DRUG COVERAGE GUIDELINES Policy Number: PHARMACY 098.175 T0 Effective Date: June 1, 2018

Total Page:16

File Type:pdf, Size:1020Kb

DRUG COVERAGE GUIDELINES Policy Number: PHARMACY 098.175 T0 Effective Date: June 1, 2018 UnitedHealthcare® Oxford Clinical Policy DRUG COVERAGE GUIDELINES Policy Number: PHARMACY 098.175 T0 Effective Date: June 1, 2018 Table of Contents Page Related Policies INSTRUCTIONS FOR USE ......................................................................... 1 Refer to Payment Guidelines below CONDITIONS OF COVERAGE ..................................................................... 1 DESCRIPTION OF SERVICES ..................................................................... 2 DEFINITIONS ......................................................................................... 3 PAYMENT GUIDELINES ............................................................................. 3 POLICY HISTORY/REVISION INFORMATION ............................................ 161 INSTRUCTIONS FOR USE This Clinical Policy provides assistance in interpreting Oxford benefit plans. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage members. Oxford reserves the right, in its sole discretion, to modify its policies as necessary. This Clinical Policy is provided for informational purposes. It does not constitute medical advice. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies. When deciding coverage, the member specific benefit plan document must be referenced. The terms of the member specific benefit plan document [e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan Description (SPD)] may differ greatly from the standard benefit plan upon which this Clinical Policy is based. In the event of a conflict, the member specific benefit plan document supersedes this Clinical Policy. All reviewers must first identify member eligibility, any federal or state regulatory requirements, and the member specific benefit plan coverage prior to use of this Clinical Policy. Other Policies may apply. UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. CONDITIONS OF COVERAGE This policy applies to Oxford plan membership. Note: Not all Oxford groups have selected the same pharmacy benefits. Refer to the group's pharmacy plan number for specific exclusions, exceptions, and dispensing limitations. New Jersey Small group plan members should refer to their Certificate of Coverage for precertification and quantity limit guidelines. New Jersey members: Refer to the policy titled Supply Limits - New Jersey Benefit Maximum Limits. Drug Coverage Guidelines Page 1 of 166 UnitedHealthcare Oxford Clinical Policy Effective 06/01/2018 ©1996-2018, Oxford Health Plans, LLC DESCRIPTION OF SERVICES The Drug Coverage Guidelines table of medications contains medications that: o Have a quantity limit in place; and/or o Require precertification through Oxford's Pharmacy Benefit Manager (PBM); and/or o Require precertification through Oxford's Medical Management; and/or o Are standard exclusions (such as weight loss medications, fluorides, vitamins) Medications are listed alphabetically with an explanation of how precertification is obtained and under which benefit it is covered. While a medication by itself may not require precertification, Home Care for the administration of a medication does require precertification. Exception: The first seven days of therapy with low molecular weight heparin are an exception to the Home Care precertification requirement. Notes: Opioid Overutilization: The Center for Disease Control (CDC) recommends that clinicians should prescribe the lowest effective dosage when opioids are started. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to 50 morphine equivalent doses (MED) or more per day, and should avoid increasing dosage to 90 MED or more per day or carefully justify a decision to titrate dosage to 90 MED or more per day. o This includes all salt forms, single and combination ingredient products, all long- and short-acting formulations, and all brand and generic formulations: codeine, dihydrocodeine, fentanyl, methadone, meperidine, morphine, hydrocodone, hydromorphone, levorphanol, oxycodone, oxymorphone, pentazocine, tapentadol, tramadol. o For additional coverage criteria for the above drugs, please refer to: Utilization Review Guideline: Opioid Overutilization Cumulative Drug Utilization Review Criteria Quantity duration (QD) and quantity level limitations (QLL) may be in place for certain medications. To request coverage for a greater quantity of a medication with a QLL, providers must call Oxford's Pharmacy Benefit Manager (PBM). For information regarding QD or QLL supply limits, refer to the following documents on UHCProvider.com > Drug Lists and Pharmacy > Supply Limits: o QD Supply Limits (defines the maximum quantity of medication that can be covered in a specified time period) o QLL Supply Limits (defines the maximum quantity of medication that is covered for one prescription or copayment) Oxford's PBM provides a nationwide network of participating pharmacies that administers prescription drugs on a retail level. Groups that purchase the Pharmacy Rider and Medicare Members with a Pharmacy benefit will have their retail pharmacy benefit administered