Paricalcitol Alternova
Synthetic Vitamin D Analogue for Secondary Hyperparathyroidism in Chronic Kidney Disease
Quick Facts About Paricalcitol Alternova
Key Takeaways About Paricalcitol Alternova
- Selective vitamin D activation: Paricalcitol targets vitamin D receptors primarily in the parathyroid glands, suppressing PTH with less risk of raising calcium and phosphorus than calcitriol
- Essential for CKD patients: Patients with CKD stages 3–5 cannot produce enough active vitamin D, making supplementation critical to prevent bone disease and cardiovascular complications
- Regular blood monitoring required: Serum calcium, phosphorus, and PTH levels must be checked regularly during treatment to prevent hypercalcaemia
- Avoid extra calcium and vitamin D: Do not take calcium or vitamin D supplements without medical advice, as this can dangerously raise blood calcium levels
- Dose is individually adjusted: Your doctor determines your dose based on laboratory results and adjusts it throughout treatment to achieve optimal PTH suppression
What Is Paricalcitol Alternova and What Is It Used For?
Paricalcitol Alternova contains paricalcitol, a synthetic form of active vitamin D. It is used to prevent and treat secondary hyperparathyroidism (SHPT) – a condition where the parathyroid glands produce too much hormone due to impaired kidney function – in adult patients with chronic kidney disease stages 3 to 5 and in children aged 10 to 16 with CKD stages 3 and 4.
Active vitamin D is essential for the normal functioning of many body tissues, including the parathyroid glands, bones, intestines, and the cardiovascular system. In healthy individuals, the kidneys convert inactive vitamin D (produced in the skin or obtained from the diet) into its active form, known as calcitriol (1,25-dihydroxyvitamin D3). However, in patients with chronic kidney disease, this conversion is markedly impaired due to the progressive loss of functional kidney tissue.
When active vitamin D levels fall, the parathyroid glands – four small glands located behind the thyroid in the neck – begin to overproduce parathyroid hormone (PTH). This condition, known as secondary hyperparathyroidism, triggers a cascade of metabolic disturbances. Elevated PTH causes calcium to be leached from bones, leading to a condition called renal osteodystrophy (CKD-related bone disease), which weakens bones and increases fracture risk. Additionally, chronically elevated PTH and disturbed calcium-phosphorus metabolism are associated with vascular calcification, which significantly increases cardiovascular morbidity and mortality in CKD patients.
Paricalcitol works by selectively activating vitamin D receptors (VDR) in the parathyroid glands, thereby suppressing the transcription of the PTH gene and reducing PTH synthesis and secretion. Compared to calcitriol (the naturally occurring active form of vitamin D), paricalcitol has a more selective action on the parathyroid glands and a reduced tendency to increase serum calcium and phosphorus levels. This selective profile is clinically significant because hypercalcaemia and hyperphosphataemia are dangerous complications in CKD patients, contributing to soft tissue calcification and cardiovascular events.
Paricalcitol Alternova is indicated for adult patients with CKD stages 3, 4, and 5, and for children and adolescents aged 10 to 16 years with CKD stages 3 and 4. The oral capsule formulation is used for all CKD stages, while the intravenous injection is primarily used for patients on haemodialysis (CKD stage 5D). The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines recommend vitamin D receptor activators as part of the comprehensive management of CKD-mineral and bone disorder (CKD-MBD).
Paricalcitol was first approved by the FDA in 1998 for intravenous use in dialysis patients, and the oral formulation was approved in 2005 for pre-dialysis CKD patients. It is authorised throughout the European Economic Area under various brand names, including Paricalcitol Alternova in the Nordic countries. The European Medicines Agency (EMA) classifies paricalcitol as an anti-parathyroid agent (ATC code H05BX02).
What Should You Know Before Taking Paricalcitol Alternova?
Before starting paricalcitol, your doctor will check your blood calcium and vitamin D levels. You must not take this medicine if you have very high calcium levels (hypercalcaemia) or vitamin D toxicity. Inform your doctor about all other medications, including calcium supplements and phosphate binders.
Contraindications
You should not take Paricalcitol Alternova if any of the following apply to you:
- Allergy to paricalcitol or any of the other ingredients in this medicine (listed in the "What Does Paricalcitol Alternova Contain?" section below)
- Very high calcium levels in the blood (hypercalcaemia) – paricalcitol can further increase calcium, potentially causing cardiac arrhythmias, kidney stones, and soft tissue calcification
- Very high vitamin D levels in the blood (vitamin D toxicity) – adding a vitamin D analogue would worsen the toxicity
Your doctor will perform blood tests to confirm that these conditions do not apply before starting treatment. If you are unsure whether any of these apply to you, talk to your doctor or pharmacist before taking Paricalcitol Alternova.
