                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    {"id":6771,"date":"2020-04-28T10:18:15","date_gmt":"2020-04-28T10:18:15","guid":{"rendered":"https:\/\/zuviuslifesciences.in\/old\/?post_type=product&#038;p=6771"},"modified":"2020-07-14T07:00:43","modified_gmt":"2020-07-14T07:00:43","slug":"zuviplexa-inj","status":"publish","type":"product","link":"https:\/\/zuviuslifesciences.in\/old\/product\/zuviplexa-inj\/","title":{"rendered":"Zuviplexa Inj"},"content":{"rendered":"<p>[vc_row][vc_column][vc_tta_tour color=&#8221;peacoc&#8221; active_section=&#8221;1&#8243;][vc_tta_section title=&#8221;Description&#8221; tab_id=&#8221;1588004385633-ad9771ae-2161&#8243;][vc_column_text]<span style=\"font-weight: 400;\">ZUVIPLEXA is Plerixafor injection. It is Clear, colourless to pale yellow solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor. Each single-use vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Plerixafor is a\u00a0hematopoietic\u00a0stem cell\u00a0mobilizer with a chemical name l, 1\u2019-[1,4phenylenebis(methylene)]-bis-1,4,8,11-tetraazacyclotetradecane. It has the molecular formula C<\/span><span style=\"font-weight: 400;\">28<\/span><span style=\"font-weight: 400;\">H<\/span><span style=\"font-weight: 400;\">54<\/span><span style=\"font-weight: 400;\">N<\/span><span style=\"font-weight: 400;\">8<\/span><span style=\"font-weight: 400;\">. The molecular weight of plerixafor is 502.79 g\/mol. The structural formula is as below.<\/span><\/p>\n<table style=\"height: 276px;\" width=\"462\">\n<tbody>\n<tr>\n<td><img loading=\"lazy\" class=\" wp-image-6782 aligncenter\" src=\"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Untitled4.jpg?resize=435%2C254&#038;ssl=1\" alt=\"Untitled4\" width=\"435\" height=\"254\" srcset=\"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Untitled4.jpg?resize=300%2C175&amp;ssl=1 300w, https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Untitled4.jpg?w=346&amp;ssl=1 346w\" sizes=\"(max-width: 435px) 100vw, 435px\" data-recalc-dims=\"1\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">Plerixafor is a CXCR4 chemokine receptor antagonist that blocks the binding of stromal cell-derived factor 1\u03b1. It inhibits the retention of haematopoietic stem cells in bone marrow, and increases their number in peripheral blood. In patients with non-Hodgkin\u2019s lymphoma or multiple myeloma, plerixafor is used, with granulocyte colony-stimulating factor (G-CSF), to mobilise stem cells for collection and subsequent autologous transplantation.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Composition&#8221; tab_id=&#8221;1593174996108-031fc94e-54cf&#8221;][vc_column_text]<\/p>\n<h3>Composition<\/h3>\n<p><span style=\"font-weight: 400;\">Each ml of the sterile solution contains:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Plerixafor\u2026\u2026\u2026\u2026\u2026\u202620mg<\/span><\/p>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Mechanism of Action&#8221; tab_id=&#8221;1584624217032-a15849ed-97bb&#8221;][vc_column_text]<span style=\"font-weight: 400;\">Plerixafor is a bicyclam derivative, a selective reversible antagonist of the CXCR4 chemokine receptor and blocks binding of its cognate ligand, stromal cell-derived factor-1\u03b1 (SDF-1\u03b1), also known as CXCL12. Plerixafor-induced leukocytosis and elevations in circulating haematopoietic progenitor cell levels are thought to result from a disruption of CXCR4 binding to its cognate ligand, resulting in the appearance of both mature and pluripotent cells in the systemic circulation. CD34+ cells mobilised by plerixafor are functional and capable of engraftment with long-term repopulating capacity.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Pharmacokinetics&#8221; tab_id=&#8221;1584624217050-ebb8ae5e-43a6&#8243;][vc_column_text]<span style=\"font-weight: 400;\">The pharmacokinetics of plerixafor have been evaluated in lymphoma and multiple myeloma patients at the clinical dose level of 0.24 mg\/kg following pre-treatment with G-CSF (10 \u03bcg\/kg once daily for 4 consecutive days).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Absorption<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Plerixafor is rapidly absorbed following subcutaneous injection, reaching peak concentrations in approximately 30 to 60 minutes (t<\/span><span style=\"font-weight: 400;\">max<\/span><span style=\"font-weight: 400;\">). Following subcutaneous administration of a 0.24 mg\/kg dose to patients after receiving 4-days of G-CSF pre-treatment, the maximal plasma concentration (C<\/span><span style=\"font-weight: 400;\">max<\/span><span style=\"font-weight: 400;\">) and systemic exposure (AUC<\/span><span style=\"font-weight: 400;\">0-24<\/span><span style=\"font-weight: 400;\">) of plerixafor were 887 \u00b1 217 ng\/ml and 4337 \u00b1 922 ng\u00b7hr\/ml, respectively.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Distribution<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Plerixafor is moderately bound to human plasma proteins up to 58%. The apparent volume of distribution of plerixafor in humans is 0.3 l\/kg demonstrating that plerixafor is largely confined to, but not limited to, the extravascular fluid space.