by the PBM. For information regarding medication coverage related to the Member's pharmacy benefit, providers may contact Oxford's PBM. For issues of medication coverage unrelated to the Member's pharmacy benefit (Intravenous infusions, intramuscular injections, etc), Oxford may be contacted directly. Over-the-Counter (OTC) Medications: o New Jersey (NJ) Plans: Prescription drugs for which there is a therapeutic over-the-counter (OTC) equivalent are not excluded from coverage. Refer to specific drug policies where applicable. o Connecticut (CT) and New York (NY) Plans: A prescription drug product that is therapeutically equivalent to an over-the-counter (OTC) drug may be covered if it is determined to be medically necessary. In order for a prescription drug to be deemed "medically necessary" when there is an equivalent OTC drug available, the physician must show that there is something about the prescription drug that is superior to the OTC drug, and likely to be more beneficial to the Member than the OTC drug. Documentation supporting medical necessity must be submitted by the provider. New FDA-approved drug products may require precertification immediately upon launch of the medication. For information on coverage of recent FDA-approved drug products for which drug-specific criteria are unavailable, please refer to Interim New Product Coverage Criteria. Review at Launch: The Review at Launch program provides Oxford the ability to review, evaluate, and implement programs for new to market medications. The medication may move to a covered status once the medication has been evaluated by the UnitedHealthcare Pharmacy and Therapeutics Committee and the appropriate system specifications have been implemented to ensure suitable utilization management strategies are in place. A medication will be subject to review at launch when the medication is listed on the Review at Launch Medication List. Please refer to the policy titled Review at Launch for New to Market Medications. Drug Coverage Guidelines Page 2 of 166 UnitedHealthcare Oxford Clinical Policy Effective 06/01/2018 ©1996-2018, Oxford Health Plans, LLC New Jersey Formulary Regulations: Members who are enrolled in a New Jersey group Product with a 3-Tier Prescription Drug Benefit and for whom the NJ Formulary Regulations apply should refer to Prior Authorization/Notification Non-Formulary (i.e., Tier 3 or higher) Copay Adjustment – New Jersey. DEFINITIONS For all of the definitions below, copayment/cost share will vary based on the Member’s plan design. Refer to the member's specific Certificate of Coverage, contract and/or Prescription Drug Rider as applicable. Mail Order Pharmacy: A network pharmacy contracted to provide up to a 90-day supply of certain prescription medications (new or refill) by mail. Retail Pharmacy: A network non-mail order pharmacy contracted to provide prescription medications (new or refill). Note: For Members enrolled in NY LOBs new and renewing on or after 01/12/12, if a retail pharmacy has contracted with the PBM, in advance, for the same rates and terms and conditions as the mail order or specialty pharmacy, covered prescriptions will be available at the same co-payment or other reimbursement level that would apply to the mail-order or non-retail specialty pharmacies (should any of these pharmacies be available in the service area). Specialty Pharmacy: A network pharmacy contracted to provide coverage for specialty medications at an in-network benefit level for members enrolled on NY and NJ LOBs. PAYMENT GUIDELINES The following list of procedure codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply
Recommended publications
  • XTANDI® (Enzalutamide): a Treatment Option for Castration-Resistant Prostate Cancer (CRPC)
    XTANDI® (enzalutamide): A Treatment Option for Castration-Resistant Prostate Cancer (CRPC) XTANDI® (enzalutamide) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with castration-resistant prostate cancer (CRPC).1 XTANDI is the first and only oral medication FDA-approved for both non-metastatic and metastatic CRPC.1 ABOUT THE ASTELLAS/PFIZER HOW XTANDI WORKS COLLABORATION Astellas and Pfizer jointly XTANDI is indicated for the treatment of CRPC, commercialize XTANDI which is defined as disease progression on in the United States. androgen deprivation therapy (luteinizing hormone-releasing hormone (LHRH) therapy Astellas has responsibility or prior bilateral orchiectomy).2 for manufacturing and all additional regulatory In prostate cancer, the androgen receptor (AR) is a key driver filings globally, as well as of progression.3 XTANDI is an AR inhibitor that is thought commercializing XTANDI to act on multiple steps of the androgen receptor signaling 1 outside the United States. pathway within the tumor cell based on in vitro studies. Select Safety Information Seizure occurred in 0.4% of patients receiving XTANDI in clinical studies. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. Patients in the study had one or more of the following pre-disposing factors: use of medications that may lower the seizure threshold; history of traumatic brain or head injury, cerebrovascular accident or transient ischemic attack, Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection.
