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Prescribing Tolvaptan Lupin
The Therapeutic Goods Administration has stipulated that prescriber education and certification on the risk of liver injury and the importance of liver function monitoring must be done monthly for the first 18 months of therapy and every 3 months thereafter.
ADPKD patients most likely to benefit from Tolvaptan Lupin appear to be those with rapidly-progressing ADPKD1,2.
Predictors of Rapid Progression
Factors associated with rapid progression may include any of the following3:
- hypertension (early onset).
- high kidney volume compared to the age-corrected mean for ADPKD patients.
- rapid deterioration of renal function.
- gross haematuria.
- PKD1 mutations or family history of ADPKD with early end-stage renal disease (especially truncating mutations).
PKD1: gene, Polycystic Kidney Disease-1 gene
References:
- 1. Tolvaptan Lupin Product Information.
- 2. Torres VE, Chapman AB, Devuyst O et al. N Engl J Med 2012; 367(25):240718.
3. Schrier RW, Brosnahan G, Cadnapaphornchai MA et al. J Am Soc Nephrol 2014; 25:2399–2418.
Prescriber education and certification on the risk of liver injury and the importance of regular liver function monitoring is compulsory. Prescribers must confirm review of educational materials by signing the Prescriber Certification Form and returning it to Lupin AU. Pharmacists should only dispense Tolvaptan Lupin prescribed by certified nephrologists.
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Tolvaptan Lupin Dosing and Titration
Tolvaptan Lupin is to be administered twice daily in split dose regimens, with a:
- • higher dose to be taken in the morning, ie. at least 30 minutes before breakfast or the morning meal; and
- • second, lower dose taken 8 hours later (with or without food).
Tolvaptan Lupin should not be taken with grapefruit juice due to increase in peak tolvaptan concentration
Dose Titration Process
Dose titration has to be performed cautiously to ensure that high doses are not poorly tolerated through overly rapid up – titration:
- • Patients may be down- titrated to lower doses based on tolerability.
- • Patients should be maintained on the highest tolerable tolvaptan dose.
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Ongoing Management
Review Patient LFTs
- • Review the patient’s ALT, AST and total bilirubin monthly for the first 18 months and at 3-monthly intervals thereafter.
- • Provide the patient with a new script if changing dose or if the patient has run out of repeats.
- • Ongoing PBS Authority STREAMLINED (code 8288).
- • Patients may continue on Tolvaptan Lupin until CKD stage 5 or until they receive a kidney transplant.
- • Advise patient to use the same pharmacy each time Tolvaptan Lupin is dispensed to ensure that there are no issues with continuity of supply.
PKD1: gene, Polycystic Kidney Disease-1 gene
References:
- ALT: Alanine Aminotransferase
- AST: Aspartate Aminotransferase
- CKD: Chronic Kidney Disease
- LFT: Liver Function Test
- PBS: Pharmaceutical Benefits Scheme
For more detailed information, please refer to the links below
About
Tolvaptan Lupin
Tolvaptan Lupin is a medicine used for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). It works by blocking the effects of vasopressin which slows down the rate at which cyst grow.
Tolvaptan Lupin may cause adverse reactions related to water loss, such as thirst, polyuria, "nocturia, and pollakiuria. Therefore, ensure that patients have access to water (or other aqueous fluids) and can drink enough of these fluids.
Things to Remember
- Provide the patient with a copy of the Patient Guide, the CMI and the Wallet Card (also provided in each pack of Tolvaptan Lupin).
- Give the patient a recurring pathology slip for liver function tests (LFTs). Ensure you request ALT, AST and total bilirubin.
- Patients must be instructed to drink plenty of water / fluids to avoid excessive thirst or dehydration. They must also consume 1 to 2 glasses of fluid before going to bed and must rehydrate overnight with each episode of nocturia.
- Volume status must be monitored because treatment with Tolvaptan Lupin may result in severe dehydration.
Please note: Not actual doctor and patient image
Frequently Asked Questions
What to do if your patient missed their dose?
If a dose is missed, patients should take the dose as soon as they remember on the same day. If patients do not take their tablets on one day, they should take their normal dose on the next day.
Patients MUST NOT take a double dose to make up for forgotten individual doses.
How to Store Tolvaptan Lupin?
Keep Tolvaptan Lupin in a cool, dry place where the temperature stays below 25° C. Keep it where young children cannot reach it.
What to do if your patient takes too much?
If the patient thinks that they have taken too much Tolvaptan Lupin, they must immediately telephone the Poisons Information Centre (telephone Australia 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital. They should do this even if there are no signs of discomfort or poisoning. They may need urgent medical attention.