Indication: Methotrexate Injection is a folate analog metabolic inhibitor indicated for: The following neoplastic diseases for the: 1. 7 Treatment of adults with rheumatoid arthritis (RA). 8 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). 9 Treatment of adults with severe psoriasis. 10 Methotrexate Injection is indicated for the treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the prophylaxis and treatment of meningeal leukemia in adult and pediatric patients. Methotrexate Injection is indicated for the treatment of adults and pediatric patients with Non-Hodgkin lymphoma. Methotrexate Injection is indicated for the treatment of adults and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the treatment of adults with breast cancer as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the treatment of adults with squamous cell carcinoma of the head and neck as a single-agent. Methotrexate Injection is indicated for the treatment of adults with gestational trophoblastic neoplasia (GTN) as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the treatment of adults with rheumatoid arthritis (RA). Methotrexate Injection is indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA). Methotrexate Injection is indicated for the treatment of adults with severe psoriasis.

Indication: Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer BRCA 1. 1 BRCA 1. 1 Breast cancer BRCA 1. 1 gBRCA 1. 1 Pancreatic cancer gBRCA 1. 1 Prostate cancer 1. 1 BRCA BRCA 1. 1 Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA [see Dosage and Administration (2. 1) ] Lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: BRCA Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2. 1) Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA [see Error! Hyperlink reference not valid. ] Lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCA [ Dosage and Administration (2. 1) Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCA [see Dosage and Administration (2. 1) Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA [see Dosage and Administration (2. 1) Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2. 1) Lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA BRCAm [see Error! Hyperlink reference not valid.

Indication: Capecitabine is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer 1. 1 Breast Cancer 1. 2 Gastric, Esophageal, or Gastroesophageal Junction Cancer 1. 3 Pancreatic Cancer 1. 4 Capecitabine tablet is indicated for the: Capecitabine tablet is indicated for the: Capecitabine tablet is indicated for the: Capecitabine tablet is indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.

Indication: TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer BRCA BRCA 1. 1 HRR Gene-Mutated mCRPC 1. 2 TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene ( BRCA BRCA [see Dosage and Administration (2. 1) TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) [see Dosage and Administration (2.

Indication: TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer BRCA BRCA 1. 1 HRR Gene-mutated mCRPC 1. 2 TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene ( BRCA BRCA [see Dosage and Administration (2. 1) TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) [see Dosage and Administration (2.

Indication: Osteoporosis
Most prospective studies of efficacy for this indication have been carried out in white menopausal women, without stratification by other risk factors, and tend to show a universally salutary effect on bone. The results of a two-year, randomized, placebo-controlled, double-blind, dose-ranging study have shown that treatment with 0.5 mg estradiol daily for 23 days (of a 28 day cycle) prevents vertebral bone mass loss in postmenopausal women. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal period. There is no evidence that estrogen replacement therapy restores bone mass to premenopausal levels.
INDICATIONS AND USAGE
Estradiol Tablets USP are indicated in the: Treatment of moderate to severe vasomotor symptoms associated with the menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL PHARMACOLOGY Clinical Studies The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.

Indication: Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 1 Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

Indication: Methotrexate Injection is a folate analog metabolic inhibitor indicated for: o 1. 10 Methotrexate Injection is indicated for the treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the prophylaxis and treatment of meningeal leukemia in adult and pediatric patients. Methotrexate Injection is indicated for the treatment of adults and pediatric patients with non-Hodgkin lymphoma. Methotrexate Injection is indicated for the treatment of adults and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the treatment of adults with breast cancer as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the treatment of adults with squamous cell carcinoma of the head and neck as a single agent. Methotrexate Injection is indicated for the treatment of adults with gestational trophoblastic neoplasia (GTN) as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the treatment of adults with rheumatoid arthritis (RA). Methotrexate Injection is indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA). Methotrexate Injection is indicated for the treatment of adults with severe psoriasis.

Indication: BEIZRAY is a microtubule inhibitor indicated for: Breast Cancer (BC) 1. 1 Non-small Cell Lung Cancer (NSCLC) 1. 2 Castration-Resistant Prostate Cancer (CRPC) 1. 3 Gastric Adenocarcinoma (GC) 1. 4 Squamous Cell Carcinoma of the Head and Neck (SCCHN) 1. 5 BEIZRAY is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. BEIZRAY in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. BEIZRAY as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. BEIZRAY in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition. BEIZRAY in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer. BEIZRAY in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease. BEIZRAY in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).