Endari lglutamine oral powder is indicated to reduce the acute complications of sickle cell disease in adults and children 5 years and older. Mozobil 20 mgml solution for injection patient information leaflet. Pdf icon download leaflet view the patient leaflet in pdf format. Sep 04, 2019 mozobil plerixafor injection, solution for subcutaneous use.
Hcp website home zoladex goserelin acetate implant. If you are a female of childbearing potential you should use an effective form of contraception during. Important safety information for mozobil plerixafor injection. Before administering panhematin, consider an appropriate period. Zaltrap, in combination with fluorouracil, leucovorin, irinotecan folfiri, is indicated for the treatment of patients with metastatic colorectal cancer mcrc that is resistant to or has progressed following an oxaliplatincontaining regimen. Mozobil will be used to mobilize hematopoietic stem cells for collection prior to autologous transplantation 2. Multiple myeloma authorization of 6 months may be granted for the treatment of multiple myeloma when all of the following criteria are met. Jan 01, 2012 plerixafor mozobil is a novel small molecule that promotes the mobilization of hscs. Highlightsof prescribing information kyprolis safely and. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers e. Restricted access do not disseminate or copy without approval.
It may occur as early as the first week after start of therapy. Nipent pentostatin for injection is supplied as a sterile, apyrogenic, lyophilized powder in singledose vials for intravenous administration. In the two randomized studies in patients with nhl and mm, a total of 301 patients were treated in the mozobil and gcsf group and 292 patients were treated in the placebo and gcsf group. All members including new members requesting authorization for continuation of therapy must meet all initial authorization criteria. Each vial contains 10 mg of pentostatin and 50 mg of mannitol, usp. About stem cell transplants stem cell mobilization benefits and risks of mozobil support glossary for healthcare professionals prescribing information. Scientific studies have shown that mozobil causes harm or death to unborn animals. Mozobil plerixafor inhibits the cxcr4 chemokine receptor and blocks binding of its cognate ligand, stromal cellderived factor1. In the 3102 study, a total of 302 patients were randomized to receive plerixafor plus gcsf n 148 or placebo plus gcsf n 154. Prescribing information enclosed in the inside back cover of this brochure. Twice weekly 2056mgm2 regimen by 30minute infusion kyprolis is administered intravenously as a 30minute infusion on two consecutive days, each week for threeweeks followed by a 12day rest period as shown in table2. Reconstitution after calculating the number of vials needed, using aseptic technique, reconstitute each vial of thymoglobulin with 5 ml of sterile water for injection, usp swfi.
Therefore, mozobil is not intended for hsc mobilization and. Highlights of prescribing information initiate promacta at. Zoladex can cause fetal harm when administered to a pregnant woman. The recommended dose of mozobil by subcutaneous injection is based on body weight. Mozobil fda prescribing information, side effects and uses. Package leaflet the leaflet in every pack of medicine that contains information on the medicine for endusers, such as patients and animal owners. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus.
Sodium mozobil contains less than 1 mmol sodium 23 mg per dose, i. Information for the user mozobil 20 mgml solution for injection plerixafor read all of this leaflet carefully before you start using this medicine because it contains important information for you. Mdwise prior authorization protocol for white blood cell stimulators neupogen filgrastim. The ph of the final product is maintained between 7. Oxaliplatin 5mgml concentrate for solution for infusion. If you are pregnant, your doctor should tell you about the potential risk to the fetus. Zoladex is contraindicated during pregnancy unless used for palliative treatment of advanced breast cancer. Oxaliplatin 5mgml concentrate for solution for infusion oxaliplatin read all of this leaflet carefully before you start using this medicine keep this leaflet. Mozobil plerixafor injection, for subcutaneous use. Before getting provenge, tell your doctor about all your medical problems, including problems with your heart or lungs, or if you have had a stroke. Begin treatment with mozobil after the patient has received gcsf once daily for four days. Administration fda approved package insert, or listed in nationally recognized compendia, for the determination of medicallyaccepted indications for offlabel uses of mozobil plerixafor and 2. If you have any further questions, ask your doctor.
