Precautions
The recommended starting dose of Renvela is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renvela for adult patients not taking a phosphate binder.
What is the recommended starting dose of Renvela?
Renvela is contraindicated in patients with bowel obstruction. Renvela is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
What are the contraindications for Renvela?
Renvela Generic name: sevelamer (se VEL a mer) Brand name: Renagel, Renvela Drug class: Phosphate binders
What is the generic name for Renvela?
Renvela is used to control phosphorus levels in people with chronic kidney disease who are on dialysis. Renvela may also be used for purposes not listed in this medication guide. You should not take Renvela if you have a bowel obstruction.
What are the uses of Renvela?
What ICD-10 covers phosphorus?
Disorder of phosphorus metabolism, unspecified E83. 30 is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes. The 2022 edition of ICD-10-CM E83. 30 became effective on October 1, 2021.
What is the ICD 10 code for low phosphorus?
E83. 39 - Other disorders of phosphorus metabolism. ICD-10-CM.
What is the ICD 10 code for medication administration?
ICD-10 code Z51. 81 for Encounter for therapeutic drug level monitoring is a medical classification as listed by WHO under the range - Factors influencing health status and contact with health services .
What diagnosis covers phosphorus?
Phosphorus levels are determined by calcium metabolism, parathyroid hormone, and to a lesser degree by intestinal absorption. Normal serum phosphorus is 2.5-4.5mg/dl. Serum phosphate levels help to detect endocrine, skeletal, and calcium disorders, and aid in the diagnosis of renal disorders and acid-base imbalance.
What is R79 89?
ICD-10 code R79. 89 for Other specified abnormal findings of blood chemistry is a medical classification as listed by WHO under the range - Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified .
What does hypophosphatemia mean?
Hypophosphatemia is defined as an adult serum phosphate level of fewer than 2.5 milligrams per deciliter (mg/dL). The normal level of serum phosphate in children is considerably higher and 7 mg/dL for infants. Hypophosphatemia is a relatively common laboratory abnormality and is often an incidental finding.
What is the ICD-10 code for medication review?
Encounter for therapeutic drug level monitoring. Z51. 81 is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes.
Can Z71 2 be used as a primary diagnosis?
Z71.2 as principal diagnosis According to the tabular index, a symbol next to the code indicates that it is an unacceptable principal diagnosis per Medicare code edits. This applies for outpatient and inpatient care.
What is ICD-10 code for medication change?
Other long term (current) drug therapy The 2022 edition of ICD-10-CM Z79. 899 became effective on October 1, 2021. This is the American ICD-10-CM version of Z79.
What is the CPT code for phosphorus?
Group 1CodeDescription84100Assay of phosphorus
Is phosphate and phosphorus the same?
Phosphorus is a mineral that combines with other substances to form organic and inorganic phosphate compounds. The terms phosphorus and phosphate are often used interchangeably when talking about testing, but it is the amount of inorganic phosphate in the blood that is measured with a serum phosphorus/phosphate test.
What is the difference between phosphate and phosphorus?
Phosphate is an electrically charged particle that contains the mineral phosphorus. Phosphorus works together with the mineral calcium to build strong bones and teeth. Normally, the kidneys filter and remove excess phosphate from the blood.
What is the active ingredient in Renvela?
The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ® ). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate-binding, is the same.
What is Renvela carbonate?
Renvela® (sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
How much sevelamer hydrochloride is needed for ciprofloxacin?
Coadministered single dose of 2.8 grams of sevelamer hydrochloride in fasted state decreased the bioavailability of ciprofloxacin by approximately 50% in healthy subjects.
What is the median response of sevelamer hydrochloride?
The distributions are similar for sevelamer hydrochloride and active control. The median response is a reduction of about 2 mg/dL in both groups. About 50% of subjects have reductions between 1 and 3 mg/dL.
How much sevelamer is needed for dialysis?
In CKD patients on dialysis, the maximum dose studied was 14 grams of sevelamer carbonate and 13 grams of sevelamer hydrochloride. There are no reports of overdosage with sevelamer carbonate or sevelamer hydrochloride in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.
How much sevelamer hydrochloride should pregnant rats take?
In pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred in mid and high-dose groups (human equivalent doses approximately equal to 3–4 times the maximum clinical trial dose of 13 g). In pregnant rabbits given oral doses of 100, 500, or 1000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical trial dose).
Does sevelamer reduce vitamin D?
In short-term clinical trials, there was no evidence of reduction in serum levels of vitamins. However, in a one-year clinical trial, 25-hydroxyvitamin D (normal range 10 to 55 ng/mL) fell from 39 ± 22 ng/mL to 34 ± 22 ng/mL (p<0.01) with sevelamer hydrochloride treatment. Most (approximately 75%) patients in sevelamer hydrochloride clinical trials were receiving vitamin supplements.
