Veltassa 8.4gm Powder

Manufacturer RELYPSA Active Ingredient Patiromer(pa TIR oh mer) Pronunciation pa-TIE-roe-mer
It is used to treat high potassium levels.
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Drug Class
Potassium binder
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Pharmacologic Class
Cation exchange polymer
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Pregnancy Category
Not available
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FDA Approved
Oct 2015
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Veltassa is a medication used to treat high potassium levels in the blood (hyperkalemia). It works by binding to potassium in your digestive system, preventing it from being absorbed into your body, and then removing it through your stool. It is not absorbed into your bloodstream.
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How to Use This Medicine

Taking Your Medication

To take this medication correctly, follow your doctor's instructions and read all the information provided. You can take it with or without food.

Preparing Your Dose

To mix the powder, follow these steps:

1. Measure 1/3 cup (80 mL) of liquid or soft food, such as water, applesauce, yogurt, or pudding.
2. Pour half of the liquid or soft food into a glass.
3. Add the powder and stir well.
4. Add the remaining liquid or soft food and stir again. The mixture will appear cloudy, as the powder will not dissolve.
5. If the mixture is too thick, you can add more liquid or soft food.

Special Instructions

If your dose is 4 grams or less, you can mix it with a smaller amount of liquid or soft food, but use at least 3 tablespoons (45 mL).
If you're not using water to mix the medication, be aware of the potassium content in the liquid or soft food you choose.
Do not heat or microwave the mixture.
Do not mix the medication with warm or hot drinks or food.
Do not take the powder dry.

Taking Your Dose

Take your dose immediately after mixing.
Do not store the mixture for future use.
After taking your dose, rinse the cup with more liquid or soft food and drink or eat it to ensure you receive the entire dose.

Storage and Disposal

Store the medication in the refrigerator. Do not freeze.
Alternatively, you can store it at room temperature, but discard any unused portion after 3 months.
Protect the medication from heat.

Missing a Dose

If you miss a dose, take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Follow your doctor's recommendations for a low-potassium diet.
  • Do not take other oral medications within 3 hours before or 3 hours after taking Veltassa, unless specifically instructed by your doctor, to avoid interactions.
  • Mix the powder with water only. Do not mix with fruit juice or other liquids. Do not heat Veltassa or add it to hot foods or liquids.
  • Take Veltassa with food or without food, but try to take it at the same time each day.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 8.4 g once daily
Dose Range: 8.4 - 25.2 mg

Condition-Specific Dosing:

hyperkalemia: Initial dose of 8.4 g once daily. Adjust dose by 8.4 g increments at 1-week intervals based on serum potassium levels and the target range. Maximum dose is 25.2 g once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment needed
Moderate: No dose adjustment needed
Severe: No dose adjustment needed
Dialysis: No dose adjustment needed (patiromer is not absorbed systemically)

Hepatic Impairment:

Mild: No dose adjustment needed
Moderate: No dose adjustment needed
Severe: No dose adjustment needed

Pharmacology

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Mechanism of Action

Patiromer is a non-absorbed, orally administered polymer that exchanges potassium for calcium in the gastrointestinal tract. It increases fecal potassium excretion, thereby lowering serum potassium levels.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible (<0.01%)
Tmax: Not applicable (not absorbed)
FoodEffect: Can be taken with or without food

Distribution:

Vd: Not applicable
ProteinBinding: Not applicable
CnssPenetration: No

Elimination:

HalfLife: Not applicable (not absorbed)
Clearance: Not applicable
ExcretionRoute: Feces
Unchanged: 100%
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Pharmacodynamics

OnsetOfAction: Reduction in serum potassium can be seen within 7 hours
PeakEffect: Achieved within 48 hours to 7 days
DurationOfAction: Sustained as long as treatment continues

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low magnesium levels, including:
+ Mood changes
+ Muscle pain or weakness
+ Muscle cramps or spasms
+ Seizures
+ Shakiness
+ Decreased appetite
+ Severe upset stomach or vomiting
+ Abnormal heartbeat

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:

Diarrhea
Constipation

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Signs of very low potassium (hypokalemia): severe muscle weakness, tingling, numbness, heart palpitations, severe constipation.
  • Signs of low magnesium (hypomagnesemia): muscle cramps, tremors, fatigue, weakness, nausea, vomiting.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bowel blockage
+ Constipation
+ Difficulty having a bowel movement

This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.

Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins

It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

To ensure optimal management of your condition, follow the personalized diet plan recommended by your doctor. It is crucial to note that this medication can interfere with the absorption of other oral medications. If you are taking other medications by mouth, consult with your doctor or pharmacist to determine whether you should take them at least 3 hours before or 3 hours after this medication.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Pregnant women, or those planning to become pregnant or breast-feed, should consult their doctor to discuss the potential benefits and risks of this medication to both themselves and their baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypokalemia (extremely low potassium levels), which can lead to life-threatening cardiac arrhythmias and muscle paralysis.
  • Severe hypomagnesemia.

What to Do:

In case of suspected overdose, seek immediate medical attention. Management typically involves monitoring serum potassium and magnesium levels, and providing potassium and/or magnesium supplementation as needed. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US).

Drug Interactions

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Major Interactions

  • Oral medications that are critical to their effect and have narrow therapeutic windows (e.g., lithium, some antiarrhythmics). Patiromer can bind to these drugs, reducing their absorption. Administer other oral medications at least 3 hours before or 3 hours after patiromer.
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Moderate Interactions

  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin)
  • Levothyroxine
  • Some antihypertensives (e.g., ACE inhibitors, ARBs, beta-blockers)
  • Some antifungals (e.g., ketoconazole)
  • Some antiepileptics (e.g., phenytoin)
  • Metformin
  • Mycophenolate mofetil
  • Warfarin

Monitoring

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Baseline Monitoring

Serum Potassium

Rationale: To establish baseline potassium level and guide initial dosing.

Timing: Prior to initiation of therapy

Serum Magnesium

Rationale: Patiromer can bind magnesium, potentially leading to hypomagnesemia.

Timing: Prior to initiation of therapy

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Routine Monitoring

Serum Potassium

Frequency: Weekly for the first month, then monthly or as clinically indicated

Target: 3.5-5.0 mEq/L (or as per clinical guidelines)

Action Threshold: Adjust dose if potassium is outside target range; consider dose reduction or discontinuation if hypokalemia develops.

Serum Magnesium

Frequency: Periodically (e.g., monthly or every 3 months), or as clinically indicated

Target: 1.7-2.2 mg/dL

Action Threshold: Supplement magnesium if hypomagnesemia develops.

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Symptom Monitoring

  • Symptoms of hypokalemia (e.g., muscle weakness, fatigue, muscle cramps, heart palpitations, constipation)
  • Symptoms of hypomagnesemia (e.g., muscle cramps, tremors, weakness, fatigue, nausea, vomiting)

Special Patient Groups

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Pregnancy

Patiromer is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Therefore, risk to the fetus is considered low.

Trimester-Specific Risks:

First Trimester: Low risk due to negligible systemic absorption.
Second Trimester: Low risk due to negligible systemic absorption.
Third Trimester: Low risk due to negligible systemic absorption.
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Lactation

Patiromer is not absorbed systemically by the mother, and breastfeeding is not expected to result in exposure of the infant to patiromer. Therefore, risk to the breastfed infant is considered low (L1).

Infant Risk: Low risk
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly patients and younger patients. No specific dose adjustment is required based on age.

Clinical Information

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Clinical Pearls

  • Always emphasize the importance of separating Veltassa administration from other oral medications by at least 3 hours before or 3 hours after to prevent drug-drug interactions.
  • Instruct patients to mix the powder only with water and to consume the mixture within 1 hour of preparation. Do not heat the mixture.
  • Regular monitoring of serum potassium and magnesium is crucial, especially during the initial weeks of therapy and after dose adjustments.
  • Veltassa is a long-term treatment for chronic hyperkalemia and should not be used for emergency treatment of life-threatening hyperkalemia due to its delayed onset of action.
  • Educate patients on symptoms of hypokalemia and hypomagnesemia and when to seek medical attention.
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Alternative Therapies

  • Sodium polystyrene sulfonate (SPS, e.g., Kayexalate, Kionex)
  • Sodium zirconium cyclosilicate (Lokelma)
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Cost & Coverage

Average Cost: Approximately $1000-$1500 per 30-day supply (8.4g/day)
Insurance Coverage: Often Tier 3 or Specialty Tier, requiring prior authorization
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.