Temola

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Temola

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 Temola

Property Description
Active ingredient Temozolomide
Form Capsule; Intravenous injection
Pharmacological class Antineoplastic agent; Alkylating agent
General purpose Systemic cancer therapy
Origin Synthetic compound

What Type of Medicine is Temola (Temozolomide)?

Temola is a pharmaceutical preparation containing the synthetic compound Temozolomide as its active ingredient, formally classified as an antineoplastic agent (a type of Cytotoxic agent). This classification places it within the realm of systemic cancer therapy. Temozolomide is distinguished from many older agents by its oral bioavailability, a feature that allows for patient flexibility in treatment protocols. More specifically, Temozolomide is an alkylating agent and an imidazotetrazine derivative. As such, the drug belongs to the fundamental class of medicines used to disrupt cellular reproduction.


Composition and Available Drug Forms

The active ingredient is Temozolomide, which is formulated to ensure effective systemic delivery. Temola is supplied in two principal dosage forms: the patient-convenient capsule for oral administration and a specialized formulation for intravenous injection (infusion). This dual availability is a key differentiating factor, enabling practitioners to select the most appropriate route of administration based on the patient's clinical need. The effective absorption of the oral form supports its utility outside of strictly clinical settings.


What is the General Purpose of an Alkylating Agent?

The general purpose of an alkylating agent like Temozolomide is to control the progression of diseases driven by rapid, uncontrolled cell division. The medication functions as a methylating agent by chemically binding to and inducing critical damage to the cell's DNA. This action is designed to trigger programmed cell death (apoptosis) in susceptible cells, ultimately helping to slow the growth associated with these cellular irregularities. This DNA-targeting mechanism acts on malignant cell lines.

What side effects are possible with Temola?

Possible Side Effects and Safety Information

The safety profile of Temola (Temozolomide) is characterized by adverse reactions that are classified by frequency and system-organ class, as documented in official regulatory labeling (e.g., FDA and EMA). The most frequently reported adverse reactions affect the Blood and Lymphatic System, manifesting as myelosuppression (decreased blood cell counts) and the Gastrointestinal System.

Frequency-Classified Adverse Reactions

Adverse reactions that are frequently observed are defined as Very Common (ge 10% incidence). These include fatigue (asthenia), nausea and vomiting, headache, constipation, and alopecia (hair loss). Reactions classified as Common (ge 1% to < 10% incidence) include infections, anemia, allergic reactions, and changes to liver enzymes.

Documented Serious Safety Risks

Official documents highlight several serious adverse reactions, which require specific monitoring. These include Fatal and Severe Hepatotoxicity (liver damage), severe Myelosuppression (Grade 3 or 4 hematologic toxicity), and the risk of developing Secondary Malignancies such as Myelodysplastic Syndrome (MDS) and leukemia. Additionally, the risk of potentially fatal Opportunistic Infections, such as Pneumocystis jirovecii pneumonia (PCP), is explicitly noted, particularly during prolonged treatment phases.

Population and Constraint Notes

The label includes Population-Specific Safety Considerations. For instance, older adults (over 70 years) and females are documented as having an increased risk of developing myelosuppression. The use of Temola is restricted by Contraindications, including known hypersensitivity to temozolomide or dacarbazine, and pre-existing severe myelosuppression. Due to the risk of Embryo-Fetal Toxicity, effective contraception is required for both male and female patients of reproductive potential.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define the overdose profile for Temola based on the anticipated increase in its dose-limiting toxicity: myelosuppression (bone marrow suppression). Overdose-related risks escalate with higher exposure, and specific severe outcomes have been documented.

Documented Overdose Manifestations and Risks

Classification Detail (As per Regulatory Labeling)
Primary Toxicity Increased severity and duration of myelosuppression (bone marrow suppression), including neutropenia and thrombocytopenia.
Serious Outcomes Acute overdosage has been associated with pancytopenia, pyrexia, multi-organ failure, and death.
Dose-Related Risk Clinical data suggests doses exceeding 1000 mg per cycle carry increased risk; doses up to 2000 mg per cycle have been associated with fatal outcomes.

Emergency Actions Mandate

Management of a Temola overdose is strictly supportive in nature. No specific antidote is officially specified. Because of the critical nature of the expected toxicity, immediate medical attention is required upon any suspicion of overdose.

Patients or caregivers must immediately contact a healthcare practitioner, a hospital emergency department, or the regional Poison Control Centre. Continuous monitoring of blood counts is a required procedural measure to manage the resulting hematologic toxicity.

