Cockayne Syndrome (CS)

FDA Label: Abstral

Disease/s that Drug Treats:breakthrough cancer pain in opiod-tolerant patients

Indications and Usage: ¹⁸ ABSTRAL is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. (1) Limitations of Use: ABSTRAL may be dispensed only to patients enrolled in the TIRF REMS Access program.

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: Aloxi

Disease/s that Drug Treats:Chemotherapy side effects

Indications and Usage: ¹⁸ ALOXI is a serotonin-3 (5-HT3) receptor antagonist indicated in adults for: Moderately emetogenic cancer chemotherapy -- prevention ofacute and delayed nausea and vomiting associated with initial andrepeat courses (1.1) Highly emetogenic cancer chemotherapy -- prevention of acutenausea and vomiting associated with initial and repeat courses(1.1) Prevention of postoperative nausea and vomiting (PONV) for upto 24 hours following surgery. Efficacy beyond 24 hours has notbeen demonstrated (1.3)ALOXI is indicated in pediatric patients aged 1 month to less than 17 yearsfor: Prevention of acute nausea and vomiting associated with initialand repeat courses of emetogenic cancer chemotherapy, includinghighly emetogenic cancer chemotherapy (1.2)

FDA Label: Anexsia

Disease/s that Drug Treats:chronic pain

Indications and Usage: ¹⁸

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: Bosulif

Disease/s that Drug Treats:Ph+ chronic myelogenous leukemia

Indications and Usage: ¹⁸ BOSULIF is a kinase inhibitor indicated for the treatment of adult patientswith chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia(CML) with resistance or intolerance to prior therapy. (1)

FDA Label: Bromfenac

Disease/s that Drug Treats:acute pain

Indications and Usage: ¹⁸ Bromfenac Ophthalmic Solutionis a nonsteroidal anti-inflamatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction (1).

FDA Label: CEA-Scan

Disease/s that Drug Treats:colorectal cancer

Indications and Usage: ¹⁸

FDA Label: Clolar

Disease/s that Drug Treats:Lymphoblastic Leukemia

Indications and Usage: ¹⁸ Clolar (clofarabine) injection is a purine nucleoside metabolic inhibitorindicated for the treatment of pediatric patients 1 to 21 years old with relapsedor refractory acute lymphoblastic leukemia after at least two prior regimens.This indication is based upon response rate. There are no trials verifying animprovement in disease-related symptoms or increased survival with Clolar.(1)

FDA Label: Degarelix

Disease/s that Drug Treats:Prostate Cancer

Indications and Usage: ¹⁸

FDA Label: Elitek

Disease/s that Drug Treats:management of plasma uric acid levels in adults with malignancies

Indications and Usage: ¹⁸ Elitek is a recombinant urate-oxidase indicated for initial management ofplasma uric acid levels in pediatric and adult patients with leukemia,lymphoma, and solid tumor malignancies who are receiving anti-cancertherapy expected to result in tumor lysis and subsequent elevation of plasmauric acid (1).Limitation of use: Elitek is indicated only for a single course of treatment (1).

FDA Label: Feridex I.V.

Disease/s that Drug Treats:liver cancer

Indications and Usage: ¹⁸

FDA Label: Folotyn

Disease/s that Drug Treats:peripheral T-cell lymphoma

Indications and Usage: ¹⁸ FOLOTYN is a folate analog metabolic inhibitor indicated for the treatment ofpatients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Thisindication is based on overall response rate. Clinical benefit such asimprovement in progression-free survival or overall survival has not beendemonstrated. (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: GastroMARK

Disease/s that Drug Treats:gastrointestinal forms of cancer

Indications and Usage: ¹⁸

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: Imbruvica

Disease/s that Drug Treats:mantle cell lymphoma/chronic lymphocytic leukemia

Indications and Usage: ¹⁸ IMBRUVICA is a kinase inhibitor indicated for the treatment of patients with: Mantle cell lymphoma (MCL) who have received at least one priortherapy (1.1).Accelerated approval was granted for this indication based on overallresponse rate. Continued approval for this indication may be contingentupon verification of clinical benefit in confirmatory trials. Chronic lymphocytic leukemia (CLL) who have received at least oneprior therapy (1.2). Chronic lymphocytic leukemia with 17p deletion (1.3). Waldenström’s macroglobulinemia (WM) (1.4).

