DOCSLIB.ORG

Package Leaflet

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Package Leaflet PACKAGE LEAFLET: INFORMATION FOR Do not take Thalidomide Celgene • you have experienced or have existing You must stop treatment and inform If you have any further questions on the use of • Feeling weak, faint or unsteady, lack of THE USER • If you are pregnant or think you may be neuropathy i.e. tingling, abnormal co-ordi- your doctor straight away if: this product, ask your doctor, pharmacist or energy or strength, low blood pressure. 6. FURTHER INFORMATION pregnant or are planning to become preg- nation or pain in your hands or feet. • You miss or think you have missed a nurse. • Fever, feeling generally unwell. —————————————————————— nant, as Thalidomide Celgene causes • you have experienced sleepiness. period, or you have unusual menstrual • A spinning feeling in your head, making it What Thalidomide Celgene contains: ® Thalidomide Celgene 50 mg birth defects and foetal death. • you have a high total amount of tumor bleeding, or suspect you are pregnant. difficult to stand up and move normally. • The active substance is thalidomide. Each hard capsules • If you are able to become pregnant but are throughout the body, including your bone • You have heterosexual intercourse 4. POSSIBLE SIDE EFFECTS • Blurred vision. capsule contains 50 mg of thalidomide. Thalidomide unable to follow the necessary pregnancy marrow. This could lead to a condition without using an effective method of • Chest infection (pneumonia), lung disease. • The other excipients are pregelatinized —————————————————————— prevention measures (outlined in the i-SE- where the tumors break down and cause contraception. Like all medicines, this medicine can cause • A slow heart rate, heart failure. starch and magnesium stearate. The CURE program). unusual levels of chemicals in the body If you do become pregnant during the treat- side effects although not everybody gets them. • Depression, confusion, mood changes, capsule shell contains gelatin and titanium • If you are allergic (hypersensitive) to thalid- which can lead to kidneys failure (this ment with thalidomide, you must stop the anxiety. dioxide (E171). The printing ink is condition is called Tumor Lysis Syndrome). WARNING omide or any of the other ingredients of treatment and inform your doctor immediately. The following side effects may happen with composed of shellac, black iron oxide • you have experienced fever, chills and Thalidomide causes birth defects and Thalidomide Celgene (listed in section 6. this medicine: Uncommon (may affect up to 1 in 100 people) (E172) and propylene glycol. severe shaking, and possibly complicated foetal death. Do not take thalidomide if "What Thalidomide Celgene contains:”). For men taking Thalidomide Celgene who • Inflammation and swelling of the tubes in by low blood pressure and confusion (these you are pregnant or could become preg- have a female partner who is able to become your lungs (bronchitis). What Thalidomide Celgene looks like and may be symptoms of severe infections). Stop taking Thalidomide Celgene and see nant. You must follow the contraception Do not take Thalidomide Celgene if any of the • Inflammation of the cells lining your stom- contents of the pack • you have had an allergic reaction whilst pregnant, please see section 2 “Take special a doctor straight away if you notice the advice given to you by your doctor. above applies to you. If you are not sure, talk ach wall. Thalidomide Celgene are white hard capsules taking thalidomide such as rash, itching, care with Thalidomide Celgene”. If your following serious side effects – you may to your doctor or pharmacist before taking • A hole in part of your large bowel (colon) marked “Thalidomide Celgene 50 mg”. The swelling, dizziness or trouble breathing. partner becomes pregnant whilst you are need urgent medical treatment: Thalidomide Celgene. taking thalidomide, you should inform your • Severe skin reactions including rashes, which can cause infection. capsules are supplied in a wallet card Read all of this leaflet carefully before you • you do not understand the contraception containing 28 capsules (2 blisters of 14 advice given to you by your doctor or if you doctor immediately. which is a common side effect and blister- start taking this medicine. capsules each). Take special care with Thalidomide do not feel able to follow this advice. ing of the skin and mucosa (Stevens John- • Keep this