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Biotransformation<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Plerixafor is not metabolised\u00a0<\/span><i><span style=\"font-weight: 400;\">in vitro<\/span><\/i><span style=\"font-weight: 400;\">\u00a0using human liver microsomes or human primary hepatocytes and does not exhibit inhibitory activity\u00a0<\/span><i><span style=\"font-weight: 400;\">in vitro<\/span><\/i><span style=\"font-weight: 400;\">\u00a0towards the major drug metabolising CYP450 enzymes (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4\/5). In<\/span><i><span style=\"font-weight: 400;\">\u00a0in vitro<\/span><\/i><span style=\"font-weight: 400;\">\u00a0studies with human hepatocytes, plerixafor does not induce CYP1A2, CYP2B6, and CYP3A4 enzymes. These findings suggest that plerixafor has a low potential for involvement in P450-dependent drug-drug interactions.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Elimination<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The major route of elimination of plerixafor is urinary. Following a 0.24 mg\/kg dose in healthy volunteers with normal renal function, approximately 70% of the dose was excreted unchanged in urine during the first 24 hours following administration. The elimination half-life (t<\/span><span style=\"font-weight: 400;\">1\/2<\/span><span style=\"font-weight: 400;\">) in plasma is 3 to 5 hours. <\/span><span style=\"font-weight: 400;\">In patients with renal impairment, the rate of elimination has been found to be reduced.\u00a0<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Indications&#8221; tab_id=&#8221;1584624459062-96fb7e5b-0e23&#8243;][vc_column_text]<span style=\"font-weight: 400;\">Plerixafor is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly.<\/span><\/p>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Dosage And Administration&#8221; tab_id=&#8221;1584624839401-59481bbb-bdc7&#8243;][vc_column_text]<span style=\"font-weight: 400;\">Plerixafor therapy should be initiated and supervised by a physician experienced in oncology and\/or haematology. The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Age over 60 and\/ or prior myelosuppressive chemotherapy and\/or extensive prior chemotherapy and\/or a peak circulating stem cell count of less than 20 stem cells\/microliter, have been identified as predictors of poor mobilisation.<\/span><\/p>\n<p><b>Adult<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Administer daily morning doses of G-CSF 10 micrograms\/kg for 4 days prior to the first evening dose of Plerixafor and on each day prior to apheresis.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The recommended daily dose of plerixafor by subcutaneous injection (SC), given 6 to 11 hours before starting apheresis, usually for up to 4 consecutive days, is:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> 20 mg fixed dose or 0.24 mg\/kg of body weight for patients weighing \u2264 83 kg.<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> 0.24 mg\/kg of body weight for patients weighing &gt; 83 kg.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Use the patient\u2019s actual body weight to calculate the volume of Plerixafor to be administered.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Each vial delivers 1.2 mL of 20 mg\/mL solution, and the volume to be administered to patients should be calculated from the following equation:\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">0.012 \u00d7 patient\u2019s actual body weight (in kg) = volume to be administered (in mL).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In clinical studies, Plerixafor dose has been calculated based on actual body weight in patients up to 175% of ideal body weight. Plerixafor dose and treatment of patients weighing more than 175% of ideal body weight have not been investigated.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ideal body weight can be determined using the following equations:<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><span style=\"font-weight: 400;\">Male (kg):<\/span><\/td>\n<td><span style=\"font-weight: 400;\">50 + 2.3 x ((Height (cm) x 0.394) \u2013 60);<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Female (kg):<\/span><\/td>\n<td><span style=\"font-weight: 400;\">45.5 + 2.3 x ((Height (cm) x 0.394) \u2013 60).<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">Based on increasing exposure with increasing body weight, the plerixafor dose should not exceed 40 mg\/day.<\/span><\/p>\n<p><b>Special populations<\/b><\/p>\n<p><b>Renal impairment<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Patients with creatinine clearance 20-50 ml\/min should have their dose of plerixafor reduced by one-third to 0.16 mg\/kg\/day (see table below). Clinical data with this dose adjustment are limited. There is insufficient clinical experience to make alternative posology recommendations for patients with a creatinine clearance &lt;20 ml\/min, as well as to make posology recommendations for patients on haemodialysis.