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Parsabiv vs Sensipar
Introduction
For patients with chronic kidney disease (CKD) or parathyroid conditions, specific drugs that modulate the levels of parathyroid hormone (PTH), calcium, and phosphorus can help in managing these complications. Parsabiv and Sensipar are two such drugs prescribed for these purposes. They each have different mechanisms of action but both work towards achieving a balance in PTH, calcium, and phosphorus levels in patients with CKD on dialysis or those with primary hyperparathyroidism (HPT). Parsabiv is a calcimimetic medication that binds to the calcium-sensing receptor on the parathyroid gland to decrease PTH secretion. On the other hand, Sensipar also belongs to calcimimetics but it works by mimicking how calcium regulates the body's production of PTH.
Parsabiv vs Sensipar Side By Side
| Attribute | Parsabiv | Sensipar |
|---|---|---|
| Brand Name | Parsabiv | Sensipar |
| Contraindications | Should not be taken with certain medications like digoxin without prior consultation with a doctor. | Should not be taken with certain medications like digoxin without prior consultation with a doctor. |
| Cost | $2,850 for a monthly supply | $900 for 30 tablets |
| Generic Name | Etelcalcetide | Cinacalcet |
| Most Serious Side Effect | Signs of an allergic reaction, low calcium levels, fast or slow heartbeat, chills, difficulty thinking clearly. | Allergic reactions, low blood calcium levels (hypocalcemia), upper stomach pain, signs of an adrenal gland problem, fast heartbeat, fainting spells. |
| Severe Drug Interactions | May worsen symptoms or lead to potential side effects if combined with certain medications without doctor's advice. | May worsen symptoms or lead to potential side effects if combined with certain medications without doctor's advice. |
| Typical Dose | 5 mg, administered three times per week at the end of hemodialysis treatment. | 30 mg/day, can be increased to 60 mg/day after two weeks, up to a maximum of 180 mg per day. |
What is Parsabiv?
Etelcalcetide (the generic name for Parsabiv) is a groundbreaking drug within the class of calcimimetic drugs, which was developed following an earlier generation of this class known as Cinacalcet (the generic name for Sensipar). Etelcalcetide was first approved by the FDA in 2017. Parsabiv works by binding to calcium-sensing receptors on the parathyroid gland, effectively mimicking calcium's effects and thereby reducing parathyroid hormone levels. It is prescribed primarily for patients with secondary hyperparathyroidism due to chronic kidney disease who are on dialysis. Parsabiv has a more direct impact compared to Sensipar because it can be given intravenously at the end of each dialysis session, allowing better control over medication adherence, whereas Sensipar requires self-administration orally at home. This results in fewer side effects from missed doses or inconsistent intake that may occur with other treatment options like Sensipar.
What conditions is Parsabiv approved to treat?
Parsabiv is approved for the treatment of conditions such as:
- Secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on hemodialysis Unlike Sensipar, which must be taken orally and may not always be effectively absorbed, Parsabiv is administered intravenously at the end of a dialysis session. This ensures complete delivery of the drug into the bloodstream.
How does Parsabiv help with these illnesses?
Parsabiv helps to manage hyperparathyroidism in patients with chronic kidney disease who are on dialysis. It does this by binding to and activating the calcium-sensing receptors on the parathyroid gland, which inhibits the release of parathyroid hormone (PTH). PTH is a hormone that plays a critical role in regulating calcium and phosphorus balance within the body. In individuals with secondary hyperparathyroidism, there's an excess production of PTH due to low levels of calcium, leading to bone pain and fractures. Therefore, by increasing activation of the calcium-sensing receptor, Parsabiv can limit the overproduction of PTH thus helping patients manage their condition and stabilize their hormonal balance.
What is Sensipar?
Sensipar, also known as cinacalcet, is a drug used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and has been approved by the FDA since 2004. It works differently from Parsabiv because it's an oral calcimimetic agent that reduces parathyroid hormone (PTH) levels by increasing the sensitivity of calcium-sensing receptors located on parathyroid cells to extracellular calcium. This action leads to reduced PTH secretion which can help control calcium and phosphorus levels in the body.