leaflet. You may need to read it Additional side effects have been reported after This is a medicament Celgene: • you have high blood pressure from the Breast-feeding: son Syndrome and toxic epidermal necrol- again. this medicine was marketed. These include: – A medicament is a product which heart to the lungs. Do not breastfeed during Thalidomide ysis, which are rare side effects). You may • If you have further questions, please ask • Underactive thyroid (hypothyroidism). affects your health, and its consump- For females taking Thalidomide Celgene • you have or have ever had previous viral Celgene treatment, during dose interruptions have a high temperature (fever) at the • Bowel obstruction. tion contrary to instructions is danger- your doctor, pharmacist or nurse. Before starting the treatment, you should ask infection, particularly varicella, zona, and for 4 weeks after stopping treatment as it same time. • Sexual dysfunction, for example impotence. ous for you. • This medicine has been prescribed for you your doctor if you are able to become preg- hepatitis B infection, or HIV. If you are in is not known if thalidomide is passed into • A fall in the number of white blood cells − Follow strictly the doctor’s prescription, Do not pass it on to others. It may harm nant, even if you think this is unlikely. doubt, talk to your doctor. Treatment with human breast milk. Tell your doctor straight away if you notice • (neutropenia) accompanied by fever and them, even if their symptoms are the same If you are able to become pregnant: thalidomide may cause virus to become any of the following serious side effects: the method of use and the instructions infection as yours. • Your doctor will make sure that you have active again in patients who carry it, result- • Numbness, tingling, abnormal co-ordi- of the pharmacist who sold the medica- Driving and using machines: • Severe blood infection (sepsis) accompa- • If any of your side effects get serious, or if pregnancy tests ing in a recurrence of the infection. Your nation or pain in your hands and feet. ment to you Do not drive or use any tools or machines if nied by fever, chills and severe shaking, you notice any side effects not listed in this ◦ before treatment doctor should check whether you have This may be due to nerve damage (called – The doctor and the pharmacist are you experience side effects, such as dizzi- and possibly complicated by low blood leaflet, please tell your doctor or pharmacist. ◦ every 4 weeks during treatment ever had hepatitis B infection. ‘peripheral neuropathy’), which is a very experts in medicine, its benefits and ness, tiredness, sleepiness or blurred vision. pressure and confusion (septic shock). ◦ 4 weeks after stopping treatment risks. common side effect. It may become very • A fall in the number of red and white blood In this leaflet • You must use two effective methods of Donating Blood: − Do not, by yourself, interrupt the period severe, painful and disabling. If you expe- cells and platelets at the same time (pan- 1. What Thalidomide Celgene is and what it contraception at the same time: You must not donate blood during Thalido- of treatment prescribed for you. 3. HOW TO TAKE THALIDOMIDE rience such symptoms, speak to your cytopenia). is used for ◦ for 4 weeks before starting treatment mide Celgene treatment, during dose interrup- − Do not repeat the same prescription CELGENE doctor straight away, who may reduce the • Tumour Lysis Syndrome - metabolic 2. Before you take Thalidomide Celgene ◦ during treatment tions and for 4 weeks after stopping treatment. dose or discontinue the treatment. This without consulting your doctor. 3. How to take Thalidomide Celgene complications that can occur during the ◦ during dose interruptions Always take Thalidomide Celgene exactly as side effect usually happens after you have 4. Possible side effects If you are not sure if any of the above apply to treatment of cancer and sometimes even Keep Medicament out of the reach and sight ◦ until 4 weeks after stopping treatment your doctor has told you to. You should check been taking this medicine for several 5. How to store Thalidomide Celgene you, talk to your doctor before taking Thalido- without treatment. These complications of children and any other person not directly You should talk to your doctor about the with your doctor if you are not sure. months but can happen sooner than this. It are caused by the break-down products of 6. Further information