<\/span><\/p>\n<p><b>Recommended Dosage of Plerixafor in Patients with Renal Impairment<\/b><\/p>\n<table>\n<tbody>\n<tr>\n<td rowspan=\"2\"><b>Estimated Creatinine Clearance (mL\/min)<\/b><\/td>\n<td colspan=\"2\"><b>Dose<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Body Weight less than or equal to 83 kg<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Body Weight greater than 83 kg and less than 160 kg<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">greater than 50<\/span><\/td>\n<td><span style=\"font-weight: 400;\">20 mg or 0.24 mg\/kg once daily<\/span><\/td>\n<td><span style=\"font-weight: 400;\">0.24 mg\/kg once daily (not to exceed 40 mg\/day)<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">less than or equal to 50<\/span><\/td>\n<td><span style=\"font-weight: 400;\">13 mg or 0.16 mg\/kg once daily<\/span><\/td>\n<td><span style=\"font-weight: 400;\">0.16 mg\/kg once daily (not to exceed 27 mg\/day)<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">There is insufficient information to make dosage recommendations in patients on hemodialysis.<\/span><\/p>\n<p><b>Paediatric population<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The safety and efficacy of Plerixafor in pediatric patients have not been established in controlled clinical studies.\u00a0<\/span><\/p>\n<p><b>Elderly patients (&gt; 65 years old)<\/b><\/p>\n<p><span style=\"font-weight: 400;\">No dose modifications are necessary in elderly patients with normal renal function. Dose adjustment in elderly patients with creatinine clearance \u2264 50 ml\/min is recommended (see Renal impairment above). In general, care should be taken in dose selection for elderly patients due to the greater frequency of decreased renal function with advanced age.<\/span><\/p>\n<p><b>Method of administration<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Plerixafor is for subcutaneous injection. Each vial is intended for single use only.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Vials should be inspected visually prior to administration and not used if there is particulate matter or discolouration. Since Plerixafor is supplied as a sterile, preservative-free formulation, aseptic technique should be followed when transferring the contents of the vial to a suitable syringe for subcutaneous administration.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section tab_id=&#8221;1584625017135-3ffdd9c5-1bd6&#8243; title=&#8221;Warnings&#8221;][vc_column_text]<span style=\"font-weight: 400;\">Tumour cell mobilisation in patients with lymphoma and multiple myeloma<\/span><\/p>\n<p><span style=\"font-weight: 400;\">When Plerixafor is used in conjunction with G-CSF for haematopoietic stem cell mobilisation in patients with lymphoma or multiple myeloma\u201a tumour cells may be released from the marrow and subsequently collected in the leukapheresis product.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Since in clinical studies mobilization with Plerixafor is achieved in combination with GSF, based on the limited experience, it is not possible to conclude on increase in mobilization of tumour cells from lymphoma or multiple myeloma because of Plerixafor over and above that from G-CSF. Further, the effect of potential reinfusion of tumor cells has not been well studied.<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Tumour cell mobilisation in leukaemia patients<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In a compassionate use programme, Plerixafor and G-CSF have been administered to patients with acute myelogenous leukaemia and plasma cell leukaemia. In some instances, these patients experienced an increase in the number of circulating leukaemia cells. For the purpose of haematopoietic stem cell mobilisation, plerixafor may cause mobilisation of leukaemic cells and subsequent contamination of the apheresis product. Therefore, plerixafor is not recommended for haematopoietic stem cell mobilisation and harvest in patients with leukaemia.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Haematological effects<\/span><\/p>\n<p><i><span style=\"font-weight: 400;\">Hyperleukocytosis<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">Administration of Plerixafor in conjunction with G-CSF increases circulating leukocytes as well as haematopoietic stem cell populations. White blood cell counts should be monitored during Plerixafor therapy. Clinical judgment should be exercised when administering Plerixafor to patients with peripheral blood neutrophil counts above 50 x 10<\/span><span style=\"font-weight: 400;\">9<\/span><span style=\"font-weight: 400;\">\/L.<\/span><\/p>\n<p><i><span style=\"font-weight: 400;\">Thrombocytopenia<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">Thrombocytopenia is a known complication of apheresis and has been observed in patients receiving Plerixafor.<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><span style=\"font-weight: 400;\">Platelet counts should be monitored in all patients receiving Plerixafor and undergoing apheresis.