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: Iressa

Disease/s that Drug Treats:Non-Small-Cell Lung Cancer

Indications and Usage: ¹⁸ IRESSA is indicated as monotherapy for the continued treatment of patients with locally advanced ormetastatic non-small cell lung cancer after failure of both platinum-based and docetaxelchemotherapies who are benefiting or have benefited from IRESSA.In light of positive survival data with other agents including another oral EGFR inhibitor, physiciansshould use other treatment options in advanced non-small cell lung cancer patient populations whohave received one or two prior chemotherapy regimens and are refractory or intolerant to their mostrecent regimen. The effectiveness of IRESSA was initially based on objective response rates (see CLINICALPHARMACOLOGY-Clinical Studies section). Subsequent studies intended to demonstrate anincrease in survival have been unsuccessful. Specifically, results from a large placebo-controlledrandomized trial in patients with advanced NSCLC who progressed while receiving or within 90 daysof the last dose of chemotherapy or were intolerant to the most recent prior chemotherapy regimen, didnot show an improvement in survival (see CLINICAL PHARMACOLOGY- Clinical Studiessection).Results from two large, controlled, randomized trials in first-line treatment of non-small cell lungcancer showed no benefit from adding IRESSA to doublet, platinum-based chemotherapy. , IRESSA is indicated as monotherapy for the continued treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies who are benefiting or have benefited from IRESSA. In light of positive survival data with other agents including another oral EGFR inhibitor, physicians should use other treatment options in advanced non-small cell lung cancer patient populations who have received one or two prior chemotherapy regimens and are refractory or intolerant to their most recent regimen. The effectiveness of IRESSA was initially based on objective response rates (see CLINICAL PHARMACOLOGY-Clinical Studies section). Subsequent studies intended to demonstrate an increase in survival have been unsuccessful. Specifically, results from a large placebo-controlled randomized trial in patients with advanced NSCLC who progressed while receiving or within 90 days of the last dose of chemotherapy or were intolerant to the most recent prior chemotherapy regimen, did not show an improvement in survival (see CLINICAL PHARMACOLOGY- Clinical Studies section). Results from two large, controlled, randomized trials in first-line treatment of non-small cell lung cancer showed no benefit from adding IRESSA to doublet, platinum-based chemotherapy.

FDA Label: Istodax

Disease/s that Drug Treats:cutaneous T-cell lymphoma

Indications and Usage: ¹⁸ ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for: Treatment of cutaneous T-cell lymphoma (CTCL) in patients who havereceived at least one prior systemic therapy (1). Treatment of peripheral T-cell lymphoma (PTCL) in patients who havereceived at least one prior therapy (1).These indications are based on response rate. Clinical benefit such asimprovement in overall survival has not been demonstrated (1).

FDA Label: Ixempra

Disease/s that Drug Treats:Breast cancer

Indications and Usage: ¹⁸ IXEMPRA, a microtubule inhibitor, in combination with capecitabine isindicated for the treatment of metastatic or locally advanced breastcancer in patients after failure of an anthracycline and a taxane (1). IXEMPRA as monotherapy is indicated for the treatment of metastaticor locally advanced breast cancer in patients after failure of ananthracycline, a taxane, and capecitabine (1).

FDA Label: Kadian

Disease/s that Drug Treats:chronic pain

Indications and Usage: ¹⁸ KADIAN is an opioid agonist indicated for the management of pain severeenough to require daily, around-the-clock, long-term opioid treatment and forwhich alternative treatment options are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even atrecommended doses, and because of the greater risks of overdose anddeath with extended-release opioid formulations, reserve KADIAN foruse in patients for whom alternative treatment options (e.g., non-opioidanalgesics or immediate-release opioids) are ineffective, not tolerated, orwould be otherwise inadequate to provide sufficient management of pain. KADIAN is not indicated as an as-needed (prn) analgesic.