mide Celgene. involved in the treatment following birth control methods. can also happen sometime after treatment dying cancer cells and may include the has stopped. It may not go away, or may following: changes to blood chemistry; Children and adolescents How much to take Manufactured by Celgene International Sarl, Examples of Effective Methods of Contra- The recommended dose is 200 mg (4 x 50 mg go away slowly. high potassium, phosphorus, uric acid, 1. WHAT THALIDOMIDE CELGENE Thalidomide Celgene is not recommended Switzerland ception capsules) a day for adults aged 75 years and • Sudden pain in your chest or difficulty and low calcium consequently leading to IS AND WHAT IT IS USED FOR for
Load more

Recommended publications
  • Thalidomide Celgene Pregnancy Prevention Programme Information
    TCPPP Healthcare Professional Booklet Thalidomide Celgene ® Pregnancy Prevention Programme Information for Healthcare Professionals ® Prescribing or Dispensing Thalidomide Celgene Celgene representative contact details: AM Mangion Ltd, Regulatory Office, “Mangion Building”, New Street Off Valletta Road, Luqa. Phone: +356 239 76333 Fax: +356 239 76123 Email: [email protected] Medical Information queries: [email protected] 2014 © Celgene Corporation Page 1 of 19 RMP/THA/001/14-03/M TCPPP Healthcare Professional Booklet This booklet is intended for healthcare professionals involved in prescribing or dispensing Thalidomide Celgene ®, and contains information about: Preventing harm to unborn babies: If Thalidomide Celgene® is taken during pregnancy it can cause severe birth defects or death to an unborn baby. Other side effects of Thalidomide Celgene®: The most commonly observed adverse reactions associated with the use of Thalidomide Celgene® in combination with melphalan and prednisone are: neutropenia, leukopenia, constipation, somnolence, paraesthesia, peripheral neuropathy, anaemia, lymphopenia, thrombocytopenia, dizziness, dysaesthesia, tremor and peripheral oedema. Further information and recommended precautions can be found in the Thalidomide Celgene® Summary of Product Characteristics (SmPC). Thalidomide Celgene® Pregnancy Prevention Programme: This Programme is designed to make sure that unborn babies are not exposed to Thalidomide Celgene®. It will provide you with information about how to follow the programme and explain your responsibilities. This booklet will help you understand these problems and make sure you know what to do before prescribing and dispensing Thalidomide Celgene®. For your patients’ own health and safety, please read this booklet carefully. You must ensure that your patients fully understand what you have told them about Thalidomide Celgene® before starting treatment.
    [Show full text]
  • Study Protocol and Statistical Analysis Plan
    Official Title: A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD- L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen NCT Number: NCT03016312 Document Date: Protocol Version 8: 14 February 2020 PROTOCOL TITLE: A PHASE III, MULTICENTER, RANDOMIZED STUDY OF ATEZOLIZUMAB (ANTIPD-L1 ANTIBODY) IN COMBINATION WITH ENZALUTAMIDE VERSUS ENZALUTAMIDE ALONE IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AFTER FAILURE OF AN ANDROGEN SYNTHESIS INHIBITOR AND FAILURE OF, INELIGIBILITY FOR, OR REFUSAL OF A TAXANE REGIMEN PROTOCOL NUMBER: CO39385 VERSION NUMBER: 8 EUDRACT NUMBER: 2016-003092-22 IND NUMBER: 131196 TEST PRODUCTS: Atezolizumab (RO5541267) and enzalutamide MEDICAL MONITOR: , M.D., Ph.D. SPONSOR: F. Hoffmann-La Roche Ltd DATE FINAL: Version 1: 29 September 2016 DATES AMENDED: Version 2: 7 March 2017 Version 3: 4 April 2017 Version 4: 29 June 2017 Version 5: 2 March 2018 Version 6: 23 August 2018 Version 7: 5 August 2019 Version 8: See electronic date stamp below. PROTOCOL AMENDMENT APPROVAL Date and Time (UTC) Title Approver's Name 14-Feb-2020 17:27:37 Company Signatory CONFIDENTIAL This clinical study is being sponsored globally by F. Hoffmann-La Roche Ltd of Basel, Switzerland. However, it may be implemented in individual countries by Roche’s local affiliates, including Genentech, Inc. in the United States. The information contained in this document, especially any unpublished data, is the property of F. Hoffmann-La Roche Ltd (or under its control) and therefore is provided to you in confidence as an investigator, potential investigator, or consultant, for review by you, your staff, and an applicable Ethics Committee or Institutional Review Board.
