Mimpara (Cinacalcet)
Calcimimetic agent for hyperparathyroidism and hypercalcemia
Quick facts about Mimpara (cinacalcet)
Key Takeaways
- Targets the parathyroid gland: Mimpara works by increasing the sensitivity of the calcium-sensing receptor, reducing PTH secretion and lowering calcium and phosphorus levels
- Primarily for dialysis patients: Most commonly prescribed for secondary hyperparathyroidism in patients with chronic kidney disease requiring dialysis
- Risk of low calcium: Can cause hypocalcemia, which may be life-threatening. Regular blood calcium monitoring is essential during treatment
- Take with food: Tablets must be swallowed whole with or shortly after a meal and should never be chewed, crushed, or split
- Multiple brand names: Available as Mimpara and several generic versions including Cinacalcet Teva, Cinacalcet Orion, and others
What Is Mimpara and What Is It Used For?
Mimpara (cinacalcet) is a calcimimetic medication that controls parathyroid hormone (PTH), calcium, and phosphorus levels. It treats secondary hyperparathyroidism in dialysis patients, reduces hypercalcemia in parathyroid cancer, and manages primary hyperparathyroidism when surgery is not an option.
Mimpara contains the active substance cinacalcet, which belongs to a class of medicines called calcimimetics. It works by acting on the calcium-sensing receptors (CaSR) found on the surface of parathyroid gland cells. By increasing the sensitivity of these receptors to calcium already present in the blood, cinacalcet signals the parathyroid glands to reduce their production and secretion of parathyroid hormone (PTH). This targeted mechanism makes Mimpara a valuable tool in conditions where PTH levels are abnormally elevated.
The parathyroid glands are four small glands located in the neck, near the thyroid gland. Their primary function is to produce PTH, which plays a critical role in regulating calcium and phosphorus balance throughout the body. When PTH levels become too high, calcium is pulled from the bones and accumulates in the blood, leading to a cascade of health problems including weakened bones, kidney stones, cardiovascular complications, and neuropsychiatric disturbances.
Approved Indications in Adults
Mimpara is approved for use in several clinical scenarios in adults:
- Secondary hyperparathyroidism in patients with severe chronic kidney disease (CKD) who require haemodialysis or peritoneal dialysis to clear waste products from the blood. In this setting, the failing kidneys cannot adequately regulate calcium and phosphorus, leading to compensatory overproduction of PTH.
- Hypercalcemia in parathyroid cancer: To reduce dangerously elevated blood calcium levels in patients diagnosed with parathyroid carcinoma, a rare but serious malignancy of the parathyroid glands.
- Primary hyperparathyroidism: To lower elevated calcium levels in patients whose parathyroid glands produce excess PTH independently of other causes, and for whom surgical removal of the affected gland(s) is not feasible or is contraindicated.
Use in Children and Adolescents
Mimpara is also approved for children aged 3 to 18 years for the treatment of secondary hyperparathyroidism in those with severe kidney disease who are on dialysis, specifically when their condition cannot be adequately controlled with other treatments. It is important to note that children under 18 with parathyroid cancer or primary hyperparathyroidism should not take Mimpara, as safety and effectiveness have not been established in these paediatric populations for those indications.
“Primary” hyperparathyroidism means the overproduction of PTH is caused by a problem within the parathyroid glands themselves, such as an adenoma or hyperplasia. “Secondary” hyperparathyroidism means the excess PTH production is a response to another condition, most commonly chronic kidney disease. Both forms can lead to decreased calcium in bones (causing bone pain, fractures, and osteoporosis), cardiovascular problems, kidney stones, psychiatric symptoms, and in severe cases, coma.
What Should You Know Before Taking Mimpara?
Do not take Mimpara if you are allergic to cinacalcet or any of its ingredients, or if your blood calcium levels are already low. Tell your doctor about any history of seizures, liver problems, or heart failure before starting treatment. Mimpara can cause life-threatening hypocalcemia.
