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Other brands with the same active ingredient
These brands contain the same active ingredient (Alectinib). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Alecinix is indicated for:
Pharmacology
Alectinib is a highly selective and potent ALK and RET tyrosine kinase inhibitor. In nonclinical studies, blocking ALK tyrosine kinase activity shut down the downstream signaling pathways, including STAT 3 and PI3K/AKT, and this caused tumor cell death (apoptosis). Alectinib was active in vitro and in vivo against mutant forms of the ALK enzyme, including mutations that cause resistance to crizotinib. The major metabolite of alectinib (M4) showed similar potency and activity in vitro.
Nonclinical data show that alectinib is not a substrate of p-glycoprotein (P-gp) or breast cancer resistance protein (BCRP). Both are efflux transporters in the blood brain barrier, so alectinib can distribute into the central nervous system and stay there. In nonclinical mouse xenograft models, alectinib caused tumor regression, including antitumor activity in the brain, and it prolonged survival in intracranial tumor animal models.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended dose of Alectinib is 600 mg, which is four 150 mg capsules, taken twice daily with food. That makes a total daily dose of 1200 mg. People with severe hepatic impairment (Child-Pugh C) should start at 450 mg twice daily with food, a total daily dose of 900 mg.
Duration of treatment
Alectinib should be continued until the disease progresses or the side effects become unacceptable.
Delayed or missed doses
If a planned dose of Alectinib is missed, the patient can make up that dose, unless the next dose is due within 6 hours. Two doses should not be taken at the same time to make up for a missed one. If vomiting happens after a dose of Alectinib, the patient should take the next dose at the usual scheduled time.
Dose adjustments
Managing adverse events may mean reducing the dose, interrupting treatment for a time, or stopping it altogether. The dose of Alectinib should be lowered in steps of 150 mg twice daily, depending on how well the patient tolerates it. If a patient can't tolerate the 300 mg twice daily dose, Alectinib treatment should be stopped permanently.
Method of administration
Alectinib is for oral use. The hard capsules must be swallowed whole, and they must not be opened or dissolved. They have to be taken with food.
Side Effects
The most common side effects seen with alectinib were constipation, edema (this includes peripheral, generalized, eyelid and periorbital edema), myalgia, nausea, increased bilirubin, anemia and rash. Myalgia was reported in 31% of people, and this figure includes myalgia and musculoskeletal pain. Increased bilirubin was seen in 21%, covering increased blood bilirubin, hyperbilirubinemia and increased bilirubin conjugated. Anemia occurred in 20%, which includes anemia and decreased hemoglobin. Rash also occurred in 20%, and this covers rash, rash maculopapular, dermatitis acneiform, erythema, rash generalized, rash papular, rash pruritic and rash macular.
Cautions & Contraindications
Warnings & Precautions
Interstitial lung disease (ILD)/pneumonitis: Cases of ILD/pneumonitis have been reported in clinical trials with Alectinib. Patients should be monitored for lung symptoms that point to pneumonitis. If ILD/pneumonitis is diagnosed, Alectinib should be interrupted immediately. It should be stopped permanently if no other possible cause of the ILD/pneumonitis has been found. Hepatotoxicity: In the pivotal Alectinib clinical trials, alanine amino transferase (ALT) and aspartate amino transferase (AST) rose to more than 5 times the upper limit of normal (ULN) in some patients, and bilirubin rose to more than 3 times the ULN. Most of these events happened during the first 3 months of treatment. Three patients with Grade 3 to 4 AST/ALT elevations were reported to have drug-induced liver injury. In 1 patient treated in the Alectinib clinical trials, ALT or AST rose to greater than or equal to three times the ULN together with total bilirubin greater than or equal to two times the ULN, while alkaline phosphatase stayed normal. Bradycardia: Alectinib can cause symptomatic bradycardia. Heart rate and blood pressure should be monitored as clinically indicated. If the bradycardia causes no symptoms, the dose does not need to change. If a patient has symptomatic bradycardia or life-threatening events, any other medicines known to cause bradycardia should be reviewed, and so should anti-hypertensive medicines. The Alectinib treatment should then be adjusted. Photosensitivity: Photosensitivity to sunlight has been reported with Alectinib. Patients should be advised to avoid prolonged sun exposure while taking Alectinib and for at least 7 days after stopping treatment. They should also be advised to use a broad-spectrum Ultraviolet A (UVA)/Ultraviolet B (UVB) sun screen and a lip balm (SPF >50) to help protect against possible sunburn. Women of child-bearing potential: Alectinib may cause foetal harm if it is given to a pregnant woman. Female patients of child-bearing potential who receive Alectinib must use highly effective contraceptive methods during treatment and for at least 3 months after the last dose. Lactose intolerance: This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption should not take it. Sodium content: This medicine contains 48 mg sodium per daily dose (1200 mg). That is equivalent to 2.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Contraindications
Alectinib must not be given to anyone who is known to be allergic to alectinib or to any of the other ingredients in the medicine.
