Cidofovir package insert pdf

Cidofovir injection, usp is a sterile, hypertonic aqueous solution for intravenous infusion only. Cidofovir is an antiviral used for the treatment of. Highlights of prescribing information these highlights do. The drug is also used to prevent a relapse of cmv after the initial treatment of. Highlights of prescribing information cardiac dysfunction. Signed informed consent form containing all potential serious adverse events related to cidofovir use as given on the package insert. The pharmacokinetics of cidofovir administered with probenecid were evaluated in 12 hiv. Iv foscarnet as drug of choice and state that iv cidofovir is a potential alternative. Each vial contains 375 mg5 ml cidofovir anhydrous as the active substance. No metabolites of cidofovir have been detected in serum or urine of patients. Eligible, privately insured patients may save on a qualifying prescription with the savings coupon for.

The symptoms of this uncommon disease may vary from hoarseness to severe obstruction of the airway. Hematuria, renal colic, costovertebral pain, and formation of uric acid stones associated with the use of probenecid in gouty patients may be prevented by alkalization of the urine. See full prescribing information for complete boxed warning. Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by aidsinfo. Interactions of cidofovirprobenecid and antihiv drugs or drugs used to treat common. What you need to know before you use cidofovir cidofovir must be administered by a healthcare professional. Recurrent respiratory papillomatosis rrp is a chronic and difficult to treat disease of the larynx. Cidofovir usp is a white crystalline powder with an aqueous solubility of. This medical coverage guideline must be read in its entirety to determine coverage eligibility, if any. Full prescribing information 1 indications and usage treatment with vivitrol should be part of a comprehensive management program that includes psychosocial support. However, since cmv usually causes latent infections and since foscarnet, like. Cidofovir therapy should be discontinued and intravenous hydration is advised if serum creatinine.

Discard product if it contains particulate matter, is cloudy, or discolored do not freeze. Easy to read fda package insert, drug facts, dosage read more. Product monograph, marcidofovir cidofovir for injection. Find informantion about acetadote and acetaminophen overdose, a dosage calculator, emergency. Cidofovir is contraindicated in patients who are receiving other nephrotoxic agents. Cidofovir should be considered a potential carcinogen in humans see section 5.

It has the molecular formula of c 26h 28clno c 6h 8o 7 and a molecular weight of 598. Cidofovir was the first nucleotide analogue approved for clinical use. Mar cidofovir for injection is supplied in a clear, singleuse, 5 ml glass vial containing 375 mg cidofovir as cidofovir dihydrate as a sterile, preservativefree, colorless, aqueous solution at a concentration of 75 mgml cidofovir as cidofovir. Ganciclovir or ganciclovirfoscarnetresistant isolates that are cross resistant to cidofovir have been obtained from drug naive patients and from. Cidofovir can be synthesized from a pyrimidone derivative and a protected derivative of glycidol. Material may be irritating to the mucous membranes and upper respiratory tract. Prevymis is a prescription medicine to help prevent cytomegalovirus cmv infection and disease in adults who have received an allogeneic hematopoietic stem cell bone marrow transplant. Highlights of prescribing information these highlights do not include all the information needed to use vivitrol safely and effectively. Eq 75mg baseml federal register determination that product was not discontinued or withdrawn for safety or efficacy reasons.

Caution should be applied when considering cidofovir treatment of patients with diabetes mellitus due to the potential increased risk of developing ocular hypotony. Apr 28, 2019 acetadote package insert pdf official website of iv acetadote acetylcysteine. Smallpox was eradicated more than 30 years ago, but heightened concerns over bioterrorism have brought smallpox and smallpox vaccination back to the forefront. Vivitrol naltrexone for extendedrelease injectable suspension, for intramuscular use initial u. Anterior uveitis and hypotony after intravenous cidofovir for the treatment of cytomegalovirus retinitis 1. Recurrent respiratory papillomatosis rrp is a chronic disease of the larynx which is difficult to treat. Find patient medical information for cidofovir intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. May 06, 2008 recurrent respiratory papillomatosis rrp is a chronic and difficult to treat disease of the larynx.

Privacy at baxter copyright and legal disclaimers linking disclaimers. Despite this, the drug failed to demonstrate any efficacy in controlled studies. Cidofovir is a medicine available in a number of countries worldwide. Mechanism of action cidofovir suppresses cytomegalovirus cmv. Medscape indicationspecific dosing for vistide cidofovir, frequencybased. Insert the syringe needle into the vial through the center of the stopper and direct the stream of sterile water for injection to the glass wall of the vial to avoid excessive foaming. Intravesical cidofovir for hemorrhagic cystitis full. Vistide is a sterile, hypertonic aqueous solution for. Dpi drug package insert epa environmental protection agency. It is provided as a deep red sterile liquid in vials for. Write the date of expiration of the constituted oral solution on the bottle label. Cidofovir injection fda prescribing information, side. Drug name active ingredients strength dosage formroute marketing status te code rld rs. Highlights of prescribing information these highlights do not include all the information needed to use promacta platelet count required to initiate antiviral therapy.

