Malignant Spiradenoma (MES)

FDA Label: Adcetris

Disease/s that Drug Treats:Hodgkin lymphoma and anaplastic large cell lymphoma

Indications and Usage: ¹⁸ ADCETRIS is a CD30-directed antibody-drug conjugate indicated fortreatment of patients with: Hodgkin lymphoma after failure of autologous stem cell transplant(ASCT) or after failure of at least two prior multi-agent chemotherapyregimens in patients who are not ASCT candidates (1.1). Systemic anaplastic large cell lymphoma after failure of at least oneprior multi-agent chemotherapy regimen (1.2).Accelerated approval was granted for the above indications based onoverall response rate. An improvement in patient-reported outcomes orsurvival has not been established. Continued approval for these indicationsmay be contingent upon verification and description of clinical benefit inconfirmatory trials.

FDA Label: Afinitor

Disease/s that Drug Treats:renal cell carcinoma/ renal angiomyolipoma associated with tuberous sclerosis complex/ advanced pancreatic neuroendocrine tumors/ hormone receptor-positive, HER2-negative breast cancer

Indications and Usage: ¹⁸ AFINITOR is a kinase inhibitor indicated for the treatment of: postmenopausal women with advanced hormone receptor-positive, HER2- negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole or anastrozole. (1.1) adults with progressive neuroendocrine tumors of pancreatic origin (PNET) that are unresectable, locally advanced or metastatic. AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors. (1.2) adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. (1.3) adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. The effectiveness of AFINITOR in the treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. Further follow-up of patients is required to determine long-term outcomes. (1.4) AFINITOR and AFINITOR DISPERZ are kinase inhibitors indicated for the treatment of: pediatric and adult patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. The effectiveness is based on demonstration of durable objective response, as evidenced by reduction in SEGA tumor volume. Improvement in diseaserelated symptoms and overall survival in patients with SEGA and TSC has not been demonstrated. (1.5)

FDA Label: Akynzeo

Disease/s that Drug Treats:chemotherapy-induced nausea and vomiting

Indications and Usage: ¹⁸ AKYNZEO is a fixed combination of netupitant, a substance P/neurokinin 1(NK1) receptor antagonist, and palonosetron, a serotonin-3 (5-HT3) receptorantagonist indicated for the prevention of acute and delayed nausea andvomiting associated with initial and repeat courses of cancer chemotherapy,including, but not limited to, highly emetogenic chemotherapy. Oralpalonosetron prevents nausea and vomiting during the acute phase andnetupitant prevents nausea and vomiting during both the acute and delayedphase after cancer chemotherapy. (1)

FDA Label: Alimta

Disease/s that Drug Treats:Mesothelioma

Indications and Usage: ¹⁸ ALIMTA® is a folate analog metabolic inhibitor indicated for: Locally Advanced or Metastatic Nonsquamous Non-Small CellLung Cancer: Initial treatment in combination with cisplatin. (1.1) Maintenance treatment of patients whose disease has notprogressed after four cycles of platinum-based first-linechemotherapy. (1.2) After prior chemotherapy as a single-agent. (1.3) Mesothelioma: in combination with cisplatin. (1.4)Limitations of Use: ALIMTA is not indicated for the treatment of patients withsquamous cell non-small cell lung cancer. (1.5)

FDA Label: Anzemet

Disease/s that Drug Treats:prevention of nausea and vomiting associated with chemotherapy and surgery/ Treatment for chemotherapy induced emesis

Indications and Usage: ¹⁸ ANZEMET Tablets are indicated for the prevention of nausea and vomiting associated withmoderately emetogenic cancer chemotherapy, including initial and repeat courses in adults andchildren 2 years and older.

FDA Label: Aredia

Disease/s that Drug Treats:osteolytic bone metastases of breast cancer

Indications and Usage: ¹⁸ Hypercalcemia of MalignancyAredia, in conjunction with adequate hydration, is indicated for the treatment of moderate or severehypercalcemia associated with malignancy, with or without bone metastases. Patients who have eitherepidermoid or non-epidermoid tumors respond to treatment with Aredia. Vigorous saline hydration, anintegral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made torestore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia maybe treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patientsshould be hydrated adequately throughout the treatment, but overhydration, especially in those patientswho have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction ofhypovolemia. The safety and efficacy of Aredia in the treatment of hypercalcemia associated withhyperparathyroidism or with other non-tumor-related conditions has not been established.Paget’s DiseaseAredia is indicated for the treatment of patients with moderate to severe Paget’s disease of bone. Theeffectiveness of Aredia was demonstrated primarily in patients with serum alkaline phosphatase ≥3 timesthe upper limit of normal. Aredia therapy in patients with Paget’s disease has been effective in reducingserum alkaline phosphatase and urinary hydroxyproline levels by ≥50% in at least 50% of patients, and by≥30% in at least 80% of patients. Aredia therapy has also been effective in reducing these biochemicalmarkers in patients with Paget’s disease who failed to respond, or no longer responded to othertreatments.Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of MultipleMyelomaAredia is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolyticbone metastases of breast cancer and osteolytic lesions of multiple myeloma. The Aredia treatment effectappeared to be smaller in the study of breast cancer patients receiving hormonal therapy than in the studyof those receiving chemotherapy, however, overall evidence of clinical benefit has been demonstrated(see CLINICAL PHARMACOLOGY, Osteolytic Bone Metastases of Breast Cancer and OsteolyticLesions of Multiple Myeloma, Clinical Trials section).

