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Drug overview for XPHOZAH (tenapanor hcl):
Generic name: tenapanor HCl (ten-A-pa-nor)
Drug class: Phosphate Binder Agents
Therapeutic class: Electrolyte Balance-Nutritional Products
Tenapanor hydrochloride is a locally acting sodium hydrogen exchanger 3 (NHE3) inhibitor.
No enhanced Uses information available for this drug.
Generic name: tenapanor HCl (ten-A-pa-nor)
Drug class: Phosphate Binder Agents
Therapeutic class: Electrolyte Balance-Nutritional Products
Tenapanor hydrochloride is a locally acting sodium hydrogen exchanger 3 (NHE3) inhibitor.
No enhanced Uses information available for this drug.
DRUG IMAGES
XPHOZAH 30 MG TABLET
XPHOZAH 20 MG TABLET
The following indications for XPHOZAH (tenapanor hcl) have been approved by the FDA:
Indications:
Renal osteodystrophy with hyperphosphatemia
Professional Synonyms:
Renal osteodystrophy with hyperphospheremia
Indications:
Renal osteodystrophy with hyperphosphatemia
Professional Synonyms:
Renal osteodystrophy with hyperphospheremia
The following dosing information is available for XPHOZAH (tenapanor hcl):
Available as tenapanor hydrochloride; dosage expressed in terms of tenapanor.
Tenapanor is administered orally as tablets. Tenapanor should be taken just prior to the first and last meals of the day. Tenapanor should not be taken right before a hemodialysis session, and instead should be taken right before the next meal following dialysis, as patients may experience diarrhea after taking tenapanor.
If a dose of tenapanor is missed, skip the missed dose and take the next dose at the regular time. Store tenapanor tablets at 20-25degreesC; excursions permitted between 15-30degreesC. Keep bottle tightly closed to protect from moisture. Store and dispense in original bottle with the desiccant.
If a dose of tenapanor is missed, skip the missed dose and take the next dose at the regular time. Store tenapanor tablets at 20-25degreesC; excursions permitted between 15-30degreesC. Keep bottle tightly closed to protect from moisture. Store and dispense in original bottle with the desiccant.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| XPHOZAH 20 MG TABLET | Maintenance | Adults take 1 tablet (20 mg) by oral route 2 times per day |
| XPHOZAH 30 MG TABLET | Maintenance | Adults take 1 tablet (30 mg) by oral route 2 times per day |
No generic dosing information available.
The following drug interaction information is available for XPHOZAH (tenapanor hcl):
There are 0 contraindications.
There are 3 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Phosphate Supplements;Urine pH Modifiers/Phosphate Reducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Lanthanum and sevelamer bind to phosphate.(1-2) Tenapanor is a sodium/hydrogen exchanger 3 (NHE3) inhibitor.(3) All three agents are used to lower phosphate absorption in the body.(1-3) CLINICAL EFFECTS: Concurrent use of phosphate supplements or urinary pH modifiers high in phosphate with agents that reduce serum phosphorus may decrease the effectiveness of both agents. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients should normally not receive phosphate supplements or urinary pH modifiers high in phosphate concurrently with agents that reduce serum phosphorus. DISCUSSION: Lanthanum, sevelamer, and tenapanor are indicated to control phosphorus levels. Consider discontinuing or holding phosphate supplements and urinary pH modifiers high in phosphate in patients receiving these agents. |
DEXTROSE 5%-ELECTROLYTE #48, GLYCOPHOS, K-PHOS NO.2, K-PHOS ORIGINAL, POTASSIUM PHOSPHATE, POTASSIUM PHOSPHATE-0.9% NACL, POTASSIUM PHOSPHATES, SODIUM PHOSPHATE, SODIUM PHOSPHATE DIBASIC, UROQID-ACID NO.2 |
| Erdafitinib/Serum Phosphate Level-Altering Drugs SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Medications that alter serum phosphate may interfere with interpretation of phosphate levels that are needed to determine initial erdafitinib dose.(1) CLINICAL EFFECTS: Serum phosphate levels that are elevated by concomitant medications may result in an inappropriately low dose and decreased effectiveness of erdafitinib. Serum phosphate levels that are decreased by concomitant medications may result in an inappropriately high dose and increased toxicity from erdafitinib. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of erdafitinib states that agents that alter serum phosphate levels should be avoided before the initial dose increase period for erdafitinib based on serum phosphate levels (days 14 to 21).(1) DISCUSSION: Concomitant administration of serum phosphate level-altering agents during the initial dose increase period of erdafitinib based on serum phosphate levels (days 14 to 21) may interfere with serum phospate levels and lead to incorrect dosing of erdafitinib.(1) Agents that may alter serum phosphate levels linked to this monograph include: aluminum carbonate, aluminum hydroxide, calcium acetate, calcium carbonate, calcium citrate, cod liver oil, ferric citrate, lanthanum, magnesium carbonate, magnesium hydroxide, potassium phosphate, sevelamer, sodium phosphate, sucroferric oxyhydroxide, tenapanor, and vitamin D.(1) |
