The percentage of patients who were alive and disease-free at 6 months was 74.9% with nivolumab and 60.3% with placebo (hazard ratio for disease recurrence or death, 0.70; 98.22% CI, 0.55 to 0.90. Nivolumab - Advanced Melanoma (Unresectable or Metastatic Melanoma) Nivolumab plus Ipilimumab - Advanced Melanoma (Unresectable or Metastatic Melanoma) Nivolumab - Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck, which is Platinum Resistant or Refractory Nivolumab - Adjuvant Treatment for Completely Resected Stage III or IV. Nivolumab o nivolumab en combinación con ipilimumab se deben suspender de forma permanente por insuficiencia suprarrenal grave (Grado 3) o por insuficiencia suprarrenal que pueda resultar potencialmente mortal (Grado 4). La monitorización de la función suprarrenal y los niveles hormonales debe continuar para asegurar que se ha utilizado el. Nivolumab or nivolumab in combination with ipilimumab. Patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1) 7dehood 0rglilfkh gho wudwwdphqwr udffrpdqgdwh shu 23',92 r shu 23',92 lq dvvrfld]lrqh 5hd]lrqh dyyhuvd lppxqr fruuhodwd 6hyhulwj 0rglilfd gho wudwwdphqwr 3roprqlwh lppxqr fruuhodwd 3roprqlwh gl judgr frpsohwdw
120( '2 0(',&$0(172 23',92 pj po frqfhqwudgr sdud vroxomr sdud shuixvmr &20326,d2 48$/,7$7,9$ ( 48$17,7$7,9$ &dgd po gh frqfhqwudgr sdud vroxomr sdud shuixvmr frqwpp pj gh qlyroxpd Nivolumab is an antibody that blocks the normal, constitutive signaling via the PD-1/PL-L1 signaling pathway, where the desired result is activation of T cells. Nivolumab enhances immune response against various cancers. But an unfortunate consequence of this activation is increased immune response against the patient's own tissues and organs Nivolumab is a human immunoglobulin G4 monoclonal antibody, which binds to the programmed death-1 (PD-1) receptor thereby potentiating an immune response to tumour cells
Ipilimumab and nivolumab. Ipilimumab and nivolumab are types of cancer treatment called immunotherapy. They are used together to treat: melanoma skin cancer that has spread (advanced) or can't be removed with surgery (unresectable) some people with advanced kidney cancer. Find out more about your cancer type Nivolumab (anti-PD-1) is a genetically engineered, fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed death-1 (PD-1,PCD-1) with immune checkpoint inhibitory and antineoplastic activities. MW : 143.597 KD OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin. OPDIVO (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic minutes, followed by ipilimumab 3 mg/kg administered as an intravenous infusion over 90 minutes 1 Nivolumab is a fully human IgG4 antibody targeting the immune checkpoint programmed death receptor-1 (PD-1). 6 This antibody was produced entirely in mice and grafted onto human kappa and IgG4 Fc region with the mutation S228P for additional stability and reduced variability. 5 It was developed by Bristol Myers Squibb. 6
Nivolumab was associated with significant improvements in overall survival and progression-free survival, as compared with dacarbazine, among previously untreated patients who had metastatic melanoma without a BRAF mutation. (Funded by Bristol-Myers Squibb; CheckMate 066 ClinicalTrials.gov number, N Opdivo (nivolumab) is an FDA approved immunotherapy cancer drug treatment that is showing great promise for treating various types of cancer, including melan..
