Renagel

Dosage Forms & Strengths

tablet

• 400mg (Renagel)
• 800mg (Renagel, Renvela)

powder packet for oral suspension

• 800mg (Renvela)
• 2400mg (Renvela)

Serum Phosphorus Regulation

Indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) who are on dialysis

Initial dose

• Not taking phosphate binder
  • Serum PO4 >9 mg/dL [2.91 mmol/L]: 1600 mg PO q8hr with meals
  • Serum PO4 7.5-9 mg/dL [2.42-2.91 mmol/L]: 1200-1600 mg PO q8hr with meals
  • Serum PO4 5.5-7.5 mg/dL [1.78-2.42 mmol/L]: 800 mg PO q8hr with meals
• Switching from calcium acetate
  • Substitute 800 mg Renagel or Renvela for 667 mg of Ca-acetate
  • Substitute 1600 Renvela or Renagel for 1334 mg of Ca-acetate
  • Substitute 2400 mg Renvela or Renagel for 2001 mg Ca-acetate

Maintenance dose

• Target goal is serum phosphorus ≤5.5 mg/dL
• Serum PO4 >5.5 mg/dL [>1.78 mmol/L]: Increase dose by 400-800 mg per meal
• Serum PO4 3.5-5.5 mg/dL [1.13-1.78 mmol/L]: Maintain current dose
• Serum PO4 <3.5 mg/dL [1.13 mmol/L] decrease by 400-800 mg per meal

Dose titration

• Titrate dose; increase by 400-800 mg per meal at 2-week intervals as necessary to achieve target serum phosphorus levels
• Based on clinical studies, the average prescribed adult daily dose is ~7.2 g/day
• Highest daily adult dose studied was 14 grams in CKD patients on dialysis

Dosing Considerations

Renagel = Renvela on a per gram basis

Dosage Forms & Strengths

tablet

• 800mg (Renvela)

powder packet for oral suspension

• 800mg (Renvela)
• 2400mg (Renvela)

Serum Phosphorus Regulation

Indicated for the control of serum phosphorus in with chronic kidney disease (CKD) who are on dialysis in children aged ≥6 yr

<6 years: Safety and efficacy not established

See Administration for oral suspension preparation instructions

Initial dose (not taking phosphate binder)

• BSA ≥0.75 to <1.2 m²: 800 mg per meal/snack; titrate up or down by 400 mg-increments
• BSA ≥1.2 m²: 1600 mg per meal/snack; titrate up or down by 800 mg-increments

• Genzyme Corporation

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of RenaGel, there are no specific foods that you must exclude from your diet when receiving RenaGel. 

Your doctor may suggest a diet low in phosphorus while taking RenaGel. Some foods high in phosphorus include:

• Dairy foods (milk, cheese, yogurt)
• Beans (baked, kidney, lima, pinto)
• Nuts and peanut butter
• Processed meats (hot dogs, canned meat)
• Cola
• Canned iced teas and lemonade
• Bran cereals
• Egg yolks

You should not take sevelamer if you are allergic to it, or if you have a bowel obstruction.

To make sure sevelamer is safe for you, tell your doctor if you have:

• trouble swallowing;

• severe constipation;

• a blockage in your intestines;

• slow digestion;

• a stomach or intestinal disorder; or

• if you have recently had stomach or intestinal surgery.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Your dose needs may be different during pregnancy.

Taking sevelamer while you are pregnant can lower your blood levels of certain vitamins or folic acid. Follow your doctor's instructions about taking vitamins or mineral supplements during pregnancy.

Because sevelamer is not absorbed into the bloodstream, it is not expected to be harmful to a nursing baby.

Sevelamer is not approved for use by anyone younger than 6 years old.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take sevelamer with meals.

Sevelamer powder must be dissolved in water before you take it. The 0.8-gram packet should be mixed with at least 1 ounce (2 tablespoons) of water. The 2.4-gram packet should be mixed with at least 2 ounces (4 tablespoons) of water.

Stir the powder in water until it is completely dissolved. Stir and drink this mixture right away. To get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

While using sevelamer, you may need frequent blood tests.

Call your doctor if you have have trouble swallowing the tablet, or if it feels like it gets stuck in your esophagus after you swallow it.

Sevelamer may be only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

Store at room temperature away from moisture and heat.

Sevelamer is used to treat hyperphosphatemia (too much phosphate in the blood) in patients with chronic kidney disease who are on dialysis.

This medicine is available only with your doctor's prescription.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very hard stools (constipation).
• Very upset stomach or throwing up.
• Very bad belly pain.
• Trouble swallowing.

Renagel is contraindicated in patients with bowel obstruction.

Renagel is contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients.

You should not take Renagel if you have a bowel obstruction.

Before taking Renagel, tell your doctor if you have severe constipation, a blockage in your intestines, a stomach or intestinal disorder, trouble swallowing, or if you have recently had stomach or intestinal surgery.

Avoid taking any other medicines within 1 hour before or 3 hours after you take Renagel. Sevelamer can bind to other medications and make them less effective.

Before taking Renagel, tell your doctor if you are taking ciprofloxacin (Cipro), a heart rhythm medication, or a seizure medication.

Do not take calcium or other mineral supplements without your doctor's advice. Use only the specific type of calcium or mineral supplement your doctor recommends.

Applies to sevelamer: oral capsule, oral powder for reconstitution, oral tablet

General

The most frequently occurring adverse reactions included nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, and constipation.[Ref]

Gastrointestinal

Gastrointestinal events are the most common adverse reactions reported with this drug. Based on studies of 8 to 52 weeks, the most common reason for drug withdrawal are gastrointestinal adverse reactions (3% to 16%).[Ref]

Very common (10% or more): Vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%)
Common (1% to 10%): Abdominal pain, flatulence, constipation, gastrointestinal reflux disease
Frequency not reported: Dysphagia, diverticulitis
Postmarketing reports: Fecal impaction, ileus, intestinal obstruction, intestinal perforation[Ref]

Immunologic

Common (1% to 10%): Peritonitis[Ref]

A clinical study in patients receiving peritoneal dialysis (n=143) found the most frequently occurring treatment emergent serious adverse reaction was peritonitis. Peritonitis occurred in 8 patients receiving sevelamer and 2 patients on active control.[Ref]

Metabolic

Common (1% to 10%): Anorexia
Uncommon (0.1% to 1%): Acidosis, increased serum chloride levels, decreased carbon dioxide[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis, bronchitis
Common (1% to 10%): Cough, upper respiratory tract infection, dyspnea[Ref]

Dermatologic

Postmarketing reports: Pruritus, rash[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Local

Common (1% to 10%): Arteriovenous fistula site complication, arteriovenous fistula site hemorrhage, arteriovenous fistula thrombosis[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache[Ref]

Other

Common (1% to 10%): Fatigue, fever[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, muscle spasms, extremity pain[Ref]

Some side effects of Renagel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.