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: Mozobil

Disease/s that Drug Treats:non-Hodgkin’s lymphoma and multiple myeloma

Indications and Usage: ¹⁸ Mozobil, a hematopoietic stem cell mobilizer, is indicated in combinationwith granulocyte-colony stimulating factor (G-CSF) to mobilizehematopoietic stem cells (HSCs) to the peripheral blood for collection andsubsequent autologous transplantation in patients with non-Hodgkin’slymphoma and multiple myeloma. (1)

FDA Label: Neumega

Disease/s that Drug Treats:platelet deficiency

Indications and Usage: ¹⁸ Neumega is indicated for the prevention of severe thrombocytopenia and the reduction of theneed for platelet transfusions following myelosuppressive chemotherapy in adult patients withnonmyeloid malignancies who are at high risk of severe thrombocytopenia. Efficacy wasdemonstrated in patients who had experienced severe thrombocytopenia following the previouschemotherapy cycle. Neumega is not indicated following myeloablative chemotherapy (seeWARNINGS, Increased Toxicity Following Myeloablative Therapy). The safety andeffectiveness of Neumega have not been established in pediatric patients.

FDA Label: Nexavar

Disease/s that Drug Treats:Renal Cell Carcinoma

Indications and Usage: ¹⁸ NEXAVAR is a kinase inhibitor indicated for the treatment of Unresecta ble hepatocellular carcinoma (1.1) adjust thyroid repla cement therapy in patients with thyroid ca ncer. (5.12) Advanced renal cell carcinoma (1.2) Locally recurrent or meta static, progressive, differentiated thyroid carcinoma refractory to ra dioactive iodine treatment (1.3)

FDA Label: Onsolis

Disease/s that Drug Treats:breakthrough cancer pain

Indications and Usage: ¹⁸ Onsolis is an opioid agonist indicated for the management of breakthrough painin cancer patients 18 years of age and older who are already receiving and whoare tolerant to opioid therapy for their underlying persistent cancer pain. (1)Limitations of Use:Onsolis may be dispensed only to patients enrolled in the TIRF REMS Accessprogram.

FDA Label: Photofrin

Disease/s that Drug Treats:Non-small cell lung cancer

Indications and Usage: ¹⁸ PHOTOFRIN is a photodynamic therapy drug indicated for:Esophageal Cancer (1.1) Palliation of patients with completely obstructing esophageal cancer, or ofpatients with partially obstructing esophageal cancer who, in the opinion oftheir physician, cannot be satisfactorily treated with Nd:YAG laser therapyEndobronchial Cancer (1.2) Treatment of microinvasive endobronchial non-small-cell lung cancer(NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients withcompletely or partially obstructing endobronchial NSCLCHigh-Grade Dysplasia in Barrett’s Esophagus (1.3) Ablation of high-grade dysplasia (HGD) in Barrett’s esophagus (BE)patients who do not undergo esophagectomy

FDA Label: Sancuso

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

Indications and Usage: ¹⁸ Sancuso is a serotonin subtype 3 (5-HT3) receptor antagonist indicated for theprevention of nausea and vomiting in patients receiving moderately and/orhighly emetogenic chemotherapy for up to 5 consecutive days. (1)

FDA Label: Sprycel

Disease/s that Drug Treats:Chronic Myeloid Leukemia

Indications and Usage: ¹⁸ SPRYCEL is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+)chronic myeloid leukemia (CML) in chronic phase. (1, 14) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+CML with resistance or intolerance to prior therapy including imatinib. (1,14) adults with Philadelphia chromosome-positive acute lymphoblasticleukemia (Ph+ ALL) with resistance or intolerance to prior therapy. (1, 14)

FDA Label: Subsys

Disease/s that Drug Treats:breakthrough cancer pain

Indications and Usage: ¹⁸ SUBSYS is an opioid agonist indicated for the management of breakthroughpain in cancer patients 18 years of age and older who are already receivingand who are tolerant to opioid therapy for their underlying persistent cancerpain. Patients must remain on around-the-clock opioids when takingSUBSYS. (1)Limitations of Use:SUBSYS may be dispensed only to patients enrolled in the TIRF REMSACCESS program.

