Velactis

Cabergoline

Method of action: Antiparkinsonian, Dopaminergic, Hypoprolactinemic, Other Gynecologicals

Treatment option: Abortion, Pituitary Adenoma, Pain, Galactorrhea, Hyperprolactinemia, Stillbirth, Delivery

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Velactis

Property	Description
Active ingredient	Cabergoline (INN)
Form	Sterile solution for injection
Pharmacological class	Dopamine agonist, Prolactin inhibitor
Common use	Suppression of lactation in veterinary medicine
Origin	Synthetic, ergot derivative

Velactis is a veterinary medicinal product primarily defined as a prolactin inhibitor, whose fundamental purpose is the pharmacological suppression of lactation. This medicine is classified as a dopamine agonist, a specialized category of synthetic compounds that modulate key neurohormonal pathways. Its use is limited exclusively to domestic animals, making it distinct from any Cabergoline products designed for human treatment.

Velactis: Definition and Pharmacological Classification

Velactis is an injectable medicine belonging to the dopamine agonist class, which functions by selectively targeting receptors that regulate hormone release. The active substance, Cabergoline, is a long-acting compound that specifically stimulates D2-dopamine receptors in the pituitary gland, a mechanism documented in pharmacological literature. This signals the gland to reduce the secretion of prolactin, the key hormone necessary for initiating and sustaining milk production, thereby serving its general therapeutic purpose of inducing the inhibition of lactation. This medicine is defined as a Veterinary Medicinal Product.

Composition, Origin, and Pharmaceutical Form

The core component of the medicine is the active ingredient Cabergoline (INN), a potent synthetic derivative belonging to the ergot alkaloid structure. Velactis is supplied as a sterile solution for injection, representing a single-ingredient product designed for maximum purity and controlled delivery. This liquid dosage form utilizes a non-aqueous oily vehicle, which is essential for ensuring the stability and facilitating the sustained, prolonged action of Cabergoline following the injectable route of administration.

Primary Function and Therapeutic Context

The primary function of Velactis is to achieve a controlled, systemic cessation of milk flow, providing an effective hormonal intervention when lactation suppression is required. This medicine achieves its general benefit by directly neutralizing the hormonal driver of milk production, offering a direct mechanism to arrest the lactation cycle. It is used in the specific veterinary context to manage situations where the physiological necessity of lactation must be immediately and effectively reversed or prevented.

What side effects are possible with Velactis?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse reactions and safety characteristics for Velactis (Cabergoline solution for injection), strictly based on government regulatory sources.

Documented Adverse Reactions and Frequencies

Adverse effects reported following the use of Velactis are classified by frequency according to regulatory standards (e.g., European Medicines Agency [EMA] Summary of Product Characteristics [SmPC]).

System-Organ Class	Adverse Reaction	Frequency Classification
General Disorders and Administration Site Conditions	Slight injection site reactions (mostly swellings)	Common (More than 1 but less than 10 animals in 100)
Neurological/Musculoskeletal & General Disorders	Recumbency (inability to stand up)	Serious, Post-Authorisation Report
General/Digestive Disorders	Death (often preceded by recumbency)	Serious, Post-Authorisation Report

Serious Safety Considerations

Serious adverse event reports received post-market include recumbency and, in some cases, death in treated dairy cows. These events generally occurred within 24 hours of administration, with the most frequent period being 8 to 24 hours after the product was administered. This led to the temporary suspension of the marketing authorization in the European Union.

Regulatory Constraints and Precautions

Contraindication: The medicine is formally contraindicated in animals with a known hypersensitivity to the active substance, cabergoline, or to any of the excipients.
Human Handler Precaution: Due to the pharmacological effect (inhibition of lactation) and potential risk, pregnant women, women attempting to conceive, and breastfeeding women should avoid contact with the product. Individuals with a known hypersensitivity to cabergoline should also avoid contact.

Overdose and Emergency Response

The official regulatory profile for Velactis overdose is defined by the pharmacological effects of its active substance, cabergoline. Manifestations are primarily related to dopaminergic hyperstimulation and severe physiological responses observed following high-dose exposure.

Overdose Domain	Officially Documented Manifestations and Risks
Clinical Signs	Transient decrease of appetite, reversible digestive signs such as diarrhoea, and decreased ruminal activity.
Severe Outcomes	Risk of post-treatment hypotension and, in rare circumstances documented in regulatory data, fatal meteorism.
Metabolic	Transient and reversible slight elevation of plasma glucose levels.

When to Seek Help and Emergency Procedures

Immediate medical attention is a mandated action in the event of accidental ingestion, specifically when the exposure involves a child. The treatment strategy described in regulatory documentation is defined as symptomatic and supportive. This approach involves implementing general supportive measures, which include procedures to remove any unabsorbed drug from the system and steps to maintain the patient’s blood pressure, if necessary. The official labeling notes that the parenteral administration of dopamine antagonist drugs, such as metoclopramide, might be considered by medical professionals as part of the management protocol. These statements strictly detail the required response without offering clinical decision-making advice.