Nivolumab is a highly selective humanised monoclonal IgG4 antibody that binds to the checkpoint receptor PD-1 on activated T cells. and blocks its interaction with PD-L1 and PD-L2, releasing the PD-1 pathway-mediated inhibition of immune response against tumour cells Nivolumab : Mécanisme d'action. Le nivolumab est un anticorps monoclonal humain (HuMAb) de type immunoglobuline G4 (IgG4), qui se lie au récepteur PD-1 (programmed death-1) et bloque son interaction avec PD-L1 et PD-L2.Le récepteur PD-1 est un régulateur négatif de l'activité des cellules T, et il a été démontré qu'il est impliqué dans le contrôle de la réponse immunitaire des. 纳武单抗OPDIVO(nivolumab)是一款治疗药物,用于先前有过治疗的晚期鳞状非小细胞肺癌(NSCLC) 患者。于2015年6月22日,美国FDA同意审评百时美施贵宝PD-1抑制剂OPDIVO(nivolumab)
Nivolumab o nivolumab in associazione ad ipilimumab può alterare lievemente la capacità di guidare veicoli e di usare macchinari. In considerazione delle potenziali reazioni avverse quali stanchezza (vedere paragrafo 4.8), i pazienti devono essere avvertiti di usare cautela nella guida di veicoli e nell'uso di macchinari finché non siano sicuri che nivolumab non interferisca. Se liste over medicin, der indeholder Nivolumab. Sundhedsstyrelsen anbefaler nu vaccination af gravide i 2. eller 3. trimester samt ammende med mRNA-vaccine mod COVID-1 nivolumab decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.. Nivolumab. Anticuerpo monoclonal humano de tipo inmunoglobulina G4 (IgG4) (HuMAb) que se une al receptor de muerte programada 1 (PD-1) y bloquea su interacción con PD-L1 y PD-L2. Nivolumab potencia las respuestas de los linfocitos-T incluyendo respuestas antitumorales, por medio del bloqueo de PD-1, evitando su unión a los ligandos PD-L1 y PD-L2 効果・効能. 通常、成人にはニボルマブ(遺伝子組換え)として、1回240mgを2週間間隔又は1回480mgを4週間間隔で点滴静注する。. ただし、悪性黒色腫における術後補助療法の場合は、投与期間は12ヵ月間までとする。. 根治切除不能な悪性黒色腫に対してイピリ.
Nivolumab therapy prolonged OS but missed statistical significance for the primary endpoint. At minimum follow-up of 22.8 months, the OS analysis showed that it did not meet the predefined threshold of statistical significance (p = 0.0419). However, OS was improved with nivolumab over sorafenib The nivolumab + ipilimumab arm met the prespecified primary endpoint threshold of 6 MPRs in 21 patients, achieving a 38% MPR rate (8/21). We observed a 22% MPR rate (5/23) in the nivolumab arm.. Nivolumab is the first PD-1 inhibitor to show superior OS, along with PFS benefit and an acceptable safety profile, in combination with chemotherapy versus chemotherapy alone in previously untreated patients with advanced gastric, gastro-oesophageal junction, or oesophageal adenocarcinoma. Nivolumab plus chemotherapy represents a new standard first-line treatment for these patients Posts about nivolumab written by straightouttasotham. i was watching footage of myself the other night with a tremendous director (and even more tremendous friend) and another special new cohort of mine. the clip is from only a few weeks ago, and i'm talking about all of
Nivolumab removes the PD-1 shield to allow your immune system to find and attack melanoma cells. Ipilimumab essentially turns on the immune response, allowing T cells to begin the attack on melanoma. Nivolumab then removes the immune protection that cancer cells put up to defend themselves from attacks. Nivolumab and ipilimumab are systemic. Opdivo (nivolumab) has been approved for the treatment of people with lung adenocarcinoma (a type of non-small cell lung cancer), squamous cell carcinoma of the lungs (another type of non-small cell lung cancer), metastatic melanoma, Hodgkin disease, head and neck cancer, Merkel cell carcinoma, and renal cell carcinoma (kidney cancer)
Nivolumab can commonly cause itching or a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction The effects of nivolumab, on the developing human fetus are unknown. For this reason women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 5 months after the last dose of nivolumab January 4, 2021. Danielle Ternyila. Bristol Myers Squibb has withdrawn the indication of nivolumab for the treatment of patients with small cell lung cancer who had disease progression after a platinum-based chemotherapy and at least 1 other line of therapy from the US market following a consultation with the FDA Nivolumab skal infunderes via et in-line filter med porestørrelse 0,2-1,2 mikrometer. Forligelighed ved infusion Må ikke blandes med andre infusionsvæsker eller tilsættes andre farmaka. Holdbarhed Opbevares i køleskab (2-8ºC) beskyttet mod lys. Må ikke fryses Nivolumab has been studied and shown to be efficacious independent of etiology. It has also shown benefit in Child-Pugh B and elderly patients. Given the favorable safety profile and the potential.
