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Vistide

"For children who have had HIV-1 infection since birth, the combination drug therapies now used to treat HIV appear to protect against the heart damage seen before combination therapies were available, according to researchers in a National Instit"...

Vistide

Vistide

Vistide Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Vistide (cidofovir) is used to treat an eye infection called cytomegalovirus retinitis (CMV) in people who are infected with HIV (human immunodeficiency virus). It is an antiviral medication. Common side effects include nausea. Headache, nausea, and vomiting may occur when used with probenecid.

Dosing of Vistide is determined by a physician and the medication is administered under a physician's supervision. Vistide may interact with acetaminophen, acyclovir, zidovudine, bumetanide, clofibrate, famotidine, furosemide, methotrexate, theophylline, aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs), ACE inhibitors, barbiturates, diazepam or similar medicines. Tell your doctor all medications you use. During pregnancy, Vistide should be used only when prescribed. It may harm a fetus. The manufacturer recommends avoiding pregnancy. Men should use effective barrier protections (such as latex or polyurethane condoms) during all sexual activity during treatment and for at least 90 days after stopping the medication. Women should use at least 2 forms of birth control (such as birth control pills and condoms) during treatment and for at least 1 month after stopping the medication. It is unknown if this medication passes into breast milk. Because of the possible risks to the infant and because breast milk can transmit HIV, do not breast-feed.

Our Vistide (cidofovir) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Vistide in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • urinating less than usual or not at all;
  • fever, chills, body aches, flu symptoms;
  • any change in your vision; or
  • increased thirst and urination, loss of appetite, weakness, constipation.

Less serious side effects are more likely to occur, such as:

  • nausea, vomiting, diarrhea, loss of appetite;
  • white patches or sores inside your mouth or on your lips;
  • headache;
  • mild skin rash;
  • hair loss; or
  • cough.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vistide (Cidofovir) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Vistide Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea may occur. Headache, nausea, and vomiting may occur with probenecid use. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: change in the amount of urine, frothy/dark urine, bloody/pink urine, swelling, loss of appetite, unusual tiredness/sluggishness, stomach/abdominal pain, muscle loss, signs of infection (e.g., fever, persistent sore throat/cough), vision changes, new/increased eye redness or irritation, new/increased eye pain, mental/mood changes (e.g., confusion), persistent nausea/vomiting, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Vistide (Cidofovir)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Vistide FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

  1. Nephrotoxicity: Renal toxicity, as manifested by ≥ 2+ proteinuria, serum creati-nine elevations of ≥ 0.4 mg/dL, or decreased creatinine clearance ≤ 55 mL/min, occurred in 79 of 135 (59%) patients receiving VISTIDE (cidofovir) 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 (cidofovir) 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 (cidofovir) 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 (cidofovir) .

In clinical trials, VISTIDE (cidofovir) 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 =135a
# patients (%)
Proteinuria ( ≥ 100 mg/dL) 68 (50)
Neutropenia ( ≤ 500 cells/mm3) 33 (24)
Decreased Intraocular Pressureb 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)
a Patients receiving 5 mg/kg maintenance regimen in Studies 105, 106 and 107.
b 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.

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 (cidofovir) and are listed below regardless of causal relationship to VISTIDE (cidofovir) . 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, lym-phadenopathy, 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, encephalopa-thy, 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 =115a
# patients (%)
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)
a Patients receiving 5 mg/kg maintenance regimen in Studies 106 and 107.

Reporting of Adverse Reactions

Malignancies or serious adverse reactions that occur in patients who have received VISTIDE (cidofovir) 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.

Read the entire FDA prescribing information for Vistide (Cidofovir) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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