FDA Label: Aromasin Tablets

Disease/s that Drug Treats:advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy

Indications and Usage: ¹⁸ AROMASIN is an aromatase inhibitor indicated for: Incidences of cardiac ischemic events (myocardial infarction, angina, adjuvant treatment of postmenopausal women with estrogen-receptor and myocardial ischemia) were AROMASIN 1.6%, tamoxifen 0.6%.positive early breast cancer who have received two to three years of Incidence of cardiac failure: AROMASIN 0.4%, tamoxifen 0.3% (6,tamoxifen and are switched to AROMASIN for completion of a total of 6.1).five consecutive years of adjuvant hormonal therapy (14.1). Advanced breast cancer: Most common adverse events were mild to treatment of advanced breast cancer in postmenopausal women whose moderate and included hot flushes (13% vs. 5%), nausea (9% vs. 5%),disease has progressed following tamoxifen therapy (14.2).

FDA Label: Bexxar

Disease/s that Drug Treats:Non-Hodgkin's Lymphoma

Indications and Usage: ¹⁸ BEXXAR (tositumomab and Iodine I 131 tositumomab) is a CD20-directedradiotherapeutic antibody indicated for the treatment of patients with CD20-positive, relapsed or refractory, low-grade, follicular, or transformed nonHodgkin'slymphoma who have progressed during or after rituximab therapy,including patients with rituximab-refractory non-Hodgkin's lymphoma. (1.1)Determination of the effectiveness of the BEXXAR therapeutic regimen isbased on overall response rates in patients whose disease is refractory tochemotherapy and rituximab. The effects of the BEXXAR therapeuticregimen on survival are not known. (1.1)Important Limitation of Use BEXXAR therapeutic regimen is only indicated for a single course oftreatment and is not indicated for a first-line treatment. (1.2)

FDA Label: Cometriq

Disease/s that Drug Treats:thyroid cancer

Indications and Usage: ¹⁸ COMETRIQ is a kinase inhibitor indicated for the treatment ofpatients with progressive, metastatic medullary thyroid cancer(MTC). (1)

FDA Label: Degarelix

Disease/s that Drug Treats:Prostate Cancer

Indications and Usage: ¹⁸

FDA Label: Doxil

Disease/s that Drug Treats:ovarian cancer that is refractory to other first-line therapies

Indications and Usage: ¹⁸ DOXIL is an anthracycline topoisomerase II inhibitor indicated for: Ovarian cancer (1.1)After failure of platinum-based chemotherapy. AIDS-related Kaposi’s Sarcoma (1.2)After failure of prior systemic chemotherapy or intolerance to such therapy. Multiple Myeloma (1.3)In combination with bortezomib in patients who have not previouslyreceived bortezomib and have received at least one prior therapy.

FDA Label: Emend

Disease/s that Drug Treats:Chemotherapy-induced Nausea and Vomiting

Indications and Usage: ¹⁸ EMEND® is a substance P/neurokinin 1 (NK1) receptor antagonist,indicated: in combination with other antiemetic agents for the:o prevention of acute and delayed nausea and vomitingassociated with initial and repeat courses of highly emetogeniccancer chemotherapy (HEC) including high-dose cisplatin (1.1)o prevention of nausea and vomiting associated with initial andrepeat courses of moderately emetogenic cancer chemotherapy(MEC) (1.1) for the prevention of postoperative nausea and vomiting (PONV)(1.2)Limitations of Use (1.3) Not studied for the treatment of established nausea and vomiting. Chronic continuous administration is not recommended.

FDA Label: Erbitux

Disease/s that Drug Treats:Colorectal Cancer

Indications and Usage: ¹⁸ Erbitux® is an epidermal growth factor receptor (EGFR) antagonist indicatedfor treatment of:Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the headand neck in combination with radiation therapy. (1.1, 14.1) Recurrent locoregional disease or metastatic squamous cell carcinomaof the head and neck in combination with platinum-based therapy with5-FU. (1.1, 14.1) Recurrent or metastatic squamous cell carcinoma of the head and neckprogressing after platinum-based therapy. (1.1, 14.1)Colorectal CancerK-Ras wild-type, EGFR-expressing, metastatic colorectal cancer asdetermined by FDA-approved tests in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory toirinotecan-based chemotherapy, as a single agent in patients who have failed oxaliplatin- andirinotecan-based chemotherapy or who are intolerant to irinotecan.(1.2, 5.7, 12.1, 14.2)Limitation of Use: Erbitux is not indicated for treatment of Ras-mutantcolorectal cancer. (5.7, 14.2)