As Sensipar does not act like traditional Vitamin D treatments or phosphate binders, its side effect profile differs. The most common adverse reactions are nausea and vomiting but they usually decrease over time with continued use. Importantly, while both drugs work towards reducing high PTH levels in different ways, some patients might respond better to Sensipar compared to Parsabiv.
What conditions is Sensipar approved to treat?
Sensipar is a medication that has received approval for the treatment of:
- Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis
- Hypercalcemia in adult patients with parathyroid carcinoma
- Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.
How does Sensipar help with these illnesses?
Calcimimetics are a class of drugs that mimic the action of calcium on tissues, specifically targeting the parathyroid glands. These glands regulate the body's calcium levels and play an important role in bone health. Sensipar (cinacalcet) is one such medication that works by increasing the sensitivity of the calcium-sensing receptor to activation by extracellular calcium, thereby decreasing parathyroid hormone secretion. This modulation helps regulate and lower high blood levels of parathyroid hormone in patients with chronic kidney disease or primary hyperparathyroidism, conditions where this hormone tends to be overproduced. While Parsabiv also works as a calcimimetic agent, it differs from Sensipar mainly in its administration route; while Sensipar is taken orally, Parsabiv must be administered intravenously at dialysis centers. Therefore, for patients seeking ease-of-use and convenience outside clinical settings, Sensipar may present an advantageous choice.
How effective are both Parsabiv and Sensipar?
Both etelcalcetide (Parsabiv) and cinacalcet (Sensipar) have been approved by the FDA for the treatment of secondary hyperparathyroidism in chronic kidney disease patients on dialysis. They work by modulating the calcium-sensing receptor to reduce parathyroid hormone levels, thereby reducing serum calcium and phosphorus levels. A 2017 double-blind clinical trial directly compared Parsabiv with Sensipar in terms of their effectiveness at lowering parathyroid hormone levels; both drugs showed similar efficacy and safety profiles. The study found no significant differences in measures such as serum calcium or phosphorus between patients receiving either medication.
A systematic review from 2016 suggested that Parsabiv is effective from its first week of administration, has a relatively mild side effect profile when compared to other treatments for secondary hyperparathyroidism, and is generally well-tolerated even among elderly populations. It was also noted that Parsabiv may be more convenient since it can be administered intravenously three times per week following hemodialysis.
On the other hand, according to a meta-analysis conducted in 2008, Sensipar appears to be slightly less effective than placebo at treating secondary hyperparathyroidism but comparable to many common treatments like vitamin D analogs or phosphate binders. While Sensipar is typically considered an alternative option after failure of initial therapy due to its oral administration route which could affect compliance among some patients, it might be suitable for those who prefer oral medications over injections or infusions.
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At what dose is Parsabiv typically prescribed?
The initial recommended dose for Parsabiv is 5 mg, administered three times per week at the end of hemodialysis treatment. The dosage can be increased in increments of 2.5 to 5 mg, up to a maximum of 15mg three times per week if there is no adequate response. On the other hand, Sensipar should start with an oral dosage of 30 mg once daily and can be increased every two to four weeks by doubling the dose until an optimal response is achieved or a total dosage of 180 mg/day has been reached. Dosage adjustments are based on serum levels of parathyroid hormone (PTH), calcium and phosphorus.
At what dose is Sensipar typically prescribed?
Sensipar treatment is typically initiated at a dosage of 30 mg/day. The dose can subsequently be increased to 60 mg/day after two weeks if serum parathyroid hormone levels are not adequately reduced. This dosage is taken orally, once daily with food or shortly after a meal. If necessary, the dose may be further increased to a maximum of 180 mg per day, which would be tested if there's no response to treatment at lower dosages within two-to-four weeks. As always, any changes in medication should only ever be made under careful medical supervision.
What are the most common side effects for Parsabiv?
Some potential side effects of Parsabiv may include:
- Muscle spasms
- Diarrhea
- Nausea, vomiting
- Headache
- Hypocalcemia (low blood calcium levels)
- Paresthesia (prickling or burning sensation on the skin)
- Upper respiratory tract infection symptoms such as cough and sore throat
On the other hand, Sensipar might lead to certain side effects such as:
- Nausea, vomiting
- Diarrhea
- Muscle pain or cramps
- Weakness, dizziness
- Low blood pressure (hypotension)
It's important to consult with a healthcare provider who can assess your individual health circumstances before starting any new medication.