Nivolumab and chemotherapy can be considered a new first-line treatment option in advanced or recurrent gastric or gastroesophageal junction cancer. ATTRACTION-4 was similar to CheckMate 649 except for two important differences: It was performed in Asian patients only, and the primary endpoints were designed for all-comers, rather than for a. The monoclonal antibodies ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1) have shown remarkable antitumor activity in an increasing number of cancers. When combined, ipilimumab and nivolumab have demonstrated superior activity in patients with metastatic melanoma (CHECKMATE-067). Here we describe the preclinical development strategy that predicted these clinical results 옵디보(Opdivo) 또는 니볼루맙(Nivolumab)은 일본[오노약품공업]](ONO)이 개발한 면역항암제를 말한다.. 3세대 면역항암제는 1960~70년대 1세대 세포독성항암제, 2000년대 초반의 2세대 표적항암제에 이어, 암치료의 새로운 패러다임이다. 사이언스지는 2013년 '올해의 연구'(breakthrough of the year)로 면역항암제를. Nivolumab infusion is compatible with PVC and polyolefin containers, glass bottles, PVC infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
Nivolumab er et IgG 4 og har derfor potensiale til å overføres fra mor til foster. Nivolumab anbefales ikke under graviditet eller til kvinner som kan bli gravide som ikke bruker sikker prevensjon, med mindre klinisk nytte oppveier potensiell risiko. Kvinner i fertil alder må bruke sikker prevensjon i minst 5 måneder etter siste dose Generic Name: Nivolumab. Nivolumab is the generic name for the trade drug name Opdivo®. In some cases, health care professionals may use the generic name nivolumab when referring to the trade name Opdivo®. Nivolumab is a targeted therapy. It is a human programmed death receptor-1 (PD-1) blocking antibody OPDIVO (nivolumab (rch)) is a fully human anti-PD-1 monoclonal antibody (IgG4) produced in mammalian (Chinese hamster ovarycells by recombinant DNA technology.) Excipient with known effect. Each 1 mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium Ipilimumab and Nivolumab are both antibodies. An antibody is a protein that attaches to other cells to fight off infection. The antibodies in ipilimumab work by not allowing cancer cell growth. The antibodies in nivolumab work by causing programmed cell death of the cancer cells
Nivolumab blocks an immune checkpoint protein on T cells called PD-1 and is already broadly used to treat melanoma and many other cancer types. Other drugs that target LAG-3 have been developed, but relatlimab is the furthest along in clinical research. However, it has not yet been approved by the Food and Drug Administration for use outside of. Nivolumab is a fully human immunoglobulin G4 programmed death-1 (PD-1) checkpoint inhibitor antibody that selectively blocks the interaction of the PD-1 receptor with its known ligands, programmed death ligand-1 (PD-L1) and programmed death ligand-2 (PD-L2), disrupting signals that downmodulate T-cell activation and proliferation. 1 Nivolumab has significant clinical activity either as. NIVOLUMAB is a monoclonal antibody. It treats certain types of cancer. Some of the cancers treated are colon cancer, head and neck cancer, Hodgkin lymphoma, lung cancer, and melanoma. Compare PD inhibitors In the nivolumab plus ipilimumab cohort, patients were randomized between January 4 and September 26, 2016. Treatment group information was blinded after randomization. Median follow-up was 30.7 months. Data cutoff for this analysis was January 2019. Patients were recruited at 31 centers in 10 countries/territories in Asia, Europe, and North.
PBS Schedule search for nivolumab Did you mean? Drug Name [ Alirocumab, Avelumab, Denosumab, Dupilumab, Durvalumab] Refine search. To refine your search select one of the options below. Body System: Antineoplastic And Immunomodulating Agents (60) Schedule:. Neoadjuvant Nivolumab Plus Chemo Improves Pathological Complete Response in Resectable NSCLC. The CheckMate-816 trial is the first positive phase 3 trial demonstrating a significant improvement in pathologic response with neoadjuvant immunotherapy plus chemotherapy in resectable non-small cell lung cancer. The addition of nivolumab (Opdivo) to.
