Veltassa 16.8gm Powder

Manufacturer RELYPSA Active Ingredient Patiromer(pa TIR oh mer) Pronunciation pa-TIR-oh-mer (Veltassa)
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
Category C
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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 (Patiromer) is a medication used to treat high potassium levels in your blood. 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. This helps to lower your blood potassium levels.
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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

1. Mix the powder with 1/3 cup (80 mL) of water, another drink, or a soft food like applesauce, yogurt, or pudding.
2. Measure out half of the liquid or soft food and pour it into a glass.
3. Add the powder to the glass and stir well.
4. Add the remaining liquid or soft food and stir again. The mixture will appear cloudy because the powder will not dissolve.
5. If the mixture is too thick, you can add more liquid or soft food.
6. For doses of 4 grams or less, you can use less liquid or soft food, but you must use at least 3 tablespoons (45 mL).
7. If you're using a liquid or soft food other than water to mix your medication, be aware of the amount of potassium it may contain.
8. Do not heat or microwave the mixture.
9. Avoid mixing the medication with warm or hot drinks or food.
10. Never take the dry powder without mixing it first.

Taking Your Prepared Dose

Take your dose immediately after preparing it. Do not store the mixture for later use.
After taking your dose, rinse the cup with more liquid or soft food and drink or eat it to ensure you get the full dose. Repeat this process as needed.

Storing Your Medication

You can store this medication in the refrigerator. Do not freeze it.
Alternatively, you can store it at room temperature, but you must 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 continue with your regular schedule.
Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take Veltassa exactly as prescribed by your doctor, usually once daily with food.
  • Mix the powder with water (or other specified liquids like apple juice, cranberry juice, pineapple juice) and stir well. Do not heat Veltassa.
  • Drink the mixture immediately. If any powder remains, add more liquid, stir, and drink.
  • Do not take other oral medications within 3 hours before or 3 hours after taking Veltassa, unless specifically instructed by your doctor, as Veltassa can bind to other medications and reduce their effectiveness.
  • Maintain adequate hydration as advised by your doctor.
  • Follow any dietary recommendations given by your doctor or dietitian regarding potassium intake.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

hyperkalemia: Initial dose 8.4 g once daily. Adjust dose in 8.4 g increments at 1-week intervals based on serum potassium levels. Maximum dose 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 adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed, as Patiromer is not systemically absorbed.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Patiromer is a non-absorbed, orally administered polymer that contains a calcium-sorbitol counterion. It increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract, primarily in the colon. The binding of potassium reduces the concentration of free potassium in the GI lumen, leading to a reduction in serum potassium levels.
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Pharmacokinetics

Absorption:

Bioavailability: Not absorbed
Tmax: Not applicable (not absorbed)
FoodEffect: Should be taken with food to ensure consistent administration, but food does not significantly alter its potassium binding capacity.

Distribution:

Vd: Not applicable (not absorbed)
ProteinBinding: Not applicable (not absorbed)
CnssPenetration: No

Elimination:

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

OnsetOfAction: Approximately 7 hours (initial decrease in serum potassium)
PeakEffect: Approximately 48 hours
DurationOfAction: Maintains effect with continued daily dosing
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Diarrhea
Constipation

Reporting Side Effects

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

  • Symptoms of low potassium (hypokalemia): muscle weakness, fatigue, muscle cramps, constipation, heart palpitations.
  • Symptoms of low magnesium (hypomagnesemia): muscle cramps, tremors, weakness, fatigue, nausea, vomiting, irregular heartbeats.
  • Severe constipation or abdominal pain.
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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 taking this medication.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Prior to initiating treatment, inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Your doctor will help you weigh the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Due to its non-systemic absorption, systemic toxicity from an overdose is unlikely.
  • Potential symptoms might include severe constipation or abdominal discomfort.

What to Do:

Contact your doctor or poison control center (1-800-222-1222) immediately. Management is supportive, focusing on symptomatic relief for gastrointestinal issues.

Drug Interactions

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Major Interactions

  • Oral medications that are susceptible to binding by cations (e.g., ciprofloxacin, levothyroxine, lithium, some antifungals like ketoconazole, mycophenolate mofetil, quinidine, tetracycline). Separate administration by at least 3 hours before or 3 hours after Patiromer.

Monitoring

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Baseline Monitoring

Serum Potassium

Rationale: To establish baseline hyperkalemia severity 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

ECG (Electrocardiogram)

Rationale: To assess for cardiac manifestations of hyperkalemia, especially in severe cases.

Timing: Prior to initiation, if clinically indicated by severe hyperkalemia

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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

Action Threshold: Adjust dose if potassium is outside target range; monitor more frequently if unstable.

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 levels fall below normal range.

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Symptom Monitoring

  • Symptoms of hyperkalemia (e.g., muscle weakness, fatigue, paresthesias, palpitations, bradycardia)
  • Symptoms of hypokalemia (e.g., muscle cramps, weakness, fatigue, constipation, palpitations)
  • Symptoms of hypomagnesemia (e.g., muscle cramps, tremors, weakness, fatigue, nausea, vomiting, cardiac arrhythmias)

Special Patient Groups

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Pregnancy

Patiromer is not systemically absorbed, and therefore, maternal use is not expected to result in fetal exposure to the drug. Use during pregnancy should only be considered if the potential benefit justifies the potential risk.

Trimester-Specific Risks:

First Trimester: Low risk expected due to lack of systemic absorption.
Second Trimester: Low risk expected due to lack of systemic absorption.
Third Trimester: Low risk expected due to lack of systemic absorption.
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Lactation

Patiromer is not systemically absorbed by the mother, so breastfeeding is not expected to result in exposure of the infant to Patiromer. Therefore, it is considered unlikely to cause harm to a breastfed infant.

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 specific dose adjustment is required for elderly patients. Clinical studies included patients 65 years and older, and no overall differences in safety or effectiveness were observed compared to younger patients.

Clinical Information

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Clinical Pearls

  • Patiromer is NOT for emergency treatment of life-threatening hyperkalemia due to its delayed onset of action. For acute, severe hyperkalemia, immediate medical intervention (e.g., IV insulin/glucose, calcium gluconate) is required.
  • Always mix the powder with water (or other approved liquids) and take with food. Do not take dry powder.
  • Ensure patients understand the importance of separating Patiromer from other oral medications by at least 3 hours before or 3 hours after administration.
  • Monitor serum magnesium levels periodically, as hypomagnesemia is a known side effect.
  • Advise patients to report any new or worsening constipation or abdominal discomfort.
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Alternative Therapies

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

Average Cost: Varies widely per 30 packets
Insurance Coverage: Tier 3 or Specialty Tier (requires 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.