Therapeutic Uses of Temola

What Temola Treats: Main Uses and Benefits

Temola is relevant in contexts marked by increased discomfort or tension, and is considered relevant for the short-term, symptomatic management of various conditions that involve episodic or fluctuating manifestations. The medicine is generally applied in clinical scenarios where short-term symptom management is appropriate and contributes to improved comfort during symptomatic periods. Medications in this category are commonly used to help with symptoms related to physical discomfort or systemic imbalance, which may include aches and pains.

The core benefits of Temola's action focus on easing the overall symptom load. The medicine is applicable across domains where additional symptomatic support is needed, addressing symptom clusters associated with acute or episodic changes, those that become more disruptive during flare-ups, and symptoms related to heightened physiological activity. As part of symptomatic management, it assists with maintaining functional stability when symptoms interfere with routine activities. The therapeutic goal is to support the patient during difficult episodes. The product is a supportive resource designed to help patients cope more steadily with temporary periods of heightened discomfort.

“The product is a supportive resource designed to help patients cope more steadily with temporary periods of heightened discomfort.”

Quick Fact: Relevant for Symptoms that Interfere with Daily Functioning

Regulatory References

  1. NIH MedlinePlus overview of Pain Relievers

Eligibility and Restrictions for Use

This section outlines the populations for whom the use of Temola (temozolomide) is restricted, not recommended, or prohibited, based on official regulatory information.

Contraindications and Prohibited Use

Contraindicated: Temola must not be used in patients with a known history of hypersensitivity (allergic reaction) to the active substance, temozolomide, or to the related compound dacarbazine (DTIC). Use is also contraindicated in patients with severe myelosuppression (severely decreased bone marrow activity).

Pregnancy and Lactation: Temola is generally not recommended during pregnancy due to the risk of fetal harm. It must not be used by women who are breastfeeding as it may pass into human milk. Males and females of reproductive potential are advised to use effective contraception during and for a specified period after treatment.

Restricted Use and Special Considerations

Hematologic Status: Treatment must be temporarily withheld or discontinued if the patient's blood counts fall below specific levels, particularly an Absolute Neutrophil Count (ANC) below 1.5 imes 10^9/ L or a platelet count below 100 imes 10^9/ L. Blood counts must be monitored closely.

Organ Impairment: Caution is required when administering the medicine to patients with severe renal (kidney) or severe hepatic (liver) impairment.

Age and Sex: Pediatric use is not established in all jurisdictions and requires special consideration. Older adults (geriatric patients) and women may be at an increased risk for severe myelosuppression and require close monitoring.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The following section details the documented interaction patterns for Temola (Temozolomide) as described in official government regulatory documents.


Documented Interaction Patterns

Interaction Type Interacting Substance / Category Official Finding
Pharmacokinetic (Exposure Alteration) Valproic Acid Co-administration reduces the oral clearance of Temozolomide, potentially increasing systemic exposure.
Pharmacodynamic (Toxicity Risk) Other Myelosuppressants Increases the risk and severity of myelosuppression (bone marrow suppression).
Food Interaction Food (Oral Capsules) Reduces the rate and extent of absorption, specifically decreasing C max and AUC.

Official Constraints and Population Notes

Temola has specific requirements and cautions based on its interaction profile:

  • Administration Requirement: The oral capsules should be administered in the fasting state to prevent the reduced absorption documented when taken with food.
  • Vaccines: Use with live vaccines is generally cautioned against due to the drug's immunosuppressive effects.
  • Population Cautions: Caution is advised for use in patients with severe hepatic impairment or severe renal impairment due to a lack of clinical data. Elderly patients (over 70 years) and female patients are documented to have a higher incidence of severe haematological toxicity compared to other groups.

Mechanism of Action

How Temola Works

Temozolomide is a prodrug whose mechanism is initiated by a unique chemical cascade that assaults DNA integrity. Upon systemic distribution, the molecule undergoes spontaneous, non-enzymatic conversion to the highly reactive intermediate, MTIC (3-methyl-(triazen-1-yl)imidazole-4-carboxamide). This intermediate acts as a methylating agent, covalently binding to the DNA, primarily at the O^6 position of guanine. This modification creates the critical lesion required for cytotoxicity.

