Vistide

Name: Vistide

Vistide Usage

Take Vistide exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Vistide at the same time.

What is Vistide (cidofovir)?

Cidofovir is an antiviral medication that prevents certain viral cells from multiplying in your body.

Cidofovir is used to treat an eye infection called cytomegalovirus retinitis (CMV) in people who have AIDS (acquired immunodeficiency syndrome). Cidofovir is not a cure for CMV or AIDS.

Cidofovir is for treating CMV only in people who have AIDS.

Cidofovir may also be used for purposes not listed in this medication guide.

Vistide (cidofovir) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • symptoms of kidney failure--swelling, rapid weight gain, little or no urinating, increased thirst, loss of appetite, constipation, pain in your side or lower back;

  • symptoms of a blood cell disorder--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, pale skin, cold or flu symptoms, cough, feeling light-headed or short of breath;

  • signs of pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  • vision changes, white patches on your eyes; or

  • cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath.

Common side effects may include:

  • nausea, vomiting, diarrhea;

  • weakness;

  • headache; or

  • hair loss.

Probenecid is given together with cidofovir, and probenecid may cause:

  • nausea, vomiting;

  • skin rash;

  • fever, chills; or

  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Introduction

Antiviral; purine nucleotide analog of cytosine.3 5 7 10 11 12 13 14 15 18 21 24

Advice to Patients

  • Advise patients that cidofovir is not a cure for CMV retinitis; they may continue to experience progression of retinitis during or following treatment.1 Regular ophthalmologic examinations are necessary.1

  • Advise HIV-infected patients receiving zidovudine to temporarily discontinue zidovudine or decrease the zidovudine dose by 50% on days cidofovir is administered.1

  • The major toxicity of cidofovir is renal impairment; dosage adjustments or discontinuance may be required.1 Importance of closely monitoring renal function (routine urinalysis, serum creatinine) during cidofovir therapy.1

  • Importance of maintaining adequate hydration and taking concomitant probenecid to minimize risk of renal impairment.1

  • Advise patients that cidofovir causes tumors (principally mammary adenocarcinomas) in animals and should be considered a potential carcinogen in humans.1

  • Advise women that only limited numbers of women were enrolled in clinical trials evaluating cidofovir.1

  • Advise patients that cidofovir caused reduced testes weight and hypospermia in animals; such changes may occur in humans and cause infertility.1

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Advise women of childbearing potential to use effective contraception during and for 1 month after cidofovir therapy. Men should be advised to practice barrier contraceptive methods during and for 3 months after cidofovir treatment.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Before Using Vistide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Cidofovir can cause serious side effects, including possible cancer and trouble in having children later. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of cidofovir in the elderly with use in other age groups.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amikacin
  • Dibekacin
  • Foscarnet
  • Framycetin
  • Gentamicin
  • Kanamycin
  • Neomycin
  • Netilmicin
  • Pentamidine
  • Streptomycin
  • Tobramycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Kidney disease—Cidofovir can cause harmful effects on the kidney

Precautions

General

Due to the potential for increased nephrotoxicity, doses greater than the recommended dose must not be administered and the frequency or rate of administration must not be exceeded (see DOSAGE AND ADMINISTRATION).

Vistide is formulated for intravenous infusion only and must not be administered by intraocular injection. Administration of Vistide by infusion must be accompanied by oral probenecid and intravenous saline prehydration (see DOSAGE AND ADMINISTRATION).

Uveitis/Iritis

Uveitis or iritis was reported in clinical trials and during postmarketing in patients receiving Vistide therapy. Treatment with topical corticosteroids with or without topical cycloplegic agents should be considered. Patients should be monitored for signs and symptoms of uveitis/iritis during Vistide therapy.

Information for Patients

Patients should be advised that Vistide is not a cure for CMV retinitis, and that they may continue to experience progression of retinitis during and following treatment. Patients receiving Vistide should be advised to have regular follow-up ophthalmologic examinations. Patients may also experience other manifestations of CMV disease despite Vistide therapy.

