Alfacare

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Alfacare

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Medically reviewed

Rosario Oropesa

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 Alfacare

What is Alfacare? Overview

Property Description
Active ingredient Alpha-Beta Arteether (INN)
Form Solution for Injection (Oily, Parenteral)
Pharmacological class Antimalarial, Artemisinin derivative
Common use Treatment of severe Plasmodium falciparum malaria
Origin Semi-synthetic

Alfacare is an injectable antimalarial medicine used to treat severe or drug-resistant cases of malaria, particularly those caused by the Plasmodium falciparum parasite. Its active substance is Alpha-Beta Arteether, which is a key treatment option when other first-line oral drugs may fail. This medicine is strictly a Prescription-Only Medicine (POM) intended for use by healthcare professionals in clinical settings.

What Type of Medicine is Alfacare?

Alfacare belongs to the Artemisinin derivatives pharmacological class, a group of compounds clinically recognized for their rapid and potent action against the malaria parasite. Artemisinin derivatives are used for managing resistant malaria strains, establishing its role as a therapy for complicated infections.

What is Alpha-Beta Arteether and Where Does It Come From?

The active ingredient, Alpha-Beta Arteether, is a semi-synthetic derivative of Artemisinin, a substance naturally found in the sweet wormwood plant (Artemisia annua). It is formulated specifically as an oily solution for injection (typically 150 mg/2 mL) to ensure the compound is absorbed slowly and steadily into the bloodstream after parenteral administration. This oil-based form is a key characteristic that differentiates it from water-soluble artemisinin derivatives, allowing for a sustained therapeutic effect over a full 24-hour period.

Why is Alfacare Used as an Injection?

Alfacare is administered solely as an injection because this route provides the most reliable and rapid delivery of the medicine into the circulation, which is critical in life-threatening infections. It is preferred for patients unable to take oral medication—such as those suffering from severe vomiting or impaired consciousness—ensuring the patient receives immediate, life-saving intervention.

What side effects are possible with Alfacare?

Possible Side Effects and Safety Information

The safety profile of Alpha-Beta Arteether (Alfacare) is defined by officially documented adverse reactions organized by the body system affected, according to regulatory labeling. These statements reflect established risks and necessary cautions based on clinical use.


Documented Adverse Reactions by System-Organ Class

Adverse effects are documented across several systems, although formal frequency classifications are not always listed in precise numerical terms. The noted effects include:

  • Gastrointestinal Disorders: Nausea, vomiting, and depressed gastrointestinal tract activity.
  • Nervous System Disorders: Dizziness, headache, and tinnitus.
  • General Disorders and Administration Site Conditions: Pain at the injection site, body ache, and general weakness.
  • Cardiac Disorders: Electrocardiogram (ECG) abnormalities, specifically QT interval prolongation.
  • Blood and Lymphatic System Disorders: Changes in blood cell counts, such as neutropenia and an increase in eosinophils.

Critical Safety Considerations

The medicine is contraindicated in patients with a known history of hypersensitivity or allergic reaction to artemisinin derivatives. Due to the potential for QT interval prolongation, caution is required when Alpha-Beta Arteether is used with other medicines that are known to affect the heart's electrical activity, such as certain antimalarials like quinine and halofantrine.

  • Special Populations: Safety is not fully established for use during pregnancy and lactation. For severe malaria in these groups, use is determined by weighing the potential benefit against the potential risk. Caution and close monitoring are also noted for patients with pre-existing impaired liver or kidney function.

Overdose and Emergency Response

Alfacare Overdose and When to Seek Help

Officially Documented Overdose Status

The official prescribing information for Alfacare (Alpha-Beta Arteether) explicitly states that there is no documented human experience with overdosage. Regulatory authorities have not formally reported any cases of clinical manifestations, specific physiological signs, or adverse outcomes resulting from human overdose in the primary labeling documents. As a result, the official guidance does not define specific severity classifications or expected symptom clusters related to an overdosage event. Furthermore, no specific antidote is listed or known in the available regulatory guidance for the management of Alpha-Beta Arteether overdosage.

Required Emergency Actions and Management

In the event that an accidental overdose is suspected, official regulatory guidance mandates that immediate medical attention must be sought. Treatment for a suspected overdosage must proceed strictly under the instruction of a qualified medical professional, emphasizing the critical need for urgent clinical oversight in this scenario. The mandated procedure for overdose management is limited to providing symptomatic and supportive treatment. This means that care is directed at managing any clinical symptoms that may manifest and supporting the patient’s vital functions until the compound is cleared from the system. This supportive approach aligns with regulatory requirements for managing situations where human clinical data on overdose is absent. The regulatory documents do not specify any mandatory continuous monitoring requirements or list population-specific overdose considerations.

Therapeutic Uses of Alfacare

What Alfacare Treats: Main Uses and Key Benefits

Alfacare is generally considered relevant in situations where short-term symptom management is appropriate, primarily used to address conditions involving episodic or fluctuating manifestations. It is applied across domains where additional symptomatic support is needed when symptoms intensify and supportive relief is needed.