BALVERSA |
| Tenapanor/Laxatives; Stool Softeners SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Tenapanor commonly causes diarrhea of mild to moderate severity. Laxatives and stool softeners may increase the incidence or severity of diarrhea.(1) CLINICAL EFFECTS: Concurrent use of laxatives or stool softeners with tenapanor may increase the risk of severe diarrhea.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of tenapanor states that patients should be instructed to avoid stool softeners and laxatives with tenapanor. If severe diarrhea occurs, tenapanor should be discontinued.(1) DISCUSSION: In clinical trials, 43-53% of CKD patients on dialysis treated with tenapanor developed diarrhea. Diarrhea usually occurred soon after treatment initiation and was severe in 5% of patients.(1) |
AMITIZA, BISACODYL, CLENPIQ, CONSTULOSE, DOCUSATE SODIUM, GAVILYTE-C, GAVILYTE-G, GAVILYTE-N, GOLYTELY, KRISTALOSE, LACTULOSE, LINZESS, LUBIPROSTONE, MAGNESIUM CITRATE, MOVIPREP, PEG 3350-ELECTROLYTE, PEG-3350 AND ELECTROLYTES, PEG3350-SOD SUL-NACL-KCL-ASB-C, PLENVU, SOD SULF-POTASS SULF-MAG SULF, SUFLAVE, SUPREP, SUTAB, TRULANCE |
There are 0 moderate interactions.
The following contraindication information is available for XPHOZAH (tenapanor hcl):
Drug contraindication overview.
*Pediatric patients less than 6 years of age due to risk of diarrhea and severe dehydration. *Known or suspected mechanical GI obstruction.
*Pediatric patients less than 6 years of age due to risk of diarrhea and severe dehydration. *Known or suspected mechanical GI obstruction.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Gastrointestinal obstruction |
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for XPHOZAH (tenapanor hcl):
Adverse reaction overview.
The most common adverse effect of tenapanor reported in clinical trials was diarrhea (43--53%).
The most common adverse effect of tenapanor reported in clinical trials was diarrhea (43--53%).
There are 2 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Dehydration Rectal bleeding |
There are 8 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal distension Diarrhea Dizziness Flatulence |
None. |
| Rare/Very Rare |
|---|
|
Bowel sounds hyperactive Pruritus of skin Skin rash Urticaria |
The following precautions are available for XPHOZAH (tenapanor hcl):
Safety and effectiveness of tenapanor in pediatric patients have not been established. Tenapanor is contraindicated in patients less than 6 years of age. In nonclinical studies, deaths occurred in young juvenile rats (approximate human age equivalent of less than 2 years) and in older juvenile rats (approximate human age equivalent of 2 years) following oral administration of tenapanor.
In a 21-day oral dose range toxicity study in juvenile rats, tenapanor was administered to neonatal rats (post-natal day 5) at doses of 5 and 10 mg/kg per day. Tenapanor was not tolerated in male and female pups and the study was terminated on post-natal day 16 due to mortalities and decreased body weight. Compared to the control group, 24% and 29% of female pups in the 5 mg/kg per day and 10 mg/kg per day groups, respectively, experienced decreased body weight; 33% of male pups that received 10 mg/kg per day experienced decreased body weight.
In a second dose range finding study, tenapanor at dosages of 0.1, 0.5, 2.5,
or 5 mg/kg per day were administered to neonatal rats from post-natal day 5 through post-natal day 24. Treatment-related mortalities were observed at 0.5, 2.5,
and 5 mg/kg per day. Premature deaths were observed as early as post-natal day 8, with the majority of deaths occurring between post-natal day 15 and 25. In the 5 mg/kg per day group, mean body weights were 47% lower for males on post-natal day 23 and 35% lower for females on post-natal day 22 when compared to the control group.
Other findings included slightly lower mean tibial lengths; lower spleen, thymus, and/or ovarian weights; GI distension; and microscopic bone findings of increased osteoclasts, eroded bone, and/or decreased bone in sternum and/or femorotibial joint in the 0.5, 2.5, and 5 mg/kg per day groups.
In juvenile rats administered tenapanor at 0.03, 0.1, or 0.3
mg/kg per day on post-natal day 5 through post-natal day 61, treatment-related mortalities were observed at 0.3 mg/kg per day. Lower mean body weight gains were noted in the 0.3
mg/kg per day group in addition to decreased food consumption, resulting in mean body weights up to 15.8% and 16.8% lower in males and females, respectively, compared to the control group.
There were no tenapanor-related effects of mean body weights, body weight gains, or food consumption in the 0.03 and 0.1 mg/kg per day groups.
A dosage of 0.1 mg/kg per day was considered to be the No Observed Adverse Effect Level (NOAEL) for juvenile toxicity of tenapanor. In weaned juvenile rats administered tenapanor 0.1,
0.3, and 0.7 (males) or 1 (females) mg/kg per day on post-natal days 21 through 80, no mortalities were observed.
