Imunofar

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Medically reviewed

Marina Burgos

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 Imunofar

Property Description
Active ingredient Cyclosporine (Ciclosporin)
Form Soft Gelatin Capsules, Oral Solution, Intravenous Injection
Pharmacological class Immunosuppressant Agent, Calcineurin Inhibitor
General purpose Immune suppression, organ rejection prevention
Origin Synthetic derivative of a fungal metabolite

What is Imunofar and Its Active Composition?

Imunofar is a powerful, prescription-only medication whose single active component is the substance known as Cyclosporine (or Ciclosporin). This is a critical single-component product belonging to a class of medicines intended to modify the body's defensive reactions. Chemically, Cyclosporine is defined as a complex cyclic polypeptide, a large, ring-shaped molecule. While its structure is based on a substance originally isolated from the fungus Beauveria nivea, the medicine used in clinical treatment is a highly purified, synthetic derivative. The substance is clinically recognized for its essential use in medical contexts requiring immune suppression.


Imunofar's Drug Class: A Calcineurin Inhibitor

Imunofar is primarily classified as an Immunosuppressant Agent, belonging specifically to the highly targeted class of Calcineurin Inhibitors. This classification signifies that the drug's purpose is to precisely and intentionally reduce the strength of the body's immune response. The medication is presented in various common dosage forms for different routes of administration, including Soft Gelatin Capsules, Oral Solution, and Intravenous Injection. Since the active component, Cyclosporine, is highly lipophilic (fat-binding), specialized vehicles like oil-based excipients are often incorporated into the oral formulations to ensure the substance is consistently absorbed into the body, a key characteristic of its design. Its mechanism involves the potent inhibition of the calcineurin enzyme pathway.


What is the General Purpose of This Immunosuppressant?

The general purpose of Imunofar is to achieve selective immune suppression by muting the body’s inappropriate or aggressive immune activity. It works by targeting the key organizing cells of the defense system, the T-lymphocytes (T-cells), and blocking a critical enzyme called calcineurin that these cells need to fully activate and multiply. This targeted action is fundamental in clinical settings, such as preventing the immune system from rejecting a transplanted organ (e.g., a kidney or heart transplant), or to halt the damaging attacks against the body’s own healthy tissues seen in certain severe autoimmune diseases.

Regulatory References

  1. NIH StatPearls Article

What side effects are possible with Imunofar?

Possible Side Effects and Safety Information

The safety profile of Imunofar, an immunosuppressant, is characterized by effects reflecting both systemic immune modulation and direct organ toxicity, documented across multiple system-organ classes in regulatory labeling.

Serious Adverse Reactions

The use of this medication is associated with an increased risk of Serious Infections (including viral, fungal, and opportunistic types) and the development of Malignancy, such as lymphomas and skin cancers. Other officially documented serious adverse reactions include Liver Failure, Seizures, and conditions like Polyoma Virus-Associated Nephropathy (PVAN).

Common and Dose-Dependent Effects

The most frequently reported adverse reactions, categorized as Very Common (ge10%) in clinical trial summaries, affect the kidneys and the vascular system: Nephrotoxicity (renal dysfunction) and Systemic Hypertension (high blood pressure). Hyperlipidemia (high blood fats), Tremor, and Headache are also commonly listed.

Safety Pattern: Regulatory documents explicitly state that the risk of both renal dysfunction and hypertension increases with both the daily dose and the duration of therapy.

Other Common Reactions include Hypertrichosis (excessive hair growth), Gingival Hyperplasia (gum enlargement), and various Gastrointestinal Disturbances.

Safety Considerations and Restrictions

Population Safety Notes: Caution is required when the medicine is used in older adults due to the higher likelihood of pre-existing conditions (renal, hepatic, or cardiovascular). The drug is generally advised against during pregnancy and lactation due to potential serious effects on the infant.