    [Show full text]
  • Cancer Drug Pharmacology Table
    CANCER DRUG PHARMACOLOGY TABLE Cytotoxic Chemotherapy Drugs are classified according to the BC Cancer Drug Manual Monographs, unless otherwise specified (see asterisks). Subclassifications are in brackets where applicable. Alkylating Agents have reactive groups (usually alkyl) that attach to Antimetabolites are structural analogues of naturally occurring molecules DNA or RNA, leading to interruption in synthesis of DNA, RNA, or required for DNA and RNA synthesis. When substituted for the natural body proteins. substances, they disrupt DNA and RNA synthesis. bendamustine (nitrogen mustard) azacitidine (pyrimidine analogue) busulfan (alkyl sulfonate) capecitabine (pyrimidine analogue) carboplatin (platinum) cladribine (adenosine analogue) carmustine (nitrosurea) cytarabine (pyrimidine analogue) chlorambucil (nitrogen mustard) fludarabine (purine analogue) cisplatin (platinum) fluorouracil (pyrimidine analogue) cyclophosphamide (nitrogen mustard) gemcitabine (pyrimidine analogue) dacarbazine (triazine) mercaptopurine (purine analogue) estramustine (nitrogen mustard with 17-beta-estradiol) methotrexate (folate analogue) hydroxyurea pralatrexate (folate analogue) ifosfamide (nitrogen mustard) pemetrexed (folate analogue) lomustine (nitrosurea) pentostatin (purine analogue) mechlorethamine (nitrogen mustard) raltitrexed (folate analogue) melphalan (nitrogen mustard) thioguanine (purine analogue) oxaliplatin (platinum) trifluridine-tipiracil (pyrimidine analogue/thymidine phosphorylase procarbazine (triazine) inhibitor)
    [Show full text]
  • Adverse Effects in Women: Implications for Drug Development and Regulatory Policies
    Review For reprint orders, please contact [email protected] Adverse effects in women: implications for drug development and regulatory policies Expert Rev. Clin. Pharmacol. 4(4), 453–466 (2011) Ameeta Parekh†1, The requirement to establish safety of drugs prior to marketing has been in place since 1938 by Emmanuel O Fadiran1, the US Food, Drug and Cosmetic Act and is by no means a new concept. The efficacy regulations Kathleen Uhl2 were enacted in 1962 via the Kefauver–Harris Amendment and the drug approval process has and Douglas C evolved thereafter. The assessment of safety and efficacy of drug products is made by 2 pharmaceutical companies during drug development, which then goes through a regulatory Throckmorton review by the US FDA for the determination of market approval or nonapproval. The drug 1Food and Drug Administration, development and regulatory approval processes have endured close ongoing scrutiny by Office of Women’s Health, 10903 New Hampshire Avenue, regulatory bodies, the public, US Congress and academic and private organizations and, as a Silver Spring, MD 10993, USA result, have ensured continual refinement. Over the years, evidence has been emerging on varied 2Food and Drug Administration, drug responses in subgroup populations, and the underlying biology associated with age, race Center for Drug Evaluation and and sex as demographic variables have been examined. The resulting growing knowledge of Research, Office of Medical Policy, 10903 New Hampshire Avenue, disease burden, treatment response and disparate outcomes has generated opportunities to Silver Spring, MD 10993, USA streamline and improve treatment outcomes in these populations. This article discusses the †Author for correspondence: historical context of women’s participation in clinical drug trials submitted to the FDA for Tel.: +1 301 796 9445 regulatory review and approval purposes.
    [Show full text]
  • New Drugs Are Not Enough‑Drug Repositioning in Oncology: an Update
    INTERNATIONAL JOURNAL OF ONCOLOGY 56: 651-684, 2020 New drugs are not enough‑drug repositioning in oncology: An update ROMINA GABRIELA ARMANDO, DIEGO LUIS MENGUAL GÓMEZ and DANIEL EDUARDO GOMEZ Laboratory of Molecular Oncology, Science and Technology Department, National University of Quilmes, Bernal B1876, Argentina Received August 15, 2019; Accepted December 16, 2019 DOI: 10.3892/ijo.2020.4966 Abstract. Drug repositioning refers to the concept of discov- 17. Lithium ering novel clinical benefits of drugs that are already known 18. Metformin for use treating other diseases. The advantages of this are that 19. Niclosamide several important drug characteristics are already established 20. Nitroxoline (including efficacy, pharmacokinetics, pharmacodynamics and 21. Nonsteroidal anti‑inflammatory drugs toxicity), making the process of research for a putative drug 22. Phosphodiesterase-5 inhibitors quicker and less costly. Drug repositioning in oncology has 23. Pimozide received extensive focus. The present review summarizes the 24. Propranolol most prominent examples of drug repositioning for the treat- 25. Riluzole ment of cancer, taking into consideration their primary use, 26. Statins proposed anticancer mechanisms and current development 27. Thalidomide status. 28. Valproic acid 29. Verapamil 30. Zidovudine Contents 31. Concluding remarks 1. Introduction 2. Artesunate 1. Introduction 3. Auranofin 4. Benzimidazole derivatives In previous decades, a considerable amount of work has been 5. Chloroquine conducted in search of novel oncological therapies; however, 6. Chlorpromazine cancer remains one of the leading causes of death globally. 7. Clomipramine The creation of novel drugs requires large volumes of capital, 8. Desmopressin alongside extensive experimentation and testing, comprising 9. Digoxin the pioneer identification of identifiable targets and corrobora- 10.