Before initiating treatment with Mimpara, it is essential that your healthcare provider has a comprehensive understanding of your medical history and current health status. Several factors can influence whether Mimpara is safe and appropriate for you, and close monitoring is required throughout treatment to minimise the risk of serious adverse effects.
Contraindications
You must not take Mimpara in the following situations:
- Allergy to cinacalcet: If you have a known hypersensitivity to cinacalcet hydrochloride or any of the excipients (inactive ingredients) listed in the product information.
- Low blood calcium (hypocalcemia): If your serum calcium level is below the lower limit of the normal range. Your doctor will check your calcium levels before starting Mimpara and will not prescribe it if they are already low.
Warnings and Precautions
Speak to your doctor, pharmacist, or nurse before taking Mimpara if you have or have ever had:
- Seizures (epilepsy or convulsions): The risk of seizures is higher if you have a prior history of seizure disorders. Cinacalcet lowers blood calcium, and low calcium levels can lower the seizure threshold.
- Liver problems: Cinacalcet is primarily metabolised in the liver. Impaired liver function may affect how the drug is processed, potentially leading to higher blood levels and increased risk of side effects.
- Heart failure: Post-marketing data have shown that a small number of patients with heart failure experienced worsening of their condition and/or low blood pressure (hypotension) during treatment with cinacalcet.
Mimpara lowers calcium levels in the blood. Life-threatening events and deaths due to low calcium (hypocalcemia) have been reported in both adults and children treated with Mimpara. Contact your doctor immediately if you experience any of the following symptoms: muscle spasms, twitching, or cramping; numbness or tingling in the fingers, toes, or around the mouth; seizures; confusion; or loss of consciousness.
Low calcium levels can also affect heart rhythm. Tell your doctor immediately if you experience unusually fast or pounding heartbeats, if you have pre-existing heart rhythm problems, or if you are taking medicines known to cause heart rhythm disturbances.
Smoking and Mimpara
If you start or stop smoking during treatment with Mimpara, inform your doctor. Smoking can affect the way cinacalcet is metabolised in the body through its interaction with certain liver enzymes (specifically CYP1A2). Changes in smoking status may alter the drug's effectiveness and may necessitate a dose adjustment.
Pregnancy and Breastfeeding
Mimpara has not been studied in pregnant women. If you are pregnant, think you may be pregnant, or are planning to have a baby, seek advice from your doctor or pharmacist before taking this medicine. If you become pregnant while taking Mimpara, your doctor may decide to change your treatment, as cinacalcet may potentially harm the developing foetus.
It is not known whether cinacalcet is excreted in human breast milk. Your doctor will discuss with you whether you should discontinue breastfeeding or discontinue treatment with Mimpara, taking into account the benefit of breastfeeding for your child and the benefit of Mimpara therapy for you.
Driving and Operating Machinery
Dizziness and seizures have been reported in patients taking Mimpara. If you experience these side effects, you should not drive or operate machinery until these symptoms have resolved. The ability to react quickly may be impaired, and operating vehicles or heavy equipment could pose a danger to yourself and others.
Lactose Content
Mimpara film-coated tablets contain lactose monohydrate as an excipient. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. The lactose content is generally small, but patients with rare hereditary conditions such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should exercise caution.
How Does Mimpara Interact with Other Drugs?
Mimpara must not be used together with etelcalcetide (another calcimimetic). Several drugs including ketoconazole, ritonavir, and fluvoxamine can increase cinacalcet levels. Mimpara can also increase levels of other medications including certain antidepressants, antiarrhythmics, and beta-blockers.
Drug interactions are an important consideration when taking Mimpara, as cinacalcet both affects and is affected by a number of other medications. Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. This includes prescription medications, over-the-counter products, herbal supplements, and vitamins.
Major Interactions
The following interaction is considered a major contraindication and these drugs should never be used together:
- Etelcalcetide (Parsabiv): You must not use Mimpara together with etelcalcetide, as both are calcimimetic agents. Using them simultaneously can lead to severe and potentially life-threatening hypocalcemia. If you are switching between these medications, an appropriate washout period should be observed.
