Xphozah 30mg Tablets
It is used to lower high phosphate levels.
Drug Class
Phosphate binder
Pharmacologic Class
Sodium-hydrogen exchanger 3 (NHE3) inhibitor
Pregnancy Category
Not available
FDA Approved
Oct 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Xphozah is a medication used to lower high phosphorus levels in the blood for adults with kidney disease who are on dialysis. It works by blocking the absorption of phosphorus from the food you eat in your intestines, so more phosphorus leaves your body in your stool.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines below.
Take your first daily dose immediately before breakfast or your first meal of the day.
Take your second daily dose immediately before dinner, unless your doctor has advised a different schedule.
If you are undergoing dialysis, do not take this medication before a dialysis session. Instead, take it before the next meal after dialysis.
If you have any questions or concerns about when to take your medication, consult your doctor.
Important Interactions
If you are also taking sodium polystyrene sulfonate (SPS), ensure you take it at least 3 hours before or 3 hours after your medication to avoid any potential interactions.
Storing and Disposing of Your Medication
To maintain the quality and effectiveness of your medication:
Store the tablets in their original container at room temperature.
Keep the container cap tightly closed at all times.
Do not remove the antimoisture cube or packet from the container.
Store the medication in a dry place, avoiding bathrooms and areas with high humidity.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines below.
Take your first daily dose immediately before breakfast or your first meal of the day.
Take your second daily dose immediately before dinner, unless your doctor has advised a different schedule.
If you are undergoing dialysis, do not take this medication before a dialysis session. Instead, take it before the next meal after dialysis.
If you have any questions or concerns about when to take your medication, consult your doctor.
Important Interactions
If you are also taking sodium polystyrene sulfonate (SPS), ensure you take it at least 3 hours before or 3 hours after your medication to avoid any potential interactions.
Storing and Disposing of Your Medication
To maintain the quality and effectiveness of your medication:
Store the tablets in their original container at room temperature.
Keep the container cap tightly closed at all times.
Do not remove the antimoisture cube or packet from the container.
Store the medication in a dry place, avoiding bathrooms and areas with high humidity.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Continue to follow your prescribed diet for kidney disease, including phosphorus restrictions, as advised by your doctor or dietitian.
- Take Xphozah exactly as prescribed, usually twice a day.
- Do not stop taking Xphozah without talking to your doctor.
- Stay hydrated, especially if you experience diarrhea.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
30 mg orally twice daily
Dose Range:
30 - 30 mg
Condition-Specific Dosing:
hyperphosphatemia_CKD_dialysis:
30 mg orally twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Dialysis:
Approved for use in patients on dialysis; no dose adjustment needed beyond standard dosing
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Pharmacology
Mechanism of Action
Tenapanor is a locally acting inhibitor of the sodium-hydrogen exchanger 3 (NHE3), which is expressed on the apical surface of enterocytes in the gastrointestinal tract. By inhibiting NHE3, tenapanor reduces the absorption of dietary sodium and phosphate from the gut, leading to increased fecal excretion of phosphate and a reduction in serum phosphorus levels.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (minimally absorbed systemically)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Can be taken with or without food
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Primarily fecal (as unchanged drug and degradation products)
Unchanged:
>90% (fecal)
Pharmacodynamics
OnsetOfAction:
Within days (reduction in serum phosphorus)
PeakEffect:
Within 1-2 weeks
DurationOfAction:
Dependent on continued dosing
Safety & Warnings
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
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 monitor your body's response. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
Diarrhea (common and potentially severe): If you experience diarrhea or stomach cramps, consult your doctor for advice on managing these symptoms and preventing dehydration. Do not attempt to treat diarrhea without first consulting your doctor.
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to 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 is available to provide medical advice on managing side effects.
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
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 monitor your body's response. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
Diarrhea (common and potentially severe): If you experience diarrhea or stomach cramps, consult your doctor for advice on managing these symptoms and preventing dehydration. Do not attempt to treat diarrhea without first consulting your doctor.
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to 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 is available to provide medical advice on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent diarrhea (contact your doctor immediately)
- Signs of dehydration (e.g., excessive thirst, decreased urination, dizziness, lightheadedness)
- Unusual muscle cramps or weakness (though less common with tenapanor, report any new or worsening symptoms)
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 symptoms you experienced.
If you have a bowel blockage, as this may affect the use of this medication.
If the patient is a child, as this medication is not approved for use in children under the age of 6. Do not administer this medication to a child younger than 6 years old.
Additionally, this medication may interact with other health conditions or medications. To ensure safe use, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor to determine if it is safe to take this medication.
Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
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 symptoms you experienced.