Are there any potential serious side effects for Parsabiv?
While Parsabiv and Sensipar are both medications used to manage secondary hyperparathyroidism in patients with chronic kidney disease, they can have different side effects. For Parsabiv, these might include:
- Signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue or throat
- Low calcium levels - muscle spasms or contractions, numbness or tingly feeling (around your mouth, fingertips, toes), irregular heartbeats
- Fast or slow heartbeat
- Chills
- Difficulty thinking clearly
On the other hand for Sensipar these could be:
- Indications of low calcium levels such as muscle stiffness/spasms/cramps/seizures.
- Feeling lightheaded like you might pass out.
- An irregular heartbeat that feels too fast or too slow.
In general if any severe symptoms occur it's important to get medical help straight away. This includes symptoms like chest pain/rapid heart rate which may signal a serious condition known as QT prolongation. Additionally seek immediate help if you experience signs of an allergic reaction such as rash/blisters/swelling in the face/tongue/throat/severe dizziness/trouble breathing – this is not a comprehensive list and there may be other rare yet serious side effects not listed here.
What are the most common side effects for Sensipar?
When taking Sensipar, potential side effects can include:
- Nausea or vomiting
- Diarrhea
- Muscle pain or spasms
- A tingling sensation in the limbs
- Shortness of breath
- Headache, dizziness
- Weakness or a lack of energy These symptoms vary from individual to individual and may not be experienced by every patient. It is important to discuss these potential side effects with your healthcare provider before starting treatment.
Are there any potential serious side effects for Sensipar?
While Sensipar is generally well-tolerated, there are certain severe side effects that may occur. These include:
- Allergic reactions: look out for symptoms such as hives, itching, difficulty breathing or swallowing, swelling around your face or throat.
- Low blood calcium levels (hypocalcemia): this can cause muscle spasms, twitches, or cramps; seizures; numbness and tingling in the fingers, toes or mouth.
- Upper stomach pain spreading to your back with nausea and vomiting could indicate a problem with the pancreas.
- Signs of an adrenal gland problem like very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired and weak mood changes not hungry weight loss
- Fast heartbeat; fainting spells If you experience any of these symptoms while taking Sensipar it's important to seek immediate medical attention.
Contraindications for Parsabiv and Sensipar?
Both Parsabiv and Sensipar, similar to many other drugs used in the management of secondary hyperparathyroidism in adults with chronic kidney disease on dialysis, may worsen symptoms or lead to potential side effects. If you notice your condition worsening, or if you experience serious side effects such as difficulty breathing or swallowing, seizures, a fast or irregular heartbeat—symptoms that could indicate allergic reactions—please seek immediate medical attention.
Neither Parsabiv nor Sensipar should be taken if you are already using certain medications like digoxin (a heart medication) without prior consultation with your doctor. Always inform your healthcare provider about all the medications and supplements you are currently taking; this is essential for preventing dangerous interactions with either Parsabiv and Sensipar. Some drugs might need a period of time to clear from your system before starting treatment with these medications.
How much do Parsabiv and Sensipar cost?
For brand name versions of these medications:
- The price for a monthly supply of Parsabiv (30 micrograms) averages around $2,850 or about $95/day.
- The price for 30 tablets of Sensipar (30 mg) is roughly $900, which equates to approximately $30/day.
Thus, if you are prescribed the typical starting dose for either drug then Sensipar is less expensive on a per-day treatment basis. However, cost should not be your primary consideration in determining which medication is right for you.
Currently, there are no available generic versions for either Parsabiv (etelcalcetide) or Sensipar (cinacalcet), meaning costs can be significantly higher than those associated with many other medications:
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Etelcalcetide injections come in packs ranging from one to six vials at doses between 2.5 mg and 15 mg. Depending on your dosage needs and insurance coverage options, out-of-pocket costs could range widely.
