Renvela: Administration, Precautions, Side Effects, Warnings and Interactions

This medicine is a phosphate binder.

Phosphate is primarily made up of the mineral phosphorus , which is an important component of normal bone structure, cell metabolism, and cell function. In the body, the kidneys help keep the amount of phosphorus in the blood at a relatively constant level.

For people with kidney problems, as their kidney function declines, less phosphorus is removed from the body, which can lead to a condition known as  hyperphosphatemia  (high levels of phosphate in the blood).

High levels of phosphorus in the blood can cause problems with the strength and structure of the bones. This condition is known as  renal osteodystrophy .

When taken with food, renvela prevents the absorption of phosphates from food by binding to phosphate. It is used specifically to control high levels of phosphate (and therefore phosphorus) in the blood of people with severe kidney disease, known as end-stage renal disease, who are on dialysis.

What form (s) is this medicine in?

Each white, oval tablet imprinted with “RENVELA 800” contains 800 mg of anhydrous sevelamer carbonate.

  • Non-medicinal ingredients:  microcrystalline cellulose, sodium chloride and zinc stearate.
  • Coating:  hypromellose and diacetylated monoglycerides.

How should you use this medicine?

The dose of renvela depends on the amount of phosphorus in the blood. The starting dose can range from 2.4 to 4.8 g per day. The total daily doses of sevelamer carbonate are generally divided according to the food servings where higher doses of sevelamer carbonate are given with larger meals.

Your doctor may gradually increase the total daily dose of renvela according to the level of phosphorus in your blood. The tablets should be taken immediately before meals or with meals. Do not chew, chew, or separate the tablet before swallowing.

Do not change the dose without your doctor’s supervision or approval.

Who should NOT take this medicine?

Do not take renvela if:

  • You are allergic to renvela or any of the ingredients in the medicine.
  • You have a bowel obstruction.
  • It has low levels of phosphorus in the body.

What side effects are possible with this drug?

Many of these side effects can be controlled, and some may go away on their own over time.

  • Headaches.
  • Heartburn or indigestion
  • Gases.
  • Constipation .
  • Diarrhea.
  • Nausea and vomiting
  • Itching and rashes.

If you have any of the following symptoms, you should see your doctor as soon as possible:

  • Abdominal pain.
  • Back pain or limb pain.
  • Difficulty to swallow.
  • Fever.
  • Signs of inflammation in the digestive system (for example: pain in the lower left abdomen, fever, nausea, diarrhea or constipation).
  • Upper respiratory tract infection (for example: bronchitis, sinusitis).

Stop taking the medicine and seek immediate medical attention if any of the following symptoms occur:

  • Signs of an allergic reaction (shortness of breath or difficulty breathing, hives, swelling of the eyes, mouth, lips or throat).
  • Signs of a blockage in the digestive system (abdominal cramps, gas pain, nausea, vomiting after meals, excessive belching).

Warnings with the use of the drug

You have to make sure, before taking the medicine, that you are not allergic to any of its components. Also discuss the use of renvela with your doctor if you have:

Gastrointestinal disorders

If you have gastrointestinal disorders (for example, dysphagia [difficulty swallowing], severe movement disorders in the gastrointestinal tract [ie esophagus, stomach, and intestine]), or if you have had major gastrointestinal surgery.

Consult with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosage and effectiveness of this medication, and if any special monitoring is needed.

Low calcium content

People with kidney disease can develop a condition called hypocalcemia (low levels of calcium in the blood). While taking this medicine, your doctor will regularly check your blood calcium levels.

If you experience signs or symptoms of low blood calcium levels, such as muscle cramps or pain, dry skin, or a tingling sensation in the fingers, lips, tongue, or feet, contact your doctor as soon as possible.

Pregnancy

Discuss the possibility of taking this medicine with your doctor if you are pregnant or planning to become pregnant.

Lactation

It is unknown if the drug passes into breast milk, so it is best to avoid taking the drug while breastfeeding. You can discuss this with your doctor.

Children and adolescents

How safe and effective the drug is for young people under the age of 18 has not yet been established.

What other drugs could interact with this medicine?

There may be an interaction between renvela and any of the following drugs:

  • Calcitriol.
  • Levothyroxine.
  • Medicines for irregular heartbeat (antiarrhythmics, such as amiodarone, propafenone).
  • Mycophenolate.
  • Phosphate-containing drugs or products.
  • Quinolone antibiotics (for example: ciprofloxacin, norfloxacin, ofloxacin).
  • Anti-seizure drugs (for example: carbamazepine, phenytoin).

If you are taking any of these medications, talk to your doctor or pharmacist.