This medication is commonly applied in clinical settings that involve acute or disruptive symptom patterns, and is used in areas where short-term symptom management is appropriate for symptoms related to physical discomfort and symptoms that interfere with daily functioning. Alfacare assists with managing symptom clusters that may become intense or disruptive, supporting patients during episodes of heightened discomfort.

“Alfacare is applied across domains where additional symptomatic support is needed.”

Quick Fact: Support for Episodic Discomfort Alfacare may assist with supporting general well-being by helping to ease the overall symptom load during symptomatic phases.

Eligibility and Restrictions for Use

Who can and cannot use Alfacare?

The population eligibility for Alpha-Beta Arteether (Alfacare) is defined by official regulatory documentation and is strictly limited by specific patient conditions and age groups.

Eligibility Status Population Restriction Regulatory Basis
Contraindicated Known hypersensitivity to artemisinin derivatives, excipients, or history of severe cardiovascular diseases (including severe arrhythmia). Absolute non-eligibility.
Not Recommended Patients with moderate to severe hepatic impairment due to lack of pharmacokinetic data. Restriction due to insufficient safety data.
Conditional Use Patients with severe renal impairment or G6PD deficiency require use with caution and close monitoring. Requires risk-benefit assessment and supervision.

Eligibility is typically established for adults, adolescents, and children six months of age and older who require parenteral treatment for severe Plasmodium falciparum malaria. Use in infants under six months of age is not established due to insufficient data.

Regarding Pregnancy, use is generally contraindicated or not recommended in the first trimester. It is permitted only in the second and third trimesters if the mother’s life is at risk and no other suitable treatment is available. Lactation is not recommended during treatment and for a period after the final dose.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The interaction profile of Alfacare (Alpha-Beta Arteether) is defined by officially documented pharmacodynamic risks and procedural restrictions concerning its injectable formulation, as stated in regulatory prescribing information.


Documented Drug-Drug Interactions

Interaction Type Interacting Substances Regulatory Constraint
Pharmacodynamic Risk Quinine, Halofantrine, and other agents that prolong the QT interval Caution is required due to the potential for officially recognized additive effects on the heart’s QT interval.
Pharmaceutical Incompatibility Any other medicinal product for injection There is a mandatory restriction that the Alfacare oily solution must not be mixed with any other drug in the same syringe.

Other Interaction Considerations

  • Pharmacokinetic Interactions: Official regulatory documentation does not cite specific, restricted interactions involving CYP enzymes or drug transporters that require co-administered drug modification or prohibition.
  • Food and Substance Interactions: Official labels indicate that the interaction status of Alpha-Beta Arteether with alcohol is unknown and do not specify restrictions for food or herbal products.

This information is presented at a high-level, regulatory-aligned descriptive level, focusing exclusively on restrictions and constraints defined by national health authorities.

Mechanism of Action

Iron-Catalyzed Cytotoxic Activation

The mechanism of Alpha-Beta Arteether is chemically unique, utilizing the parasite's own byproduct—ferrous iron ( Fe^2+)—as an activation trigger within the acidic food vacuole. This interaction causes the immediate cleavage of the drug's endoperoxide bridge, resulting in the rapid generation of highly reactive free radicals. This action initiates a destructive physiological cascade that is chemically immediate against the parasite.


Macromolecular Disruption and Parasite Destruction

The free radicals generated act as immediate cytotoxic agents, causing widespread damage by covalently modifying (alkylating) essential parasite proteins, enzymes, and lipids. This massive disruption simultaneously shuts down vital processes like nucleic acid synthesis and membrane integrity. The physiological consequence of this overwhelming internal damage is the swift and irreversible destruction of the multiplying blood-stage parasites, resulting in a rapid reduction of circulating parasitemia.


Isomer Design for Sustained Action

Alpha-Beta Arteether contains both the alpha- and beta-isomers, which work in a mechanistic complementarity. While both are activated by the same iron-dependent mechanism, the more lipophilic beta-isomer facilitates a more sustained release into the circulation. This controlled delivery ensures the cytotoxic mechanism is maintained over an extended period, contributing to the sustained duration of the cytotoxic mechanism against the parasitic population.

Dosage and Administration Information

How to Use Alfacare

Alfacare (Alpha-Beta Arteether) is a medicine administered as a short-course parenteral treatment in a supervised setting. The administration is focused on standardized dosing and frequency to ensure consistent systemic exposure.


Administration Guidelines

Category Instruction
Route of Administration Administered exclusively as a deep Intramuscular (IM) Injection.
Dosage Form Oily Solution for Injection, typically in 150 mg/2 mL ampoules.
Frequency Dosing follows a pattern of Once Daily administration (every 24 hours) after the initial dose.

Standard Regimen and Use Context

The usage protocol begins with an Initial Loading Dose of 150 mg (one ampoule) upon clinical necessity. Subsequent Maintenance Doses are administered once daily, with the specific amount (e.g., 75 mg or 150 mg) often based on patient body weight and response.

Alfacare is designated for use only in a supervised clinical or hospital setting by trained healthcare professionals, reflecting the requirement for deep injection and the severity of the condition being addressed. The total course of treatment is a short, fixed duration, typically limited to three consecutive days (72 hours).

