About Tolvaptan

Through the Lupin Genesis Patient Support Program, you will have access to services such as a single point of contact and nurses who can help answer questions about Tolvaptan. You can read more about an overview of services offered by the Lupin Genesis Patient Support Program by clicking here.

By transitioning to LUPIN-TOLVAPTAN, you will have access to the Lupin Genesis Patient Support Program, which includes services such as a single point of contact and access to nurses who can help answer questions about LUPIN-TOLVAPTAN. You can read more about an overview of services offered by the Lupin Genesis Patient Support Program by clicking here.

ADPKD is a genetic disorder which leads to the growth of multiple cysts (sacs filled with fluid) on the kidneys. Over time, the cysts grow in size, which can damage the way your kidneys work, and may ultimately lead to kidney failure.

Vasopressin is a hormone that promotes cyst growth in the kidneys in patients with ADPKD.

Tolvaptan works by blocking the effects of vasopressin. By blocking its effect, Tolvaptan is able to reduce the growth of cysts in the kidneys and slow the decline of kidney function. This should help protect your kidneys from damage and failure.

During treatment with Tolvaptan, your doctor will arrange blood tests to check for changes in your liver function, as follows:

• before starting treatment with Tolvaptan
• every month for the first 18 months, then
• every 3 months thereafter during treatment for the next 12 months, and every 3-6 months thereafter during treatment

Before taking Tolvaptan you should discuss carefully with your doctor if this medication is suitable for you, taking into consideration the potential benefits and risks involved.

Once you and your doctor have agreed that Tolvaptan is suitable for you, your doctor will ask that you sign a patient-prescriber agreement form (PPAF), stating that:

• you understand the benefits and risks of treatment
• you agree to take blood tests as prescribed by your doctor to start and remain on treatment

Do not take Tolvaptan if:

• you have been asked to permanently discontinue Tolvaptan in the past.
• you are allergic to Tolvaptan, benzazepine or benzazepine derivatives, or any non-medicinal ingredients in the formulation.
• you cannot replace fluids by drinking or you cannot feel if you are thirsty.
• you have elevated sodium (salt) in your blood.
• you have a condition associated with a low blood volume.
• your liver is not functioning properly and in a way that is of concern to your doctor. The presence of hepatic cysts in and of themselves should not be an impediment to initiation of Tolvaptan treatment.
• you are pregnant or plan to become pregnant. It is not known if Tolvaptan will harm your unborn baby.
• you are breastfeeding. It is not known if Tolvaptan passes into your breast milk. You and your healthcare provider should decide if you will take Tolvaptan or breastfeed. You should not do both.
• your body is not able to make any urine. Tolvaptan will not help your condition.
• you take certain medicines. These medicines could cause you to have too much Tolvaptan in your blood:
  • the antibiotic medicines, clarithromycin or telithromycin
  • the antifungal medicines, ketoconazole or itraconazole
  • the anti-HIV medicines, ritonavir, indinavir, nelfinavir, saquinavir
  • the antidepressant medicine, nefazodone
• you have one of the following rare hereditary diseases:
  • Galactose intolerance
  • Lapp lactase deficiency
  • Glucose-galactose malabsorption because lactose is a non-medicinal ingredient in Tolvaptan.

To prevent pregnancy while on Tolvaptan treatment, women of childbearing potential must have effective contraceptive measures in place before and during treatment.

Do not take Tolvaptan if you are pregnant or planning to become pregnant. It is not known if Tolvaptan will harm your unborn baby.

Always take Tolvaptan exactly as your doctor has prescribed. Check with your doctor, nurse or pharmacist if you are not sure. You can take Tolvaptan with or without food.

Tolvaptan is taken twice a day in two different doses. There are three possible dose combinations that your doctor may prescribe:

• Take one tablet of the higher dose (45 mg, 60 mg or 90 mg) in the morning.
• 8 hours later take one tablet of the lower dose (15 mg or 30 mg).
• This schedule was designed to give you the best balance between the amount of medicine in your body and possible side effects (especially night time urination).
• Do not drink grapefruit juice during treatment with Tolvaptan. This could cause you to have too great of a drug effect while taking Tolvaptan.

Adjusted dose if you are taking certain medicines:

Your doctor will tell you to reduce your usual dose of Tolvaptan if you take certain medicines as these medicines could cause you to have too much Tolvaptan in your blood. Your doctor may reduce your dose to the following:

Do not miss or skip doses of Tolvaptan. If you miss a dose, take your next dose at the scheduled time and prescribed level. Do not take 2 doses at the same time.

Side effects of Tolvaptan treatment may include:

• Thirst
• Increased amount of urine
• Increased frequency of urination during the day and at night
• Headache
• Constipation, diarrhea, dry mouth, indigestion, decreased appetite
• Fatigue, weakness, dizziness
• Trouble sleeping
• Muscle spasms
• Rash, itching
• Abdominal pain

If any of these affects you severely, tell your doctor, nurse or pharmacist.

Talk with your doctor, nurse or pharmacist if you experience any of the following:

• Increased levels of potassium in the blood: irregular heart beats, muscle weakness and generally feeling unwell
• Increased levels of uric acid in the blood/Gout: joint pain, commonly in the big toe, followed by redness, swelling, warmth
• Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite

Stop taking Tolvaptan and seek immediate medical help if you experience any of the following:

• Dehydration: increased thirst, dry mouth and/or skin, fatigue, decreased amount of urine, headache, dizziness, irregular heart beats
• Angioedema and Severe Allergic Reactions: swelling of the face, eyes, or tongue, difficulty swallowing, wheezing, hives and generalized itching, rash, fever, abdominal cramps, chest discomfort or tightness, difficulty breathing, unconsciousness

This is not a complete list of side effects. For any unexpected side effects while taking Tolvaptan, contact your doctor, nurse or pharmacist.

Before starting any new treatment, tell your healthcare provider you are on Tolvaptan.

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

Always take Tolvaptan exactly as your doctor has prescribed. Check with your doctor, nurse or pharmacist if you are not sure.

While taking Tolvaptan you will produce more urine, urinate more frequently, and urinate at night. If this causes you concern, consult your doctor, nurse or pharmacist. This side effect should become less pronounced with time.

Here is a list of potential reasons you can give when you need to use the bathroom:

• I forgot something in the bathroom.
• I’m going to grab a quick snack.
• I need to make a phone call.
• I need to get my steps in for the day.
• I’m going to go out and quickly stretch my legs.

• Make it part of your morning routine and drink a glass of water when you first wake up in the morning
• Carry a water bottle with you and take sips throughout the day
• Take a sip of water whenever you pass a drinking fountain
• Try adding sugarless flavouring or a slice of lemon or lime to your water