    [Show full text]
  • Thalidomide and Pregnancy
    Thalidomide This sheet talks about exposure to thalidomide in pregnancy and while breastfeeding. This information should not take the place of medical care and advice from your healthcare provider. What is thalidomide? Thalidomide is a sedative that also changes the body’s immune response and reduces the ability of the body to grow new blood vessels. Thalidomide was one of the first medications recognized to cause birth defects in humans. Thalidomide was not released in the United States until 1998. It has been used to treat several medical conditions, such as leprosy, certain types of cancer, inflammatory bowel disease and complications from HIV infection. It is sold under the brand name Thalomid®. I take thalidomide. Can it make it harder for me to get pregnant? There has been one small study that looked at women who had inflammatory bowel disease and were treated with thalidomide. This study suggested exposure to thalidomide might reduce the number of eggs in the ovaries. It is not clear if this would affect fertility. Further study is needed. Because thalidomide can cause birth defects when taken early in pregnancy, often before a woman recognizes that she is pregnant, it is very important that effective methods of birth control be used correctly and all of the time. It is recommended that two different and reliable methods of birth control be used if a woman is taking thalidomide. Thalidomide may decrease the effectiveness of oral contraceptives (birth control pills). The manufacturer developed the REMS (Risk Evaluation and Mitigation Strategy) program (formerly known as the S.T.E.P.S.® program) to help prevent exposure to pregnant women.
    [Show full text]
  • Pharmacogenomic Biomarkers in Docetaxel Treatment of Prostate Cancer: from Discovery to Implementation
    G C A T T A C G G C A T genes Review Pharmacogenomic Biomarkers in Docetaxel Treatment of Prostate Cancer: From Discovery to Implementation Reka Varnai 1,2, Leena M. Koskinen 3, Laura E. Mäntylä 3, Istvan Szabo 4,5, Liesel M. FitzGerald 6 and Csilla Sipeky 3,* 1 Department of Primary Health Care, University of Pécs, Rákóczi u 2, H-7623 Pécs, Hungary 2 Faculty of Health Sciences, Doctoral School of Health Sciences, University of Pécs, Vörösmarty u 4, H-7621 Pécs, Hungary 3 Institute of Biomedicine, University of Turku, Kiinamyllynkatu 10, FI-20520 Turku, Finland 4 Institute of Sport Sciences and Physical Education, University of Pécs, Ifjúság útja 6, H-7624 Pécs, Hungary 5 Faculty of Sciences, Doctoral School of Biology and Sportbiology, University of Pécs, Ifjúság útja 6, H-7624 Pécs, Hungary 6 Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania 7000, Australia * Correspondence: csilla.sipeky@utu.fi Received: 17 June 2019; Accepted: 5 August 2019; Published: 8 August 2019 Abstract: Prostate cancer is the fifth leading cause of male cancer death worldwide. Although docetaxel chemotherapy has been used for more than fifteen years to treat metastatic castration resistant prostate cancer, the high inter-individual variability of treatment efficacy and toxicity is still not well understood. Since prostate cancer has a high heritability, inherited biomarkers of the genomic signature may be appropriate tools to guide treatment. In this review, we provide an extensive overview and discuss the current state of the art of pharmacogenomic biomarkers modulating docetaxel treatment of prostate cancer. This includes (1) research studies with a focus on germline genomic biomarkers, (2) clinical trials including a range of genetic signatures, and (3) their implementation in treatment guidelines.