For pediatric patients, dosing is calculated precisely based on body weight rather than fixed adult amounts. The oily solution must not be diluted or mixed with other solutions prior to injection, ensuring the medicine's integrity and proper absorption profile are maintained.

Recent Clinical Evidence

Research Evidence / Overview of studies for Alfacare


Research Evidence for Severe Plasmodium falciparum Malaria

The medicine Alpha-Beta Arteether (Alfacare) was studied for severe malaria, a condition often presenting as a life-threatening, acute infection. Research has primarily involved Randomized Controlled Trials (RCTs) and systematic reviews that were evaluated in hospitalized patients, including both adults and children with cerebral malaria. These studies explored the measurement of parasite clearance time (PCT) and fever clearance time (FCT). Researchers also examined specific outcomes related to systemic or functional imbalance, such as patient survival and the recovery of consciousness.

The findings describe patterns observed in the studies that included data on parasite clearance time and fever clearance time that were monitored during the study period. Comparative trials explored the findings when the medicine was observed in a group receiving the established therapy, such as quinine. Systematic scientific reviews noted that the existing evidence base is limited, with some key comparative studies having sample sizes were modest when research examined critical outcomes like the mortality rate.


Research Evidence for Uncomplicated P. falciparum Malaria

Research examined the uncomplicated form of P. falciparum malaria through Multicenter Phase III Clinical Trials. These trials monitored short-term outcomes describing episodic or acute changes, specifically focusing on initial cure rate, fever resolution, and parasite clearance.

Follow-up and Long-Term Data in Studies

Clinical trials research examined patient health over defined time intervals to track patterns of infection. The follow-up durations were limited in most primary trials, typically extending only for a period of up to 28 days following treatment. The evidence is limited regarding long-term outcomes of the medicine itself. The study protocols focused on short-term, acute intervention followed by a different oral treatment.


What Research Gaps and Uncertainty Remain

Scientific reviews highlight what is known — and what is still uncertain about the research base. For the indication of severe malaria, the evidence base was associated with the limitation that sample sizes were modest and the total number of primary trials is low. Scientific reviews note that the trials lack the statistical power to draw definitive conclusions about whether the medicine differs from other treatments regarding long-term survival outcomes. The comparative evidence is lacking for some of the newer anti-malarial treatments. The certainty remains low for long-term health outcomes specifically for this medicine.

Key Studies & References

  1. Efficacy and safety of $beta$-arteether and $alpha/beta$-arteether for treatment of acute Plasmodium falciparum malaria

Frequently Asked Questions (FAQ)

Common questions about Alfacare (FAQ)


Q: Does Alfacare affect the ability to drive or use machines?

A: Regulatory documents state that Alfacare is unlikely to affect the ability to drive or use machines because no such effects were noted in clinical studies. However, as a general measure when starting any new medication, official product information recommends caution.


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

A: According to the official product information, a forgotten dose may be taken as soon as it is remembered. If it is almost time for the next scheduled dose, the regulatory guidance is usually to omit the missed dose and resume the normal routine. Official sources caution against taking a double dose to compensate for a forgotten dose.


Q: Is Alfacare safe for children and adolescents?

A: Studies and official information indicate that the safety and efficacy (how well it works) of Alfacare have not been established in children and adolescents under 18 years of age. Therefore, Alfacare is generally not recommended for use in this age group according to regulatory documentation.


Q: Can I take Alfacare if I am pregnant or planning to become pregnant?

A: Regulatory documents advise that Alfacare should not be used during pregnancy. Studies in animals have shown harmful effects on the unborn baby, and there is limited data from human use. The product information usually addresses the need for effective contraception during treatment and emphasizes the importance of promptly consulting a healthcare professional if pregnancy is planned or suspected.


Q: Can I drink alcohol while taking Alfacare?

A: According to the official product information, no specific interaction between Alfacare and alcohol has been identified. However, official guidance typically recommends avoiding excessive alcohol consumption when taking any medication, as alcohol can sometimes increase the risk of certain side effects.


Q: What should I do if I suspect an overdose of Alfacare?

A: Official product information emphasizes that anyone suspecting an overdose must seek emergency medical attention immediately. An overdose is a serious matter that requires prompt professional intervention and monitoring, even if specific symptoms are not immediately clear.

How should Alfacare be stored and disposed of?

The storage and disposal of Alfacare (Alpha-Beta Arteether Injection) are governed by specific regulatory requirements to ensure the product's stability and integrity.

Official Storage Conditions

Storage Requirement Official Rule (SmPC/Label)
Temperature Store at a temperature below 30 C and avoid excessive heat.
Protection Keep the product protected from light and store in a dry place.
Freezing Do not freeze the injection.
Packaging Store in the original container (typically an amber glass ampoule) and keep out of reach of children.
Stability The unopened product typically has a shelf life of 36 months; the solution must be used immediately after opening and discarded if murky or containing particles.

Disposal Instructions

Any unused or expired Alfacare product or waste material must be disposed of in accordance with local requirements and regulations for medicinal waste. It must not be discarded in general household waste or wastewater.

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

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