The median time from randomisation to administration of subsequent systemic therapy was NR (95% CI, 59.6-NR) with nivolumab plus ipilimumab and 25.2 months (95% CI, 16.0-43.2) with nivolumab alone compared with 8.0 months (95% CI, 6.5-8.7) with ipilimumab. At 60 months among patients who were alive and followed on study, 112/151 (74%), 75. Nivolumab. Nivolumab is an IgG4 fully human antibody targeting PD1 that is approved for unresectable or metastatic melanoma, metastatic NSCLC after platinum-based chemotherapy, and metastatic renal cell carcinoma in the second line setting, at a dose of 3 mg/kg Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular. Nivolumab binds to PD-1 with high affinity and specificity, and effectively inhibits the interaction between PD-1 and its ligands. In vitro assays demonstrated the ability of nivolumab to potently enhance T-cell responses and cytokine production in the mixed lymphocyte reaction and superantigen or cytomegalovirus stimulation assays Opdivo (Nivolumab) treatment costs. The cost for a monthly or yearly treatment of Opdivo (Nivolumab) depends on your prescription requirements which includes the dosage in mg/ml and medicine type (Single vial). The price of the medicines you see on sale is the cost set by the manufacturer
NIVOLUMAB BMS 10 mg/ml, solution à diluer pour perfusion 1 flacon(s) en verre de 4 ml (CIP : 34009 550 076 1 6) 1 flacon(s) en verre de 10 ml (CIP : 34009 550 076 2 3) Toutes nos publications sur Nivolumab, a fully human, monoclonal, antiprogrammed death-1 (PD-1) antibody, was the first PD-1 inhibitor to demonstrate clinically meaningful activity in NSCLC. 15 Nivolumab is approved in the United States, the European Union, and other countries for second-line treatment of advanced NSCLC, based on improved overall survival (OS) and a. A Novel PD-1 Inhibitor for Advanced Melanoma. On December 22, 2014, the FDA approved nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma and disease progression after ipilimumab therapy and, if the patient is positive for a BRAF V600 mutation, after treatment with a BRAF inhibitor.10,11 Nivolumab is a monoclonal antibody that blocks. 서울대학교암병원 335 암예방 캠페인 영양 3. 5. 매일 3끼 균형잡힌 식사 5가지 이상 채소 섭취 운동 3.5. 하루 30분씩 일주일에 5번 운동 체중 3.5. 체질량 지수 23이하로 유지하고 25넘지 않 Nivolumab is given alone to treat melanoma, non-small cell lung cancer (NSCLC), Hodgkin lymphoma, head and neck cancer, urothelial cancer, advanced RCC, colorectal cancer, or hepatocellular carcinoma, it is usually
increased hunger, thirst, and urination. indigestion. mental depression. pains in the stomach, side, or abdomen, possibly radiating to the back. redness of the eye. sensitivity of the eyes to light. skin rash. swelling of the face, feet, or lower legs. tearing Nivolumab (Opdivo) es un medicamento que se emplea en el tratamiento de varios tipos de cáncer.Pertenece al grupo de los anticuerpos monoclonales.Se une al receptor de muerte programada 1 (PD-1) de los linfocitos T. [1] [2] Indicaciones. Tratamiento en monoterapia de cáncer de pulmón no microcítico de histología no escamosa, localmente avanzado o metastásico después de quimioterapia previa Nivolumab binds to a completely different area than pembrolizumab. These results provide the basis for the design of future inhibitory molecules targeting PD-1. Programmed cell death 1 (PD-1) is a.
Nivolumab geeft auto-immuun bijwerkingen die ontstaan door een te actief immuunsysteem. Wanneer het immuunsysteem geactiveerd is, kan het soms lichaamseigen cellen beginnen aanvallen. Met andere woorden: de witte bloedcellen zijn 'over'actief en veroorzaken een soort ontstekingsreactie. Dat ka This single-arm, phase I dose-escalation trial ([NCT02983045][1]) evaluated bempegaldesleukin (NKTR-214/BEMPEG), a CD122-preferential IL2 pathway agonist, plus nivolumab in 38 patients with selected immunotherapy-naïve advanced solid tumors (melanoma, renal cell carcinoma, and non-small cell lung cancer). Three dose-limiting toxicities were reported in 2 of 17 patients during dose. Nivolumab is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain. Patients and treatment. The clinical characteristics of the patients are shown in Table 1.A total of 28 patients with a diagnosis of metastatic (n = 26) or unresectable (n = 2) soft tissue or bone sarcoma received IV nivolumab every 2 weeks; median age was 57 years, female to male ratio was 14:14, ECOG performance status was 0-1 for 24 patients, and 2 for the remaining 4 patients
