Hepatitis b virus hbv reactivation hbv reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Relapsed or refractory, lowgrade or follicular, cd20positive, bcell nhl as a single agent. Cangene corporation confidential and proprietary page 2 of 27 full prescribing information 1 indications and usage ixinity is a coagulation factor ix recombinant indicated in adults and children. Pfizer rxpathways connects eligible patients, regardless of their insurance status, to a range of assistance programs that offer insurance support, copay help, and medicines for free or at a savings. Shake onfi oral suspension well before every administration. Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large bcell lymphoma in adults who have had at least 2 prior therapies. Dailymed kariva desogestrelethinyl estradiol and ethinyl. Csl behring immune globulin intravenous human, 10% liquid privigen us package insert july 2007 page 4 version 10. Infusion reactions and cardiopulmonary arrest 1 indications and usage 1. The recommended dose is 100 mgm2 administered intravenously over 30 minutes on days 1 and 2 of a 28day cycle, up to 6 cycles. Highlights of prescribing information infusionrelated. Highlights of prescribing information these highlights do not include all the information needed to use picato gel safely and effectively. See full prescribing information for additional information on the administration and preparation of xenleta tablets and injection.
Serious infections leading to hospitalization or death including. Betapace af, sotalol hydrochloride, is an antiarrhythmic drug with class ii betaadrenoreceptor blocking and class iii cardiac action potential duration prolongation properties. Dec 17, 2018 mesnex mesna is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. 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. Rituxan fda prescribing information, side effects and uses. Use relistor with caution in patients with known or suspected lesions of the gi tract. Rituximab is a genetically engineered chimeric mousehuman monoclonal antibody. Previously untreated follicular, cd20positive, bcell nhl in combination with first line chemotherapy and, in patients achieving a complete or partial response to. Rituxan can increase your risk of getting infections and can lower the ability of your immune system to fight infections. Nardil should not be used in patients who are hypersensitive to the drug or its ingredients, with pheochromocytoma, congestive heart failure, severe renal impairment or renal disease, a history of liver disease, or abnormal liver function tests.
The ph of the final product is maintained between 7. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for imdur isosorbide mononitrate. The following list does not include adverse reactions. Store neurontin capsules and tablets between 68f to 77f 20c to 25c. Highlights of prescribing information the dose for ra in. Screen all patients for hbv infection before treatment initiation, and monitor patients during and after. Highlights of prescribing information for intravenous. Within 4 hours after rituximab infusion, administer 0. Highlights of prescribing information these highlights do not include all the information needed to use hydrea safely and effectively. Fludarabine phosphate injection, usp is a sterile solution intended for intravenous administration. This solution is readytouse and may be administered directly to the patient without further preparation. Ninlaro ixazomib capsules, for oral use hepatotoxicity.
Highlights of prescribing information in patients with severe. Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. Rituxan rituximab injection, for intravenous use initial u. Pba occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing andor crying. Highlights of prescribing information childpugh class b. Nipent pentostatin for injection is supplied as a sterile, apyrogenic, lyophilized powder in singledose vials for intravenous administration. Advise pregnant womenof the potential risk to a fetus. Full prescribing information 1 indications and usage ocrevus is indicated for the treatment of. Highlights of prescribing information these highlights. If side effects occur, the infusion should be slowed or stopped until the symptoms subside. Lcysteine hydrochloride hydrate 10 mg, sodium bisul.
Light orange gelatin capsule imprinted with takeda on the cap and 4 mg on the body in black ink. Rituxan rituximab is indicated for the treatment of patients with. Place thumb and index finger on the outside of the package, on top of the ends. Product information imuran tablets and powder for injection. The active ingredient, mesna, is a synthetic sulfhydryl compound designated as sodium2mercaptoethane sulfonate with a molecular formula of c 2 h 5 nao 3 s 2 and a molecular weight of 164. Actemra subcutaneous formulation is not intended for. Immune globulin intravenous human, 10% liquid privigen.
Highlights of prescribing information coadministration with. Full prescribing information 1 indications and usage nuedexta is indicated for the treatment of pseudobulbar affect pba. After receiving rituxan, some people have developed low levels. Cimzia is a biologic treatment for multiple chronic inflammatory conditions.