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before taking Paricalcitol Alternova. Several important precautions should be considered:
- Dietary phosphate restriction: Before starting paricalcitol, it is important to reduce the amount of phosphate in your diet. High phosphate levels combined with active vitamin D therapy can increase the calcium-phosphorus product, raising the risk of ectopic calcification (calcium deposits in blood vessels, organs, and soft tissues).
- Phosphate binders may be needed: Your doctor may prescribe phosphate-binding medications to control phosphorus levels. If you are using calcium-based phosphate binders, your doctor may need to reduce their dose when starting paricalcitol to prevent hypercalcaemia.
- Regular blood monitoring is essential: Your doctor will order blood tests to monitor serum calcium, serum phosphorus, calcium-phosphorus product (Ca × P), and intact PTH (iPTH) levels throughout treatment. Initially, these tests may be done every two weeks; once stable, monitoring typically continues every one to three months.
- Serum creatinine may rise: In some patients with CKD stages 3 and 4, an increase in serum creatinine has been observed during paricalcitol treatment. This laboratory finding does not necessarily indicate worsening kidney function and should be interpreted in the clinical context by your doctor.
- Digitalised patients require extra caution: If you are taking digoxin or other cardiac glycosides, hypercalcaemia caused by any vitamin D analogue can precipitate potentially dangerous cardiac arrhythmias.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, are planning to have a baby, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy: There is insufficient clinical data on the use of paricalcitol in pregnant women, and the potential risk to the unborn child is unknown. Paricalcitol should only be used during pregnancy if the treating physician considers it absolutely necessary and the potential benefit justifies the potential risk to the foetus.
Breastfeeding: It is not known whether paricalcitol passes into human breast milk. Talk to your doctor before breastfeeding if you are taking Paricalcitol Alternova. Your doctor will help you decide whether to discontinue breastfeeding or discontinue the medication, taking into account the benefit of breastfeeding for your child and the benefit of treatment for you.
Driving and Operating Machinery
Paricalcitol Alternova is not expected to affect your ability to drive or use machines. However, dizziness is listed as an uncommon side effect of paricalcitol. If you experience dizziness or any other symptom that could impair your concentration, do not drive or operate machinery until the symptoms resolve. You are responsible for assessing your own fitness to drive – if in doubt, consult your doctor.
Important Information About Capsule Ingredients
Paricalcitol Alternova soft capsules contain a small amount of ethanol (alcohol) – approximately 1.42 mg per capsule. This is equivalent to less than 0.035 ml of beer or 0.014 ml of wine. The amount is negligible and will not produce any noticeable effects, even in people who are sensitive to alcohol or who avoid alcohol for religious or medical reasons.
How Does Paricalcitol Alternova Interact with Other Drugs?
Paricalcitol can interact with antifungal medications (ketoconazole), heart medications (digoxin, diuretics), calcium and vitamin D supplements, phosphate binders, cholesterol-lowering agents (cholestyramine), and aluminium- or magnesium-containing antacids. Always tell your doctor about all medications and supplements you take.
Paricalcitol is metabolised primarily by the liver enzymes CYP3A4 and CYP24A1. Drugs that strongly inhibit CYP3A4 can increase paricalcitol blood levels and potentially enhance its effects and side effects. Additionally, because paricalcitol affects calcium and phosphorus metabolism, it can interact pharmacodynamically with other agents that influence these mineral levels.