Drugs That Affect Mimpara
The following medicines may affect how Mimpara works by altering its blood levels:
| Drug | Category | Mechanism | Clinical Significance |
|---|---|---|---|
| Ketoconazole | Antifungal | Inhibits CYP3A4 enzyme | May significantly increase cinacalcet levels |
| Itraconazole | Antifungal | Inhibits CYP3A4 enzyme | May increase cinacalcet levels |
| Voriconazole | Antifungal | Inhibits CYP3A4 enzyme | May increase cinacalcet levels |
| Ritonavir | HIV antiretroviral | Potent CYP3A4 inhibitor | May significantly increase cinacalcet levels |
| Fluvoxamine | Antidepressant (SSRI) | Inhibits CYP1A2 enzyme | May increase cinacalcet levels |
| Rifampicin | Antibiotic | Induces CYP3A4 and CYP1A2 enzymes | May decrease cinacalcet levels |
| Ciprofloxacin | Antibiotic | Inhibits CYP1A2 enzyme | May increase cinacalcet levels |
| Telithromycin | Antibiotic | Inhibits CYP3A4 enzyme | May increase cinacalcet levels |
Drugs Affected by Mimpara
Cinacalcet is a strong inhibitor of the CYP2D6 enzyme. This means Mimpara can increase the blood levels of other drugs that are broken down by this enzyme. Dose adjustments of the following medications may be necessary:
- Tricyclic antidepressants: Amitriptyline, desipramine, nortriptyline, and clomipramine – levels may be increased, potentially enhancing both therapeutic and adverse effects.
- Dextromethorphan: A cough suppressant found in many over-the-counter cough medicines – increased levels may lead to enhanced side effects.
- Flecainide and propafenone: Antiarrhythmic medications used to treat irregular heart rhythms – increased levels may enhance cardiac effects and require careful monitoring.
- Metoprolol: A beta-blocker used for high blood pressure and heart conditions – increased levels may lead to excessive heart rate slowing or blood pressure lowering.
Mimpara should be taken with or shortly after food. Taking cinacalcet with a meal increases its absorption (bioavailability) compared to taking it on an empty stomach. Consistent timing with meals helps maintain stable drug levels and optimises therapeutic effectiveness.
What Is the Correct Dosage of Mimpara?
For secondary hyperparathyroidism, the usual starting dose is 30 mg once daily. For parathyroid cancer or primary hyperparathyroidism, the starting dose is 30 mg twice daily. Doses are adjusted by the doctor based on regular blood tests. Tablets must be swallowed whole with food.
Always take Mimpara exactly as your doctor or pharmacist has instructed. Do not alter your dose without consulting your healthcare provider. The dosage is individualised and will be adjusted based on your response, as determined by regular blood tests measuring PTH, calcium, and phosphorus levels.
Adults – Secondary Hyperparathyroidism (Dialysis Patients)
Starting Dose
30 mg (one tablet) taken once daily with food.
Your doctor will monitor your PTH and calcium levels and may increase the dose gradually. The dose is typically titrated every 2 to 4 weeks to achieve target PTH levels. Available dose increments are 30 mg, 60 mg, 90 mg, 120 mg, and 180 mg once daily.
Adults – Parathyroid Cancer or Primary Hyperparathyroidism
Starting Dose
30 mg (one tablet) taken twice daily with food.
Your doctor will titrate the dose based on serum calcium levels. The dose may be increased sequentially through 60 mg twice daily, 90 mg twice daily, and up to a maximum of 90 mg three or four times daily, as needed to normalise calcium levels.
Children (3 to 18 Years) – Secondary Hyperparathyroidism
Starting Dose
The maximum starting dose is 0.20 mg/kg/day, calculated based on the child's body weight. Mimpara is also available as granules in capsules designed to be opened, which is suitable for children who require lower doses than 30 mg or who cannot swallow tablets.