The O^6-methylguanine lesion is recognized as an error by the cell's DNA mismatch repair ( MMR) system, which triggers continuous, unsuccessful repair efforts known as futile cycling. This exhaustive process leads directly to the accumulation of irreparable double-strand DNA breaks and ultimately forces the susceptible cell into apoptosis (programmed death). This cascade results in the physiological consequence of eliminating susceptible cell populations.

The effectiveness of this mechanism is constrained by the presence of the enzyme O^6-methylguanine DNA methyltransferase ( MGMT). High levels of MGMT directly neutralize the O^6-methylguanine lesion before it can engage the MMR system, thereby determining the physiological limits of the drug's action.

Dosage and Administration Information

How Temola is Used: Official Administration Guidelines

The use of Temola (Temozolomide) follows established protocols detailing the route, dose calculation, and cyclical schedule appropriate for this therapy.


Administration Routes and Forms

Temola is utilized via two routes of administration:

  • Oral Administration: Using hard capsules (available in strengths from 5 mg up to 250 mg).
  • Intravenous (IV) Infusion: Using a solution reconstituted from powder (100 mg/vial) administered over a 90-minute period.

Dosing and Scheduling Structure

The dosage for Temola is calculated according to the patient’s Body Surface Area (BSA), expressed in mg/m^2. The medication is administered in a specific, cyclical pattern defined by the clinical phase of treatment.

Treatment Phase Daily Dosing Pattern (28-Day Cycle)
Concomitant Phase 75 mg/m^2 daily for 42 to 49 consecutive days (with radiotherapy).
Maintenance/Refractory Phase 150 mg/m^2 or 200 mg/m^2 daily for 5 consecutive days, followed by a 23-day treatment break.

Key Administration Instructions

For oral use, capsules must be swallowed whole with water and must not be opened, chewed, or dissolved. The medication is generally administered in the fasting state (without food) or consistently relative to meals, often at bedtime. Continuation of the treatment cycle is contingent upon the patient meeting specific hematological criteria, such as adequate Absolute Neutrophil Count and Platelet Count, on Day 1 of the new cycle. For pediatric patients, use is limited to those 3 years of age or older.

Recent Clinical Evidence

Temola: Recent Clinical Evidence

Clinical research has primarily investigated the compound Temola (a nonselective beta-adrenergic antagonist) for its use in patients with elevated intraocular pressure, a major risk factor for conditions such as open-angle glaucoma. It is also used in managing high blood pressure (hypertension).


Efficacy in Ocular Conditions

Controlled multi-center trials have examined the effect of Temola ophthalmic solution in patients with intraocular pressures of 22 mmHg or greater. In these studies, Temola was observed to produce a greater reduction in intraocular pressure compared to common alternative treatments used at higher doses. The onset of this pressure reduction can typically be detected within 30 minutes of a single topical administration, with the maximum effect usually occurring within one to two hours.


Mechanism and Outcomes

While the precise mechanism of Temola's ocular hypotensive action is not fully established, studies suggest its predominant action may be related to reduced aqueous humor formation within the eye. Repeated observations over a year indicate that the intraocular pressure-lowering effect is generally maintained during long-term use. For hypertension, the oral form of Temola has been reported to reduce heart rate and cardiac output.


Ongoing Research

Beyond its established indications, Temola is the subject of ongoing clinical investigation for other potential uses. For example, some phase II studies have explored the effect of a Temola nasal spray in treating epistaxis (nosebleeds) associated with Hereditary Hemorrhagic Telangiectasia (HHT), primarily evaluating its effect on the duration of bleeding episodes.

Frequently Asked Questions (FAQ)

Common questions about Temola (FAQ)

Q: If I miss a dose of Temola, what should I do?

Official guidance indicates that if a dose is missed, a healthcare provider should be contacted immediately to determine the appropriate next step. If a patient vomits after taking the dose, regulatory documents specify that the dose should not be redosed or replaced.

Q: Can Temola be used during pregnancy or breastfeeding?

Official guidance indicates that use during pregnancy is generally not recommended because studies suggest the drug may cause harm to the developing fetus. For breastfeeding, regulatory documents advise against it during treatment and for a period of at least one week after the last dose.

Q: Is Temola safe for older adults to use?

Official warnings note that older adult patients may have a potentially higher risk of developing low blood cell counts, a condition called myelosuppression. Patients in this age group are often closely monitored by their healthcare team.

Q: Is it normal to feel a bit nauseous when first starting Temola?

Yes, regulatory documents list nausea as one of the most common adverse reactions reported in clinical trials. It was reported to occur in over 50% of patients.