Major Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Ketoconazole | Antifungal (CYP3A4 inhibitor) | Approximately doubles paricalcitol blood levels by blocking its metabolism | Your doctor may reduce the paricalcitol dose; monitor calcium levels closely |
| Digoxin | Cardiac glycoside | Paricalcitol-induced hypercalcaemia can potentiate digoxin toxicity, risking fatal cardiac arrhythmias | Monitor serum calcium and digoxin levels; use with extreme caution |
| Calcium supplements / Vitamin D products | Mineral and vitamin supplements | Additive increase in serum calcium, leading to hypercalcaemia | Do not take without doctor's guidance; dose adjustments required |
| Calcium-based phosphate binders | Phosphate binders (e.g. calcium carbonate, calcium acetate) | Combined calcium load increases risk of hypercalcaemia | Doctor may reduce phosphate binder dose when starting paricalcitol |
Moderate and Minor Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Thiazide diuretics | Blood pressure / diuretic | Thiazides reduce calcium excretion by the kidney, increasing risk of hypercalcaemia when combined with paricalcitol | Monitor calcium levels during concomitant use |
| Aluminium-containing antacids | Antacid / Phosphate binder | Vitamin D analogues may increase aluminium absorption from the gut, risking aluminium toxicity (especially in CKD) | Avoid long-term concomitant use; use non-aluminium alternatives |
| Magnesium-containing antacids | Antacid | Vitamin D analogues may increase magnesium absorption, risking hypermagnesaemia (especially with impaired renal clearance) | Use with caution; monitor magnesium levels |
| Cholestyramine | Bile acid sequestrant (cholesterol-lowering) | May reduce intestinal absorption of paricalcitol, decreasing its effectiveness | Separate administration by at least 2 hours; monitor PTH response |
| Phosphate-containing preparations | Phosphate supplements / medications | Paricalcitol may increase phosphate absorption, worsening hyperphosphataemia in CKD | Avoid concurrent use; monitor serum phosphorus |
Always inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter products, herbal supplements, and multivitamins. This is particularly important for CKD patients, who often take multiple medications simultaneously.
Paricalcitol Alternova capsules can be taken with or without food. No significant food interactions have been identified. However, patients should follow the dietary phosphate restrictions recommended by their renal team, as a high-phosphorus diet can counteract the therapeutic effects of paricalcitol.
What Is the Correct Dosage of Paricalcitol Alternova?
The dose of Paricalcitol Alternova is individually determined by your doctor based on your blood test results, particularly your intact PTH (iPTH) and calcium levels. The usual starting dose for adults is 1 microgram daily or every other day, up to three times per week. Your doctor will adjust your dose throughout treatment.
Always take this medicine exactly as your doctor or pharmacist has told you. Do not change your dose without consulting your doctor first. The capsules should be swallowed whole and can be taken at any time of day, with or without food.
Adults – CKD Stages 3 and 4 (Pre-Dialysis)
Standard Dosing
Starting dose: 1 microgram daily, or 1 microgram every other day (up to 3 times per week)
Dose adjustment: Based on laboratory results (iPTH, calcium, phosphorus). Your doctor may increase or decrease the dose in increments of 1 microgram at intervals of 2–4 weeks.
The goal is to reduce iPTH to the target range recommended by your nephrologist (typically within 2–9 times the upper limit of normal for the assay used, as per KDIGO guidelines), while keeping calcium and phosphorus within acceptable limits.
Adults – CKD Stage 5 (Dialysis)
Oral Capsule Dosing
Starting dose: 1 microgram every other day, up to 3 times per week
Dose adjustment: Based on iPTH levels, adjusted at 2–4 week intervals. Doses should not be given more frequently than every other day.
For patients on haemodialysis, the intravenous injection formulation (5 µg/ml) may be administered during the dialysis procedure, typically three times per week.
Kidney Transplant Recipients
Post-Transplant Dosing
Starting dose: 1 microgram daily, or 1 microgram every other day (3 times per week)
Dose adjustment: Based on laboratory results. Your doctor will use your blood test results to determine the correct dose and adjust as needed depending on your response to treatment.
Persistent hyperparathyroidism after kidney transplantation is common and may require active vitamin D therapy. Your transplant team will manage this alongside your immunosuppressive regimen.
Children and Adolescents (10–16 years)
CKD Stages 3 and 4 Only
Starting dose: 1 microgram every other day, up to 3 times per week
Dose adjustment: Your doctor will use laboratory results to determine the appropriate dose and adjust as your child responds to treatment.
Important: The effectiveness of Paricalcitol Alternova in children with CKD stage 5 has not been established. There is no information on use in children under 10 years of age.
Elderly Patients
There is limited experience with paricalcitol in patients aged 65 years and older. In general, clinical studies showed no significant differences in safety or efficacy between elderly and younger patients. No specific dose adjustment is routinely required based on age alone, but as with all medications in the elderly, careful monitoring is advisable.
Patients with Liver Impairment
For patients with mild to moderate liver disease, no dose adjustment is required. However, there is no clinical experience with paricalcitol in patients with severe liver impairment. If you have significant liver disease, your doctor will weigh the benefits and risks carefully and may monitor you more closely.
Missed Dose
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose. If you miss doses frequently, consider setting a daily alarm or keeping your medication in a visible location as a reminder.
Overdose
Taking too much Paricalcitol Alternova can cause abnormally high levels of calcium in the blood (hypercalcaemia), which can be harmful. Contact your doctor, hospital, or poison control centre immediately if you or someone else has taken more than the prescribed dose.
Acute symptoms may include weakness, drowsiness, headache, nausea, vomiting, dry mouth, constipation, muscle or bone pain, and a metallic taste in the mouth.
Chronic overdose symptoms may include loss of appetite, weight loss, eye pain, runny nose, itching, feeling feverish, impotence, severe abdominal pain (due to inflamed pancreas), and kidney stones. Blood pressure may be affected and irregular heartbeats (palpitations) may occur. Laboratory tests may show elevated cholesterol, urea nitrogen, and liver enzymes. In rare cases, paricalcitol overdose can cause mental changes including confusion, drowsiness, insomnia, and nervousness.
Stopping Paricalcitol
Do not stop taking Paricalcitol Alternova unless your doctor tells you to. Stopping treatment abruptly can lead to a rebound rise in PTH levels, which may worsen bone disease and metabolic disturbances. If your doctor decides to discontinue paricalcitol, they will typically taper the dose and monitor your PTH and calcium levels during the transition.
What Are the Side Effects of Paricalcitol Alternova?
The most common side effects are elevated blood calcium levels (hypercalcaemia) and an elevated calcium-phosphorus product, particularly in patients with severe CKD. Uncommon side effects include nausea, diarrhoea, taste changes, headache, dizziness, rash, and muscle cramps. Contact your doctor immediately if you experience signs of an allergic reaction.
Like all medicines, Paricalcitol Alternova can cause side effects, although not everybody gets them. Many of the side effects are related to changes in calcium and phosphorus levels and can be managed through dose adjustment and regular blood monitoring. If any side effect becomes severe or you notice any effects not listed here, please tell your doctor or pharmacist.
- Difficulty breathing, wheezing, or shortness of breath
- Swelling of the face, lips, tongue, or throat
- Skin rash, hives, or severe itching
- These may be signs of a serious allergic reaction that requires emergency treatment
Common
May affect up to 1 in 10 people
- Elevated blood calcium levels (hypercalcaemia)
- Elevated calcium-phosphorus product (in patients with severe CKD)
- Elevated blood phosphorus levels (hyperphosphataemia)
Uncommon
May affect up to 1 in 100 people
- Pneumonia (lung infection)
- Decreased parathyroid hormone levels (oversuppression)
- Loss of appetite
- Decreased blood calcium levels (hypocalcaemia)
- Dizziness
- Taste changes (dysgeusia)
- Headache
- Irregular heart rhythm (cardiac arrhythmia)
- Stomach discomfort or abdominal pain
- Constipation
- Diarrhoea
- Dry mouth
- Heartburn (gastro-oesophageal reflux / indigestion)
- Nausea
- Vomiting
- Acne
- Itching (pruritus)
- Skin rash
- Hives (urticaria)
- Muscle cramps
- Muscle pain (myalgia)
- Breast tenderness
- Weakness (asthenia)
- Fatigue, general feeling of being unwell (malaise)
- Swelling of the legs (peripheral oedema)
- Pain
- Elevated creatinine levels
- Abnormal liver function test results
Rare or Post-Marketing Reports
May affect fewer than 1 in 1,000 people
- Severe allergic reactions (angioedema, anaphylaxis)
- Pancreatitis (inflammation of the pancreas)
- Confusion or mental changes
It is important to report suspected side effects after a medicine has been authorised. This makes it possible to continuously monitor the medicine's benefit-risk balance. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national medicines regulatory authority.
How Should You Store Paricalcitol Alternova?
Store Paricalcitol Alternova out of the sight and reach of children. No special storage conditions are required. Do not use after the expiry date printed on the packaging.
Keep this medicine out of the sight and reach of children at all times. Store the capsules in their original packaging to protect them from moisture. There are no special temperature requirements for storage – normal room temperature is suitable.
Do not use this medicine after the expiry date stated on the carton and label after "EXP". The expiry date refers to the last day of that month. Once the expiry date has passed, return any unused medicine to your pharmacist for proper disposal.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment and reduce the risk of accidental exposure.
What Does Paricalcitol Alternova Contain?
