"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
FOR INTRAVENOUS INFUSION ONLY.
NOT FOR INTRAOCULAR INJECTION.
- Patient Information:
Details with Side Effects
RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF VISTIDE (cidofovir) . CASES OF ACUTE RENAL FAILURE RESULTING IN DIALYSIS AND/OR CONTRIBUTING TO DEATH HAVE OCCURRED WITH AS FEW AS ONE OR TWO DOSES OF VISTIDE (cidofovir) . TO REDUCE POSSIBLE NEPHROTOXICITY, INTRAVENOUS PREHYDRATION WITH NORMAL SALINE AND ADMINISTRATION OF PROBENECID MUST BE USED WITH EACH VISTIDE (cidofovir) INFUSION. RENAL FUNCTION (SERUM CREATININE AND URINE PROTEIN) MUST BE MONITORED WITHIN 48 HOURS PRIOR TO EACH DOSE OF VISTIDE (cidofovir) AND THE DOSE OF VISTIDE (cidofovir) MODIFIED FOR CHANGES IN RENAL FUNCTION AS APPROPRIATE (SEE DOSAGE AND ADMINISTRATION). VISTIDE (cidofovir) IS CONTRAINDICATED IN PATIENTS WHO ARE RECEIVING OTHER NEPHROTOXIC AGENTS.
NEUTROPENIA HAS BEEN OBSERVED IN ASSOCIATION WITH VISTIDE (cidofovir) TREATMENT. THEREFORE, NEUTROPHIL COUNTS SHOULD BE MONITORED DURING VISTIDE (cidofovir) THERAPY.
VISTIDE (cidofovir) IS INDICATED ONLY FOR THE TREATMENT OF CMV RETINITIS IN PATIENTS WITH ACQUIRED IMMUNODEFICIENCY SYNDROME.
IN ANIMAL STUDIES CIDOFOVIR WAS CARCINOGENIC, TERATOGENIC AND CAUSED HYPOSPERMIA (SEE CARCINOGENESIS, MUTAGENESIS, & IMPAIRMENT OF FERTILITY).
VISTIDE® is the brand name for cidofovir injection. The chemical name of cidofovir is 1-[(S)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine dihydrate (HPMPC), with the molecular formula of C8H14N3O6P•2H2O and a molecular weight of 315.22 (279.19 for anhydrous). The chemical structure is:
Cidofovir is a white crystalline powder with an aqueous solubility of ≥ 170 mg/mL at pH 6-8 and a log P (octanol/aqueous buffer, pH 7.1) value of -3.3.
VISTIDE (cidofovir) is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear and colorless. It is supplied in clear glass vials, each containing 375 mg of anhydrous cidofovir in 5 mL aqueous solution at a concentration of 75 mg/mL. The formulation is pH-adjusted to 7.4 with sodium hydroxide and/or hydrochloric acid and contains no preservatives. The appropriate volume of VISTIDE (cidofovir) must be removed from the single-use vial and diluted prior to administration (see DOSAGE AND ADMINISTRATION).
What are the possible side effects of cidofovir (Vistide)?
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...
What are the precautions when taking cidofovir (Vistide)?
Before using cidofovir, tell your doctor or pharmacist if you are allergic to it; or to other antivirals (e.g., ganciclovir); or to probenecid; or to other sulfa drugs (e.g., sulfamethoxazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, ganciclovir eye implant, mild/moderate kidney disease.
This drug may cause vision changes. Do not drive, use machinery, or...
Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Vistide Information
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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