Drug Information
The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Route & Dosage
The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Drug Package Information
The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Product Application & Marketing Information
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
When will the ICD-10 T50.905A be released?
The 2022 edition of ICD-10-CM T50.905A became effective on October 1, 2021.
What is the secondary code for Chapter 20?
Use secondary code (s) from Chapter 20, External causes of morbidity, to indicate cause of injury. Codes within the T section that include the external cause do not require an additional external cause code. Type 1 Excludes.
What is Renvela?
Renvela (sevelamer) is a phosphate binder. Sevelamer helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus.
How old do you have to be to use Renvela?
Renvela is not approved for use by anyone younger than 6 years old.
What other drugs will affect Renvela?
Other drugs may interact with Renvela, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
How long after taking Renvela can you take Sevelamer?
Avoid taking any other medicines within 1 hour before or 3 hours after you take Renvela. Sevelamer can bind to other medications and make them less effective.
Is Renvela safe for babies?
To make sure Renvela 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.
What to tell your doctor before taking Renvela?
Before taking Renvela, 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.
Can Renvela harm a baby?
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 Renvela while you are pregnant can lower your blood levels of certain vitamins or folic acid.
What is Renvela used for?
Renvela ® (sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
Can sevelamer cause dysphagia?
Cases of dysphagia and esophageal tablet re tention have been reported in association with use of the tablet formulation of sevelamer, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders.
Can you heat Renvela powder?
As an alternative to water, the entire contents of the packet may be pre-mixed with a small amount of food or beverage and consumed immediately (within 30 minutes) as part of the meal. Do not heat Renvela powder (e.g., microwave) or add to heated foods or liquids.
Can you switch from Sevelamer to Sevelamer?
Switching from Sevelamer Hydrochloride Tablets. For adult patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams.
Is Renvela contraindicated?
Renvela is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
Indications and Usage For Renvela
Sevelamer is used to lower high blood phosphorus (phosphate) levels in patients who are on dialysis due to severe kidney disease.
May Treat: Renal osteodystrophy with hyperphosphatemia
Alternate Brand Names: Renagel
Drug Class: Phosphate Binders
Availability: Prescription Required
Pregnancy: Consult a doctor before using
May Treat: Renal osteodystrophy with hyperphosphatemia
Alternate Brand Names: Renagel
Drug Class: Phosphate Binders
Availability: Prescription Required
Pregnancy: Consult a doctor before using
Lactation: Consult a doctor before using
Alcohol: Limit intake while taking this medication
Driving: May cause drowsiness or dizziness. Use caution
Manufacturer: GENZYME
Precautions
- Take with meal(s) for better drug activity.
- Call Doctor right away if you get constipated
- It is important to follow an appropriate diet
- Take with meal(s) for better drug activity.
- Call Doctor right away if you get constipated
- It is important to follow an appropriate diet
- Skip missed dose unless you have just eaten.
- Lab tests may be ordered to monitor therapy
- Review all drugs you are taking with your doctor
- For powder in packet products : Mix drug in water and drink as directed. Tell doctor your complete medical history.
- For tablet products : Swallow whole. Do not break/chew/crush/dissolve. Do not use with feeding tube due to clogging.
Renvela Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
- General Dosing Information
Starting Dose for Adult Patients Not Taking a Phosphate Binder.The recommended starting dose of Renvela is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting doses of Renvela for adult patients not taking a phosphate bind… - Sevelamer Carbonate Powder Preparation Instructions
Sevelamer carbonate powder is available in 0.8 or 2.4 g packets. For dose increments of 0.4 g, use one half of a 0.8 g packet. Place the sevelamer carbonate powder in a cup and suspend in the amount of water described in Table 4. Instruct patients to stir the mixture vigorously (it does no…
Drug Interactions
- Tablets: 800 mg white oval, film-coated, compressed tablets imprinted with "Renvela 800" Powder: 0.8 g and 2.4 g pale-yellow powder packaged in an opaque, foil-lined, heat-sealed packet
Use in Specific Populations
- Renvela is contraindicated in patients with bowel obstruction. Renvela is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
Overdosage
- Gastrointestinal Adverse Events
Cases of dysphagia and esophageal tablet retention have been reported in association with use of the tablet formulation of sevelamer, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders. Cases of bowel o… - Reductions in Vitamins D, E, K (clotting factors) and Folic Acid Levels
In preclinical studies in rats and dogs, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, reduced vitamins D, E, and K (coagulation parameters) and folic acid levels at doses of 6–10 times the recommended human dose. In short-term clinical trials, t…
Renvela Description
- Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. There are limited clinical trial da… - Postmarketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. The following adverse reactions have been identified during postapproval use of sevel…
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