Veltassa 25.2gm 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
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 is a medication used to treat high potassium levels in your blood, a condition called hyperkalemia. It works by binding to potassium in your digestive system, which helps your body remove excess potassium through your stool. It is a powder that you mix with water or soft food and take once a day.
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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 the Medication

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 1/3 cup (80 mL) of liquid or soft food and pour half of it into a glass.
3. Add the medication 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 does not dissolve.
5. If the mixture is too thick, you can add a bit more liquid or soft food.
6. For doses of 4 grams or less, you can use less liquid or soft food, but make sure to use at least 3 tablespoons (45 mL).
7. If you're using a liquid or soft food other than water to mix the medication, be aware of the amount of potassium it may contain.

Important Mixing Instructions

- Do not heat or microwave the mixture.
- Avoid mixing the medication with warm or hot drinks or food.
- Never take the powder dry.

Taking Your Dose

- Take your dose immediately after mixing.
- 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 any unused portion must be discarded 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 extra doses.
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Lifestyle & Tips

  • Continue to follow any dietary restrictions for potassium as advised by your doctor or dietitian.
  • Do not take other oral medications within 3 hours before or 3 hours after taking Veltassa, unless specifically instructed by your doctor, to prevent Veltassa from interfering with their absorption.
  • Mix the powder thoroughly with water or soft food (e.g., apple sauce, yogurt, pudding) and consume immediately. Do not heat Veltassa or add it to hot liquids.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 8.4 g orally 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 24-hour or longer intervals based on serum potassium levels, up to a maximum of 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; Patiromer is indicated for hyperkalemia, which is common in patients with renal impairment, including those on dialysis. Its efficacy and safety are not affected by renal function.

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, potassium-binding polymer that contains a calcium-sorbitol counterion. It increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium occurs primarily in the colon, where the concentration of free potassium is highest. The binding of potassium by patiromer 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 (0%)
Tmax: Not applicable (not absorbed)
FoodEffect: Can be taken with or without food. Food does not affect 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: Within 7 hours (initial potassium reduction)
PeakEffect: Within 48 hours (maximal potassium reduction)
DurationOfAction: Maintained as long as treatment continues; effects on potassium levels persist for at least 24 hours after a dose.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:

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. Although many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Diarrhea
Constipation

Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, 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.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of very low potassium (hypokalemia): severe muscle weakness, muscle cramps, irregular heartbeats, feeling very tired.
  • Symptoms of low magnesium (hypomagnesemia): muscle cramps, tremors, weakness, feeling dizzy, irregular heartbeats.
  • Symptoms of high potassium (if treatment is not effective or dose is too low): muscle weakness, fatigue, tingling or numbness, heart palpitations.
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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. Do not initiate, stop, or modify the dosage 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 manage your condition effectively, 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 drugs 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 drug, as you may be more susceptible to side effects. Pregnant women, or those planning to become pregnant or breast-feed, should notify their doctor. 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:

  • Severe hypokalemia (extremely low potassium levels)
  • Severe hypomagnesemia (extremely low magnesium levels)

What to Do:

Contact your doctor or emergency services immediately. Treatment would involve correcting electrolyte imbalances (e.g., potassium or magnesium supplementation) and supportive care. Call 1-800-222-1222 (Poison Control) for further guidance.

Drug Interactions

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Major Interactions

  • Oral medications that are highly susceptible to binding in the GI tract (e.g., ciprofloxacin, levothyroxine, mycophenolate mofetil, some oral anticoagulants like dabigatran, some anti-epileptics like phenytoin, some anti-arrhythmics like digoxin, some anti-retrovirals). Administer other oral medications at least 3 hours before or 3 hours after patiromer.
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Moderate Interactions

  • Certain oral medications (e.g., amlodipine, furosemide, metoprolol, warfarin) may have reduced absorption if co-administered. Separate administration by at least 3 hours.

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 in the GI tract, potentially leading to hypomagnesemia.

Timing: Prior to initiation of therapy

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Routine Monitoring

Serum Potassium

Frequency: Initially weekly for the first month, then monthly or as clinically indicated.

Target: 3.5-5.0 mEq/L (or target range set by clinician)

Action Threshold: <3.5 mEq/L (consider dose reduction or temporary discontinuation); >5.0 mEq/L (consider dose increase)

Serum Magnesium

Frequency: Initially weekly for the first month, then monthly or as clinically indicated.

Target: 1.7-2.2 mg/dL

Action Threshold: <1.7 mg/dL (consider magnesium supplementation or dose adjustment of patiromer)

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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, constipation, palpitations, irregular heartbeats)
  • Symptoms of hypomagnesemia (e.g., muscle cramps, weakness, tremors, seizures, cardiac arrhythmias)

Special Patient Groups

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Pregnancy

Patiromer is not absorbed systemically, so maternal use is not expected to result in fetal exposure to the drug. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

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

Patiromer is not absorbed systemically by the mother, so breastfeeding is not expected to result in exposure of the infant to the drug. It is considered compatible with breastfeeding.

Infant Risk: Low risk
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Not recommended for use in patients under 18 years of age.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly patients (65 years and over) and younger patients. No specific dose adjustment is required based on age.

Clinical Information

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Clinical Pearls

  • Patiromer is a non-absorbed polymer, meaning it works locally in the gut and is not absorbed into the bloodstream, which minimizes systemic side effects.
  • Crucial to separate administration of Patiromer from other oral medications by at least 3 hours to prevent drug-drug interactions due to binding.
  • Patients should be educated on the importance of consistent daily dosing and regular monitoring of serum potassium and magnesium levels.
  • It is important to mix the powder thoroughly with water or soft food and consume immediately. Do not heat the mixture.
  • Patiromer is not for emergency treatment of life-threatening hyperkalemia due to its delayed onset of action compared to IV therapies.
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Alternative Therapies

  • Sodium polystyrene sulfonate (SPS, Kayexalate, Kionex)
  • Sodium zirconium cyclosilicate (SZC, Lokelma)
  • Dietary potassium restriction
  • Diuretics (e.g., loop diuretics)
  • Insulin/dextrose
  • Beta-2 agonists (e.g., albuterol)
  • Calcium gluconate (for cardiac stabilization in severe hyperkalemia)
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Cost & Coverage

Average Cost: $1000 - $1500 per 30 packets (25.2g)
Insurance Coverage: 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 promptly. To ensure safe and effective treatment, 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.