Alfacalcidol Teva

Quick links

Choose a section

Quick links to important sections

Advertisements
Advertisements

Overview of Alfacalcidol Teva

Alfacalcidol Teva is a prescription-only medicine containing the active ingredient Alfacalcidol (1alpha-hydroxycholecalciferol), a synthetic compound critical for regulating mineral balance. This preparation is formally classified as a Vitamin D analogue and a dedicated Antihypocalcemic agent.

Property Description
Active Ingredient Alfacalcidol (1alpha-hydroxycholecalciferol)
Form Oral solution, Soft/Hard capsules
Pharmacological Class Vitamin D analogue
Origin Synthetic, Steroid derivative
General Purpose Regulator of calcium and phosphate metabolism

What Type of Medicine is Alfacalcidol Teva?

Alfacalcidol Teva is a monocomponent drug that belongs to the Vitamin D analogue class, a group of agents that perform vital functions in the regulation of calcium balance and bone metabolism. Unlike the natural form of Vitamin D (cholecalciferol), Alfacalcidol is a synthetic steroid derivative designed to enter the body's activation pathway at a later stage. It functions as a prodrug, meaning it requires only one single metabolic transformation step in the liver to become the fully active hormone, Calcitriol. This simplified activation mechanism provides a functional pathway for patients with reduced kidney function.


Composition and General Purpose

The sole therapeutic component is the active ingredient, Alfacalcidol, a substance that is lipid-soluble. Alfacalcidol Teva is typically available for oral administration as soft capsules or an oral solution, with these oral forms often formulated using an oily vehicle to aid dissolution and absorption. The compound’s core function is its high efficiency as a regulator of calcium and phosphate metabolism. For example, the compound is often chosen for patients requiring reliable management of low calcium levels that result from difficulties in activating Vitamin D. By providing the body with this readily activatable form, the compound significantly enhances the intestinal absorption of calcium and phosphate from the diet, ensuring the maintenance of necessary mineral levels in the bloodstream.

Advertisements

What side effects are possible with Alfacalcidol Teva?

Official Safety Characteristics and Adverse Reactions

The most significant and commonly reported safety characteristic of Alfacalcidol Teva is its effect on mineral balance, with the key adverse reaction being hypercalcaemia (elevated calcium levels in the blood). This reaction is classified as Common in regulatory documents and results directly from the medicine's function as a potent Vitamin D analogue.


Frequency and System-Organ Classes

Adverse effects are officially documented across several System-Organ Classes and classified by frequency:

  • Metabolism and Nutrition Disorders: This category includes Hypercalcaemia (Common) and Hyperphosphataemia (elevated phosphate), a frequency for which is sometimes classified as Not Known.
  • Gastrointestinal and Nervous System Disorders: Common reactions include Nausea, Vomiting, Abdominal pain, Headache, and Dizziness.
  • Skin and Musculoskeletal Disorders: Skin reactions (e.g., pruritus, rash) are listed as Common, while Constipation, Fatigue, and Musculoskeletal pain are classified as Uncommon.

Serious Risks and Safety Constraints

Serious adverse reactions documented in official labeling include severe hypercalcaemia, which carries a risk of serious long-term outcomes such as Nephrocalcinosis (calcification of the kidneys) and marked deterioration of Renal Function.

The drug is formally restricted (contraindicated) for individuals with pre-existing conditions of hypercalcaemia, hyperphosphataemia (unless on dialysis), or known metastatic calcification. Furthermore, regulatory notes highlight that patients with renal impairment are at a heightened risk for developing hypercalcaemia and related complications. The risk of high calcium levels is explicitly noted to occur early in treatment or during dose adjustment, while the most serious effects are associated with prolonged high mineral levels.

Advertisements

Overdose and Emergency Response

Overdose of Alfacalcidol Teva is defined in regulatory documents as a state of mineral overload, resulting primarily in Hypercalcemia (abnormally high calcium levels in the blood). This condition may occur from acute or chronic excessive intake.

Documented Overdose Manifestations

Official prescribing information lists manifestations tied to hypercalcemia, including nausea, vomiting, anorexia, headache, somnolence, excessive thirst (polydipsia), and excessive urination (polyuria). Other documented signs include muscle pain, weakness, hypertension, and metallic taste.

When to Seek Urgent Help

Regulators mandate that if overdose is suspected or hypercalcemia is detected, treatment with Alfacalcidol must be immediately discontinued. Individuals must seek immediate medical attention by contacting a healthcare professional, hospital, or poison control centre if symptoms are progressive or severe.

