Alecensa medicine 150mg Alectinib treatment of lung cancer

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Alecensa is a monotherapy indicated for the first treatment of adult patients with advanced non-small cell lung cancer (ANSCL) Anaplastic Lymphoma Kinase (ALK, self-transplanting kinase lymphocyte).

Alecensa is a monotherapy indicated for the treatment of adult patients with advanced NSCLC-positive ALK previously treated with crizotinib ( Xalkori, Crizonix ).

Alecensa medicine 150mg Alectinib treatment of end-stage metastatic lung cancer 

• Brand name: Alecensa 150mg
• Active ingredient: Alectinib
• Manufacturer: Roche
• Content: 150mg
• Form: Capsules
• Package: Box of 224 tablets inside contains 4 small boxes of 56 tablets

What is Alecensa? What treatment does Alectinib treat?

• Alecensa  (alectinib)  is a  drug treatment of cancer on target hinder the development and spread of cancer cells in the body.
• Alecensa is used to treat non-small cell lung cancer  caused by a gene that mutates when the cancer spreads to other parts of the body.
• Alecensa may also be used for purposes not listed in this medication guide.

Indications for treatment of Alecensa drug

Alecensa is the monotherapy indicated for the first treatment of adult patients with advanced non-small cell lung cancer (ANSCL) Anaplastic Lymphoma Kinase (ALK, Self-transplanting kinase lymphocyte).

Alecensa is monotherapy indicated to treat adult patients with advanced NSCLC positive ALK previously treated with crizotinib (Xalkori, Criznix).

Important information about Alecensa 150mg 

Alecensa can cause serious or life-threatening side effects.

Call your doctor right away if you have:  problems with patient heart  vertigo severe bradycardia; lung problems  – chest pain, cough, shortness of breath; kidney problems  – a change in urine color, little or no urine, swelling in the lower legs; or  liver problems –  headache, dark urine, loss of appetite, jaundice or eyes.

Before taking this medication

You should not use Alecensa if you are allergic to alectinib.

To make sure Alecensa is safe for you, tell your doctor if you:

• lung or breathing problems other than lung cancer;
• liver failure;
• kidney disease; or
• bradycardia or other heart rhythm disturbances.

Do not use Alecensa if you are pregnant. It can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 week after your last dose.

If you are a man, use effective contraception if your partner could be pregnant. An infant can be hurt if a man holds the child while he is taking Alecensa. Continue using birth control for at least 3 months after the end of treatment.

Tell your doctor right away if a pregnancy occurs while the mother or father is taking this medication.

It is not known whether alectinib can pass into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking Alecensa and for at least 1 week after your last dose.

How to use Alecensa medicine?

Before starting treatment with Alecensa, your doctor will perform a special test to make sure that alectinib is the best treatment for your type of lung cancer.

Follow all directions on your prescription medication label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Alecensa is usually taken twice daily. Alectinib works best if you take it with food.

Do not crush, chew, melt, or open an Alecensa capsule. Swallow it whole.

If you vomit right after taking the capsule, do not take another one. Wait until your next scheduled dose and take a regular dose at that time.

While using Alecensa, your heart rate and blood pressure will need to be checked often. You also need frequent blood tests to check your liver function. Your cancer treatment may be delayed based on the results of these tests.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Store at room temperature away from moisture, heat, and light.

Alecensa dosage information

Treatment with Alecensa should be conducted and supervised by a physician experienced in the use of anti-cancer products.

A certified ALK test is needed to select an ALK positive NSCLC patient. ALK-positive NSCLC status should be established prior to initiating treatment with Alecensa.

Usual adult dose for non-small cell lung cancer:

• The recommended dose of Alecensa is 600 mg (4 tablets 150 mg) taken twice daily with food (total daily dose is 1200 mg).

Duration of treatment

• Treatment with Alecensa should be continued until the disease progresses or intoxication is not accepted.

Slow or miss doses

• If the missed dose of Alecensa is missed, the patient can make up the dose unless the next dose is right within 6 hours. Patients should not take two doses at once to make up for a missed dose. If vomiting occurs after taking a dose of Alecensa, the patient should take the next dose at the right time.

Adjust the dose

Managing adverse events may require dose reduction, temporary interruption, or discontinuation of treatment with Alecensa. Alecensa dose should be reduced in steps of 150 mg twice daily based on tolerability. Treatment with Alecensa should be discontinued permanently if the patient is unable to tolerate a dose of 300 mg twice daily.

Instructions for modifying dosages are provided in Tables 1 and 2 below.

