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Quarterly Review
Tropical Gastroenterology 2008.29;4:187–193 Quarterly Have hematopoietic growth factors made an Review impact on the management of liver disease? Pankaj Tyagi and Kaushal Madan ABSTRACT Department of Gastroenterology, It is clear that the major indication for the use of hematopoietic growth factors in hepatology GB Pant Hospital & Department of is to counteract the adverse effects of interferons (neutropenia and thrombocytopenia) and Medical Hepatology, ribavirin (hemolytic anaemia) during the treatment of hepatitis C infection. This is important Institute of Liver and Biliary Sciences, because the probability of SVR depends on proper adherence to therapy (at least 80% of the New Delhi requisite dose maintained for at least 80% of the requisite duration) and proper adherence can only be achieved if the side effects are reduced to a minimum. Even though the studies Correspondence: Dr. Kaushal Madan have demonstrated beyond doubt that the use of hematopoietic growth factors does indeed Email: [email protected] reduce the incidence and severity of these adverse effects and helps the patients to complete the course of therapy, the data on improvement of SVR is still limited. There is only one study of darbepoetin and filgrastim showing the beneficial effect on SVR. Even among the hematological side effects, possibly the only significant effect which limits the use of optimal HCV therapy is the hemolytic anaemia induced by ribavirin. The other two main side effects, i.e. neutropenia and thrombocytopenia are not clinically problematic. The use of such growth factors would be particularly effective if patients who have advanced liver disease or cirrhosis are able to receive adequate anti-viral therapy as has been demonstrated in the study of eltrombopag among HCV cirrhotics. -
Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients
antibodies Review Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients Andrew T. Lucas 1,2,3,*, Ryan Robinson 3, Allison N. Schorzman 2, Joseph A. Piscitelli 1, Juan F. Razo 1 and William C. Zamboni 1,2,3 1 University of North Carolina (UNC), Eshelman School of Pharmacy, Chapel Hill, NC 27599, USA; [email protected] (J.A.P.); [email protected] (J.F.R.); [email protected] (W.C.Z.) 2 Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] 3 Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-919-966-5242; Fax: +1-919-966-5863 Received: 30 November 2018; Accepted: 22 December 2018; Published: 1 January 2019 Abstract: The rapid advancement in the development of therapeutic proteins, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), has created a novel mechanism to selectively deliver highly potent cytotoxic agents in the treatment of cancer. These agents provide numerous benefits compared to traditional small molecule drugs, though their clinical use still requires optimization. The pharmacology of mAbs/ADCs is complex and because ADCs are comprised of multiple components, individual agent characteristics and patient variables can affect their disposition. To further improve the clinical use and rational development of these agents, it is imperative to comprehend the complex mechanisms employed by antibody-based agents in traversing numerous biological barriers and how agent/patient factors affect tumor delivery, toxicities, efficacy, and ultimately, biodistribution. -
Managing Adverse Effects and Complications in Completing Treatment for Hepatitis C Virus Infection
HCV Treatment Complications Volume 20 Issue 4 October/November 2012 Perspective Managing Adverse Effects and Complications in Completing Treatment for Hepatitis C Virus Infection The addition of direct-acting antivirals (DAAs) to hepatitis C virus (HCV) Psychiatric Complications treatment regimens has made treatment more effective and patient Depression is the most common psy- management more complex. Shepherding patients through a full course of chiatric complication encountered in HCV therapy requires motivation and involvement on the part of the patient HCV patients, with mild to moderate and the physician. Indeed, physician inexperience and lack of confidence in depression found in as much as 80% of guiding patients through the challenges of treatment appears to be a primary patients. Bipolar disorder and schizo- reason for early discontinuation of therapy. Among the many complications phrenia are also not infrequently en- of HCV treatment that must be managed efficiently and effectively are countered. depression and other psychiatric disorders; hematologic abnormalities There is little evidence to support including DAA- and ribavirin-associated anemia and peginterferon alfa- a benefit of preemptive antidepres- associated neutropenia and thrombocytopenia; rash and drug eruptions, sant therapy in all patients undergo- including telaprevir-associated rash; and weight loss. Practical considerations ing HCV treatment, though a recent in management of these common complications are offered. This article randomized trial of HCV patients -