Severe Outcomes and Management

Overdose is classified as potentially severe due to the risk of life-threatening complications, including cardiac arrhythmias and serious kidney damage such as nephrocalcinosis. The risk of cardiac arrhythmias is explicitly noted to be higher in patients taking digitalis glycosides. No specific antidote is known. Management focuses on supportive measures and reversing the hypercalcemia, often requiring close monitoring of plasma calcium and electrocardiographs (ECGs).

Advertisements

Therapeutic Uses of Alfacalcidol Teva

What Alfacalcidol Teva Treats: Main Uses and Benefits

Alfacalcidol Teva is commonly used to help with symptoms related to systemic imbalance, particularly in patients whose bodies may struggle to properly process Vitamin D, such as those with chronic kidney disease. This supportive treatment is relevant for easing symptomatic discomfort and helps with managing structural changes related to mineral issues.

The medication is used across domains where additional symptomatic support is needed to manage conditions that affect bone health. The primary indications include bone disease caused by kidney failure (renal osteodystrophy), osteomalacia (softening of adult bones), and rickets (in children and in forms where Vitamin D processing is impaired), as well as low calcium levels due to underactive parathyroid glands (hypoparathyroidism).

The treatment is commonly used during phases when symptoms become more noticeable and may assist with maintaining functional stability. The medication supports patients during episodes of heightened discomfort and helps with managing symptoms that interfere with daily comfort. This focus on mineral stability is commonly used to help with symptoms of systemic imbalance, such as muscle cramps, and supports general well-being during symptomatic phases.


Quick Fact: Supports Bone and Muscle Discomfort

Alfacalcidol Teva provides supportive relief to manage chronic aches and weakness associated with mineral imbalances.

Advertisements

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Alfacalcidol Teva — Official Regulatory Information

The eligibility profile for Alfacalcidol Teva is strictly defined by regulatory documents, focusing on existing physiological conditions and patient demographics.

Eligibility Scope Official Regulatory Statement
Populations for Whom Use is Contraindicated Patients with hypercalcaemia (high calcium levels), Vitamin D toxicity, hyperphosphatemia, or known hypersensitivity to the active substance or excipients.
Condition-Specific Eligibility Rules Use requires caution in patients with a history of nephrolithiasis (kidney stones) or granulomatous diseases (such as sarcoidosis). Use is restricted in patients taking digitalis glycosides if hypercalcaemia is present.
Age-Related Eligibility Rules Use is not recommended in children under 4 years in some product labeling. Adults and adolescents are the standard indicated age groups, but elderly patients require closer monitoring.
Pregnancy and Lactation Eligibility Status Use is generally not recommended during pregnancy. Breastfeeding should be avoided while receiving treatment.

Eligibility Classifications (High-Level)

Classification Regulatory Basis
Eligibility Severity Classification Contraindicated (e.g., hypercalcaemia), Not Recommended (e.g., pregnancy), Use with Caution (e.g., sarcoidosis).
Eligibility-Context Constraints Mineral status-dependent (must check calcium/phosphate levels); Age-dependent (pediatric threshold); Pre-existing pathology-dependent.

Connection to the overall eligibility profile: Official regulatory documents strictly define who cannot use the medicine by listing absolute contraindications based on pre-existing high mineral levels. Furthermore, the profile defines limited eligibility for specific age groups and requires conditional use for patients with certain comorbidities, such as kidney stone history, to manage potential risks.

Advertisements

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Alfacalcidol Teva is structured around the potential for combined effects that modify systemic exposure or increase the risk of mineral imbalance. All information below is derived strictly from official government regulatory documents.


Contraindicated and Restricted Combinations

Co-administration of Digitalis Glycosides (e.g., Digoxin) is contraindicated if hypercalcaemia (high calcium levels) is present, as this condition significantly increases the potential for cardiac arrhythmias. Use of magnesium-containing antacids or laxatives should also be avoided due to an increased risk of hypermagnesaemia.

Additive Effects and Metabolism

Thiazide diuretics (e.g., Hydrochlorothiazide), calcium-containing preparations, and other Vitamin D analogues may enhance the risk of hypercalcaemia through additive pharmacodynamic effects. Conversely, certain enzyme-inducing anticonvulsants (e.g., Phenytoin, Carbamazepine) lead to the increased metabolism of Alfacalcidol, which may alter its expected exposure profile.