HIV-infected patients may continue taking antiretroviral therapy, but those taking zidovudine should be advised to temporarily discontinue zidovudine administration or decrease their zidovudine dose by 50%, on days of Vistide administration only, because probenecid reduces metabolic clearance of zidovudine.

Patients should be informed of the major toxicity of Vistide, namely renal impairment, and that dose modification, including reduction, interruption, and possibly discontinuation, may be required. Close monitoring of renal function (routine urinalysis and serum creatinine) while on therapy should be emphasized.

The importance of completing a full course of probenecid with each Vistide dose should be emphasized. Patients should be warned of potential adverse events caused by probenecid (e.g., headache, nausea, vomiting, and hypersensitivity reactions). Hypersensitivity/allergic reactions may include rash, fever, chills and anaphylaxis. Administration of probenecid after a meal or use of antiemetics may decrease the nausea. Prophylactic or therapeutic antihistamines and/or acetaminophen can be used to ameliorate hypersensitivity reactions.

Patients should be advised that cidofovir causes tumors, primarily mammary adenocarcinomas, in rats. Vistide should be considered a potential carcinogen in humans (See Carcinogenesis, Mutagenesis, & Impairment of Fertility). Women should be advised of the limited enrollment of women in clinical trials of Vistide.

Patients should be advised that Vistide caused reduced testes weight and hypospermia in animals. Such changes may occur in humans and cause infertility. Women of childbearing potential should be advised that cidofovir is embryotoxic in animals and should not be used during pregnancy. Women of childbearing potential should be advised to use effective contraception during and for 1 month following treatment with Vistide. Men should be advised to practice barrier contraceptive methods during and for 3 months after treatment with Vistide.

Drug Interactions

Probenecid

Probenecid is known to interact with the metabolism or renal tubular excretion of many drugs (e.g., acetaminophen, acyclovir, angiotensin-converting enzyme inhibitors, aminosalicylic acid, barbiturates, benzodiazepines, bumetanide, clofibrate, methotrexate, famotidine, furosemide, nonsteroidal anti-inflammatory agents, theophylline, and zidovudine). Concomitant medications should be carefully assessed. Zidovudine should either be temporarily discontinued or decreased by 50% when coadministered with probenecid on the day of Vistide infusion.

Nephrotoxic agents

Concomitant administration of Vistide and agents with nephrotoxic potential [e.g., intravenous aminoglycosides (e.g., tobramycin, gentamicin, and amikacin), amphotericin B, foscarnet, intravenous pentamidine, vancomycin, and nonsteroidal anti-inflammatory agents] is contraindicated. Such agents must be discontinued at least seven days prior to starting therapy with Vistide.

Carcinogenesis, Mutagenesis, & Impairment of Fertility

Chronic, two-year carcinogenicity studies in rats and mice have not been carried out to evaluate the carcinogenic potential of cidofovir. However, a 26-week toxicology study evaluating once weekly subscapular subcutaneous injections of cidofovir in rats was terminated at 19 weeks because of the induction, in females, of palpable masses, the first of which was detected after six doses. The masses were diagnosed as mammary adenocarcinomas which developed at doses as low as 0.6 mg/kg/week, equivalent to 0.04 times the human systemic exposure at the recommended intravenous Vistide dose based on AUC comparisons.

In a 26-week intravenous toxicology study in which rats received 0.6, 3, or 15 mg/kg cidofovir once weekly, a significant increase in mammary adenocarcinomas in female rats as well as a significant incidence of Zymbal's gland carcinomas in male and female rats were seen at the high dose but not at the lower two doses. The high dose was equivalent to 1.1 times the human systemic exposure at the recommended dose of Vistide, based on comparisons of AUC measurements. In light of the results of these studies, cidofovir should be considered to be a carcinogen in rats as well as a potential carcinogen in humans.

