advise patients to notify their healthcare provider of any bleeding or spontaneous bruising while on bicalutamide tablets and taking anticoagulants [see Warnings and Precautions ( 5.2) and Adverse Reactions ( 6.2)].

Glucose Tolerance

Inform patients that diabetes or loss of glycemic control in patients with pre-existing diabetes has been reported during treatment with LHRH agonists. Consideration should therefore be given to monitoring blood glucose in patients receiving bicalutamide tablets in combination with LHRH agonists [see Warnings and Precautions ( 5.4)] .

Somnolence

During treatment with bicalutamide tablets, somnolence has been reported. Advise patients who experience this symptom to observe caution when driving or operating machines [see Adverse Reactions ( 6.1)] .

Photosensitivity

Inform patients that cases of photosensitivity have been reported during treatment with bicalutamide tablets and that they should avoid direct exposure to excessive sunlight or UV-light exposure. Consideration should be given to the use of sunscreen [see Adverse Reactions ( 6.2)] .

Contraception and fertility

Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after the last dose of bicalutamide tablets therapy. Advise male patients that bicalutamide tablets may impair fertility [see Use in Specific Populations ( 8.3)].

Manufactured for:

Northstar Rx LLC

Memphis, TN 38141

Manufactured by:

Intas Pharmaceuticals Ltd.

Ahmedabad, India — 382210

Issued: May 2018

Patient Information

Bicalutamide (bye″ ka loo′ ta mide) Tablets, USP

What is bicalutamide tablets?

Bicalutamide tablets are a prescription medicine called an androgen receptor inhibitor, used in combination with lutenizing hormone-releasing hormone (LHRH) medicines to treat stage D2 metastatic prostate cancer.

Bicalutamide 150 mg daily is not approved for use alone or with other treatments.

It is not known if bicalutamide is safe and effective in children.

Do not take bicalutamide tablets if you are:

  • allergic to bicalutamide or any of the ingredients in bicalutamide tablets. See the end of this Patient Information leaflet for a complete list of ingredients in bicalutamide tablets. Get medical help right away if you develop any of the following symptoms of an allergic reaction:
  • itching
  • hives (raised bumps)
  • swelling of the face, lips or tongue
  • trouble breathing or swallowing
  • female. Bicalutamide is not for use by women.
  • pregnant or may become pregnant. Bicalutamide may harm your unborn baby.

Before taking bicalutamide tablets, tell your healthcare provider about all your medical conditions, including if you:

  • have liver problems.
  • take a medicine to thin your blood. Ask your healthcare provider or pharmacist if you are not sure if your medicine is a blood thinner.
  • have diabetes
  • have a female partner who can become pregnant. Males who have a female partner who can become pregnant should use effective birth control during treatment with bicalutamide tablets and for 130 days after the final dose. Talk to your healthcare provider if you have any questions about birth control.

Tell your healthcare provider about all the medicines you take , including prescription and over the counter medicines, vitamins and herbal supplements. Bicalutamide tablets may affect the way other medicines work, and other medicines may affect how bicalutamide tablets works, causing side effects.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.

How should I take bicalutamide tablets?

  • Take bicalutamide tablets exactly as your healthcare provider tells you to take it.
  • Do not stop taking bicalutamide tablets unless your healthcare provider tells you to.
  • Bicalutamide tablets can be taken either in the morning or in the evening, but you should take it at the same time everyday.
  • Your treatment with bicalutamide tablets should start at the same time as your treatment with the LHRH medicine.
  • If you miss a bicalutamide tablets dose do not take the missed dose, take the next dose at your next scheduled time. Do not take 2 doses at the same time.
  • Bicalutamide tablets can be taken with or without food.
  • If you take too much bicalutamide tablets, call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room right away.

What should I avoid during treatment with bicalutamide tablets?

  • Do not drive, operate machinery, or do other dangerous activities until you know how bicalutamide tablets affects you. Bicalutamide can make you sleepy.
  • Avoid sunlight, sunlamps, and tanning beds, and consider using sunscreen during treatment with bicalutamide tablets. Some people have had skin sensitivity to sunlight during treatment with bicalutamide tablets.

What are the possible side effects of bicalutamide tablets?

Bicalutamide tablets may cause serious side effects, including:

  • Liver problems. Severe liver problems including liver failure that may need to be treated in a hospital or that may lead to death have happened in people who take bicalutamide tablets.
  • Your healthcare provider should do blood tests to check your liver function before and during treatment with bicalutamide tablets. Tell your healthcare provider right away if you develop any of these symptoms of liver problems during treatment:
    • yellowing of the skin and eyes (jaundice)
    • dark urine
    • right upper stomach pain
    • nausea
    • vomiting
    • tiredness
    • loss of appetite
    • chills
    • fever
  • Bleeding problems. Serious bleeding problems have happened in people who take bicalutamide tablets in combination with a blood thinner medicine (coumarin anticoagulants). Bleeding problems have happened days to weeks after starting bicalutamide tablets treatment. If you take a blood thinner medicine during treatment with bicalutamide tablets, tell your healthcare provider if you develop any bleeding or unexplained bruising.
  • Breast enlargement (gynecomastia) and breast pain.
  • Blood sugar problems. Poor blood sugar control can happen in people who take bicalutamide tablets in combination with LHRH medicines.

Your healthcare provider may do blood tests during treatment with bicalutamide tablets to check for side effects.

Your prostate cancer may get worse during treatment with bicalutamide tablets in combination with LHRH medicines. Regular monitoring of your prostate cancer with your healthcare provider is important to determine if your disease is worse.

Tell your healthcare provider if you have trouble breathing with or without a cough or fever. Some people taking bicalutamide tablets get an inflammation in the lungs called interstitial lung disease.

The most common side effects of bicalutamide tablets include:

  • hot flashes, or short periods of feeling warm and sweating
  • body pain (including back, pelvis, stomach)
  • feeling weak
  • constipation
  • infection
  • nausea
  • swelling in your ankles, legs or feet
  • shortness of breath (dyspnea)
  • dizziness
  • diarrhea
  • blood in your urine
  • frequent urination at night
  • a decrease in red blood cells (anemia)

Bicalutamide may have an effect on male fertility which could be reversible. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of bicalutamide. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store bicalutamide tablets?

Store bicalutamide tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Keep bicalutamide tablets and all medicines out of the reach of children.

General information about the safe and effective use of bicalutamide tablets.

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use bicalutamide tablets for a condition for which it was not prescribed. Do not give bicalutamide tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about bicalutamide tablets. If you would like more information about bicalutamide talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about bicalutamide tablets that is written for health professionals.

What are the ingredients in bicalutamide tablets?

Active ingredient: bicalutamide, USP

Inactive ingredients: lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate (type A), talc and titanium dioxide.

Manufactured for: Northstar Rx LLC Memphis, TN 38141
Manufactured by: Intas Pharmaceuticals Ltd.,
Ahmedabad, India — 382210 For more information, call 1-800-206-7821.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Issued – 05/2018

10 2950 0 682617

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