Balsalazide disodium (prodrug of mesalamine) 1.1g; tabs; contains sodium 126mg/tab.
Treatment of mildly-to-moderately active ulcerative colitis in
male patients.
Limitations of use: effectiveness in treatment of female patients was not demonstrated. Safety and effectiveness of therapy beyond 8 weeks have not been established.
To reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in primary (heterozygous familial and non-familial) or mixed hyperlipidemia. To reduce elevated total-C and LDL-C in homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable.
Limitations of use: No incremental benefit on cardiovascular morbidity/mortality over and above that demonstrated for atorvastatin has been established. Not studied in Fredrickson type I, III, IV, and V dyslipidemias.
Multiple myeloma, in patients who have received at least two prior therapies (including lenalidomide and bortezomib), and have shown disease progression on or within 60 days of completion of the last therapy. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Mipomersen sodium 200mg/mL; soln for SC inj; preservative-free.
Adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
Ado-trastuzumab emtansine 100mg, 160mg; per vial; powder; for IV infusion after reconstitution.
Treatment in patients with HER2-positive (+), metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease or developed disease recurrence during or within
6 months of completing adjuvant therapy.
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). Limitation of use: not for treatment of type 1 diabetes or diabetic ketoacidosis.
Varicella zoster immune globulin (human) 125 IU; per vial; lyophilized pwd for IM inj after reconstitution; contains <250mg of total protein (mostly human IgG), <40mcg/mL of IgA; preservative- and mercury-free.
Postexposure prophylaxis of varicella in high risk individuals (include immunocompromised children and adults, newborns of mothers with varicella shortly before or after delivery, premature infants, neonates and infants <1 year old, adults without evidence of immunity, pregnant women). To reduce severity of varicella.
Vincristine sulfate liposome injection; after preparation, each vial contains 0.16mg/mL; for IV infusion.
Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or has progressed following ≥2 anti-leukemia therapies.
Chronic, accelerated, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.
Omacetaxine mepesuccinate 3.5mg/vial; lyophilized powder for SC injection after reconstitution; contains mannitol; preservative-free.
Treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI).
Adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia.
Limitations of use:
The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
The effect of Vascepa on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
As an adjunct to low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce LDL-C, total cholesterol, apo B, and non-HDL-C in patients with homozygous familial hypercholesterolemia (HoFH). Not for patients with hypercholesterolemia who do not have HoFH. Effect on cardiovascular morbidity, mortality has not been determined.
Treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX); may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs). Do not use in combination with biologic DMARDs or potent immunosuppressants (eg, azathioprine, cyclosporine).
Treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
Treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.
As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30kg/m2 or ≥27kg/m2 in the presence of at least one weight related co-morbidity (eg, HTN, T2DM or dyslipidemia).
Ziv-aflibercept 25mg/mL; soln for IV infusion after dilution; preservative-free.
In combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.
Carfilzomib 60mg/vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Carfilzomib 60mg/vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Pertuzumab 420mg/14mL (30mg/mL); soln for IV infusion; preservative-free.
In combination with trastuzumab and docetaxel: to treat patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
A short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30kg/m2, or ≥27kg/m2 in the presence of other risk factors (eg, hypertension, diabetes, hyperlipidemia).
To control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and have failed surgery or are not candidates for surgery.
Glucarpidase; 1,000 Units/vial; lyophilized powder for IV injection after reconstitution; preservative-free.
Treatment of toxic plasma methotrexate (MTX) concentrations (>1 micromole per liter) in patients with delayed MTX clearance due to impaired renal function.
As needed use for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Not indicated for treatment of middle-of-the-night insomnia when the patient has <4 hours of bedtime remaining before the planned time of waking.
Treatment of adults with metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.
Exenatide extended-release 2mg; pwd for SC inj after reconstitution.
As adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes. Not for first-line therapy in patients inadequately controlled on diet and exercise.
Hypertension (HTN) in patients not adequately controlled with monotherapy. As initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
Relief of signs/symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers (eg, gastric and/or duodenal ulcer), in patients who are taking ibuprofen for those indications.
Treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis.
Amiodarone HCl 1.5mg/mL, 1.8mg/mL; premixed in dextrose; soln for IV infusion.
Initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy or when oral form is not feasible.
Asparaginase Erwinia chrysanthemi 10,000 IU; per vial; lyophilized pwd for IM inj after reconstitution.
As a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.
Brentuximab vedotin 50mg/vial; powder for IV infusion after reconstitution; preservative-free.
Treatment of Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. Treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
In patients for whom treatment with both sitagliptin and simvastatin is appropriate. Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Simvastatin is indicated as an adjunctive therapy to diet to: reduce risk of total mortality by reducing CHD deaths and reduce risk of non-fatal MI, stroke, and the need for revascularization procedures in patients at high risk of coronary events; reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia; reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia.
Breakthrough pain, in opioid-tolerant patients already receiving and who are tolerant to continuous opioid therapy for underlying persistent cancer pain. Opioid-tolerant patients are those taking oral morphine ≥60mg/day, transdermal fentanyl ≥25mcg/hr, oral oxycodone ≥30mg/day, oral hydromorphone ≥8mg/day, oral oxymorphone ≥25mg/day, or equianalgesic dose of another opioid for ≥1 week.
Treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
To reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS) (unstable angina or non-ST-elevation myocardial infarction [MI] or ST-elevation MI).
To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery.
Chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have previously been treated with interferon-based therapy, including prior null responders, and relapsers. Not for use as monotherapy.
Peginterferon alfa-2b 296mcg, 444mcg, 888mcg; per vial; pwd for SC inj after reconstitution.
Adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.