FDA Label: Erwinaze

Disease/s that Drug Treats:acute lymphoblastic leukemia

Indications and Usage: ¹⁸ ERWINAZE (asparaginase Erwinia chrysanthemi) is an asparagine specificenzyme indicated as a component of a multi-agent chemotherapeutic regimenfor the treatment of patients with acute lymphoblastic leukemia (ALL) whohave developed hypersensitivity to E. coli-derived asparaginase. (1)

FDA Label: Eulexin

Disease/s that Drug Treats:prostate cancer

Indications and Usage: ¹⁸ EULEXIN capsules are indicated for use in combination with LHRH agonists for the management of locally confined Stage B2C and Stage D2 metastatic carcinoma of the prostate. Stage B2C Prostatic Carcinoma: Treatment with EUlEXIN an the goserelin acetate implant shouls start 8 weeks prior to initiating radiation therapy and continue during radiation therapy. Stage D2 Metastatic Carcinoma: To acheive benefit from treatment, EULEXIN Capsules should be initiated with the LHRH-agonist and continued until progression.

FDA Label: Evista

Disease/s that Drug Treats:osteoporosis and reduction of breast cancer risk in postmenopausal women

Indications and Usage: ¹⁸ EVISTA is an estrogen agonist/antagonist indicated for Treatment and prevention of osteoporosis in postmenopausal women.(1.1)

FDA Label: Farydak

Disease/s that Drug Treats:Multiple myeloma

Indications and Usage: ¹⁸ FARYDAK, a histone deacetylase inhibitor, in combination with bortezomiband dexamethasone, is indicated for the treatment of patients with multiplemyeloma who have received at least 2 prior regimens, including bortezomiband an immunomodulatory agent. This indication is approved underaccelerated approval based on progression free survival. Continued approvalfor this indication may be contingent upon verification and description ofclinical benefit in confirmatory trials. (1)

FDA Label: Gardasil

Disease/s that Drug Treats:Cervical Cancer Caused by Human Papillomavirus

Indications and Usage: ¹⁸ GARDASIL is a vaccine indicated in girls and women 9 through 26years of age for the prevention of the following diseases caused byHuman Papillomavirus (HPV) types included in the vaccine: Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16and 18 (1.1) Genital warts (condyloma acuminata) caused by HPV types 6 and11 (1.1)And the following precancerous or dysplastic lesions caused by HPVtypes 6, 11, 16, and 18: Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervicaladenocarcinoma in situ (AIS) (1.1) Cervical intraepithelial neoplasia (CIN) grade 1 (1.1) Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3 (1.1) Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3 (1.1) Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 (1.1)GARDASIL is indicated in boys and men 9 through 26 years of age forthe prevention of the following diseases caused by HPV types includedin the vaccine: Anal cancer caused by HPV types 16 and 18 (1.2) Genital warts (condyloma acuminata) caused by HPV types 6 and11 (1.2)And the following precancerous or dysplastic lesions caused by HPVtypes 6, 11, 16, and 18: Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. (1.2)Limitations of GARDASIL Use and Effectiveness: GARDASIL does not eliminate the necessity for women tocontinue to undergo recommended cervical cancer screening.(1.3, 17) Recipients of GARDASIL should not discontinue anal cancerscreening if it has been recommended by a health care provider.(1.3, 17) GARDASIL has not been demonstrated to provide protectionagainst disease from vaccine and non-vaccine HPV types to whicha person has previously been exposed through sexual activity.(1.3, 14.4, 14.5) GARDASIL is not intended to be used for treatment of activeexternal genital lesions; cervical, vulvar, vaginal, and analcancers; CIN; VIN; VaIN, or AIN. (1.3) GARDASIL has not been demonstrated to protect againstdiseases due to HPV types not contained in the vaccine. (1.3,14.4, 14.5) Not all vulvar, vaginal, and anal cancers are caused by HPV, andGARDASIL protects only against those vulvar, vaginal, and analcancers caused by HPV 16 and 18. (1.3) GARDASIL does not protect against genital diseases not causedby HPV. (1.3) Vaccination with GARDASIL may not result in protection in allvaccine recipients. (1.3) GARDASIL has not been demonstrated to prevent HPV-relatedCIN 2/3 or worse in women older than 26 years of age. (14.7)

FDA Label: Gleevec

Disease/s that Drug Treats:chronic myeloid leukemia/Gastrointestinal stromal tumors (GISTs)