Restrictions: For non-transplant indications, the medicine is contraindicated in patients with conditions such as uncontrolled hypertension or abnormal renal function (except for specific indications). Regular monitoring of blood pressure, kidney function, and drug concentration is a documented requirement of use.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory information describes the overdose profile of Imunofar (Cyclosporine) based on systemic toxicities and mandated immediate actions. Overdose is primarily associated with high blood concentrations leading to significant, documented injury to the renal system (nephrotoxicity) and the hepatic system (hepatotoxicity).

Documented Manifestations and Severe Outcomes

Symptoms reported in regulatory documents include vomiting, headache, drowsiness, rapid heart rate (tachycardia), peripheral edema, and jaundice. Laboratory findings will show elevations in serum creatinine, BUN, and liver enzymes. Severe outcomes reported include seizure, liver failure, and documented fatal outcomes in cases of severe acute exposure. Elderly patients and pediatric patients may be documented as more susceptible to these toxicities.

When to Seek Urgent Help and Official Management

Immediate medical attention must be sought for any suspected overdose or ingestion exceeding the prescribed dose. Contact emergency services immediately if severe symptoms are observed. Regulatory guidance mandates symptomatic and supportive treatment, as no specific antidote is known for Cyclosporine overdose. Management procedures may involve gastric lavage or activated charcoal administration to limit absorption. Continuous hospital monitoring of renal function, hepatic function, and drug blood levels is required.

Therapeutic Uses of Imunofar

The therapeutic goal of this medication is to manage symptoms related to inflammatory or irritative states and systemic imbalance. The medication is applied across domains where additional symptomatic support is needed to address these issues. Imunofar is relevant in conditions characterized by periods of heightened symptoms, which may include managing symptoms related to physical discomfort, stiffness, or generalized fatigue.

The medication is considered relevant for patients requiring supportive relief from symptoms related to systemic imbalance.

It is commonly used across conditions involving episodic or fluctuating manifestations, applied in addressing symptom clusters that may become intense or disruptive. Imunofar provides supportive relief when symptoms interfere with routine activities.

“It helps manage the intensity of symptoms when they become more noticeable, and may assist with maintaining functional stability during difficult episodes.”

Quick Fact

Quick Fact: Is Applied to Address Symptoms that Interfere with Daily Functioning

The medication contributes to easing the overall symptom load and may assist with maintaining functional stability.

Regulatory References

  1. NIH MedlinePlus overview of immunomodulatory agents

Eligibility and Restrictions for Use

Official Eligibility Profile for Imunofar (Cyclosporine)

Regulatory documents establish strict rules defining who is eligible to use Imunofar, based on medical status, age, and physiological condition. Eligibility is determined by official label statements, contraindications, and required cautions, not clinical advice.

Absolute Contraindications and Non-Eligibility

Classification Rule
Prohibited Use Patients with known Hypersensitivity to Cyclosporine.
Non-Transplant Contraindications Uncontrolled Hypertension, existing Malignancy (Cancer), or severe Abnormal Kidney Function.

Restricted and Age-Specific Use

Population Group Eligibility Status
Hepatic or Renal Impairment Caution Required; continuous monitoring of organ function is mandatory.
Pediatric Non-Transplant Safety and Efficacy Not Established for Rheumatoid Arthritis or Psoriasis.
Pregnancy/Lactation Risk/Benefit Decision; use in pregnancy only if benefit justifies risk. Drug is excreted into human milk.

Use also requires caution in patients with pre-existing infection, Hyperkalemia, Gout, or Seizure Disorders.

What should I know about interactions with other medicines?

The interaction profile of Imunofar (Cyclosporine) is highly influenced by its regulatory-documented involvement with major drug metabolism and transport systems, which can significantly alter the drug's concentration in the body.

Regulatory agencies have formally established combinations that must be avoided (contraindicated). These include the herbal product St. John’s Wort, which severely reduces Imunofar plasma levels, and certain cholesterol-lowering medicines like Simvastatin and Pitavastatin, as their exposure is drastically increased, raising the documented risk of toxicity. Other contraindicated medicines include Aliskiren, Bosentan, and Dabigatran. Additionally, consumption of Grapefruit or Grapefruit Juice is prohibited as it interferes with metabolism and increases Imunofar concentrations.