The doctor will monitor calcium levels before starting and regularly during treatment. It is critical that children take the prescribed dose exactly as directed by their doctor.
| Indication | Patient Group | Starting Dose | Maximum Dose |
|---|---|---|---|
| Secondary hyperparathyroidism | Adults on dialysis | 30 mg once daily | 180 mg once daily |
| Parathyroid cancer | Adults | 30 mg twice daily | 90 mg 3-4 times daily |
| Primary hyperparathyroidism | Adults (surgery not feasible) | 30 mg twice daily | 90 mg 3-4 times daily |
| Secondary hyperparathyroidism | Children 3–18 years on dialysis | ≤0.20 mg/kg/day | As directed by physician |
How to Take Mimpara
Follow these guidelines for proper administration:
- Take Mimpara orally, with or shortly after a meal
- Swallow the tablets whole – do not chew, crush, or split them
- Take the medicine at approximately the same time each day for consistent blood levels
- Your doctor will perform regular blood tests to monitor your response and adjust the dose accordingly
Missed Dose
If you forget to take a dose of Mimpara, do not take a double dose to make up for the missed one. Simply take your next dose at the usual scheduled time. Skipping a single dose is unlikely to have a significant clinical impact, but you should inform your doctor if you frequently miss doses, as this can affect the overall management of your condition.
Overdose
If you take more Mimpara than prescribed, contact your doctor or go to a hospital emergency department immediately. Possible signs of overdose reflect the consequences of severe hypocalcemia and may include:
- Numbness and tingling around the mouth, in the fingers and toes
- Muscle pain, cramps, or spasms
- Seizures (convulsions)
- Confusion or altered consciousness
Treatment of overdose is supportive and focused on correcting hypocalcemia through intravenous calcium administration and careful monitoring of cardiac rhythm.
What Are the Side Effects of Mimpara?
The most common side effects are nausea and vomiting (affecting more than 1 in 10 patients), which are usually mild and transient. Other common effects include dizziness, numbness, muscle pain, low calcium levels, and reduced appetite. Seek immediate medical attention for signs of severe hypocalcemia or angioedema.
Like all medicines, Mimpara can cause side effects, although not everybody gets them. Understanding the frequency and nature of potential side effects helps you and your healthcare team make informed decisions about your treatment and recognise problems early.
- Numbness and tingling around the mouth, muscle pain, cramping, and seizures – these may indicate dangerously low calcium levels (hypocalcemia)
- Swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema)
Very Common
- Nausea
- Vomiting
These side effects are generally mild and do not last long. They tend to improve as your body adjusts to the medication.
Common
- Dizziness
- Numbness and tingling (paraesthesia)
- Loss of appetite (anorexia) or decreased appetite
- Muscle pain (myalgia)
- Weakness (asthenia)
- Skin rash
- Decreased testosterone levels
- High potassium levels (hyperkalaemia)
- Allergic reactions (hypersensitivity)
- Headache
- Seizures
- Low blood pressure (hypotension)
- Upper respiratory tract infection
- Breathing difficulties (dyspnoea)
- Cough
- Indigestion (dyspepsia)
- Diarrhoea
- Abdominal pain (including upper abdomen)
- Constipation
- Muscle spasms
- Back pain
- Low blood calcium (hypocalcemia)
Not Known Frequency
- Hives (urticaria)
- Swelling of face, lips, mouth, tongue or throat (angioedema)
- Unusually rapid or pounding heartbeats due to low calcium (QT prolongation and ventricular arrhythmia secondary to hypocalcemia)
- Worsening of heart failure (in patients with pre-existing heart failure)
Hypocalcemia – The Most Important Risk
Low blood calcium (hypocalcemia) is the most clinically significant risk associated with Mimpara therapy. Because the drug's mechanism of action involves lowering PTH and consequently calcium, hypocalcemia is an expected pharmacological effect that can become dangerous if not properly monitored and managed.
Symptoms of hypocalcemia can range from mild (tingling sensations, minor muscle twitching) to severe and life-threatening (seizures, cardiac arrhythmias, laryngospasm). Your doctor will monitor your calcium levels closely, particularly during dose adjustments, and may prescribe calcium and/or vitamin D supplements to help maintain adequate calcium levels.