Cynomolgus monkeys received intravenous cidofovir, alone and in conjunction with concomitant oral probenecid, intravenously once weekly for 52 weeks at doses resulting in exposures of approximately 0.7 times the human systemic exposure at the recommended dose of Vistide. No tumors were detected. However, the study was not designed as a carcinogenicity study due to the small number of animals at each dose and the short duration of treatment.

No mutagenic response was observed in microbial mutagenicity assays involving Salmonella typhimurium (Ames) and Escherichia coli in the presence and absence of metabolic activation. An increase in micronucleated polychromatic erythrocytes in vivo was seen in mice receiving ≥ 2000 mg/kg, a dosage approximately 65-fold higher than the maximum recommended clinical intravenous Vistide dose based on body surface area estimations. Cidofovir induced chromosomal aberrations in human peripheral blood lymphocytes in vitro without metabolic activation. At the 4 cidofovir levels tested, the percentage of damaged metaphases and number of aberrations per cell increased in a concentration-dependent manner.

Studies showed that cidofovir caused inhibition of spermatogenesis in rats and monkeys. However, no adverse effects on fertility or reproduction were seen following once weekly intravenous injections of cidofovir in male rats for 13 consecutive weeks at doses up to 15 mg/kg/week (equivalent to 1.1 times the recommended human dose based on AUC comparisons). Female rats dosed intravenously once weekly at 1.2 mg/kg/week (equivalent to 0.09 times the recommended human dose based on AUC) or higher, for up to 6 weeks prior to mating and for 2 weeks post mating had decreased litter sizes and live births per litter and increased early resorptions per litter. Peri- and post-natal development studies in which female rats received subcutaneous injections of cidofovir once daily at doses up to 1.0 mg/kg/day from day 7 of gestation through day 21 postpartum (approximately 5 weeks) resulted in no adverse effects on viability, growth, behavior, sexual maturation or reproductive capacity in the offspring.

Pregnancy

Category C

Cidofovir was embryotoxic (reduced fetal body weights) in rats at 1.5 mg/kg/day and in rabbits at 1.0 mg/kg/day, doses which were also maternally toxic, following daily intravenous dosing during the period of organogenesis. The no-observable-effect levels for embryotoxicity in rats (0.5 mg/kg/day) and in rabbits (0.25 mg/kg/day) were approximately 0.04 and 0.05 times the clinical dose (5 mg/kg every other week) based on AUC, respectively. An increased incidence of fetal external, soft tissue and skeletal anomalies (meningocele, short snout, and short maxillary bones) occurred in rabbits at the high dose (1.0 mg/kg/day) which was also maternally toxic. There are no adequate and well-controlled studies in pregnant women. Vistide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether cidofovir is excreted in human milk. Since many drugs are excreted in human milk and because of the potential for adverse reactions as well as the potential for tumorigenicity shown for cidofovir in animal studies, Vistide should not be administered to nursing mothers. The U.S. Public Health Service Centers for Disease Control and Prevention advises HIV-infected women not to breast-feed to avoid postnatal transmission of HIV to a child who may not yet be infected.

Pediatric Use

Safety and effectiveness in children have not been studied. The use of Vistide in children with AIDS warrants extreme caution due to the risk of long-term carcinogenicity and reproductive toxicity. Administration of Vistide to children should be undertaken only after careful evaluation and only if the potential benefits of treatment outweigh the risks.

Geriatric Use

No studies of the safety or efficacy of Vistide in patients over the age of 60 have been conducted. Since elderly individuals frequently have reduced glomerular filtration, particular attention should be paid to assessing renal function before and during Vistide administration (see DOSAGE AND ADMINISTRATION).