Indications and Usage: ¹⁸ Gleevec™ (imatinib mesylate) is indicated for the treatment of newly diagnosed adultpatients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in chronicphase. Follow-up is limited. Page 10Gleevec is also indicated for the treatment of patients with Philadelphia chromosomepositive chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronicphase after failure of interferon-alpha therapy. Gleevec is also indicated for the treatment ofpediatric patients with Ph+ chronic phase CML whose disease has recurred after stem celltransplant or who are resistant to interferon alpha therapy. There are no controlled trialsdemonstrating a clinical benefit, such as improvement in disease-related symptoms orincreased survival.Gleevec is also indicated for the treatment of patients with Kit (CD117) positiveunresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (SeeCLINICAL STUDIES: Gastrointestinal Stromal Tumors.) The effectiveness of Gleevec inGIST is based on objective response rate (see CLINICAL STUDIES). There are no controlledtrials demonstrating a clinical benefit, such as improvement in disease-related symptoms orincreased survival.

FDA Label: Halaven

Disease/s that Drug Treats:metastatic breast cancer

Indications and Usage: ¹⁸ HALAVEN is a microtubule inhibitor indicated for the treatment ofpatients with metastatic breast cancer who have previously receivedat least two chemotherapeutic regimens for the treatment ofmetastatic disease. Prior therapy should have included ananthracycline and a taxane in either the adjuvant or metastaticsetting (1)

FDA Label: Intron A

Disease/s that Drug Treats:non-Hodgkin's lymphoma/ malignant melanoma / Hepatitis C

Indications and Usage: ¹⁸ Hairy Cell Leukemia INTRON® A is indicated for the treatment of patients 18 years ofage or older with hairy cell leukemia.Malignant Melanoma INTRON A is indicated as adjuvant to surgical treatment inpatients 18 years of age or older with malignant melanoma who are free of disease butat high risk for systemic recurrence, within 56 days of surgery.Follicular Lymphoma INTRON A is indicated for the initial treatment of clinicallyaggressive (see Clinical Pharmacology) follicular Non-Hodgkin’s Lymphoma inconjunction with anthracycline-containing combination chemotherapy in patients 18years of age or older. Efficacy of INTRON A therapy in patients with low-grade, lowtumorburden follicular Non-Hodgkin’s Lymphoma has not been demonstrated.Condylomata Acuminata INTRON A is indicated for intralesional treatment of selectedpatients 18 years of age or older with condylomata acuminata involving externalsurfaces of the genital and perianal areas (see DOSAGE AND ADMINISTRATION).The use of this product in adolescents has not been studied.AIDS-Related Kaposi's Sarcoma INTRON A is indicated for the treatment of selectedpatients 18 years of age or older with AIDS-Related Kaposi's Sarcoma. The likelihoodof response to INTRON A therapy is greater in patients who are without systemic symptoms, who have limited lymphadenopathy and who have a relatively intact immunesystem as indicated by total CD4 count.Chronic Hepatitis C INTRON A is indicated for the treatment of chronic hepatitis C inpatients 18 years of age or older with compensated liver disease who have a history ofblood or blood-product exposure and/or are HCV antibody positive. Studies in thesepatients demonstrated that INTRON A therapy can produce clinically meaningful effectson this disease, manifested by normalization of serum alanine aminotransferase (ALT)and reduction in liver necrosis and degeneration.A liver biopsy should be performed to establish the diagnosis of chronic hepatitis.Patients should be tested for the presence of antibody to HCV. Patients with othercauses of chronic hepatitis, including autoimmune hepatitis, should be excluded. Priorto initiation of INTRON A therapy, the physician should establish that the patient hascompensated liver disease. The following patient entrance criteria for compensated liverdisease were used in the clinical studies and should be considered before INTRON Atreatment of patients with chronic hepatitis C: No history of hepatic encephalopathy, variceal bleeding, ascites, or otherclinical signs of decompensation Bilirubin Less than or equal to 2 mg/dL Albumin Stable and within normal limits Prothrombin Time Less than 3 seconds prolonged WBC Greater than or equal to 3000/mm3 Platelets Greater than or equal to 70,000/mm3Serum creatinine should be normal or near normal.Prior to initiation of INTRON A therapy, CBC and platelet counts should beevaluated in order to establish baselines for monitoring potential toxicity. These testsshould be repeated at Weeks 1 and 2 following initiation of INTRON A therapy, andmonthly thereafter. Serum ALT should be evaluated at approximately 3-month intervalsto assess response to treatment (see DOSAGE AND ADMINISTRATION).Patients with preexisting thyroid abnormalities may be treated if thyroidstimulatinghormone (TSH) levels can be maintained in the normal range by medication.TSH levels must be within normal limits upon initiation of INTRON A treatment and TSHtesting should be repeated at 3 and 6 months (see PRECAUTIONS, LaboratoryTests).INTRON A in combination with REBETOL® is indicated for the treatment ofchronic hepatitis C in patients 3 years of age and older with compensated liver diseasepreviously untreated with alpha interferon therapy and in patients 18 years of age andolder who have relapsed following alpha interferon therapy. See REBETOL prescribinginformation for additional information. Chronic Hepatitis B INTRON A is indicated for the treatment of chronic hepatitis B inpatients 1 year of age or older with compensated liver disease. Patients who have beenserum HBsAg positive for at least 6 months and have evidence of HBV replication(serum HBeAg positive) with elevated serum ALT are candidates for treatment. Studiesin these patients demonstrated that INTRON A therapy can produce virologic remissionof this disease (loss of serum HBeAg) and normalization of serum aminotransferases.INTRON A therapy resulted in the loss of serum HBsAg in some responding patients.Prior to initiation of INTRON A therapy, it is recommended that a liver biopsy beperformed to establish the presence of chronic hepatitis and the extent of liver damage.The physician should establish that the patient has compensated liver disease. Thefollowing patient entrance criteria for compensated liver disease were used in theclinical studies and should be considered before INTRON A treatment of patients withchronic hepatitis B: No history of hepatic encephalopathy, variceal bleeding, ascites, or othersigns of clinical decompensation Bilirubin Normal Albumin Stable and within normal limits Prothrombin Time Adults less than 3 seconds prolongedPediatrics less than or equal to 2 seconds prolonged WBC Greater than or equal to 4000/mm3 Platelets Adults greater than or equal to 100,000/mm3Pediatrics greater than or equal to 150,000/mm3Patients with causes of chronic hepatitis other than chronic hepatitis B or chronichepatitis C should not be treated with INTRON A. CBC and platelet counts should beevaluated prior to initiation of INTRON A therapy in order to establish baselines formonitoring potential toxicity. These tests should be repeated at treatment Weeks 1, 2,4, 8, 12, and 16. Liver function tests, including serum ALT, albumin, and bilirubin,should be evaluated at treatment Weeks 1, 2, 4, 8, 12, and 16. HBeAg, HBsAg, andALT should be evaluated at the end of therapy, as well as 3- and 6-months posttherapy,since patients may become virologic responders during the 6-month periodfollowing the end of treatment. In clinical studies in adults, 39% (15/38) of respondingpatients lost HBeAg 1 to 6 months following the end of INTRON A therapy. Ofresponding patients who lost HBsAg, 58% (7/12) did so 1 to 6 months post-treatment.A transient increase in ALT greater than or equal to 2 times baseline value (flare)can occur during INTRON A therapy for chronic hepatitis B. In clinical trials in adultsand pediatrics, this flare generally occurred 8 to 12 weeks after initiation of therapy andwas more frequent in responders (adults 63%, 24/38; pediatrics 59%, 10/17) than innonresponders (adults 27%, 13/48; pediatrics 35%, 19/55). However, in adults andpediatrics, elevations in bilirubin greater than or equal to 3 mg/dL (greater than or equalto 2 times ULN) occurred infrequently (adults 2%, 2/86; pediatrics 3%, 2/72) duringtherapy. When ALT flare occurs, in general, INTRON A therapy should be continued unless signs and symptoms of liver failure are observed. During ALT flare, clinicalsymptomatology and liver function tests including ALT, prothrombin time, alkalinephosphatase, albumin, and bilirubin, should be monitored at approximately 2-weekintervals (see WARNINGS).