    [Show full text]
  • 2019 Aetna Pharmacy Drug Guide Aetna Premier Plus Plan
    Plan for your best health 2019 Aetna Pharmacy Drug Guide Aetna Premier Plus Plan aetna.com 05.02.414.1 O (12/19) Aetna is the brand name used for products and services provided by one or more of the Aetna group of subsidiary companies, including Aetna Life Insurance Company and its affiliates (Aetna). Aetna Pharmacy Management refers to an internal business unit of Aetna Health Management, LLC. Aetna Pharmacy Management administers, but does not offer, insure or otherwise underwrite the prescription drug benefits portion of your health plan and has no financial responsibility therefor. 2019 Aetna Commercial Plan (Premier Plus) Table of Contents INFORMATIONAL SECTION..................................................................................................................7 *5-HT4 RECEPTOR AGONISTS*** - DRUGS FOR THE STOMACH................................................ 18 *ADHD/ANTI-NARCOLEPSY/ANTI-OBESITY/ANOREXIANTS* - DRUGS FOR THE NERVOUS SYSTEM.................................................................................................................................18 *AGENTS FOR NARCOTIC WITHDRAWAL*** - DRUGS FOR ADDICTION............................... 22 *AGENTS FOR OPIOID WITHDRAWAL*** - DRUGS FOR ADDICTION......................................22 *AMEBICIDES* - DRUGS FOR INFECTIONS.....................................................................................22 *AMINO ACIDS*** - DRUGS FOR NUTRITION................................................................................ 22 *AMINOGLYCOSIDES* - DRUGS FOR
    [Show full text]
  • ( 12 ) United States Patent
    US010376507B2 (12 ) United States Patent (10 ) Patent No. : US 10 , 376 , 507 B2 Srinivasan et al. (45 ) Date of Patent: Aug. 13 , 2019 CRESEMBA® ( isavuconazonium sulfate ) , Highlights of Prescrib (54 ) METHOD OF TREATING A PATIENT WITH ing Information , Label ; Patient Information approved by the U . S . A CYP3A4 SUBSTRATE DRUG Food and Drug Administration ; Astellas Pharma US , Inc. ( Licensed from Basilea Pharmaceutics International Ltd . ) , Illinois, USA , Ini (71 ) Applicant: Bow River LLC , Corona Del Mar , CA tial U . S . Approval: 2015 , Revised Mar. 2015 , Reference ID : 3712237, ( US ) 28 pages . DIFLUCAN® ( fluconazole ), Label ; Patient Information , Reference ( 72 ) Inventors : Sundar Srinivasan , Corona Del Mar, ID : 3650838 , Roerig , Division of Pfizer Inc ., New York , NY, Revised Mar. 2013 , 35 pages. CA (US ) ; Christina Chow , Seattle , WA NIZORAL® (ketoconazole )Label ; Patient Information approved by (US ) the U . S . Food and Drug Administration , Reference ID : 3458324 , Copyright 2014 Janssen Pharmaceuticals, Inc . , New Jersey, USA , ( 73 ) Assignee : BOW RIVER LLC , Corona del Mar , Revised Feb . 2014 , 23 pages . NOXAFIL® (posaconazole ) , Highlights of Prescribing Informa CA (US ) tion , Label ; Patient Information approved by the U . S . Food and Drug Administration ; Copyright © 2006 , 2010 , 2013 , 2014 Merck ( * ) Notice : Subject to any disclaimer , the term of this Sharp & Dohme Corp . , a subsidiary of Merck & Co ., Inc ., New patent is extended or adjusted under 35 Jersey , USA , Revised Sep . 2016 , Reference ID : 3983525, 37 pages . U . S . C . 154 (b ) by 0 days. ORAVIG® (miconazole ) , Highlights of Prescribing Information , Label ; Patient Information approved by the U . S . Food and Drug Administration ; Copyright 2012 Praelia Pharmaceuticals , Inc . , North (21 ) Appl.