Adverse Reactions

1. Nephrotoxicity: Renal toxicity, as manifested by ≥ 2+ proteinuria, serum creatinine elevations of ≥ 0.4 mg/dL, or decreased creatinine clearance ≤ 55 mL/min, occurred in 79 of 135 (59%) patients receiving Vistide at a maintenance dose of 5 mg/kg every other week. Maintenance dose reductions from 5 mg/kg to 3 mg/kg due to proteinuria or serum creatinine elevations were made in 12 of 41 (29%) patients who had not received prior therapy for CMV retinitis (Study 106) and in 19 of 74 (26%) patients who had received prior therapy for CMV retinitis (Study 107). Prior foscarnet use has been associated with an increased risk of nephrotoxicity; therefore, such patients must be monitored closely (see CONTRAINDICATIONS, WARNINGS, DOSAGE AND ADMINISTRATION). 2. Neutropenia: In clinical trials, at the 5 mg/kg maintenance dose, a decrease in absolute neutrophil count to ≤ 500 cells/mm3 occurred in 24% of patients. Granulocyte colony stimulating factor (GCSF) was used in 39% of patients. 3. Decreased Intraocular Pressure/Ocular Hypotony: Among the subset of patients monitored for intraocular pressure changes, a ≥ 50% decrease from baseline intraocular pressure was reported in 17 of 70 (24%) patients at the 5 mg/kg maintenance dose. Severe hypotony (intraocular pressure of 0–1 mm Hg) has been reported in 3 patients. Risk of ocular hypotony may be increased in patients with preexisting diabetes mellitus. 4. Anterior Uveitis/Iritis: Uveitis or iritis has been reported in clinical trials and during postmarketing in patients receiving Vistide therapy. Uveitis or iritis was reported in 15 of 135 (11%) patients receiving 5 mg/kg maintenance dosing. Treatment with topical corticosteroids with or without topical cycloplegic agents may be considered. Patients should be monitored for signs and symptoms of uveitis/iritis during Vistide therapy. 5. Metabolic Acidosis: A diagnosis of Fanconi's syndrome, as manifested by multiple abnormalities of proximal renal tubular function, was reported in 1% of patients. Decreases in serum bicarbonate to ≤ 16 mEq/L occurred in 16% of cidofovir-treated patients. Cases of metabolic acidosis in association with liver dysfunction and pancreatitis resulting in death have been reported in patients receiving Vistide.

In clinical trials, Vistide was withdrawn due to adverse events in 39% of patients treated with 5 mg/kg every other week as maintenance therapy.

The incidence of adverse reactions reported as serious in three controlled clinical studies in patients with CMV retinitis, regardless of presumed relationship to drug, is listed in Table 4.

Table 4. Serious Clinical Adverse Events or Laboratory Abnormalities Occurring in > 5% of Patients
   N = 135*
# patients (%)
* Patients receiving 5 mg/kg maintenance regimen in Studies 105, 106 and 107. † Defined as decreased intraocular pressure (IOP) to ≤ 50% that at baseline. Based on 70 patients receiving 5 mg/kg maintenance dosing (Studies 105, 106 and 107), for whom baseline and follow-up IOP determinations were recorded.
Proteinuria (≥ 100 mg/dL) 68 (50)
Neutropenia (≤ 500 cells/mm3) 33 (24)
Decreased Intraocular Pressure† 17 (24)
Decreased Serum Bicarbonate (≤ 16 mEq/L) 21 (16)
Fever 19 (14)
Infection 16 (12)
Creatinine Elevation (≥ 2.0 mg/dL) 16 (12)
Pneumonia 12 (9)
Dyspnea 11 (8)
Nausea with Vomiting 10 (7)

The most frequently reported adverse events regardless of relationship to study drugs (cidofovir or probenecid) or severity are shown in Table 5.

The following additional list of adverse events/intercurrent illnesses have been observed in clinical studies of Vistide and are listed below regardless of causal relationship to Vistide. Evaluation of these reports was difficult because of the diverse manifestations of the underlying disease and because most patients received numerous concomitant medicines.