Revised 6/29/2020 GEORGIA MEDICAID FEE-FOR-SERVICE
GEORGIA MEDICAID FEE-FOR-SERVICE BIOLOGIC IMMUNOMODULATORS PA SUMMARY Preferred Non-Preferred Arcalyst (rilonacept) Actemra subcutaneous (tocilizumab) Benlysta subcutaneous (belimumab) Cimzia (certolizumab) Enbrel (etanercept) Cosentyx (secukinumab) Humira (adalimumab) Dupixent (dupilumab) Ilaris (canakinumab) Fasenra Pen (benralizumab autoinjector)Kevzara Xeljanz (tofacitinib) (sarilumab) Xeljanz XR (tofacitinib extended-release) Kineret (anakinra) Nucala Pen (mepolizumab autoinjector) Olumiant (baricitinib) Orencia subcutaneous (abatacept) Otezla (apremilast) Rinvoq (upadacitinib) Siliq (brodalumab) Simponi (golimumab) Stelara (ustekinumab) Skyrizi (risankizumab) Taltz (ixekizumab) Tremfya (guselkumab) The drug names above include all available oral or subcutaneous formulations under the same primary name. LENGTH OF AUTHORIZATION: Varies NOTES: ▪ All preferred and non-preferred products require prior authorization. Intravenous (IV) formulations of the biologic immunomodulators are not covered under Pharmacy Services. ▪ The criteria details below are for the outpatient pharmacy program. If a medication is being administered in a physician’s office or clinic, then the medication must be billed through the DCH physician services program and not the outpatient pharmacy program. Information regarding the physician services program is located at www.mmis.georgia.gov. PA CRITERIA: Actemra Subcutaneous ❖ Approvable for members 2 years of age or older with a diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis -
Revlimid U.S. Full Prescribing Information
HIGHLIGHTS OF PRESCRIBING INFORMATION • FL or MZL: 20 mg once daily orally on Days 1-21 of repeated 28-day cycles for up to These highlights do not include all the information needed to use REVLIMID® safely 12 cycles (2.4). and effectively. See full prescribing information for REVLIMID. • Renal impairment: Adjust starting dose based on the creatinine clearance value (2.6). • For concomitant therapy doses, see Full Prescribing Information (2.1, 2.4, 14.1, 14.4). REVLIMID (lenalidomide) capsules, for oral use Initial U.S. Approval: 2005 ------------------------- DOSAGE FORMS AND STRENGTHS ------------------------- Capsules: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg (3). WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, -------------------------------- CONTRAINDICATIONS -------------------------------- and VENOUS and ARTERIAL THROMBOEMBOLISM • Pregnancy (Boxed Warning, 4.1, 5.1, 8.1). See full prescribing information for complete boxed warning. • Demonstrated severe hypersensitivity to lenalidomide (4.2, 5.9, 5.15). EMBRYO-FETAL TOXICITY --------------------------- WARNINGS AND PRECAUTIONS --------------------------- • Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide • Increased Mortality: serious and fatal cardiac adverse reactions occurred in patients in humans. If lenalidomide is used during pregnancy, it may cause birth with CLL treated with REVLIMID (lenalidomide) (5.5). defects or embryo-fetal death. • Second Primary Malignancies (SPM): Higher incidences of SPM were observed in • Pregnancy must be excluded before start of treatment. Prevent pregnancy controlled trials of patients with MM receiving REVLIMID (5.6). during treatment by the use of two reliable methods of contraception (5.1). • Increased Mortality: Observed in patients with MM when pembrolizumab was added REVLIMID is available only through a restricted distribution program, called the to dexamethasone and a thalidomide analogue (5.7). -
Fasenra, INN-Benralizumab
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Fasenra 30 mg solution for injection in pre-filled syringe Fasenra 30 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe Each pre-filled syringe contains 30 mg benralizumab* in 1 mL. Pre-filled pen Each pre-filled pen contains 30 mg benralizumab* in 1 mL. *Benralizumab is a humanised monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe (injection) Solution for injection in pre-filled pen (injection) (Fasenra Pen) Clear to opalescent, colourless to yellow solution and may contain translucent or white to off-white particles. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists (see section 5.1). 4.2 Posology and method of administration Fasenra treatment should be initiated by a physician experienced in the diagnosis and treatment of severe asthma. After proper training in the subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4), patients with no known history of anaphylaxis or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary. -
FLT3 Inhibitors in Acute Myeloid Leukemia Mei Wu1, Chuntuan Li2 and Xiongpeng Zhu2*