    [Show full text]
  • AHFS Pharmacologic-Therapeutic Classification System
    AHFS Pharmacologic-Therapeutic Classification System Abacavir 48:24 - Mucolytic Agents - 382638 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Acitretin 84:92 - Skin and Mucous Membrane Agents, Abaloparatide 68:24.08 - Parathyroid Agents - 317036 Aclidinium Abatacept 12:08.08 - Antimuscarinics/Antispasmodics - 313022 92:36 - Disease-modifying Antirheumatic Drugs - Acrivastine 92:20 - Immunomodulatory Agents - 306003 4:08 - Second Generation Antihistamines - 394040 Abciximab 48:04.08 - Second Generation Antihistamines - 394040 20:12.18 - Platelet-aggregation Inhibitors - 395014 Acyclovir Abemaciclib 8:18.32 - Nucleosides and Nucleotides - 381045 10:00 - Antineoplastic Agents - 317058 84:04.06 - Antivirals - 381036 Abiraterone Adalimumab; -adaz 10:00 - Antineoplastic Agents - 311027 92:36 - Disease-modifying Antirheumatic Drugs - AbobotulinumtoxinA 56:92 - GI Drugs, Miscellaneous - 302046 92:20 - Immunomodulatory Agents - 302046 92:92 - Other Miscellaneous Therapeutic Agents - 12:20.92 - Skeletal Muscle Relaxants, Miscellaneous - Adapalene 84:92 - Skin and Mucous Membrane Agents, Acalabrutinib 10:00 - Antineoplastic Agents - 317059 Adefovir Acamprosate 8:18.32 - Nucleosides and Nucleotides - 302036 28:92 - Central Nervous System Agents, Adenosine 24:04.04.24 - Class IV Antiarrhythmics - 304010 Acarbose Adenovirus Vaccine Live Oral 68:20.02 - alpha-Glucosidase Inhibitors - 396015 80:12 - Vaccines - 315016 Acebutolol Ado-Trastuzumab 24:24 - beta-Adrenergic Blocking Agents - 387003 10:00 - Antineoplastic Agents - 313041 12:16.08.08 - Selective
    [Show full text]
  • Addyi Generic Name: Flibanserin Manufacturer
    Brand Name: Addyi Generic Name: Flibanserin Manufacturer: Sprout Pharmaceuticals Drug Class: Central Nervous System Agent, Serotonin Agonist, Dopamine antagonist Uses: Labeled Uses: Indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: A co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. Unlabeled Uses: none. Mechanism of Action: The mechanism of action for flibanserin in the treatment of hypoactive sexual desire disorder is unknown. Flibanserin has high affinity for serotonin (5-hydroxytryptamine or 5-HT) 1A receptors, as an agonist, and 5-HT2A receptors, as an antagonist, and moderate affinity for 5- HT2B, 5-HT2C, and dopamine D4 receptors as an antagonist Pharmacokinetics: Absorption: Tmax 0.75 hours Vd 50L t ½ 11 hours Clearance Not reported Protein binding 98% (albumin) Bioavailability 33% Metabolism: Flibanserin is extensively metabolized primarily by CYP3A4 and, to a lesser extent, CYP2C19 to at least 35 metabolites, with most of the metabolites occurring in low concentrations in plasma. Elimination: Flibanserin is primarily excreted through the kidneys in to urine (44%) and feces (51%). Two metabolites could be characterized that showed plasma concentration similar to that achieved with flibanserin: 6,21-dihydroxy-flibanserin-6,21-disulfate and 6- hydroxy-flibanserin-6-sulfate. These two metabolites are inactive. Efficacy: Katz M, DeRogatis LR, Ackerman R, et al. Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. J Sex Med.