Body as a Whole: abdominal pain, accidental injury, AIDS, allergic reaction, back pain, catheter blocked, cellulitis, chest pain, chills and fever, cryptococcosis, cyst, death, face edema, flu-like syndrome, hypothermia, injection site reaction, malaise, mucous membrane disorder, neck pain, overdose, photosensitivity reaction, sarcoma, sepsis

Cardiovascular System: cardiomyopathy, cardiovascular disorder, congestive heart failure, hypertension, hypotension, migraine, pallor, peripheral vascular disorder, phlebitis, postural hypotension, shock, syncope, tachycardia, vascular disorder, edema

Digestive System: cholangitis, colitis, constipation, esophagitis, dyspepsia, dysphagia, fecal incontinence, flatulence, gastritis, gastrointestinal hemorrhage, gingivitis, hepatitis, hepatomegaly, hepatosplenomegaly, jaundice, abnormal liver function, liver damage, liver necrosis, melena, pancreatitis, proctitis, rectal disorder, stomatitis, aphthous stomatitis, tongue discoloration, mouth ulceration, tooth caries

Endocrine System: adrenal cortex insufficiency

Hemic & Lymphatic System: hypochromic anemia, leukocytosis, leukopenia, lymphadenopathy, lymphoma like reaction, pancytopenia, splenic disorder, splenomegaly, thrombocytopenia, thrombocytopenic purpura

Metabolic & Nutritional System: cachexia, dehydration, edema, hypercalcemia, hyperglycemia, hyperkalemia, hyperlipemia, hypocalcemia, hypoglycemia, hypoglycemic reaction, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, hypoproteinemia, increased alkaline phosphatase, increased BUN, increased lactic dehydrogenase, increased SGOT, increased SGPT, peripheral edema, respiratory alkalosis, thirst, weight loss, weight gain

Musculoskeletal System: arthralgia, arthrosis, bone necrosis, bone pain, joint disorder, leg cramps, myalgia, myasthenia, pathological fracture

Nervous System: abnormal dreams, abnormal gait, acute brain syndrome, agitation, amnesia, anxiety, ataxia, cerebrovascular disorder, confusion, convulsion, delirium, dementia, depression, dizziness, drug dependence, dry mouth, encephalopathy, facial paralysis, hallucinations, hemiplegia, hyperesthesia, hypertonia, hypotony, incoordination, increased libido, insomnia, myoclonus, nervousness, neuropathy, paresthesia, personality disorder, somnolence, speech disorder, tremor, twitching, vasodilatation, vertigo

Respiratory System: asthma, bronchitis, epistaxis, hemoptysis, hiccup, hyperventilation, hypoxia, increased sputum, larynx edema, lung disorder, pharyngitis, pneumothorax, rhinitis, sinusitis

Skin & Appendages: acne, angioedema, dry skin, eczema, exfoliative dermatitis, furunculosis, herpes simplex, nail disorder, pruritus, rash, seborrhea, skin discoloration, skin disorder, skin hypertrophy, skin ulcer, sweating, urticaria

Special Senses: abnormal vision, amblyopia, blindness, cataract, conjunctivitis, corneal lesion, corneal opacity, diplopia, dry eyes, ear disorder, ear pain, eye disorder, eye pain, hyperacusis, iritis, keratitis, miosis, otitis externa, otitis media, refraction disorder, retinal detachment, retinal disorder, taste perversion, tinnitus, uveitis, visual field defect, hearing loss

Urogenital System: decreased creatinine clearance, dysuria, glycosuria, hematuria, kidney stone, mastitis, metorrhagia, nocturia, polyuria, prostatic disorder, toxic nephrophathy, urethritis, urinary casts, urinary incontinence, urinary retention, urinary tract infection

