Pomalyst Package Insert

Initial REMS Approval 8/2010 Most Recent Modification 9/2014
Initial REMS Approval 8/2010 Most Recent Modification 9/2014 . THALOMID ® (thalidomide) NDA # 020785 Celgene Corporation 86 Morris Avenue Summit, NJ 07901 ... Fetch Doc

UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program ...
A. Pomalyst will be approved based on the following criterion: (1) Patient does not show evidence of progressive disease while on Pomalyst therapy Authorization will be issued for 12 months. 3. Additional Clinical Rules: Supply limits may be in place. 4. References: 1. Pomalyst [package insert]. Summit, NJ: Celgene Corporation; April 2015. 2. ... Access Document

---WARNI NGS A D PRECAUTIONS HIGHLIGHTS OF PRESCRIBING ...
FULL PRESCRIBING INFORMATION WARNING: EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM EMBRYO-FETAL TOXICITY If thalidomide is taken during pregnancy, it can cause severe birth defects or embryo-fetal death. ... Content Retrieval

HIGHLIGHTS OF PRESCRIBING INFORMATION These ... - Folotyn
Dosage and Administration (2.1, 2.2, 2.3) 5/2012 Warnings and Precautions, Risk of Increased Toxicity in the Presence of Impaired Renal Function (5.6) 5/2012 -----INDICATIONS AND USAGE----- FOLOTYN is a folate analog metabolic inhibitor indicated for the treatment of ... Access Doc

Imnovid EPAR Summary Updated IA-01
A risk management plan has been developed to ensure that Imnovid is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imnovid , including the appropriate precautions to be followed by healthcare professionals and patients. ... Retrieve Doc

Sample Exam & Answer Key (Correct Answers Highlighted In Yellow)
(Correct answers highlighted in yellow) 1 Pomalidomide (Pomalyst) is a useful agent for treating multiple myeloma. Which of the following is The following is in the package insert (label) for Panitumumab (Vectibix): Approved for use in treating ... Retrieve Full Source

HIGHLIGHTS OF PRESCRIBING INFORMATION Venous Thromboembolism ...
Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information. 2.5 Recommended Dosage for ATC The recommended dose of MEKINIST is 2 mg orally taken once daily in combination with dabrafenib until disease recurrence or unacceptable toxicity. Refer to the dabrafenib prescribing information for recommended ... Fetch This Document

From Www.bloodjournal.org For Personal Use Only.
Pomalidomide (Pomalyst) package insert. Summit, NJ: Celgene Corporation; 2014. 9. Attal M, Lauwers-Cances V, Marit G, et al; IFM Investigators. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012; ... Document Retrieval

NCCN Submission Pomalidomide Daratumumab Dexamethasone (DPd ...
POMALYST is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome ... Retrieve Document

PURPOSE OF THE POLICY STATEMENT OF THE POLICY PROCEDURES
PURPOSE OF THE POLICY. Health Alliance Medical Plans will approve the use of Pomalyst when the following criteria have been met: PROCEDURES . 1. Coverage Criteria. 3.1 Pomalyst [ package insert] Celgene Corporation Summit, NJ 07901 . Health . ... Retrieve Content

A Phase 1b Study Of Durvalumab (MEDI4736) Alone Or In ...
A Phase 1b Study of Durvalumab (MEDI4736) Alone or in Combination With Pomalidomide With or Without Low-Dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma ... Retrieve Content

HIGHLIGHTS OF PRESCRIBING INFORMATION ABRAXANE
ABRAXANE is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. 2 DOSAGE AND ADMINISTRATION . 2.1 Metastatic Breast Cancer . ... Doc Retrieval

High-Priced Drugs: Estimates Of Annual Per-Patient ...
Trial data detailed in the package insert and noted in the Appendix Footnotes; • For those medications having an indefinite duration of use (e.g., dosing until disease progression), the average duration of use was estimated from clinical trial data included in the package insert and noted in the Appendix Footnotes. Otherwise, 12 months of use was ... Get Content Here

Pomalidomide And Dexamethasone (Pom-Dex) With Or Without ...
POMALYST® (pomalidomide) capsules, for oral use [package insert]. DARZALEX® (daratumumab) injection, for intravenous use [package insert]. Horsham, PA: Janssen Biotech, Inc; 2018. 10. Chari A, et al. Presented at: Annual Meeting of the American Society of ... Read Full Source

LETTER Pomalidomide Is Teratogenic In Rats And Rabbits And ...
LETTER Pomalidomide is teratogenic in rats and rabbits and can be neurotoxic in humans We are concerned about the conclusions 4 Pomalyst (Pomaliomide; US Package Insert). Summit, NJ: Celgene ... Read Content

Submitted By: Eulena Horne, PharmD - Oncology
FDA Clearance: POMALYST is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion ... Visit Document

Celgene ist ein amerikanisches Pharmaunternehmen, das sich auf die Herstellung von Arzneimitteln gegen Krebserkrankungen und Krankheiten des Immunsystems spezialisiert hat.Der Sitz von Celgene befindet sich in Summit, New Jersey.Das sich als biopharmaceutical company beschreibende Unternehmen beschäftigt rund 7.500 Mitarbeiter bei einem Umsatz von 13,0 Mrd. ... Read Article

FARYDAK® (panobinostat) Oral Capsule
(thalidomide), Revlimid (lenalidomide), Pomalyst (pomalidomide)]. Continued approval for this indication may be Package Insert. Revised by manufacturer 2/2016. Accessed 05-23-2016. Farydak. Package Insert. Revised by manufacturer 2/2015. Accessed 05-08-2015. ... View This Document

Medical Department Procedure Manual - Home - AvMed
3.1 Medical Department staff has access to the Medical Department Procedure Manual and receives notice from management when procedures are developed, updated and/or revised, or archived. (Pomalyst) 2.0 Request for 1. Darzalex [package insert]. Horsham, PA; Janssen Biotech, Inc. November ... Get Content Here

Blue Cross And Blue Shield Of Vermont And The Vermont Health ...
Blue Cross and Blue Shield of Vermont and The Vermont Health Plan Prior Approval Guidelines POMALYST® (pomalidomide) Starting dose of POMALYST is 4 mg once daily orally on Days 1-21 Pomalyst® product package insert, ... View This Document