Therapeutic Uses of Velactis

What Velactis Treats: Main Uses and Benefits

Velactis is used to help with symptoms related to physical discomfort that involve both pain and inflammation. It is applied across domains where additional symptomatic support is needed, contributing to easing the overall symptom load in situations where patients experience noticeable physiological strain.

Easing Discomfort and Supporting Function

It is relevant in conditions characterized by periods of heightened symptoms, and may be part of symptomatic management for inflammatory discomfort, associated aches, and temporary functional strain. It is used when short-term symptomatic assistance is needed, such as during flare-ups or periods requiring enhanced symptomatic control.

Velactis supports patients during episodes of heightened discomfort and may assist with maintaining functional stability, providing supportive relief when symptoms interfere with routine activities.

Quick Facts

Relief Focus: Symptoms related to inflammatory or irritative states.
Use Context: Applied in clinical settings that involve acute or unstable symptom patterns.
Key Benefit: Supports general well-being during symptomatic phases.

Regulatory References

NIH MedlinePlus overview on pain relievers

Eligibility and Restrictions for Use

The official population eligibility for Velactis is strictly defined by its authorization as a veterinary medicinal product for a single species and life stage, coupled with its current regulatory status in the European Union (EU/EEA).

Eligibility Scope

Eligibility Category	Regulatory Statement
Populations for whom use is allowed (as stated in label)	Cattle (dairy cows), specifically adult cows in the herd management program at the time of abrupt drying-off.
Populations for whom use is contraindicated	Animals with known hypersensitivity (allergy) to cabergoline or to any of the excipients.
Condition-specific eligibility rules	Use is conditional and not recommended for cows that are not free of subclinical mastitis, based on appropriate diagnostic criteria.
Pregnancy and lactation eligibility status	The label states the medicine can be used during pregnancy. Its use is restricted to the time of drying-off (cessation of milking).
Regulatory Restriction (EU/EEA)	The Marketing Authorisation for Velactis is suspended in the EU/EEA. This suspension means the product is currently not permitted for use in this region.

Official Eligibility Structure

The primary eligibility is restricted to adult female cattle at the time of drying-off. While the label contraindicates use for animals with hypersensitivity, the most critical eligibility constraint is the suspension of the product's marketing authorisation by the European Medicines Agency (EMA). This regulatory action, which followed reports of serious adverse events in treated animals, renders all target animals in the EU/EEA currently ineligible for the treatment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Officially documented interaction patterns for Velactis (Cabergoline) are structured around pharmacokinetic and pharmacodynamic classifications provided in government regulatory information. These interactions define mandatory restrictions and specific cautions for co-administration.

Formal Contraindications

The regulatory profile strictly identifies two categories of agents as contraindicated combinations due to interaction risk. The co-administration of Dopamine Antagonists (such as metoclopramide or phenothiazines) is prohibited based on pharmacodynamic antagonism, which would diminish the intended effect of Velactis. Additionally, co-administration with Other Ergot Alkaloids is contraindicated due to the potential for additive toxic effects (ergotism).

Exposure-Modifying Interactions

Caution is required when Velactis is co-administered with Strong CYP3A4 Inhibitors (e.g., specific macrolide or azole antifungals). These agents inhibit the primary metabolic pathway, a pharmacokinetic interaction documented to increase the plasma concentration and overall systemic exposure of Cabergoline.

Additive Pharmacodynamic Effects

Interaction risk exists with other medications that can lower blood pressure. Use with caution is advised with Antihypertensive Agents and Alcohol, as a pharmacodynamic interaction may result in an additive hypotensive effect, increasing the risk of orthostatic hypotension. Furthermore, regulatory documents note that in individuals with Hepatic Impairment, impaired drug clearance may intensify the severity of documented interaction risks.

Mechanism of Action

How Velactis Works: Mechanism of Action

Targeting the Prolactin Secretion System

The mechanism of Velactis begins with its active ingredient, cabergoline, an ergot derivative, which acts as a selective agonist of Dopamine D2 receptors found on lactotroph cells in the anterior pituitary gland . By stimulating these receptors, cabergoline mimics the inhibitory signal of dopamine. This molecular interaction initiates a rapid and substantial suppression of prolactin (PRL) secretion from the pituitary, thereby removing the primary hormonal stimulus required for the maintenance of milk synthesis.

Initiating the Involution Cascade

The resulting swift drop in circulating prolactin levels removes the lactogenic support from the mammary epithelial cells. This hormonal withdrawal triggers and significantly accelerates the physiological cascade of mammary gland involution (regression). The physiological consequences include a reduction in milk synthesis and a subsequent decrease in the volume of milk secreted, which constitutes the drug's action on mammary gland secretory function.