Table 5. All Clinical Adverse Events, Laboratory Abnormalities or Intercurrent Illnesses Regardless of Severity Occurring in > 15% of Patients
   N = 115*
# patients (%)
* Patients receiving 5 mg/kg maintenance regimen in Studies 106 and 107.
Any Adverse Event 115 (100)
Proteinuria (≥ 30 mg/dL) 101 (88)
Nausea +/- Vomiting 79 (69)
Fever 67 (58)
Neutropenia (< 750 cells/mm3) 50 (43)
Asthenia 50 (43)
Headache 34 (30)
Rash 34 (30)
Infection 32 (28)
Alopecia 31 (27)
Diarrhea 30 (26)
Pain 29 (25)
Creatinine Elevation (> 1.5 mg/dL) 28 (24)
Anemia 28 (24)
Anorexia 26 (23)
Dyspnea 26 (23)
Chills 25 (22)
Increased Cough 22 (19)
Oral Moniliasis 21 (18)

Reporting of Adverse Reactions

Malignancies or serious adverse reactions that occur in patients who have received Vistide should be reported to Gilead in writing to the Director of Clinical Research, Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404 or by calling 1-800-GILEAD-5 (445-3235), or to FDA MedWatch 1-800-FDA-1088/fax 1-800-FDA-0178.

PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton

NDC 61958-0101-1

Vistide®
(cidofovir injection)

Each 5 mL single-use vial contains
375 mg (75 mg/mL)
of cidofovir (anhydrous)

Rx only

DILUTE BEFORE USE

For Intravenous Infusion Only.
Not For Intraocular Injection.

GILEAD

Vistide 
cidofovir injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61958-0101
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIDOFOVIR (CIDOFOVIR ANHYDROUS) CIDOFOVIR ANHYDROUS 75 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:61958-0101-1 1 VIAL, SINGLE-USE in 1 CARTON
1 5 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020638 06/26/1996
Labeler - Gilead Sciences, Inc. (185049848)
Revised: 09/2013   Gilead Sciences, Inc.

For Healthcare Professionals

Applies to cidofovir: intravenous solution

General

The most commonly reported adverse events include proteinuria, increased serum creatinine, neutropenia, decreased serum bicarbonate, decreased intraocular pressure, fever, and infection.[Ref]

Renal

Very common (10% or more): Proteinuria (up to 88%), elevated creatinine (up to 24%), nephrotoxicity (up to 59%)
Frequency not reported: Increased BUN[Ref]

Nephrotoxicity may be irreversible. Renal impairment, including cases of acute renal failure resulting in dialysis and/or contributing to death, has occurred with as few as one or two doses of the drug. Proteinuria (greater than 2+), reduced creatinine clearance (less than or equal to 55 mL/min), and/or elevations of serum creatinine concentration (greater than 0.4 mg/dL) occurred in about 59% of patients receiving a maintenance dose of 5 mg/kg every other week. Toxic nephropathy has also been reported.[Ref]

Ocular

The risk of ocular hypotony may be increased in patients with diabetes mellitus.

Uveitis or iritis was reported in 15 (11%) of 135 patients who were administered the 5 mg/kg maintenance dose. Patients should be monitored for signs and symptoms of these complications and if they develop, treatment with topical corticosteroids with or without topical cycloplegic agents may be useful.[Ref]

Very common (10% or more): Anterior uveitis/iritis (11%); decreased intraocular pressure (24%)
Rare (0.01% to 0.1%): Ocular hypotony
Frequency not reported: Abnormal vision, amblyopia, blindness, cataract, conjunctivitis, corneal lesion, corneal opacity, diplopia, dry eyes, eye pain, iritis, keratitis, refraction disorder, retinal detachment, retinal disorder, uveitis, visual field defect, miosis[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 23%), decreased serum bicarbonate (16%)
Common (1% to 10%): Fanconi-like syndrome
Frequency not reported: Weight loss, weight gain, thirst, respiratory alkalosis, hyperkalemia, hypophosphatemia, hypokalemia, hypomagnesemia, hyperglycemia, dehydration, hypocalcemia, cachexia, hypercalcemia, hyperlipidemia, hypoglycemia, hypoglycemic reaction, hyponatremia, hypoproteinemia, metabolic acidosis[Ref]