If you have any further questions, ask your doctor, pharmacist or nurse. Neupogen is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresissee clinical studies 14. Pegaptanib is a selective vascular endothelial growth factor vegf antagonist. There is an increased risk for pregnancy loss due to expected hormonal. Mozobil plerixafor injection official patient site. Individuals receiving mozobil in conjunction with gcsf who report left upper abdominal pain andor scapular or shoulder pain should be evaluated for splenic integrity. Plerixafor is a selective antagonist of cxcr4 used for mobilization of hematopoietic stem. Plerixafor reversibly binds and blocks cxcr4 on stem cells to inhibit interaction with. Safety data for mozobil in combination with gcsf were obtained from two randomized placebocontrolled studies 301 patients and 10 uncontrolled studies 242 patients. A pharmacokinetic study of plerixafor in subjects with varying. Mozobil, a hematopoietic stem cel1 mobilizer, is indicated in combination with grulocytecolony stimulating factor gcsf to mobilize hematopoietic stem cells to the perpheral blood for collection and subsequent. Mozobil plerixafor product monograph page 5 of 40 reactions to occur following treatment with mozobil see warnings and precautions, general. Mozobil plerixafor prior auth criteria proprietary information. Relapsed refractory multiple myeloma treatment pomalyst.
Highlights of prescribing information doses up to 1,000 u. The mix2vial transfer device must be positioned completely vertical prior to penetrating the stopper closure. Mozobil is indicated in combination with granulocytecolony stimulating factor g csf to mobilize. Plerixafor plus granulocyte colonystimulating factor. Full prescribing information 1 indications and usage ocrevus is indicated for the treatment of.
In the two randomized studies in patients with nhl and mm, a total of301 patients were treated in the mozobil and gcsf group and 292 patients were treated in the placebo and gcsf group. Genzyme corporationmozobil plerixafor injection package insert. University of alberta starts the mozobil phasei clinical. Each ml of the sterile solution contains 20 mg of plerixafor. Requirements for prior authorization of mozobil plerixafor. The text will be printed on the drugs package insert, on the fdas web pages and on many other web pages and reference books that doctors commonly use to get information on he drugs. Mozobil plerixafor rationale for inclusion in pa program. The most common side effects in clinical studies were constipation, nausea, headache, pain in the stomach area, cough, pain in the hands or feet, back pain, and chest pain. Mozobil is indicated in combination with gcsf to enhance mobilisation of haematopoietic stem cells to the peripheral. Risk for hepatic decompensationin patients with chronic hepatitis candrisk of hepatotoxicity in patients with chronic hepatitis c, promacta in combination with interferon and ribavirin may increase the risk of hepatic decompensationsee warnings and precautions 5. Relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults primary progressive ms, in adults 2 dosage and administration. Mozobil 20 mgml solution for injection patient information leaflet pil by sanofi genzyme.
It inhibits the binding of the chemokine receptor cxcr4, which is expressed on hscs, to its ligand, stromal cellderived factor1a sdf1a, secreted by bone marrow stroma cells cashen, 2009. Is being prescribed mozobil plerixafor by a bone marrow transplant specialist, hematologist or oncologist or. Mozobil plerixafor injection is a sterile, preservativefree, clear, colorless to paleyellow, isotonic solution for subcutaneous injection. Injectafer ferric carboxymaltose injection, for intravenous use initial u. Examples of unacceptable toxicity include the following. If you get any side effects talk to your doctor,pharmacist or nurse. Highlights of prescribing information valcytefor oral. Macugen solution is supplied in a singledose, prefilled syringe. Mozobil can harm the unborn child when administered to a pregnant woman. Mozobil plerixafor is a hematopoietic stem cell mobilizer indicated in. The nccn compendium is a derivative work of the nccn guidelines. Aortitis has been reported in patients receiving filgrastim products. These highlights do not include all the information needed to use. Mozobil, a hematopoietic stem cell mobilizer, is indicated in combination.
Mozobil will not be used beyond 4 consecutive days or after completion of stem cell harvestapheresis. Patients were primarily treated with mozobil at daily doses of 0. Mozobil is indicated in combination with gcsf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either. Median exposure to mozobil in these studies was 2 days range 1 to 7 days. Mozobil plerixafor dosing, indications, interactions. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. Refer to the dexamethasone prescribing information for other information on that product.
Administer mozobil approximately for 11 hours prior to initiation of apheresis for up to 4 consecutive days. Introduction hematopoietic stem cells hscs are primitive cells capable of both self renewal and producing progenitor cells that can differentiate into all the cells of the hematopoietic system figure 1. Multiple sclerosis ms only prescribers registered in the ms touch prescribing program may prescribe tysabri for multiple sclerosis see warnings and precautions 5. Mozobil is indicated in combination with granulocytecolony stimulating factor gcsf to mobilize. Administer mozobil approximately 11 hours prior to initiation of each apheresis for up to 4 consecutive days. Please see full prescribing information on each of our product pages for fdaapproved indications and dosage. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of mozobil while maintaining optimal therapeutic outcomes. A black box warning is a serious warning placed inside a black box in the fdamandated drug labeling. Jun 17, 2019 mozobil plerixafor injection is a sterile, preservativefree, clear, colorless to paleyellow, isotonic solution for subcutaneous injection.
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