Vistide, inncidofovir european medicines agency europa eu. Cidofovir injection vistide is an antiviral drug used to treat an eye infection cytomegalovirus retinitis, cmv in people who are infected with the hiv virus. Cidofovir was discovered at the institute of organic chemistry and biochemistry, prague, by antonin holy, and developed by gilead sciences and is marketed with the brand name vistide by gilead in the usa, and by pfizer elsewhere. Cidofovir was approved as an intravenous treatment for aidsrelated. Not available, vistide cidofovir injection package insert. Cidofovir is used to treat the symptoms of cytomegalovirus cmv infection of the eyes cmv retinitis in patients with acquired immune deficiency syndrome aids. Cidofovir cidofovir anhydrous injection, solution dailymed. Dec 31, 2019 see the package leaflet for further information. In animal studies gcv was both carcinogenic and teratogenic and caused aspermatogenesis. Cidofovir is being investigated as a complementary intralesional therapy against papillomatosis caused by hpv. The patient package insert,which includes the dosing instructions for patients,and 2 oral dispensers should be dispensed to the patientsee patient counseling information 17. Genvoya elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide tablets, for oral use. It is supplied in clear glass vials, each containing 375 mg of anhydrous cidofovir usp in 5 ml aqueous solution at a concentration of 75 mgml.

Highlights of prescribing information these highlights do not include all the information needed to use valcyte safely and effectively. Cidofovir was well tolerated in the majority of patients. Esbriet pirfenidone capsules and filmcoated tablets, for oral use initial u. Cidofovir package insert pdf may 1, 2020posted byadmin suspension of maintenance treatment with cidofovir should be considered in accordance with local see the package leaflet for further. Vistide is a sterile, hypertonic aqueous solution for intravenous infusion only. Anterior uveitis and hypotony after intravenous cidofovir.

Cidofovir is a white crystalline powder with an aqueous solubility of. Individuals using assistive technology may not be able to fully access the information contained in this file. Probenecid is soluble in dilute alkali, in alcohol, in chloroform, and in acetone. Pharmacokinetics and safety of intravenous cidofovir for life. A list of us medications equivalent to cidofovir is available on the drugs. Argatroban package insert pdf store in original package until time of use. In vitro, cidofovir was less than 6% bound to plasma or serum proteins over the cidofovir concentration range 0. By connor th, mackenzie ba, debord dg, trout db, ocallaghan jp. Vistide cidofovir dosing, indications, interactions. In 1998, the first article was published that described the use of the antiviral substance cidofovir to treat this disease. Cidofovir was approved as an intravenous treatment for aidsrelated cmv retinitis, a potentially severe eye infection that can lead to blindness. Learn about how prevymis may be able to help keep you from getting sick from cmv, and talk to your doctor to see if prevymis is right for you. Marcidofovir is indicated for the treatment of cytomegalovirus cmv retinitis. Individuals using assistive technology may not be able to.

Reduce zinecard dosage in patients with moderate to severe renal impairment creatinine clearance values less than 40 mlmin by 50% zinecard to doxorubicin. Pharmaceutical form concentrate for solution for infusion. Several fdaapproved drug labels may be available for symfi. Acetadote package insert pdf official website of iv acetadote acetylcysteine. Pediatric blood and marrow transplant program brincidofovir cmx001 is well tolerated in highly immunocompromised pediatric patients v. Cidofovir will not cure this eye infection, but it may help to keep the symptoms from becoming worse. Find out more information about prevymis letermovir. Highlights of prescribing information valcytefor oral. Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of streptomyces coeruleorubidus.

Sideeffects of cidofovir in the treatment of recurrent. Cidofovir reference guide for safe and effective use from the american. The indication for treatment of acyclovir resistant hsv infections in immunocompromised patients with hiv infections is based primarily on the. May be harmful by inhalation, ingestion, or skin absorption. Highlights of prescribing information these highlights do not include all the information needed to use hydrea safely and effectively. The drug has been employed almost exclusively to treat cytomegalovirus cmv retinitis in patients with the acquired immunodeficiency syndrome aids. Highlights of prescribing information these highlights. Highlights of prescribing information these highlights do not include all the information needed to use esbriet safely and effectively. Vistide cidofovir dosing, indications, interactions, adverse effects. Aidsinfo provides the following drug label solely as an example of the labels available for symfi. The educational content on wikidoc drug pages is based upon the fda package insert, national library of medicine content and practice guidelines consensus statements. Sexually transmitted diseases treatment guidelines, 2010 pdf. Cidofovir injection vistide side effects, medical uses.

Probenecid is a white or nearly white, fine, crystalline powder. Niosh list of antineoplastic and other hazardous drugs in. Each vial of cytoveneiv contains the equivalent 21 of 500 mg ganciclovir as the sodium salt 46 mg sodium. Pdr drug summaries are concise pointofcare prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice pdr s drug summaries are. Fda approves cidofovir for aidsrelated retinitis news. Gently swirl the vial for at least 15 seconds to dissolve the lyophilized powder. Cidofovir is given intravenously every week for two. After incorporation into the host cell, cidofovir is phosphorylated by pyruvate kinases to its active metabolite cidofovir diphosphate. Antiviral drugs for cytomegalovirus diseases sciencedirect. Cidofovir shows antibk virus activity in a subgroup of transplant recipients. Valcytevalganciclovirtablets, valcytevalganciclovir hydrochloride fororal solution initial u.

The disease is caused by an infection with human papilloma viruses hpv. Cidofovir, brand name vistide, is an injectable antiviral medication primarily used as a. Cidofovir anhydrous is an anhydrous form of cidofovir, a synthetic, acyclic monophosphate nucleotide analog of deoxycytidine with antiviral activity, mostly used against cytomegalovirus cmv. Although the results are promising, there remains some concern about the potential carcinogenicity of cidofovir. Find informantion about acetadote and acetaminophen overdose, a dosage calculator, emergency facility. Highlights of prescribing information these highlights do not include all the information needed to use genvoya safely and effectively. Fda has approved cidofovir trade name vistide, for treating aidsassociated retinitis. Vistide cidofovir injection coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the members specific benefit plan. Cidofovir is designed to fight certain viruses by blocking the virus cells from dividing. Highlights of prescribing information these highlights do not.