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Allergic reactions<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Plerixafor has been uncommonly associated with potential systemic reactions related to subcutaneous injection such as urticaria, periorbital swelling, dyspnoea, or hypoxia. Symptoms responded to treatments (e.g., antihistamines, corticosteroids, hydration or supplemental oxygen) or resolved spontaneously. Cases of anaphylactic reactions, including anaphylactic shock, have been reported from world-wide post-marketing experience. Appropriate precautions should be taken because of the potential for these reactions.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Vasovagal reactions<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Vasovagal reactions, orthostatic hypotension, and\/or syncope can occur following subcutaneous injections. Appropriate precautions should be taken because of the potential for these reactions.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Effect on the spleen<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In preclinical studies, higher absolute and relative spleen weights associated with extramedullary haematopoiesis were observed following prolonged (2 to 4 weeks) daily plerixafor subcutaneous administration in rats at doses approximately 4 fold higher than the recommended human dose.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The effect of plerixafor on spleen size in patients has not been specifically evaluated in clinical studies. Cases of splenic enlargement and\/or rupture have been reported following the administration of Plerixafor in conjunction with growth factor G-CSF. Individuals receiving Plerixafor in conjunction with G-CSF who report left upper abdominal pain and\/or scapular or shoulder pain should be evaluated for splenic integrity.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section tab_id=&#8221;1588004155234-9eb27d85-6ba1&#8243; title=&#8221;Precautions&#8221;][vc_column_text]<b>Women of childbearing potential<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Women of childbearing potential should use effective contraception during treatment.<\/span><\/p>\n<p><b>Pregnancy<\/b><\/p>\n<p><span style=\"font-weight: 400;\">There are no adequate data on the use of plerixafor in pregnant women.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Based on the pharmacodynamic mechanism of action, plerixafor is suggested to cause congenital malformations when administered during pregnancy. Studies in animals have shown teratogenicity. Plerixafor should not be used during pregnancy unless the clinical condition of the woman requires treatment with plerixafor.<\/span><\/p>\n<p><b>Breast-feeding<\/b><\/p>\n<p><span style=\"font-weight: 400;\">It is unknown whether plerixafor is excreted in human milk. A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued during treatment with Plerixafor.<\/span><\/p>\n<p><b>Fertility<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The effects of plerixafor on male and female fertility are not known.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Adverse Reactions (Side Effects)&#8221; tab_id=&#8221;1588004219145-c96da97e-bf1f&#8221;][vc_column_text]<span style=\"font-weight: 400;\">Summary of the safety profile<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Safety data for Plerixafor in conjunction with G-CSF in oncology patients with lymphoma and multiple myeloma were obtained from 2 placebo-controlled Phase III studies (301 patients) and 10 uncontrolled Phase II studies (242 patients). Patients were primarily treated with daily doses of 0.24 mg\/kg plerixafor by subcutaneous injection. The exposure to plerixafor in these studies ranged from 1 to 7 consecutive days (median = 2 days).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In the two Phase III studies in non-Hodgkin&#8217;s lymphoma and multiple myeloma patients (AMD3100-3101 and AMD3100-3102, respectively), a total of 301 patients were treated in the Plerixafor and G-CSF group and 292 patients were treated in the placebo and G-CSF group. Patients received daily morning doses of G-CSF 10 \u03bcg\/kg for 4 days prior to the first dose of plerixafor or placebo and on each morning prior to apheresis. Adverse reactions that occurred more frequently with Plerixafor and G-CSF than placebo and G-CSF and were reported as related in \u22651% of the patients who received Plerixafor, during haematopoietic stem cell mobilisation and apheresis and prior to chemotherapy\/ablative treatment in preparation for transplantation are shown in Table 1.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">From chemotherapy\/ablative treatment in preparation of transplantation through 12 months post-transplantation, no significant differences in the incidence of adverse reactions were observed across treatment groups.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Tabulated list of adverse reactions<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Adverse reactions are listed by System Organ Class and frequency. Frequencies are defined according to the following convention: very common (\u2265 1\/10); common (\u2265 1\/100 to &lt; 1\/10); uncommon (\u2265 1\/1,000 to &lt; 1\/100), rare (\u2265 1\/10,000 to &lt; 1\/1,000); very rare (&lt; 1\/10,000); not known (cannot be estimated from the available data).<\/span><\/p>\n<p><b>Table 1. Adverse reactions occurring more frequently with Plerixafor than placebo and considered related to Plerixafor during mobilisation and apheresis in phase III studies.