LBA6_PR - Nivolumab (nivo) plus chemotherapy (chemo) versus chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma (EAC): First results of the CheckMate 649 stud Nivolumab is an immuno-oncology drug.Annotated peptide sequences for this antibody are available from its IMGT/mAb-DB record.Sequence analysis of the light and heavy chain variable region peptides of nivolumab shows exact matches with claimed peptide sequences of monoclonal 5C4 contained in patent WO2006121168 This phase 1-2 study evaluated brentuximab vedotin (BV) combined with nivolumab (Nivo) as first salvage therapy in patients with relapsed/refractory (r/r) classical Hodgkin lymphoma (cHL). In parts 1 and 2, patients received staggered dosing of BV and Nivo in cycle 1, followed by same-day dosing in cycles 2 to 4
Purpose: We conducted a phase I/II study to investigate the safety and efficacy of nivolumab with paclitaxel plus ramucirumab. Patients and Methods: Patients with advanced gastric cancer (AGC) refractory to first-line chemotherapy were included. Patients received nivolumab (3 mg/kg on days 1 and 15) combined with paclitaxel (80 mg/m2 on days 1, 8, and 15) and ramucirumab (8 mg/kg on days 1 and. Nivolumab is a prescription drug indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab.. Nivolumab is also indicated for the treatment of. ニボルマブ(Nivolumab). 免疫チェックポイント阻害剤の一つで、商品名は「オプジーボ」といいます。. 分子標的治療薬の一つで、ヒト型抗ヒトPD-1モノクローナル抗体医薬品です。. Tリンパ球上にあるPD-1とがん細胞表面にあるPD-L1が結合するとTリンパ球は.
OPDIVO ® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received. FDA-Approved Indications. KEYTRUDA is a prescription medicine used to treat a kind of lung cancer called non-small cell lung cancer (NSCLC).. KEYTRUDA may be used with the chemotherapy medicines pemetrexed and a platinum as your first treatment when your lung cancer has spread (advanced NSCLC) and is a type called nonsquamous and your tumor does not have an abnormal EGFR or ALK gene Nivolumab is the first systemic immunotherapy to demonstrate a statistically significant and clinically meaningful improvement in outcomes when administered as adjuvant therapy to patients with muscle-invasive urothelial carcinoma, lead author Dean Bajorin, MD, the Frederick R. Adler Senior Faculty Chair at Memorial Sloan Kettering Cancer.
Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or. OPDIVO ® (nivolumab) is a prescription medicine used in combination with YERVOY ® (ipilimumab) to treat adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR.
PFS also favored nivolumab (HR, 0.84; 95% CI, 0.72-0.99; P = .0331). The most common treatment-related adverse events of any grade were fatigue (34.7%) and pruritus (15.5%) with nivolumab and fatigue (34.5%) and stomatitis (29.5%) with everolimus. HRQOL improved from baseline with nivolumab but remained the same or deteriorated with everolimus OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H. Based on its mechanism of action and data from animal studies, OPDIVO can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death Opdivo (Nivolumab) is an immunotherapy drug for advanced non-small cell lung cancer. Learn about the use of Opdivo for those with recurrent mesothelioma 上海陶术生物科技有限公司致力于服务化合物筛选领域,可提供新药研发过程中从虚拟筛选到实体化合物分子供应、从对明确靶点的分子对接到对明确分子的多靶点筛选、从高通量筛选到化学结构优化的全流程服务
Studies employing nivolumab, pembrolizumab or MDPL3280A in combination with target therapies or chemotherapic agents and trials with PD-L1 expression evaluated in tumor infiltrating immune cells, or different assay from IHC, were excluded as well. Search Strategy. Deadline for trial publication and/or presentation was February 15 th, 2015 Nivolumab comes as a liquid to be injected into a vein over 30 minutes by a doctor or nurse in a hospital or medical facility. When nivolumab is given alone to treat melanoma, non-small cell lung cancer (NSCLC), Hodgkin lymphoma, head and neck cancer, urothelial cancer, advanced RCC, colorectal cancer, esophageal cancer, or hepatocellular.
Median response duration was 28.4 months (95% CI, 4.9 months to not reached) with nivolumab/ipilimumab and 9.7 months with nivolumab (95% CI, 4.2-23.1 months). Grade 3 or higher treatment-related adverse events occurred in 49 of 124 patients (39.5%) who received nivolumab/ipilimumab and in 41 of 123 (33.3%) who received nivolumab alone OPDIVO (nivolumab) Is Added to a Thalidomide Analogue and Dexamethasone 6 16ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Immunogenicity 6.3 Postmarketing Experience 8 USE IN SPECIFIC POPULATIONS Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOG