Complete SPL Sections
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Bicalutamide tablets, USP 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets, USP 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies (14.2)].
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Bicalutamide 50 mg tablets for oral administration.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Bicalutamide is contraindicated in: Hypersensitivity Bicalutamide is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet’s components. Hypersensitivity reactions including angioneurotic edema and urticaria have been reported. Women Bicalutamide has no indication for women, and should not be used in this population. Pregnancy Bicalutamide can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
Clinical studies have not shown any drug interactions between bicalutamide and LHRH analogs (goserelin or leuprolide). There is no evidence that bicalutamide induces hepatic enzymes. In vitro studies have shown that R-bicalutamide is an inhibitor of CYP 3A4 with lesser inhibitory effects on CYP 2C9, 2C19 and 2D6 activity. Clinical studies have shown that with coadministration of bicalutamide, mean midazolam (a CYP 3A4 substrate) levels may be increased 1.5-fold (for C max ) and 1.9-fold (for AUC). Hence, caution should be exercised when bicalutamide is coadministered with CYP 3A4 substrates. In vitro protein-binding studies have shown that bicalutamide can displace coumarin anticoagulants from binding sites. PT/INR should be closely monitored in patients concomitantly receiving coumarin anticoagulants and bicalutamide. Adjustment of the anticoagulant dose may be necessary [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
Long-term clinical trials have been conducted with dosages up to 200 mg of bicalutamide daily and these dosages have been well tolerated. A single dose of bicalutamide that results in symptoms of an overdose considered to be life threatening has not been established. There is no specific antidote; treatment of an overdose should be symptomatic. In the management of an overdose with bicalutamide, vomiting may be induced if the patient is alert. It should be remembered that, in this patient population, multiple drugs may have been taken. Dialysis is not likely to be helpful since bicalutamide is highly protein bound and is extensively metabolized. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
11 DESCRIPTION
DESCRIPTION SECTION
Bicalutamide tablets contain 50 mg of bicalutamide USP, a non-steroidal androgen receptor inhibitor with no other known endocrine activity. The chemical name is propanamide, N [4 cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-,(+-). The structural and molecular formulas are: Bicalutamide has a molecular weight of 430.37. The pKa is approximately 12. Bicalutamide is a fine white to off-white powder which is practically insoluble in water at 37°C (5 mg per 1000 mL), slightly soluble in chloroform and absolute ethanol, sparingly soluble in methanol, and soluble in acetone and tetrahydrofuran. Bicalutamide tablet is a racemate with its antiandrogenic activity being almost exclusively exhibited by the R-enantiomer of bicalutamide; the S-enantiomer is essentially inactive. The inactive ingredients of bicalutamide tablets are lactose monohydrate, sodium starch glycolate type A, povidone, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
White to off white, circular, biconvex, film-coated tablets debossed with “485” on one side and plain on other side. Bottles of 30 with Child Resistant Cap……….…..…. NDC 47335-485-83 Bottles of 100 with Child Resistant Cap………….…..NDC 47335-485-88 Bottles of 100…..…….…..…….…..…….…..…….…..…….NDC 47335-485-08 Bottles of 1000…..…….…..…….…..…….…..…….……….NDC 47335-485-18
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patient to read the FDA-approved patient labeling (Patient Information). Dose and Schedule: Inform patients that therapy with bicalutamide 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 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. Advise patients to notify their healthcare provider of any bleeding or spontaneous bruising while on bicalutamide 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 preexisting diabetes has been reported during treatment with LHRH agonists. Consideration should therefore be given to monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists [see Warnings and Precautions (5.4)]. Somnolence: During treatment with bicalutamide, 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 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 therapy. Advise male patients that bicalutamide may impair fertility [see Use in Specific Populations (8.3)]. Dispense with Patient Information available at: https://www.sunpharma.com/usa/products
Patient Information
SPL PATIENT PACKAGE INSERT SECTION
Bicalutamide (BYE-ka-LOO-ta-mide) Tablets, USP What are bicalutamide tablets? Bicalutamide tablets are prescription medicines called androgen receptor inhibitors, used in combination with luteinizing hormone-releasing hormone (LHRH) medicines to treat Stage D 2 metastatic prostate cancer. Bicalutamide tablet 150 mg daily is not approved for use alone or with other treatments. It is not known if bicalutamidetablets are 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 tablets are 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 work, 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 every day. 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 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 affect you. Bicalutamide tablets 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 (short periods of feeling warm and sweating) body pain (including back, pelvis, stomach) feeling weak constipation infection nausea swelling in your arms, 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 tablets 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 tablets. 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 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). • Bicalutamide tablets come in a child-resistant package. 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 tablets, 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 Inactive ingredients : lactose monohydrate, sodium starch glycolate type A, povidone, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide For more information, call 1-800-818-4555. This Patient Information has been approved by the U.S. Food and Drug Administration. # All trademark names are the property of their respective owners. Dispense with Patient Information available at: https://www.sunpharma.com/usa/products Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India. ISS. 10/2023 5246064
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-485-83 Bicalutamide Tablets, USP 50 mg Rx only 30 Tablets SUN PHARMA