Ideenat 150 Tablet

Description of Ideenat 150 (Idelalisib 150 mg) tablet

Ideenat 150 tablet is a phosphoinositide-3-kinase (PI3K) inhibitor comprising of Idelalisib, which is an oral antineoplastic agent. The medicine was designed to attack the PI3K–delta isoenzyme, which is an essential mediator of survival and proliferation in malignancy B cells. The unregulated cell proliferation, as well as the resistance to apoptosis, in many types of hematologic malignancies, occurs after the aberrant activation of this signaling pathway. Idelalisib blocks the activation of PI3K- delta to disrupt the cellular signalling pathways that maintain the viability of tumour cells, inhibiting the progression of a range of selected cancerous hematologic malignancies and improving the disease management of infected persons.

Indications of Ideenat 150 (Idelalisib 150 mg) tablet

The application of idelalisib is directed to the treatment of certain hematologic malignancies; among them, chronic lymphocytic leukaemia (CLL) is a gradually progressing neoplasm that is marked with the concentration of lymphocytes in the lymph nodes. Small lymphocytic lymphoma (SLL) is a non-progressive, non-myelinating lymphoma that is confined to lymph nodes, and causes malignant proliferation of lymphocytes (i.e. the leukocytes), but follicular lymphoma (FL) is another disease in this continuum.

Mechanism of Action of Ideenat 150 (Idelalisib 150 mg) tablet

Selective inhibition of the delta isoform of phosphoinositide -3 -kinase (PI3K delta ) which is an enzyme expressed mostly by B -cells of the adaptive immune system mediates the therapeutic efficacy of Idelalisib. This is an enzyme that coordinates signal transduction cascades that regulate cell proliferation, cell survival and cell migration. PI3K pathway constitute the uninhibited proliferation and resistance of B-cell malignancies through aberrant activation; therefore, Idelalisib inhibition of this signal pathway prevents the growth of malignant B-lymphocytes and promotes their destruction.

How to Consume Ideenat 150 (Idelalisib 150 mg) tablet

Idelalisib is taken orally in tablet. The drug can be administered twice per day either with food or without it depending on the prescriber. The tablet is to be swallowed in entirety using water and not to be crushed or chewed. The response of the patient to the treatment and the general clinical condition determines the duration of the therapy.

Side Effects of Ideenat 150 (Idelalisib 150 mg) tablet

1. Common side effects

• Diarrhea
• Fatigue
• Fever
• Nausea
• Cough

2. Serious side effects

• Severe liver toxicity
• Serious infections
• Severe diarrhea or colitis
• Pneumonitis

3. Rare side effects

• Severe allergic reactions
• Intestinal perforation
• Severe skin reactions

Safety Advice for Ideenat 150 (Idelalisib 150 mg) tablet

Routine medical monitoring should be done to patients who are being treated with Idelalisib; this should include regular evaluation of liver functionality and hematologic variables.

Breastfeeding: Lactation should not be initiated under Idelalisib therapy because the drug may be excreted into breast milk wherein it may be harmful to the nursing child.

Pregnancy: Idelalisib should not be used by pregnant women due to the possible teratogenic effect and the possibility of foetal morbidity.

Alcohol: The alcohol use should be minimised as alcohol consumption with concomitant hepatotoxicity may increase the alcohol intake.

Liver Disease: Patients with already damaged hepatic functions require careful observation, as Idelalisib has the tendency of increasing the hepatic transaminases.

Lung disease: Onset or exacerbation of respiratory symptoms should be immediately reported, Idelalisib is associated with the risk of developing pneumonitis.

Kidney disease: Repeated monitoring of the renal parameters is justified in the course of treatment, to show the possible nephrotoxicity.

Driving: Patients with fatigue or dizziness need to avoid driving or operating machines as they are not able to do it because of the poor psychomotor functioning.

Interaction of Ideenat 150 (Idelalisib 150 mg) tablet

• Drug–Drug Interaction

Ketoconazole × Idelalisib
Co-administration with ketoconazole is also likely to increase Idelalisib plasma concentration by suppressing metabolism via CYP3A, which would increase the chances of adverse drug reaction.

Rifampicin × Idelalisib
Rifampicin tolerance causes metabolic enzyme activation and this causes a significant decrease in the activity of Idelalletib.

Clarithromycin × Idelalisib
Coadministration will potentially increase the Idelalisib plasma levels, which can increase the rate of adverse events.