FDA Label: Lynparza

Disease/s that Drug Treats:previously treated BRCA mutated advanced ovarian cancer

Indications and Usage: ¹⁸ Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated asmonotherapy in patients with deleterious or suspected deleterious germlineBRCA mutated (as detected by an FDA-approved test) advanced ovariancancer who have been treated with three or more prior lines of chemotherapy.(1.1)The indication is approved under accelerated approval based on objectiveresponse rate and duration of response. Continued approval for this indicationmay be contingent upon verification and description of clinical benefit inconfirmatory trials. (1 1, 14)

FDA Label: Marqibo

Disease/s that Drug Treats:Ph- acute lymphoblastic leukemia

Indications and Usage: ¹⁸ Marqibo is a vinca alkaloid indicated for the treatment of adult patients withPhiladelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL)in second or greater relapse or whose disease has progressed following two ormore anti-leukemia therapies. This indication is based on overall responserate. Clinical benefit such as improvement in overall survival has not beenverified (1.1).

FDA Label: Miraluma Test

Disease/s that Drug Treats:breast imaging

Indications and Usage: ¹⁸ Breast Imaging: MIRALUMA, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection, is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. MIRALUMA is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.

FDA Label: Mylotarg

Disease/s that Drug Treats:Acute Myeloid Leukemia (AML)

Indications and Usage: ¹⁸ Mylotarg is indicated for the treatment of patients with CD33 positive acute myeloid leukemia infirst relapse who are 60 years of age or older and who are not considered candidates for othercytotoxic chemotherapy. The safety and efficacy of Mylotarg in patients with poor performancestatus and organ dysfunction has not been established.The effectiveness of Mylotarg is based on OR rates (see CLINICAL STUDIES section). Thereare no controlled trials demonstrating a clinical benefit, such as improvement in disease-relatedsymptoms or increased survival, compared to any other treatment.

FDA Label: Premarin

Disease/s that Drug Treats:prevention of postmenopausal osteoporosis and treatment of vasomotor menopause symptoms

Indications and Usage: ¹⁸ PREMARIN is a mixture of estrogens indicated for: Treatment of Moderate to Severe Vasomotor Symptoms due toMenopause (1.1) Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due toMenopause (1.2) Treatment of Hypoestrogenism due to Hypogonadism, Castration orPrimary Ovarian Failure (1.3) Treatment of Breast Cancer (for Palliation Only) in AppropriatelySelected Women and Men with Metastatic Disease (1.4) Treatment of Advanced Androgen-Dependent Carcinoma of theProstate (for Palliation Only) (1.5) Prevention of Postmenopausal Osteoporosis (1.6)

FDA Label: Revlimid

Disease/s that Drug Treats:mantle cell lymphoma

Indications and Usage: ¹⁸ REVLIMID is a thalidomide analogue indicated for the treatment of patientswith: Multiple myeloma (MM), in combination with dexamethasone (1.1). Transfusion-dependent anemia due to low- or intermediate-1-riskmyelodysplastic syndromes (MDS) associated with a deletion 5qabnormality with or without additional cytogenetic abnormalities (1.2). Mantle cell lymphoma (MCL) whose disease has relapsed or progressedafter two prior therapies, one of which included bortezomib (1.3).Limitations of Use: REVLIMID is not indicated and is not recommended for the treatmentof patients with chronic lymphocytic leukemia (CLL) outside ofcontrolled clinical trials (1.4).

FDA Label: Rituxan

Disease/s that Drug Treats:non-hodgkin's lymphoma

Indications and Usage: ¹⁸ Rituxan® (rituximab) is a CD20-directed cytolytic antibody indicated for thetreatment of patients with: Non-Hodgkin’s Lymphoma (NHL) (1.1) Chronic Lymphocytic Leukemia (CLL) (1.2) Rheumatoid Arthritis (RA) in combination with methotrexate in adultpatients with moderately-to severely-active RA who have inadequateresponse to one or more TNF antagonist therapies (1.3) Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) andMicroscopic Polyangiitis (MPA) in adult patients in combination withglucocorticoids (1.4)Limitations of Use: Rituxan is not recommended for use in patients withsevere, active infections (1.5).

FDA Label: Sensipar

Disease/s that Drug Treats:Hyperparathyroidism / Hypercalcemia

Indications and Usage: ¹⁸ Sensipar is a calcium-sensing receptor agonist indicated for: concentration time curve) is increased in patients with moderate and Secondary Hyperparathyroidism (HPT) in adult patients with chronic severe hepatic impairment. Patients should be closely monitored forkidney disease (CKD) on dialysis. (1.1) serum calcium, serum phosphorus, and iPTH levels throughout Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2) treatment. (5.3, 8.7) Hypercalcemia in adult patients with primary HPT for whomparathyroidectomy would be indicated on the basis of serum calciumlevels, but who are unable to undergo parathyroidectomy. (1.3)

FDA Label: Stivarga

Disease/s that Drug Treats:gastrointestinal stromal tumor/ metastatic colorectal cancer

Indications and Usage: ¹⁸ Stivarga is a kinase inhibitor indicated for the treatment of patients with: Metastatic colorectal cancer (CRC) who have been previously treated withfluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an antiVEGFtherapy, and, if KRAS wild type, an anti-EGFR therapy. (1.1) Locally advanced, unresectable or metastatic gastrointestinal stromal tumor(GIST) who have been previously treated with imatinib mesylate andsunitinib malate. (1.2)

FDA Label: Sutent

Disease/s that Drug Treats:pancreatic neuroendocrine tumors/ Kidney Cancer/Gastrointestinal Stromal Tumors

Indications and Usage: ¹⁸ SUTENT is a kinase inhibitor indicated for the treatment of: Gastrointestinal stromal tumor (GIST) after disease progression on orintolerance to imatinib mesylate. (1.1) Advanced renal cell carcinoma (RCC). (1.2) Progressive, well-differentiated pancreatic neuroendocrine tumors(pNET) in patients with unresectable locally advanced or metastaticdisease. (1.3)

FDA Label: Synercid I.V.

Disease/s that Drug Treats:For serious or life-threatening infections associated w/ vancomycin-resistant Enterococcus faecium (VREF) bacteremia.

Indications and Usage: ¹⁸ Synercid is indicated in adults for the treatment of the following infections when caused bysusceptible strains of the designated microorganisms.Complicated skin and skin structure infections caused by Staphylococcus aureus (methicillinsusceptible) or Streptococcus pyogenes. (See CLINICAL STUDIES.)