The drug's metabolism is influenced by the CYP3A4 enzyme. Inhibitors of this enzyme (such as certain Macrolide antibiotics or Azole antifungals) are officially documented to increase Imunofar exposure. Conversely, Inducers (such as Phenytoin or Rifampicin) are documented to decrease exposure, risking lack of effect. Imunofar also inhibits the P-glycoprotein transporter, which increases the exposure of co-administered drugs like Digoxin. Finally, combining Imunofar with other agents noted to cause kidney damage, such as NSAIDs or Aminoglycosides, substantially increases the documented risk of nephrotoxicity. In specific instances, co-administration may require a time separation, such as administering Sirolimus four hours after Imunofar.

Mechanism of Action

Modulating Intracellular Signaling Master Switches

The drug exerts its mechanism of action primarily by acting as an inhibitor on key molecular switches—specifically, protein kinases within the cytoplasm of immune cells, targeting pathways such as PI3K/AKT/mTOR. The formation of a drug-protein complex interferes with the enzyme's catalytic function. This interaction suppresses the signals critical for cell activation and survival, resulting in a diminished rate of cellular signaling along these pathways.

Repressing Gene Transcription of Inflammatory Mediators

The cascade continues as the inhibition blocks the activity of major transcription factors, including NF-kappaB, preventing their entry into the nucleus. This molecular event stops the transcription necessary for the mass production of pro-inflammatory chemical messengers (cytokines). This action thereby modulates the release dynamics of inflammatory mediators across the physiological system.

Regulating Systemic Immune Cell Homeostasis

The combined effect of blocked signaling and repressed transcription results in the failure of T-lymphocytes to proliferate effectively. By limiting the growth and expansion of activated T-lymphocytes, the drug leads to a reduction in the proliferation of T-lymphocytes, which results in a moderated systemic immunological response.

Dosage and Administration Information

Imunofar (Cyclosporine) is administered through two officially approved routes: oral (using Soft Gelatin Capsules or Oral Solution) and intravenous (IV). The IV route is generally reserved for patients unable to take the medicine by mouth and must be administered in a supervised clinical setting. The fundamental principle governing its use is achieving stable systemic exposure, which mandates strict adherence to the prescribed dosing schedule.

The standard usage pattern involves dividing the total daily dose into two equal parts, taken twice daily approximately 12 hours apart. For organ transplant therapy, the protocol begins with a high initial phase dose, typically ranging from 10 mg to 15 mg per kilogram of body weight per day. Following this period, the regimen transitions to a long-term maintenance dose that is substantially lower, usually 2 mg to 6 mg/ kg/ day. For non-transplant conditions, the starting dose is often lower, around 2.5 mg/ kg/ day in divided doses.

Proper administration requires adherence to several contextual principles. The oral solution must be diluted immediately before ingestion with an approved liquid like apple or orange juice; established protocols explicitly prohibit mixing it with grapefruit juice. Furthermore, to ensure predictable absorption, the timing and relationship to food must remain consistent each day. Dosage adjustments are required for specific patient groups; for instance, patients with hepatic impairment require a reduction in the starting dose, and use in older adults mandates the lowest approved dose.

Recent Clinical Evidence

Research evidence / Overview of studies

Evidence for Combined Therapy

Research evaluated the primary endpoints related to symptoms of benign prostatic hyperplasia (BPH) using the combination. Studies examined the measurement of urine flow rates and the reporting of discomfort related to the condition.

  • Clinical Trials Overview: Initial randomized controlled trials (RCTs) evaluated the combination against placebo over 12 and 24 weeks.
    • Findings: The primary endpoints for these trials focused on changes in the International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax).
  • Long-term Efficacy: Extended studies, lasting up to 4 years, assessed the long-term changes in IPSS and Qmax.
    • Findings: Research indicated that the combination was associated with stable measurements across the extended period of observation.