Warfarin × Idelalisib
Coagulation parameters Monitors are recommended in case of warfarin combination with idelalisib because of an increased bleeding risk.

Carbamazepine × Idelalisib

Carbamazepine stimulates hepatic enzymes of metabolism, which can reduce the plasma concentration of Idelalisib.

• Drug–Food Interaction

Grapefruit

Grapefruit or grapefruit juice should also be avoided because it can decrease the CYP3A activity and hence systemic exposure to Idelalisib.

• Drug–Disease Interaction of Ideenat 150 (Idelalisib 150 mg) tablet

Liver Disease

The hepatic impairment could lead to increased exposure of the drug systemic to the drug, thus enhancing hepatotoxicity. Liver enzyme monitoring should be therefore conducted routinely when the treatment is underway.

Infections:

Idelalisib suppresses the immune system of the cell, which increases the risk of serious bacterial, viral, and fungal infections.

Gastrointestinal Disorders:

Patients who take Idelalisib have been recorded experiencing severe diarrhoea and colitis. Patients who have a history of gastrointestinal disorders should be carefully monitored since they have a high risk of developing enteric complications.

Pulmonary Disease:

Idelalisib can cause pulmonary inflammatory lesion like pneumonitis; patients with underlying respiratory disorders are to be analysed carefully.

Contraindication of Ideenat 150 (Idelalisib 150 mg) tablet

It is contraindicated patient who has a known hypersensitivity response to the active ingredient or any of its excipients. The drug is contraindicated in pregnancy which is due to the possible teratogenic effect on the foetus.

Dosage of Ideenat 150 (Idelalisib 150 mg) tablet

Ideenat 150 tablets dosing schedule is one that is established by the administering physician and is based on the clinical condition and treatment responses of the patient. The dose of the drug is taken twice a day.

Storage of Ideenat 150 (Idelalisib 150 mg) tablet

Storage of the pills is to be under room temperature and should be under extreme heat and moisture. The drug must be stored in its packs and in another location other than where children can access it.

Missed Dose of Ideenat 150 (Idelalisib 150 mg) tablet

In case of a missed dose, the dose is to be given at once provided it is within six hours of time. In case of a longer delay, the missed dose should be avoided and the next dosage scheduled.

Other General Information of Ideenat 150 (Idelalisib 150 mg) tablet

Patients undergoing Idelalisib should have regular clinical cheque-ups where they can determine the success of the therapy and also provide early detection of adverse events. The nutrition diet should be balanced and have appropriate hydration to support the overall well-being in the treatment process. Patients should inform their medical practitioners in time whenever they have persistent diarrhoea and pyrexia and dyspnea.

FAQs of Ideenat 150 (Idelalisib 150 mg) tablet

1. What are the reasons why Idelalisib is a targeted therapy?

Isoenzyme idelalisib specifically blocks phosphoinositide 3-kinase delta (PI3K 6 ) which is mostly expressed in B-cell lymphocytes. This selective inhibition enables this agent to selectively target malignant B-cells and spares normal tissues and thus qualifies to be targeted therapeutic.

2. Is Idelalisib severe diarrhoea-inducing?

Yes. Patients who have been treated with Idelalisib develop severe diarrhoea or colitis. Constant or increasing gastrointestinal symptoms should be followed with a doctor consultation as soon as possible.

3. What is the significance of liver functioning tests when in therapy?

As Idelalisib has the potential to increase hepatic transaminases, frequent examination of hepatotoxicity is advised to identify the early hepatotoxicity and aid in clinical decision-making.

4. Is it true that Idelalisib suppresses the immune system?

Yes. Idelalesib may weaken immune cell function by inhibiting PI3K delta-mediated signalling, which can then predispose a person to getting an infection.

5. Does it use Idelalisib in long-term treatment?

Yes. The continuation of on-going treatment can be over a long period provided the patient is getting clinical benefit and the side effects are kept under control.

Fact Box of Ideenat 150 (Idelalisib 150 mg) tablet

References

• FDA Prescribing Information – Ideenat (Idelalisib)
  https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206545s019lbl.pdf
• National Cancer Institute – Idelalisib
  https://www.cancer.gov/about-cancer/treatment/drugs/idelalisib
• DrugBank – Idelalisib
  https://go.drugbank.com/drugs/DB09054
• European Medicines Agency – Ideenat Product Information
  https://www.ema.europa.eu/en/documents/product-information/Ideenat-epar-product-information_en.pdf