Absorption and Timing Rules

Substances such as bile acid sequestrants (e.g., Cholestyramine) and mineral oil may impair the intestinal absorption of Alfacalcidol. To mitigate this effect, a mandatory administration separation is required: Alfacalcidol must be administered at least 1 hour before, or 4 to 6 hours after the intake of these agents.

Alfacalcidol also increases the serum concentration of aluminium from co-administered aluminium-containing preparations, which is a heightened concern for patients with renal impairment.

Advertisements

Mechanism of Action

The action of Alfacalcidol Teva is centered on the biological process of providing the active hormone for mineral balance, bypassing a key renal activation step. This mechanism operates across three primary domains:


Single-Step Activation and VDR Agonism

This mechanism involves the drug acting as a prodrug that requires only a rapid single-step conversion in the liver by the enzyme 25-hydroxylase to become the hormone, calcitriol. The resulting calcitriol is an agonist for the Vitamin D Receptor (VDR), triggering a genetic response that modulates mineral transport.


Enhanced Intestinal Mineral Absorption

VDR activation initiates a mechanistic cascade by upregulating the transcription of genes, such as those responsible for the production of Calbindin, in the small intestine and kidneys. This molecular action leads directly to the physiological consequence of enhanced absorption of calcium and phosphate from the diet, while supporting the kidney's ability to conserve these minerals.


Suppression of Parathyroid Hormone (PTH)

The active hormone also targets VDRs in the parathyroid glands, activating a negative feedback loop that directly suppresses the synthesis and release of Parathyroid Hormone (PTH). This systemic effect acts via VDR activation to suppress PTH secretion, modulating the hormonal drive for mineral loss from the bone.

Advertisements

Dosage and Administration Information

How to Use Alfacalcidol Teva

Alfacalcidol is used according to highly individualized prescribing principles that govern its administration route, dosage, and frequency, based on the patient's biochemical response. The medicine is available for oral administration as capsules, tablets, or drops, and for intravenous (IV) injection in specialized settings such as dialysis.

Dosing and Titration

The dose of alfacalcidol is not fixed and must be carefully individualized, reflecting its narrow therapeutic margin. Treatment typically begins with a set initial dose that is then adjusted (titrated) according to plasma calcium levels. For adults, the general initial dose is 1 mcg per day, although a lower dose of 0.25 mcg per day may be used for patients with chronic renal impairment not yet on dialysis. Dosing adjustments, which occur in increments of 0.25 mcg to 0.5 mcg, are made at intervals of two to four weeks.

Administration Context and Frequency

Oral doses can be administered with or without food. Most patients take the medicine once daily. However, for patients receiving dialysis, an intermittent dosing schedule (e.g., two or three times per week) may be employed. A fundamental instruction is the necessity of adequate daily calcium intake (e.g., 800 mg to 1000 mg per day) for the medication to achieve its intended effect.

Procedural Adjustments

The protocol includes specific steps for dose management. If a patient experiences hypercalcaemia, the medicine must be stopped until mineral levels normalize, and then restarted at half the last administered dose. Standard protocol for a missed dose involves taking it as soon as possible, but the protocol prohibits doubling the dose to make up for the omission.

Advertisements

Recent Clinical Evidence

Evidence for Use in Chronic Kidney Disease (CKD) and Related Bone Disorders

Research explores the role of Alfacalcidol Teva in adults with CKD, including those on hemodialysis, primarily through Randomized Controlled Trials (RCTs) and meta-analyses. These studies monitored patient outcomes over time, focusing on shifts in Parathyroid Hormone (PTH) concentration and the tracking of serum calcium and phosphate levels. While studies reported measured changes in these mineral markers, evidence remains limited regarding long-term, complex endpoints such as fracture risk and cardiovascular events, with findings often being mixed or heterogeneous across cohorts.


Evidence for Use in Hypoparathyroidism

Clinical trials and observational studies have examined Alfacalcidol Teva’s role in patients with hypoparathyroidism. Research focused on achieving and maintaining stable serum calcium levels and tracking associated markers like serum phosphate and calcium in the urine (hypercalciuria). Findings describe patterns where treatment was associated with a measured shift in serum calcium levels. Due to the rarity of the condition, there is a lack of large, long-term RCTs to establish the durability of the response over many years.


Evidence for Use in Osteomalacia and Rickets

The foundation for use in bone conditions involving impaired mineralization, such as osteomalacia in adults and rickets in children, is supported by consensus from clinical experience and multiple trials. Research monitored changes in mineral deficits (calcium and phosphate) and related physical outcomes. Findings show treatment was associated with measured changes in mineral levels. Current research provides limited insight into long-term comparative evidence against all available newer therapies.


