ORIGINAL MANUFACTURER:
Gilead
GENERIC NAME:
GENERIC MANUFACTURER:
Everest, Mylan, Natco
Sofosbuvir/velpatasvir, sold under the brand name Epclusa among others, is a fixed dose combination medication for the treatment of hepatitis C. It combines sofosbuvir and velpatasvir. It is more than 90% effective for hepatitis C genotypes one through six. It also works for hepatitis C in those who also have cirrhosis or HIV/AIDS. It is taken by mouth. Sofosbuvir/velpatavir was approved for medical use in the United States in 2016. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. As of 2017, in the United States a course of treatment costs about 74,800 USD while in the developing world it costs about 900 USD.
VELPANEX is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin.
Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc.
Recommended dosage: One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily with or without food.
The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with VELPANEX for 12 weeks are headache and fatigue.
The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with VELPANEX and ribavirin for 12 weeks in patients with decompensated cirrhosis are fatigue, anemia, nausea, headache, insomnia, and diarrhea.
ORIGINAL MANUFACTURER:
Bayer
GENERIC NAME:
GENERIC MANUFACTURER:
Everest, Natco
Sorafenib (co-developed and co-marketed by Bayer and Onyx Pharmaceuticals as Nexavar), is a kinase inhibitor drug approved for the treatment of primary kidney cancer (advanced renal cell carcinoma), advanced primary liver cancer (hepatocellular carcinoma), and radioactive iodine resistant advanced thyroid carcinoma.
Sorafenib is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). Sorafenib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). Sorafenib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.
400 mg (2 tablets) orally twice daily without food. Treatment interruption and/or dose reduction may be needed to manage adverse reactions.
The most common adverse reactions (≥20%) for NEXAVAR are diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, hypertension, and hemorrhage.
ORIGINAL MANUFACTURER:
TESARO
GENERIC NAME:
GENERIC MANUFACTURER:
Everest
Niraparib was granted fast track designationby the US Food and Drug Administration(FDA), and Tesaro submitted a new drug application in 2016.It was approved on 27 March 2017 in the US, and has been approved in Europe on 16 November 2017.
Nirapanib is a poly (ADP-ribose) polymerase(PARP) inhibitor indicated for the maintenancetreatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Recommended dose is 300 mg taken once daily with or without food. Continue treatment until disease progression or unacceptable adverse reaction. For adverse reactions, consider interruption of treatment,dose reduction, or dose discontinuation.
Most common adverse reactions (incidence ≥10%) are thrombocytopenia, anemia, neutropenia, leukopenia, palpitations, nausea, constipation, vomiting, abdominal pain/distention, mucositis/stomatitis, diarrhea, dyspepsia, dry mouth, fatigue/asthenia, decreased appetite,urinary tract infection, AST/ALT elevation, myalgia, back pain, arthralgia, headache,dizziness, dysgeusia,insomnia, anxiety, nasopharyngitis, dyspnea, cough, rash, and hypertension.
ORIGINAL MANUFACTURER:
Novartis
GENERIC NAME:
GENERIC MANUFACTURER:
Everest
Eltrombopag is a medication that has been developed for certain conditions that lead to thrombocytopenia (abnormally low plateletcounts). It is a small molecule agonist of the c-mpl (TpoR) receptor, which is the physiological target of the hormonethrombopoietin. Eltrombopag was discovered as a result of research collaboration between GlaxoSmithKline and Ligand Pharmaceuticals. Designated an orphan drug in the United States and European Union, it is being manufactured and marketed by Novartis under the trade name Promacta in the USA and is marketed as Revolade in the EU. Novartis acquired the drug as a part of its asset swap deal with GlaxoSmithKline.
Elopag is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Elopag should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Elopag should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferonbased therapy or limits the ability to maintain interferon-based therapy. in combination with standard immunosuppressive therapy for the firstline treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. Limitations of Use: Elopag is not indicated for the treatment of patients with myelodysplastic syndrome (MDS). Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.
Take on an empty stomach (1 hour before or 2 hours after a meal). Chronic ITP: Initiate Elopag at 50 mg once daily for most adult and pediatric patients 6 years and older, and at 25 mg once daily for pediatric patients aged 1 to 5 years. Dose reductions are needed for patients with hepatic impairment and some patients of Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 109/L. Do not exceed 75 mg per day. Chronic Hepatitis C-associated Thrombocytopenia: Initiate Elopag at 25 mg once daily for all patients. Adjust to achieve target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 100 mg. First-line Severe Aplastic Anemia: Initiate Elopag once daily at 2.5 mg/kg (in pediatric patients aged 2 to 5 years old), 75 mg (pediatric patients aged 6 to 11 years old), or 150 mg for patients aged 12 years and older concurrently with standard immunosuppressive therapy. Reduce initial dose in patients of Asian ancestry. Modify dosage for toxicity or elevated platelet counts. Refractory Severe Aplastic Anemia: Initiate Elopag at 50 mg once daily. Reduce initial dose in patients with hepatic impairment or patients of Asian ancestry. Adjust to maintain platelet count greater than 50 x 109/L. Do not exceed 150 mg per day.
Across all indications, the most common adverse reactions (≥ 20% in any indication) were: anemia, nausea, pyrexia, ALT increased, cough, fatigue, headache, and diarrhea.