Effects on Heart Rhythm
Low calcium levels caused by Mimpara can affect the electrical conduction system of the heart, potentially leading to QT prolongation and ventricular arrhythmias. Patients with pre-existing heart conditions, particularly those already taking medications known to affect heart rhythm, require especially careful monitoring. Report any palpitations, rapid heartbeat, lightheadedness, or fainting episodes to your doctor immediately.
Heart Failure Considerations
A small number of patients with pre-existing heart failure have experienced worsening of their condition and/or hypotension while taking Mimpara. If you have heart failure, your doctor should weigh the benefits of treatment against these potential risks and monitor your cardiovascular status throughout therapy.
It is important to report suspected side effects after a medicine has been authorised. This enables ongoing monitoring of the medicine's benefit-risk balance. Healthcare professionals and patients can report adverse reactions to their national pharmacovigilance authority (e.g., the EMA in Europe, the FDA in the United States, or the MHRA in the United Kingdom).
How Should You Store Mimpara?
Store Mimpara out of the sight and reach of children. Use before the expiry date printed on the packaging. No special storage conditions are required – store at room temperature away from excessive heat and moisture.
Proper storage of medications is essential to maintain their efficacy and safety throughout their shelf life. Mimpara film-coated tablets do not require any special storage conditions, making them convenient for home use. However, the following general guidelines should be followed:
- Keep the medicine out of the sight and reach of children at all times
- Do not use after the expiry date stated on the carton and blister pack after “EXP”. The expiry date refers to the last day of the stated month
- Store at room temperature, protected from excessive heat, direct sunlight, and moisture
- Keep the tablets in their original blister packaging until ready to take
- Do not dispose of medicines via wastewater or household waste. Ask your pharmacist about proper disposal methods for medicines you no longer use. These measures help protect the environment
What Does Mimpara Contain?
Each Mimpara tablet contains cinacalcet (as hydrochloride) in strengths of 30 mg, 60 mg, or 90 mg. Tablets are light green, oval, film-coated, and marked with their strength on one side and “AMG” on the other.
Active Ingredient
The active substance is cinacalcet (as cinacalcet hydrochloride). Each film-coated tablet contains 30 mg, 60 mg, or 90 mg of cinacalcet respectively. Cinacalcet hydrochloride is a synthetic small molecule that acts as an allosteric modulator of the calcium-sensing receptor.
Inactive Ingredients (Excipients)
The tablet core contains:
- Pregelatinised maize starch
- Microcrystalline cellulose
- Povidone
- Crospovidone
- Magnesium stearate
- Colloidal anhydrous silica
The tablet coating contains:
- Carnauba wax
- Opadry green (containing lactose monohydrate, hypromellose, titanium dioxide [E171], glycerol triacetate, indigo carmine [E132], yellow iron oxide [E172])
- Opadry clear (containing hypromellose, macrogol)
Appearance and Pack Sizes
Mimpara tablets are light green, oval, film-coated tablets. They are marked with their respective strength (“30”, “60”, or “90”) on one side and “AMG” on the other side. Approximate tablet dimensions:
| Strength | Length | Width |
|---|---|---|
| 30 mg | 9.7 mm | 6.0 mm |
| 60 mg | 12.2 mm | 7.6 mm |
| 90 mg | 13.9 mm | 8.7 mm |
Mimpara is available in blister packs containing 14, 28, or 84 film-coated tablets. Not all pack sizes may be marketed in all countries. The marketing authorisation holder is Amgen Europe B.V.
Generic Alternatives
Several generic versions of cinacalcet are available, including Cinacalcet Orion, Cinacalcet Accordpharma, Cinacalcet Teva, Cinacalcet Amarox, and Cinacalcet Viatris. These contain the same active ingredient at the same strengths and have been demonstrated to be bioequivalent to the originator product. Your pharmacist may dispense a generic version unless your doctor specifies otherwise.
Frequently Asked Questions About Mimpara
Mimpara (cinacalcet) is used to treat three main conditions: (1) secondary hyperparathyroidism in adults and children aged 3+ with severe chronic kidney disease who are on dialysis, (2) high blood calcium levels (hypercalcemia) in adults with parathyroid cancer, and (3) high blood calcium in adults with primary hyperparathyroidism when surgical removal of the parathyroid glands is not feasible. It works by making the calcium-sensing receptors on the parathyroid glands more sensitive, which reduces the overproduction of parathyroid hormone (PTH).
Cinacalcet begins to lower PTH levels within hours of taking the first dose, with peak plasma concentrations typically reached within 2 to 6 hours after oral administration. However, the full clinical benefit – including stabilisation of calcium, phosphorus, and PTH levels – usually takes several weeks to achieve, as the dose is gradually titrated based on regular blood test results. Your doctor will typically check your PTH and calcium levels every 1 to 4 weeks during dose adjustment.
Mimpara should be taken with or shortly after a meal, not on an empty stomach. Taking it with food significantly increases the absorption of cinacalcet, improving its bioavailability and helping to ensure consistent drug levels. Taking it without food may result in reduced drug absorption and less effective control of PTH and calcium levels.
Muscle cramps, spasms, or twitching while taking Mimpara may indicate low calcium levels (hypocalcemia), which can be a serious side effect. Contact your doctor promptly – they will likely order a blood test to check your calcium levels. If calcium is found to be low, your doctor may adjust your Mimpara dose, prescribe calcium and/or vitamin D supplements, or take other measures. Do not stop taking Mimpara without first consulting your doctor, as sudden discontinuation can cause a rapid rise in PTH and calcium levels.
No, Mimpara film-coated tablets must be swallowed whole. They should not be chewed, crushed, or split. The film coating is designed to protect the active ingredient and ensure proper absorption. For children or patients who have difficulty swallowing tablets, Mimpara is also available as granules in capsules intended to be opened and mixed with food or drink – ask your doctor or pharmacist about this alternative formulation.
Mimpara has not been studied in pregnant women, and its safety during pregnancy is not established. Animal studies have shown potential risks to the developing foetus. If you are pregnant or planning to become pregnant, your doctor may switch you to an alternative treatment. It is also unknown whether cinacalcet passes into breast milk. Your doctor will help you weigh the benefits of breastfeeding against the benefits of continuing Mimpara treatment and advise on the best course of action.
References
This article is based on the following peer-reviewed sources and international guidelines:
- European Medicines Agency (EMA). Mimpara (cinacalcet) – Summary of Product Characteristics. Available at: EMA Mimpara EPAR.
- KDIGO 2024 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD). Kidney International Supplements.
- Block GA, Martin KJ, de Francisco ALM, et al. Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis. New England Journal of Medicine. 2004;350(15):1516–1525.
- EVOLVE Trial Investigators. Effect of Cinacalcet on Cardiovascular Disease in Patients Undergoing Dialysis. New England Journal of Medicine. 2012;367(26):2482–2494.
- National Institute for Health and Care Excellence (NICE). Cinacalcet for the treatment of secondary hyperparathyroidism. NICE Technology Appraisal Guidance [TA117].
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd list (2023).
- Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of CKD-MBD. Kidney International Supplements. 2017;7(1):1–59.
- Marcocci C, Bollerslev J, Khan AA, Shoback DM. Medical Management of Primary Hyperparathyroidism: Proceedings of the Fourth International Workshop. Journal of Clinical Endocrinology & Metabolism. 2014;99(10):3607–3618.
About Our Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising board-certified specialists in nephrology, endocrinology, and clinical pharmacology. Our editorial process follows international medical guidelines (KDIGO, EMA, WHO) and the GRADE evidence framework to ensure the highest standards of accuracy and reliability.
All content is independently reviewed by specialist physicians with expertise in the relevant medical field. Our review process ensures clinical accuracy, appropriate context, and evidence-based recommendations.
We follow evidence level 1A standards based on systematic reviews and meta-analyses of randomised controlled trials. All medical claims are supported by peer-reviewed sources. No commercial funding or pharmaceutical sponsorship influences our content.