Table 1 Dose reduction chart

Reduce the dose	The dose level
Starting dose	600 mg twice daily
Reduce the first dose	450 mg twice daily
Reduce the second dose	300 mg twice daily

Table 2 Advice on dosage modification for adverse reactions indicated

CTCAE level	Treatment of Alecensa
Severe ILD / pneumonia	Immediately stop and permanently stop Alecensa if there is no other potential cause of pneumonia / pneumonia.
ALT or AST elevations ≥ 3 (> 5 times higher than ULN) with total bilirubin ≤ 2 times higher than ULN	Temporarily withhold until baseline recovery or ≤ Class 1 (≤ 3 times ULN), then further reduce dose (see Table 1).
ALT or AST of class ≥ 2 (> 3 times ULN) with total bilirubin elevation> 2 times ULN in the absence of cholestasis or hemolysis	Discontinue Alecensa permanently.
Grade 2 or 3 bradycardia (symptoms, can be serious and have medical implications, medical intervention indicates)	Temporarily withhold until recovery to ≤ Slow heart rate at level 1 (asymptomatic) or heart rate ≥ 60 beats / minute. Evaluate equivalent drug products that cause bradycardia, as well as anti-hypertensive products.If an equivalent drug product is identified and discontinued, or adjusted, restore the dose before recovering to a slow or non-bradycardia of ≥ 60 times / minute. If it is not possible to identify the same drug product or if donation of equivalent drug products does not stop or change the dose, continue to reduce the dose (see Table 1) when recovering to bradycardia or no heartbeat ≥ 60 bpm .
4 grade bradycardia (life-threatening consequences, urgent intervention indicated)	Discontinue permanently if the corresponding drug product cannot be identified.If an equivalent drug product is identified and discontinued, or adjusted, continue to reduce the dose (see Table 1) when recovering to bradycardia ≤ Grade 1 (asymptomatic) or heart rate ≥ 60 times / minute, regularly monitored clinically indicated. Stopped permanently in case of recurrence.
CPK elevation> 5 times ULN	Temporarily withhold until recovery of baseline or ≤ 2.5 times that of ULN, then continue at the same dose.
CPK elevation> 10 times ULN or second occurrence of CPK elevation> 5 times ULN	Temporarily withhold until recovery of baseline or ≤ 2.5 times that of ULN, then continue dose reduction according to Table 1.

ALT = aminotransferase alanin; AST = aspartate aminotransferase; CPK = creatine phosphokinase; CTCAE = NCI General terminology Criteria for Adverse impacts; ILD = interstitial lung disease; ULN = upper limit of normal

heart rate less than 60 beats per minute (bpm).

Special department

Liver failure

• Do not adjust the dose in patients with mild hepatic impairment. Alecensa has not been studied in patients with moderate to severe hepatic impairment. Therefore, Alecensa is not recommended in patients with moderate to severe hepatic impairment.

CKD

• No dose adjustment is necessary in patients with mild or moderate renal impairment. Alecensa has not been studied in patients with severe renal impairment. However, since renal elimination of alectinib is negligible, no dose adjustment is necessary in patients with severe renal impairment.

Elderly people (≥ 65 years)

• Limited data on the safety and efficacy of Alecensa in patients 65 years of age and older do not indicate need for dose adjustment in elderly patients. There are no data available on patients over 80 years of age.

Child population

• The safety and effectiveness of Alecensa in children and adolescents under 18 years of age have not been established. No data.

Extremely high body weight (> 130 kg)

• Although PK simulations for Alecensa do not show low exposure in patients with extremely fast body mass (> 130 kg), alectinib is widely distributed and clinical studies are available for treated patients. equal to alectinib within the body weight range of 36.9-123 kg. There are no data available on patients weighing more than 130 kg.

Treatments

• Alecensa used for oral administration. Hard capsules must be swallowed whole, and must not be opened or dissolved. Must be taken with food.

What should i avoid while taking alecensa?

Avoid exposure to sunlight or tanning beds during treatment and for at least 7 days after the last dose of Alecensa  . This medicine can make you sunburn more easily. Wear protective clothing and use sunscreen and lip balm (SPF 50 or higher) when you are outdoors.

Side effects of Alecensa

Get emergency medical help if you have  signs of an allergic reaction  : rash; shortness of breath; swelling of face, lips, tongue, or throat.

Call your doctor at once if you:

• very slow heart rate;
• a light feeling, like you can overcome;
• unexplained muscle pain, pain, or weakness;
• lung problems  – sudden or uncomfortable chest pain, wheezing, dry cough or cough with mucus, feeling short of breath;
• low red blood cells (anemia)  – pale skin, unusual tiredness, feeling light-headed or short-lived, cold hands and hands;
• kidney problems  – a change in urine color, little or no urine, swelling in your feet or ankles; or
• liver problems  – stomach pain (upper right), loss of appetite, easy bruising or bleeding, feeling tired, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatment may be delayed or stopped permanently if you have certain side effects.

Common side effects may include:

• anemia;
• constipation;
• swelling of the face, eyelids, hands, or lower legs;
• feeling tired; or
• myalgia.

What other drugs will affect Alecensa?

Other drugs may interact with alectinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicines you start or stop using.

How much does Alecensa 150mg Alectinib cost?

• How much does Alecensa 150mg Alectinib cost?
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Note: Information article about Alecensa 150mg Alectinib drug for the purpose of sharing knowledge for reference only, patients are not allowed to use the drug on their own, all information on drug use must be under the direction of a qualified physician.

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