    [Show full text]
  • Thalidomide Pregnancy Prevention Programme Information For
    Thalidomide Healthcare Professional Brochure Celgene Corporation Thalidomide Pregnancy Prevention Programme Information for Healthcare Professionals Prescribing or Dispensing Thalidomide RMP/THA/001/20-07/M 1 Thalidomide Healthcare Professional Brochure Celgene Corporation This brochure is intended for healthcare professionals involved in prescribing or dispensing thalidomide, and contains information about: Preventing harm to unborn babies: If thalidomide is taken during pregnancy it can cause severe birth defects or death to an unborn baby. Other side effects of thalidomide: Ischaemic heart disease including myocardial infarction. Further information and recommended precautions can be found in the thalidomide Summary of Product Characteristics (SmPC). Thalidomide Pregnancy Prevention Programme: This Programme is designed to prevent unborn babies being exposed to thalidomide. It will provide you with information about how to follow the programme and explain your responsibilities. It is a requirement of the Pregnancy Prevention Programme that all healthcare professionals ensure that they have read and understood this brochure To ensure your patients’ safety, please read this brochure carefully. You must ensure that your patients fully understand what you have told them about thalidomide before starting treatment. RMP/THA/001/20-07/M 2 Thalidomide Healthcare Professional Brochure Celgene Corporation CONTENTS Introduction ..................................................................................... 4 Thalidomide ..................................................................................................................
    [Show full text]
  • Volume , Number
    Volume 3, Number 6 for health professionals who care for cancer patients June 2000 were intended for patients who are treated as I NSIDE THIS ISSUE inpatient for the first two of five daily treatments. It . Alert! – GUEP Pre-printed Order must be ensured that the full 5 days of Misinterpretation, LUCAV, LUALTE, LUALTL chemotherapy is given, not just the final three days. Pre-printed Order Error Note that both GUEP and GUBEP protocols are . Protocol Update – BRAVCAP, BRAVTRAP, five-day treatments. GUVIP2, HNFUA, LYCDA, SCHYPCAL, UBRAVTR The GUEP pre-printed orders have been revised to . Cancer Management Manual – Genitourinary, prevent potential misinterpretation and treatment Lymphoma, Nutritional Care error. Other pre-printed orders are being reviewed . Pre-Printed Order Update – Lymphoma New to identify if similar potential for misinterpretation Patient Consultation, GUMVAC, LUCAV, exists. LUALTE, LUALTL, LYECV, LYACOP6, LYACOP12, LYCOPA LUCAV, LUALTE, LUALTL Pre-printed . Drug Update – Dacarbazine, Flutamide, Oral Orders Error The Vancouver Cancer Centre pre- Phosphate, Thalidomide, Trastuzumab printed orders (last revised 8 March) for these (Herceptin®) protocols, titled LUCAV, LUALTE-CAV, . Continuing Education – Canadian Association th LUALTL-CAV, respectively, contain a significant of Nurses in Oncology 12 Annual Conference, error. There is a statement that the chemotherapy is BCCA Annual Clinical Cancer Conference Days 1-3. This should be a Day 1 dose only. Comments to the Editor – Scent-free Workplace Please discard all previous versions and replace with new versions dated 26 May 2000. FAX request form and IN TOUCH phone list are provided if additional information is needed. PROTOCOL UPDATE Protocol codes for treatments requiring ALERT! “Undesignated Indication” approval prior to use are It has come to our attention that one pre-printed prefixed with the letter U.
    [Show full text]
  • Thalidomide in Leprosy Do Not Require Any Specific Treatment Except with Some Thalidomide: a Few Years Later, However, the Analgesics/Antipyretics
    FEATURE The Return of Thalidomide in Leprosy do not require any specific treatment except with some Thalidomide: A few years later, however, the analgesics/antipyretics. In those drug thalidomide was suffering ENL associated neuritis, New Uses and reintroduced as treatment for a the drug of choice is Renewed complication of leprosy called prednisolone. For chronic erythema nodosum leprosum recurrent reactions the drug of Concerns (ENL). Although the evidence choice is clofazimine. Dr V Pannikar, Medical was not fully established, very soon the drug was heralded as Thalidomide in other Officer, Communicable the drug of choice for the indications Diseases (Leprosy management of ENL reactions in Group), WHO leprosy and regulatory The above points clearly authorities granted exemption demonstrate that there is no place for thalidomide in leprosy. History from licensing requirements to enable doctors to obtain limited But very often this disease is Thalidomide or α-(N- supplies of thalidomide under used as an entry point to phthalimido) glutarimide was strictly controlled circumstances reintroduce thalidomide for a marketed in 1957 for morning for use in named patients. multitude of other indications. sickness and nausea and soon Thalidomide's effectiveness in Millions of treatments are being became the ‘drug of choice to minimizing symptoms of ENL was prescribed annually and almost help pregnant women’. It went mainly due to its antipyretic all of it is for non-leprosy into general use by the following action. Its effectiveness in conditions including cancer year and was widely prescribed controlling neuritis, the major treatment and use in HIV. There in Europe, Australia, Asia, Africa cause of permanent disabilities in are limited trials demonstrating 1 leprosy, was limited.
