Patient Medication Information: uses, side effects, how to take - Fosrenol
What is FOSRENOL used for?
FOSRENOL is used to lower blood phosphorus levels. It is used in adults with end-stage kidney disease who are on dialysis.
How does FOSRENOL work?
FOSRENOL binds to phosphate in your gut. This lowers the amount of phosphate that is absorbed from the food you eat.
What are the ingredients in FOSRENOL?
Medicinal ingredients: Lanthanum carbonate hydrate
Non-medicinal ingredients: colloidal silicon dioxide, dextrates (hydrated) and magnesium stearate.
FOSRENOL comes in the following dosage forms:
Chewable tablets: 500 mg, 750 mg and 1000 mg
Do not use FOSRENOL if:
- you have a blockage in the intestine;
- you have severe constipation;
- you have hypophosphatemia. This is when blood phosphate levels are low;
- you are allergic to lanthanum carbonate or any of the ingredients in FOSRENOL.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take FOSRENOL. Talk about any health conditions or problems you may have, including if you:
- have had a blockage in the intestine, tear of the intestine wall, constipation, or diabetes,
- have had previous abdominal surgery,
- have suffered from peritonitis (inflammation of the abdomen) or diverticulitis (infection or inflammation in the intestine),
- have previously had stomach or intestinal cancer,
- suffer from acute peptic ulcer, ulcerative colitis, or Crohn’s disease,
- suffer from liver problems or a blocked bile duct,
- are taking chelation therapy.
Other warnings you should know about:
Treatment with FOSRENOL increases your risk for constipation, blockage in the intestine and tearing of the intestine wall. These could cause you to be hospitalized. You might need surgery. Watch for signs of stomach or intestinal problems, which can include constipation, abdominal pain and bloating. Tell your doctor about these symptoms, if they happen to you.
FOSRENOL may build up in your bones and digestive tract. Your healthcare professional will consider this, if you need to take FOSRENOL for a long time.
Your healthcare professional may recommend that you follow a specific diet. This diet would control the fluids you drink and the amount of phosphate you eat.
Pregnancy and breastfeeding:
- Taking FOSRENOL during pregnancy is not recommended.
- It is not known if FOSRENOL passes into breast milk.
Talk to your healthcare professional:
- if you are pregnant or are planning to become pregnant.
- about the best ways to feed your baby while you are taking FOSRENOL.
X-rays: Tell your doctor that you are taking FOSRENOL before having an X-ray of your abdomen. This is because FOSRENOL may affect the results.
Endoscopy: Tell your doctor that you are taking FOSRENOL before your gastrointestinal endoscopy. This is because FOSRENOL might leave lanthanum deposits in the digestive tract.
Blood tests: You will need to have regular blood tests to measure the amount of phosphate in your blood.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with FOSRENOL:
- Some medicines used to treat bacterial infections including ciprofloxacin
- A medicine used to treat an underactive thyroid called levothyroxine.
Some medicines should not be taken within 2 hours before or 2 hours after taking FOSRENOL. These include:
- Two medicines used to treat bacterial infections, including acne called tetracycline and doxycycline.
- A medicine used to treat malaria called chloroquine.
- A medicine used to treat rheumatoid arthritis and malaria called hydroxychloroquine.
- A medicine used to treat fungal infections called ketoconazole.
How to take FOSRENOL:
- Take exactly as directed by your healthcare professional.
- Your healthcare professional will tell you how much FOSRENOL to take.
- Divide your daily dose as directed by your healthcare professional.
- Take your FOSRENOL with or right after eating a meal.
- Chew tablets completely before swallowing. Do NOT swallow tablets whole. This is because serious stomach and intestinal problems can happen including nausea, vomiting, abdominal cramps and diarrhea.
- If you cannot chew tablets, crush them completely before swallowing.
Usual dose:
Usual starting dose: 750 mg to 1500 mg per day.
Maintenance dose: 1500 mg to 3000 mg per day.
Your healthcare professional will tell you how much FOSRENOL to take and will adjust your dose every 2 to 3 weeks to find the dose that is right for you.
Overdose:
The symptoms of overdose may be headache, nausea and vomiting.
| If you think you, or a person you are caring for, have taken too much FOSRENOL, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you miss a dose, take your next dose at your usual time with or right after a meal. Taking a dose without food may lead to nausea and vomiting. Do not take two doses at once to make up for a missed dose.
What are possible side effects from using FOSRENOL?
These are not all the possible side effects you may feel when taking FOSRENOL. If you experience any side effects not listed here, contact your healthcare professional.
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FOSRENOL can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
VERY COMMON Allergic skin reaction: rash, hives, itching | √ | ||
COMMON Dialysis graft complications including occlusion (problems with the dialysis access tube): fever, chills, blood or pus draining from access tube, sudden swelling or bulging, redness and pain around graft access, hand or arm is numb, cool or pale | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness | √ | ||
UNCOMMON Chest pain | √ | ||
| Eosinophilia (abnormal white blood cell count): abdominal pain, rash, weight loss, wheezing | √ | ||
| Gastrointestinal obstruction complete (ileus) or incomplete (subileus) [blockage that stops or impairs passage of contents of intestines]: abdominal bloating, abdominal pain, swelling or cramps, constipation, vomiting | √ | ||
| Hyperparathyroidism (enlarged parathyroid glands): tingling or burning of fingertips, toes or lips, muscle aches, cramps or spasms, fatigue, weakness, | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| painful menstrual period, dry skin, brittle nails, depression or anxiety | |||
| Hypocalcemia (low blood calcium levels): confusion or memory loss, muscle cramps or spasms, numbness and tingling in hands, feet or face, weak and brittle nails | √ | ||
| Osteoporosis (bone disease): back pain, loss of height over time, stooped posture, broken bones | √ | ||
| Peripheral edema (swelling of limbs) | √ | ||
RARE Gastrointestinal perforation (tear or hole in the wall of the stomach or intestine): sudden severe abdominal pain, swelling and or bloating of the stomach area, nausea, vomiting, fever and chills | √ | ||
| UNKNOWN FREQUENCY | |||
| Product residue present in digestive tract: (detectable with endoscopy) abdominal bloating, abdominal pain, swelling or cramps, constipation, vomiting | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
Storage:
Store between 15-25°C. Protect from moisture.
Keep out of reach and sight of children and pets.
If you want more information about FOSRENOL:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.takeda.com/en-ca, or by calling 1-800-268-2772.
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto Ontario M5H 4E3
Last Revised: MAR 28, 2024
FOSRENOL® and the FOSRENOL Logo are registered trademarks of Shire International Licensing BV, a Takeda company.
TAKEDA® and the TAKEDA Logo are registered trademarks of Takeda Pharmaceutical Company Limited, used under license.