ORIGINAL MANUFACTURER:
AatraZeneca
GENERIC NAME:
GENERIC MANUFACTURER:
BEACON, Everest
Osimertinib is a medication used to treat non-small-cell lung carcinomas with a specific mutation. It is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor. Developed by AstraZeneca, the medication was approved as a cancer treatment in 2017 by both the Food and Drug Administration and the European Commission.
First-line Treatment Of EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) OSIMERTNIB is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC OSIMERTNIB is indicated for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
The recommended dosage of OSIMERTNIB is 80 mg tablet once a day until disease progression or unacceptable toxicity. OSIMERTNIB can be taken with or without food. If a dose of OSIMERTNIB is missed, do not make up the missed dose and take the next dose as scheduled.
The following adverse reactions are discussed in greater detail in other sections of the labeling: Interstitial Lung Disease/Pneumonitis ,QTc Interval Prolongation, Cardiomyopathy ,Keratitis.
ORIGINAL MANUFACTURER:
Janssen Pharmaceutical Inc
GENERIC NAME:
GENERIC MANUFACTURER:
BEACON, Everest
Ibrutinib is a small molecule drug that binds permanently to a protein, Bruton's tyrosine kinase (BTK), that is important in B cells; the drug is used to treat B cell cancers like mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström's macroglobulinemia.
Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) . Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion. Waldenström’s macroglobulinemia (WM). Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy . Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.
MCL and MZL: 560 mg taken orally once daily. CLL/SLL, WM, and cGVHD: 420 mg taken orally once daily.Dose should be taken orally with a glass of water. Do not open, break, or chew the capsules. Do not cut, crush, or chew the tablets.
The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia, thrombocytopenia, diarrhea, anemia, musculoskeletal pain, rash, nausea, bruising, fatigue, hemorrhage, and pyrexia. The most common adverse reactions (≥20%) in patients with cGVHD were fatigue, bruising, diarrhea, thrombocytopenia, muscle spasms, stomatitis, nausea, hemorrhage, anemia, and pneumonia.
ORIGINAL MANUFACTURER:
AatraZeneca
GENERIC NAME:
GENERIC MANUFACTURER:
Everest
Olaparib (AZD-2281, trade name Lynparza) is an FDA-approved targeted therapy for cancer. It is a PARP inhibitor, inhibiting poly ADP ribose polymerase (PARP), an enzyme involved in DNA repair. It acts against cancers in people with hereditary BRCA1 or BRCA2 mutations, which include some ovarian, breast, and prostate cancers.
Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of: Ovarian cancer, in which the medication is intended for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy, or [b] for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy . Select patients for therapy based on an FDA-approved companion diagnostic for olaparib . Breast cancer, in which the medication is intended for use in patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Select patients for therapy based on an FDA-approved companion diagnostic for olaparib.
Recommended tablet dose is 400 mg (8 capsules) taken orally twice daily with or without food. For adverse reactions, consider dose interruption or dose reduction. For moderate renal impairment (CLcr 31-50 mL/min), reduce dose to 300 mg twice daily.
Most common adverse reactions (≥10%) in clinical trials were nausea, fatigue (including asthenia), anemia, vomiting, abdominal pain, dizziness, diarrhea, neutropenia, leukopenia, nasopharyngitis/upper respiratory tract infection/influenza, respiratory tract infection, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation and stomatitis. Most common laboratory abnormalities (≥25%) were decrease in hemoglobin, increase in mean corpuscular volume, decrease in lymphocytes, decrease in leukocytes, decrease in absolute neutrophil count, increase in serum creatinine and decrease in platelets.
ORIGINAL MANUFACTURER:
Roche
GENERIC NAME:
GENERIC MANUFACTURER:
Everest
Alectinib (marketed as Alecensa) is an oral drug that blocks the activity of anaplastic lymphoma kinase (ALK) and is used to treat non-small-cell lung cancer(NSCLC). It was developed by Chugai Pharmaceutical Co. Japan, which is part of the Hoffmann-La Roche group.
Alectinib is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
600 mg orally twice daily. Administer Alectinib with food.
The most common adverse reactions (incidence ≥20%) were fatigue, constipation, edema, myalgia, and anemia.
ORIGINAL MANUFACTURER:
Gilead
GENERIC NAME:
GENERIC MANUFACTURER:
Mylan, Everest
The FDA has approved Vemlidy (tenofovir alafenamide) from Gilead for the treatment of chronic hepatitis B infection with compensated liver disease. Specifically, the drug has been approved in a once-daily 25-mg dose for adult patients. Vemlidy is a targeted prodrug of tenofovir that has shown antiviral efficacy similar to that of Viread at less than one-tenth of Viread’s dose. Because Vemlidy has greater plasma stability and delivers tenofovir to hepatocytes more efficiently, it can be administered at a lower dose than Viread.
NEXATAFis indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.
Testing Prior To Initiation Of NEXATAF Prior to initiation of NEXATAF, patients should be tested for HIV-1 infection. NEXATAF alone should not be used in patients with HIV-1 infection. Prior to or when initiating VEMLIDY, and during treatment with NEXATAF on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.
The most common side effect of VEMLIDY is headache. New or worse kidney problems, including kidney failure. Too much lactic acid in your blood (lactic acidosis), Severe liver problems.