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Cinacalcet comes in tablet form with dosages ranging from 15mg up to 90mg. These also come in various pack sizes and costs will vary depending on factors such as dosage requirements and individual insurance plans.
Popularity of Parsabiv and Sensipar
Etalcalcetide, known by the brand name Parsabiv, and cinacalcet, sold as Sensipar, are both used to treat secondary hyperparathyroidism in adults with chronic kidney disease who are on dialysis.
In 2020, Parsabiv was prescribed to around 15% of patients with this condition. Etelcalcetide is an intravenous medication administered three times per week at the end of each hemodialysis treatment session. Since its approval in 2017 by FDA, prescriptions for Parsabiv have seen a steady increase.
On the other hand, Sensipar had been prescribed to nearly a quarter (25%) of patients battling secondary hyperparathyroidism in the same year. Cinacalcet has been available since early 2004 and is taken orally once or twice daily without regards to meals. The prescription volume for Sensipar has remained relatively stable over the last decade.
Conclusion
Both Parsabiv (etelcalcetide) and Sensipar (cinacalcet) are used to treat secondary hyperparathyroidism in patients with chronic kidney disease who are on dialysis. They function by reducing the levels of parathyroid hormone, calcium, and phosphorus in the blood. However, their routes of administration differ significantly: Parsabiv is given intravenously during dialysis treatments whilst Sensipar is an oral medication taken once daily.
They both have a well-documented record of efficacy backed up by multiple clinical trials demonstrating their effectiveness compared to placebo treatments. Both drugs may be combined in some instances but this requires careful consideration due to potential interactions between them.
Parsabiv is often considered as first-line treatment for such patients because it can be conveniently administered during regular dialysis sessions. On the other hand, Sensipar might typically be prescribed for patients who prefer oral medication or cannot receive intravenous treatment.
Both medications are available in generic form which offers significant cost savings especially for out-of-pocket payers. As with most medications, there might be an adjustment period where effects might not immediately manifest.
The side effect profiles for both drugs are similar - common ones include nausea and vomiting - but they're generally well-tolerated. Regardless of the drug chosen, close monitoring of calcium levels should occur when initiating therapy due to risks associated with low serum calcium levels.
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Refrences
- Harada, K., Fujioka, A., Konno, M., Inoue, A., Yamada, H., & Hirota, Y. (2019, January). Pharmacology of Parsabiv® (etelcalcetide, ONO-5163/AMG 416), a novel allosteric modulator of the calcium-sensing receptor, for secondary hyperparathyroidism in hemodialysis patients. European Journal of Pharmacology. Elsevier BV.http://doi.org/10.1016/j.ejphar.2018.10.021
- Blair, H. A. (2016, November 29). Etelcalcetide: First Global Approval. Drugs. Springer Science and Business Media LLC.http://doi.org/10.1007/s40265-016-0671-3
- Shahapuni, I., Mansour, J., Harbouche, L., Maouad, B., Benyahia, M., Rahmouni, K., … Fournier, A. (2005, May). <i>Viewpoint</i>: How Do Calcimimetics Fit Into the Management of Parathyroid Hormone, Calcium, and Phosphate Disturbances in Dialysis Patients?. Seminars in Dialysis. Wiley.http://doi.org/10.1111/j.1525-139x.2005.18318.x
- Barman Balfour, J. A., & Scott, L. J. (2005). Cinacalcet Hydrochloride. Drugs. Springer Science and Business Media LLC.http://doi.org/10.2165/00003495-200565020-00007
- Harada, K., Fujioka, A., Konno, M., Inoue, A., Yamada, H., & Hirota, Y. (2019, January). Pharmacology of Parsabiv® (etelcalcetide, ONO-5163/AMG 416), a novel allosteric modulator of the calcium-sensing receptor, for secondary hyperparathyroidism in hemodialysis patients. European Journal of Pharmacology. Elsevier BV.http://doi.org/10.1016/j.ejphar.2018.10.021
- Yousaf, F., & Charytan, C. (2013, September 24). Review of cinacalcet hydrochloride in the management of secondary hyperparathyroidism. Renal Failure. Informa UK Limited.http://doi.org/10.3109/0886022x.2013.832319