Research Gaps and Uncertainty

Beyond the primary indications, research has explored the role of Alfacalcidol Teva in studies of physical function in older adults. However, findings were mixed regarding major clinical outcomes like the reduction in fall frequency. The existing evidence base highlights that a key uncertainty involves the relationship between measured biochemical changes and long-term hard clinical outcomes. Certainty remains low for making broad statements about fall risk, and comparative evidence is lacking for many long-term endpoints.

Key Studies & References

  1. Systematic review of the benefits and harms of calcitriol and alfacalcidol for fractures and falls
  2. Rickets - StatPearls - NCBI Bookshelf
Advertisements

Frequently Asked Questions (FAQ)

Common questions about Alfacalcidol Teva (FAQ)

Q: Does Alfacalcidol Teva help with calcium levels?

A: According to official regulatory documents, the primary purpose of this medicine is the regulation of calcium and phosphate metabolism. It is specifically indicated for managing conditions that involve a disturbance in mineral balance, such as low calcium levels, also known as hypocalcaemia.

Q: What are the most common things people feel when they first start taking it?

A: Common effects documented in official sources include headache, dizziness, nausea, vomiting, abdominal pain, and skin reactions. Regulatory information notes that the most significant adverse effect, high calcium levels (hypercalcaemia), is often observed early in the course of treatment or during dose adjustments.

Q: How long does it typically take before Alfacalcidol Teva starts to show effects?

A: The time it takes to see the effects of this medicine can vary, as dose adjustments are commonly made every two to four weeks based on blood test results. The active form of the medicine, calcitriol, has been observed to reach its highest concentration in the blood about 8 to 18 hours after an oral dose.

Q: Can Alfacalcidol Teva be used by people with a history of kidney stones?

A: Regulatory documents state that use requires caution in patients with a history of nephrolithiasis (kidney stones). This is because Alfacalcidol regulates mineral balance, and its effects could potentially influence calcium levels in a way that is monitored closely.

Q: Can Alfacalcidol Teva be crushed or chewed if it is a capsule?

A: For the oral capsule form of the medicine, official administration advice typically describes the need to swallow the capsule whole with water. The capsules are generally not designed to be opened, crushed, or chewed.

Q: Can people with liver problems use Alfacalcidol Teva?

A: This medicine is described as requiring a single metabolic step in the liver to become fully active. Official documentation advises that use requires caution in patients who have a history of liver diseases or conditions.

Q: Are there specific foods or drinks that should be avoided while taking Alfacalcidol Teva?

A: Official instructions state that oral doses can be taken with or without food and/or drink. The medicine's official instructions note the necessity of ensuring adequate daily calcium intake (e.g., 800 mg to 1000 mg per day) for the medicine to work as intended.

Q: Is it normal to feel thirsty or have a dry mouth while using this medicine?

A: Increased thirst and dryness of the mouth are symptoms described in regulatory documents as possible signs of hypercalcaemia (high calcium levels). Hypercalcaemia is a common adverse reaction associated with this type of medicine.

Q: Is it true that Alfacalcidol Teva can affect the amount of phosphate in the blood?

A: Yes, official regulatory documents describe the medicine's core function as a regulator of calcium and phosphate metabolism. It enhances the absorption of both minerals, and having high phosphate levels (hyperphosphataemia) is a documented risk.

Q: Is Alfacalcidol Teva considered a long-term treatment?

A: The medicine is generally used to treat chronic, or long-term, conditions involving mineral imbalance. Official monitoring guidance refers to establishing maintenance doses and continued monitoring throughout the duration of therapy, suggesting a potentially long-term use.

Q: Is there a link between Alfacalcidol Teva and an increased risk of nausea or stomach upset?

A: Yes, regulatory documentation lists both nausea and abdominal pain (stomach upset) as Common adverse effects of the medicine.

Q: Is Alfacalcidol Teva safe to use during pregnancy or while breastfeeding?

A: Use of Alfacalcidol Teva is generally not recommended during pregnancy. This is due to the potential risk of hypercalcaemia (high calcium) in the mother, which may lead to congenital disorders in the baby. Additionally, breastfeeding should be avoided as the medicine may pass into human milk.

Q: What if I'm taking other calcium supplements; does that change anything with Alfacalcidol Teva?