Pregnancy & Breastfeeding
Pregnancy: There's little or no data on the use of Alectinib in pregnant women. Going by how the medicine works, Alectinib may harm the foetus when a pregnant woman takes it. Animal studies have shown reproductive toxicity. Female patients who become pregnant while taking Alectinib, or during the 3 months after the last dose, must contact their doctor and should be told about the possible harm to the foetus.
Breast-feeding: It isn't known whether Alectinib and its metabolites pass into human milk, so a risk to the newborn or infant can't be ruled out. Mothers should be advised not to breast-feed while they are receiving Alectinib.
Fertility: No fertility studies have been done in animals to look at the effect of Alectinib. General toxicology studies did not show any adverse effects on the male or female reproductive organs.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Hepatic impairment: Patients with underlying mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment need no change to the starting dose. Patients with underlying severe hepatic impairment (Child-Pugh C) should start on 450 mg taken twice daily (a total of 900 mg). In all patients with hepatic impairment, appropriate monitoring (for example markers of liver function) is advised.
Renal impairment: No dose adjustment is needed in patients with mild or moderate renal impairment. Alectinib has not been studied in severe renal impairment. But because very little Alectinib leaves the body through the kidney, no dose adjustment is needed in severe renal impairment either.
Elderly (>65 years): There are only limited data on the safety and efficacy of Alectinib in patients aged 65 years and older, and they do not suggest that the dose needs adjusting. No data are available for patients over 80 years of age.
Paediatric population: The safety and efficacy of Alectinib in children and adolescents below 18 years of age have not been established. No data are available.
Extreme body weight (>130 kg): PK simulations for Alectinib do not show low exposure in patients with extreme body weight (that is, >130 kg). Even so, Alectinib is widely distributed, and the clinical studies enrolled patients weighing between 36.9 and 123 kg. There are no data on patients with a body weight above 130 kg.
Overdose
A person who has taken too much Alectinib should be watched closely and given general supportive care. There is no specific antidote for an Alectinib overdose.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Alectinib below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Alecinix 150 mg
What is Alecinix 150 mg Capsule?
Alecinix 150 mg Capsule is a medicine that contains Alectinib. It is made by Beacon Pharmaceuticals PLC. It belongs to the Anti neoplastic preparations group of medicines.
What is Alecinix used for?
Alecinix is used for: Cancer.
What are the side effects of Alecinix?
The most common side effects seen with alectinib were constipation, edema (this includes peripheral, generalized, eyelid and periorbital edema), myalgia, nausea, increased bilirubin, anemia and rash. Myalgia was reported in 31% of people, and this figure includes myalgia and musculoskeletal pain.
Can I take Alecinix during pregnancy or while breastfeeding?
Pregnancy: There's little or no data on the use of Alectinib in pregnant women. Going by how the medicine works, Alectinib may harm the foetus when a pregnant woman takes it. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Alecinix?
A person who has taken too much Alectinib should be watched closely and given general supportive care. There is no specific antidote for an Alectinib overdose. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Alecinix?
Store Alectinib below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Alecinix?
Some medicines can interact with Alectinib, for example: Carbamazepine, Rifampicin, Itraconazole, Telithromycin, Saquinavir, Ritonavir. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Alecinix?
Alecinix is a prescription (Rx) medicine. Take it as your doctor advises.