The reconstituted vial contains 20 mgml dalbavancin as a clear, colorless to yellow solution. On july 23, 2019, the fda approved pfizers abla for ruxience rituximab pvvr, a biosimilar of genentechs rituxan. Mar 05, 2018 package insert profilnine sd pdf 280kb supporting documents. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for rituxan rituximab skip to. For sc administration, preferably using a 1ml polypropylene syringe fitted with a disposable 21 to 27gauge x 0. Rituximab 375 mgm2 cyclophosphamide 750 mgm2 doxorubicin 50 mgm2 day 1 rest period prednisone 100 mgm2 day 1 day 2 day 3 day 4 day 5 rest period dosing may continue for two more cycles for a total of eight cycles if response is first seen at cycle 6. Each 50 ml vial of mabthera 500mg concentrate for intravenous iv infusion contains 500 mg of rituximab. Types of serious infections that can happen with rituxan include bacterial, fungal, and viral infections. Titrate the astagraf xl dosage based on clinical assessments of rejection and tolerability, and to achieve target trough concentration ranges. Rituxan rituximab is indicated for the treatment of adult patients with. Store neurontin oral solution in the refrigerator between 36f to 46f 2c to 8c. Relistor tablets and relistor injection are indicated for the treatment of opioidinduced constipation oic in adults with chronic noncancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent e. Supporting documents older than three years profilnine sd factor ix complex. Sample coding information and resources for denials and appeals.
Tepezza teprotumumabtrbw for injection, for intravenous use. Fatal infusionrelated reactions, severe mucocutaneous reactions, hepatitis b virus reactivation and progressive multifocal leukoencephalopathy see full prescribing information for complete boxed warning. Mononine fda prescribing information, side effects and uses. Mabthera 500 mg concentrate for solution for infusion each ml contains 10 mg of rituximab. Administer rituxan and in111zevalin 79 days prior to rituxan and y90 zevalin. According to its approved package insert, ruxience is indicated for the treatment of certain types of nonhodgkins lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis wegeners granulomatosis, and microscopic polyangiitis. Risk of serious infections see full prescribing information for complete boxed warning. Administer polivy, bendamustine, and rituximab product in any order on day 1 of each cycle. Withdraw the reconstituted solution into the syringe. Jakafi is indicated for treatment of intermediate or highrisk myelofibrosis mf, including primary mf, postpolycythemia vera mf and postessential thrombocythemia mf in adults. The recommended dose is 100 mgm2 administered intravenously over 10 minutes on days 1 and 2 of a 28day cycle, up to 6 cycles. General information about the safe and effective use of neurontin. Please refer to the full prescribing information of fulvestrant.
Aseptically transfer the required dose of reconstituted dalbavancin solution. The recommended dose of bendamustine is 90 mgm day on day 1 and 2 when administered with polivy and a rituximab product. Imuran is available in film coated tablets and powder for injection. Since grapefruit juice is known to inhibit cyp3amediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, do not drink grapefruit juice during treatment with oral amiodarone see drug interactions 7. Ninlaro 4 mg capsules contain 4 mg of ixazomib equivalent to 5. Apr 30, 2017 kariva desogestrelethinyl estradiol and ethinyl estradiol tablets usp provides an oral contraceptive regimen of 21 white, round tablets each containing 0. Pull the solid white rod from the package and put it back in the package laying it carefully alongside the insertion tube, making sure the distal end of the rod remains sterile. Each carton includes two syringes, but only one syringe should be used for dosing. Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction see warnings and. The approval of polivy is based on a type of response rate.
Recommended dose for rheumatoid arthritis ra administer rituxan as two mg intravenous infusions separated by. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. In vivo, nilutamide interacts with the androgen receptor and prevents the normal androgenic response. If response to mg daily is inadequate, increase dose to 1500 mg daily. Highlights of prescribing information do not shake during. Mar 23, 2020 insert the vented filter spike into the stopper of the mononine vial, invert the vial, and position the filter spike so that the orifice is at the inside edge of the stopper. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for aricept donepezil.
