Buy Alecinix 150 mg online, Buy Alecensa 150 mg online, Buy Alectinib 150 mg 

Alecinix (Alecensa) Alectinib 150 mg by Beacon Pharmaceuticals is used to treat Non-Small Cell Lung Cancer (NSCLC).

Alecinix is the alternative & generic version of Alecensa by Chugai Pharmaceutical Co. Alecinix is manufactured by Beacon Pharmaceuticals Bangladesh which is the biggest pharmaceutical company in Bangladesh.

Therapeutic Class

Anti-neoplastic preparations, Protein kinase inhibitor

Pharmacology

Alectinib is a highly selective and potent ALK and RET tyrosine kinase inhibitor. In nonclinical studies, inhibition of ALK tyrosine kinase activity led to blockage of downstream signaling pathways including STAT 3 and PI3K/AKT and induced tumor cell death (apoptosis).

Alectinib demonstrated in vitroand in vivo activity against mutant forms of the ALK enzyme, including mutations responsible for resistance to crizotinib.The major metabolite of alectinib (M4) has shown similar in vitropotency and activity.

Based on nonclinical data, Alecensa is not a substrate of p-glycoprotein (P-gp) or breast cancer resistance protein (BCRP), which are both efflux transporters in the blood brain barrier, and is therefore able to distribute into and be retained within the central nervous system.

Dosage

The recommended dose of Alecensa is 600 mg (four 150 mg capsules) given orally, twice daily (total daily dose of 1200 mg). Patients with underlying severe hepatic impairment should receive a dose of 450 mg given orally twice daily (total daily dose of 900 mg).

Alecensa hard capsules should be taken with food, swallowed whole and must not be opened or dissolved.

Administration

Duration of Treatment: It is recommended that patients are treated with Alecensa until disease progression or unmanageable toxicity.

Dose Modifications: Management of adverse events may require temporary interruption, dose reduction, or discontinuation of treatment with Alecensa. The dose of Alectinib should be reduced in steps of 150 mg twice daily based on tolerability.

Alectinib treatment should be permanently discontinued if patients are unable to tolerate the 300 mg twice-daily dose.

Interaction

In vitro studies indicate that neither Alecensa nor its major active metabolite (M4) inhibits CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6 at clinically relevant concentrations. Alectinib and M4 show weak time-dependent inhibition of CYP3A4.

Results from a clinical drug-drug interaction study in ALK-positive NSCLC patients demonstrated that multiple doses of Alecensa had no influence on the exposure of midazolam, a sensitive CYP3A substrate. Therefore, no dose adjustment is required for co-administered CYP3A substrates.

Although in vitro studies indicate that Alecensa is an inhibitor of CYP2C8, physiologically based pharmacokinetic (PBPK) modeling supports that at clinically relevant concentrations alectinib does not have the potential to increase plasma Contraindications

Alectinib is contraindicated in patients with a known hypersensitivity to Alecensa or any of the excipients.

Side Effects

The most common adverse drug reactions were constipation, edema including peripheral, generalized, eyelid, periorbital; myalgia (31% including myalgia and musculoskeletal pain), nausea, increased bilirubin (21% including increased blood bilirubin,

hyperbilirubinemia and increased bilirubin conjugated), anemia (20%, including anemia and hemoglobin decreased), and rash (20%, including rash, rash maculopapular, dermatitis acneiform, erythema, rash generalized, rash papular, rash pruritic and rash macular).

Pregnancy & Lactation

Pregnancy: Women of childbearing potential must be advised to avoid pregnancy while on Alectinib. No clinical studies of Alecensa in pregnant women have been performed. Based on its mechanism of action, Alecensa may cause fetal harm when administered to a pregnant woman.

Female patients or women who are partners of male patients receiving Alecensa, who become pregnant while taking Alectinib or during the 3 months following the last dose of Alecensa must contact their doctor and should be advised of the potential harm to the fetus.

Lactation: It is not known whether Alecensa is excreted in human breast milk. No studies have been conducted to assess the impact of Alecensa on milk production or its presence in breast milk.

Contraception: Female patients of child-bearing potential, or women of child-bearing potential who are partners of male patients receiving Alecensa, must use highly effective contraceptive methods during treatment and for at least 3 months following the last dose of Alectinib

Precautions & Warnings

Interstitial lung disease (ILD)/pneumonitis: Cases of ILD/pneumonitishave been reported in clinical trials with Alecensa. Patients should be monitored for pulmonary symptoms indicative of pneumonitis.

Hepatotoxicity: Elevations in alanine amino transferase (ALT) and aspartate amino transferase (AST) greater than 5 times the upper limit of normal (ULN) as well as bilirubin elevations of more than 3 times the ULN occurred in patients in pivotal clinical trials with Alectinib.

Most of these events occurred during the first 3months of treatment. In the pivotal Alecensa clinical trials it was reported that three patients with Grade 3‒4 AST/ALT elevations had drug-induced liver injury.

Concurrent elevations in ALT or AST greater than or equal to three times the ULN and total bilirubin greater than or equal to two times the ULN, with normal alkaline phosphatase, occurred in 1 patient treated in Alectinib clinical trials.

Use in Special Populations

Pediatric use: The safety and efficacy of Alecensa in children and adolescents (<18 years) have not been studied.

Geriatric use: No dose adjustment of Alecensa is required in patients≥65 years of age.

Renal impairment: No dose adjustment is required in patients with mild or moderate renal impairment. alectinib has not been studied in patients with severe renal impairment, however,since Alecensa elimination via the kidney is negligible

Hepatic impairment: No dose adjustment is required in patients with underlying mild or moderate hepatic impairment. Patients with underlying severe hepatic impairment should receive a dose of 450 mg given orally twice daily (total daily dose of 900 mg)

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.