    [Show full text]
  • M2021: Pharmacogenetic Testing
    Pharmacogenetic Testing Policy Number: AHS – M2021 – Pharmacogenetic Prior Policy Name and Number, as applicable: Testing • M2021 – Cytochrome P450 Initial Presentation Date: 06/16/2021 Revision Date: N/A I. Policy Description Pharmacogenetics is defined as the study of variability in drug response due to heredity (Nebert, 1999). Cytochrome (CYP) P450 enzymes are a class of enzymes essential in the synthesis and breakdown metabolism of various molecules and chemicals. Found primarily in the liver, these enzymes are also essential for the metabolism of many medications. CYP P450 are essential to produce many biochemical building blocks, such as cholesterol, fatty acids, and bile acids. Additional cytochrome P450 are involved in the metabolism of drugs, carcinogens, and internal substances, such as toxins formed within cells. Mutations in CYP P450 genes can result in the inability to properly metabolize medications and other substances, leading to increased levels of toxic substances in the body. Approximately 58 CYP genes are in humans (Bains, 2013; Tantisira & Weiss, 2019). Thiopurine methyltransferase (TPMT) is an enzyme that methylates azathioprine, mercaptopurine and thioguanine into active thioguanine nucleotide metabolites. Azathioprine and mercaptopurine are used for treatment of nonmalignant immunologic disorders; mercaptopurine is used for treatment of lymphoid malignancies; and thioguanine is used for treatment of myeloid leukemias (Relling et al., 2011). Dihydropyrimidine dehydrogenase (DPD), encoded by the gene DPYD, is a rate-limiting enzyme responsible for fluoropyrimidine catabolism. The fluoropyrimidines (5-fluorouracil and capecitabine) are drugs used in the treatment of solid tumors, such as colorectal, breast, and aerodigestive tract tumors (Amstutz et al., 2018). A variety of cell surface proteins, such as antigen-presenting molecules and other proteins, are encoded by the human leukocyte antigen genes (HLAs).
    [Show full text]
  • Clinical Efficacy of Enzalutamide Vs Bicalutamide Combined with Androgen Deprivation Therapy in Men with Metastatic Hormone-Sens
    Henry Ford Health System Henry Ford Health System Scholarly Commons Hematology Oncology Articles Hematology-Oncology 1-4-2021 Clinical Efficacy of Enzalutamide vs Bicalutamide Combined With Androgen Deprivation Therapy in Men With Metastatic Hormone- Sensitive Prostate Cancer: A Randomized Clinical Trial Ulka N. Vaishampayan Lance K. Heilbrun Paul Monk Sheela Tejwani Guru Sonpavde See next page for additional authors Follow this and additional works at: https://scholarlycommons.henryford.com/ hematologyoncology_articles Authors Ulka N. Vaishampayan, Lance K. Heilbrun, Paul Monk, Sheela Tejwani, Guru Sonpavde, Clara Hwang, Daryn Smith, Pallavi Jasti, Kimberlee Dobson, Brenda Dickow, Elisabeth I. Heath, Louie Semaan, Michael L. Cher, Joseph A. Fontana, and Sreenivasa Chinni Original Investigation | Oncology Clinical Efficacy of Enzalutamide vs Bicalutamide Combined With Androgen Deprivation Therapy in Men With Metastatic Hormone-Sensitive Prostate Cancer A Randomized Clinical Trial Ulka N. Vaishampayan, MD; Lance K. Heilbrun, PhD; Paul Monk III, MD; Sheela Tejwani, MD; Guru Sonpavde, MD; Clara Hwang, MD; Daryn Smith, MS; Pallavi Jasti, MD; Kimberlee Dobson, BS; Brenda Dickow, RN; Elisabeth I. Heath, MD; Louie Semaan, BS; Michael L. Cher, MD; Joseph A. Fontana, MD; Sreenivasa Chinni, PhD Abstract Key Points Question Is enzalutamide combined IMPORTANCE Black patients have been underrepresented in prospective clinical trials of advanced with androgen deprivation therapy prostate cancer. This study evaluated the efficacy of enzalutamide compared with bicalutamide, with associated with better outcomes than planned subset analysis of Black patients with metastatic hormone-sensitive prostate cancer treatment with bicalutamide in Black (mHSPC), which is a disease state responsive to androgen deprivation therapy (ADT). men with metastatic hormone-sensitive prostate cancer (mHSPC)? OBJECTIVE To compare the efficacy of enzalutamide vs bicalutamide in combination with ADT in men with mHSPC, with a subset analysis of Black patients.