If you have a bowel blockage, as this may affect the use of this medication.
If the patient is a child, as this medication is not approved for use in children under the age of 6. Do not administer this medication to a child younger than 6 years old.
Additionally, this medication may interact with other health conditions or medications. To ensure safe use, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor to determine if it is safe to take this medication.
Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe diarrhea
- Abdominal discomfort
- Potential for dehydration and electrolyte imbalance due to severe diarrhea
What to Do:
There is no specific antidote. Treatment is supportive and symptomatic, focusing on managing diarrhea, maintaining hydration, and correcting electrolyte imbalances. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Serum Phosphorus
Rationale: To establish baseline levels and guide initial therapy.
Timing: Prior to initiation of therapy
Serum Calcium
Rationale: To assess for potential electrolyte imbalances.
Timing: Prior to initiation of therapy
Serum Parathyroid Hormone (PTH)
Rationale: To assess bone and mineral metabolism status.
Timing: Prior to initiation of therapy
Routine Monitoring
Serum Phosphorus
Frequency: Weekly for the first 2-4 weeks, then monthly or as clinically indicated
Target: 2.5-4.5 mg/dL (target for CKD-MBD)
Action Threshold: If phosphorus levels are not adequately controlled, assess adherence and consider alternative or additional therapies. If levels are too low, consider dose reduction or interruption.
Serum Calcium
Frequency: Monthly or as clinically indicated
Target: Normal range (e.g., 8.5-10.2 mg/dL)
Action Threshold: Monitor for hypocalcemia or hypercalcemia, especially if other calcium-containing medications are used.
Diarrhea
Frequency: Regularly, especially during initial therapy
Target: Not applicable
Action Threshold: If severe diarrhea occurs, consider dose reduction or temporary discontinuation. Advise patients to report persistent or severe diarrhea.
Symptom Monitoring
- Diarrhea (frequency, severity, abdominal discomfort)
- Signs of electrolyte imbalance (e.g., muscle cramps, weakness, fatigue, irregular heartbeat, if hypocalcemia occurs, though not a direct effect of tenapanor)
- Signs of dehydration (due to severe diarrhea)
Special Patient Groups
Pregnancy
Limited human data on tenapanor use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. Animal studies have shown no evidence of developmental toxicity at clinically relevant exposures. Due to minimal systemic absorption, maternal use is not expected to result in fetal exposure.
Trimester-Specific Risks:
First Trimester:
Low risk expected due to minimal systemic absorption.
Second Trimester:
Low risk expected due to minimal systemic absorption.
Third Trimester:
Low risk expected due to minimal systemic absorption.
Lactation
There are no data on the presence of tenapanor in human milk, the effects on the breastfed infant, or the effects on milk production. Due to minimal systemic absorption, tenapanor is not expected to be present in human milk or to cause any effects on the breastfed infant. Consider the benefits of breastfeeding, the mother’s clinical need for Xphozah, and any potential adverse effects on the breastfed infant from Xphozah or from the underlying maternal condition.
Infant Risk:
Low risk expected due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established for the treatment of hyperphosphatemia in CKD on dialysis. Xphozah is not indicated for pediatric use.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (65 years and older) and younger adult patients. No dose adjustment is required based on age.
Clinical Information
Clinical Pearls
- Tenapanor is a novel, non-calcium, non-metal phosphate binder that works by inhibiting NHE3 in the gut, offering an alternative mechanism to traditional phosphate binders.
- Its minimal systemic absorption means it has a low risk of systemic drug interactions and is not affected by renal or hepatic impairment.
- Diarrhea is the most common adverse effect and can be severe; patients should be counseled on this and advised to report it.
- Unlike traditional phosphate binders, tenapanor does not bind to phosphate directly but rather reduces its absorption, which may be beneficial for patients struggling with pill burden or adherence to other binders.
- It is specifically approved for hyperphosphatemia in adults with CKD on dialysis.
Alternative Therapies
- Sevelamer (Renvela, Renagel) - non-calcium, non-aluminum, non-iron phosphate binder
- Lanthanum carbonate (Fosrenol) - chewable, non-calcium, non-aluminum, non-iron phosphate binder
- Calcium acetate (PhosLo) - calcium-based phosphate binder
- Calcium carbonate - calcium-based phosphate binder
- Sucroferric oxyhydroxide (Velphoro) - iron-based phosphate binder
- Ferric citrate (Auryxia) - iron-based phosphate binder
Cost & Coverage
Average Cost:
High (e.g., $1,500 - $2,500+) per 60 tablets (30mg x 60)
Insurance Coverage:
Tier 3 or 4 (Specialty)
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.