Avandia is not recommended in patients with symptomatic heart failure. When administering the oral suspension, use only the oral dosing syringe provided with the product. Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. Naropin may be associated with adverse reactions which are characteristic of those associated with other amidetype local anesthetics. Insert the syringe needle into the vial through the dosage in adult kidney transplant recipients nulojix should be administered in combination with basiliximab induction, mycophenolate mofetil mmf, and corticosteroids. Rituxan rituximab for ra, nhl, cll, gpa, mpa, and pv. They also contain the excipients hypromellose, lactose, macrogol 400, magnesium stearate, starchmaize, starchpregelatinised maize and stearic acid. Follicular lymphoma as an initial treatment with chemotherapy and, in patients whose initial treatment was successful, as a singleagent followup therapy. Each bag contains the following inactive ingredients.
Committed to helping patients access the rituxan they need. Highlights of prescribing information these highlights do. The second oral syringe is reserved as a replacement in case the first syringe is damaged or lost. To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. Initiation of avandia in patients with established nyha class iii or iv heart failure is contraindicated. Refer to the zevalin package insert for full prescribing information regarding the zevalin therapeutic regimen. Imuran film coated tablets contain either 25 mg or 50 mg of the active azathioprine. Each ml of the sterile solution contains 20 mg of plerixafor.
Advise patients to discontinue therapy with relistorand promptly notify their physician if they develop severe, persistent, andor worsening abdominal symptoms. Relapsed or refractory, lowgrade or follicular, cd20positive, bcell nhl as a single agent previously untreated follicular, cd20positive, bcell nhl in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituxan in. Each 10 ml vial of mabthera 100mg concentrate for intravenous iv infusion contains 100 mg of rituximab. Follicular lymphoma fl as a singleagent therapy in patients whose disease recurred or did not respond to initial treatment. Ervebo ebola zaire vaccine, live suspension for intramuscular injection. Gazyva dosing and administration guide indications gazyva is a cd20directed cytolytic antibody and is indicated. See full prescribing information including boxed warning on serious infections. Hypersensitivity to any component of paragard including. When given with kisqali, the recommended dose of fulvestrant is 500 mg administered on days 1, 15, 29, and once monthly thereafter. Perform venipuncture using the enclosed winged needle with microbore tubing. In vitro, nilutamide blocks the effects of testosterone at the androgen receptor level.
Fda approves ruxience, pfizers rituximab biosimilar. Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide. Relistor methylnaltrexone bromide injection, solution. Prophylaxis of dvt following hip or knee replacement surgery. Saxenda liraglutide injection, for subcutaneous use. Enhertu famtrastuzumab deruxtecannxki for injection, for intravenous use. Advise females of reproductive potential to use effective contraception while receiving dacogenand for 6 months following the last. Sirturo is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients 12 to less than 18. The recommended dose of rituximab product is 375 mgm. Rituxan rituximab is indicated, in combination with fludarabine and cyclophosphamide fc, for the treatment of patients with previously untreated and previously treated cd20positive cll.
In preclinical studies in mice and rats, decitabine caused adverse developmental outcomes includingembryofetal lethality and malformations. In combination with chemotherapy followed by gazyva monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage ii bulky, iii or iv follicular lymphoma fl. When used as part of the zevalin therapeutic regimen, infuse 250 mgm 2 in accordance with the zevalin package insert. If blood appears in the syringe, the product can no longer be used. Keep neurontin and all medicines out of the reach of children. Download and submit our new forms for simpler, faster and more intuitive enrollment. Mozobil plerixafor injection is a sterile, preservativefree, clear, colorless to paleyellow, isotonic solution for subcutaneous injection. Dose delays, dose modifications and reinitiation of therapy for cll. When given with kisqali, refer to the full prescribing information for the recommended dose of the aromatase inhibitor being used. Cytoxan cyclophosphamide for injection, usp cytoxan. Administer rituxan hycela 1,400 mg23,400 units on day 1 of cycles 28 of chop chemotherapy for up to 7 cycles. Discontinue the injection and discard the syringe and the needle reconstitute a new dose for the. Each vial contains 10 mg of pentostatin and 50 mg of mannitol, usp. Naropin ropivacaine hcl injection a fresenius kabi site.
1452 106 148 288 1524 1351 1497 1366 298 159 962 164 870 1485 636 1190 277 1359 525 1418 1354 842 1233 1103 1194 1150 1170 1371 835 465 1546 1103 512 1409 1461 458 6 1354 1057 1242 504 934 687