FDA Label: Taxotere

Disease/s that Drug Treats:breast cancer

Indications and Usage: ¹⁸ TAXOTERE is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BCafter chemotherapy failure; and with doxorubicin andcyclophosphamide as adjuvant treatment of operable node-positive BC(1.1) Non-Small Cell Lung Cancer (NSCLC): single agent for locallyadvanced or metastatic NSCLC after platinum therapy failure; andwith cisplatin for unresectable, locally advanced or metastaticuntreated NSCLC (1.2) Hormone Refractory Prostate Cancer (HRPC): with prednisone inandrogen independent (hormone refractory) metastatic prostate cancer(1.3) Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil foruntreated, advanced GC, including the gastroesophageal junction (1.4) Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN):with cisplatin and fluorouracil for induction treatment of locallyadvanced SCCHN (1.5)

FDA Label: UroXatral

Disease/s that Drug Treats:Benign Prostatic Hyperplasia

Indications and Usage: ¹⁸ UROXATRAL is an alpha adrenergic antagonist, indicated for thetreatment of signs and symptoms of benign prostatic hyperplasia. (1)Important Limitations of Use:UROXATRAL is not indicated for treatment of hypertension. (1.1)UROXATRAL is not indicated for use in the pediatric population. (1.1,8.4, 12.3)

FDA Label: Xalkori

Disease/s that Drug Treats:ALK+ non-small cell lung cancer

Indications and Usage: ¹⁸ XALKORI is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplasticlymphoma kinase (ALK)-positive as detected by an FDA-approved test. (1), XALKORI is a kinase inhibitor indicated for the treatment of patients with: * metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. (1.1) * metastatic NSCLC whose tumors are ROS1-positive. (1.2)

FDA Label: Zuplenz

Disease/s that Drug Treats:post-operative, chemotherapy and radiotherapy induced nausea and vomiting

Indications and Usage: ¹⁸ ZUPLENZ is a 5-HT3 receptor antagonist indicated for: Prevention of nausea and vomiting associated with highly emetogenic cancerchemotherapy. (1.1) Prevention of nausea and vomiting associated with initial and repeat coursesof moderately emetogenic cancer chemotherapy. (1.2) Prevention of nausea and vomiting associated with radiotherapy in patientsreceiving total body irradiation, single high-dose fraction to abdomen, ordaily fractions to the abdomen. (1.3) Prevention of postoperative nausea and/or vomiting. (1.4)

FDA Label: Adempas

Disease/s that Drug Treats:Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension

Indications and Usage: ¹⁸ Adempas is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of adults with: * Persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class. (1.1) * Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening. (1.2)

FDA Label: Advair

Disease/s that Drug Treats:asthma and chronic obstructive pulmonary disease

Indications and Usage: ¹⁸ ADVAIR DISKUS is a combination product containing a corticosteroid and a LABA indicated for: * Treatment of asthma in patients aged 4 years and older. (1.1) * Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2) Important limitation: * Not indicated for the relief of acute bronchospasm. (1.1, 1.2)

FDA Label: Aldurazyme

Disease/s that Drug Treats:Mucopolysaccharidosis I

Indications and Usage: ¹⁸ ALDURAZYME is a hydrolytic lysosomal glycosaminoglycan (GAG)- specific enzyme indicated for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms. The risks and benefits of treating mildly affected patients with the Scheie form have not been established. ALDURAZYME has been shown to improve pulmonary function and walking capacity. ALDURAZYME has not been evaluated for effects on the central nervous system manifestations of the disorder (1).

FDA Label: Alvesco

Disease/s that Drug Treats:asthma

Indications and Usage: ¹⁸ ALVESCO is an inhaled corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. (1) ALVESCO is NOT indicated for the relief of acute bronchospasm. (1)

FDA Label: Atrovent

Disease/s that Drug Treats:runny nose due to allergies and the common cold

Indications and Usage: ¹⁸ ATROVENT Nasal Spray 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ATROVENT Nasal Spray 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. CONTRAINDICATIONS Atrovent® (ipratropium bromide) Nasal Spray 0.03% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients. WARNINGS Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

FDA Label: Augmentin

Disease/s that Drug Treats:sinusitis, bronchitis, pneumonia

Indications and Usage: ¹⁸ AUGMENTIN is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following: Lower respiratory tract infections (1.1) Acute bacterial otitis media (1.2) Sinusitis (1.3) Skin and skin structure infections (1.4) Urinary tract infections (1.5)

FDA Label: Azmacort

Disease/s that Drug Treats:asthma

Indications and Usage: ¹⁸ Azmacort Inhalation Aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy. Azmacort Inhalation Aerosol is also indicated for asthma patients who require systemic corticosteroid administration, where adding Azmacort may reduce or eliminate the need for the systemic corticosteroids. Azmacort Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.

