Details for: JINARC
Company: OTSUKA PHARMACEUTICAL CO LTD
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02491575 | JINARC | TOLVAPTAN; TOLVAPTAN | 15 MG; 15 MG | TABLET | ORAL |
02491583 | JINARC | TOLVAPTAN; TOLVAPTAN | 30 MG; 15 MG | TABLET | ORAL |
02437503 | JINARC | TOLVAPTAN; TOLVAPTAN | 45 MG; 15 MG | TABLET | ORAL |
02437511 | JINARC | TOLVAPTAN; TOLVAPTAN | 60 MG; 30 MG | TABLET | ORAL |
02437538 | JINARC | TOLVAPTAN; TOLVAPTAN | 90 MG; 30 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
JINARC is used in adults to treat autosomal dominant
polycystic kidney disease (ADPKD).
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.
JINARC should only be prescribed by a doctor experienced
in the diagnosis and treatment of ADPKD.
What it does
JINARC works by blocking the effects of a hormone called
vasopressin, which promotes cyst growth in the kidneys in
patients with ADPKD. By blocking the effects of the
hormone, JINARC is able to reduce the growth of the cysts in
the kidneys and slow the decline of kidney function. This
should help protect your kidneys from damage and failure.
Because of the way that JINARC works, you will produce
more urine causing you to urinate more frequently during the
day and at night. This may become less pronounced over
time.
Before starting this medication:
Before taking JINARC 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 JINARC 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 and that you agree to take
blood tests as prescribed by your doctor to start and remain
on treatment. For more information on JINARC controlled
hepatic safety monitoring and distribution programme, please
call 1-844-254-6272. In order to gather information on the
long-term clinical outcomes with JINARC, your doctor may
discuss with you the possibility to participate in the Canadian
JINARC patient outcomes registry. For more information on
the study, please call 1-877-341-9245 or go to
www.clinicaltrials.gov, study ID NCT02925221.
When it should not be used
Do not take JINARC if:
- you have been asked to permanently discontinue tolvaptan in the past
- you are allergic to tolvaptan, benzazepine or benzazepine derivatives (e.g. REMERON®), or any non-medicinal ingredients in the formulation.
- you can not replace fluids by drinking or you can not 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 JINARC treatment.
- you are pregnant or plan to become pregnant. It is not known if JINARC will harm your unborn baby.
- you are breast-feeding. It is not known if JINARC passes into your breast milk. You and your healthcare provider should decide if you will take JINARC or breast-feed. You should not do both.
- your body is not able to make any urine. JINARC will not help your condition.
- you take certain medicines. These medicines could cause you to have too much JINARC in your blood:
- the antibiotic medicines, clarithromycin or telithromycin
- the antifungal medicines, ketoconazole or itraconazole
- the anti-HIV medicines, ritonavir, indinavir, nelfinavir, and saquinavir
- the antidepressant medicine, nefazodone
- you have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
What the medicinal ingredient is
tolvaptan
What the non-medicinal ingredients are
Corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and FD&C Blue No. 2 Aluminum Lake as colorant.
What dosage form it comes in
Weekly combination blister packs of 15+15 mg, 30+15 mg, 45+15 mg, 60+30 mg, and 90+30 mg tablets.
Warnings and precautions
Serious Warnings and Precautions
Your doctor will arrange blood tests before you start treatment with JINARC and then at regular intervals during treatment to check for changes in your liver function.
To prevent pregnancy while on JINARC treatment, women
of childbearing potential must have effective contraceptive
measures in place before and during treatment.
BEFORE you use JINARC talk to your doctor, nurse or
pharmacist if you:
- have difficulty urinating or have an enlarged prostate
- are dehydrated or suffer from excessive vomiting, diarrhea or sweating
- have low levels of sodium in your blood
- have high potassium levels in your blood
- have high levels of uric acid in your blood or gout
- are taking medication to treat high blood pressure
- are less than 18 years old
- have been asked to permanently discontinue tolvaptan in the past
Interactions with this medication
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.
The following may interact with JINARC: clarithromycin,
ketoconazole, ritonavir, saquinavir, rifampicin, phenytoin,
carbamazepine, St. John’s Wort, cyclosporin, quinidine,
verapamil, erythromycin, fluconazole, hypertonic saline
solutions, drugs that increase serum sodium concentrations,
drugs known to increase serum potassium levels (such as
spironolactone), digoxin, consuming grapefruit juice, or
vasopressin drugs, such as desmopressin, used to control
bleeding.
Always take JINARC exactly as your doctor has prescribed.
Check with your doctor, nurse or pharmacist if you are not
sure.
You can take JINARC with or without food.
While taking JINARC you will produce more urine, urinate
more frequently, and urinate at night. If this causes you
concern, consult your doctor, nurse or pharmacist. This sideeffect should become less pronounced with time.
To prevent becoming dehydrated, have water available to
drink at all times while taking JINARC. Unless your doctor
tells you otherwise, drink plenty of water during the day and
one or two glasses before going to bed. If you suffer from
vomiting, diarrhea or any other condition that might cause
you to become dehydrated while taking JINARC call your
doctor.
Blood tests:
During treatment with JINARC, your doctor will arrange
blood tests to check for changes in your liver function, as
follows:
- before starting treatment with JINARC
- 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
Proper use of this medication
Usual Dose
- JINARC is to be taken twice a day in two different doses. There are three possible dose combinations that your doctor may prescribe:
- 45+15 mg, for a total daily dose of 60 mg, or
- 60+30 mg, for a total daily dose of 90 mg, or
- 90+30 mg, for a total daily dose of 120 mg.
- 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 JINARC. This could cause you to have too great of a drug effect, while taking JINARC.
Adjusted dose if you are taking certain medicines:
Your doctor will tell you to reduce your usual dose of
JINARC if you take certain medicines as these medicines
could cause you to have too much JINARC in your blood.
Your doctor may reduce your dose to the following:
- 15 mg + 15 mg, for a total daily dose of 30 mg. or
- 30 mg +15 mg, for a total daily dose of 45 mg.
Overdose
Missed Dose
Do not miss or skip doses of JINARC. 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 and what to do about them
Side effects 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
Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and seek immediate medical help |
---|---|---|---|
Common | |||
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 | ✔ | ||
Uncommon | |||
Dehydration: increased thirst, dry mouth and/or skin, fatigue, decreased amount of urine, headache, dizziness, irregular heart beats | ✔ | ||
Rare or Uncommon | |||
Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
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, unconsciousn ess. | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking JINARC contact your doctor, nurse or pharmacist.
How to store
Store JINARC between 15°C to 30°C. Keep JINARC out of sight and reach of children.
Reporting side effects
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found at:
www.otsukacanada.com
or by contacting the marketer, Otsuka Canada Pharmaceutical
Inc., at:
1-877-341-9245.
This leaflet was prepared by Otsuka Pharmaceutical Co., Ltd.
Imported by: Otsuka Canada Pharmaceutical Inc.
Last revised: October 23, 2019
JINARC is a trademark of Otsuka Pharmaceutical Co., Ltd.,
used under licence by Otsuka Canada Pharmaceutical Inc.