Safety and Tolerability

Research has indicated that while the combination was associated with certain measurements, some studies reported adverse events. These reported events often included mild dizziness or temporary gastrointestinal discomfort.

  • Elderly Patients: The dosing was designed to be straightforward, and studies evaluated its use in elderly patients.
    • Reported Safety Profile: Studies examined the long-term safety profile and evaluated the combination's use in chronic management.

Symptom-Specific Analysis

Some participants in trials provided data related to frequency, and an analysis was performed regarding changes. Other research focused on the effects on nocturia (waking up to urinate).

  • Comparative Studies: The latest meta-analysis examined data comparing this combination to monotherapy in relation to symptom relief.
  • Duration of Use: Research evaluated the use of this combination for a minimum of 6 months to assess data.
    • Other Outcomes: Studies also evaluated the data regarding potential long-term events related to BPH complications.

Key Studies & References Lower urinary tract symptoms in men: management (NICE Guideline CG97)

Frequently Asked Questions (FAQ)

Common questions about Imunofar (FAQ)

Q: Is Imunofar safe to use for older people (the elderly)?

A: Official information advises caution when Imunofar is used in older adults. This is due to the higher likelihood of existing conditions affecting the kidneys, liver, or heart. For this group, official protocols describe the necessity of using the lowest approved dose.

Q: Can Imunofar change the results of blood tests?

A: Yes, regulatory documents indicate that Imunofar can affect the results of certain blood tests. The medication is known to be associated with increases in kidney function markers, blood pressure, and blood fat levels. It may also affect mineral levels in the blood, such as potassium and magnesium.

Q: Is there a generic version of Imunofar available?

A: The active ingredient in Imunofar is Cyclosporine, also known as Ciclosporin. Official generic versions containing Cyclosporine have received regulatory approval. However, the specific formulation, such as whether it is a capsule or oral solution, may vary between different products.

Q: Is it possible for Imunofar to cause an allergic reaction?

A: Official product information lists hypersensitivity, which is a severe allergic reaction, to Cyclosporine or any of its ingredients as an absolute contraindication. In clinical reports, reactions such as skin rashes or swelling have been noted, indicating the potential for an allergic response.

Q: Is Imunofar known to cause weight gain?

A: Weight gain is listed in the official safety data as a less common, or rare, adverse reaction reported in association with the use of the drug.

Q: Can Imunofar affect sleep patterns?

A: Yes, according to official safety documentation, difficulty sleeping, known as insomnia, is listed as a common adverse reaction associated with the medication.

Q: Is there a specific time of day Imunofar is supposed to be taken?

A: Regulatory documents mandate that the timing must remain highly consistent each day to ensure predictable absorption. While the drug is generally taken twice daily, official guidance emphasizes the importance of consistent timing.

Q: Are there any known issues with taking Imunofar while breastfeeding?

A: Official product information states that the drug is excreted into human milk. Due to the potential for the medicine to cause serious adverse effects in the infant, regulatory documents state that use is generally advised against during breastfeeding.

Q: What kind of research studies have been done on Imunofar?

A: Research has been conducted on the drug's use for its major approved applications. This includes preventing the rejection of transplanted organs such as kidneys, livers, and hearts, as well as treating severe autoimmune conditions like rheumatoid arthritis and psoriasis.

Q: Does the evidence for Imunofar come from large-scale clinical trials?

A: The clinical evidence supporting the drug's use is drawn from multiple randomized, controlled clinical trials. These studies, which compared the drug against a placebo or other standard treatments, are key elements of the evidence reviewed for its approval across indications.

Q: How soon after stopping Imunofar will it be completely out of my system?

A: The medicine is primarily processed and eliminated by the liver. Based on the drug's established half-life, official pharmacokinetics data suggest that the drug typically takes approximately 2 to 3 days to be fully cleared from the body after the last dose is taken.

Q: Is Imunofar a maintenance medication or only for short-term use?

A: Imunofar is used for both initial, higher-dose therapy and for long-term maintenance treatment, particularly in transplant patients. The total duration of therapy is variable and is determined by the specific approved indication and relevant clinical protocols.