Genitourinary

Frequency not reported: Glycosuria[Ref]

Hematologic

Very common (10% or more): Neutropenia (up to 43%), anemia (up to 24%)
Frequency not reported: Hypochromic anemia, leukocytosis, leukopenia, lymphadenopathy, lymphoma like reaction, pancytopenia, splenic disorder, splenomegaly, thrombocytopenia, thrombocytopenic purpura[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity, allergic reaction[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 69%), diarrhea (up to 26%). oral moniliasis (up to 18%)
Common (1% to 10%): Nausea with vomiting
Frequency not reported: Dyspepsia, constipation, abdominal pain, cholangitis, colitis, esophagitis, dysphagia, fecal incontinence, flatulence, gastritis, gastrointestinal hemorrhage, gingivitis, melena, pancreatitis, proctitis, rectal disorder, stomatitis, aphthous stomatitis, tongue discoloration, mouth ulceration, tooth caries, dry mouth[Ref]

Administration of probenecid after a meal and/or therapy with antiemetics may alleviate the nausea and vomiting associated with probenecid.[Ref]

Cardiovascular

Frequency not reported: Cardiomyopathy, cardiovascular disorder, congestive heart failure, hypertension, hypotension, peripheral vascular disorder, phlebitis, postural hypotension, shock, syncope, tachycardia, vascular disorder, edema, chest pain[Ref]

Dermatologic

Very common (10% or more): Alopecia (up to 27%), rash (up to 30%)
Frequency not reported: Cellulitis, cyst, face edema, photosensitivity reaction, acne, angioedema, dry skin, eczema, exfoliative dermatitis, furunculosis, herpes, simplex nail disorder, pruritus, rash, seborrhea, skin discoloration, skin disorder, skin hypertrophy, skin ulcer, sweating, urticaria[Ref]

Local

Frequency not reported: Blocked catheter, injection site reaction[Ref]

Endocrine

Frequency not reported: Adrenal cortex insufficiency[Ref]

Hepatic

Frequency not reported: Hepatitis, hepatomegaly, hepatosplenomegaly, jaundice, abnormal liver function, liver damage, liver necrosis, increased transaminases, increased alkaline phosphatase, increased lactic dehydrogenase[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, arthrosis, bone necrosis, bone pain, joint disorder, leg cramps, myalgia, myasthenia, pathological fracture, neck pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 30%)
Frequency not reported: Acute brain syndrome, cerebrovascular disorder, convulsion, delirium, dementia, dizziness, encephalopathy, facial paralysis, hemiplegia, hyperesthesia, hypertonia, hypotony, incoordination, myoclonus, neuropathy, paresthesia, somnolence, tremor, twitching, ataxia, taste perversion, speech disorder, abnormal gait, peripheral neuritis[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 23%), increased cough (up to 19%)
Frequency not reported: Asthma, bronchitis, epistaxis, hemoptysis, hiccup, hyperventilation, hypoxia, increased sputum, larynx edema, lung disorder, pharyngitis, pneumothorax, rhinitis, sinusitis, hyperventilation[Ref]

Other

Very common (10% or more): Fever (up to 58%), asthenia (up to 43%), chills (up to 22%)
Frequency not reported: Ear disorder, ear pain, hyperacusis, otitis externa, otitis media, tinnitus, hearing loss, vertigo, malaise[Ref]

Immunologic

Very common (10% or more): Infection (up to 28%)
Frequency not reported: Sepsis, flu-like syndrome

Psychiatric

Frequency not reported: Abnormal dreams, agitation, amnesia, anxiety, confusion, depression, drug dependence, insomnia, personality disorder

Some side effects of Vistide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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