Wu et al. Journal of Hematology & Oncology (2018) 11:133 https://doi.org/10.1186/s13045-018-0675-4 REVIEW Open Access FLT3 inhibitors in acute myeloid leukemia Mei Wu1, Chuntuan Li2 and Xiongpeng Zhu2* Abstract FLT3 mutations are one of the most common findings in acute myeloid leukemia (AML). FLT3 inhibitors have been in active clinical development. Midostaurin as the first-in-class FLT3 inhibitor has been approved for treatment of patients with FLT3-mutated AML. In this review, we summarized the preclinical and clinical studies on new FLT3 inhibitors, including sorafenib, lestaurtinib, sunitinib, tandutinib, quizartinib, midostaurin, gilteritinib, crenolanib, cabozantinib, Sel24-B489, G-749, AMG 925, TTT-3002, and FF-10101. New generation FLT3 inhibitors and combination therapies may overcome resistance to first-generation agents. Keywords: FMS-like tyrosine kinase 3 inhibitors, Acute myeloid leukemia, Midostaurin, FLT3 Introduction RAS, MEK, and PI3K/AKT pathways [10], and ultim- Acute myeloid leukemia (AML) remains a highly resist- ately causes suppression of apoptosis and differentiation ant disease to conventional chemotherapy, with a me- of leukemic cells, including dysregulation of leukemic dian survival of only 4 months for relapsed and/or cell proliferation [11]. refractory disease [1]. Molecular profiling by PCR and Multiple FLT3 inhibitors are in clinical trials for treat- next-generation sequencing has revealed a variety of re- ing patients with FLT3/ITD-mutated AML. In this re- current gene mutations [2–4]. New agents are rapidly view, we summarized the preclinical and clinical studies emerging as targeted therapy for high-risk AML [5, 6]. on new FLT3 inhibitors, including sorafenib, lestaurtinib, In 1996, FMS-like tyrosine kinase 3/internal tandem du- sunitinib, tandutinib, quizartinib, midostaurin, gilteriti- plication (FLT3/ITD) was first recognized as a frequently nib, crenolanib, cabozantinib, Sel24-B489, G-749, AMG mutated gene in AML [7]. -
Revlimid-INN Lenalidomide
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Revlimid 2.5 mg hard capsules Revlimid 5 mg hard capsules Revlimid 7.5 mg hard capsules Revlimid 10 mg hard capsules Revlimid 15 mg hard capsules Revlimid 20 mg hard capsules Revlimid 25 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Revlimid 2.5 mg hard capsules Each capsule contains 2.5 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 73.5 mg of lactose (as anhydrous lactose). Revlimid 5 mg hard capsules Each capsule contains 5 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 147 mg of lactose (as anhydrous lactose). Revlimid 7.5 mg hard capsules Each capsule contains 7.5 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 144.5 mg of lactose (as anhydrous lactose). Revlimid 10 mg hard capsules Each capsule contains 10 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 294 mg of lactose (as anhydrous lactose). Revlimid 15 mg hard capsules Each capsule contains 15 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 289 mg of lactose (as anhydrous lactose). Revlimid 20 mg hard capsules Each capsule contains 20 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 244.5 mg of lactose (as anhydrous lactose). -
Federal Register Notice 5-1-2020 Pdf Icon[PDF – 358
Federal Register / Vol. 85, No. 85 / Friday, May 1, 2020 / Notices 25439 confidential by the respondent (5 U.S.C. schedules. Other than examination DEPARTMENT OF HEALTH AND 552(b)(4)). reports, it provides the only financial HUMAN SERVICES Current actions: The Board has data available for these corporations. temporarily revised the instructions to The Federal Reserve is solely Centers for Disease Control and the FR Y–9C report to accurately reflect responsible for authorizing, supervising, Prevention the revised definition of ‘‘savings and assigning ratings to Edges. The [CDC–2020–0046; NIOSH–233–C] deposits’’ in accordance with the Federal Reserve uses the data collected amendments to Regulation D in the on the FR 2886b to identify present and Hazardous Drugs: Draft NIOSH List of interim final rule published on April 28, potential problems and monitor and Hazardous Drugs in Healthcare 2020 (85 FR 23445). Specifically, the develop a better understanding of Settings, 2020; Procedures; and Risk Board has temporarily revised the activities within the industry. Management Information instructions on the FR Y–9C, Schedule HC–E, items 1(b), 1(c), 2(c) and glossary Legal authorization and AGENCY: Centers for Disease Control and content to remove the transfer or confidentiality: Sections 25 and 25A of Prevention, HHS. withdrawal limit. As a result of the the Federal Reserve Act authorize the ACTION: Notice and request for comment. revision, if a depository institution Federal Reserve to collect the FR 2886b chooses to suspend enforcement of the (12 U.S.C. 602, 625). The obligation to SUMMARY: The National Institute for six transfer limit on a ‘‘savings deposit,’’ report this information is mandatory. -