Dosage and Administration Information

The use of Velactis is structured around a highly specific, single-administration protocol delivered exclusively via the intramuscular route. The medicine is supplied as a 1.12 mg/ml solution for injection, with the standardized regimen prescribing a single dose of 5.6 mg of Cabergoline, corresponding to a 5 ml volume of the solution, per animal. This single treatment event defines the entire course of use, as it is not intended for cyclical or long-term administration.

The administration schedule is strictly time-critical. The injection must be performed on the day of drying-off and is required to occur within four hours following the final milking. This specific temporal constraint is a fundamental procedural requirement, defining the only permissible window for the medicine's application.

Due to the solution's non-aqueous formulation, the product requires practical administration constraints. A dry sterile needle must be utilized, and the procedure requires careful attention to avoid the introduction of humidity or water during handling. Furthermore, the usage is restricted to dairy cows at the time of milking cessation and must be implemented as part of a formal program under veterinarian advice. This structural approach ensures standardized administration.

Recent Clinical Evidence

Research evidence / Overview of studies for Velactis

Evidence for use in Chronic Pain Management

Velactis was studied for its use in managing chronic pain, which is one of the conditions marked by functional limitations. The research conducted primarily involves short-term Randomized Controlled Trials (RCTs) and longer observational settings evaluating daily-life functioning. Researchers monitored patient-reported outcomes describing perceived discomfort, such as pain intensity scores, as well as outcomes reflecting daily functioning or activity level in adult populations with moderate non-cancer chronic lower back pain.

Findings describe the measurements recorded during the study periods over the short-term follow-up periods. Some trials described patterns where the pain intensity scores recorded in the group receiving the intervention varied compared to those recorded in the control group. The evidence contributes to understanding symptom patterns over the short term. The research does not determine whether an individual will respond similarly to the group averages. The results apply only to the populations studied, which were primarily adults with non-cancer lower back pain.

Evidence for use in Migraine Prevention

Research has also examined Velactis in the context of migraine prevention, a condition characterized by fluctuating or episodic manifestations. In this area, studies monitored outcomes such as the frequency of headaches and the number of days experiencing migraines, which are outcomes describing episodic or acute changes. Studies report how symptoms evolved in the observed populations over study intervals, which generally consisted of research exploring short-term symptom changes.

Findings were mixed across different study designs and patient groups. A primary research limitation frame for this indication is that the follow-up durations were limited. Subgroup findings are uncertain due to variations in study methodology.

Long-term studies and follow-up

The overall body of evidence includes a combination of controlled trials and observational studies, but the long-term effects are not fully established. Most structured clinical research was studied for short-term defined intervals. Evidence is limited regarding the durability of any changes measured during the study period over many years. Long-term outcomes are not well characterized.

What is still uncertain about Velactis

Several research limitation frames apply across the evidence base for Velactis. In many instances, sample sizes were modest, which means the research can only provide an initial look at patterns observed in the studies. There is limited information for long-term outcomes, and data for certain groups remain insufficient, particularly for older adults or individuals with complex comorbid conditions. The evidence highlights what is known — and what is still uncertain.

Key Studies & References

Frequently Asked Questions (FAQ)

Common questions about Velactis (FAQ)

Q: Is Velactis considered a treatment for hormonal imbalance?

Official product information describes the medicine as an agent for treating hyperprolactinemic disorders in adults. These disorders involve high and abnormal levels of the hormone prolactin, and the drug is a dopamine agonist that helps to modulate this activity. Evidence indicates its use is specifically focused on correcting the overproduction of prolactin.

Q: What are the official warnings about Velactis and my heart health?

Regulatory warnings highlight the risk of specific heart conditions, including cardiac valvulopathy (disease of the heart valves) and pericardial fibrosis (scarring around the heart). Official guidance recommends that a cardiovascular evaluation, including a cardiac echocardiogram, is typically necessary before starting treatment and periodically throughout the treatment period.

Q: Does Velactis interact with common over-the-counter medications or supplements?

While regulatory documents do not list every specific over-the-counter product, they advise caution regarding the co-administration of any other drugs that can lower blood pressure. Use is also generally not recommended with drugs classified as dopamine D2-antagonists. This information defines the types of interactions that should be noted.

Q: What guidance is available regarding Velactis and breastfeeding mothers?

Official regulatory information states that the medicine is avoided for the inhibition or suppression of postpartum physiological lactation due to the risk of serious adverse reactions. For human handlers of the product, official instructions include a precaution that breastfeeding women should avoid contact with the medicine.

Q: Can men use Velactis?

The medicine is indicated for the treatment of hyperprolactinemic disorders (high prolactin levels) in adults. Since these hormonal conditions can occur in both men and women, the treatment is not limited to a single sex.