Significant decreases in mean body weights were observed in the 0.3 and 0.7 mg/kg per day males throughout the dosing period and in the 1 mg/kg per day females between postnatal days 23 to 35, with food consumption notably decreased between post-natal days 21 to 29.
The NOAEL was considered to be 0.1 mg/kg per day for juvenile toxicity of tenapanor.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
In a 21-day oral dose range toxicity study in juvenile rats, tenapanor was administered to neonatal rats (post-natal day 5) at doses of 5 and 10 mg/kg per day. Tenapanor was not tolerated in male and female pups and the study was terminated on post-natal day 16 due to mortalities and decreased body weight. Compared to the control group, 24% and 29% of female pups in the 5 mg/kg per day and 10 mg/kg per day groups, respectively, experienced decreased body weight; 33% of male pups that received 10 mg/kg per day experienced decreased body weight.
In a second dose range finding study, tenapanor at dosages of 0.1, 0.5, 2.5,
or 5 mg/kg per day were administered to neonatal rats from post-natal day 5 through post-natal day 24. Treatment-related mortalities were observed at 0.5, 2.5,
and 5 mg/kg per day. Premature deaths were observed as early as post-natal day 8, with the majority of deaths occurring between post-natal day 15 and 25. In the 5 mg/kg per day group, mean body weights were 47% lower for males on post-natal day 23 and 35% lower for females on post-natal day 22 when compared to the control group.
Other findings included slightly lower mean tibial lengths; lower spleen, thymus, and/or ovarian weights; GI distension; and microscopic bone findings of increased osteoclasts, eroded bone, and/or decreased bone in sternum and/or femorotibial joint in the 0.5, 2.5, and 5 mg/kg per day groups.
In juvenile rats administered tenapanor at 0.03, 0.1, or 0.3
mg/kg per day on post-natal day 5 through post-natal day 61, treatment-related mortalities were observed at 0.3 mg/kg per day. Lower mean body weight gains were noted in the 0.3
mg/kg per day group in addition to decreased food consumption, resulting in mean body weights up to 15.8% and 16.8% lower in males and females, respectively, compared to the control group.
There were no tenapanor-related effects of mean body weights, body weight gains, or food consumption in the 0.03 and 0.1 mg/kg per day groups.
A dosage of 0.1 mg/kg per day was considered to be the No Observed Adverse Effect Level (NOAEL) for juvenile toxicity of tenapanor. In weaned juvenile rats administered tenapanor 0.1,
0.3, and 0.7 (males) or 1 (females) mg/kg per day on post-natal days 21 through 80, no mortalities were observed.
Significant decreases in mean body weights were observed in the 0.3 and 0.7 mg/kg per day males throughout the dosing period and in the 1 mg/kg per day females between postnatal days 23 to 35, with food consumption notably decreased between post-natal days 21 to 29.
The NOAEL was considered to be 0.1 mg/kg per day for juvenile toxicity of tenapanor.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Tenapanor is essentially non-absorbed systemically, with plasma concentrations below the limit of quantification (less than 0.5 ng/mL) following oral administration. Therefore, maternal use is not expected to result in fetal exposure to the drug. The available data on tenapanor exposure from a small number of pregnant women have not identified any drug associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
In reproduction studies in pregnant rats and rabbits, no adverse fetal effects were observed in rats at 0.2 times the maximum recommended human dose and in rabbits up to 15 times the maximum recommended human dose (based on body surface area). In a pre- and post-natal development study in mice, tenapanor at doses up to 200 mg/kg per day (approximately 16.5 times the maximum recommended human dose based on body surface area) had no effect on pre- and post-natal development.
In reproduction studies in pregnant rats and rabbits, no adverse fetal effects were observed in rats at 0.2 times the maximum recommended human dose and in rabbits up to 15 times the maximum recommended human dose (based on body surface area). In a pre- and post-natal development study in mice, tenapanor at doses up to 200 mg/kg per day (approximately 16.5 times the maximum recommended human dose based on body surface area) had no effect on pre- and post-natal development.
There are no data on the presence of tenapanor in human milk, the effects on the breast-fed child, or the effects on milk production. The minimal systemic absorption of tenapanor will not result in a clinically relevant exposure to breast-fed infants. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tenapanor or any potential adverse effects on the breast-fed infant from tenapanor or from the underlying maternal condition.
Clinical studies with tenapanor did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently than younger patients. Among 1,010 patients with CKD on dialysis who were treated with tenapanor or tenapanor in combination with phosphate binders, 282 (28%) patients were 65 years of age and older.
The following prioritized warning is available for XPHOZAH (tenapanor hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for XPHOZAH (tenapanor hcl)'s list of indications:
| Renal osteodystrophy with hyperphosphatemia | |
| N25.0 | Renal osteodystrophy |
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