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: Tasigna

Disease/s that Drug Treats:chronic myelogenous leukemia

Indications and Usage: ¹⁸ Tasigna is a kinase inhibitor indicated for:The treatment of newly diagnosed adult patients with Philadelphiachromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.The treatment of chronic phase (CP) and accelerated phase (AP) Ph+ CML inadult patients resistant to or intolerant to prior therapy that included imatinib.(1.2)--------------

FDA Label: Torisel

Disease/s that Drug Treats:renal cell carcinoma

Indications and Usage: ¹⁸ TORISEL® is a kinase inhibitor indicated for the treatment of advanced renalcell carcinoma. (1)

FDA Label: Trelstar Depot/ Trelstar LA

Disease/s that Drug Treats:advanced prostate cancer/ Prostate cancer

Indications and Usage: ¹⁸ TRELSTAR is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatmentof advanced prostate cancer. (1)

FDA Label: Trisenox

Disease/s that Drug Treats:Acute Promyelocytic Leukemia

Indications and Usage: ¹⁸ TRISENOX is an arsenical indicated for induction of remission andconsolidation in patients with acute promyelocytic leukemia (APL) who arerefractory to, or have relapsed from, retinoid and anthracycline chemotherapy,and whose APL is characterized by the presence of the t(15;17) translocationor PML/RAR-alpha gene expression.

FDA Label: Tykerb

Disease/s that Drug Treats:breast cancer

Indications and Usage: ¹⁸ TYKERB, a kinase inhibitor, is indicated in combination with: (1) capecitabine, for the treatment of patients with advanced or metastatic breastcancer whose tumors overexpress HER2 and who have received prior therapyincluding an anthracycline, a taxane, and trastuzumab.Limitation of Use: Patients should have disease progression on trastuzumabprior to initiation of treatment with TYKERB in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptorpositivemetastatic breast cancer that overexpresses the HER2 receptor forwhom hormonal therapy is indicated.TYKERB in combination with an aromatase inhibitor has not been comparedto a trastuzumab-containing chemotherapy regimen for the treatment ofmetastatic breast cancer.

FDA Label: Unituxin

Disease/s that Drug Treats:pediatrics with high-risk neuroblastoma

Indications and Usage: ¹⁸ Unituxin is a GD2-binding monoclonal antibody indicated, incombination with granulocyte-macrophage colony-stimulating factor(GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for thetreatment of pediatric patients with high-risk neuroblastoma whoachieve at least a partial response to prior first-line multiagent,multimodality therapy. (1)

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: Valchlor

Disease/s that Drug Treats:Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma

Indications and Usage: ¹⁸ VALCHLOR is an alkylating drug indicated for the topical treatmentof Stage IA and IB mycosis fungoides‐type cutaneous T‐celllymphoma in patients who have received prior skin‐directed therapy(1).  

FDA Label: Vectibix

Disease/s that Drug Treats:colorectal cancer

Indications and Usage: ¹⁸ Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicatedfor the treatment of wild-type KRAS (exon 2) metastatic colorectal cancer(mCRC) as determined by an FDA-approved test for this use: In combination with FOLFOX for first-line treatment. (1.1, 14.2) As monotherapy following disease progression after prior treatment withfluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.(1.1, 14.1) Limitation of Use: Vectibix is not indicated for the treatment of patientswith RAS-mutant mCRC or for whom RAS mutation status is unknown.(1.1, 2.1, 5.2, 12.1)

FDA Label: Xofigo

Disease/s that Drug Treats:prostate cancer with bone metastases

Indications and Usage: ¹⁸ Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated forthe treatment of patients with castration-resistant prostate cancer, symptomaticbone metastases and no known visceral metastatic disease. (1)

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: 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: Anoro Ellipta

Disease/s that Drug Treats:chronic obstructive pulmonary disease

Indications and Usage: ¹⁸ ANORO ELLIPTA is a combination of umeclidinium, an anticholinergic, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). (1) Important limitations: Not indicated for the relief of acute bronchospasm or for the treatment of asthma. (1, 5.2)

FDA Label: Arnuity Ellipta

Disease/s that Drug Treats:asthma

Indications and Usage: ¹⁸

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)