FDA Label: Cayston

Disease/s that Drug Treats:cystic fibrosis patients with Pseudomonas aeruginosa

Indications and Usage: ¹⁸ CAYSTON is a monobactam antibacterial indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia. (1)

FDA Label: Cedax

Disease/s that Drug Treats:chronic bronchitis, infection of the middle ear, pharyngitis/tonsillitis

Indications and Usage: ¹⁸ CEDAX (ceftibuten) is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES sections). Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamaseproducing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only). NOTE: In acute bacterial exacerbations of chronic bronchitis clinical trials where Moraxella catarrhalis was isolated from infected sputum at baseline, ceftibuten clinical efficacy was 22% less than control. Acute Bacterial Otitis Media due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pyogenes. NOTE: Although ceftibuten used empirically was equivalent to comparators in the treatment of clinically and/or microbiologically documented acute otitis media, the efficacy against Streptococcus pneumoniae was 23% less than control. Therefore, ceftibuten should be given empirically only when adequate antimicrobial coverage against Streptococcus pneumoniae has been previously administered. Pharyngitis and Tonsillitis due to Streptococcus pyogenes. NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Ceftibuten is generally effective in the eradication of Streptococcus pyogenes from the oropharynx; however, data establishing the efficacy of the CEDAX product for the prophylaxis of subsequent rheumatic fever are not available.

FDA Label: Dulera

Disease/s that Drug Treats:asthma

Indications and Usage: ¹⁸ DULERA combines an inhaled corticosteroid medicine, mometasone furoate (the same medicine found in ASMANEX TWISTHALER), and a long-acting beta2-agonist medicine (LABA), formoterol (the same medicine found in FORADIL® AEROLIZER®). * Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to asthma symptoms. * LABA medicines are used in people with asthma. LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. In severe cases, wheezing can stop your breathing and may lead to death if not treated right away. DULERA is used to control symptoms of asthma and prevent symptoms such as wheezing in people 12 years of age and older. DULERA should not be used as a rescue inhaler. Do not use DULERA unless your healthcare provider has taught you and you understand everything. Ask your healthcare provider or pharmacist if you have any questions. * Use DULERA exactly as prescribed. Do not use DULERA more often than prescribed. DULERA comes in 2 strengths. Your healthcare provider has prescribed the strength that is best for you. Note the differences between DULERA and your other inhaled medications, including the differences in prescribed use and physical appearance. * DULERA should be taken every day as 2 puffs in the morning and 2 puffs in the evening. * If you miss a dose of DULERA, skip your missed dose and take your next dose at your regular time. Do not take DULERA more often or use more puffs than you have been prescribed. * While you are using DULERA 2 times each day, do not use other medicines that contain a longacting beta2-agonist (LABA) for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines. * If you take more DULERA than your healthcare provider has prescribed, get medical help right away if you have any unusual symptoms, such as problems breathing, palpitations, chest pain, increased heart rate, nervousness or shakiness. * Do not change or stop using DULERA or other asthma medicines used to control or treat your breathing problems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines as needed. * DULERA does not relieve sudden asthma symptoms. Always have a rescue inhaler with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of DULERA. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you. * Remove the cap from the mouthpiece of the actuator before using DULERA. * DO NOT remove the canister from the actuator because: o You may not receive the correct amount of medication. o The dose counter may not function properly. o Reinsertion may cause the dose counter to count down by 1 and may discharge a puff. * Rinse your mouth with water after each dose (2 puffs) of DULERA. This will help to lessen the chance of getting a yeast infection (thrush) in the mouth and throat. * Do not spray DULERA in your eyes. If you accidentally get DULERA in your eyes, rinse your eyes with water and if redness or irritation continues, call your healthcare provider. * Call your healthcare provider or get medical care right away if: o your breathing problems worsen with DULERA o you need to use your rescue inhaler more often than usual o your rescue inhaler does not work as well for you at relieving symptoms o you need to use 4 or more inhalations of your rescue inhaler for 2 or more days in a row o you use 1 whole canister of your rescue inhaler in 8 weeks’ time o your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you. o you have asthma and your symptoms do not improve after using DULERA regularly for 1 to 2 weeks

FDA Label: Esbriet

Disease/s that Drug Treats:idiopathic pulmonary fibrosis

Indications and Usage: ¹⁸ ESBRIET is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). (1)

FDA Label: Ketek

Disease/s that Drug Treats:Respiratory Infections

Indications and Usage: ¹⁸ KETEK is a ketolide antibacterial indicated for the treatment of community-acquired pneumonia of mild to moderate severity. (1) To reduce the development of drug-resistant bacteria and maintain the effectiveness of KETEK and other antibacterial drugs, KETEK should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1)

FDA Label: Nasacort AQ Nasal Spray

Disease/s that Drug Treats:allergic rhinitis

Indications and Usage: ¹⁸

FDA Label: Patanase

Disease/s that Drug Treats:seasonal allergic rhinitis

Indications and Usage: ¹⁸ PATANASE Nasal Spray is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older. (1)