    [Show full text]
  • 2021 Formulary List of Covered Prescription Drugs
    2021 Formulary List of covered prescription drugs This drug list applies to all Individual HMO products and the following Small Group HMO products: Sharp Platinum 90 Performance HMO, Sharp Platinum 90 Performance HMO AI-AN, Sharp Platinum 90 Premier HMO, Sharp Platinum 90 Premier HMO AI-AN, Sharp Gold 80 Performance HMO, Sharp Gold 80 Performance HMO AI-AN, Sharp Gold 80 Premier HMO, Sharp Gold 80 Premier HMO AI-AN, Sharp Silver 70 Performance HMO, Sharp Silver 70 Performance HMO AI-AN, Sharp Silver 70 Premier HMO, Sharp Silver 70 Premier HMO AI-AN, Sharp Silver 73 Performance HMO, Sharp Silver 73 Premier HMO, Sharp Silver 87 Performance HMO, Sharp Silver 87 Premier HMO, Sharp Silver 94 Performance HMO, Sharp Silver 94 Premier HMO, Sharp Bronze 60 Performance HMO, Sharp Bronze 60 Performance HMO AI-AN, Sharp Bronze 60 Premier HDHP HMO, Sharp Bronze 60 Premier HDHP HMO AI-AN, Sharp Minimum Coverage Performance HMO, Sharp $0 Cost Share Performance HMO AI-AN, Sharp $0 Cost Share Premier HMO AI-AN, Sharp Silver 70 Off Exchange Performance HMO, Sharp Silver 70 Off Exchange Premier HMO, Sharp Performance Platinum 90 HMO 0/15 + Child Dental, Sharp Premier Platinum 90 HMO 0/20 + Child Dental, Sharp Performance Gold 80 HMO 350 /25 + Child Dental, Sharp Premier Gold 80 HMO 250/35 + Child Dental, Sharp Performance Silver 70 HMO 2250/50 + Child Dental, Sharp Premier Silver 70 HMO 2250/55 + Child Dental, Sharp Premier Silver 70 HDHP HMO 2500/20% + Child Dental, Sharp Performance Bronze 60 HMO 6300/65 + Child Dental, Sharp Premier Bronze 60 HDHP HMO
    [Show full text]
  • Recent Advances in the Management of Hormone Refractory Prostate Cancer
    Korean J Uro-Oncol 2004;2(3):147-153 Recent Advances in the Management of Hormone Refractory Prostate Cancer Mari Nakabayashi, William K. Oh Lank Center for Genitourinary Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA A typical treatment strategy after AAWD is to use secondary INTRODUCTION hormonal manipulations, although studies have not yet demonstrated a survival benefit with this class of treatment. Prostate cancer is the most common cancer in men in the Options in this category include (1) the secondary use of anti- United States and accounted for 29,900 deaths in 2003.1 androgens (e.g., high-dose bicalutamide, nilutamide), (2) thera- Although most men with advanced prostate cancer respond pies targeted against adrenal steroid synthesis (e.g., ketocona- initially to androgen deprivation therapies (ADT) by either zole, corticosteroids), and (3) estrogenic therapies (e.g. diethy- bilateral orchiectomy or leuteinizing hormone releasing hor- lstilbestrol). Symptomatic improvement and PSA responses mone (LHRH) analogues, patients eventually progress to an (defined as PSA decline ＞50% after treatment) have been androgen-independent state in which the initial ADT no longer reported in approximately 20% to 80% of patients with is adequate to control disease.2 Progression of the disease hormone-refractory prostate cancer (HRPC) with a typical manifests as an increase in serum prostate-specific antigen duration of response of 2 to 6 months. Toxicity is generally (PSA) or may be accompanied by radiographic evidence of mild for these oral therapies, although serious side effects, tumor growth. Here we report a brief summary of recent including adrenal insufficiency, liver toxicity, and thrombosis, advances in the management of hormone refractory prostate may occur (Table 1).
    [Show full text]