<\/b><\/p>\n<table>\n<tbody>\n<tr>\n<td colspan=\"2\"><b>Blood and lymphatic system disorders<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Not known<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Splenomegaly, splenic rupture**<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><b>Immune system disorders<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Uncommon<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Allergic reaction*<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Anaphylactic reactions, including anaphylactic shock**<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><b>Psychiatric disorders<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Common<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Insomnia<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Uncommon<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Abnormal dreams, nightmares<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><b>Nervous system disorders<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Common<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Dizziness, headache<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><b>Gastrointestinal disorders<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Very common<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Diarrhoea, nausea<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Common<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Vomiting, abdominal pain, stomach discomfort, dyspepsia, abdominal distention, constipation, flatulence, hypoaesthesia oral, dry mouth<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><b>Skin and subcutaneous tissue disorders<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Common<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Hyperhidrosis, erythema<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><b>Musculoskeletal and connective tissue disorders<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Common<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Arthralgia, musculoskeletal pain<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"2\"><b>General disorders and administration site conditions<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Very common<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Injection and infusion site reactions<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Common<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Fatigue, malaise<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p><i><span style=\"font-weight: 400;\">*\u00a0<\/span><\/i><span style=\"font-weight: 400;\">The frequency of allergic reactions presented is based on adverse reactions that occurred in the oncology studies (679 patients). Events included one or more of the following: urticaria (n = 2), periorbital swelling (n = 2), dyspnoea (n = 1) or hypoxia (n = 1). These events were generally mild or moderate and occurred within approximately 30 min after Plerixafor administration.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">** From post-marketing experience<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The adverse reactions reported in patients with lymphoma and multiple myeloma who received Plerixafor in the controlled Phase III studies and uncontrolled studies, including a Phase II study of Plerixafor as monotherapy for haematopoietic stem cell mobilisation, are similar. No significant differences in the incidence of adverse reactions were observed for oncology patients by disease, age, or gender.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Drug Interactions&#8221; tab_id=&#8221;1588004246143-da131a40-78a3&#8243;][vc_column_text]<span style=\"font-weight: 400;\">No interaction studies have been performed.\u00a0<\/span><i><span style=\"font-weight: 400;\">In vitro<\/span><\/i><span style=\"font-weight: 400;\">\u00a0tests showed that plerixafor was not metabolised by P450 CYP enzymes, did not inhibit or induce P450 CYP enzymes. Plerixafor did not act as a substrate or inhibitor of P-glycoprotein in an\u00a0<\/span><i><span style=\"font-weight: 400;\">in vitro<\/span><\/i><span style=\"font-weight: 400;\">\u00a0study.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Overdose And Contradiction&#8221; tab_id=&#8221;1588004284140-0d63f957-72bf&#8221;][vc_column_text]<span style=\"font-weight: 400;\">No case of overdose has been reported. Based on limited data at doses above the recommended dose and up to 0.48 mg\/kg the frequency of gastrointestinal disorders, vasovagal reactions, orthostatic hypotension, and\/or syncope may be higher.<\/span><\/p>\n<p><b>CONTRAINDICATIONS\u00a0<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Plerixafor is contraindicated in patients having hypersensitivity to the active substance or to any of the excipients of the formulation.