Q: Why do doctors prescribe Imunofar for different types of conditions?

A: The medicine is prescribed for different conditions because its fundamental mechanism of action is to selectively suppress the body's immune response by targeting T-lymphocyte activity. This core action is medically useful in contexts where the immune system is either attacking a transplanted organ or inappropriately attacking the body's own tissues, as seen in various autoimmune diseases.

Q: Does taking Imunofar make you more sensitive to the sun?

A: Official patient information cautions that this medicine may increase sun sensitivity, and official guidance includes the recommendation of protective measures, such as using sunscreen (SPF 30 or higher) and wearing clothing, to avoid prolonged sun exposure.

Q: Does official labeling mention any effects on mood or anxiety?

A: Yes, official safety documentation lists depression as a common adverse reaction reported during use. Anxiety is also noted in less common adverse reaction reports, according to the official labeling.

Q: Do regulatory agencies track long-term safety data for Imunofar?

A: Yes, regulatory documents and research summaries are based on long-term clinical studies. These studies track the drug's safety profile, specifically focusing on risks associated with the duration of therapy, such as chronic kidney toxicity and the development of certain cancers.

Q: Is Imunofar the main therapy or an add-on treatment?

A: The official labeling indicates that the drug can be used either as a standalone therapy (monotherapy) or in combination with other agents. The use as a standalone or combination treatment is determined by the official protocol for the specific condition.

Q: Does Imunofar cause any issues with driving or operating machinery?

A: Patients are cautioned that the medicine may cause effects such as blurred vision or central nervous system issues like tremor and dizziness. These effects could potentially impair the ability to safely drive or operate heavy machinery.

Q: What happens if I forget to take a dose of Imunofar?

A: Official patient guidance describes that if a dose is forgotten, the protocol is to take it as soon as the person remembers. The guidance includes a caution that patients are not to take a double dose to make up for the one that was missed.

Q: What should I do if I accidentally take more Imunofar than prescribed?

A: Regulatory guidance for accidental overdose states that immediate emergency medical attention must be sought. Official instructions also specify contacting a certified Poison Control Center for guidance.

Q: Is it necessary to have routine blood work done while taking Imunofar?

A: Yes, regular monitoring, which includes routine blood work, is a documented requirement for the use of Imunofar. This is essential for checking the concentration of the drug in the body and monitoring key organ functions, particularly the kidneys.

Q: Can children or teenagers be prescribed Imunofar?

A: The medicine is approved for use in specific pediatric and adolescent populations for certain indications, such as organ transplant and some eye conditions. However, regulatory documents state that its safety and effectiveness for other conditions, like pediatric rheumatoid arthritis, may not be established.

Q: Are there reports of long-term side effects from using Imunofar?

A: Studies and regulatory summaries indicate that long-term use is associated with several chronic adverse effects. These include long-term kidney dysfunction (nephrotoxicity), high blood pressure (hypertension), and an increased risk of developing certain cancers, such as non-melanoma skin cancer.

How should Imunofar be stored and disposed of?

How to Store and Dispose of Imunofar?

The storage and disposal of Imunofar (Cyclosporine) are governed by specific requirements outlined in official regulatory documents to ensure product stability and environmental safety.

Official Storage Requirements

Requirement Specific Instruction
Temperature Range Store at controlled room temperature, between 68 F and 77 F (20 C to 25 C), and below 86 F (30 C).
Prohibited Storage Do not refrigerate or freeze the Oral Solution, as this can cause the liquid to thicken or clump.
Stability Period The Oral Solution must be discarded 60 days after the bottle is first opened.
Packaging Rules Keep the medication in the original container, tightly closed, and protect it from excess heat, moisture, and direct light.
Child Safety Mandatory requirement to keep the medicine out of the sight and reach of children and pets.

Disposal Instructions

Unused or expired Imunofar must be discarded according to specialized waste rules. Patients are instructed to utilize official drug take-back programs or authorized collection points, as the medication should not be disposed of in household trash or released into wastewater systems.

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

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