    [Show full text]
  • Disposition of T Oxic Drugs and Chemicals
    Disposition of Toxic Drugs and Chemicals in Man, Eleventh Edition Eleventh Edition in Man and Chemicals Drugs Toxic Disposition of The purpose of this work is to present in a single convenient source the current essential information on the disposition of the chemi- cals and drugs most frequently encountered in episodes of human poisoning. The data included relate to the body fluid concentrations of substances in normal or therapeutic situations, concentrations in fluids and tissues in instances of toxicity and the known metabolic fate of these substances in man. Brief mention is made of specific analytical procedures that are applicable to the determination of each substance and its active metabolites in biological specimens. It is expected that such information will be of particular interest and use to toxicologists, pharmacologists, clinical chemists and clinicians who have need either to conduct an analytical search for these materials in specimens of human origin or to interpret 30 Amberwood Parkway analytical data resulting from such a search. Ashland, OH 44805 by Randall C. Baselt, Ph.D. Former Director, Chemical Toxicology Institute Bookmasters Foster City, California HARD BOUND, 7” x 10”, 2500 pp., 2017 ISBN 978-0-692-77499-1 USA Reviewer Comments on the Tenth Edition “...equally useful for clinical scientists and poison information centers and others engaged in practice and research involving drugs.” Y. Caplan, J. Anal. Tox. “...continues to be an invaluable and essential resource for the forensic toxicologist and pathologist.” D. Fuller, SOFT ToxTalk “...has become an essential reference book in many laboratories that deal with clinical or forensic cases of poisoning.” M.
    [Show full text]
  • Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors
    UnitedHealthcare® Community Plan Medical Benefit Drug Policy Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors Policy Number: CS2021D0042S Effective Date: March 1, 2021 Instructions for Use Table of Contents Page Related Community Plan Policies Application.......................................................................................... 1 • Macular Degeneration Treatment Procedures Coverage Rationale ........................................................................... 1 • Maximum Dosage and Frequency Definitions ........................................................................................... 3 • Oncology Medication Clinical Coverage Applicable Codes .............................................................................. 3 Background ........................................................................................ 3 Commercial Policy Clinical Evidence .............................................................................23 • Ophthalmologic Policy: Vascular Endothelial Growth U.S. Food and Drug Administration ..............................................34 Factor (VEGF) Inhibitors Centers for Medicare and Medicaid Services .............................35 References .......................................................................................35 Policy History/Revision Information..............................................39 Instructions for Use .........................................................................39 Application This Medical Benefit
    [Show full text]
  • (Flibanserin) (Flibanserin) Tablets
    ™ MEDICATION GUIDE addyi ADDYI™ (add-ee) (flibanserin) (flibanserin) Tablets Read this Medication Guide before you start taking ADDYI™ and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor. What is the most important information I should know about ADDYI? Your risk of severe low blood pressure and fainting (loss of consciousness) is increased if you take ADDYI and: • drink alcohol. Do not drink alcohol if you take ADDYI. • take certain prescription medicines, over-the-counter medicines, or herbal supplements. Do not take or start taking any prescription medicines, over-the-counter medicines, or herbal supplements while taking ADDYI until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking ADDYI. • have liver problems. Do not take ADDYI if you have liver problems. If you take ADDYI and you feel lightheaded or dizzy, lie down right away. Get emergency medical help or ask someone to get emergency medical help for you if the symptoms do not go away or if you faint (lose consciousness). If you faint (lose consciousness), tell your doctor as soon as you can. ADDYI is only available through the ADDYI Risk Evaluation and Mitigation Strategy (REMS) Program because of the increased risk of severe low blood pressure and fainting (loss of consciousness) with alcohol use. You can only get ADDYI from pharmacies that are enrolled in the ADDYI REMS Program. For more information about the Program and a list of pharmacies that are enrolled in the ADDYI REMS Program, go to www.AddyiREMS.com or call 1-844-PINK-PILL (1-844- 746-5745).