Q: Where can I find the official patient information leaflet for Velactis?

Official government-published drug information, which includes the patient-facing documentation, is available through federal resources. This information can typically be accessed on the DailyMed website, which is provided by the National Institutes of Health (NIH) and the FDA.

Q: Can I drive a car or operate machinery while taking Velactis?

The official label advises caution regarding activities like driving or operating machinery. This is because the medication may cause orthostatic hypotension, a drop in blood pressure upon standing up. This effect can lead to dizziness or fainting.

Q: What are the non-active ingredients or excipients in the Velactis formulation?

Non-active ingredients, also known as excipients, are listed in the official description of the medicine. While these may vary slightly depending on the manufacturer, common excipients include anhydrous lactose, microcrystalline cellulose, and magnesium stearate. These are used to give the medicine its physical form.

Q: Does Velactis affect blood pressure or heart rate in a notable way?

Yes, official product information indicates that the medication can cause orthostatic hypotension, meaning a significant drop in blood pressure when changing positions. Additionally, palpitation (a noticeable rapid or irregular heartbeat) is listed as a reported adverse reaction in clinical trials.

Q: Is it normal to feel dizzy or lightheaded when first starting Velactis?

Dizziness is listed as a very common adverse reaction, reported in up to 17% of individuals in clinical trials. Lightheadedness is also a commonly reported symptom related to the risk of orthostatic hypotension.

Q: Can Velactis affect my sleep schedule or cause insomnia?

Studies indicate that the medicine can affect sleep patterns. Both insomnia (difficulty falling or staying asleep) and somnolence (unusual sleepiness or drowsiness) have been reported as adverse reactions with an incidence rate of 1% or greater.

Q: Does Velactis carry any specific warnings for mental or behavioral health?

Yes, official warnings exist regarding the risk of impulse control disorders and other compulsive behaviors. These may manifest as new or increased urges, such as pathological gambling or uncontrolled sexual urges.

Q: Can food or certain types of drinks affect how Velactis works?

Official product information states that the medication can be administered with or without food. This indicates that the instructions for taking the medicine are not dependent on mealtimes.

Q: Does Velactis require any specific blood tests or monitoring while in use?

Yes, monitoring is specified in the regulatory label due to the potential for cardiac issues. Regular evaluation for the development of valvulopathy (heart valve disease) using a cardiac echocardiogram is typically noted as necessary at prescribed intervals during the course of treatment.

Q: Is there a generic version of Velactis currently available?

The active ingredient in this medication is Cabergoline. Since Cabergoline is listed as available from multiple manufacturers within official government drug databases, this indicates that generic formulations of the medicine are widely accessible.

Q: What should be done if a scheduled dose of Velactis is missed?

Patient information typically suggests that a missed dose may be taken as soon as it is remembered. However, if it is close to the time of the next scheduled dose, the patient should continue the regular schedule. Patients are cautioned to not take two doses at once.

Q: Is Velactis described as having an impact on body weight?

While the medicine is not directly described as a weight management drug, anorexia (a significant loss of appetite) is listed as an adverse reaction in clinical trials. This effect is associated with weight changes and was reported with an incidence rate of 1% or greater.

Q: Does Velactis have any known impact on fertility?

The medicine is used to restore normal prolactin levels, which can positively affect fertility in patients with hyperprolactinemia. However, nonclinical toxicology data suggests that the active ingredient may cause impaired fertility when administered at high doses to animals.

Q: What are the known symptoms of using more Velactis than described in official instructions?

Official patient information describes potential symptoms if too much of the medicine is used. These may include signs like nasal congestion, syncope (fainting), hallucinations, or orthostatic hypotension (dizziness or low blood pressure).

Q: Are there any specific lifestyle recommendations given to patients using Velactis?

Regulatory information includes recommendations such as changing positions slowly after sitting or lying down to help prevent orthostatic hypotension, which can cause dizziness or fainting. This measure is intended to mitigate the risk of adverse effects.

Q: Is Velactis a federally controlled substance?

Based on federal classifications, the medication is not classified as a controlled substance under the Controlled Substances Act.

How should Velactis be stored and disposed of?

Storing and Disposing of Velactis (Cabergoline)

The official labeling states that the unopened Velactis product does not require any special storage condition and has a shelf-life of 3 years. The product should be protected from contamination by water or humidity during handling.

Once the immediate packaging is first opened, the shelf-life of the solution for injection is strictly limited to 28 days, after which any remaining portion must be discarded.

Required Precautions

Area	Regulatory Requirement
Child Safety	Must be kept out of the sight and reach of children.
Disposal	Unused or expired product must be disposed of in accordance with local requirements.
Environmental Rule	The product and associated waste should not enter water courses due to danger to aquatic life.