Each Paricalcitol Alternova soft capsule contains either 1 or 2 micrograms of paricalcitol as the active substance. The capsules also contain medium-chain triglycerides, ethanol, and butylhydroxytoluene (BHT). The capsule shell is made of gelatin, glycerol, titanium dioxide, and iron oxide colouring agents.
Active Substance
The active substance is paricalcitol. Each soft capsule contains either 1 microgram or 2 micrograms of paricalcitol.
Other Ingredients (Excipients)
Capsule contents: Medium-chain triglycerides, ethanol (alcohol), butylhydroxytoluene (BHT, an antioxidant).
Capsule shell: Gelatin, glycerol (anhydrous), titanium dioxide (E171).
- 1 microgram capsules: Grey, oval soft gelatin capsules – additionally contain iron oxide, black (E172)
- 2 microgram capsules: Light brown, oval soft gelatin capsules – additionally contain iron oxide, yellow (E172) and iron oxide, red (E172)
Pack Sizes
Paricalcitol Alternova is available in blister packs of 7, 28, or 30 capsules. Not all pack sizes may be marketed in your country.
Frequently Asked Questions About Paricalcitol Alternova
Regular vitamin D supplements (such as cholecalciferol or ergocalciferol) need to be converted by the kidneys into their active form to work. In patients with chronic kidney disease, the kidneys cannot perform this conversion adequately. Paricalcitol is a synthetic analogue of the already-active form of vitamin D, so it works directly without requiring kidney activation. Furthermore, paricalcitol selectively targets the parathyroid glands with less risk of raising calcium and phosphorus compared to calcitriol, the naturally occurring active vitamin D.
At the start of treatment, your doctor will typically check your blood calcium, phosphorus, and parathyroid hormone (PTH) levels every two weeks. Once your levels are stable and your dose is established, blood tests are usually done every one to three months. Your doctor will inform you of the exact schedule. It is important not to miss these appointments, as they are essential for safe treatment.
No – you should not take any calcium supplements, vitamin D supplements, or multivitamins containing calcium or vitamin D without your doctor's explicit guidance. Paricalcitol raises the active vitamin D effect in your body, and additional calcium or vitamin D can cause dangerously high blood calcium levels (hypercalcaemia). Always check with your doctor or pharmacist before taking any new supplement.
Hypercalcaemia (high blood calcium) can cause symptoms such as nausea, vomiting, loss of appetite, constipation, excessive thirst, frequent urination, muscle weakness, confusion, drowsiness, bone pain, and irregular heartbeats. In severe cases, it can lead to kidney stones, kidney damage, and cardiac arrhythmias. If you experience any of these symptoms while taking paricalcitol, contact your doctor promptly. Regular blood tests help detect hypercalcaemia before symptoms develop.
No. While both are active vitamin D compounds, paricalcitol is a synthetic analogue with a modified chemical structure. The key clinical difference is that paricalcitol has a more selective action on the parathyroid glands and a lower tendency to increase calcium and phosphorus levels compared to calcitriol. This makes paricalcitol a preferred choice for many nephrologists when managing secondary hyperparathyroidism in CKD patients, as it carries a lower risk of hypercalcaemia and hyperphosphataemia.
Paricalcitol Alternova can be used in children and adolescents aged 10 to 16 years with chronic kidney disease stages 3 and 4. The usual starting dose is 1 microgram every other day, up to three times per week, with dose adjustments based on laboratory results. However, the effectiveness in children with CKD stage 5 has not been established, and there is no information on use in children under 10 years of age.
References and Sources
- KDIGO (2024). 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.
- European Medicines Agency (EMA). Paricalcitol – Summary of Product Characteristics (SmPC). European public assessment database.
- Teng M, Wolf M, Ofsthun MN, et al. (2005). Activated injectable vitamin D and hemodialysis survival: a historical cohort study. Journal of the American Society of Nephrology, 16(4): 1115–1125.
- Sprague SM, Llach F, Amdahl M, et al. (2003). Paricalcitol versus calcitriol in the treatment of secondary hyperparathyroidism. Kidney International, 63(4): 1483–1490.
- World Health Organization (WHO). Model List of Essential Medicines, 23rd edition (2023). Geneva: WHO.
- National Institute for Health and Care Excellence (NICE). Chronic kidney disease: assessment and management (NG203). Updated 2024.
- British National Formulary (BNF). Paricalcitol. NICE Evidence Services, 2024.
- U.S. Food and Drug Administration (FDA). Zemplar (paricalcitol) prescribing information. Highlights of prescribing information.
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