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JINARC is a brand name for Tolvaptan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dehydration Due to a prominent aquaretic effect, treatment with tolvaptan may result in dehydration which constitutes a risk factor for renal dysfunction. If dehydration becomes evident, take appropriate action which may include the need to interrupt or reduce the dose of tolvaptan and increase fluid intake.
g. in case of vomiting or diarrhea. JINARC should not be prescribed to patients who cannot perceive or respond to thirst (see CONTRAINDICATIONS). Tolvaptan may cause undesirable effects related to water loss such as thirst, polyuria, nocturia, and pollakiuria.
Therefore, it is imperative that patients should have access to water (or other aqueous fluids) and be able to drink sufficient amounts of these fluids. Patients should be instructed to drink water or other aqueous fluids at the first sign of thirst in order to avoid excessive thirst or dehydration (see DOSAGE AND ADMINISTRATION).
Patients should be generally encouraged to drink water while taking JINARC to avoid development of dehydration or hypernatremia, and to improve tolerability of tolvaptan. Drugs metabolised by CYP-3A or transported by P-gp JINARC is a substrate of CYP-3A and co-administration with CYP-3A inhibitors or CYP-3A inducers may lead to a change in exposure.
Patient response should be monitored and the dose adjusted accordingly, as appropriate. CYP-3A Inhibitors CYP3A4 is the predominant enzyme involved in tolvaptan metabolism. Concomitant use with strong CYP3A4 inhibitors is contraindicated as this may lead to a significant increase in tolvaptan exposure.
4-fold (as determined by AUC∞). (see CONTRAINIDICATIONS). , verapamil, fluconazole and erythromycin, requires lowered dosing of JINARC (see DRUG INTERACTIONS, and DOSAGE AND ADMINISTRATION, CYP-3A Inhibitors).
WARNING:
IDIOSYNCRATIC HEPATIC TOXICITY JINARC (tolvaptan) use has led to idiosyncratic elevations of blood alanine and aspartate aminotransferases (ALT & AST), rarely associated with concomitant elevations of total bilirubin (see Hepatotoxicity, below).
To help mitigate the risk of liver injury, blood testing for hepatic transaminases and total bilirubin is required prior to initiation of JINARC, then hepatic transaminases continuing monthly for 18 months, every 3 months for the next 12 months, and then every 3-6 months thereafter during treatment with JINARC (see DOSAGE AND ADMINISTRATION, Dosing Considerations; See WARNINGS AND PRECAUTIONS, Hepatotoxicity).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tolvaptan in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Therefore, JINARC is available for treatment of patients with ADPKD only through a controlled hepatic safety monitoring and distribution (HSMD) programme conducted and maintained by, or for, the market authorization holder of JINARC.
JINARC® Product Monograph Page 6 of 43 JINARC should not be taken with grapefruit juice. g. rifampin, phenytoin, carbamazepine, St. John’s Wort (see DRUG INTERACTIONS, and DOSAGE AND ADMINISTRATION, CYP-3A Inducers). P-gp Inhibitors Reduction in the dose of JINARC may be required in patients concomitantly treated with P-glycoprotein (P-gp) inhibitors, such as cyclosporine and quinidine, based on clinical response (see DRUG INTERACTIONS, and DOSAGE AND ADMINISTRATION, P-gp Inhibitors).
, ketoconazole, clarithromycin, ritonavir, saquinavir), is contraindicated (see CONTRAINDICATIONS). Hepatotoxicity Tolvaptan has been associated with idiosyncratic drug-induced hepatocellular injury, as seen by elevations of serum alanine and aspartate aminotransferases (ALT and AST), rarely associated with concomitant elevations of total bilirubin (BT).
8% (4/484) patients on placebo when monitoring for liver enzymes elevation was every 3-4 months (also, see ADVERSE REACTIONS, Hepatic Injury). 2%) of these tolvaptan treated-patients, as well as a third patient from an extension open-label trial, exhibited increases in hepatic enzymes (>3 x ULN) with concomitant elevations in total bilirubin (>2 x ULN).
The period of onset of hepatocellular injury, as reflected by ALT elevations >3 x ULN, was within 3 to 14 months after initiating treatment, and these increases were reversible, with ALT returning to <3 x ULN within 1 to 4 months. While these concomitant elevations were gradually reversible with prompt discontinuation of tolvaptan, they represent a potential for significant liver injury.
Similar changes with other drugs have been associated with the potential to cause irreversible and potentially life-threatening liver injury. The incidence of hepatotoxicity does not appear to be dose related. To date, there is no evidence of hepatocellular injury with tolvaptan when used in patients not treated for ADPKD.
In post-marketing experience with tolvaptan in ADPKD, acute liver failure requiring liver transplantation has been reported. In another double-blind placebo-controlled trial (called REPRISE) including patients with later stages of ADPKD, all patients were monitored monthly for liver enzymes elevation.
2% (3/1,477) of patients on tolvaptan, respectively. […]