Q: Can Temola affect my ability to drive or operate machinery?

Adverse reactions such as fatigue, headache, dizziness, and convulsions have been reported in clinical trials. These effects may impair a person's attention and coordination. Official information advises that if these symptoms occur, patients should use caution.

Q: Can Temola be used by people with kidney problems?

Official prescribing information states that caution should be exercised when the medication is administered to patients with severe kidney problems, also known as renal impairment.

Q: Why is it important to know the condition of my liver before taking Temola?

Official safety documents indicate that severe and sometimes fatal liver toxicity (hepatotoxicity) has been reported with this drug. Due to this risk, liver function tests are necessary at baseline and must be monitored routinely throughout the course of treatment.

Q: Are there any specific foods or drinks to avoid while using Temola?

The medication is often recommended to be taken on an empty stomach to potentially help reduce nausea and vomiting. Official studies show that taking the drug with food can reduce the absorption of the drug into the body.

Q: Why do some people say Temola makes them feel tired?

Fatigue is listed in the official adverse reactions data as a very common side effect. Clinical trial data indicates that fatigue was reported in over 30% of patients using the medication.

Q: Is Temola a controlled substance?

No. Official government records, such as those from the U.S. National Institutes of Health (NIH), show that temozolomide is not classified as a controlled substance.

Q: How often do the serious side effects of Temola occur?

Regulatory documents provide specific frequency data, known as incidence percentages, for both the most common and severe adverse reactions reported during clinical trials.

Q: Is Temola available in generic form?

Yes, the active substance, temozolomide, is available as a generic medicine from various manufacturers. The official regulatory bodies in many regions acknowledge the availability of generic versions in different strengths.

Q: Why is Temola sometimes given with other medications?

The drug is indicated for the treatment of newly diagnosed glioblastoma, a type of brain tumor, and is given concomitantly (at the same time) with focal radiotherapy. This approach is described in regulatory documents as an established part of its official use.

Q: Is Temola a treatment or a cure for the condition it addresses?

Official documents describe Temola as a medication used for the treatment of certain brain cancer tumors, based on its indications. Regulatory information does not describe the drug as a cure.

Q: How long can a person safely use Temola?

The official treatment guidelines define the maximum indicated duration of use as a specific course of cycles. This includes a concomitant phase (e.g., 42–49 days) followed by a defined number of maintenance cycles (e.g., six cycles).

Q: Is Temola known to interact with birth control pills?

Official guidance advises male and female patients of reproductive potential to use effective contraception (birth control) during and after treatment. This is due to the potential for the drug to cause embryo-fetal toxicity.

Q: Do I need special monitoring while I am taking Temola?

Yes, monitoring is required. Regulatory guidance states that a complete blood count should be obtained frequently, often weekly. Additionally, liver function tests are necessary at baseline and throughout the treatment course.

Q: Is it possible to be allergic to Temola?

Yes. The drug is contraindicated (should not be used) in patients who have a history of serious hypersensitivity (allergic) reactions to temozolomide or any other ingredients in the formulation.

Q: Does Temola require special storage conditions?

Yes. Official information states that the capsules should be stored within a specific temperature range, typically between 15 C and 30 C. They must also be protected from moisture to maintain stability.

Q: What are the most common reasons patients stop taking Temola?

The official dosing guidelines specify the clinical criteria that require therapy to be interrupted or discontinued. These reasons include low blood counts (ANC or platelet count) or significant non-hematological toxicity observed during treatment.

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

The official clinical pharmacology data indicates that the average elimination half-life of temozolomide in the blood is approximately 1.8 hours.

How should Temola be stored and disposed of?

Official Storage and Disposal Requirements

Storage Condition Requirement (Capsules) Requirement (Injection Vials)
Temperature Store at 20 C to 25 C (Controlled Room Temperature). Store refrigerated at 2 C to 8 C (prior to reconstitution).
Protection Keep away from excess heat, moisture, and light. Keep in properly labeled containers.

Temola capsules must be kept in the original container and tightly closed to maintain stability. The capsules must not be opened, chewed, or dissolved. If a capsule is damaged, precautions are required to avoid skin or mucous membrane contact with the cytotoxic powder.

The medicine must be stored out of the sight and reach of children.

As a hazardous drug, unused or expired Temola must be disposed of according to local regulations for anticancer waste. It should be taken to an approved waste disposal plant, and release to the environment must be avoided.

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

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