A: Taking calcium-containing supplements concurrently may enhance the risk of hypercalcaemia (high calcium levels) through additive effects. Official guidance indicates that mineral levels are required to be monitored more closely when these preparations are used together.

Q: Do patients typically have to change their diet when taking Alfacalcidol Teva?

A: Official instructions emphasize the necessity of ensuring adequate daily calcium intake (e.g., 800 mg to 1000 mg per day) for the medication to work properly. No formal change to the entire diet is required beyond managing this necessary calcium component.

Q: How quickly does Alfacalcidol Teva leave the body?

A: Regulatory documents indicate that the biological half-life of Alfacalcidol itself has been estimated to be approximately 3 hours in the presence of reduced kidney function. However, its active form, calcitriol, remains measurable for at least 48 hours.

Q: Why is it important to have regular blood tests while taking this medicine?

A: Regular blood tests (monitoring serum calcium and phosphate) are commonly employed because the medicine has a narrow therapeutic margin (a small difference between the effective dose and the harmful dose). This monitoring is documented as necessary to help guide dose adjustments and manage the risk of hypercalcaemia (high calcium levels), which carries a risk of serious long-term outcomes like kidney calcification.

Q: Has Alfacalcidol Teva been studied in children?

A: Yes, official regulatory documents confirm its use in children. The documents provide specific dosing information based on the child’s body weight and list indications such as rickets in children and neonatal hypocalcaemia.

Q: What should I know about taking Alfacalcidol Teva and water pills (diuretics)?

A: Thiazide diuretics (a type of water pill) may enhance the risk of hypercalcaemia (high calcium levels) through additive effects. Official guidance indicates that calcium levels are required to be monitored more closely when these two types of medicines are used concurrently.

Q: Can Alfacalcidol Teva cause headaches?

A: Yes, official documentation lists Headache as a Common adverse effect of the medicine.

Q: Can I take Alfacalcidol Teva with other vitamins?

A: Official documents specifically warn against combining Alfacalcidol with other Vitamin D analogues as this combination may increase the risk of hypercalcaemia (high calcium levels). No specific warning is given for other common vitamin types.

Q: What kind of research is available on Alfacalcidol Teva?

A: Research exploring the use of Alfacalcidol Teva includes studies such as Randomized Controlled Trials (RCTs), meta-analyses, and observational studies. This research has examined patient outcomes and changes in mineral markers across the approved uses of the medicine.

Q: Do official documents mention anything about Alfacalcidol Teva causing pain in muscles or joints?

A: Official documentation lists Musculoskeletal pain as an Uncommon adverse effect. Additionally, muscle pain and bone pain are noted as potential signs of having too much calcium or phosphate in the blood.

Q: What are the known drug interactions related to how the body processes Alfacalcidol Teva?

A: The metabolism of Alfacalcidol may be increased by certain enzyme-inducing anticonvulsants (such as Phenytoin and Carbamazepine). This increased metabolism can alter the expected exposure profile of the medicine in the body.

Q: Are there certain groups of people who might need a different monitoring schedule?

A: Official documentation highlights that the monitoring of serum calcium and phosphate levels should be especially close for specific groups. These groups include children, elderly patients, patients with reduced kidney function, or those receiving high doses.

Q: Is the onset of action different for Alfacalcidol Teva compared to active Vitamin D?

A: Yes, the onset of action is different because Alfacalcidol requires an initial activation step in the liver. Due to this process, the active form, calcitriol, reaches its highest concentration in the blood around 8 to 18 hours after an oral dose of Alfacalcidol, which is slower than when calcitriol itself is taken directly.

Advertisements

How should Alfacalcidol Teva be stored and disposed of?

How to Store and Dispose of Alfacalcidol Teva?

The storage and disposal instructions for Alfacalcidol Teva are specified in the official labeling to maintain the product's quality and ensure safety.


Storage Requirements

Item Official Requirement
Temperature/Conditions Some labels state no special storage conditions are required; others specify storage at room temperature (15 C to 25 C) and to protect from light.
Protection Must be stored out of the sight and reach of children. Must be kept in the original container to maintain integrity.
Handling Do not freeze (especially liquid formulations). Do not use after the expiry date printed on the packaging.

Disposal Instructions

Any unused or expired Alfacalcidol Teva must be discarded properly. Official guidance specifies that the medicine should not be thrown away in household waste or wastewater. Disposal of unused product and waste material must be carried out in accordance with local requirements established for pharmaceutical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Alfacalcidol Teva found in:

A-Z Index: