Polycystic Kidney Disease (PKD) Support Group
Polycystic kidney disease (PKD) is a progressive, genetic disorder of the kidneys. It occurs in humans and other organisms. PKD is characterised by the presence of multiple cysts (polycystic) in both kidneys. The disease can also damage the liver, pancreas and rarely the heart and brain.
At my nephrologists appointment yesterday he told me about Tolvaptan. Here is a summary of what he said:
Avoid use of Samsca in patients with underlying liver
disease, including cirrhosis,
because the ability to recover from liver injury
may be impaired
.
Report adverse events involving Samsca to the FDA MedWatch program, using the
information in the Contact FDA box at the bottom of the page.
Data Summary
Sam
sca (tolvaptan) was approved in May 2009 for the treatment of clinically significant
euvolemic and hypervolemic hyponatremia. Patients
should be in a hospital for initiation and
re
-
initiation of therapy to evaluate the therapeutic response
before subseque
ntly receiving
Samsca in the outpatient setting.
Tolvaptan is being studied for another indication: delay in progression of renal disease in adult
patients with autosomal dominant polycystic kidney disease (ADPKD).1 Three cases of serious
liver injury att
ributed to tolvaptan were observed in a placebo
-
controlled trial in ADPKD and its
open
-
label extension study, indicating the potential for the drug to cause liver injury that could
progress to liver failure. In addition, tolvaptan was associated with an i
ncreased incidence of
ALT elevations greater than three times the upper limit of normal: 42 subjects out of 958 (4.4%)
in the tolvaptan group, compared to five subjects out of 484 (1.0%) in the placebo group. The
serious liver injury cases were consistent
with Hys law. Hys law is a prognostic indicator that
FDA follows to evaluate the potential for drug
-
induced severe liver injury and typically refers to
significant elevations of liver enzymes with concomitantly elevated bilirubin where etiologies
other
than the drug have been ruled out.
See
Guidance for Industry Drug
-
Induced Liver Injury:
Premarketing Clinical Evaluation, Final, July 2009
.
In the ADPKD trials, the earliest case of severe
liver injury was observed three months after initiation of tolvaptan.
Analysis of safety information in the clinical trials that supported the hyponatremia indication
(and in other populations such as thos
e with heart failure) did not demonstrate hepatotoxicity.
However, the controlled hyponatremia trials were of short duration
about 30 days. Although
FDA has received spontaneous postmarketing reports of elevated liver enzymes and other liver
events in pat
ients taking tolvaptan, these reports are difficult to interpret because many of the
patients had underlying disease that can be associated with elevated
liver enzymes or liver
injury
(cirrhosis, heart failure, or cancer). Based on the cases of liver inj
ury in patients
participating in the ADPKD trials, FDA worked with the manufacturer to revise the Samsca drug
label to include the above information, to reduce the potential for serious liver injury.
End Quote
He also said there have been deaths from it so it is not going to be recommended to me to take.
My potassium was low so he ordered prescription potassium.
How are all of you faring that participated in the Tolvaptan clinical trials.
I hope you are well.
Jessica
Avoid use of Samsca in patients with underlying liver
disease, including cirrhosis,
because the ability to recover from liver injury
may be impaired
.
Report adverse events involving Samsca to the FDA MedWatch program, using the
information in the Contact FDA box at the bottom of the page.
Data Summary
Sam
sca (tolvaptan) was approved in May 2009 for the treatment of clinically significant
euvolemic and hypervolemic hyponatremia. Patients
should be in a hospital for initiation and
re
-
initiation of therapy to evaluate the therapeutic response
before subseque
ntly receiving
Samsca in the outpatient setting.
Tolvaptan is being studied for another indication: delay in progression of renal disease in adult
patients with autosomal dominant polycystic kidney disease (ADPKD).1 Three cases of serious
liver injury att
ributed to tolvaptan were observed in a placebo
-
controlled trial in ADPKD and its
open
-
label extension study, indicating the potential for the drug to cause liver injury that could
progress to liver failure. In addition, tolvaptan was associated with an i
ncreased incidence of
ALT elevations greater than three times the upper limit of normal: 42 subjects out of 958 (4.4%)
in the tolvaptan group, compared to five subjects out of 484 (1.0%) in the placebo group. The
serious liver injury cases were consistent
with Hys law. Hys law is a prognostic indicator that
FDA follows to evaluate the potential for drug
-
induced severe liver injury and typically refers to
significant elevations of liver enzymes with concomitantly elevated bilirubin where etiologies
other
than the drug have been ruled out.
See
Guidance for Industry Drug
-
Induced Liver Injury:
Premarketing Clinical Evaluation, Final, July 2009
.
In the ADPKD trials, the earliest case of severe
liver injury was observed three months after initiation of tolvaptan.
Analysis of safety information in the clinical trials that supported the hyponatremia indication
(and in other populations such as thos
e with heart failure) did not demonstrate hepatotoxicity.