    [Show full text]
  • Full Prescribing Information for • Hypersensitivity: Discontinue XTANDI
    HIGHLIGHTS OF PRESCRIBING INFORMATION • Posterior reversible encephalopathy syndrome (PRES): These highlights do not include all the information needed to use Discontinue XTANDI. (5.2) XTANDI® safely and effectively. See full prescribing information for • Hypersensitivity: Discontinue XTANDI. (5.3) XTANDI. • Ischemic Heart Disease: Optimize management of cardiovascular XTANDI® (enzalutamide) capsules, for oral use risk factors. Discontinue XTANDI for Grade 3-4 events. (5.4) XTANDI® (enzalutamide) tablets, for oral use • Falls and Fractures occurred in 11% and 10% of patients receiving XTANDI, respectively. Evaluate patients for fracture and fall risk, Initial U.S. Approval: 2012 and treat patients with bone-targeted agents according to established guidelines. (5.5) -------------------------- RECENT MAJOR CHANGES -------------------------- • Embryo-Fetal Toxicity: XTANDI can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive Dosage and Administration – Dosing Information (2.1) 10/2020 potential to use effective contraception. (5.6, 8.1, 8.3) ------------------------------ ADVERSE REACTIONS ----------------------------- --------------------------- INDICATIONS AND USAGE -------------------------- The most common adverse reactions (≥ 10%) that occurred more frequently XTANDI is an androgen receptor inhibitor indicated for the treatment of (≥ 2% over placebo) in the XTANDI-treated patients are asthenia/fatigue, patients with: back pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, and • castration-resistant prostate cancer. (1) hypertension. (6.1) • metastatic castration-sensitive prostate cancer. (1) To report SUSPECTED ADVERSE REACTIONS, contact Astellas ---------------------- DOSAGE AND ADMINISTRATION ---------------------- Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or XTANDI 160 mg (two 80 mg tablets or four 40 mg tablets or four 40 mg www.fda.gov/medwatch. capsules) administered orally once daily.
    [Show full text]
  • Comparison of Clinical Pharmacology of Voriconazole and Posaconazole 367
    Review Despite greater knowledge and pos- sibilities in pharmacotherapy, fungal infections remain a challenge for cli- nicians. As the population of immu- Comparison of clinical nocompromised patients and those treated for their hematologic ailments pharmacology of voriconazole increases, the number of fungal infec- tions grows too. This is why there is and posaconazole still a quest for new antifungal drugs as well as for optimization of phar- macotherapy with already registered pharmaceutics. Voriconazole and posaconazole are broad-spectrum, new generation, tri- Beata M. Sienkiewicz, Łukasz Łapiński, Anna Wiela-Hojeńska azole antifungal agents. The drugs are used in the pharmacotherapy of Wroclaw Medical University, Wroclaw, Poland invasive aspergillosis, Candida and Fusarium infections. Voriconazole is also used in infections caused by Sce- dosporium. Posaconazole is used in Introduction the treatment of coccidioidomycosis Fungal infections are one of the most severe problems in clinical practice, and chromoblastomycosis. Besides some similarities, the two mentioned especially in hematology and oncology units. They make up from 9 to 10% drugs also show differences in thera- of all infections developing among hospitalized patients. Fungemia can be peutic indications, pharmacokinetics either a complication connected with the malignancy itself or an adverse (mainly absorption and metabolism), effect of the oncological treatment (chemo-, radio- and corticotherapy). Fur- frequency and severity of adverse thermore, it can influence the final
    [Show full text]