Efficacy and Safety of Midostaurin-Based Induction and Maintenance Therapy for Newly Diagnosed AML
POST-ASH Issue 4, 2016 Efficacy and Safety of Midostaurin-Based Induction and Maintenance Therapy for Newly Diagnosed AML For more visit ResearchToPractice.com/5MJCASH2016 CME INFORMATION OVERVIEW OF ACTIVITY Each year, thousands of clinicians, basic scientists and other industry professionals sojourn to major international oncology conferences, like the American Society of Hematology (ASH) annual meeting, to hone their skills, network with colleagues and learn about recent advances altering state-of-the-art management in hematologic oncology. These events have become global stages where exciting science, cutting-edge concepts and practice-changing data emerge on a truly grand scale. This massive outpouring of information has enormous benefits for the hematologic oncology community, but the truth is it also creates a major challenge for practicing oncologists and hematologists. Although original data are consistently being presented and published, the flood of information unveiled during a major academic conference is unmatched and leaves in its wake an enormous volume of new knowledge that practicing oncologists must try to sift through, evaluate and consider applying. Unfortunately and quite commonly, time constraints and an inability to access these data sets leave many oncologists struggling to ensure that they’re aware of crucial practice-altering findings. This creates an almost insurmountable obstacle for clinicians in community practice because they are not only confronted almost overnight with thousands of new presentations and -
Overcoming the Immunosuppressive Tumor Microenvironment in Multiple Myeloma
cancers Review Overcoming the Immunosuppressive Tumor Microenvironment in Multiple Myeloma Fatih M. Uckun 1,2,3 1 Norris Comprehensive Cancer Center and Childrens Center for Cancer and Blood Diseases, University of Southern California Keck School of Medicine (USC KSOM), Los Angeles, CA 90027, USA; [email protected] 2 Department of Developmental Therapeutics, Immunology, and Integrative Medicine, Drug Discovery Institute, Ares Pharmaceuticals, St. Paul, MN 55110, USA 3 Reven Pharmaceuticals, Translational Oncology Program, Golden, CO 80401, USA Simple Summary: This article provides a comprehensive review of new and emerging treatment strategies against multiple myeloma that employ precision medicines and/or drugs capable of improving the ability of the immune system to prevent or slow down the progression of multiple myeloma. These rationally designed new treatment methods have the potential to change the therapeutic landscape in multiple myeloma and improve the long-term survival outcome. Abstract: SeverFigurel cellular elements of the bone marrow (BM) microenvironment in multiple myeloma (MM) patients contribute to the immune evasion, proliferation, and drug resistance of MM cells, including myeloid-derived suppressor cells (MDSCs), tumor-associated M2-like, “alter- natively activated” macrophages, CD38+ regulatory B-cells (Bregs), and regulatory T-cells (Tregs). These immunosuppressive elements in bidirectional and multi-directional crosstalk with each other inhibit both memory and cytotoxic effector T-cell populations as well as natural killer (NK) cells. Immunomodulatory imide drugs (IMiDs), protease inhibitors (PI), monoclonal antibodies (MoAb), Citation: Uckun, F.M. Overcoming the Immunosuppressive Tumor adoptive T-cell/NK cell therapy, and inhibitors of anti-apoptotic signaling pathways have emerged as Microenvironment in Multiple promising therapeutic platforms that can be employed in various combinations as part of a rationally Myeloma. -
Investor Presentation
Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Q1 2021 Results Investor presentation 1 Investor Relations │ Q1 2021 Results Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding the impact of the COVID-19 pandemic on certain therapeutic areas including dermatology, ophthalmology, our breast cancer portfolio, some newly launched brands and the Sandoz retail and anti-infectives business, and on drug development operations; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings of the Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions; or regarding the Group’s liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our collaboration with Molecular Partners to develop, manufacture and commercialize potential medicines for the prevention and treatment of COVID- 19 and our joining of the industry-wide efforts to meet global demand for COVID-19 vaccines and therapeutics by leveraging our manufacturing capacity and capabilities to support the production of the Pfizer-BioNTech vaccine and to manufacture the mRNA and bulk drug product for the vaccine candidate CVnCoV from CureVac.