<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Storage&#8221; tab_id=&#8221;1588004331495-1ab925f1-7cf0&#8243;][vc_column_text]<span style=\"font-weight: 400;\">Store at 25<\/span><span style=\"font-weight: 400;\">0 <\/span><span style=\"font-weight: 400;\">C (77<\/span><span style=\"font-weight: 400;\">0<\/span><span style=\"font-weight: 400;\">F); excursions permitted to 15 to 30<\/span><span style=\"font-weight: 400;\">0<\/span><span style=\"font-weight: 400;\"> C (59<\/span><span style=\"font-weight: 400;\">0<\/span><span style=\"font-weight: 400;\">\u2013 86<\/span><span style=\"font-weight: 400;\">0<\/span><span style=\"font-weight: 400;\"> F).<\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Presentation&#8221; tab_id=&#8221;1588004354380-1368228c-d47c&#8221;][vc_column_text]<span style=\"font-weight: 400;\">Carton containing single use vial.<\/span>[\/vc_column_text][\/vc_tta_section][\/vc_tta_tour][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p><strong>\u00a0Plerixafor Inj &#8211; 200mg<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">Plerixafor is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilize poorly.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"featured_media":7335,"template":"","meta":{"spay_email":""},"product_cat":[66,176,67],"product_tag":[175,174],"jetpack-related-posts":[{"id":6689,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/dazine-inj\/","url_meta":{"origin":6771,"position":0},"title":"Dazine Inj","date":"April 25, 2020","format":false,"excerpt":"Dacarbazine Inj - 200 MG, 500MG Dazine is indicated in the treatment of metastatic malignant melanoma, Hodgkin' disease as a secondary-line therapy when used in combination with other effective agents, neuroblastoma, soft-tissue sarcoma including leiomyosarcoma","rel":"","context":"Similar post","img":{"alt_text":"Dazine 200mg & 500mg_3_000 x 1000px","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Dazine-200mg-500mg_3_000-x-1000px.jpg?fit=1000%2C1000&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6701,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/z-blastin-inj\/","url_meta":{"origin":6771,"position":1},"title":"Z-Blastin Inj","date":"April 26, 2020","format":false,"excerpt":"Vinblastine Inj - 10MG \u00a0","rel":"","context":"Similar post","img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/image-10-3.jpg?fit=615%2C385&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6743,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/z-cristin-inj\/","url_meta":{"origin":6771,"position":2},"title":"Z-cristin Inj","date":"April 27, 2020","format":false,"excerpt":"Vincristine Inj - 1MG Vincristine sulfate injection is indicated in acute leukemia. Vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin\u2019s disease, non\u2013Hodgkin\u2019s malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms\u2019 tumor.","rel":"","context":"Similar post","img":{"alt_text":"Z-cristin","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/image-44.jpg?fit=615%2C385&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6750,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/zemecon-inj\/","url_meta":{"origin":6771,"position":3},"title":"Zemecon Inj","date":"April 27, 2020","format":false,"excerpt":"Fosaprepitant Inj - 150 MG Fosaprepitant for Injection is a substance P\/neurokinin-1 (NK,) receptor antagonist indicated in adults for use in combination with other antiemetic agents for the: prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose\u2026","rel":"","context":"Similar post","img":{"alt_text":"Zemecon","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Zemecon-150mg_1_1000-x-1000px.jpg?fit=1000%2C1000&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6673,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/zuviplat-inj\/","url_meta":{"origin":6771,"position":4},"title":"Zuviplat Inj","date":"April 25, 2020","format":false,"excerpt":"Cisplatin\u00a0 Inj- 10MG, 50MG ZUVIPLAT can be used itself or in addition to other modalities or preferable in established combination therapy with other approved chemotherapeutic agents. It is indicated in metastatic ovarian turnovers, squamous cell carcinoma of the head and neck, and advanced bladder carcinoma.","rel":"","context":"Similar post","img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Zuviplat-Group-1_1000-x-1000px.jpg?fit=1000%2C1000&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6717,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/zolon-inj\/","url_meta":{"origin":6771,"position":5},"title":"Zolon Inj","date":"April 27, 2020","format":false,"excerpt":"Oxaliplatin Inj - 150MG 100MG 50MG Oxaliplatin is indicated in the treatment of metastatic colorectal cancers after the failure of treatment of fluoropyrimidines, alone by monochemotherapy or along with fluoropyrimidines. \u00a0","rel":"","context":"Similar post","img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zuviuslifesciences.in\/old\/wp-content\/uploads\/2020\/04\/Zolon-Group-2_1000-x-1000px.jpg?fit=1000%2C1000&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/product\/6771"}],"collection":[{"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/media\/7335"}],"wp:attachment":[{"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/media?parent=6771"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/product_cat?post=6771"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/zuviuslifesciences.in\/old\/wp-json\/wp\/v2\/product_tag?post=6771"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}