However, the controlled hyponatremia trials were of short duration
about 30 days. Although
FDA has received spontaneous postmarketing reports of elevated liver enzymes and other liver
events in pat
ients taking tolvaptan, these reports are difficult to interpret because many of the
patients had underlying disease that can be associated with elevated
liver enzymes or liver
injury
(cirrhosis, heart failure, or cancer). Based on the cases of liver inj
ury in patients
participating in the ADPKD trials, FDA worked with the manufacturer to revise the Samsca drug
label to include the above information, to reduce the potential for serious liver injury.
End Quote
He also said there have been deaths from it so it is not going to be recommended to me to take.
My potassium was low so he ordered prescription potassium.
How are all of you faring that participated in the Tolvaptan clinical trials.
I hope you are well.
Jessica
-
My 6mo twin DD's are EBF and just started rice cereal on the first. Everything has been going fine except this morning one of them had a diaper rash (lots of redness around her anus). I read this as one of the signs of an allergy. BUT I did just buy a different brand diaper yesterday (which they have used randomly before w/no issues). Do you think its the cereal or the diaper? Im ready to start...
Another article about Tolvaptan.
So, my dear PKD friends...continue to drink lots of WATER. I like to put freshly squeezed lemon juice in my water. It has an alkalizing effect on the blood. I have a prescription from my neph for potassium supplements because my potassium was low.
I have been reading all your posts today and I am encouraged by the support given. I too have to deal with nausea and hypertensive episodes. I feel for those having to take an early retirement due to PKD. I wish you well and hope you can still find satisfying and fulfilling work. My neph said yesterday to me that I should not stop working. Keep doing the things you love. I did change the type of work I did. I went from a highly stressful hospital nursing job to painting portraits and landscapes for commission. My schedule fits to how I feel during the day. I am blessed with a wonderful husband who works at a great job and I am under his insurance.
When the time comes I have a few options to consider. My husband has told me he will go through the process to see if he can donate his kidney to me. I am all for transplant and see how others have benefited from their transplant.
Thank you to all of you for posting on here how you are doing with this disease we share in common.
I hope I have been a little helpful although I can't express myself as well as some of you.
Jessica
Thanks for sharing.
Chewitt
Thank you for your kind reply.
Yes, my nephrologist is concerned about my grossly enlarged polycystic liver being damaged by Tolvaptan.
I too have difficulty drinking 4 Liters of water but I have accepted the frequent bathroom visits when I am out shopping or golfing as my "new normal". Now I am focusing on getting sufficient potassium in my diet to help keep my blood pressure down. I just read about a 2005 study from St. George Medical School in London that proves one can indeed lower their blood pressure through diet and exercise. They listed potassium rich foods that also have antioxidants and fiber as an added bonus.
Are their any foods you avoid because of your liver? I can't eat cheese, pickles, olives, chocolate or white sugar. I am a beekeeper and have honey throughout the day.
My neph. told me the combined weight of my kidneys and liver is 12 lbs. It's like carrying around a 10 lb. baby. I have to keep my back healthy. I go for a bone density scan today. I have shrunk from 5'5 1/2" to 5'4". Do you put veggies in your smoothies too?
Thank you for sharing too. ;-)
Well, that's as I thought with regard to the Tolvaptan. Perhaps my renal consultant will reach the same conclusion when he finds out more about it. He seems to know very little, given that kidneys are his specialist area.
As for foods, there's nothing in particular that I avoid because of my liver, apart from soy products owing to its possible oestogenic effects. Do you avoid the foods you mention because you know them to be bad for the liver, or because they disagree with you? I don't eat fatty foods because of the terrible heartburn and nausea that results. I've even wondered if my gall bladder isn't working well or whether there might possibly be pressure on the bile duct affecting digestion of fats. The easiest thing is to avoid them. I don't eat any cheese because it has a high sodium content. I don't eat anything containing sodium, even bread: I make my own salt free bread. Pickles I love, but they are also off the menu as most are salty, as are olives. I must confess to eating a very, very small amount if chocolate, but that's the only caffeine in my diet. I'm not a fan of smoothies I'm afraid. I've read that even a modest amount of fruit juice/smoothie can contribute to developing fatty liver, and that's the last thing I want. It would seem that the fruit sugars are converted to fat in the liver in a way that's not the case if you eat the actual fruit itself. In addition, juices and smoothies contain less of the fibre, which is an important part of the diet. Vegetable smoothies are probably great, but I'm not keen on them. What's a good combination?
I have osteopenia, and have a bone density scan every few years. I walk daily and take calcium/vitamin D3 to try to maintain bone density. My poor bones may be attributable to a diet very lacking in calcium and high in fizzy drinks as I was growing up and beyond. Damage limitation is the best I can do now. I think I may have shrunk a little, but don't want to confirm that! I also have a mild scoliosis, which doesn't help. Last time I checked I was 5'3 1/2", but I'm pretty sure I used to be 5'4". Everybody shrinks with age, though some more than others.
Hope the bone density scan isn't too bad.
Take care,
Chewitt